H. Rept. 112-495 - 112th Congress (2011-2012)
May 25, 2012, As Reported by the Energy and Commerce Committee

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House Report 112-495 - FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

[House Report 112-495]
[From the U.S. Government Printing Office]


112th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     112-495

======================================================================



 
            FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

                                _______
                                

  May 25, 2012.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 5651]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5651) to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs and for medical devices, to establish user-
fee programs for generic drugs and biosimilars, and for other 
purposes, having considered the same, report favorably thereon 
without amendment and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     1
Background and Need for Legislation..............................     2
Hearings.........................................................     3
Committee Consideration..........................................     6
Committee Votes..................................................     6
Committee Oversight Findings.....................................     8
Statement of General Performance Goals and Objectives............     8
New Budget Authority, Entitlement Authority, and Tax Expenditures     8
Earmark..........................................................     8
Committee Cost Estimate..........................................     8
Congressional Budget Office Estimate.............................     8
Applicability to Legislative Branch..............................    17
Section-by-Section Analysis of the Legislation...................    17
Changes in Existing Law Made by the Bill, as Reported............    42

                          Purpose and Summary

    H.R. 5651, the ``Food and Drug Administration Reform Act of 
2012,'' was introduced on May 9, 2012, by Chairman Fred Upton 
(R-MI), Ranking Member Henry Waxman (D-CA), Subcommittee on 
Health Chairman Joseph R. Pitts (R-PA), Subcommittee on Health 
Ranking Member Frank Pallone, Jr. (D-NJ), Chairman Emeritus Joe 
Barton (R-TX), and Chairman Emeritus John D. Dingell (D-MI) and 
referred to the Committee on Energy and Commerce.
    The legislation would reauthorize the prescription drug 
user fee and medical device user fee, authorize a generic drug 
user fee and biosimilar user fee, reauthorize the Best 
Pharmaceuticals for Children Act and Pediatric Research Equity 
Act, institute reforms at the Food and Drug Administration 
(FDA) to improve the predictability, consistency, and 
transparency of its regulation of drugs and devices, and 
establish policies to address the drug shortage crisis.

                  Background and Need for Legislation

    The United States (U.S.) has led the global medical device 
and biopharmaceutical industries for decades. This leadership 
has made the U.S. the medical innovation capital of the world, 
bringing hundreds of thousands of high-paying jobs to our 
country and life-saving devices and drugs to our nation's 
patients. The Prescription Drug User Fee Act and Medical Device 
User Fee and Modernization Act, enacted in 1992 and 2002, 
respectively, were essential in giving FDA the resources it 
needed to expedite device and drug reviews and thus help foster 
medical innovation.
    Unfortunately, our nation's device and biopharmaceutical 
leadership is under threat. According to President Obama's Job 
Council, this threat comes, in part, from ``the uncertain FDA 
regulatory environment.''\1\ The Jobs Council acknowledges, of 
course, that ``[p]rotecting patients from harm is without 
question an essential element of what the public expects from 
the FDA'' and notes that enabling the timely development of new 
therapies and technologies is another important such element, 
concluding that ``[a]chieving both goals simultaneously is the 
critical challenge for the new drug and device approval 
process.''
---------------------------------------------------------------------------
    \1\The Council commented as follows: ``Today, however, our medical 
innovation ecosystem is in jeopardy. Investment in the life sciences 
area is declining at an alarming rate because of the escalating cost, 
time, and risk of developing new drugs and devices. While many factors 
have contributed to this decline . . . an important factor is the 
uncertain FDA regulatory environment.'' President's Council on Jobs and 
Competitiveness, Interim Report, Building Confidence: Five Common-Sense 
Initiatives to Boost Jobs and Competitiveness (29).
---------------------------------------------------------------------------
    The Committee believes that the significant policy reforms 
contained in H.R. 5651, along with the additional resources and 
accountability measures in the user fee agreements, will 
address the regulatory uncertainty at FDA so the U.S. remains 
the world leader in medical innovation, device and drug jobs 
remain in the U.S., and U.S patients continue to benefit from 
new devices and drugs, without compromising FDA's appropriately 
stringent standards that protect patients from unsafe or 
ineffective devices and drugs.
    H.R. 5651 also would authorize two new user fees. The new 
generic drug user fee would provide additional resources for 
the review and regulation of generic drugs. These resources 
would bring faster and more predictable review of generic drug 
applications and increased inspections of generic drug 
facilities, bringing parity to the frequency of inspections of 
foreign and domestic generic drug facilities. The new 
biosimilar user fee would provide additional resources to FDA 
for the review of biosimilar applications.
    H.R. 5651 also would take important steps to address the 
current drug shortage crisis affecting the U.S. Although the 
root causes of drug shortages are complex and multi-faceted, 
the result is clear: patients, physicians, nurses, and 
pharmacists across the country face daily challenges in 
obtaining the drugs they need.
    Finally, H.R. 5651 would modernize the Federal Food, Drug, 
and Cosmetic Act (FFDCA) to give FDA the tools necessary to 
deal with the increased globalization of the pharmaceutical 
supply chain.

                                Hearings


        IMPACT OF MEDICAL DEVICE REGULATION ON JOBS AND PATIENTS

    On February 17, 2011, the Subcommittee on Health held a 
hearing to examine the state of the medical device industry and 
the impact of regulations on job creation and patient access. 
The Subcommittee received testimony from Dr. Jeffrey E. Shuren, 
Director, Center for Devices and Radiological Health, FDA; 
ExploraMed Development, Limited Liability Company; the Foundry; 
Ralph Hall; Dr. Rita Redberg; and Dr. Steven E. Nissen.

     IMPORT SAFETY: STATUS OF FDA'S SCREENING EFFORTS AT THE BORDER

    On April 13, 2011, the Subcommittee on Oversight and 
Investigations held a hearing entitled ``Import Safety: Status 
of FDA's Screening Efforts at the Border.'' The purpose of this 
hearing was to examine the current state of FDA's import 
screening processes and the pace of FDA's nationwide rollout of 
the automated entry review system, known as PREDICT. The 
witness for this hearing was the Honorable Margaret A. Hamburg, 
M.D., Commissioner of FDA.

            PDUFA V: MEDICAL INNOVATION, JOBS, AND PATIENTS

    On July 7, 2011, the Subcommittee on Health held a hearing 
entitled ``PDUFA V: Medical Innovation, Jobs, and Patients.'' 
The purpose of the hearing was to examine issues expected to be 
discussed as part of the reauthorization of the Prescription 
Drug User Fee Act. The Subcommittee received testimony from 
Janet Woodcock, M.D., Director, Center for Drug Evaluation and 
Research, FDA; OncoMed Pharmaceuticals Incorporation on behalf 
of the Biotechnology Industry Organization; Warburg Pincus 
Limited Liability Company; National Health Council; Friends of 
Cancer Research; and the Pew Charitable Trusts.

 REGULATORY REFORM SERIES #5--FDA MEDICAL DEVICE REGULATION: IMPACT ON 
                 AMERICAN PATIENTS, INNOVATION AND JOBS

    On July 20, 2011, the Subcommittee on Oversight and 
Investigations held a hearing entitled ``Regulatory Reform 
Series #5--FDA Medical Device Regulation: Impact on American 
Patients, Innovation and Jobs.'' The purpose of the hearing was 
to examine the state of the medical device industry and the 
impact regulations and policies at the Center for Devices and 
Radiological Health have on patient access, innovation, and job 
creation. The Subcommittee received testimony from Dr. Jeffrey 
E. Shuren, Director, Center for Devices and Radiological 
Health, FDA; Fischell Biomedical; Transcend Medical Inc.; 
Progressive Policy Institute; New England Journal of Medicine; 
Marti Conger; Carol Murphy; and Pam Sagan.

                EXAMINING THE INCREASE IN DRUG SHORTAGES

    On September 23, 2011, the Subcommittee on Health held a 
hearing entitled ``Examining the Increase in Drug Shortages.'' 
The hearing examined the causes and effects of drug shortages 
in the U.S. health care system. The Subcommittee heard 
testimony from the Honorable Howard K. Koh, M.D., Assistant 
Secretary for Health, U.S. Department of Health and Human 
Services; Teva Health Systems; Healthcare Distribution 
Management Association; American Society of Health-System 
Pharmacists; Premier, Inc.; American Society of Clinical 
Oncology; Lancaster General Health; and the Cancer Institute of 
New Jersey.

 IMPACT OF MEDICAL DEVICE AND DRUG REGULATION ON INNOVATION, JOBS AND 
                     PATIENTS: A LOCAL PERSPECTIVE

    On September 26, 2011, the Subcommittee on Health held a 
field hearing entitled ``Impact of Medical Device and Drug 
Regulation on Innovation, Jobs and Patients: A Local 
Perspective.'' The Subcommittee investigated how Federal 
regulations are impacting the medical device community. The 
Subcommittee received testimony from the California Healthcare 
Institute; Conatus Pharmaceuticals, Inc.; National Venture 
Capital Association; West Wireless Health Institute; BIOCOM, 
CONNECT; and TherOx, Inc.

   REAUTHORIZATION OF PDUFA: WHAT IT MEANS FOR JOBS, INNOVATION AND 
                                PATIENTS

    On February 1, 2012, the Subcommittee on Health held a 
hearing entitled ``Reauthorization of PDUFA: What It Means for 
Jobs, Innovation, and Patients.'' The Subcommittee examined 
issues pertaining to the reauthorization of the Prescription 
Drug User Fee Act (PDUFA). This hearing also focused on the 
reauthorization of the Best Pharmaceuticals for Children Act 
(BPCA) and Pediatric Research Equity Act (PREA) and 
pharmaceutical supply chain issues. The Subcommittee received 
testimony from the Honorable Margaret A. Hamburg, M.D., 
Commissioner, FDA; Pfizer, Inc.; California Health Institute; 
Biotechnology Industry Organization; Pharmaceutical Research 
and Manufacturers of America; the Pew Charitable Trusts; 
National Organization for Rare Disorders; and American Academy 
of Pediatrics.

  REVIEW OF THE PROPOSED GENERIC DRUG AND BIOSIMILARS, USER FEES AND 
                 FURTHER EXAMINATION OF DRUG SHORTAGES

    On February 9, 2012, the Subcommittee on Health held a 
hearing entitled ``The Review of the Proposed Generic Drug and 
Biosimilars User Fees and Further Examination of Drug 
Shortages.'' The Subcommittee examined issues pertaining to the 
proposed generic and biosimilars user fees and drug shortages. 
The Subcommittee received testimony from Janet Woodcock, M.D., 
Director, Center for Drug Evaluation and Research, FDA; Mylan, 
Inc.; Generic Pharmaceutical Association; and St. Jude 
Children's Research Hospital.

   REAUTHORIZATION OF MDUFA: WHAT IT MEANS FOR JOBS, INNOVATION AND 
                                PATIENTS

    On February 15, 2012, the Subcommittee on Health held a 
hearing entitled ``Reauthorization of MDUFA: What It Means for 
Jobs, Innovation, and Patients.'' The Subcommittee examined 
issues pertaining to the reauthorization of medical device user 
fees. The Subcommittee received testimony from Dr. Jeffrey E. 
Shuren, Director, Center for Devices and Radiological Health, 
FDA; Terumo BCT; Philips Healthcare; Versant Ventures; 
Consumers Union; Ralph Hall; Art Sedrakyan, M.D., Ph.D.; Aaron 
S. Kesselheim, M.D., J.D., M.P.H.; and Jim Shull.

FDA USER FEES 2012: HEARING ON ISSUES RELATED TO ACCELERATED APPROVAL, 
   MEDICAL GAS, ANTIBIOTIC DEVELOPMENT AND DOWNSTREAM PHARMACEUTICAL 
                              SUPPLY CHAIN

    On March 8, 2012, the Subcommittee on Health held a hearing 
entitled ``FDA User Fees 2012: Hearing on Issues Related to 
Accelerated Approval, Medical Gas, Antibiotic Development and 
Downstream Pharmaceutical Supply Chain.'' The Subcommittee 
examined issues pertaining to the reauthorization of FDA user 
fees. The Subcommittee received testimony from Janet Woodcock, 
M.D., Director, Center for Drug Evaluation and Research, FDA; 
Alnylam Pharmaceuticals; Friends of Cancer Research; Cubist 
Pharmaceuticals; John H. Powers, MD; Compressed Gas 
Association; Generic Pharmaceutical Association; Healthcare 
Distribution Management Association; National Community 
Pharmacists Association; and the Pew Charitable Trusts.

                EXAMINING THE CURRENT STATE OF COSMETICS

    On March 27, 2012, the Subcommittee on Health held a 
hearing entitled ``Examining the Current State of Cosmetics.'' 
The Subcommittee evaluated the current state of the cosmetic 
industry. The Subcommittee received testimony from Michael M. 
Landa, J.D., Director, Center for Food Safety and Applied 
Nutrition, FDA; Personal Care Products Council; Jack Black 
Skincare; Peter Barton Hutt; Wholesale Supplies Plus; and 
California Department of Public Health.

       FDA USER FEES 2012: HOW INNOVATION HELPS PATIENTS AND JOBS

    On April 18, 2012, the Subcommittee on Health held a 
hearing entitled ``FDA User Fees 2012: How Innovation Helps 
Patients and Jobs.'' The Subcommittee examined the impact of 
FDA user fees on patients and jobs. The Subcommittee received 
testimony from Dr. Janet Woodcock, Director, Center for Drug 
Evaluation and Research, FDA; Dr. Jeffrey E. Shuren, Director, 
Center for Devices and Radiological Health, FDA; Pharmaceutical 
Research and Manufacturers of America; Biotechnology Industry 
Organization; Generic Pharmaceutical Association; Advanced 
Medical Technology Association; and Pew Charitable Trusts.

                        Committee Consideration

    The Subcommittee on Health held a legislative hearing on 
April 18, 2012, entitled, ``FDA User Fees 2012: How Innovation 
Helps Patients and Jobs.''
    On May 8, 2012, the Subcommittee met in open markup session 
to consider a Committee Print to reauthorize various FDA user 
fee programs. The Subcommittee adopted an amendment, which 
included technical changes recommended by the FDA. Thereafter, 
the Subcommittee forwarded the Committee Print to the full 
Committee for consideration.
    H.R. 5651, the ``Food and Drug Administration Reform Act of 
2012,'' was introduced on May 9, 2012, by Fred Upton (R-MI), 
Ranking Member Henry Waxman (D-CA), Subcommittee on Health 
Chairman Joseph R. Pitts (R-PA), Subcommittee on Health Ranking 
Member Frank Pallone, Jr. (D-NJ), Chairman Emeritus Joe Barton 
(R-TX), and Chairman Emeritus John D. Dingell (D-MI) and was 
referred to the Committee on Energy and Commerce.
    On May 10, 2012, the Committee on Energy and Commerce met 
in open markup session to consider H.R. 5651, as introduced. 
The full Committee ordered H.R. 5651 to be reported to the 
House, without amendment, by a recorded vote of 46 yeas and 0 
nays.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. A 
motion by Mr. Upton to order H.R. 5651 reported to the House, 
without amendment, was agreed to by a record vote of 46 yeas 
and 0 nays.
    The following reflects the recorded votes taken during the 
Committee's consideration of the bill:



                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held legislative and 
oversight hearings and made findings that are reflected in this 
report.

         Statement of General Performance Goals and Objectives

    In accordance with clause 3(c)(4) of rule XIII of the Rules 
of the House of Representatives, the performance goals and 
objectives of the Committee are reflected in the descriptive 
portions of this report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
5651, the ``Food and Drug Administration Reform Act of 2012,'' 
would result in no new or increased budget authority, 
entitlement authority, tax expenditures or revenues.

                                Earmark

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 5651, the ``Food and Drug Administration Reform 
Act of 2012,'' contains no earmarks, limited tax benefits, or 
limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                      Washington, DC, May 24, 2012.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman:, The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 5651, the Food and 
Drug Administration Reform Act of 2012.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                      Douglas W. Elmendorf,
                                                          Director.
    Enclosure.

H.R. 5651--Food and Drug Administration Reform Act of 2012

    Summary: H.R. 5651 would authorize the collection and 
spending of fees by the Food and Drug Administration (FDA) for 
certain activities to expedite the marketing approval of 
prescription drugs and medical devices and to regulate drugs 
after they enter the market. The bill would provide the FDA 
with additional regulatory authority to improve the safety of 
the drug supply chain and establish an early warning 
notification system to mitigate or prevent critical drug 
shortages. It also would create a new approval procedure for 
breakthrough drug therapies and offer financial incentives to 
drug sponsors to produce certain antimicrobial drugs. The 
legislation would require FDA to publish the scientific or 
regulatory rationale for significant decisions issued by the 
agency regarding a device and establish an expedited process to 
appeal such decisions. In addition, the bill would permanently 
reauthorize FDA's programs that evaluate the use of drugs by 
children.
    CBO expects that enacting the bill would affect the average 
price of prescription drugs available in the market. Some 
provisions in the bill would result in higher average prices 
for certain drugs; other provisions would accelerate the entry 
of generic versions of some drugs, which would lead to lower 
average prices. CBO estimates that the net effect of enacting 
H.R. 5651 would be to reduce the average price of prescription 
drugs slightly through 2017 and to increase prices in 
subsequent years.
    CBO estimates that enacting H.R. 5651 would:
     Reduce direct spending, on net, by $72 million 
over the 2013-2017 period but increase direct spending by $244 
million over the 2013-2022 period.
     Increase federal revenues by less than $500,000 
over the 2013-2017 period but lower revenues, on net, by about 
$3 million over the 2013-2022 period.
    Considering both the direct spending and revenue effects, 
we estimate that enacting H.R. 5651 would reduce budget 
deficits by approximately $72 million over the 2013-2017 period 
and increase them by $247 million over the 2013-2022 period. 
Pay-as-you-go procedures apply because enacting the legislation 
would affect direct spending and revenues.
    Pursuant to section 504 of H. Con. Res. 112, the Concurrent 
Resolution on the Budget--Fiscal Year 2013, CBO estimates H.R. 
5651 would increase direct spending by more than $5 billion in 
at least one of the four consecutive 10-year periods starting 
in 2023.
    Implementing H.R. 5651 would also have several effects on 
spending subject to appropriation. The bill would authorize 
increased funding for a variety of FDA activities, but CBO 
estimates that the majority of the gross increase in FDA 
spending would be offset by increased collections of fees that 
would be credited against discretionary spending. On balance, 
CBO estimates that net discretionary spending (primarily by 
FDA) would rise by $337 million over the 2013-2017 period, 
assuming appropriation actions consistent with the bill.
    H.R. 5651 contains both intergovernmental and private-
sector mandates as defined in the Unfunded Mandates Reform Act 
(UMRA). Extending the requirement to pay fees for medical 
devices and expanding the registration standards applied to 
drug manufacturers would be intergovernmental mandates as 
defined in UMRA for state, local, or tribal governments that 
manufacture medical devices for commercial purposes. However, 
CBO estimates that the costs of complying with those mandates 
would be minimal and well below the threshold established in 
UMRA for intergovernmental mandates ($73 million in 2012, 
adjusted annually for inflation).
    The legislation contains several mandates on the private 
sector as defined in UMRA. The most costly of those mandates 
would require that manufacturers of different types of drug and 
medical device products pay fees to the FDA. CBO estimates that 
the direct cost of all private-sector mandates in the bill 
would greatly exceed the annual threshold specified in UMRA 
($146 million in 2012, adjusted annually for inflation) in each 
of the first five years that the mandates would be effective.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 5651 is shown in the following table. 
The effects of this legislation fall primarily within budget 
functions 550 (health) and 570 (Medicare).

----------------------------------------------------------------------------------------------------------------
                                                            By fiscal year, in millions of dollars--
                                              ------------------------------------------------------------------
                                                  2013       2014       2015       2016       2017     2013-2017
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Collections from Fees:
    Prescription Drugs.......................       -720       -756       -800       -847       -945      -4,068
    Medical Devices..........................        -98       -115       -129       -133       -134        -609
    Generic Drugs............................       -299       -306       -315       -323       -332      -1,575
    Biosimilar Biological Products...........        -20        -21        -23        -28        -36        -128
    Priority Review Vouchers.................          0         -6         -6         -6         -6         -23
                                              ------------------------------------------------------------------
      Subtotal, Estimated Authorization Level     -1,137     -1,204     -1,273     -1,337     -1,453      -6,403
      Subtotal, Estimated Outlays............     -1,137     -1,204     -1,273     -1,337     -1,453      -6,403
Spending of Fees:
    Prescription Drugs.......................        720        756        800        847        945       4,068
    Medical Devices..........................         98        115        129        133        134         609
    Generic Drugs............................        299        306        315        323        332       1,575
    Biosimilar Biological Products...........         20         21         23         28         36         128
    Priority Review Vouchers.................          0          6          6          6          6          23
                                              ------------------------------------------------------------------
      Subtotal, Estimated Authorization Level      1,137      1,204      1,273      1,337      1,453       6,403
      Subtotal, Estimated Outlays............        721      1,043      1,329      1,446      1,481       6,021
Net Changes from Fees:
    Estimated Authorization Level............          0          0          0          0          0           0
    Estimated Outlays........................       -416       -160         57        109         28        -383
Other Proposed Changes:
    Provisions Affecting Prescription Drugs
     (Titles VIII and IX):
        Estimated Authorization Level........         59         68         77         77         77         359
        Estimated Outlays....................         31         58         72         75         76         313
    Provisions Affecting Pediatric
     Populations (Title V):
        Estimated Authorization Level........         46         61         62         63         71         303
        Estimated Outlays....................         24         52         59         62         69         266
    Provisions Affecting Medical Devices
     (Title VII):
        Estimated Authorization Level........         14         23         32         32         33         134
        Estimated Outlays....................         10         18         27         31         33         118
    Other Provisions and Effects:
        Estimated Authorization Level........          3          5          5          6          6          25
        Estimated Outlays....................          3          4          4          6          6          23
Total Changes in Discretionary Spending:
    Estimated Authorization Level............        122        157        176        178        187         821
    Estimated Outlays........................       -349        -28        219        283        212         337

                                           CHANGES IN DIRECT SPENDINGa

Estimated Budget Authority...................        -14        -12        -15        -16        -14         -72
Estimated Outlays............................        -14        -12        -15        -16        -14         -72

                                               CHANGE IN REVENUESa

Estimated Revenues...........................          0          *          *          *          *          *
----------------------------------------------------------------------------------------------------------------
aCBO estimates that enacting the bill would increase direct spending, on net, by $244 million over the 2013-2022
  period and decrease revenues by about $3 million over that period. There would be a small effect on spending
  for health benefits by the United States Postal Service, which is classified as off budget. CBO estimates
  those amounts would be between -$500,000 and $500,000 annually over the 2013-2022 period.
Note: * = less than $500,000; components may not sum to totals because of rounding.

    Basis of Estimate: For this estimate, CBO assumes that the 
legislation will be enacted by the end of fiscal year 2012 and 
that the Congress will take appropriation actions consistent 
with the bill for the funding of FDA activities and for 
triggering the collections of fees to offset the costs of some 
of those activities.
    H.R. 5651 would reauthorize FDA's branded prescription drug 
and medical device fee programs through 2017 and would 
establish new fee programs covering generic drugs and 
biosimilar biological products. (Biological drugs are products 
derived from living organisms; biosimilars are those products 
that meet certain statutory requirements and are determined by 
FDA to be highly similar to drugs for which licenses were 
originally granted to innovator drug companies.) The bill also 
would establish a new fee program that provides vouchers for 
priority drug reviews to sponsors of marketing applications for 
drugs that treat rare pediatric diseases.
    In addition, the legislation would authorize a number of 
other activities that are not supported by fees that would 
modify how the FDA regulates drugs and devices in a broad range 
of areas.

Spending Subject to Appropriation

    Assuming appropriation action consistent with the bill, CBO 
estimates that implementing H.R. 5651 would reduce net 
discretionary outlays, primarily for FDA, by $349 million in 
2013 and $28 million in 2014, mostly because the spending of 
fees lags somewhat behind their collection. CBO estimates that 
gross FDA spending in subsequent years would exceed the amounts 
collected from fees (because some of the spending under the 
bill would not be offset by fees) and that the net 
discretionary cost of implementing the bill would amount to 
$337 million over the 2013-2017 period.
    Fee Programs Administered by FDA. H.R. 5651 would authorize 
five different fee programs within FDA to cover specific costs 
relating to the approval and marketing of prescription drugs 
(branded, generic, and biosimilar biological products) and 
medical devices, and to cover costs of conducting priority drug 
reviews through an incentive program that awards redeemable 
vouchers for such reviews to sponsors of certain applications 
for drugs that treat rare pediatric diseases. In fiscal year 
2012, CBO estimates that FDA will collect $760 million in fees 
associated with the existing branded prescription drug and 
medical device fee programs that expire at the end of the year.
    Under the bill, CBO estimates that FDA would assess about 
$6.4 billion in aggregate fees over the 2013-2017 period. Of 
that amount, $1.7 billion in collections would be generated by 
the new fee programs for generic and biosimilar biological 
drugs and for priority review vouchers created under the 
legislation, and $4.7 billion in collections would be generated 
by the fee programs for branded prescription drugs and medical 
devices reauthorized by the bill. Except for the voucher 
program, the fee programs authorized under the bill would 
expire at the end of fiscal year 2017. The authority to award 
vouchers expires one year after the third voucher is awarded, 
but there is no limit on when the voucher can be redeemed.
    H.R. 5651 specifies that drug and medical device fees would 
be collected and made available for obligation only to the 
extent, and in the amounts, provided in advance in 
appropriation acts, with one exception. The bill would allow 
certain new fees authorized for generic and biosimilar 
biological drugs to be collected and spent during the first 
program year (fiscal year 2013) until the date of enactment of 
a law providing appropriations through September 30, 2013. By 
allowing the assessment and spending of fee collections outside 
of an appropriation action, H.R. 5651 could generate increases 
in revenue or direct spending attributable to such fees. 
However, for this estimate, CBO assumes that both enactment of 
H.R. 5651 and the necessary appropriation action will occur 
before the end of fiscal year 2012. As a result, we expect that 
any fees assessed and spent in fiscal year 2013 would be 
classified as offsetting collections (that is, as an offset to 
discretionary spending).
    CBO estimates that appropriation action consistent with the 
bill's authorizations for fee programs would reduce net 
discretionary outlays for FDA by $383 million over the 2013-
2017 period. Because FDA would have the authority to spend the 
collections, the estimated budget authority for collections and 
spending would offset each other exactly for each fiscal year, 
while the spending of fee collections would initially lag 
behind the collections and thus generate net discretionary 
savings over the 2013-2017 period.
    Costs for Activities Not Supported by Fees. H.R. 5651 would 
require that FDA modify certain agency procedures relating to 
the oversight of prescription drugs and devices; costs for many 
of the new activities would not be covered by fees. CBO 
estimates that activities not supported by fees under the bill 
would cost $720 million over the 2013-2017 period, assuming the 
appropriation of the necessary amounts.
    Provisions Affecting Prescription Drugs (Titles VIII and 
IX). H.R. 5651 would enhance FDA's regulatory authorities 
relating to prescription drugs in several key areas. It would 
expand advance notification requirements for potential drug 
shortages and strengthen FDA's authority to expedite drug 
reviews and inspections of facilities that address critical 
drug shortages. The bill would increase FDA's oversight 
authority of the drug supply chain both in the United States 
and overseas through new registration and inspection 
requirements. The bill also would allow FDA to destroy certain 
counterfeit or adulterated imports valued at less than $2,000. 
To advance the development of breakthrough drug therapies, H.R. 
5651 would create a new approval procedure for such products. 
CBO estimates that implementing such provisions and complying 
with other requirements contained in titles VIII and IX would 
increase FDA's costs by about $313 million over the 2013-2017 
period.
    Provisions Affecting Pediatric Populations (Title V). H.R. 
5651 would permanently authorize FDA's pediatric drug programs. 
The bill would make permanent:
           An incentive program that grants market 
        exclusivity to manufacturers that voluntarily conduct 
        specified studies on the use of drugs in certain 
        pediatric populations, the so-called pediatric 
        exclusivity program;\1\ and
---------------------------------------------------------------------------
    \1\During such periods of pediatric exclusivity, FDA will not 
permit another manufacturer to market a version of the drug.
---------------------------------------------------------------------------
           FDA's authority to require that drug 
        manufacturers conduct tests on drugs for pediatric 
        populations and make necessary labeling changes to 
        reflect the appropriate information.
    The legislation also would authorize the appropriation of 
$25 million per year to extend the research program at the 
National Institutes of Health for pediatric studies on drugs 
for each year from 2013 through 2017. The bill would also 
authorize the appropriation of $30 million annually over the 
2013-2017 period to extend FDA's grant and contracts program 
for orphan products.
    Assuming the appropriation of the necessary amounts, CBO 
estimates that implementing provisions that affect pediatric 
populations in title V of the bill would have a discretionary 
cost of $266 million the over 2013-2017 period.
    Provisions Affecting Medical Devices (Title VII). Title VII 
would modify regulatory procedures under which FDA evaluates 
and approves medical device applications and tracks the safety 
of such devices. Among those changes the bill would:
           Include devices in FDA's system for 
        identifying risks after a product is on the market;
           Require FDA to publish the scientific and 
        regulatory rationale for any significant decision 
        regarding a report or application;
           Establish a process for manufacturers that 
        are seeking to submit or that have submitted a report 
        or application to review with FDA the agency's 
        documentation of significant decisions;
           Require FDA to regularly publish detailed 
        decision summaries for each clearance of certain 
        devices; and
           Extend and enhance the incentive program for 
        device manufacturers to develop medical devices 
        specifically designed for pediatric patients.
    CBO estimates that the provisions affecting the regulation 
of medical devices under title VII would increase FDA's costs 
by about $118 million over the 2013-2017 period, assuming the 
appropriation of the necessary amounts.
    Other Provisions and Effects. CBO estimates that 
implementing title VI and preparing certain regulatory science 
reports not covered by fees would cost $31 million over the 
2013-2017 period, assuming the appropriation of the necessary 
amounts.
    Several provisions in the bill would affect when lower-
priced drugs enter the market. Changing the timing of 
availability of lower-priced drugs affects spending in federal 
health programs that pay for prescription drugs and biological 
products. We expect that enacting the bill would reduce the 
average price of drugs in the market slightly over the 2013-
2017 period. CBO estimates that spending for federal health 
programs subject to appropriation--such as those operated by 
the Departments of Veterans Affairs and Defense--would fall by 
$8 million over that period, assuming that appropriation 
actions reflect the estimated reductions in costs.

Direct Spending

    CBO estimates that enacting H.R. 5651 would reduce direct 
spending for federal health programs by $72 million over the 
2013-2017 period but would increase direct spending by $244 
million over the 2013-2022 period. That net impact reflects an 
increase in direct spending owing to provisions that would 
delay market entry of certain drugs (causing some federal 
health programs to have higher spending than under current law) 
and a decrease in direct spending owing to other provisions 
that would lower average prices paid for some drugs (allowing 
federal health programs to reduce their costs). CBO estimates 
that direct spending, on net, would begin to increase starting 
in 2018, when the effects of provisions that would delay the 
entry of lower-priced drugs exceeds the effects of provisions 
that would lead to earlier entry of lower-priced drugs.
    Provisions that are expected to delay entry of lower-priced 
generic or biosimilar biological drugs are those that provide 
market exclusivity--periods during which FDA will not permit 
another manufacturer to market a version of the drug. Those 
provisions are aimed at encouraging the development of certain 
types of anti-microbial medications, innovative single 
enantiomer drugs, and pediatric indications and formulations 
for drugs.\2\
---------------------------------------------------------------------------
    \2\Enantiomers are a class of molecules that are arranged as mirror 
images to one another. Such molecules can be found together in a 
mixture that forms the basis of many drugs.
---------------------------------------------------------------------------
    Section 862 would change the rules governing when a generic 
drug manufacturer forfeits its rights to market exclusivity 
because of failure to receive tentative approval from FDA. The 
legislation would increase the allowable time period to obtain 
such approval--now set at 30 months after filing an 
application--before forfeiture occurs. Thus, the bill would 
allow affected firms to retain sole marketing rights. In cases 
where fewer generic firms compete on products because a 
forfeiture is avoided, we anticipate that higher average prices 
would be charged in the market. Because CBO expects that the 
implementation of the fee program for the review of generic 
drugs will accelerate review times and lead to fewer 
forfeitures, holding all else equal, the estimated costs for 
section 862 reflect the incremental effect of this provision 
beyond the effect of the fee program.
    Taken together, CBO estimates that provisions delaying the 
entry of generic or biosimilar biological drugs would increase 
the average prices of certain drugs and thereby increase direct 
spending for mandatory health programs such as Medicare, 
Medicaid, subsidies for enrollees in health insurance 
exchanges, and the Federal Employees Health Benefits and 
TRICARE-for-Life programs, by $412 million over the 2013-2022 
period.
    CBO expects that other provisions of H.R. 5651 would reduce 
the average price charged for drugs in the market. We estimate 
that the provision with the greatest effect on market entry by 
lower-priced generic drugs is section 863. It would reduce by 
30 days the statutory timeframe for final agency action 
relating to certain citizen petitions that ask for a stay of 
FDA approval on a pending generic drug application. (Under the 
bill, the limitation on the determination period would be 150 
days.)
    When both approval of the generic application and marketing 
of the drug hinge on the final determination date, earlier 
administrative action under the bill could lead to earlier 
generic entry. (Sometimes patents or market exclusivities delay 
entry of generics regardless of the date on which a citizen 
petition is resolved.) Thus, in certain cases, CBO expects that 
reducing the statutory timeframe by 30 days could lead to 
earlier marketing of lower-priced drugs.
    CBO estimates that implementing section 863 and other 
provisions that shorten administrative timeframes for review of 
certain petitions would reduce direct spending for mandatory 
health programs by $168 million over the 2013-2022 period. CBO 
anticipates that the implementation of the fee program in title 
III would allow FDA to use its resources in such a manner that 
we can reasonably expect that the average review times for 
certain petitions would also fall over time because of that 
program. Thus, estimated savings generated by provisions that 
would shorten administrative timeframes in the bill reflect the 
incremental effect of such provisions beyond the effect of the 
fee program.

Revenues

    H.R. 5651 would affect revenues in two ways. First, CBO 
expects that enacting H.R. 5651 would result in slightly higher 
costs for private health insurance plans over the 2013-2022 
period. In turn, raising the costs of health insurance plans 
would increase federal subsidies for health insurance purchased 
through an exchange. The portion of those tax credits that 
exceed taxpayers' liabilities are classified as outlays (and 
those effects are included in the direct spending estimate 
above), while the portions that reduce taxpayers' liabilities 
are recorded as changes in revenues. CBO estimates that H.R. 
5651 would lower federal revenues by $3 million over the 2013-
2022 period.
    In addition, the bill would make certain violations of new 
requirements subject to criminal and civil money penalties. 
Collections of such penalties are classified as federal 
revenues. Criminal fines are deposited in the Crime Victims 
Fund, and later spent; however, CBO estimates that any net 
effects would not be significant in each year because of the 
small number of cases likely to be affected.
    Pay-as-you-go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting on-budget direct spending 
or revenues. The net changes in outlays and revenues that are 
subject to those pay-as-you-go procedures are shown in the 
following table.

          CBO ESTIMATE OF PAY-AS-YOU-GO EFFECTS FOR H.R. 5651 AS ORDERED REPORTED BY THE HOUSE COMMITTEE ON ENERGY AND COMMERCE ON MAY 10, 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 By fiscal year, in millions of dollars--
                                                 -------------------------------------------------------------------------------------------------------
                                                   2012   2013    2014    2015    2016    2017    2018   2019   2020   2021   2022  2012-2017  2012-2022
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  NET INCREASE OR DECREASE (-) IN THE ON-BUDGET DEFICIT

Statutory Pay-As-You-Go Impact..................      0     -14     -12     -15     -16     -15      7     73     61     66    112       -73       247
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Components may not sum to totals because of rounding.

    Estimated impact on state, local, and tribal governments: 
By continuing FDA's fee program, the bill would extend a 
requirement to pay fees on state, local, or tribal governments 
that manufacture medical devices for commercial purposes. That 
requirement would be an intergovernmental mandate as defined in 
UMRA, but CBO is unaware of any case in which a state, local, 
or tribal entity manufactures such devices for commercial 
purposes. CBO is aware of public institutions of higher 
education that manufacture drugs and are subject to FDA's 
registration and inspection standards. Thus, the provisions in 
the bill that increase the stringency of those standards would 
impose an intergovernmental mandate. Because few public 
institutions of higher education would be required to comply 
with the new standards, CBO estimates that the costs of 
complying with the mandates in H.R. 5651 would be minimal and 
well below the threshold established in UMRA ($73 million in 
2012, adjusted annually for inflation).
    Because the bill's requirements would result in lower costs 
for prescription drugs provided under the Medicaid program, CBO 
estimates that state spending for Medicaid would decrease by 
about $6 million over the 2013-2017 period.
    Estimated impact on the private sector: The legislation 
contains several mandates on the private sector as defined in 
UMRA. The most costly of those mandates would require that 
manufacturers of branded prescription drugs, generic drugs, 
biosimilar biological products, and medical devices pay fees to 
FDA. CBO estimates that the direct cost of all private-sector 
mandates in the bill would greatly exceed the annual threshold 
specified in UMRA ($146 million in 2012, adjusted annually for 
inflation) in each of the first five years that the mandates 
would be effective.
    In addition to imposing an increase in fees, H.R. 5651 also 
would impose a number of other mandates on the private sector. 
For example, several provisions in the bill would grant periods 
of market exclusivity for certain types of drugs. Those 
provisions impose a mandate by preventing manufacturers of 
generic or biosimilar versions of the drug from entering the 
market during that period. The bill also would expand 
requirements relating to the approval of pediatric drugs and 
would expand registration requirements on certain entities 
involved in the manufacture, preparation, propagation, 
compounding, or processing of drugs. Title VIII also would 
authorize the Secretary of Health and Human Services to destroy 
certain drugs intended for import that are refused admission to 
the United States. Title IX would require that manufacturers of 
certain drugs notify the FDA before discontinuing production of 
those drugs.
    Previous CBO estimate: On May 11, 2012, CBO transmitted a 
cost estimate for S. 2516, the Food and Drug Administration 
Safety and Innovation Act, as reported by the Senate Committee 
on Health, Education, Labor, and Pensions on May 7, 2012. Both 
the House and Senate bills would make significant changes to 
the regulatory authority of the Food and Drug Administration 
relating to prescription drugs and devices. Although the bills 
contain many similar provisions, H.R. 5651 would address 
certain regulatory issues in different ways. CBO's cost 
estimates reflect those differences.
    Estimate prepared by: Federal Costs: Julia Christensen, 
Lisa Ramirez-Branum, Daniel Hoople, Jamease Miles, Kalyani 
Parthasarathy, Ellen Werble, and Rebecca Yip; Impact on State, 
Local, and Tribal Governments: Lisa Ramirez-Branum; Impact on 
the Private Sector: Jimmy Jin.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2012

    The first title would authorize the Prescription Drug User 
Fee Amendments of 2012 (PDUFA).

Section 101--Short title; findings

    In this section, Congress would find that the prescription 
drug user fee funds must go toward, as set forth in the goals 
identified in the letters from the Secretary of Health and 
Human Services to the Chairman of the House Committee on Energy 
and Commerce and Chairman of the Senate Committee on Health, 
Education, Labor, and Pensions, expediting the drug development 
process and review of human drug applications, including 
postmarket safety activities. These goals would include meeting 
time goals regarding the review of priority and standard drug 
applications, fostering greater interaction between drug 
sponsors and FDA, and increasing engagement with patients, 
including those with rare diseases.

Section 102--Definitions

    This section would amend a statutory definition associated 
with the user fee.

Section 103--Authority to assess and use drug fees

    This section would establish the user fee amounts for 
fiscal years 2013 through 2017 and adjustments to, and 
methodologies for calculating, those fees. FDA would collect 
these funds through application, establishment, and product 
fees. The section also would require FDA to contract with an 
independent firm to analyze the adequacy of those adjustments 
and methodologies. Finally, based on such analysis, FDA could 
adopt changes to the methodologies.

Section 104--Reauthorization; reporting requirements

    This section would require FDA to report, not later than 
120 days after the end of each fiscal year, on its success in 
achieving the goals set forth in the letter from the Secretary 
of Health and Human Services to the Chairman of the House 
Committee on Energy and Commerce and Chairman of the Senate 
Committee on Health, Education, Labor, and Pensions. This 
report would include the status of the independent assessment 
of the Program for New Molecular Entities. This report also 
would include the progress of the review divisions of FDA's 
Center for Drug Evaluation and Research and Center for 
Biologics Evaluation and Research on the following topics: (1) 
number of original standard new drug applications and biologics 
license applications filed per fiscal year; (2) number of 
original priority new drug applications and biologics license 
applications filed per fiscal year; (3) number of standard 
efficacy supplements filed per fiscal year; (4) number of 
priority efficacy supplements filed per fiscal year; (5) number 
of applications filed for review under accelerated approval per 
fiscal year; (6) number of applications filed for review as 
fast track products per fiscal year; and (7) number of 
applications filed for orphan-designated products per fiscal 
year. The section also would require FDA to submit a fiscal 
report on the use of the fees collected under the authority 
granted under Title I.
    The section would authorize FDA to develop and present 
recommendations to Congress on the reauthorization of the user 
fee program by January 15, 2017.

Section 105--Sunset dates

    The section would establish sunset dates for the user fee 
and related programs and provide technical clarifications for 
previous user fee legislation.

Section 106--Effective date

    The title would take effect on October 1, 2012, or the date 
of enactment, whichever is later.

Section 107--Savings clause

    This section would limit the effect of Title I on those 
applications and supplements filed before enactment of the 
title and clarify that the prescription drug user fee 
provisions in effect prior to October 1, 2012 would apply to 
such submissions.

            TITLE II--MEDICAL DEVICE USER AMENDMENTS OF 2012

    The second title would authorize the Medical Device User 
Fee Amendments of 2012.

Section 201--Short title; finding

    In this section, Congress would find that the medical 
device user fee funds must go toward, as set forth in the goals 
identified in the letters from the Secretary of Health and 
Human Services to the Chairman of the House Committee on Energy 
and Commerce and Chairman of the Senate Committee on Health, 
Education, Labor, and Pensions, expediting the process for the 
review of device applications and assuring the safety and 
effectiveness of devices.

Section 202--Definitions

    This section would amend certain definitions in Section 737 
of the FFDCA.

Section 203--Authority to assess and use device fees

    This section would reauthorize the user fee program and set 
forth changes in the fees beginning in 2013. Under this 
section, FDA would collect the following amounts under the 
medical device user fee program: $97,722,301 for fiscal year 
2013; $112,580,497 for fiscal year 2014; $125,767,107 for 
fiscal year 2015; $129,339,949 for fiscal year 2016; and 
$130,184,348 for fiscal year 2017. FDA would collect these 
funds through fees associated with submissions and 
establishment registration.

Section 204--Reauthorization; reporting requirements

    This section would require FDA to report, not later than 
120 days after the end of each fiscal year, on its success in 
achieving the goals set forth in the letter from the Secretary 
of Health and Human Services to the Chairman of the House 
Committee on Energy and Commerce and Chairman of the Senate 
Committee on Health, Education, Labor, and Pensions. The 
section also would require FDA to submit a fiscal report on the 
use of the fees collected under the authority granted under 
Title II.
    The user fee agreement would include the following 
improvements: (1) FDA would have to report its total time for 
reviewing devices; (2) FDA's review process would include 
greater interaction between sponsors and the Agency; and (3) an 
independent entity would assess the device approval and 
clearance processes, and FDA would have to implement a 
corrective action plan to address deficiencies. In addition to 
the annual report referenced above, FDA would have to post 
certain information on its success in achieving the goals on a 
quarterly basis, including the status of the independent 
assessment.
    Part of the user fee agreement includes the development of 
a transitional In Vitro Diagnostics (IVD) approach. The 
Committee applauds FDA for its commitment, as expressed in the 
MDUFA III Commitment Letter, to work with industry to develop a 
transitional IVD approach for the regulation of emerging 
diagnostic tests. The Committee is highly interested in 
developments with respect to the Agency's plans to develop a 
transitional IVD approach and looks forward to reviewing steps 
taken related to its implementation.
    The section would authorize FDA to develop and present 
recommendations to Congress on the reauthorization of the user 
fee program by January 15, 2017.

Section 205--Savings Clause

    This section would limit the effect of Title II on those 
applications and supplements filed before enactment of the 
Title, and clarify that the medical device user fee provisions 
in effect prior to October 1, 2012 would apply to such 
submissions.

Section 206--Effective date

    Under this section, Title II would take effect on October 
1, 2012, or the date of enactment, whichever is later.

Section 207--Sunset Clause

    This section would set the expiration dates of the medical 
device user fee as October 1, 2017, and the expiration of the 
reporting requirement as January 31, 2018.

Section 208--Streamlined hiring authority to support activities related 
        to the process for the review of device applications

    This section would authorize FDA to streamline the hiring 
process to expedite the hiring of personnel necessary to 
achieve the performance goals.

               TITLE III--FEES RELATING TO GENERIC DRUGS

    This title would authorize the Generic Drug User Fee 
Amendments of 2012 (GDUFA).

Section 301--Short title; findings

    In this section, Congress would find that the generic drug 
user fee funds must go toward, as set forth in the goals 
identified in the letters from the Secretary of Health and 
Human Services to the Chairman of the House Committee on Energy 
and Commerce and Chairman of the Senate Committee on Health, 
Education, Labor, and Pensions, human generic drug activities, 
which include the review of abbreviated new drug applications 
and facility inspections.

Section 302--Authority to assess and use human generic drug fees

    This section would codify definitions key to implementing 
this new user fee, including the types of activities that FDA 
could fund with these fees. With respect to user fees, the 
section would authorize the following: one-time backlog fee; 
drug master file fee; abbreviated new drug application and 
prior approval supplement filing fee; and generic drug and 
active pharmaceutical facility fee. These fees would generate 
approximately $299,000,000 per year for fiscal years 2013 to 
2017. For fiscal year 2013, $50,000,000 would come from the 
one-time backlog fee for applications pending with FDA on 
October 1, 2012, and the rest would come from the remaining 
user fees as follows: 6 percent from drug master file fees; 24 
percent from abbreviated new drug and prior approval supplement 
filing fees; 56 percent from generic facility fees; and 14 
percent from active pharmaceutical ingredient filing fees. In 
the fiscal years 2014 to 2017, there would be no backlog fee; 
the approximately $299,000,000 would come in each year from the 
remaining user fees in the percentages outlined in the previous 
sentence.

Section 303--Reauthorization; reporting requirements

    This section would require FDA to report, not later than 
120 days after the end of each fiscal year, on its success in 
achieving the goals set forth in the letter from the Secretary 
of Health and Human Services to the Chairman of the House 
Committee on Energy and Commerce and Chairman of the Senate 
Committee on Health, Education, Labor, and Pensions. The 
section also would require FDA to submit a fiscal report on the 
use of the fees collected under the authority granted under 
Title III. Finally, the section would authorize FDA to develop 
and present recommendations to Congress on the reauthorization 
of the user fee by January 15, 2017.

Section 304--Sunset dates

    This section would set the expiration dates of the generic 
drug user fee program as October 1, 2017, and the expiration of 
the reporting requirement, described in section 303, as January 
31, 2018.

Section 305--Effective date

    Under this section, Title III would take effect on October 
1, 2012, or the date of enactment, whichever is later.

Section 306--Amendment with respect to misbranding

    This section would subject a manufacturer to a misbranding 
violation of the FFDCA for, if required, not paying a facility 
fee under section 744B(a)(4) or failing to provide a facility 
identification required under section 744B(f).

Section 307--Streamlined hiring authority to support activities related 
        to the process for the review of generic drug applications

    This section would authorize FDA to streamline its hiring 
process so it could hire the personnel necessary to achieve the 
performance goals.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

    Title IV contains language that would authorize the 
Biosimilars User Fee Amendments of 2012 (BSUFA).

Section 401--Short title; findings

    In this section, Congress would find that the user fee 
funds must go toward, as set forth in the goals identified in 
the letters from the Secretary of Health and Human Services to 
the Chairman of the House Committee on Energy and Commerce and 
Chairman of the Senate Committee on Health, Education, Labor, 
and Pensions, expediting the process for the review of 
biosimilar biological product applications, including 
postmarket safety activities.

Section 402--Fees relating to biosimilar biological products

    This section would codify definitions key to implementing 
these new user fees, including the types of activities that FDA 
could fund with these fees. This section also would authorize 
the following four types of user fees: application, product, 
establishment, and biosimilar product development. The first 
three would be set equal to the PDUFA rate for each type of 
fee. The product development fee would be set at 10 percent of 
the PDUFA application fee.

Section 403--Reauthorization; reporting requirements

    This section would require FDA to report, not later than 
120 days after the end of each fiscal year, on its success in 
achieving the goals set forth in the letter from the Secretary 
of Health and Human Services to the Chairman of the House 
Committee on Energy and Commerce and Chairman of the Senate 
Committee on Health, Education, Labor, and Pensions. The 
section also would require FDA to submit a fiscal report on the 
use of the fees collected under the authority granted under 
Title IV. Under the section, a third party assessment will 
study the workload volume and full costs associated with 
biosimilar product applications. Finally, the section would 
authorize FDA to develop and present recommendations to 
Congress on the reauthorization of the user fee program by 
January 15, 2017.

Section 404--Sunset dates

    This section would set the expiration date of the 
biosimilar user fee program as October 1, 2017, and the 
expiration of the reporting requirement, described in section 
403, as January 31, 2018.

Section 405--Effective date

    Under this section, Title IV would take effect on October 
1, 2012, or the date of enactment, whichever is later.

Section 406--Savings clause

    This section would limit the effect of Title IV on those 
applications and supplements filed before enactment of the 
title and clarify that the prescription drug user fee 
provisions in effect prior to October 1, 2012 would apply to 
such submissions.

Section 407--Conforming amendment

    This section would conform section 735 of FFDCA to reflect 
the new biosimilars user fee.

  TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT (BPCA) AND PEDIATRIC 
                       RESEARCH EQUITY ACT (PREA)

    The Best Pharmaceuticals for Children Act (BPCA) and the 
Pediatric Research Equity Act (PREA) foster the development of 
prescription drugs for children and safe use of drugs by 
children.
    BPCA was established in 1997. It provides FDA with the 
authority to add six months to existing marketing exclusivity 
periods and listed patents for a drug or biologic in return for 
FDA-requested submission of pediatric studies.
    PREA requires a manufacturer of a drug or biologic who 
submits an application to market a new active ingredient, new 
indication, new dosage form, new dosing regimen, or new route 
of administration to also submit a pediatric assessment for 
that product.
    BPCA has been very successful in spurring research in the 
pediatric population for rare conditions and encouraging 
companies to undertake research where there was no incentive to 
do so. The Committee commends the evaluation of promising 
pediatric cancer therapies for children with cancer through the 
pediatric preclinical testing program established in 2002 under 
BPCA. The Committee encourages the Department of Health and 
Human Services to continue to report to Congress on patient 
access to new therapeutic agents for pediatric cancer.

Section 501--Permanent extension of Best Pharmaceuticals for Children 
        Act and Pediatric Research Equity Act

    This section would reauthorize BPCA and PREA. It also would 
clarify that exclusivity under BPCA can only be granted based 
on a written request issued by FDA and that studies conducted 
under PREA could be included in a written request. It also 
would ensure safety-related labeling changes made for branded 
drugs as a result of BPCA are included on generic labels in all 
appropriate sections.
    With respect to PREA, it would create a deferral extension 
pathway and require FDA to publicly report each deferral and 
deferral extension issued under PREA, including the name of the 
product sponsor and the date the drug was initially approved. 
The section also would remove a requirement that declined 
Written Requests be referred to the National Institutes of 
Health (NIH) Foundation, instead allowing these studies to be 
immediately referred to the National Institute for Child Health 
and Human Development. In addition, the section would allow FDA 
to issue a non-compliance letter to a product sponsor who fails 
to meet its post-marketing requirements under PREA and would 
require the product sponsor to respond to FDA's allegations in 
writing. These letters would be made public. Finally, regarding 
PREA, the section would require product sponsors to submit an 
``Initial Pediatric Plan'' as part of the drug application 
process and outlines the process for submission. The plan would 
be submitted no later than 60 days after the end of phase 2 
clinical trials or such other time negotiated between FDA and 
the sponsor and would include an outline of proposed pediatric 
studies and any request for a waiver or deferral of PREA 
requirements.
    In addition to that described above, the section would 
require FDA to conduct a public meeting regarding the impact of 
BPCA and PREA on the development of new therapies for children 
with cancer.
    Finally, this section would reauthorize the NIH fund, which 
is used to study ``off-patent'' drugs, at $25,000,000 for each 
fiscal year 2013 to 2017. This is the appropriated level in 
fiscal year 2012.

Section 502--Food and Drug Administration Report

    The section would require FDA to submit a report to the 
Chairman of the House Committee on Energy and the Commerce and 
Chairman of the Senate Committee on Health, Education, Labor, 
and Pensions within 4 years of enactment and every 5 years 
thereafter. The report would have to include the following 
information: the number of waivers, deferrals, and non-
compliance letters issued under PREA; an assessment of the 
effectiveness of pediatric study plans under PREA; the number 
of Written Requests issued, accepted, and declined under BPCA; 
an assessment of the effectiveness of studying drugs for rare 
diseases under BPCA; an assessment of the effectiveness of 
studying pediatric oncology drugs under BPCA and PREA; an 
assessment of the effectiveness of studying drugs in neonates 
under BPCA and PREA; an assessment of the effectiveness of 
studying biologics in pediatric populations under BPCA and 
PREA; and any suggestions for modification to BPCA and PREA 
that would improve pediatric drug research. Prior to submitting 
this report, FDA would have to consult with stakeholders.
    Section 503--Internal Committee for Review of Pediatric 
Plans, Assessments, Deferrals, Deferral Extensions, and Waivers
    The section would clarify the authority of FDA's Pediatric 
Review Committee (PeRC) to review deferral extensions under 
PREA. The section also would require the PeRC to include a 
neonatologist.

Section 504--Staff of Office of Pediatric Therapeutics

    The section would require FDA's Office of Pediatric 
Therapeutics to have a neonatologist and pediatric 
epidemiologist on staff.

Section 505--Continuation of operation of Pediatric Advisory Committee

    The section would reauthorize FDA's Pediatric Advisory 
Committee.

Section 506--Pediatric Subcommittee of the Oncologic Drugs Advisory 
        Committee

    The section would reauthorize the Pediatric Subcommittee of 
FDA's Oncologic Drugs Advisory Committee (ODAC).

                  TITLE VI--FDA ADMINISTRATIVE REFORMS

    Title VI includes sections that would apply to the issuance 
of FDA guidance documents, conflicts of interest, electronic 
submission of applications, and regulation of laboratory 
developed tests.

Section 601--Public Participation in issuance of FDA guidance documents

    The section would improve FDA's guidance document process 
by encouraging public participation in development of the draft 
guidance documents FDA utilizes to explain the agency's 
positions. The Committee believes that some draft guidance 
documents, in part due to lack of public participation in the 
development process, have created uncertainty and significant 
implementation issues. One example is the draft guidance 
entitled ''Guidance for Industry and FDA Staff--510(k) Device 
Modifications: Deciding When to Submit a 510(k) for a Change to 
an Existing Device'' issued on July 27, 2011.
    The section would require that, for certain guidance 
documents, FDA would have to provide at least 30 days notice of 
its intent to issue the guidance document. During that 30-day 
period, FDA could meet with interested stakeholders. If FDA 
were to decide that such pre-issuance notice and involvement is 
impracticable, unnecessary, or contrary to the public interest, 
FDA would have to provide a reason why pre-issuance public 
notice and involvement is impracticable, unnecessary, or 
contrary to the public interest and publish the reason in the 
Federal Register.
    Upon the issuance of a draft guidance document under the 
section, FDA would have to finalize the document within 18 
months of the close of the comment period or the document would 
be null and void. Such time period could be extended by 180 
days if FDA publishes a notification of such an extension in 
the Federal Register.
    Every 5 years after the issuance of a final guidance under 
this section, the section would require FDA to analyze the 
guidance document and if warranted by its analysis, modify, 
streamline, expand or repeal the document.
    With respect to devices, the process set forth above would 
apply to notice to industry guidance letters and notice to 
industry advisory letters that meet the definition of a 
guidance document.

Section 602--Conflicts of interest

    The Food and Drug Administration Amendments Act of 2007 
(FDAAA, Public Law 110-85), included a provision designed to 
limit conflicts of interest and restrict those eligible to 
serve on FDA advisory committees. The Committee believes this 
provision has discouraged the use of the most qualified experts 
from serving on FDA advisory committees, thus preventing the 
advisory committees from providing the best guidance to FDA on 
important scientific issues. According to the testimony of Marc 
Boutin of the National Health Council before the Health 
Subcommittee in July, 2011, at the time of the testimony, FDA 
had a vacancy rate of 23 percent for its advisory committees, 
and this was attributable in part to the conflicts of interest 
policy.\2\
---------------------------------------------------------------------------
    \2\Marc Boutin, Testimony before the Committee on Energy and 
Commerce, Subcommittee on Oversight and Investigations, Hearing: 
``Regulatory Reform Series #5--FDA Medical Device Regulation: Impact on 
American Patients, Innovation and Jobs'' (July 20, 2011), available at: 
http://energycommerce.house.gov/hearings/
hearingdetail.aspx?NewsID=8806.
---------------------------------------------------------------------------
    This section is intended to improve FDA's conflict of 
interest rules so the Agency's advisory committees have better 
access to the most knowledgeable experts. The section would 
strike the current statutory provisions governing recruitment 
and limits on waivers. In their place, the section would 
require FDA to actively recruit to fill the advisory committees 
so FDA has access to the most current expert advice. It also 
would require FDA to provide transparency regarding the type, 
nature, and magnitude of relevant financial interests of 
advisory committee members. Finally, the section would require 
FDA to provide an annual report on the implementation of the 
section and to update as necessary the guidance on disclosure 
of advisory committee conflicts of interest.

Section 603--Electronic submission of applications

    This section would require electronic submission of drug, 
generic drug, biologic, and biosimilar applications following 
issuance of a final guidance by FDA. This section also would 
require an electronic copy for device pre-submissions and 
submissions following issuance of a final guidance by FDA

Section 604--Notification of FDA intent to regulate laboratory-
        developed tests

    The section would prohibit FDA from issuing both draft and 
final guidance on the regulation of laboratory developed tests 
unless it notifies the House Energy and Commerce Committee and 
the Senate Committee on Health, Education, Labor, and Pensions 
of its intent to take such action at least 60 days prior to the 
issuance of such guidance.

              TITLE VII--MEDICAL DEVICE REGULATORY REFORMS

    Title VII includes significant reforms to premarket and 
postmarket device regulation.

                  Subtitle A--Premarket Predictability

    The Committee believes the sections in Subtitle A would add 
predictability, consistency, and transparency to the medical 
device premarket review process.

Sections 701--Investigational Device Exemption

    The goal of section 701 is to address concerns that FDA may 
be disapproving pivotal investigations of new technologies 
solely because the output of the investigation will not yield a 
classification or approval status that could result in the 
marketing of a device. On the other hand, the Committee also 
heard reports from FDA that FDA had, in the past, permitted 
studies to go forward that FDA believed would not support 
approval, and when sponsors completed those trials, FDA was 
unable to approve the device. Nonetheless, as reflected in 
Section 701, the Committee believes manufacturers should be 
free to assume the risk that their studies may not support 
approval of a marketing application if the studies will provide 
useful information, so long as the study is conducted ethically 
and with reasonable risk to patients.
    Because the investigation of a device may involve many 
steps to optimize its design, its intended use, and ultimately, 
its safety and effectiveness, the Committee sees little merit 
in limiting device investigations only to those that would 
likely support a marketing decision. A clinical investigation 
that would not demonstrate a reasonable assurance of safety and 
effectiveness to justify an approval, and yet provide valuable 
information to optimize the design and development of the 
device, should be approved and undertaken to develop that data 
and information. Under the section, FDA's approval of an IDE 
would signify that regulatory requirements have been met, and 
would not reflect FDA's judgment of the adequacy of the study 
design or the likelihood that the study will support a 
marketing application.
    Accordingly, the sections would amend section 520(g) to 
prohibit FDA from disapproving an investigational device 
application because it may not support or meet the requirements 
of a substantial equivalence determination or a premarket 
approval if the investigational device application otherwise 
meets the requirements in section 520(g). Additionally, FDA 
would be barred from disapproving an investigational device 
application solely because additional or different 
investigations may be necessary to support a marketing 
application.

Section 702--Clarification of the Least Burdensome Standard

    This section would reaffirm the least burdensome provisions 
added during the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) and codify in statute the least burdensome 
concept as expressed in FDA's 2002 Guidance Document, ``The 
Least Burdensome Provisions of the FDA Modernization Act of 
1997: Concept and Principles; Final Guidance for FDA and 
Industry.'' Specifically, section 702 would define the word 
``necessary'' for purposes of ensuring that the information 
requested in the premarket notification and premarket approval 
contexts is only that information required to make a regulatory 
determination and does not include information that is merely 
of interest. This provision was prompted by reports that 
despite FDA's own guidance stating that information requests 
should be limited to those relevant to making a regulatory 
decision, FDA's premarket notification and premarket approval 
reviews were becoming longer and more burdensome because some 
reviewers requested information that was unnecessary for 
regulatory decisions.
    The section would define ``necessary'' in the premarket 
notification context to mean ``the minimum required information 
that would support a determination of substantial equivalence 
between a new device and a predicate device.'' For example, in 
the premarket notification context, the Committee intends that 
FDA limit its requests for additional information to only that 
information that FDA needs to determine whether or not one 
device is substantially equivalent to a predicate device.

Section 703--Agency Documentation and Review of Significant Decisions

    Section 703 would address concerns expressed by some in 
industry that significant premarket regulatory decisions are 
not adequately documented with a scientific or regulatory 
rationale. In some instances, FDA consideration of 
administrative appeals to supervisors sometimes takes longer 
than many original decisions. To address these concerns and 
problems, the section would require that the Agency completely 
document certain significant premarket decisions, including 
significant differences of opinion that occur during device 
reviews. Also, this section would clarify the process under 21 
CFR 10.75 to persons who challenge significant premarket review 
decisions, that occur in the context of 510(k) submissions, and 
premarket approval and investigational device applications, and 
provide specific timelines for the reviews for those appeals.

Section 704--Transparency in the Clearance Process

    Consistent with the direction in section 703 to require 
documentation of Agency decision-making, section 704 would 
require ``detailed decision summaries'' of certain 510(k) 
determinations. Only by creating transparency in decision-
making can we ensure the review process functions as intended.

Section 705--Device Modifications Requiring Premarket Notification 
        Prior to Marketing

    Section 705 addresses when premarket notifications are 
required for legally marketed devices that have been modified. 
The Committee is very interested in this important 
determination. On July 27, 2011, FDA issued a draft guidance 
entitled ``Guidance for Industry and FDA Staff-510(k) Device 
Modifications: Deciding When to Submit a 510(k) for a Change to 
an Existing Device,'' that, when finalized, would replace the 
1997 guidance on 510(k) device modification entitled ``Deciding 
When to Submit a 510(k) for a Change to an Existing Device.'' 
The FDA issued the 2011 draft guidance because some 
stakeholders advocated the need to provide greater clarity and 
certainty to the 510(k) modification process. However, the 
Committee heard reports from stakeholders and some companies 
that the 1997 guidance document was satisfactory in addressing 
the many very difficult device assessment issues associated 
with modifications, and the new draft guidance created too much 
uncertainty in the device industry.
    Accordingly, the section would require that FDA submit a 
report to the House Committee on Energy and Commerce and the 
Senate Committee on Health, Education, Labor, and Pension 
within 18 months. This report would include: (1) FDA's 
interpretation of key terms in FDA's regulations as specified 
in the section (see 21 CFR Sec. 807.81(a)(3)); (2) analysis on 
how to leverage design controls that are a part of FDA's 
Quality System Regulation (see 21 CFR Sec. 820.30), to reduce 
premarket submission burdens for changes that do not merit 
FDA's review resources; and (3) methods to ensure continued 
improvement of legally marketed devices. The section would 
require FDA to withdraw its July 27, 2011 draft device 
modification guidance and instead rely upon the January 10, 
1997 guidance on device modification. Finally, this section 
would prohibit a draft version of such guidance until the 
report is submitted to the Committee, and further would 
prohibit a final version of such a guidance or regulation until 
one year after the Committee's receipt of the report.

                    Subtitle B--Patients Come First

    This Subtitle would bring predictability, consistency, and 
transparency to device post-market activities of FDA.

Section 711--Establishment of Schedule and Promulgation of Regulation

    The section would reaffirm the mandate of the Safe Medical 
Devices Act of 1990 (and recommendation of GAO) that FDA 
require premarket approval applications for pre-amendment Class 
III devices or reclassify them into Class I or Class II.\3\
---------------------------------------------------------------------------
    \3\Public Law 101-629; Government Accountability Office, MEDICAL 
DEVICES: FDA Should Take Steps to Ensure That High-Risk Device Types 
Are Approved through the Most Stringent Premarket Review Process (GAO-
09-190) (January 2009), available at: http://www.gao.gov/new.items/
d09190.pdf.
---------------------------------------------------------------------------

Section 712--Program to Improve the Device Recall System

    The Committee believes that FDA must learn from recall 
experience to minimize harms related to devices. Accordingly, 
the section would require FDA to establish a program to assess 
recalls and identify strategies to mitigate health risks. In 
support of this goal, the section would require: clarification 
of recall audit procedures to improve recall effectiveness 
checks; development of criteria to assess the effectiveness of 
corrections or action plans associated with recalls; and 
documentation of recall terminations. The program would 
identify, at a minimum, recall trends, the devices most subject 
to recalls, and the underlying causes of recalls.

               Subtitle C--Novel Device Regulatory Relief


Section 721--Modification of de novo application process

    This section would streamline the de novo classification 
process, which is used for novel, innovative devices of low to 
moderate risk. A device sponsor would no longer be required to 
submit a premarket notification and obtain a ``not 
substantially equivalent'' determination when it is clear that 
no predicate device exists for purposes of a substantial 
equivalence determination. Under these circumstances, the first 
submission could be a de novo request for classification. If 
FDA believes a predicate device exists, or that the device is 
not of low to moderate risk, or that special controls to 
mitigate the risks cannot be developed for the device (i.e., 
that the device requires a PMA), the Agency could decline to 
review the submission under its de novo authority. Also, to 
facilitate the de novo process, submitters seeking a class II 
de novo classification would be required to provide a ``special 
controls'' proposal for FDA's consideration. By doing so, the 
Committee believes that the submitter could help identify the 
merits of a class II recommendation and assist prompt decisions 
by the FDA.

     Subtitle D--Keeping American Competitive Through Harmonization


Section 731--Harmonization of device premarket review, inspection, and 
        labeling symbols; report

    The section clarifies that FDA could enter into agreements, 
when appropriate, with foreign countries on harmonizing 
regulatory requirements for activities, including inspections 
and common international labeling symbols of medical devices.

Section 732--Participation in International Fora

    The section clarifies that FDA could, to the extent 
appropriate, provide transparency regarding FDA's involvement 
in international activities.

 Subtitle E--FDA Renewing Efficiency From Outsider Reviewer Management


Section 741--Reauthorization of third party review

    Consistent with ensuring timely and thorough reviews of 
certain premarket notification submissions, section 741 would 
reauthorize third party review of 510(k) submissions until 
October 1, 2017. Persons accredited by FDA could carry some of 
the review burden associated with determining whether a device 
is substantially equivalent to a predicate device.

Section 742--Reauthorization of third party inspection

    This section would reauthorize the third inspection program 
until 2017.

                 Subtitle F--Humanitarian Device Reform


Section 751--Expanded access to humanitarian use devices

    This section would extend the exemption from the 
prohibition against profit-making for pediatric devices that 
have been granted Humanitarian Device Exemptions to include 
certain devices intended for use in adults, and would establish 
that distribution of these devices under the profit exception 
is limited to the ``annual distribution number.'' The 
Humanitarian Device Exemption would continue to be used to 
provide access to medical devices with conditions that affect 
4,000 individuals or fewer. The ``annual distribution number'' 
in the section would mean the number of such devices needed to 
treat, diagnose, or cure a population of 4,000 individuals in 
the United States. Under this section, the Secretary would 
determine the number of such devices necessary to treat each 
such individual when the Secretary grants such exemption, or, 
for existing devices for which an exemption was already 
approved, at the time of the ``determination.''

               Subtitle H--Records and Reports on Devices


Section 761--Unique Device identification system regulations

    In 2007, under FDAAA, FDA was required to develop a 
regulation that would allow for a unique identifier on each 
medical device. FDA has not yet promulgated the regulation. The 
section would require FDA to issue the regulations not later 
than 120 days after enactment.

Section 762--Effective device sentinel system

    This section would extend FDA's ``Sentinel'' postmarket 
risk identification and evaluation system to include medical 
devices and allow a broad use of data from a wide variety of 
sources in establishing the ``Sentinel'' system. The section 
would require FDA to engage stakeholders when developing the 
system for devices.

                       Subtitle I--Miscellaneous


Section 771--Custom Devices

    This section would clarify FDA's policy on custom devices 
for the unique needs of individuals and would require FDA to 
issue a final guidance on replication of custom devices within 
two years. As a condition of being exempt from sections 514 and 
515 of the FFDCA, the manufacturer of a custom device must 
notify the Secretary of such device in a manner prescribed by 
the Secretary.

Section 772--Pediatric device reauthorization

    This section would reauthorize, at the current 
authorization level, demonstration grants for non-profit 
consortia to promote pediatric device development.

Section 773--Report on regulation of health information technology

    Under this section the Secretary of Health and Human 
Services, in consultation with the FDA Commissioner, the 
National Coordinator of Health Information Technology, and the 
Chairman of the Federal Communication Commission, would be 
charged with developing a report containing (1) recommendations 
on an appropriate regulatory framework for health information 
technology that is risk based and (2) a strategy to avoid 
regulatory duplication.

                  TITLE VIII--DRUG REGULATORY REFORMS

    The bill includes numerous provisions to modernize FDA's 
drug authority to reflect the globalization of the 
pharmaceutical industry and to improve the drug review 
process.\4\
---------------------------------------------------------------------------
    \4\Although not specifically part of this bill, over-the-counter 
(OTC) medicines play an increasingly vital role in America's health 
care system, and applications to switch drugs from prescription to OTC 
status are the primary source for expanding self-care into additional 
health categories. The Committee encourages FDA to improve the 
prescription-to-OTC switch process by, for example, addressing 
communication issues during sponsor preparation for advisory committee 
meetings, and by working with stakeholders to finalize draft guidance 
on self-selection studies for nonprescription drug products, since 
these studies are a critical part of prescription-to-nonprescription 
switch applications.
---------------------------------------------------------------------------

                     Subtitle A--Drug Supply Chain


Section 801--Registration of producers of drugs

    This section would effectuate a change to the timing of 
drug establishment registration so that FDA has accurate and 
up-to-date information on domestic and foreign drug 
manufacturing facilities. Additionally, it would render 
misbranded drugs made in foreign facilities that are not duly 
registered, treating them the same as domestically made drugs.

Section 802--Inspection of Drugs

    This section would authorize FDA to inspect domestic and 
foreign drug facilities on a risk-based schedule based on 
multiple risk factors, such as compliance history of the 
establishment; the inspection frequency and history of the 
establishment, including whether the facility has been 
inspected within the last four years; recalls associated with 
such facility; and the inherent risk of the drug associated 
with the establishment. FDA also could consider other factors 
deemed appropriate for establishing the risk-based schedule. 
The section also would require FDA to issue an annual report on 
inspections and make the report available to the public.
    The Committee believes that this section would focus FDA 
resources on high-risk facilities that present the greatest 
risk to consumers and away from unnecessary or duplicative 
inspections of facilities with exceptional compliance 
histories. The Committee also believes a risk-based schedule 
would help to ensure inspection parity of domestic and foreign 
drug facilities.

Section 803--Drug supply quality and safety

    This section would incorporate quality risk management 
oversight and controls into FDA's good manufacturing practices 
(GMP) authority.

Section 804--Prohibition against delaying, denying, limiting or 
        refusing inspection

    This section would render misbranded drugs from an 
establishment that is deemed to have delayed, limited, or 
denied an FDA inspection, thereby authorizing FDA to bar entry 
of such drugs. This would allow FDA to deny such products entry 
to domestic commerce. The section also would require FDA to 
issue guidance that defines the circumstances that would 
constitute delaying, denying, or limiting inspection, or 
refusing to permit entry or inspection.

Section 805--Destruction of adulterated, misbranded, or counterfeit 
        drugs offered for import

    This section would allow FDA to destroy counterfeit or 
adulterated imported drug products of minor monetary value or 
that have a reasonable probability of causing serious adverse 
health consequences or death. It is aimed at giving FDA a tool 
to address the large volume of small packages of misbranded, 
adulterated, or unapproved drugs coming through the country's 
international mail facilities. The section also would require 
FDA to issue regulations providing for notice and opportunity 
for a hearing on the destruction of such drugs either before or 
after destruction and establish an administrative process for 
restitution to ensure due process.

Section 806--Administrative detention

    This section would allow FDA to detain, for a reasonable 
period, drugs found during inspection that the inspecting 
officer has reason to believe are adulterated or misbranded and 
require FDA to issue implementing regulations with respect to 
this authority.

Section 807--Enhanced criminal penalty for counterfeit drugs

    This section would provide for up to 20 years of 
imprisonment for any person who knowingly holds, sells, or 
dispenses a counterfeit drug, and up to life imprisonment if 
the use of the counterfeit drug is the proximate cause of the 
consumer's death.

Section 808--Unique facility identification number

    This section would require drug facilities and commercial 
importers of drugs to have a unique facility identification 
number that will be submitted to FDA at registration and at 
import. It requires FDA to issue guidance specifying the unique 
facility identifier system to be used and to take into account 
the utilization of existing unique identifiers and 
compatibility with customs automated systems to aid facilities 
in achieving compliance with this section. The provision also 
would authorize refusal of admission for imports if the 
appropriate UFIs are not provided.

Section 809--Documentation for admissibility of imports

    This section would allow FDA to require certain 
documentation and information from importers so FDA can 
implement a risk-based approach to import screening. This 
section also would require FDA to issue regulations specifying 
the documentation or other information necessary to achieve 
compliance with this section, including the authority to exempt 
drugs such as those imported for research purposes only from 
the requirements on this section.

Section 810--Registration of commercial imports

    This section would require commercial drug importers to 
register with FDA and mandate that FDA issue regulations 
clarifying the registration requirement included in this 
section and establishing good importer practices that specify 
measures importers shall take to ensure imported drugs are in 
compliance. Good importer practice regulations also could 
provide for expedited clearance for importers who volunteer to 
participate in partnership programs for highly compliant 
companies.

Section 811--Notification

    This section would require a manufacturer, commercial 
importer, wholesale distributor, or other distributor (other 
than someone distributing drugs exclusively for retail sale) to 
notify the FDA if it knows the use of the drug could lead to 
serious injury or death, or if the drug is subject to 
significant loss or stolen, or if it is counterfeited. Further, 
such notification would be made in such manner and by such 
means as FDA may specify by regulation or guidance.

Section 812--Exchange of information

    This section would allow the FDA to ensure protection of 
information received under this authority. This section also 
would allow, upon satisfaction of several procedural 
protections, the FDA to share certain information that is 
otherwise exempt from disclosure with trusted foreign countries 
to better leverage resources. The section also would require 
FDA to ensure protection of information exchanged under this 
authority.

Section 813--Extraterritorial jurisdiction

    This section would provide for explicit extraterritorial 
federal jurisdiction over a violation of the FFDCA to aid U.S. 
authorities in holding accountable those violating the Act, 
regardless of where the violative acts occur.

Section 814--Protection against international adulteration

    This section would increase penalties for intentional 
adulteration of drugs that could cause serious adverse health 
consequences or death.

Section 815--Records for inspection

    This section would allow the FDA to require documents in 
lieu of or in advance of a physical inspection.

                     Subtitle B--Medical Gas Safety

    Medical gases are a class of drug products that have been 
used for over 100 years to treat medical conditions. Sections 
821, 822, and 823 would streamline and modernize the regulation 
of medical gases.

Section 821--Regulation of medical gases

    The section would define the current core medical gases and 
provide FDA the authority to add additional medical gases as it 
deems appropriate. The term ``Designated Medical Gas'' would 
include: Oxygen; Nitrogen; Nitrous Oxide; Carbon Dioxide; 
Helium; Carbon Monoxide; and Medical Air. The Committee intends 
the section to allow the Secretary to add new medical gases 
that have a history of safe and effective use, but prohibit FDA 
from adding a medical gas to the Designated Medical Gas list if 
that gas is subject to exclusivity under a New Drug 
Application. Prior to adding a new Designated Medical Gas, FDA 
would have to assess whether any investigational new drug 
applications for medical gases intended for humans or animals 
were pending.
    The section would establish a process for the filing of a 
certification for a Designated Medical Gas. The FDA approval of 
a certification for a Designated Medical Gas would have the 
effect of deeming the Designated Medical Gas as approved under 
Section 505 or 512 of the FFDCA. The certification would 
provide approval for the certified Designated Medical Gas and 
any combination of certified Designated Medical Gases, as 
medically appropriate. The Committee intends the certification 
process to include common mixtures of the core gases. The 
Designated Medical Gas would be approved for specific uses 
listed in the statute. The section further provides that FDA 
would have the authority to add additional uses to the list of 
approved uses so long as the uses are not subject to 
exclusivity under a New Drug Application.
    The section also would do the following: (1) authorize FDA 
to promulgate warning statements for medical gases and set 
forth specific labeling requirements for medical gases because 
medical gas labels do not contain specific uses as is the case 
for other drug labels; (2) clarify the effect of certification 
on certain exclusivity rights traditionally granted for newly 
approved drugs; (3) guarantee FDA authority to withdraw or 
suspend a drug approval as provided under the FFDCA; (4) 
clarify the FFDCA prescription requirements as they are applied 
to Designated Medical Gases; and (5) ensure that Designated 
Medical Gases and combinations of Designated Medical Gases 
deemed to be approved under this Act would not be subject to 
FDA fees as the result of becoming approved through 
certification.

Section 822--Changes to regulations

    This section would require FDA to, within 18 months, obtain 
input from medical gas manufacturers regarding the 
applicability of current federal drug regulations to medical 
gases, determine whether any changes are necessary to existing 
federal drug regulations, and submit a report to Congress 
regarding changes in the current federal drug regulations that 
the Secretary determines are necessary for medical gases.
    FDA would be required to issue final regulations addressing 
those items identified in the report to Congress with 48 
months. The Committee expects this process to address 
longstanding regulatory issues faced by the medical gas 
industry based on the unique characteristics of medical gases.

Section 823--Rules of construction

    This section would preserve the NDA process for medical 
gases. The Committee believes this section would maintain the 
incentive to innovate and develop new uses for a new medical 
gas added to the list of Designated Medical Gases.

            Subtitle C--Generating Antibiotic Incentives Now

    The goal of this Subtitle is to foster the development of 
antibacterial and antifungal drugs that treat pathogens that 
cause serious and life-threatening infections. The Committee 
expects that antibacterial and antifungal drugs that are 
directed against the qualified pathogens listed generally would 
qualify for FDA's fast track and priority review process to 
speed drug approval because the Committee presumes that most of 
the new drugs generally would be intended to treat serious or 
life-threatening infections for which there is an unmet medical 
need. In five years, the Secretary would have to review the 
antibacterial and antifungal drugs that have been designated 
under this Subtitle to determine if the incentives listed are 
adequate to generate needed antibacterial and antifungal drugs. 
Additionally, at that time, the Secretary would review the list 
of qualifying pathogens to determine if changes are needed to 
address current unmet public health concerns.

Section 831--Extension of exclusivity period for drugs

    This section would extend the exclusivity period for drugs 
that are determined to be a qualified infectious disease 
product for five additional years. Any extension would be in 
addition to pediatric exclusivity. Limitations to the 
exclusivity extension are outlined. The Secretary would 
designate a qualified infectious disease product based on it 
being an antibacterial or antifungal drug for humans to treat 
or prevent an infection caused by a qualifying pathogen--a 
resistant gram-positive pathogen, multidrug resistant gram-
negative bacteria, multi-drug resistant tuberculosis, or any 
other infectious pathogen identified by the Secretary.

Section 832--Study on incentives for qualified infectious disease 
        biological products

    This section would direct the Government Accountability 
Office (GAO) to conduct a study to determine the need for 
incentives to encourage research, development, and marketing 
for qualified infectious disease biological products.

Section 833--Clinical trials

    This section would require the Secretary to review the 
guidance for clinical trials with respect to antibacterial and 
antifungal drugs, revise the guidance to reflect scientific and 
medical advancements, and clarify the procedures and 
requirements for approval. This provision will address 
appropriate animal models of infection, in vitro techniques, 
and clinical study design for antimicrobial agents.

Section 834--Reassessment of qualified infectious disease product 
        incentives in 5 years

    This section would require the Secretary, in conjunction 
with the FDA and CDC, to provide a reassessment report on 
qualified infectious disease product incentives in five years. 
Based on the information presented, recommendations would be 
made regarding changes in the list of pathogens, additional 
program or incentive enhancements, and ways to encourage 
stewardship programs.

Section 835--Guidance on pathogen-focused antibacterial drug 
        development

    This section would instruct the Secretary to provide draft 
guidance on pathogen-focused antibacterial drug development by 
December 31, 2013, and final guidance by December 31, 2014.

                    Subtitle D--Accelerated Approval


Section 841--Expedited approval of drugs for serious or life-
        threatening diseases or conditions

    The section would provide findings and a Sense of Congress 
that the accelerated approval and fast track provisions of 
Section 506 of the FFDCA should be enhanced and FDA should 
apply the provisions to help expedite the development and 
availability of treatments for serious or life-threatening 
diseases or conditions while maintaining existing safety and 
efficacy standards for such treatments.
    The section also would require FDA to facilitate the 
development and expedite review of a drug intended to treat a 
serious or life-threatening disease or condition and 
demonstrating potential to address unmet medical needs through, 
among other processes, conducting a rolling review of a 
submission for a fast track product. A sponsor of such a drug, 
known as a ``fast track product'' in the section, would have 
the ability to request a designation as a fast track product 
after the submission of an application for investigation, and 
FDA would have 60 days to review such request.
    Under the section, FDA could approve an application for a 
product upon making a determination that, taking into account 
the severity or rarity of the disease or condition and the 
availability of alternative treatments, it has an effect on a 
surrogate endpoint that is reasonably likely to predict 
clinical benefit or a clinical endpoint that can be measured 
earlier than irreversible morbidity or mortality, that is 
reasonably likely to predict an effect on irreversible 
morbidity or mortality, or other clinical benefit. This 
provision is intended to clarify the existing standards for 
accelerated approval.
    The section also would grant FDA the authority to use 
expedited procedures as prescribed by regulation to withdraw 
approval of a product approved under section 506 under certain 
conditions.
    Finally, FDA would have to disseminate information to 
patients, doctors, and industry regarding the section and 
establish a program to foster the development of surrogate and 
clinical endpoints.
    The Committee believes this section is especially important 
to those patients with rare diseases. Rare diseases affect more 
than 25 million Americans, yet only 5 percent of these diseases 
have FDA-approved treatments. The Committee recommends that FDA 
make use of the Agency's accelerated approval process across 
all applicable review divisions to the greatest extent possible 
without compromising existing standards to ensure products are 
safe and effective, so that safe and effective treatments 
designed to treat serious or life-threatening rare diseases can 
be brought to the marketplace in the most expeditious manner.

Section 842--Guidance; amended regulations

    The section would require FDA to issue draft guidance to 
implement section 841 within one year of enactment. Within 1 
year of issuance of the draft guidance, FDA must issue final 
guidance implementing section 841 and amend the accelerated 
approval regulations in parts 341 and 601 of title 21 of the 
Code of Federal Regulations as necessary to conform such 
regulations with the amendments made by section 841. In 
developing the guidance, FDA must consider ``how to incorporate 
novel approaches to the review of surrogate endpoints based on 
physiologic and pharmacologic evidence in such guidance, 
especially in instances where the low prevalence of a disease 
renders the existence or collection of other types of data 
unlikely or impractical.''

Section 843--Independent review

    The section would allow FDA to authorize an independent 
assessment of the implementation of Section 841, including the 
impact on the development and timely availability of innovative 
treatments for patients suffering from serious or life-
threatening conditions.

               Subtitle E--Critical Path Reauthorization


Section 851--Reauthorization of the Critical Path Program

    The section would reauthorize the Critical Path Public-
Private Partnerships program at the current level of $6,000,000 
per year.
    The Committee acknowledges the work being done by the FDA 
in partnership with universities and non-profit organizations 
to create collaborations among health care practitioners, 
researchers, medical product manufacturers, and others to help 
accelerate development of new medical products that are 
essential for public health and to foster innovation in the 
manufacturing of medical products. The Committee encourages the 
Commissioner to continue to explore and fund these partnerships 
including those whose work includes modernizing and improving 
pharmaceutical manufacturing in the United States.
    The Committee is aware of the important collaborative work 
that the FDA, Critical Path Institute (C-Path) and the Clinical 
Data Interchange Standards Consortium (CDISC) have done to 
establish the data standards for Alzheimer's disease clinical 
research and also to create a publicly available database of 22 
industry trials containing data on 6,100 individual patients 
with Alzheimer's disease. In addition, 7 new testing methods 
have been designated by FDA as ``qualified'' for use in drug 
development and another 44 are in various stages of review by 
the FDA. We understand the FDA has asked CDISC and C-Path to 
work to develop data standards for additional, high priority, 
therapeutic areas. We encourage the FDA and its partners to 
continue this work on these important therapeutic areas because 
data standards and consensus on testing methods will speed the 
development and review of new medical products.

                       Subtitle F--Miscellaneous


Section 861--Reauthorization of provision relating to exclusivity of 
        certain drugs containing single enantiomers

    This section would reauthorize for an additional 5 years 
the enantiomer exclusivity authorized in 2007 that otherwise 
expires in 2012.

Section 862--Extension of period for first applicant to obtain 
        tentative approval without forfeiting 180-day exclusivity 
        period

    Under current law, if a generic drug manufacturer 
challenges a brand manufacturer's patent as being either 
invalid or will not be infringed, and if it is the first 
generic drug manufacturer to make such challenge or makes it on 
the same day as the first challenger, it can be awarded 180 
days of exclusivity from other generic competition. Except in 
certain circumstances, if FDA does not grant tentative approval 
within 30 months of the filing of the generic drug application, 
the generic company forfeits the 180-day exclusivity period. 
The provision would temporarily increase that tentative 
approval time period to 45 months. (The current average time 
for FDA to approve a generic drug application is 31 months.) 
This 45-month period would be gradually phased back down to 30 
months as the FDA eliminates the backlog of pending generic 
applications pursuant to the generic drug user fee agreement.

Section 863--Final agency action relating to petitions and civil 
        actions

    Certain citizen petitions ask the Agency for a stay of 
action related to FDA approval of a pending application 
submitted under section 505(b)(2) or 505(j) of the Act due to 
scientific or medical questions about the application. The FDA 
is required to take final agency action on the petition within 
180 days. This section would require the FDA to take final 
agency action on the petition within 150 days.

Section 864--Deadline for determination of certain petitions

    Current law allows the FDA to deny a generic application if 
the drug that the generic application is referencing was 
withdrawn for safety or effectiveness reasons. Current FDA 
regulations allow a company to petition the FDA to determine if 
the reference drug was withdrawn for safety or effectiveness 
reasons. However, there is no timeframe under which the FDA 
must respond to the petition, and there have been instances of 
decision times lasting over 2 years. This section would require 
the FDA to respond to these petitions within 270 days, which 
should result in the quicker approval of generic drugs.

Section 865--Rare pediatric disease priority review voucher incentive 
        program

    This section would create a demonstration project that 
provides priority review vouchers to companies that develop a 
drug for a pediatric rare disease. The voucher would be 
redeemed by the company for a subsequent application or could 
be transferred to another company. The section would require 
the GAO to conduct a study for Congress on the effectiveness of 
the program. The study would have to be completed 1 year after 
the third priority review voucher is issued. The Secretary 
could no longer issue new priority review vouchers 1 year after 
the third voucher is issued so Congress may determine whether 
to continue the incentive.

Section 866--Combating prescription drug abuse

    This section would task the Secretary of HHS with reviewing 
and reporting to Congress on current federal initiatives and 
identifying gaps and opportunities with respect to ensuring the 
safe use of prescription drugs with the potential for abuse.

Section 867--Assessment and modification of REMS

    This section would make the Risk Evaluation and Mitigation 
Strategy (REMS) system more efficient by facilitating minor 
modifications of a drug's REMS with an adequate rationale to 
support such modification. Certain drugs are required to have 
REMS to ensure that the benefits of the drug outweigh the 
risks. Currently, the law is unclear as to whether sponsors can 
make minor modifications to the REMS without the need to have a 
full reassessment of the REMS. This provision would clarify the 
circumstances under which certain modifications could be 
initiated by sponsors and the FDA and made without a full 
assessment of the REMS.

Section 868--Consultation with external experts on rare diseases, 
        targeted therapies, and genetic targeting of treatments

    This section would provide for the creation of a list of 
external experts on products for rare diseases with whom FDA 
may consult.

Section 869--Breakthrough therapies

    This section would expedite the development and review of a 
drug designated a ``breakthrough therapy'' through increased 
interaction with the Agency during the development process. To 
achieve this designation, a drug would have to be intended to 
treat a serious or life-threatening disease or condition, and 
have preliminary clinical evidence indicating that it may 
demonstrate substantial improvement over existing therapies.

Section 870--Grants and contracts for the development of orphan drugs

    This section would reauthorize FDA's orphan drug grant 
program at the current level for five years. This grant program 
helps facilitate the development of orphan disease products.

                        TITLE IX--DRUG SHORTAGES

    The frequency and impact of drug shortages have risen to 
critical levels, more than tripling since 2005. These shortages 
affect all segments of healthcare, including critically ill 
patients and patients undergoing surgery. There appear to be 
multiple causes of drug shortages, including issues involving 
manufacturing, raw materials, supply chain, consolidation, 
government regulations, and businesses decisions. Physicians, 
pharmacists, and patients are challenged daily to obtain the 
drugs they need. Title IX would aid in mitigating drug 
shortages and require a root cause analysis of the problem.

Section 901--Discontinuance and interruptions of manufacturing of 
        certain drugs

    This section would alter section 506C of the FFDCA to 
require manufacturers of certain drugs to notify FDA of a 
discontinuance of the manufacture of a drug, or an interruption 
of the manufacture of the drug that is likely to produce a 
meaningful disruption in market supply. The notification 
requirement would apply to drugs that are: (1) life-supporting, 
life-sustaining, intended for use in the prevention or 
treatment of a debilitating disease or condition; and (2) that 
are not radiopharmaceutical products or products derived from 
human plasma protein and their recombinant analogs. This 
section also would require the manufacturer to notify the 
Secretary at least six months prior to the date of the 
discontinuance or interruption, or if the discontinuance or 
interruption in manufacturing is impossible to predict 6 months 
in advance, as soon as practicable after the manufacturer 
learns of the discontinuance or interruption in manufacturing.
    The section would require the Secretary to distribute 
information on the discontinuation or interruption of the 
manufacture of such drugs to appropriate physician, provider, 
and patient organizations. The bill would not authorize the 
Secretary to disclose trade secret or confidential commercial 
information subject to section 552(b)(4) of title 5, United 
States Code, or section 1905 of title 18, United States Code.
    Under the section, FDA would have to request that the 
Attorney General adjust the quotas of certain drugs and 
ingredients subject to the Controlled Substance Act if the 
Secretary receives a report under 506C and concludes that an 
adjustment is necessary to address shortages of these drugs.
    Also, the section would establish a process relating to a 
manufacturer's failure to notify FDA under section 506C. If a 
manufacturer fails to submit information required, the 
Secretary would issue a letter, and a response would be 
required within 30 days. FDA would make the letter available to 
the public except for certain circumstances.
    Finally, the section would require FDA to issue final 
regulations on key terms within 18 months.
    As a whole, the Committee intends the terms ``life-
supporting, life-sustaining, or intended for use in the 
prevention or treatment of a debilitating disease or medical 
condition'' to mean any drug that is used to treat or prevent a 
serious disease or medical condition.
    For example, the Committee considers any drug that is 
required during emergency or critical situations to stabilize 
organ systems or perform necessary procedures (such as 
resuscitation, surgery, ventilator support, etc.) to be a 
``life-supporting'' drug for purposes of reporting to FDA a 
discontinuance or interruption in manufacturing of the product 
under this section. Examples include\5\:
---------------------------------------------------------------------------
    \5\Drugs may fit into more than one of these definitions depending 
on the intended use. If a drug falls within any of the definitions 
listed, the drug must be reported if its manufacture is interrupted.

------------------------------------------------------------------------
          Name of drug                    Use            Type of drug
------------------------------------------------------------------------
Norepinephrine..................  Treatment of shock  Autonomic
                                                       neurotransmitter
Etomidate.......................  General anesthesia  Anesthetic
Amiodarone......................  Anti-arrhythmic...  Cardiovascular
Furosemide......................  Heart failure,      Cardiovascular
                                   hypertension.
Heparin.........................  Treatment of        Hematology
                                   thrombosis.
Phenytoin.......................  Epilepsy..........  Neurology
Sodium Chloride--IV.............  Fluid               Electrolyte
                                   resuscitation.      solution
Morphine........................  Pain control......  Narcotic
Midazolam.......................  Sedation..........  Anti-anxiety agent
Diazepam........................  Treatment of        Neurology
                                   Status
                                   Epilepticus.
------------------------------------------------------------------------

    Additionally the Committee considers any drug that aims to 
treat serious illness or infection, is essential to, or that 
yields information that is essential to, the restoration or 
continuation of a bodily function important to the continuation 
of human life by restoring or taking over a vital bodily 
function to be a ``life-sustaining'' drug for the purposes of 
reporting to FDA a discontinuance or interruption in 
manufacturing of the product under this section. Examples 
include:

------------------------------------------------------------------------
          Name of drug                    Use            Type of drug
------------------------------------------------------------------------
Amikacin........................  Systemic infection  Antibiotic
Azithromycin....................  Infection.........  Antibiotic
Agalsidase beta.................  Fabry disease.....  Enzyme replacement
Cisplatin.......................  Cancer............  Oncology
Haloperidol.....................  Schizophrenia.....  Psychiatry
Levothyroxine...................  Hypothyroidism....  Endocrinology
Cyclosporine....................  Prevents rejection  Immunosuppressive
                                   of transplants.     agent
Components of parenteral          Provides nutrition  Parenteral
 nutrition.                                            nutrition
------------------------------------------------------------------------

    Finally, the Committee considers prevention measures, such 
as vaccines, drugs that stabilize a debilitating disease or 
serious condition, and drugs used to treat chronic medical 
conditions, such as diabetes, to be included within the phrase 
``intended for use in the prevention or treatment of a 
debilitating disease or serious condition'' for the purposes of 
reporting to FDA a discontinuance or interruption in 
manufacturing of the product under this section. Examples 
include:

------------------------------------------------------------------------
          Name of drug                    Use            Type of drug
------------------------------------------------------------------------
MMR & V vaccine live............  Measles, Mumps,     Vaccine
                                   etc. vaccine.
Dextroamphetamine and             ADHD..............  Amphetamine
 Amphetamine salts.
Fluoxetine......................  Depression........  Psychiatry
Albuterol.......................  Asthma............  Pulmonary
------------------------------------------------------------------------

Section 902--Drug shortage list

    The section would require FDA to maintain a drug shortage 
list and provide patients, providers, and the public with such 
information in order to prevent, mitigate, and manage drug 
shortages on the ground. The bill would include safeguards to 
prevent the release of trade secrets and confidential 
commercial information or information that could adversely 
affect public health, including if the release of the 
information would increase the possibility of hoarding.

Section 903--Quotas applicable to drugs in shortage

    This section would amend section 306 of the Controlled 
Substances Act to require the Drug Enforcement Agency (DEA) to 
review requests to increase quotas of controlled substances and 
make a determination within 30 days if such a request pertains 
to a drug verified to be in shortage.

Section 904. Expedited review of major manufacturing changes for 
        potential and verified shortages of drugs that are life-
        supporting, life-sustaining, or intended for use in the 
        prevention of a debilitating disease or condition

    This section would require FDA to expedite review of a 
supplemental application for a major manufacturing change if 
the manufacturer has submitted a notice to FDA under section 
506C that a drug product is subject to a discontinuance or 
interruption in manufacturing and the manufacturer certifies 
that the major manufacturing change may prevent or alleviate 
the discontinuance or interruption in manufacturing of the 
drug. FDA would be required to complete the review within 60 
days. The provision also would deny expedited review to 
manufacturers who make a certification in bad faith.

Section 905--Study on drug shortages

    The section would authorize GAO to conduct a study to 
examine the causes of drug shortages and issue recommendations 
on how to prevent or alleviate a drug shortage. This provision 
would provide needed data on how the regulatory framework, 
manufacturing challenges, drug pricing, or other factors 
contribute to drug shortages, as well as recommendations to 
address such issues.
    The Committee has heard concerns that drug shortages are 
having a significant impact on important advancements in basic, 
clinical, and translational biomedical research, including 
clinical trials. The Committee also has been notified of 
studies and clinical trials which have been delayed, suspended, 
or halted due to shortages of drugs required for these studies. 
For example, there have been instances where oncology drugs on 
drug shortage lists are urgently needed for cancer clinical 
trials and other forms of cancer research.

Section 906--Annual report on drug shortages

    This section would require FDA to issue an annual report on 
drug shortages that describes communication between FDA field 
inspectors and the drug shortage program, as well as 
coordination between FDA and DEA, and detail uses of 
authorities to address drug shortages.

Section 907--Attorney General report on drug shortages

    This section would require DEA to issue an annual report on 
controlled substances that are in shortage, DEA actions when a 
shortage is identified, and a description of the coordination 
between DEA and FDA in mitigating shortages of these controlled 
substances.

Section 908--Hospital repackaging of drugs in shortage

    This section would provide that a hospital within a health 
system (or a collection of hospitals that are owned and 
operated by the same entity and share access to databases with 
drug order information for their patients) would not need to 
register with FDA under section 510, on the basis that it 
engages in a type of repackaging in which the hospital divides 
the volume of a drug into smaller amounts to extend the supply 
of a drug in shortage and facilitate access to that drug to 
other hospitals within the same health system. This would apply 
only to hospitals within the same health system, and the 
repackaging would have to comply with State rules. This section 
would not apply after FDA issues final guidance on this issue.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT




           *       *       *       *       *       *       *
                        CHAPTER II--DEFINITIONS

  Sec. 201. For the purposes of this Act--
  (a) * * *

           *       *       *       *       *       *       *

  (g)(1) * * *
  (2) The term ``counterfeit drug'' means a drug which, or the 
container or labeling of which, without authorization, bears 
the trademark, trade name, or other identifying mark, imprint, 
or device, or any likeness thereof, of a drug manufacturer, 
processor, packer, or distributor other than the person or 
persons who in fact manufactured, processed, packed, or 
distributed such drug and which thereby falsely purports or is 
represented to be the product of, or to have been packed or 
distributed by, such other drug manufacturer, processor, 
packer, or distributor. The term ``counterfeit drug'' shall not 
include a drug or placebo intended for use in a clinical trial 
that is intentionally labeled or marked to maintain proper 
blinding of the study.

           *       *       *       *       *       *       *


               CHAPTER III--PROHIBITED ACTS AND PENALTIES


                            PROHIBITED ACTS

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *

           *       *       *       *       *       *       *

  (aaa) The failure to register in accordance with section 
801(s).
  (bbb) The failure to notify the Secretary in violation of 
section 568.

           *       *       *       *       *       *       *


                               PENALTIES

  Sec. 303. (a)(1) * * *

           *       *       *       *       *       *       *

  (3) Notwithstanding paragraph (2), any person who engages in 
any conduct described in section 301(i)(2) knowing or having 
reason to know that the conduct concerns the rendering of a 
drug as a counterfeit drug, or who engages in conduct described 
in section 301(i)(3) knowing or having reason to know that the 
conduct will cause a drug to be a counterfeit drug or knowing 
or having reason to know that a drug held, sold, or dispensed 
is a counterfeit drug, shall be fined in accordance with title 
18, United States Code, or imprisoned not more than 20 years, 
or both, except that if the use of the counterfeit drug by a 
consumer is the proximate cause of the death of the consumer, 
the term of imprisonment shall be any term of years or for 
life.
  (b)(1) * * *

           *       *       *       *       *       *       *

          (7) Notwithstanding subsection (a)(2), any person 
        that knowingly and intentionally engages in an activity 
        that results in a drug becoming adulterated under 
        subsection (a)(1), (b), (c), or (d) of section 501 and 
        having a reasonable probability of causing serious 
        adverse health consequences or death shall be 
        imprisoned for not more than 20 years or fined not more 
        than $1,000,000, or both.

           *       *       *       *       *       *       *


                                SEIZURE

  Sec. 304. (a) * * *

           *       *       *       *       *       *       *

  (g)(1) If during an inspection conducted under section 704 of 
a facility or a vehicle, a device, drug, or tobacco product 
which the officer or employee making the inspection has reason 
to believe is adulterated or misbranded is found in such 
facility or vehicle, such officer or employee may order the 
device, drug, or tobacco product detained (in accordance with 
regulations prescribed by the Secretary) for a reasonable 
period which may not exceed twenty days unless the Secretary 
determines that a period of detention greater than twenty days 
is required to institute an action under subsection (a) or 
section 302, in which case he may authorize a detention period 
of not to exceed thirty days. Regulations of the Secretary 
prescribed under this paragraph shall require that before a 
device, drug, or tobacco product may be ordered detained under 
this paragraph the Secretary or an officer or employee 
designated by the Secretary approve such order. A detention 
order under this paragraph may require the labeling or marking 
of a device, drug, or tobacco product during the period of its 
detention for the purpose of identifying the device, drug, or 
tobacco product as detained. Any person who would be entitled 
to claim a device, drug, or tobacco product if it were seized 
under subsection (a) may appeal to the Secretary a detention of 
such device, drug, or tobacco product under this paragraph. 
Within five days of the date an appeal of a detention is filed 
with the Secretary, the Secretary shall after affording 
opportunity for an informal hearing by order confirm the 
detention or revoke it.
  (2)(A) Except as authorized by subparagraph (B), a device, 
drug, or tobacco product subject to a detention order issued 
under paragraph (1) shall not be moved by any person from the 
place at which it is ordered detained until--
          (i) * * *

           *       *       *       *       *       *       *

whichever occurs first.
  (B) A device or drug subject to a detention order under 
paragraph (1) may be moved--
          (i) * * *
          (ii) if not in final form for shipment, at the 
        discretion of the manufacturer of the device or drug 
        for the purpose of completing the work required to put 
        it in such form.

           *       *       *       *       *       *       *


SEC. 311. EXTRATERRITORIAL JURISDICTION.

  There is extraterritorial jurisdiction over any violation of 
this Act relating to any article regulated under this Act if 
such article was intended for import into the United States or 
if any act in furtherance of the violation was committed in the 
United States.

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES

                    Subchapter A--Drugs and Devices

                     ADULTERATED DRUGS AND DEVICES

  Sec. 501. A drug or device shall be deemed to be 
adulterated--
  (a)(1) If it consists in whole or in part of any filthy, 
putrid, or decomposed substance; or (2)(A) if it has been 
prepared, packed, or held under insanitary conditions whereby 
it may have been contaminated with filth, or whereby it may 
have been rendered injurious to health; or (B) if it is a drug 
and the methods used in, or the facilities or controls used 
for, its manufacture, processing, packing, or holding do not 
conform to or are not operated or administered in conformity 
with current good manufacturing practice to assure that such 
drug meets the requirements of this Act as to safety and has 
the identity and strength, and meets the quality and purity 
characteristics, which it purports or is represented to 
possess; or (C) if it is a compounded positron emission 
tomography drug and the methods used in, or the facilities and 
controls used for, its compounding, processing, packing, or 
holding do not conform to or are not operated or administered 
in conformity with the positron emission tomography compounding 
standards and the official monographs of the United States 
Pharmacopoeia to assure that such drug meets the requirements 
of this Act as to safety and has the identity and strength, and 
meets the quality and purity characteristics, that it purports 
or is represented to possess; or (3) if its container is 
composed, in whole or in part, of any poisonous or deleterious 
substance which may render the contents injurious to health; or 
(4) if (A) it bears or contains, for purposes of coloring only, 
a color additive which is unsafe within the meaning of section 
721(a), or (B) it is a color additive the intended use of which 
in or on drugs or devices is for purposes of coloring only and 
is unsafe within the meaning of section 721(a); or (5) if it is 
a new animal drug which is unsafe within the meaning of section 
512; or (6) if it is an animal feed bearing or containing a new 
animal drug, and such animal feed is unsafe within the meaning 
of section 512. For purposes of subparagraph (2)(B), the term 
``current good manufacturing practice'' includes the 
implementation of oversight and controls over the manufacture 
of drugs to ensure quality, including managing the risk of and 
establishing the safety of raw materials, materials used in the 
manufacturing of drugs, and finished drug products.

           *       *       *       *       *       *       *

  (j) If it is a drug and it has been manufactured, processed, 
packed, or held in any factory, warehouse, or establishment and 
the owner, operator, or agent of such factory, warehouse, or 
establishment delays, denies, or limits an inspection, or 
refuses to permit entry or inspection.

                      MISBRANDED DRUGS AND DEVICES

  Sec. 502. A drug or device shall be deemed to be misbranded--
  (a) * * *

           *       *       *       *       *       *       *

  (o) If it was manufactured, prepared, propagated, compounded, 
or processed in an establishment [in any State] not duly 
registered under section 510, if it is a drug and was imported 
or offered for import by a commercial importer of drugs not 
duly registered under section 801(s), if it was not included in 
a list required by section 510(j), if a notice or other 
information respecting it was not provided as required by such 
section or section 510(k), or if it does not bear such symbols 
from the uniform system for identification of devices 
prescribed under section 510(e) as the Secretary by regulation 
requires.

           *       *       *       *       *       *       *

  (aa) If it is a drug, or an active pharmaceutical ingredient, 
and it was manufactured, prepared, propagated, compounded, or 
processed in a facility for which fees have not been paid as 
required by section 744A(a)(4) or for which identifying 
information required by section 744B(f) has not been submitted, 
or it contains an active pharmaceutical ingredient that was 
manufactured, prepared, propagated, compounded, or processed in 
such a facility.

           *       *       *       *       *       *       *


                               NEW DRUGS

  Sec. 505. (a) * * *

           *       *       *       *       *       *       *

  (j)(1) * * *

           *       *       *       *       *       *       *

  (5)(A) * * *

           *       *       *       *       *       *       *

          (D) Forfeiture of 180-day exclusivity period.--
                  (i) Definition of forfeiture event.--In this 
                subparagraph, the term ``forfeiture event'', 
                with respect to an application under this 
                subsection, means the occurrence of any of the 
                following:
                          (I) * * *

           *       *       *       *       *       *       *

                          [(IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within 30 months after the 
                        date on which the application is filed, 
                        unless the failure is caused by a 
                        change in or a review of the 
                        requirements for approval of the 
                        application imposed after the date on 
                        which the application is filed.]
                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within 45 months after the 
                        date on which--
                                  (aa) the application is filed 
                                and initially contains a 
                                certification described in 
                                paragraph (2)(A)(vii)(IV), or
                                  (bb) the application is 
                                amended to first contain such a 
                                certification,
                                unless the failure is caused by 
                                a change in or a review of the 
                                requirements for approval of 
                                the application imposed after 
                                the date on which the 
                                application is so filed or 
                                amended.

 [Effective on October 1, 2013, subclause (IV), (as amended by section 
862(a)(1)), is further amended by subsection (b)(1)(A) of such section 
                              as follows:]

                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within [45] 42 months after 
                        the date on which--
                                  (aa) the application is filed 
                                and initially contains a 
                                certification described in 
                                paragraph (2)(A)(vii)(IV), or
                                  (bb) the application is 
                                amended to first contain such a 
                                certification,
                                unless the failure is caused by 
                                a change in or a review of the 
                                requirements for approval of 
                                the application imposed after 
                                the date on which the 
                                application is so filed or 
                                amended.

 [Effective on October 1, 2014, subclause (IV), (as amended by section 
862(a)(1) and (b)(1)(A)), is further amended by subsection (b)(1)(B) of 
                       such section as follows:]

                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within [42] 39 months after 
                        the date on which--
                                  (aa) the application is filed 
                                and initially contains a 
                                certification described in 
                                paragraph (2)(A)(vii)(IV), or
                                  (bb) the application is 
                                amended to first contain such a 
                                certification,
                                unless the failure is caused by 
                                a change in or a review of the 
                                requirements for approval of 
                                the application imposed after 
                                the date on which the 
                                application is so filed or 
                                amended.

 [Effective on October 1, 2015, subclause (IV), (as amended by section 
862(a)(1), (b)(1)(A), and (b)(1)(B)), is further amended by subsection 
                 (b)(1)(C) of such section as follows:]

                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within [39] 36 months after 
                        the date on which--
                                  (aa) the application is filed 
                                and initially contains a 
                                certification described in 
                                paragraph (2)(A)(vii)(IV), or
                                  (bb) the application is 
                                amended to first contain such a 
                                certification,
                                unless the failure is caused by 
                                a change in or a review of the 
                                requirements for approval of 
                                the application imposed after 
                                the date on which the 
                                application is so filed or 
                                amended.

 [Effective on October 1, 2016, subclause (IV), (as amended by section 
862(a)(1), (b)(1)(A), (b)(1)(B), and (b)(1)(C)), is further amended by 
           subsection (b)(1)(D) of such section as follows:]

                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within [36] 33 months after 
                        the date on which--
                                  (aa) the application is filed 
                                and initially contains a 
                                certification described in 
                                paragraph (2)(A)(vii)(IV), or
                                  (bb) the application is 
                                amended to first contain such a 
                                certification,
                                unless the failure is caused by 
                                a change in or a review of the 
                                requirements for approval of 
                                the application imposed after 
                                the date on which the 
                                application is so filed or 
                                amended.

 [Effective on October 1, 2017, subclause (IV), (as amended by section 
862(a)(1), (b)(1)(A), (b)(1)(B), (b)(1)(C), and (b)(1)(D)), is further 
      amended by subsection (b)(1)(E) of such section as follows:]

                          (IV) Failure to obtain tentative 
                        approval.--The first applicant fails to 
                        obtain tentative approval of the 
                        application within [33] 30 months after 
                        the date on which--
                                  (aa) the application is filed 
                                and initially contains a 
                                certification described in 
                                paragraph (2)(A)(vii)(IV), or
                                  (bb) the application is 
                                amended to first contain such a 
                                certification,
                                unless the failure is caused by 
                                a change in or a review of the 
                                requirements for approval of 
                                the application imposed after 
                                the date on which the 
                                application is so filed or 
                                amended.

           *       *       *       *       *       *       *

  (k)(1) * * *

           *       *       *       *       *       *       *

          (3) Active postmarket risk identification.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) Establishment of the postmarket risk 
                identification and analysis system.--
                          (i) In general.--The Secretary shall, 
                        not later than 1 year after the 
                        development of the risk identification 
                        and analysis methods under subparagraph 
                        (B), establish and maintain 
                        procedures--
                                  (I) * * *
                                  [(II) for the reporting (in a 
                                standardized form) of data on 
                                all serious adverse drug 
                                experiences (as defined in 
                                section 505-1(b)) submitted to 
                                the Secretary under paragraph 
                                (1), and those adverse events 
                                submitted by patients, 
                                providers, and drug sponsors, 
                                when appropriate;]
                                  [(III)] (II) to provide for 
                                active adverse event 
                                surveillance using the 
                                following data sources, as 
                                available:
                                          (aa) * * *
                                          (bb) private sector 
                                        health-related 
                                        electronic data (such 
                                        as [pharmaceutical 
                                        purchase data and 
                                        health insurance claims 
                                        data] medical device 
                                        utilization data, 
                                        health insurance claims 
                                        data, and procedure and 
                                        device registries); and

           *       *       *       *       *       *       *

                                  [(IV)] (III) to identify 
                                certain trends and patterns 
                                with respect to data accessed 
                                by the system;
                                  [(V)] (IV) to provide regular 
                                reports to the Secretary 
                                concerning adverse event 
                                trends, adverse event patterns, 
                                incidence and prevalence of 
                                adverse events, and other 
                                information the Secretary 
                                determines appropriate, which 
                                may include data on comparative 
                                national adverse event trends; 
                                and
                                  [(VI)] (V) to enable the 
                                program to export data in a 
                                form appropriate for further 
                                aggregation, statistical 
                                analysis, and reporting.

           *       *       *       *       *       *       *

  (q) Petitions and Civil Actions Regarding Approval of Certain 
Applications.--
          (1) In general.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (F) Final agency action.--The Secretary shall 
                take final agency action on a petition not 
                later than [180 days] 150 days after the date 
                on which the petition is submitted. The 
                Secretary shall not extend such period for any 
                reason, including--
                          (i) * * *

           *       *       *       *       *       *       *

                  (G) Extension of [30-month period] period.--
                If the filing of an application resulted in 
                first-applicant status under subsection 
                (j)(5)(D)(i)(IV) and approval of the 
                application was delayed because of a petition, 
                [the 30-month period] the period under such 
                subsection is deemed to be extended by a period 
                of time equal to the period beginning on the 
                date on which the Secretary received the 
                petition and ending on the date of final agency 
                action on the petition (inclusive of such 
                beginning and ending dates), without regard to 
                whether the Secretary grants, in whole or in 
                part, or denies, in whole or in part, the 
                petition.

           *       *       *       *       *       *       *

          (2) Exhaustion of administrative remedies.--
                  (A) Final agency action within [180] 150 
                days.--The Secretary shall be considered to 
                have taken final agency action on a petition 
                if--
                          (i) during the [180-day] 150-day 
                        period referred to in paragraph (1)(F), 
                        the Secretary makes a final decision 
                        within the meaning of section 10.45(d) 
                        of title 21, Code of Federal 
                        Regulations (or any successor 
                        regulation); or

           *       *       *       *       *       *       *

  (u) Certain Drugs Containing Single Enantiomers.--
          (1) * * *

           *       *       *       *       *       *       *

          (4) Availability.--The election referred to in 
        paragraph (1) may be made only in an application that 
        is submitted to the Secretary after the date of the 
        enactment of this subsection and before October 1, 
        [2012] 2017.

           *       *       *       *       *       *       *

  (w) Deadline for Determination on Certain Petitions.--The 
Secretary shall issue a final, substantive determination on a 
petition submitted pursuant to subsection (b) of section 
314.161 of title 21, Code of Federal Regulations (or any 
successor regulations), no later than 270 days after the date 
the petition is submitted.

SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.

  (a) * * *

           *       *       *       *       *       *       *

  (g) Assessment and Modification of Approved Strategy.--
          (1) Voluntary assessments.--After the approval of a 
        risk evaluation and mitigation strategy under 
        subsection (a), the responsible person involved may, 
        subject to paragraph (2), submit to the Secretary an 
        assessment of[, and propose a modification to,] the 
        approved strategy for the drug involved at any time.
          (2) Required assessments.--A responsible person 
        shall[, subject to paragraph (5),] submit an assessment 
        of[, and may propose a modification to,] the approved 
        risk evaluation and mitigation strategy for a drug--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) within a time period to be determined by 
                the Secretary, if the Secretary, in 
                consultation with the offices described in 
                subsection (c)(2), determines that [new safety 
                or effectiveness information indicates that--
                          [(i) an element under subsection (d) 
                        or (e) should be modified or included 
                        in the strategy; or
                          [(ii) an element under subsection (f) 
                        should be modified or included in the 
                        strategy; or] an assessment is needed 
                        to evaluate whether the approved 
                        strategy should be modified to--
                          (i) ensure the benefits of the drug 
                        outweigh the risks of the drug; or
                          (ii) minimize the burden on the 
                        health care delivery system of 
                        complying with the strategy.
                  [(D) within 15 days when ordered by the 
                Secretary, in consultation with the offices 
                described in subsection (c)(2), if the 
                Secretary determines that there may be a cause 
                for action by the Secretary under section 
                505(e).]
          (3) Requirements for assessments.--An assessment 
        under paragraph (1) or (2) of an approved risk 
        evaluation and mitigation strategy [for a drug shall 
        include--
                  [(A) with respect to any goal under 
                subsection (f), an assessment of the extent to 
                which the elements to assure safe use are 
                meeting the goal or whether the goal or such 
                elements should be modified;
                  [(B) with respect to any postapproval study 
                required under section 505(o) or otherwise 
                undertaken by the responsible person to 
                investigate a safety issue, the status of such 
                study, including whether any difficulties 
                completing the study have been encountered; and
                  [(C) with respect to any postapproval 
                clinical trial required under section 505(o) or 
                otherwise undertaken by the responsible party 
                to investigate a safety issue, the status of 
                such clinical trial, including whether 
                enrollment has begun, the number of 
                participants enrolled, the expected completion 
                date, whether any difficulties completing the 
                clinical trial have been encountered, and 
                registration information with respect to 
                requirements under subsections (i) and (j) of 
                section 402 of the Public Health Service Act.] 
                for a drug shall include, with respect to each 
                goal included in the strategy, an assessment of 
                the extent to which the approved strategy, 
                including each element of the strategy, is 
                meeting the goal or whether 1 or more such 
                goals or such elements should be modified.
          [(4) Modification.--A modification (whether an 
        enhancement or a reduction) to the approved risk 
        evaluation and mitigation strategy for a drug may 
        include the addition or modification of any element 
        under subsection (d) or the addition, modification, or 
        removal of any element under subsection (e) or (f), 
        such as--
                  [(A) modifying the timetable for assessments 
                of the strategy as provided in subsection 
                (d)(3), including to eliminate assessments; or
                  [(B) adding, modifying, or removing an 
                element to assure safe use under subsection 
                (f).]
          (4) Modification.--
                  (A) On initiative of responsible person.--
                After the approval of a risk evaluation and 
                mitigation strategy by the Secretary, the 
                responsible person may, at any time, submit to 
                the Secretary a proposal to modify the approved 
                strategy. Such proposal may propose the 
                addition, modification, or removal of any goal 
                or element of the approved strategy and shall 
                include an adequate rationale to support such 
                proposed addition, modification, or removal of 
                any goal or element of the strategy.
                  (B) On initiative of Secretary.--After the 
                approval of a risk evaluation and mitigation 
                strategy by the Secretary, the Secretary may, 
                at any time, require a responsible person to 
                submit a proposed modification to the strategy 
                within 120 days or within such reasonable time 
                as the Secretary specifies, if the Secretary, 
                in consultation with the offices described in 
                subsection (c)(2), determines that 1 or more 
                goals or elements should be added, modified, or 
                removed from the approved strategy to--
                          (i) ensure the benefits of the drug 
                        outweigh the risks of the drug; or
                          (ii) minimize the burden on the 
                        health care delivery system of 
                        complying with the strategy.
  (h) Review of Proposed Strategies; Review of Assessments and 
Modifications of Approved Strategies.--
          (1) In general.--The Secretary, in consultation with 
        the offices described in subsection (c)(2), shall 
        promptly review each proposed risk evaluation and 
        mitigation strategy for a drug submitted under 
        subsection (a) and each assessment of and proposed 
        modification to an approved risk evaluation and 
        mitigation strategy for a drug submitted under 
        subsection (g), and, if necessary, promptly initiate 
        discussions with the responsible person about such 
        proposed strategy, assessment, or modification.
          [(2) Discussion.--The Secretary, in consultation with 
        the offices described in subsection (c)(2), shall 
        initiate discussions with the responsible person for 
        purposes of this subsection to determine a strategy not 
        later than 60 days after any such assessment is 
        submitted or, in the case of an assessment submitted 
        under subsection (g)(2)(D), not later than 30 days 
        after such assessment is submitted.]
          [(3)] (2) Action.--
                  [(A) In general.--Unless the dispute 
                resolution process described under paragraph 
                (4) or (5) applies, the Secretary, in 
                consultation with the offices described in 
                subsection (c)(2), shall describe any required 
                risk evaluation and mitigation strategy for a 
                drug, or any modification to any required 
                strategy--
                          [(i) as part of the action letter on 
                        the application, when a proposed 
                        strategy is submitted under subsection 
                        (a) or a modification to the strategy 
                        is proposed as part of an assessment of 
                        the strategy submitted under subsection 
                        (g)(1); or
                          [(ii) in an order issued not later 
                        than 90 days after the date discussions 
                        of such modification begin under 
                        paragraph (2), when a modification to 
                        the strategy is proposed as part of an 
                        assessment of the strategy submitted 
                        under subsection (g)(1) or under any of 
                        subparagraphs (B) through (D) of 
                        subsection (g)(2).]
                  (A) In general.--
                          (i) Timeframe.--Unless the dispute 
                        resolution process described under 
                        paragraph (3) or (4) applies, and, 
                        except as provided in clause (ii) or 
                        clause (iii) below, the Secretary, in 
                        consultation with the offices described 
                        in subsection (c)(2), shall review and 
                        act on the proposed risk evaluation and 
                        mitigation strategy for a drug or any 
                        proposed modification to any required 
                        strategy within 180 days of receipt of 
                        the proposed strategy or modification.
                          (ii) Minor modifications.--The 
                        Secretary shall review and act on a 
                        proposed minor modification, as defined 
                        by the Secretary in guidance, within 60 
                        days of receipt of such modification.
                          (iii) REMS modification due to safety 
                        label changes.--Not later than 60 days 
                        after the Secretary receives a proposed 
                        modification to an approved risk 
                        evaluation and mitigation strategy to 
                        conform the strategy to approved safety 
                        label changes, including safety 
                        labeling changes initiated by the 
                        sponsor in accordance with FDA 
                        regulatory requirements, or to a safety 
                        label change that the Secretary has 
                        directed the holder of the application 
                        to make pursuant to section 505(o)(4), 
                        the Secretary shall review and act on 
                        such proposed modification to the 
                        approved strategy.
                          (iv) Guidance.--The Secretary shall 
                        establish, through guidance, that 
                        responsible persons may implement 
                        certain modifications to an approved 
                        risk evaluation and mitigation strategy 
                        following notification to the 
                        Secretary.

           *       *       *       *       *       *       *

                  [(C) Public availability.--Any action letter 
                described in subparagraph (A)(i) or order 
                described in subparagraph (A)(ii) shall be made 
                publicly available.]
                  (C) Public availability.--Upon acting on a 
                proposed risk evaluation and mitigation 
                strategy or proposed modification to a risk 
                evaluation and mitigation strategy under 
                subparagraph (A), the Secretary shall make 
                publicly available an action letter describing 
                the actions taken by the Secretary under such 
                subparagraph (A).
          [(4)] (3) Dispute resolution at initial approval.--If 
        a proposed risk evaluation and mitigation strategy is 
        submitted under subsection (a)(1) in an application for 
        initial approval of a drug and there is a dispute about 
        the strategy, the responsible person shall use the 
        major dispute resolution procedures as set forth in the 
        letters described in section 101(c) of the Food and 
        Drug Administration Amendments Act of 2007.
          [(5)] (4) Dispute resolution in all other cases.--
                  (A) Request for review.--
                          (i) In general.--[Not earlier than 15 
                        days, and not later than 35 days, after 
                        discussions under paragraph (2) have 
                        begun, the] The responsible person may, 
                        after the sponsor is required to make a 
                        submission under subsection (a)(2) or 
                        (g), request in writing that a dispute 
                        about the strategy be reviewed by the 
                        Drug Safety Oversight Board under 
                        subsection (j), except that the 
                        determination of the Secretary to 
                        require a risk evaluation and 
                        mitigation strategy is not subject to 
                        review under this paragraph. The 
                        preceding sentence does not prohibit 
                        review under this paragraph of the 
                        particular elements of such a strategy.

           *       *       *       *       *       *       *

                  (I) Effect on action deadline.--With respect 
                to a proposal or assessment referred to in 
                paragraph (1), the Secretary shall be 
                considered to have met the action deadline for 
                the action letter on the application if the 
                responsible person requests the dispute 
                resolution process described in this paragraph 
                and [if the Secretary--] if the Secretary has 
                complied with the timing requirements of 
                scheduling review by the Drug Safety Oversight 
                Board, providing a written recommendation, and 
                issuing an action letter under subparagraphs 
                (B), (F), and (G), respectively.
                          [(i) has initiated the discussions 
                        described under paragraph (2) not less 
                        than 60 days before such action 
                        deadline; and
                          [(ii) has complied with the timing 
                        requirements of scheduling review by 
                        the Drug Safety Oversight Board, 
                        providing a written recommendation, and 
                        issuing an action letter under 
                        subparagraphs (B), (F), and (G), 
                        respectively.]

           *       *       *       *       *       *       *

          [(6)] (5) Use of advisory committees.--The Secretary 
        may convene a meeting of 1 or more advisory committees 
        of the Food and Drug Administration to--
                  (A) review a concern about the safety of a 
                drug or class of drugs, including before an 
                assessment of the risk evaluation and 
                mitigation strategy or strategies of such drug 
                or drugs is required to be submitted under any 
                of subparagraphs (B) through (D) of subsection 
                (g)(2);

           *       *       *       *       *       *       *

                  (C) review a dispute under [paragraph (4) or 
                (5)] paragraph (3) or (4).
          [(7)] (6) Process for addressing drug class 
        effects.--
                  (A) * * *

           *       *       *       *       *       *       *

          [(8)] (7) International coordination.--The Secretary, 
        in consultation with the offices described in 
        subsection (c)(2), may coordinate the timetable for 
        submission of assessments under subsection (d), or a 
        study or clinical trial under section 505(o)(3), with 
        efforts to identify and assess the serious risks of 
        such drug by the marketing authorities of other 
        countries whose drug approval and risk management 
        processes the Secretary deems comparable to the drug 
        approval and risk management processes of the United 
        States. If the Secretary takes action to coordinate 
        such timetable, the Secretary shall give notice to the 
        responsible person.
          [(9)] (8) Effect.--Use of the processes described in 
        [paragraphs (7) and (8)] paragraphs (6) and (7). shall 
        not be the sole source of delay of action on an 
        application or a supplement to an application for a 
        drug.

           *       *       *       *       *       *       *


SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

  (a) * * *

           *       *       *       *       *       *       *

  (d) Conduct of Pediatric Studies.--
          (1) Request for studies.--
                  (A) In general.--The Secretary may, after 
                consultation with the sponsor of an application 
                for an investigational new drug under section 
                505(i), the sponsor of an application for a new 
                drug under section 505(b)(1), or the holder of 
                an approved application for a drug under 
                section 505(b)(1), issue to the sponsor or 
                holder a written request for the conduct of 
                pediatric studies for such drug. In issuing 
                such request, the Secretary shall take into 
                account adequate representation of children of 
                ethnic and racial minorities. Such request to 
                conduct pediatric studies shall be in writing 
                and shall include a timeframe for such studies 
                and a request to the sponsor or holder to 
                propose pediatric labeling resulting from such 
                studies. If a request under this subparagraph 
                does not request studies in neonates, such 
                request shall include a statement describing 
                the rationale for not requesting studies in 
                neonates.

           *       *       *       *       *       *       *

  [(h) Relationship to Pediatric Research Requirements.--
Notwithstanding any other provision of law, if any pediatric 
study is required by a provision of law (including a 
regulation) other than this section and such study meets the 
completeness, timeliness, and other requirements of this 
section, such study shall be deemed to satisfy the requirement 
for market exclusivity pursuant to this section.]
  (h) Relationship to Pediatric Research Requirements.--
Exclusivity under this section shall only be granted for the 
completion of a study or studies that are the subject of a 
written request and for which reports are submitted and 
accepted in accordance with subsection (d)(3). Written requests 
under this section may consist of a study or studies required 
under section 505B.

           *       *       *       *       *       *       *

  (k) Dissemination of Pediatric Information.--
          (1) * * *
          (2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of the enactment of the 
        Best Pharmaceuticals for Children Act of 2007, the 
        Secretary shall include as a requirement of a written 
        request that the sponsors of the studies that result in 
        labeling changes that are reflected in the annual 
        summary developed pursuant to [subsection (f)(3)(F)] 
        subsection (f)(6)(F) distribute, at least annually (or 
        more frequently if the Secretary determines that it 
        would be beneficial to the public health), such 
        information to physicians and other health care 
        providers.

           *       *       *       *       *       *       *

  (l) Adverse Event Reporting.--
          (1) Reporting in [year one] first 18-month period.--
        Beginning on the date of the enactment of the Best 
        Pharmaceuticals for Children Act of 2007, during the 
        [one-year] 18-month period beginning on the date a 
        labeling change is approved pursuant to subsection (i), 
        the Secretary shall ensure that all adverse event 
        reports that have been received for such drug 
        (regardless of when such report was received) are 
        referred to the Office of Pediatric Therapeutics 
        established under section 6 of the Best Pharmaceuticals 
        for Children Act (Public Law 107-109). In considering 
        the reports, the Director of such Office shall provide 
        for the review of the reports by the Pediatric Advisory 
        Committee, including obtaining any recommendations of 
        such Committee regarding whether the Secretary should 
        take action under this Act in response to such reports.
          (2) Reporting in subsequent [years] periods.--
        Following the [one-year period] 18-month period 
        described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric 
        Therapeutics all pediatric adverse event reports for a 
        drug for which a pediatric study was conducted under 
        this section. In considering such reports, the Director 
        of such Office may provide for the review of such 
        reports by the Pediatric Advisory Committee, including 
        obtaining any recommendation of such Committee 
        regarding whether the Secretary should take action in 
        response to such reports.
          (3) Preservation of authority.--Nothing in this 
        subsection shall prohibit the Office of Pediatric 
        Therapeutics from providing for the review of adverse 
        event reports by the Pediatric Advisory Committee prior 
        to the 18-month period referred to in paragraph (1), if 
        such review is necessary to ensure safe use of a drug 
        in a pediatric population.
          [(3)] (4) Effect.--The requirements of this 
        subsection shall supplement, not supplant, other review 
        of such adverse event reports by the Secretary.

           *       *       *       *       *       *       *

  (n) Referral if Pediatric Studies Not [Completed] 
Submitted.--
          (1) In general.--Beginning on the date of the 
        enactment of the Best Pharmaceuticals for Children Act 
        of 2007, if pediatric studies of a drug [have not been 
        completed] have not been submitted by the date 
        specified in the written request issued and agreed upon 
        under subsection (d) and if the Secretary, through the 
        committee established under section 505C, determines 
        that there is a continuing need for information 
        relating to the use of the drug in the pediatric 
        population (including neonates, as appropriate), the 
        Secretary shall carry out the following:
                  [(A) For a drug for which a listed patent has 
                not expired, make a determination regarding 
                whether an assessment shall be required to be 
                submitted under section 505B(b). Prior to 
                making such a determination, the Secretary may 
                not take more than 30 days to certify whether 
                the Foundation for the National Institutes of 
                Health has sufficient funding at the time of 
                such certification to initiate and fund all of 
                the studies in the written request in their 
                entirety within the timeframes specified within 
                the written request. Only if the Secretary 
                makes such certification in the affirmative, 
                the Secretary shall refer all pediatric studies 
                in the written request to the Foundation for 
                the National Institutes of Health for the 
                conduct of such studies, and such Foundation 
                shall fund such studies. If no certification 
                has been made at the end of the 30-day period, 
                or if the Secretary certifies that funds are 
                not sufficient to initiate and fund all the 
                studies in their entirety, the Secretary shall 
                consider whether assessments shall be required 
                under section 505B(b) for such drug.
                  [(B) For a drug that has no listed patents or 
                has 1 or more listed patents that have expired, 
                the Secretary shall refer the drug for 
                inclusion on the list established under section 
                409I of the Public Health Service Act for the 
                conduct of studies.]
                  (A) For a drug for which there remains any 
                listed patent or exclusivity protection 
                eligible for extension under subsection (b)(1) 
                or (c)(1) of this section, or any exclusivity 
                protection eligible for extension under 
                subsection (m)(2) or (m)(3) of section 351 of 
                the Public Health Service Act, the Secretary 
                shall make a determination regarding whether an 
                assessment shall be required to be submitted 
                under section 505B(b).
                  (B) For a drug that has no remaining listed 
                patents or exclusivity protection eligible for 
                extension under subsection (b)(1) or (c)(1) of 
                this section, or any exclusivity protection 
                eligible for extension under subsection (m)(2) 
                or (m)(3) of section 351 of the Public Health 
                Service Act, the Secretary shall refer the drug 
                for inclusion on the list established under 
                section 409I of the Public Health Service Act 
                for the conduct of studies.

           *       *       *       *       *       *       *

  (o) Prompt Approval of Drugs Under Section 505(j) When 
Pediatric Information Is Added to Labeling.--
          (1) * * *
          (2) Labeling.--Notwithstanding clauses (iii) and (iv) 
        of section 505(j)(5)(F), the Secretary may require that 
        the labeling of a drug approved under section 505(j) 
        that omits a pediatric indication or other aspect of 
        labeling as described in paragraph (1) include--
                  (A) * * *
                  [(B) a statement of any appropriate pediatric 
                contraindications, warnings, or precautions 
                that the Secretary considers necessary.]
                  (B) a statement of any appropriate pediatric 
                contraindications, warnings, precautions, or 
                other information that the Secretary considers 
                necessary to assure safe use.

           *       *       *       *       *       *       *

  [(q) Sunset.--A drug may not receive any 6-month period under 
subsection (b) or (c) unless--
          [(1) on or before October 1, 2012, the Secretary 
        makes a written request for pediatric studies of the 
        drug;
          [(2) on or before October 1, 2012, an application for 
        the drug is accepted for filing under section 505(b); 
        and
          [(3) all requirements of this section are met.]

SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL 
                    PRODUCTS.

  (a) New Drugs and Biological Products.--
          (1) In general.--A person that submits, on or after 
        the date of the enactment of the Pediatric Research 
        Equity Act of 2007, an application (or supplement to an 
        application) for a drug--
                  (A) * * *

           *       *       *       *       *       *       *

          (3) Deferral.--
                  (A) * * *
                  (B) Deferral extension.--On the initiative of 
                the Secretary or at the request of the 
                applicant, the Secretary may grant an extension 
                of a deferral under subparagraph (A) if--
                          (i) the Secretary finds that the 
                        criteria specified in subclause (II) or 
                        (III) of subparagraph (A)(i) continue 
                        to be met; and
                          (ii) the applicant submits the 
                        materials required under subparagraph 
                        (A)(ii).
                  (C) Consideration during deferral period.--If 
                the Secretary has under this paragraph deferred 
                the date by which an assessment must be 
                submitted, then until the date specified in the 
                deferral under subparagraph (A) (including any 
                extension of such date under subparagraph 
                (B))--
                          (i) the assessment shall not be 
                        considered late or delayed;
                          (ii) the Secretary shall not classify 
                        the assessment as late or delayed in 
                        any report, database, or public 
                        posting.
                  [(B)] (D) Annual review.--
                          (i) * * *
                          [(ii) Public availability.--The 
                        information submitted through the 
                        annual review under clause (i) shall 
                        promptly be made available to the 
                        public in an easily accessible manner, 
                        including through the Web site of the 
                        Food and Drug Administration.]
                          (ii) Public availability.--Not later 
                        than 60 days after the submission to 
                        the Secretary of the information 
                        submitted through the annual review 
                        under clause (i), the Secretary shall 
                        make available to the public in an 
                        easily accessible manner, including 
                        through the Web site of the Food and 
                        Drug Administration--
                                  (I) such information;
                                  (II) the name of the 
                                applicant for the product 
                                subject to the assessment;
                                  (III) the date on which the 
                                product was approved; and
                                  (IV) the date of each 
                                deferral or deferral extension 
                                under this paragraph for the 
                                product.
          (4) Waivers.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) Pediatric formulation not possible.--If a 
                partial waiver is granted on the ground that it 
                is not possible to develop a pediatric 
                formulation, the waiver shall cover only the 
                pediatric groups requiring that formulation. An 
                applicant seeking [either a full or partial 
                waiver] a partial waiver shall submit to the 
                Secretary documentation detailing why a 
                pediatric formulation cannot be developed and, 
                if the waiver is granted, the applicant's 
                submission shall promptly be made available to 
                the public in an easily accessible manner, 
                including through posting on the Web site of 
                the Food and Drug Administration.

           *       *       *       *       *       *       *

  (b) Marketed Drugs and Biological Products.--
          (1) In general.--[After providing notice in the form 
        of a letter (that, for a drug approved under section 
        505, references a declined written request under 
        section 505A for a labeled indication which written 
        request is not referred under section 505A(n)(1)(A) to 
        the Foundation of the National Institutes of Health for 
        the pediatric studies), the Secretary] The Secretary 
        may (by order in the form of a letter) require the 
        sponsor or holder of an approved application for a drug 
        under section 505 or the holder of a license for a 
        biological product under section 351 of the Public 
        Health Service Act to submit by a specified date the 
        assessments described in subsection (a)(2), if the 
        Secretary finds that--
                  (A) * * *

           *       *       *       *       *       *       *

  [(d) Submission of Assessments.--If a person fails to submit 
an assessment described in subsection (a)(2), or a request for 
approval of a pediatric formulation described in subsection (a) 
or (b), in accordance with applicable provisions of subsections 
(a) and (b)--
          [(1) the drug or biological product that is the 
        subject of the assessment or request may be considered 
        misbranded solely because of that failure and subject 
        to relevant enforcement action (except that the drug or 
        biological product shall not be subject to action under 
        section 303); but
          [(2) the failure to submit the assessment or request 
        shall not be the basis for a proceeding--
                  [(A) to withdraw approval for a drug under 
                section 505(e); or
                  [(B) to revoke the license for a biological 
                product under section 351 of the Public Health 
                Service Act.
  [(e) Meetings.--Before and during the investigational process 
for a new drug or biological product, the Secretary shall meet 
at appropriate times with the sponsor of the new drug or 
biological product to discuss--
          [(1) information that the sponsor submits on plans 
        and timelines for pediatric studies; or
          [(2) any planned request by the sponsor for waiver or 
        deferral of pediatric studies.]
  (d) Failure To Meet Requirements.--If a person fails to 
submit a required assessment described in subsection (a)(2), 
fails to meet the applicable requirements in subsection (a)(3), 
or fails to submit a request for approval of a pediatric 
formulation described in subsection (a) or (b), in accordance 
with applicable provisions of subsections (a) and (b)--
          (1)(A) the Secretary shall issue a letter to such 
        person informing such person of such failure;
          (B) not later than 30 calendar days after the 
        issuance of a letter under subparagraph (A), the person 
        who receives such letter shall submit to the Secretary 
        a written response to such letter; and
          (C) not later than 45 calendar days after the 
        issuance of a letter under subparagraph (A), the 
        Secretary shall make such letter, and any response to 
        such letter under subparagraph (B), available to the 
        public on the Web site of the Food and Drug 
        Administration, with appropriate redactions made to 
        protect trade secrets and confidential commercial 
        information, except that, if the Secretary determines 
        that the letter under subparagraph (A) was issued in 
        error, the requirements of this subparagraph shall not 
        apply with respect to such letter; and
          (2)(A) the drug or biological product that is the 
        subject of the required assessment, applicable 
        requirements in subsection (a)(3), or required request 
        for approval of a pediatric formulation may be 
        considered misbranded solely because of that failure 
        and subject to relevant enforcement action (except that 
        the drug or biological product shall not be subject to 
        action under section 303); but
          (B) the failure to submit the required assessment, 
        meet the applicable requirements in subsection (a)(3), 
        or submit the required request for approval of a 
        pediatric formulation shall not be the basis for a 
        proceeding--
                  (i) to withdraw approval for a drug under 
                section 505(e); or
                  (ii) to revoke the license for a biological 
                product under section 351 of the Public Health 
                Service Act.
  (e) Initial Pediatric Plan.--
          (1) In general.--
                  (A) Submission.--An applicant who is required 
                to submit an assessment under subsection (a)(1) 
                shall submit an initial pediatric plan.
                  (B) Timing.--An applicant shall submit the 
                initial pediatric plan under paragraph (1)--
                          (i) before the date on which the 
                        applicant submits the assessments under 
                        subsection (a)(2); and
                          (ii) not later than--
                                  (I) 60 calendar days after 
                                the date of end-of-Phase 2 
                                meeting (as such term is used 
                                in section 312.47 of title 21, 
                                Code of Federal Regulations, or 
                                successor regulations); or
                                  (II) such other time as may 
                                be agreed upon between the 
                                Secretary and the applicant.
                Nothing in this section shall preclude the 
                Secretary from accepting the submission of an 
                initial pediatric plan earlier than the date 
                otherwise applicable under this subparagraph.
                  (C) Contents.--The initial pediatric plan 
                shall include--
                          (i) an outline of the pediatric 
                        studies that the applicant plans to 
                        conduct;
                          (ii) any request for a deferral, 
                        partial waiver, or waiver under this 
                        section, along with supporting 
                        information; and
                          (iii) other information the Secretary 
                        determines necessary, including any 
                        information specified in regulations 
                        under paragraph (5).
          (2) Meeting.--
                  (A) In general.--Subject to subparagraph (B), 
                not later than 90 calendar days after receiving 
                an initial pediatric plan under paragraph (1), 
                the Secretary shall meet with the applicant to 
                discuss the plan.
                  (B) Written response.--If the Secretary 
                determines that a written response to the 
                initial pediatric plan is sufficient to 
                communicate comments on the initial pediatric 
                plan, and that no meeting is necessary the 
                Secretary shall, not later than 90 days after 
                receiving an initial pediatric plan under 
                paragraph (1)--
                          (i) notify the applicant of such 
                        determination; and
                          (ii) provide to the applicant the 
                        Secretary's written comments on the 
                        plan.
          (3) Agreed pediatric plan.--
                  (A) Submission.--The applicant shall submit 
                to the Secretary a document reflecting the 
                agreement between the Secretary and the 
                applicant on the initial pediatric plan 
                (referred to in this subsection as an ``agreed 
                pediatric plan'').
                  (B) Confirmation.--Not later than 30 days 
                after receiving the agreed pediatric plan under 
                subparagraph (A), the Secretary shall provide 
                written confirmation to the applicant that such 
                plan reflects the agreement of the Secretary.
                  (C) Deferral and waiver.--If the agreed 
                pediatric plan contains a request from the 
                applicant for a deferral, partial waiver, or 
                waiver under this section, the written 
                confirmation under subparagraph (B) shall 
                include a recommendation from the Secretary as 
                to whether such request meets the standards 
                under paragraphs (3) or (4) of subsection (a).
                  (D) Amendments to the plan.--At the 
                initiative of the Secretary or the applicant, 
                the agreed pediatric plan may be amended at any 
                time. The requirements of paragraph (2) shall 
                apply to any such proposed amendment in the 
                same manner and to the same extent as such 
                requirements apply to an initial pediatric plan 
                under paragraph (1). The requirements of 
                subparagraphs (A) through (C) of this paragraph 
                shall apply to any agreement resulting from 
                such proposed amendment in the same manner and 
                to the same extent as such requirements apply 
                to an agreed pediatric plan.
          (4) Internal committee.--The Secretary shall consult 
        the internal committee under section 505C on the review 
        of the initial pediatric plan, agreed pediatric plan, 
        and any amendments to such plans.
          (5) Mandatory rulemaking.--Not later than one year 
        after the date of enactment of the Food and Drug 
        Administration Reform Act of 2012, the Secretary shall 
        promulgate proposed regulations and guidance to 
        implement the provisions of this subsection.
          (6) Effective date.--The provisions of this 
        subsection shall take effect 180 calendar days after 
        the date of enactment of the Food and Drug 
        Administration Reform Act of 2012, irrespective of 
        whether the Secretary has promulgated final regulations 
        to carry out this subsection by such date.
  (f) Review of Pediatric Plans, Assessments, Deferrals, 
Deferral Extensions, and Waivers.--
          (1) * * *

           *       *       *       *       *       *       *

          (4) Review of pediatric plans, assessments, 
        deferrals, deferral extensions, and waivers.--
        Consultation on pediatric plans and assessments by the 
        committee referred to in paragraph (1) pursuant to this 
        section shall occur prior to approval of an application 
        or supplement for which a pediatric assessment is 
        required under this section. The committee shall review 
        all requests for deferrals, deferral extensions, and 
        waivers from the requirement to submit a pediatric 
        assessment granted under this section and shall provide 
        recommendations as needed to reviewing divisions, 
        including with respect to whether such a supplement, 
        when submitted, shall be considered for priority 
        review.

           *       *       *       *       *       *       *

          (6) Tracking of assessments and labeling changes.--
        The Secretary, in consultation with the committee 
        referred to in paragraph (1), shall track and make 
        available to the public in an easily accessible manner, 
        including through posting on the Web site of the Food 
        and Drug Administration--
                  (A) * * *

           *       *       *       *       *       *       *

                  (D) the total number of deferrals and 
                deferral extensions requested and granted under 
                this section and, if granted, the reasons for 
                such deferrals and deferral extensions, the 
                timeline for completion, and the number 
                completed and pending by the specified date, as 
                outlined in subsection (a)(3);

           *       *       *       *       *       *       *

  (g) Labeling Changes.--
          (1) Dispute resolution.--
                  (A) Request for labeling change and failure 
                to agree.--If, on or after the date of the 
                enactment of the Pediatric Research Equity Act 
                of 2007, the Commissioner determines that a 
                sponsor and the Commissioner have been unable 
                to reach agreement on appropriate changes to 
                the labeling for the drug that is the subject 
                of the application or supplement, not later 
                than 180 days [after the date of the submission 
                of the application or supplement] after the 
                date of the submission of an application or 
                supplement that receives a priority review or 
                330 days after the date of the submission of an 
                application or supplement that receives a 
                standard review--
                          (i) * * *

           *       *       *       *       *       *       *

          (2) Other labeling changes.--If, on or after the date 
        of the enactment of the Pediatric Research Equity Act 
        of 2007, the Secretary makes a determination that a 
        pediatric assessment conducted under this section does 
        or does not demonstrate that the drug that is the 
        subject of such assessment is safe and effective in 
        pediatric populations or subpopulations, including 
        whether such assessment results are inconclusive, the 
        Secretary shall order [the label of such product] the 
        labeling of such product to include information about 
        the results of the assessment and a statement of the 
        Secretary's determination.
  (h) Dissemination of Pediatric Information.--
          (1) In general.--Not later than 210 days after the 
        date of submission of an application (or supplement to 
        an application) that contains a pediatric assessment 
        under this section, if the application (or supplement) 
        receives a priority review, or not later than 330 days 
        after the date of submission of an application (or 
        supplement to an application) that contains a pediatric 
        assessment under this section, if the application (or 
        supplement) receives a standard review, the Secretary 
        shall make available to the public in an easily 
        accessible manner the medical, statistical, and 
        clinical pharmacology reviews of such pediatric 
        assessments, and shall post such assessments on the Web 
        site of the Food and Drug Administration.

           *       *       *       *       *       *       *

  (i) Adverse Event Reporting.--
          (1) Reporting in [year one] first 18-month period.--
        Beginning on the date of the enactment of the Pediatric 
        Research Equity Act of 2007, during the [one-year] 18-
        month period beginning on the date a labeling change is 
        made pursuant to subsection (g), the Secretary shall 
        ensure that all adverse event reports that have been 
        received for such drug (regardless of when such report 
        was received) are referred to the Office of Pediatric 
        Therapeutics. In considering such reports, the Director 
        of such Office shall provide for the review of such 
        reports by the Pediatric Advisory Committee, including 
        obtaining any recommendations of such committee 
        regarding whether the Secretary should take action 
        under this Act in response to such reports.
          (2) Reporting in subsequent [years] periods.--
        Following the [one-year period] 18-month period 
        described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric 
        Therapeutics all pediatric adverse event reports for a 
        drug for which a pediatric study was conducted under 
        this section. In considering such reports, the Director 
        of such Office may provide for the review of such 
        reports by the Pediatric Advisory Committee, including 
        obtaining any recommendation of such Committee 
        regarding whether the Secretary should take action in 
        response to such reports.
          (3) Preservation of authority.--Nothing in this 
        subsection shall prohibit the Office of Pediatric 
        Therapeutics from providing for the review of adverse 
        event reports by the Pediatric Advisory Committee prior 
        to the 18-month period referred to in paragraph (1), if 
        such review is necessary to ensure safe use of a drug 
        in a pediatric population.
          [(3)] (4) Effect.--The requirements of this 
        subsection shall supplement, not supplant, other review 
        of such adverse event reports by the Secretary.

           *       *       *       *       *       *       *

  [(m) Integration With Other Pediatric Studies.--The authority 
under this section shall remain in effect so long as an 
application subject to this section may be accepted for filing 
by the Secretary on or before the date specified in section 
505A(q).]
  [(n)] (m) New Active Ingredient.--
          (1) * * *

           *       *       *       *       *       *       *


SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, 
                    ASSESSMENTS, DEFERRALS, DEFERRAL EXTENSIONS, AND 
                    WAIVERS.

  The Secretary shall establish an internal committee within 
the Food and Drug Administration to carry out the activities as 
described in sections 505A(f) and 505B(f). Such internal 
committee shall include employees of the Food and Drug 
Administration, with expertise in pediatrics (including 
representation from the Office of Pediatric Therapeutics), 
biopharmacology, statistics, chemistry, legal issues, pediatric 
ethics neonatology, and the appropriate expertise pertaining to 
the pediatric product under review, such as expertise in child 
and adolescent psychiatry, and other individuals designated by 
the Secretary.

           *       *       *       *       *       *       *


SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED INFECTIOUS 
                    DISEASE PRODUCTS.

  (a) Extension.--If the Secretary approves an application 
pursuant to section 505 for a drug that has been determined to 
be a qualified infectious disease product under subsection (d), 
then the four- and five-year periods described in subsections 
(c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the three-year 
periods described in clauses (iii) and (iv) of subsection 
(c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of 
section 505, or the seven year period described in section 527, 
as applicable, shall be extended by five years.
  (b) Relation to Pediatric Exclusivity.--Any extension under 
subsection (a) of a period shall be in addition to any 
extension of the period under section 505A with respect to the 
drug.
  (c) Limitations.--Subsection (a) does not apply to the 
approval of--
          (1) a supplement to an application under section 
        505(b) for any qualified infectious disease product for 
        which an extension described in subsection (a) is in 
        effect or has expired;
          (2) a subsequent application filed by the same 
        sponsor or manufacturer of a qualified infectious 
        disease product described in paragraph (1) (or a 
        licensor, predecessor in interest, or other related 
        entity) for--
                  (A) a change (not including a modification to 
                the active moiety of the qualified infectious 
                disease product) that results in a new 
                indication, route of administration, dosing 
                schedule, dosage form, delivery system, 
                delivery device, or strength; or
                  (B) a modification to the active moiety of 
                the qualified infectious disease product that 
                does not result in a change in safety or 
                effectiveness; or
          (3) a product that does not meet the definition of a 
        qualified infectious disease product under subsection 
        (f) based upon its approved uses.
  (d) Determination.--The manufacturer or sponsor of a drug may 
request that the Secretary designate a drug as a qualified 
infectious disease product at any time in the drug development 
process prior to the submission of an application under section 
505(b) for the drug, but not later than 45 days before the 
submission of such application. The Secretary shall, not later 
than 30 days after the submission of such request, determine 
whether the drug is a qualified infectious disease product.
  (e) Regulations.--The Secretary shall promulgate regulations 
for carrying out this section. The Secretary shall promulgate 
the initial regulations for carrying out this section not later 
than 12 months after the date of the enactment of this section.
  (f) Definitions.--In this section:
          (1) Qualified infectious disease product.--The term 
        ``qualified infectious disease product'' means an 
        antibacterial or antifungal drug for human use that 
        treats or prevents an infection caused by a qualifying 
        pathogen.
          (2) Qualifying pathogen.--The term ``qualifying 
        pathogen'' means--
                  (A) resistant gram-positive pathogens, 
                including methicillin-resistant Staphylococcus 
                aureus (MRSA), vancomycin-resistant 
                Staphylococcus aureus (VRSA), and vancomycin-
                resistant enterococcus (VRE);
                  (B) multidrug resistant gram-negative 
                bacteria, including Acinetobacter, Klebsiella, 
                Pseudomonas, and E. coli species;
                  (C) multi-drug resistant tuberculosis; or
                  (D) any other infectious pathogen identified 
                for purposes of this section by the Secretary.

[SEC. 506. FAST TRACK PRODUCTS.

  [(a) Designation of Drug as a Fast Track Product.--
          [(1) In general.--The Secretary shall, at the request 
        of the sponsor of a new drug, facilitate the 
        development and expedite the review of such drug if it 
        is intended for the treatment of a serious or life-
        threatening condition and it demonstrates the potential 
        to address unmet medical needs for such a condition. 
        (In this section, such a drug is referred to as a 
        ``fast track product''.)
          [(2) Request for designation.--The sponsor of a new 
        drug may request the Secretary to designate the drug as 
        a fast track product. A request for the designation may 
        be made concurrently with, or at any time after, 
        submission of an application for the investigation of 
        the drug under section 505(i) or section 351(a)(3) of 
        the Public Health Service Act.
          [(3) Designation.--Within 60 calendar days after the 
        receipt of a request under paragraph (2), the Secretary 
        shall determine whether the drug that is the subject of 
        the request meets the criteria described in paragraph 
        (1). If the Secretary finds that the drug meets the 
        criteria, the Secretary shall designate the drug as a 
        fast track product and shall take such actions as are 
        appropriate to expedite the development and review of 
        the application for approval of such product.
  [(b) Approval of Application for a Fast Track Product.--
          [(1) In general.--The Secretary may approve an 
        application for approval of a fast track product under 
        section 505(c) or section 351 of the Public Health 
        Service Act upon a determination that the product has 
        an effect on a clinical endpoint or on a surrogate 
        endpoint that is reasonably likely to predict clinical 
        benefit.
          [(2) Limitation.--Approval of a fast track product 
        under this subsection may be subject to the 
        requirements--
                  [(A) that the sponsor conduct appropriate 
                post-approval studies to validate the surrogate 
                endpoint or otherwise confirm the effect on the 
                clinical endpoint; and
                  [(B) that the sponsor submit copies of all 
                promotional materials related to the fast track 
                product during the preapproval review period 
                and, following approval and for such period 
                thereafter as the Secretary determines to be 
                appropriate, at least 30 days prior to 
                dissemination of the materials.
          [(3) Expedited withdrawal of approval.--The Secretary 
        may withdraw approval of a fast track product using 
        expedited procedures (as prescribed by the Secretary in 
        regulations which shall include an opportunity for an 
        informal hearing) if--
                  [(A) the sponsor fails to conduct any 
                required post-approval study of the fast track 
                drug with due diligence;
                  [(B) a post-approval study of the fast track 
                product fails to verify clinical benefit of the 
                product;
                  [(C) other evidence demonstrates that the 
                fast track product is not safe or effective 
                under the conditions of use; or
                  [(D) the sponsor disseminates false or 
                misleading promotional materials with respect 
                to the product.
  [(c) Review of Incomplete Applications for Approval of a Fast 
Track Product.--
          [(1) In general.--If the Secretary determines, after 
        preliminary evaluation of clinical data submitted by 
        the sponsor, that a fast track product may be 
        effective, the Secretary shall evaluate for filing, and 
        may commence review of portions of, an application for 
        the approval of the product before the sponsor submits 
        a complete application. The Secretary shall commence 
        such review only if the applicant--
                  [(A) provides a schedule for submission of 
                information necessary to make the application 
                complete; and
                  [(B) pays any fee that may be required under 
                section 736.
          [(2) Exception.--Any time period for review of human 
        drug applications that has been agreed to by the 
        Secretary and that has been set forth in goals 
        identified in letters of the Secretary (relating to the 
        use of fees collected under section 736 to expedite the 
        drug development process and the review of human drug 
        applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which 
        the application is complete.
  [(d) Awareness Efforts.--The Secretary shall--
          [(1) develop and disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology 
        companies, and other appropriate persons a description 
        of the provisions of this section applicable to fast 
        track products; and
          [(2) establish a program to encourage the development 
        of surrogate endpoints that are reasonably likely to 
        predict clinical benefit for serious or life-
        threatening conditions for which there exist 
        significant unmet medical needs.]

SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-THREATENING 
                    DISEASES OR CONDITIONS.

  (a) Designation of a Drug as a Breakthrough Therapy.--
          (1) In general.--The Secretary shall, at the request 
        of the sponsor of a drug, expedite the development and 
        review of such drug if the drug is intended, alone or 
        in combination with 1 or more other drugs, to treat a 
        serious or life-threatening disease or condition and 
        preliminary clinical evidence indicates that the drug 
        may demonstrate substantial improvement over existing 
        therapies on 1 or more clinically significant 
        endpoints, such as substantial treatment effects 
        observed early in clinical development. (In this 
        section, such a drug is referred to as a ``breakthrough 
        therapy''.)
          (2) Request for designation.--The sponsor of a drug 
        may request the Secretary to designate the drug as a 
        breakthrough therapy. A request for the designation may 
        be made concurrently with, or at any time after, the 
        submission of an application for the investigation of 
        the drug under section 505(i) or section 351(a)(3) of 
        the Public Health Service Act.
          (3) Designation.--
                  (A) In general.--Not later than 60 calendar 
                days after the receipt of a request under 
                paragraph (2), the Secretary shall determine 
                whether the drug that is the subject of the 
                request meets the criteria described in 
                paragraph (1). If the Secretary finds that the 
                drug meets the criteria, the Secretary shall 
                designate the drug as a breakthrough therapy 
                and shall take such actions as are appropriate 
                to expedite the development and review of the 
                application for approval of such drug.
                  (B) Actions.--The actions to expedite the 
                development and review of an application under 
                subparagraph (A) may include, as appropriate--
                          (i) holding meetings with the sponsor 
                        and the review team throughout the 
                        development of the drug;
                          (ii) providing timely advice to, and 
                        interactive communication with, the 
                        sponsor regarding the development of 
                        the drug to ensure that the development 
                        program to gather the non-clinical and 
                        clinical data necessary for approval is 
                        as efficient as practicable;
                          (iii) involving senior managers and 
                        experienced review staff, as 
                        appropriate, in a collaborative, cross-
                        disciplinary review;
                          (iv) assigning a cross-disciplinary 
                        project lead for the Food and Drug 
                        Administration review team to 
                        facilitate an efficient review of the 
                        development program and to serve as a 
                        scientific liaison between the review 
                        team and the sponsor; and
                          (v) taking steps to ensure that the 
                        design of the clinical trials is as 
                        efficient as practicable, when 
                        scientifically appropriate, such as by 
                        minimizing the number of patients 
                        exposed to a potentially less 
                        efficacious treatment.
  (b) Designation of Drug as a Fast Track Product.--
          (1) In general.--The Secretary shall, at the request 
        of the sponsor of a new drug, facilitate the 
        development and expedite the review of such drug if it 
        is intended, whether alone or in combination with one 
        or more other drugs, for the treatment of a serious or 
        life-threatening disease or condition, and it 
        demonstrates the potential to address unmet medical 
        needs for such a disease or condition. (In this 
        section, such a drug is referred to as a ``fast track 
        product''.)
          (2) Request for designation.--The sponsor of a new 
        drug may request the Secretary to designate the drug as 
        a fast track product. A request for the designation may 
        be made concurrently with, or at any time after, 
        submission of an application for the investigation of 
        the drug under section 505(i) of this Act or section 
        351(a)(3) of the Public Health Service Act.
          (3) Designation.--Within 60 calendar days after the 
        receipt of a request under paragraph (2), the Secretary 
        shall determine whether the drug that is the subject of 
        the request meets the criteria described in paragraph 
        (1). If the Secretary finds that the drug meets the 
        criteria, the Secretary shall designate the drug as a 
        fast track product and shall take such actions as are 
        appropriate to expedite the development and review of 
        the application for approval of such product.
  (c) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track 
Product.--
          (1) In general.--The Secretary may approve an 
        application for approval of a product for a serious or 
        life-threatening disease or condition, including a fast 
        track product, under section 505(c) of this Act or 
        section 351(a) of the Public Health Service Act upon 
        making a determination that the product has an effect 
        on--
                  (A) a surrogate endpoint that is reasonably 
                likely to predict clinical benefit; or
                  (B) a clinical endpoint that can be measured 
                earlier than irreversible morbidity or 
                mortality, that is reasonably likely to predict 
                an effect on irreversible morbidity or 
                mortality or other clinical benefit,
        taking into account the severity or rarity of the 
        disease or condition and the availability of 
        alternative treatments. The evidence to support that an 
        endpoint is reasonably likely to predict clinical 
        benefit may include epidemiological, pathophysiologic, 
        pharmacologic, therapeutic or other evidence developed 
        using, for example, biomarkers, or other scientific 
        methods or tools.
          (2) Limitation.--Approval of a product under this 
        subsection may, as determined by the Secretary, be 
        subject to the following requirements--
                  (A) that the sponsor conduct appropriate 
                post-approval studies to verify and describe 
                the predicted effect of the product on 
                irreversible morbidity or mortality or other 
                clinical benefit; and
                  (B) that the sponsor submit copies of all 
                promotional materials related to the product, 
                at least 30 days prior to dissemination of the 
                materials--
                          (i) during the preapproval review 
                        period; and
                          (ii) following approval, for a period 
                        that the Secretary determines to be 
                        appropriate.
          (3) Expedited withdrawal of approval.--The Secretary 
        may withdraw approval of a product approved pursuant to 
        this subsection using expedited procedures (as 
        prescribed by the Secretary in regulations, which shall 
        include an opportunity for an informal hearing) if--
                  (A) the sponsor fails to conduct any required 
                post-approval study of the product with due 
                diligence;
                  (B) a study required to verify and describe 
                the predicted effect on irreversible morbidity 
                or mortality or other clinical benefit of the 
                product fails to verify and describe such 
                effect or benefit;
                  (C) other evidence demonstrates that the 
                product is not safe or effective under the 
                conditions of use; or
                  (D) the sponsor disseminates false or 
                misleading promotional materials with respect 
                to the product.
  (d) Review of Incomplete Applications for Approval of a Fast 
Track Product.--
          (1) In general.--If the Secretary determines, after 
        preliminary evaluation of clinical data submitted by 
        the sponsor, that a fast track product may be 
        effective, the Secretary shall evaluate for filing, and 
        may commence review of portions of, an application for 
        the approval of the product before the sponsor submits 
        a complete application. The Secretary shall commence 
        such review only if the applicant--
                  (A) provides a schedule for submission of 
                information necessary to make the application 
                complete; and
                  (B) pays any fee that may be required under 
                section 736.
          (2) Exception.--Any time period for review of human 
        drug applications that has been agreed to by the 
        Secretary and that has been set forth in goals 
        identified in letters of the Secretary (relating to the 
        use of fees collected under section 736 to expedite the 
        drug development process and the review of human drug 
        applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which 
        the application is complete.
  (f) Awareness Efforts.--The Secretary shall--
          (1) develop and disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology 
        companies, and other appropriate persons a description 
        of the provisions of this section applicable to 
        breakthrough therapies, accelerated approval, and and 
        fast track products; and
          (2) establish a program to encourage the development 
        of surrogate and clinical endpoints, including 
        biomarkers, and other scientific methods and tools that 
        can assist the Secretary in determining whether the 
        evidence submitted in an application is reasonably 
        likely to predict clinical benefit for serious or life-
        threatening conditions for which there exist 
        significant unmet medical needs.
  (g) Report.--Beginning in fiscal year 2013, the Secretary 
shall annually prepare and submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives, and 
make publicly available, with respect to this section for the 
previous fiscal year--
          (1) the number of drugs for which a sponsor requested 
        designation as a breakthrough therapy;
          (2) the number of products designated as a 
        breakthrough therapy; and
          (3) for each product designated as a breakthrough 
        therapy, a summary of the actions taken under 
        subsection (a)(3).

           *       *       *       *       *       *       *


SEC. 506A. MANUFACTURING CHANGES.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Major Manufacturing Changes.--
          (1) * * *

           *       *       *       *       *       *       *

          (3) Changes addressing a drug shortage.--
                  (A) Certification.--
                          (i) Description.--A certification is 
                        described in this subparagraph if the 
                        manufacturer, having notified the 
                        Secretary of an interruption or 
                        discontinuance of a drug in accordance 
                        with Section 506C, certifies (in such 
                        certification) that the major 
                        manufacturing change for which approval 
                        is being sought may prevent or 
                        alleviate a discontinuance or 
                        interruption of such drug.
                          (ii) Bad faith exception.--
                        Subparagraphs (B) and (C) do not apply 
                        in the case of a certification which 
                        the Secretary determines to be made in 
                        bad faith.
                  (B) Expedited review.--If a certification 
                described in subparagraph (A) is submitted in 
                connection with a supplemental application for 
                a major manufacturing change, the Secretary 
                shall--
                          (i) expedite any technical review or 
                        inspection necessary for consideration 
                        of the supplemental application;
                          (ii) provide any technical assistance 
                        necessary to facilitate approval of the 
                        supplemental application; and
                          (iii) not later than 60 days after 
                        receipt of the certification, complete 
                        review of the supplemental application.

           *       *       *       *       *       *       *


SEC. 506B. REPORTS OF POSTMARKETING STUDIES.

  (a) * * *

           *       *       *       *       *       *       *

  (e) Notification.--With respect to studies of the type 
required under [section 506(b)(2)(A)] section 506(c)(2)(A) or 
under section 314.510 or 601.41 of title 21, Code of Federal 
Regulations, as each of such sections was in effect on the day 
before the effective date of this subsection, the Secretary may 
require that a sponsor who, for reasons not satisfactory to the 
Secretary, fails to complete by its deadline a study under any 
of such sections of such type for a drug or biological product 
(including such a study conducted after such effective date) 
notify practitioners who prescribe such drug or biological 
product of the failure to complete such study and the questions 
of clinical benefit, and, where appropriate, questions of 
safety, that remain unanswered as a result of the failure to 
complete such study. Nothing in this subsection shall be 
construed as altering the requirements of the types of studies 
required under [section 506(b)(2)(A)] section 506(c)(2)(A) or 
under section 314.510 or 601.41 of title 21, Code of Federal 
Regulations, as so in effect, or as prohibiting the Secretary 
from modifying such sections of title 21 of such Code to 
provide for studies in addition to those of such type.

[SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT.

  [(a) In General.--A manufacturer that is the sole 
manufacturer of a drug--
          [(1) that is--
                  [(A) life-supporting;
                  [(B) life-sustaining; or
                  [(C) intended for use in the prevention of a 
                debilitating disease or condition;
          [(2) for which an application has been approved under 
        section 505(b) or 505(j); and
          [(3) that is not a product that was originally 
        derived from human tissue and was replaced by a 
        recombinant product,
shall notify the Secretary of a discontinuance of the 
manufacture of the drug at least 6 months prior to the date of 
the discontinuance.
  [(b) Reduction in Notification Period.--The notification 
period required under subsection (a) for a manufacturer may be 
reduced if the manufacturer certifies to the Secretary that 
good cause exists for the reduction, such as a situation in 
which--
          [(1) a public health problem may result from 
        continuation of the manufacturing for the 6-month 
        period;
          [(2) a biomaterials shortage prevents the 
        continuation of the manufacturing for the 6-month 
        period;
          [(3) a liability problem may exist for the 
        manufacturer if the manufacturing is continued for the 
        6-month period;
          [(4) continuation of the manufacturing for the 6-
        month period may cause substantial economic hardship 
        for the manufacturer;
          [(5) the manufacturer has filed for bankruptcy under 
        chapter 7 or 11 of title 11, United States Code; or
          [(6) the manufacturer can continue the distribution 
        of the drug involved for 6 months.
  [(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute information on the discontinuation 
of the drugs described in subsection (a) to appropriate 
physician and patient organizations.]

SEC. 506C. DISCONTINUANCE AND INTERRUPTIONS OF MANUFACTURING OF CERTAIN 
                    DRUGS.

  (a) In General.--A manufacturer of a drug subject to section 
503(b)(1)--
          (1) that is--
                  (A) life-supporting;
                  (B) life-sustaining; or
                  (C) intended for use in the prevention or 
                treatment of a debilitating disease or 
                condition; and
          (2) that is not a radio pharmaceutical drug product, 
        a product derived from human plasma protein and their 
        recombinant analogs, or any other product as designated 
        by the Secretary,
shall notify the Secretary of a discontinuance of the 
manufacture of the drug, or an interruption of the manufacture 
of the drug that is likely to lead to a meaningful disruption 
in the manufacturer's supply of the drug, and the reason for 
such discontinuance or interruption, in accordance with 
subsection (b).
  (b) Timing.--A notice required by subsection (a) shall be 
submitted to the Secretary--
          (1) at least 6 months prior to the date of the 
        discontinuance or interruption; or
          (2) if compliance with paragraph (1) is not possible, 
        as soon as practicable.
  (c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute information on the discontinuation 
or interruption of the manufacture of the drugs described in 
subsection (a) to appropriate organizations, including 
physician, health provider, and patient organizations, as 
described in section 506D.
  (d) Confidentiality.--Nothing in this section shall be 
construed as authorizing the Secretary to disclose any 
information that is a trade secret or confidential information 
subject to section 552(b)(4) of title 5, United States Code, or 
section 1905 of title 18, United States Code.
  (e) Coordination With Attorney General.--Not later than 30 
days after the receipt of a notification described in 
subsection (a), the Secretary shall--
          (1) determine whether the notification pertains to a 
        controlled substance subject to a production quota 
        under section 306 of the Controlled Substances Act; and
          (2) if necessary, as determined by the Secretary--
                  (A) notify the Attorney General that the 
                Secretary has received such a notification;
                  (B) request that the Attorney General 
                increase the aggregate and individual 
                production quotas under section 306 of the 
                Controlled Substances Act applicable to such 
                controlled substance and any ingredient therein 
                to a level the Secretary deems necessary to 
                address a shortage of a controlled substance 
                based on the best available market data; and
                  (C) if the Attorney General determines that 
                the level requested is not necessary to address 
                a shortage of a controlled substance, the 
                Attorney General shall provide to the Secretary 
                a written response detailing the basis for the 
                Attorney General's determination.
        The Secretary shall make the written response provided 
        under subparagraph (C) available to the public on the 
        Web site of the Food and Drug Administration.
  (f) Failure To Meet Requirements.--If a person fails to 
submit information required under subsection (a) in accordance 
with subsection (b)--
          (1) the Secretary shall issue a letter to such person 
        informing such person of such failure;
          (2) not later than 30 calendar days after the 
        issuance of a letter under paragraph (1), the person 
        who receives such letter shall submit to the Secretary 
        a written response to such letter setting forth the 
        basis for noncompliance and providing information 
        required under subsection (a); and
          (3) not later than 45 calendar days after the 
        issuance of a letter under paragraph (1), the Secretary 
        shall make such letter and any response to such letter 
        under paragraph (2) available to the public on the Web 
        site of the Food and Drug Administration, with 
        appropriate redactions made to protect information 
        described in subsection (d), except that, if the 
        Secretary determines that the letter under paragraph 
        (1) was issued in error or, after review of such 
        response, the person had a reasonable basis for not 
        notifying as required under subsection (a), the 
        requirements of this paragraph shall not apply.

SEC. 506D. DRUG SHORTAGE LIST.

  (a) Establishment.--The Secretary shall maintain an up-to-
date list of drugs that are determined by the Secretary to be 
in shortage in the United States.
  (b) Contents.--For each drug on such list, the Secretary 
shall include the following information:
          (1) The name of the drug in shortage.
          (2) The name of each manufacturer of such drug.
          (3) The reason for the shortage, as determined by the 
        Secretary, selecting from the following categories:
                  (A) Requirements related to complying with 
                good manufacturing practices.
                  (B) Regulatory delay.
                  (C) Shortage of an active ingredient.
                  (D) Shortage of an inactive ingredient 
                component.
                  (E) Discontinuation of the manufacture of the 
                drug.
                  (F) Delay in shipping of the drug.
                  (G) Demand increase for the drug.
          (4) The estimated duration of the shortage as 
        determined by the Secretary.
  (c) Public Availability.--
          (1) In general.--Subject to paragraphs (2) and (3), 
        the Secretary shall make the information in such list 
        publicly available.
          (2) Trade secrets and confidential information.--
        Nothing in this section alters or amends section 1905 
        of title 18, United States Code, or section 552(b)(4) 
        of title 5 of such Code.
          (3) Public health exception.--The Secretary may 
        choose not to make information collected under this 
        section publicly available under paragraph (1) if the 
        Secretary determines that disclosure of such 
        information would adversely affect the public health 
        (such as by increasing the possibility of hoarding or 
        other disruption of the availability of drug products 
        to patients).

SEC. 506E. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.

  (a) Definitions.--In this section:
          (1) Drug.--The term ``drug'' excludes any controlled 
        substance (as such term is defined in section 102 of 
        the Controlled Substances Act).
          (2) Health system.--The term ``health system'' means 
        a collection of hospitals that are owned and operated 
        by the same entity and that share access to databases 
        with drug order information for their patients.
          (3) Repackage.--For the purposes of this section 
        only, the term ``repackage'', with respect to a drug, 
        means to divide the volume of a drug into smaller 
        amounts in order to--
                  (A) extend the supply of a drug in response 
                to the placement of the drug on a drug shortage 
                list described in subsection (b); and
                  (B) facilitate access to the drug by 
                hospitals within the same health system.
  (b) Exclusion From Registration.--Notwithstanding any other 
provision of this Act, a hospital shall not be considered an 
establishment for which registration is required under section 
510 solely because it repackages a drug and transfers it to 
another hospital within the same health system in accordance 
with the conditions in subsection (c)--
          (1) during any period in which the drug is listed on 
        the Drug Shortage List of the Food and Drug 
        Administration; or
          (2) during the 60-day period following any period 
        described in paragraph (1).
  (c) Conditions.--Subsection (b) shall only apply to a 
hospital, with respect to the repackaging of a drug for 
transfers to another hospital within the same health system, if 
the following conditions are met:
          (1) Drug for intrasystem use only.--In no case may a 
        drug that has been repackaged in accordance with this 
        section be sold or otherwise distributed by the health 
        system or a hospital within the system to an entity or 
        individual that is not a hospital within such health 
        system.
          (2) Compliance with state rules.--Repackaging of a 
        drug under this section shall be done in compliance 
        with applicable State requirements in which the health 
        system is located.
  (d) Termination.--This section shall not apply on or after 
the date on which the Secretary issues final guidance that 
clarifies the policy of the Food and Drug Administration 
regarding hospital pharmacies repackaging and safely 
transferring repackaged drugs to other hospitals within the 
same health system during a drug shortage.

           *       *       *       *       *       *       *

  Sec. 510. (a) * * *
  (b)(1) [On or before] During the period beginning on October 
1 and ending on December 31 of each year every person who owns 
or operates any establishment in any State engaged in the 
manufacture, preparation, propagation, compounding, or 
processing of a drug or drugs shall register with the Secretary 
his name, places of business, [and all such establishments] all 
such establishments, and the unique facility identifier of each 
such establishment.

           *       *       *       *       *       *       *

  (c) Every person upon first engaging in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
or drugs or a device or devices in any establishment which he 
owns or operates in any State shall immediately register with 
the Secretary his name, place of business, [and such 
establishment] such establishment, and the unique facility 
identifier of such establishment.

           *       *       *       *       *       *       *

  (h)(1) Every establishment in any State registered with the 
Secretary pursuant to this section with respect to the 
manufacture, preparation, propagation, compounding, or 
processing of a device shall be subject to inspection pursuant 
to section 704 and every such establishment engaged in the 
manufacture, propagation, compounding, or processing [of a drug 
or drugs or] of a device or devices classified in class II or 
III shall be so inspected by one or more officers or employees 
duly designated by the Secretary, or by persons accredited to 
conduct inspections under section 704(g), at least once in the 
2-year period beginning with the date of registration of such 
establishment pursuant to this section and at least once in 
every successive 2-year period thereafter.
  (2) Inspections With Respect to Drug Establishments.--With 
respect to the manufacture, preparation, propagation, 
compounding, or processing of a drug:
          (A) In general.--Every establishment that is required 
        to be registered with the Secretary under this section 
        shall be subject to inspection pursuant to section 704.
          (B) Risk-based schedule.--In the case of an 
        establishment that is engaged in the manufacture, 
        preparation, propagation, compounding, or processing of 
        a drug or drugs (referred to in this subsection as a 
        ``drug establishment''), the inspections required under 
        subparagraph (A) shall be conducted by officers or 
        employees duly designated by the Secretary, on a risk-
        based schedule established by the Secretary.
          (C) Risk factors.--In establishing the risk-based 
        schedule under subparagraph (B), the Secretary shall 
        allocate resources to inspect establishments according 
        to the known safety risks of such establishments, based 
        on the following factors:
                  (i) The compliance history of the 
                establishment.
                  (ii) The inspection frequency and history of 
                the establishment, including whether it has 
                been inspected pursuant to section 704 within 
                the last four years.
                  (iii) The record, history, and nature of 
                recalls linked to the establishment.
                  (iv) The inherent risk of the drug 
                manufactured, prepared, propagated, compounded, 
                or processed at the establishment.
                  (v) Any other criteria deemed necessary and 
                appropriate by the Secretary for purposes of 
                allocating inspection resources.
          (D) Effect of status.--In determining the risk 
        associated with an establishment for purposes of 
        establishing a risk-based schedule under subparagraph 
        (B), the Secretary shall not consider whether the drugs 
        manufactured, prepared, propagated, compounded, or 
        processed by such establishment are drugs described in 
        section 503(b)(1).
          (E) Annual report on inspections of establishments.--
        Not later than February 1 of each year, the Secretary 
        shall submit to Congress a report that contains the 
        following:
                  (i) The number of domestic and foreign 
                establishments registered pursuant to this 
                section in the previous calendar year.
                  (ii) The number of such registered domestic 
                and foreign establishments that the Secretary 
                inspected in the previous calendar year.
                  (iii) The number of such registered 
                establishments that list one or more drugs 
                approved pursuant to an application filed under 
                section 505(j).
                  (iv) The number of such registered 
                establishments that list one or more drugs 
                approved pursuant to an application filed under 
                section 505(b).
                  (v) The number of registered establishments 
                that list both drug products approved pursuant 
                to an application filed under section 505(j) 
                and drug products approved pursuant to an 
                application filed under section 505(b).
                  (vi) A description of how the Secretary 
                implemented the risk-based schedule under 
                subparagraph (B) utilizing the factors under 
                subparagraph (C).
          (F) Public availability of annual reports.--The 
        Secretary shall make the report required under 
        subparagraph (E) available to the public on the 
        Internet Web site of the Food and Drug Administration.
  (i)(1) Any establishment within any foreign country engaged 
in the manufacture, preparation, propagation, compounding, or 
processing of a drug or device that is imported or offered for 
import into the United States shall, through electronic means 
in accordance with the criteria of the Secretary--
          (A) upon first engaging in any such activity, 
        immediately register with the Secretary the name and 
        place of business of the establishment, the unique 
        facility identifier of the establishment, the name of 
        the United States agent for the establishment, the name 
        of each importer of such drug or device in the United 
        States that is known to the establishment, and the name 
        of each person who imports or offers for import such 
        drug or device to the United States for purposes of 
        importation; and
          (B) each establishment subject to the requirements of 
        subparagraph (A) shall thereafter--
                  (i) with respect to drugs, register with the 
                Secretary [on or before] during the period 
                beginning on October 1 and ending on December 
                31 of each year; and

           *       *       *       *       *       *       *

  [(n)] (n)(1) The Secretary shall review the report required 
in subsection (k) and make a determination under section 
513(f)(1) not later than 90 days after receiving the report.
          (2)(A) Not later than 18 months after the enactment 
        of this paragraph, the Secretary shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, 
        Labor, and Pensions of the Senate a report regarding 
        when a premarket notification under subsection (k) 
        should be submitted for a modification or change to a 
        legally marketed device. The report shall include the 
        Secretary's interpretation of the following terms: 
        ``could significantly affect the safety or 
        effectiveness of the device'', ``a significant change 
        or modification in design, material, chemical 
        composition, energy source, or manufacturing 
        process,'', and ``major change or modification in the 
        intended use of the device''. The report also shall 
        discuss possible processes for industry to use to 
        determine whether a new submission under subsection (k) 
        is required and shall analyze how to leverage existing 
        quality system requirements to reduce premarket burden, 
        facilitate continual device improvement. and provide 
        reasonable assurance of safety and effectiveness of 
        modified devices. In developing such report, the 
        Secretary shall consider the input of interested 
        stakeholders.
          (B) The Secretary shall withdraw the Food and Drug 
        Administration draft guidance entitled ``Guidance for 
        Industry and FDA Staff--510(k) Device Modifications: 
        Deciding When to Submit a 510(k) for a Change to an 
        Existing Device'', dated July 27, 2011, and shall not 
        use this draft guidance as part of, or for the basis 
        of, any premarket review or any compliance or 
        enforcement decisions or actions. The Secretary shall 
        not issue--
                  (i) any draft guidance or proposed regulation 
                that addresses when to submit a premarket 
                notification submission for changes and 
                modifications made to a manufacturer's 
                previously cleared device before the receipt by 
                the Committee on Energy and Commerce of the 
                House of Representatives and the Committee on 
                Health, Education, Labor, and Pensions of the 
                Senate of the report required in subparagraph 
                (A); and
                  (ii) any final guidance or regulation on that 
                topic for one year after date of receipt of 
                such report by the Committee on Energy and 
                Commerce of the House of Representatives and 
                the Committee on Health, Education, Labor, and 
                Pensions of the Senate.
          (C) The Food and Drug Administration guidance 
        entitled ``Deciding When to Submit a 510(k) for a 
        Change to an Existing Device'', dated January 10, 1997, 
        shall be in effect until the subsequent issuance of 
        guidance or promulgation, if appropriate, of a 
        regulation described in subparagraph (B), and the 
        Secretary shall interpret such guidance in a manner 
        that is consistent with the manner in which the 
        Secretary has interpreted such guidance since 1997.

           *       *       *       *       *       *       *

  (q) Guidance on Submission of Unique Facility Identifiers.--
          (1) In general.--Not later than 2 years after the 
        date of the enactment of this subsection, the Secretary 
        shall, by guidance, specify--
                  (A) the unique facility identifier system to 
                be used to meet the requirements of--
                          (i) subsections (b)(1), (c), and 
                        (i)(1)(A) of this section; and
                          (ii) section 801(s) (relating to 
                        registration of commercial importers); 
                        and
                  (B) the form, manner, and timing of 
                submissions of unique facility identifiers 
                under the provisions specified in subparagraph 
                (A).
          (2) Consideration.--In developing the guidance under 
        paragraph (1), the Secretary shall take into account 
        the utilization of existing unique identification 
        schemes and compatibility with customs automated 
        systems.

           *       *       *       *       *       *       *


            CLASSIFICATION OF DEVICES INTENDED FOR HUMAN USE

                             Device Classes

  Sec. 513. (a)(1) * * *

           *       *       *       *       *       *       *

  (3)(A) * * *

           *       *       *       *       *       *       *

  (D)(i) * * *

           *       *       *       *       *       *       *

                          (iii) For purposes of clause (ii), 
                        the term ``necessary'' means the 
                        minimum required information that would 
                        support a determination by the 
                        Secretary that an application provides 
                        reasonable assurance of the 
                        effectiveness of the device.
                          (iv) Nothing in this subparagraph 
                        shall alter the criteria for evaluating 
                        an application for premarket approval 
                        of a device.
  [(iii)] (v) The determination of the Secretary with respect 
to the specification of valid scientific evidence under clauses 
(i) and (ii) shall be binding upon the Secretary, unless such 
determination by the Secretary could be contrary to the public 
health.

           *       *       *       *       *       *       *


     Initial Classification and Reclassification of Certain Devices

  (f)(1) Any device intended for human use which was not 
introduced or delivered for introduction into interstate 
commerce for commercial distribution before the date of the 
enactment of this section is classified in class III unless--
          (A) the device--
                  (i) * * *
                  (ii) is substantially equivalent to another 
                device within such type[, or];
          (B) the Secretary in response to a petition submitted 
        under paragraph (3) has classified such device in class 
        I or II[.]; or
                  (C) the device is classified pursuant to a 
                request submitted under paragraph (2).

           *       *       *       *       *       *       *

  (2)(A)(i) Any person who submits a report under section 
510(k) for a type of device that has not been previously 
classified under this Act, and that is classified into class 
III under paragraph (1), may request, within 30 days after 
receiving written notice of such a classification, the 
Secretary to classify the device [under the criteria set forth 
in subparagraphs (A) through (C) of subsection (a)(1). The 
person may, in the request, recommend to the Secretary a 
classification for the device. Any such request shall describe 
the device and provide detailed information and reasons for the 
recommended classification.].
  (ii) In lieu of submitting a report under section 510(k) and 
submitting a request for classification under clause (i) for a 
device, if a person determines there is no legally marketed 
device upon which to base a determination of substantial 
equivalence (as defined in subsection (i)), a person may submit 
a request under this clause for the Secretary to classify the 
device.
  (iii) Upon receipt of a request under clause (i) or (ii), the 
Secretary shall classify the device subject to the request 
under the criteria set forth in subparagraphs (A) through (C) 
of subsection (a)(1) within 120 days.
  (iv) Notwithstanding clause (iii), the Secretary may decline 
to undertake a classification of a device pursuant to a request 
under clause (ii) if the Secretary--
          (I) identifies a legally marketed device that would 
        permit a substantial equivalence determination under 
        paragraph (1) for the device; or
          (II) determines that the device submitted is not of 
        low-moderate risk or special controls to mitigate the 
        risks cannot be developed for the device.
  (v) The person submitting the request for classification 
under this subparagraph may recommend to the Secretary a 
classification for the device and shall, if recommending 
classification in class II, include in the request an initial 
draft proposal for applicable special controls, as described in 
subsection (a)(1)(B), that are necessary, in conjunction with 
general controls, to provide reasonable assurance of safety and 
effectiveness and a description of how the special controls 
provide such assurance. Any such request shall describe the 
device and provide detailed information and reasons for the 
recommended classification.
  (B)(i) [Not later than 60 days after the date of the 
submission of the request under subparagraph (A), the 
Secretary] The Secretary shall by written order classify the 
device involved. Such classification shall be the initial 
classification of the device for purposes of paragraph (1) and 
any device classified under this paragraph shall be a predicate 
device for determining substantial equivalence under paragraph 
(1).

           *       *       *       *       *       *       *


                        Substantial Equivalence

  (i)(1)(A) * * *

           *       *       *       *       *       *       *

  (D)(i) Whenever the Secretary requests information to 
demonstrate that devices with differing technological 
characteristics are substantially equivalent, the Secretary 
shall only request information that is necessary to making 
substantial equivalence determinations. In making such request, 
the Secretary shall consider the least burdensome means of 
demonstrating substantial equivalence and request information 
accordingly.
  (ii) For purposes of clause (i), the term ``necessary'' means 
the minimum required information that would support a 
determination of substantial equivalence between a new device 
and a predicate device.
  (iii) Nothing in this subparagraph shall alter the standard 
for determining substantial equivalence between a new device 
and a predicate device.

           *       *       *       *       *       *       *


                           PREMARKET APPROVAL

  Sec. 515. (a) * * *

           *       *       *       *       *       *       *


                   Application for Premarket Approval

  (c)(1) * * *

           *       *       *       *       *       *       *

  (4)(A) Prior to the submission of an application under this 
subsection, the Secretary shall accept and review any portion 
of the application that the applicant and the Secretary agree 
is complete, ready, and appropriate for review, except that 
such requirement does not apply, and the Secretary has 
discretion whether to accept and review such portion, during 
any period in which, under section [738(g)] 738(h), the 
Secretary does not have the authority to collect fees under 
section 738(a).

           *       *       *       *       *       *       *


SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS 
                    REGARDING DEVICES.

  (a) Documentation of Rationale for Significant Decisions.--
          (1) In general.--The Secretary shall completely 
        document the scientific and regulatory rationale for 
        any significant decision of the Center for Devices and 
        Radiological Health regarding submission or review of a 
        report under section 510(k), an application under 
        section 515, or an application for an exemption under 
        section 520(g), including documentation of significant 
        controversies or differences of opinion and the 
        resolution of such controversies or differences of 
        opinion.
          (2) Provision of documentation.--Upon request, the 
        Secretary shall furnish such complete documentation to 
        the person who is seeking to submit, or who has 
        submitted, such report or application.
  (b) Review of Significant Decisions.--
          (1) Request for supervisory review of significant 
        decision.--Any person may request a supervisory review 
        of the significant decision described in subsection 
        (a)(1). Such review may be conducted at the next 
        supervisory level or higher above the individual who 
        made the significant decision.
          (2) Submission of request.--A person requesting a 
        supervisory review under paragraph (1) shall submit 
        such request to the Secretary not later than 30 days 
        after such decision and shall indicate in the request 
        whether such person seeks an in-person meeting or a 
        teleconference review.
          (3) Timeframe.--
                  (A) In general.--Except as provided in 
                subparagraph (B), the Secretary shall schedule 
                an in-person or teleconference review, if so 
                requested, not later than 30 days after such 
                request is made. The Secretary shall issue a 
                decision to the person requesting a review 
                under this subsection not later than 45 days 
                after the request is made under paragraph (1), 
                or, in the case of a person who requests an in-
                person meeting or teleconference, 30 days after 
                such meeting or teleconference.
                  (B) Exception.--Subparagraph (A) shall not 
                apply in cases that are referred to experts 
                outside of the Food and Drug Administration.

           *       *       *       *       *       *       *


SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

  (a) In General.--The Secretary shall--
          (1) establish a program to routinely and 
        systematically assess information relating to device 
        recalls and use such information to proactively 
        identify strategies for mitigating health risks 
        presented by defective or unsafe devices;
          (2) clarify procedures for conducting device recall 
        audit checks to improve the ability of investigators to 
        perform those checks in a consistent manner;
          (3) develop detailed criteria for assessing whether a 
        person performing a device recall has performed an 
        effective correction or action plan for the recall; and
          (4) document the basis for each termination by the 
        Food and Drug Administration of a device recall.
  (b) Assessment Content.--The program established under 
subsection (a)(1) shall, at a minimum, identify--
          (1) trends in the number and types of device recalls;
          (2) devices that are most frequently the subject of a 
        recall; and
          (3) underlying causes of device recalls.
  (c) Definition.--In this section, the term ``recall'' means--
          (1) the removal from the market of a device pursuant 
        to an order of the Secretary under subsection (b) or 
        (e) of section 518; or
          (2) the correction or removal from the market of a 
        device at the initiative of the manufacturer or 
        importer of the device that is required to be reported 
        to the Secretary under section 519(g).

                     RECORDS AND REPORTS ON DEVICES

  Sec. 519. (a) * * *

           *       *       *       *       *       *       *

  (h) Inclusion of Devices in Postmarket Risk Identification 
and Analysis System.--
          (1) In general.--The Secretary shall amend the 
        procedures established and maintained under clauses 
        (i), (ii), (iii), and (v) of section 505(k)(3)(C) in 
        order to expand the postmarket risk identification and 
        analysis system established under such section to 
        include and apply to devices.
          (2) Data.--In expanding the system as described in 
        paragraph (1), the Secretary shall use relevant data 
        with respect to devices cleared under section 510(k) or 
        approved under section 515, which may include claims 
        data, patient survey data, and standardized analytic 
        files that allow for the pooling and analysis of data 
        from disparate data environments.
          (3) Stakeholder input.--To help ensure effective 
        implementation of the system as described in paragraph 
        (1) with respect to devices, the Secretary shall engage 
        outside stakeholders in development of the system, and 
        gather information from outside stakeholders regarding 
        the content of an effective sentinel program, through a 
        public hearing, advisory committee meeting, maintenance 
        of a public docket, or other similar public measures.
          (4) Voluntary surveys.--Chapter 35 of title 44, 
        United States Code, shall not apply to the collection 
        of voluntary information from health care providers, 
        such as voluntary surveys or questionnaires, initiated 
        by the Secretary for purposes of postmarket risk 
        identification, mitigation, and analysis for devices.

GENERAL PROVISIONS RESPECTING CONTROL OF DEVICES INTENDED FOR HUMAN USE

  Sec. 520. (a) * * *

                            [Custom Devices

  [(b) Sections 514 and 515 do not apply to any device which, 
in order to comply with the order of an individual physician or 
dentist (or any other specially qualified person designated 
under regulations promulgated by the Secretary after an 
opportunity for an oral hearing) necessarily deviates from an 
otherwise applicable performance standard or requirement 
prescribed by or under section 515 if (1) the device is not 
generally available in finished form for purchase or for 
dispensing upon prescription and is not offered through 
labeling or advertising by the manufacturer, importer, or 
distributor thereof for commercial distribution, and (2) such 
device--
          [(A)(i) is intended for use by an individual patient 
        named in such order of such physician or dentist (or 
        other specially qualified person so designated) and is 
        to be made in a specific form for such patient, or
          [(ii) is intended to meet the special needs of such 
        physician or dentist (or other specially qualified 
        person so designated) in the course of the professional 
        practice of such physician or dentist (or other 
        specially qualified person so designated), and
          [(B) is not generally available to or generally used 
        by other physicians or dentists (or other specially 
        qualified persons so designated).]
  (b) Custom Devices.--
          (1) In general.--The requirements of sections 514 and 
        515 shall not apply to a device that--
                  (A) is created or modified in order to comply 
                with the order of an individual physician or 
                dentist (or any other specially qualified 
                person designated under regulations promulgated 
                by the Secretary after an opportunity for an 
                oral hearing);
                  (B) in order to comply with an order 
                described in subparagraph (A), necessarily 
                deviates from an otherwise applicable 
                performance standard under section 514 or 
                requirement under section 515;
                  (C) is not generally available in the United 
                States in finished form through labeling or 
                advertising by the manufacturer, importer, or 
                distributor for commercial distribution;
                  (D) is designed to treat a unique pathology 
                or physiological condition that no other device 
                is domestically available to treat;
                  (E)(i) is intended to meet the special needs 
                of such physician or dentist (or other 
                specially qualified person so designated) in 
                the course of the professional practice of such 
                physician or dentist (or other specially 
                qualified person so designated); or
                  (ii) is intended for use by an individual 
                patient named in such order of such physician 
                or dentist (or other specially qualified person 
                so designated);
                  (F) is assembled from components or 
                manufactured and finished on a case-by-case 
                basis to accommodate the unique needs of 
                individuals described in clause (i) or (ii) of 
                subparagraph (E); and
                  (G) may have common, standardized design 
                characteristics, chemical and material 
                compositions, and manufacturing processes as 
                commercially distributed devices.
          (2) Limitations.--Paragraph (1) shall apply to a 
        device only if--
                  (A) such device is for the purpose of 
                treating a sufficiently rare condition, such 
                that conducting clinical investigations on such 
                device would be impractical; and
                  (B) production of such device under paragraph 
                (1) is limited to no more than 5 units per year 
                of a particular device type, provided that such 
                replication otherwise complies with this 
                section.
          (3) Guidance.--Not later than 2 years after the date 
        of enactment of this section, the Secretary shall issue 
        final guidance on replication of multiple devices 
        described in paragraph (2)(B).
          (4) Notification to the secretary.--The manufacturer 
        of such device created or modified as described in 
        paragraph (1) shall notify the Secretary on an annual 
        basis, in a manner prescribed by the Secretary, of the 
        manufacture of such device.

           *       *       *       *       *       *       *


             Exemption for Devices for Investigational Use

  (g)(1) * * *
  (2)(A) * * *
  (B) The conditions prescribed pursuant to subparagraph (A) 
shall include the following:
          (i) * * *
          (ii) A requirement that the person applying for an 
        exemption for a device assure the establishment and 
        maintenance of such records, and the making of such 
        reports to the Secretary of safety or effectiveness 
        data obtained as a result of the investigational use of 
        the device during the exemption, as the Secretary 
        determines will enable him to assure compliance with 
        such conditions, review the progress of the 
        investigation, and evaluate the safety and 
        effectiveness of the device.

           *       *       *       *       *       *       *

  (4)(A) * * *

           *       *       *       *       *       *       *

  (C) Consistent with paragraph (1), the Secretary shall not 
disapprove an application under this subsection because the 
Secretary determines that--
          (i) the investigation may not support a substantial 
        equivalence or de novo classification determination or 
        approval of the device;
          (ii) the investigation may not meet a requirement, 
        including a data requirement, relating to the approval 
        or clearance of a device; or
          (iii) an additional or different investigation may be 
        necessary to support clearance or approval of the 
        device.

            Release of Safety and Effectiveness Information

  (h)(1) * * *

           *       *       *       *       *       *       *

  (5) Subject to subsection (c) and section 301(j), the 
Secretary shall regularly publish detailed decision summaries 
for each clearance of a device under section 510(k) requiring 
clinical data.

           *       *       *       *       *       *       *


                     Humanitarian Device Exemption

  (m)(1) * * *

           *       *       *       *       *       *       *

  (6)(A) Except as provided in [subparagraph (D)] subparagraph 
(C), the prohibition in paragraph (3) shall not apply with 
respect to a person granted an exemption under paragraph (2) if 
each of the following conditions apply:
          [(i)(I) The device with respect to which the 
        exemption is granted is intended for the treatment or 
        diagnosis of a disease or condition that occurs in 
        pediatric patients or in a pediatric subpopulation, and 
        such device is labeled for use in pediatric patients or 
        in a pediatric subpopulation in which the disease or 
        condition occurs.
          [(II) The device was not previously approved under 
        this subsection for the pediatric patients or the 
        pediatric subpopulation described in subclause (I) 
        prior to the date of the enactment of the Pediatric 
        Medical Device Safety and Improvement Act of 2007.
          [(ii) During any calendar year, the number of such 
        devices distributed during that year does not exceed 
        the annual distribution number specified by the 
        Secretary when the Secretary grants such exemption. The 
        annual distribution number shall be based on the number 
        of individuals affected by the disease or condition 
        that such device is intended to treat, diagnose, or 
        cure, and of that number, the number of individuals 
        likely to use the device, and the number of devices 
        reasonably necessary to treat such individuals. In no 
        case shall the annual distribution number exceed the 
        number identified in paragraph (2)(A).]
          (i) The device with respect to which the exemption is 
        granted--
                  (I) is intended for the treatment or 
                diagnosis of a disease or condition that occurs 
                in pediatric patients or in a pediatric 
                subpopulation, and such device is labeled for 
                use in pediatric patients or in a pediatric 
                subpopulation in which the disease or condition 
                occurs; or
                  (II) is intended for the treatment or 
                diagnosis of a disease or condition that does 
                not occur in pediatric patients or that occurs 
                in pediatric patients in such numbers that the 
                development of the device for such patients is 
                impossible, highly impracticable, or unsafe.
          (ii) During any calendar year, the number of such 
        devices distributed during that year under each 
        exemption granted under this subsection does not exceed 
        the number of such devices needed to treat, diagnose, 
        or cure a population of 4,000 individuals in the United 
        States (referred to in this paragraph as the ``annual 
        distribution number'').

           *       *       *       *       *       *       *

          (iv) The request for such exemption is submitted on 
        or before October 1, [2012] 2017.

           *       *       *       *       *       *       *

  [(C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under 
subparagraph (A)(ii) with respect to a device if additional 
information on the number of individuals affected by the 
disease or condition arises, and the Secretary may modify such 
number but in no case shall the annual distribution number 
exceed the number identified in paragraph (2)(A).]
  [(D)] (C) If a person notifies the Secretary, or the 
Secretary determines through an inspection under subparagraph 
(B), that the number of devices distributed during any calendar 
year exceeds the annual distribution number, as required under 
subparagraph (A)(iii), [and modified under subparagraph (C), if 
applicable,] then the prohibition in paragraph (3) shall apply 
with respect to such person for such device for any sales of 
such device after such notification.
  [(E)] (D)(i) * * *

           *       *       *       *       *       *       *

  (7) The Secretary shall refer any report of an adverse event 
[regarding a device] regarding a device described in paragraph 
(6)(A)(i)(I) for which the prohibition under paragraph (3) does 
not apply pursuant to paragraph (6)(A) that the Secretary 
receives to the Office of Pediatric Therapeutics, established 
under section 6 of the Best Pharmaceuticals for Children Act 
(Public Law 107-109). In considering the report, the Director 
of the Office of Pediatric Therapeutics, in consultation with 
experts in the Center for Devices and Radiological Health, 
shall provide for periodic review of the report by the 
Pediatric Advisory Committee, including obtaining any 
recommendations of such committee regarding whether the 
Secretary should take action under this Act in response to the 
report.
  (8) The Secretary, acting through the Office of Pediatric 
Therapeutics and the Center for Devices and Radiological 
Health, shall provide for an annual review by the Pediatric 
Advisory Committee [of all devices described in paragraph (6)] 
of all devices described in paragraph (6)(A)(i)(I) to ensure 
that the exemption under paragraph (2) remains appropriate for 
the pediatric populations for which it is granted.

           *       *       *       *       *       *       *


SEC. 523. ACCREDITED PERSONS.

  (a) * * *
  (b) Accreditation.--
          (1) * * *
          (2) Accreditation.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (E) Periodic reaccreditation.--
                          (i) Period.--Subject to suspension or 
                        withdrawal under subparagraph (B), any 
                        accreditation under this section shall 
                        be valid for a period of 3 years after 
                        its issuance.
                          (ii) Response to reaccreditation 
                        request.--Upon the submission of a 
                        request by an accredited person for 
                        reaccreditation under this section, the 
                        Secretary shall approve or deny such 
                        request not later than 60 days after 
                        receipt of the request.
                          (iii) Criteria.--Not later than 120 
                        days after the date of the enactment of 
                        this subparagraph, the Secretary shall 
                        establish and publish in the Federal 
                        Register criteria to reaccredit or deny 
                        reaccreditation to persons under this 
                        section. The reaccreditation of persons 
                        under this section shall specify the 
                        particular activities under subsection 
                        (a), and the devices, for which such 
                        persons are reaccredited.

           *       *       *       *       *       *       *

  (c) Duration.--The authority provided by this section 
terminates [October 1, 2012] October 1, 2017.

           *       *       *       *       *       *       *


Subchapter B--Drugs for Rare Diseases or Conditions

           *       *       *       *       *       *       *


SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC 
                    DISEASES.

  (a) Definitions.--In this section:
          (1) Priority review.--The term ``priority review'', 
        with respect to a human drug application as defined in 
        section 735(1), means review and action by the 
        Secretary on such application not later than 6 months 
        after receipt by the Secretary of such application, as 
        described in the Manual of Policies and Procedures of 
        the Food and Drug Administration and goals identified 
        in the letters described in section 101(b) of the 
        Prescription Drug User Fee Amendments of 2012.
          (2) Priority review voucher.--The term ``priority 
        review voucher'' means a voucher issued by the 
        Secretary to the sponsor of a rare pediatric disease 
        product application that entitles the holder of such 
        voucher to priority review of a single human drug 
        application submitted under section 505(b)(1) or 
        section 351(a) of the Public Health Service Act after 
        the date of approval of the rare pediatric disease 
        product application.
          (3) Rare pediatric disease.--The term ``rare 
        pediatric disease'' means a disease that meets each of 
        the following criteria:
                  (A) The disease primarily affects individuals 
                aged from birth to 18 years, including age 
                groups often called neonates, infants, 
                children, and adolescents.
                  (B) The disease is a rare disease or 
                condition, within the meaning of section 526.
          (4) Rare pediatric disease product application.--The 
        term ``rare pediatric disease product application'' 
        means a human drug application, as defined in section 
        735(1), that--
                  (A) is for a drug or biological product--
                          (i) that is for the prevention or 
                        treatment of a rare pediatric disease;
                          (ii) that contains no active 
                        ingredient (including any ester or salt 
                        of the active ingredient) that has been 
                        previously approved in any other 
                        application under section 505(b)(1), 
                        505(b)(2), or 505(j) of this Act or 
                        section 351(a) or 351(k) of the Public 
                        Health Service Act;
                  (B) is submitted under section 505(b)(1) of 
                this Act or section 351(a) of the Public Health 
                Service Act;
                  (C) the Secretary deems eligible for priority 
                review;
                  (D) that relies on clinical data derived from 
                studies examining a pediatric population and 
                dosages of the drug intended for that 
                population;
                  (E) that does not seek approval for an adult 
                indication in the original rare pediatric 
                disease product application; and
                  (F) is approved after the date of the 
                enactment of the Prescription Drug User Fee 
                Amendments of 2012.
  (b) Priority Review Voucher.--
          (1) In general.--The Secretary shall award a priority 
        review voucher to the sponsor of a rare pediatric 
        disease product application upon approval by the 
        Secretary of such rare pediatric disease product 
        application.
          (2) Transferability.--
                  (A) In general.--The sponsor of a rare 
                pediatric disease product application that 
                receives a priority review voucher under this 
                section may transfer (including by sale) the 
                entitlement to such voucher. There is no limit 
                on the number of times a priority review 
                voucher may be transferred before such voucher 
                is used.
                  (B) Notification of transfer.--Each person to 
                whom a voucher is transferred shall notify the 
                Secretary of such change in ownership of the 
                voucher not later than 30 days after such 
                transfer.
          (3) Limitation.--A sponsor of a rare pediatric 
        disease product application may not receive a priority 
        review voucher under this section if the rare pediatric 
        disease product application was submitted to the 
        Secretary prior to the date that is 90 days after the 
        date of enactment of the Prescription Drug User Fee 
        Amendments of 2012.
          (4) Notification.--
                  (A) In general.--The sponsor of a human drug 
                application shall notify the Secretary not 
                later than 90 days prior to submission of the 
                human drug application that is the subject of a 
                priority review voucher of an intent to submit 
                the human drug application, including the date 
                on which the sponsor intends to submit the 
                application. Such notification shall be a 
                legally binding commitment to pay for the user 
                fee to be assessed in accordance with this 
                section.
                  (B) Transfer after notice.--The sponsor of a 
                human drug application that provides 
                notification of the intent of such sponsor to 
                use the voucher for the human drug application 
                under subparagraph (A) may transfer the voucher 
                after such notification is provided, if such 
                sponsor has not yet submitted the human drug 
                application described in the notification.
          (5) Termination of authority.--The Secretary may not 
        award any priority review vouchers under paragraph (1) 
        after the last day of the 1-year period that begins on 
        the date that the Secretary awards the third rare 
        pediatric disease priority voucher under this section.
  (c) Priority Review User Fee.--
          (1) In general.--The Secretary shall establish a user 
        fee program under which a sponsor of a human drug 
        application that is the subject of a priority review 
        voucher shall pay to the Secretary a fee determined 
        under paragraph (2). Such fee shall be in addition to 
        any fee required to be submitted by the sponsor under 
        chapter VII.
          (2) Fee amount.--The amount of the priority review 
        user fee shall be determined each fiscal year by the 
        Secretary, based on the difference between--
                  (A) the average cost incurred by the Food and 
                Drug Administration in the review of a human 
                drug application subject to priority review in 
                the previous fiscal year; and
                  (B) the average cost incurred by the Food and 
                Drug Administration in the review of a human 
                drug application that is not subject to 
                priority review in the previous fiscal year.
          (3) Annual fee setting.--The Secretary shall 
        establish, before the beginning of each fiscal year 
        beginning after September 30, 2012, the amount of the 
        priority review user fee for that fiscal year.
          (4) Payment.--
                  (A) In general.--The priority review user fee 
                required by this subsection shall be due upon 
                the notification by a sponsor of the intent of 
                such sponsor to use the voucher, as specified 
                in subsection (b)(4)(A). All other user fees 
                associated with the human drug application 
                shall be due as required by the Secretary or 
                under applicable law.
                  (B) Complete application.--An application 
                described under subparagraph (A) for which the 
                sponsor requests the use of a priority review 
                voucher shall be considered incomplete if the 
                fee required by this subsection and all other 
                applicable user fees are not paid in accordance 
                with the Secretary's procedures for paying such 
                fees.
                  (C) No waivers, exemptions, reductions, or 
                refunds.--The Secretary may not grant a waiver, 
                exemption, reduction, or refund of any fees due 
                and payable under this section.
          (5) Offsetting collections.--Fees collected pursuant 
        to this subsection for any fiscal year--
                  (A) shall be deposited and credited as 
                offsetting collections to the account providing 
                appropriations to the Food and Drug 
                Administration; and
                  (B) shall not be collected for any fiscal 
                year except to the extent provided in advance 
                in appropriation Acts.
  (d) Designation Process.--
          (1) In general.--Upon the request of the manufacturer 
        or the sponsor of a new drug, the Secretary may 
        designate--
                  (A) the new drug as a drug for a rare 
                pediatric disease; and
                  (B) the application for the new drug as a 
                rare pediatric disease product application.
          (2) Request for designation.--The request for a 
        designation under paragraph (1), shall be made at the 
        same time a request for designation of orphan disease 
        status under section 526 or fast-track designation 
        under section 506 is made. Requesting designation under 
        this subsection is not a prerequisite to receiving a 
        priority review voucher under this section.
          (3) Determination by secretary.--Not later than 60 
        days after a request is submitted under paragraph (1), 
        the Secretary shall determine whether--
                  (A) the disease or condition that is the 
                subject of such request is a rare pediatric 
                disease; and
                  (B) the application for the new drug is a 
                rare pediatric disease product application.
  (e) Marketing of Rare Pediatric Disease Products.--
          (1) In general.--The Secretary shall deem a rare 
        pediatric disease product application incomplete if 
        such application does not contain a description of the 
        plan of the sponsor of such application to market the 
        product in the United States.
          (2) Revocation.--The Secretary may revoke any 
        priority review voucher awarded under subsection (b) if 
        the rare pediatric disease product for which such 
        voucher was awarded is not marketed in the United 
        States within the 365 day period beginning on the date 
        of the approval of such drug under section 505 of this 
        Act or section 351 of the Public Health Service Act.
          (3) Postapproval production report.--The sponsor of 
        an approved rare pediatric disease product shall submit 
        a report to the Secretary not later than 5 years after 
        the approval of the applicable rare pediatric disease 
        product application. Such report shall provide the 
        following information, with respect to each of the 
        first 4 years after approval of such product:
                  (A) The estimated population in the United 
                States suffering from the rare pediatric 
                disease.
                  (B) The estimated demand in the United States 
                for such rare pediatric disease product.
                  (C) The actual amount of such rare pediatric 
                disease product distributed in the United 
                States.
  (f) Notice and Report.--
          (1) Notice of issuance of voucher and approval of 
        products under voucher.--The Secretary shall publish a 
        notice in the Federal Register and on the Web site of 
        the Food and Drug Administration not later than 30 days 
        after the occurrence of each of the following:
                  (A) The Secretary issues a priority review 
                voucher under this section.
                  (B) The Secretary approves a drug pursuant to 
                an application submitted under section 505(b) 
                of this Act or section 351(a) of the Public 
                Health Service Act for which the sponsor of the 
                application used a priority review voucher 
                under this section.
          (2) Report.--If, after the last day of the 1-year 
        period that begins on the date that the Secretary 
        awards the third rare pediatric disease priority 
        voucher under this section, a sponsor of an application 
        submitted under section 505(b) of this Act or section 
        351(a) of the Public Health Service Act for a drug uses 
        a priority review voucher under this section for such 
        application, the Secretary shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, 
        Labor, and Pensions of the Senate a document--
                  (A) notifying such Committees of the use of 
                such voucher; and
                  (B) identifying the drug for which such 
                priority review voucher is used.
  (g) Eligibility for Other Programs.--Nothing in this section 
precludes a sponsor who seeks a priority review voucher under 
this section from participating in any other incentive program, 
including under this Act.
  (h) Relation to Other Provisions.--The provisions of this 
section shall supplement, not supplant, any other provisions of 
this Act or the Public Health Service Act that encourage the 
development of drugs for tropical diseases and rare pediatric 
diseases.
  (i) GAO Study and Report.--
          (1) Study.--
                  (A) In general.--Beginning on the date that 
                the Secretary awards the third rare pediatric 
                disease priority voucher under this section, 
                the Comptroller General of the United States 
                shall conduct a study of the effectiveness of 
                awarding rare pediatric disease priority 
                vouchers under this section in the development 
                of on human drug products that treat or prevent 
                such diseases.
                  (B) Contents of study.--In conducting the 
                study under subparagraph (A), the Comptroller 
                General shall examine the following:
                          (i) The indications for which each 
                        rare disease product for which a 
                        priority review voucher was awarded was 
                        approved under section 505 or section 
                        351 of the Public Health Service Act.
                          (ii) Whether, and to what extent, an 
                        unmet need related to the treatment or 
                        prevention of a rare pediatric disease 
                        was met through the approval of such a 
                        rare disease product.
                          (iii) The value of the priority 
                        review voucher if transferred.
                          (iv) Identification of each drug for 
                        which a priority review voucher was 
                        used.
                          (v) The length of the period of time 
                        between the date on which a priority 
                        review voucher was awarded and the date 
                        on which it was used.
          (2) Report.--Not later than 1 year after the date 
        under paragraph (1)(A), the Comptroller General shall 
        submit to the Committee on Energy and Commerce of the 
        House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate, a report 
        containing the results of the study under paragraph 
        (1).

           *       *       *       *       *       *       *


Subchapter E--General Provisions Relating to Drugs and Devices

           *       *       *       *       *       *       *


SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

  (a) * * *

           *       *       *       *       *       *       *

  [(f) Authorization of Appropriations.--To carry out this 
section, there are authorized to be appropriated $5,000,000 for 
fiscal year 2008 and such sums as may be necessary for each of 
fiscal years 2009 through 2012.]
  (f) Authorization of Appropriations.--To carry out this 
section, there is authorized to be appropriated $6,000,000 for 
each of fiscal years 2013 through 2017.

           *       *       *       *       *       *       *


SEC. 568 NOTIFICATION.

  (a) Notification to Secretary.--With respect to a drug, the 
Secretary may require notification to the Secretary by a 
regulated person if the regulated person knows--
          (1) that the use of such drug in the United States 
        may result in serious injury or death;
          (2) of a significant loss or known theft of such drug 
        intended for use in the United States; or
          (3) that--
                  (A) such drug has been or is being 
                counterfeited; and
                  (B)(i) the counterfeit product is in commerce 
                in the United States or could be reasonably 
                expected to be introduced into commerce; or
                  (ii) such drug has been or is being imported 
                into the United States or may reasonably be 
                expected to be offered for import into the 
                United States.
  (b) Manner of Notification.--Notification under this section 
shall be made in such manner and by such means as the Secretary 
may specify by regulation or guidance.
  (c) Savings Clause.--Nothing in this section shall be 
construed as limiting any other authority of the Secretary to 
require notifications related to a drug under any other 
provision of this Act or the Public Health Service Act.
  (d) Definition.--In this section, the term ``regulated 
person'' means--
          (1) a person who is required to register under 
        section 510 or 801(s);
          (2) a wholesale distributor of a drug product; or
          (3) any other person that distributes drugs except a 
        person that distributes drugs exclusively for retail 
        sale.

SEC. 568. CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED 
                    THERAPIES, AND GENETIC TARGETING OF TREATMENTS.

  (a) In General.--For the purpose of promoting the efficiency 
of and informing the review by the Food and Drug Administration 
of new drugs and biological products for rare diseases and 
drugs and biological products that are genetically targeted, 
the following shall apply:
          (1) Consultation with stakeholders.--Consistent with 
        sections X.C and IX.E.4 of the PDUFA Reauthorization 
        Performance Goals and Procedures Fiscal Years 2013 
        through 2017, as referenced in the letters described in 
        section 101(b) of the Prescription Drug User Fee 
        Amendments of 2012, the Secretary shall ensure that 
        opportunities exist, at a time the Secretary determines 
        appropriate, for consultations with stakeholders on the 
        topics described in subsection (b).
          (2) Consultation with external experts.--
                  (A) In general.--The Secretary shall develop 
                and maintain a list of external experts who, 
                because of their special expertise, are 
                qualified to provide advice on rare disease 
                issues, including topics described in 
                subsection (c). The Secretary may, when 
                appropriate to address a specific regulatory 
                question, consult such external experts on 
                issues related to the review of new drugs and 
                biological products for rare diseases and drugs 
                and biological products that are genetically 
                targeted, including the topics described in 
                subsection (b), when such consultation is 
                necessary because the Secretary lacks the 
                specific scientific, medical, or technical 
                expertise necessary for the performance of the 
                Secretary's regulatory responsibilities and the 
                necessary expertise can be provided by the 
                external experts.
                  (B) External experts.--For purposes of 
                subparagraph (A), external experts are 
                individuals who possess scientific or medical 
                training that the Secretary lacks with respect 
                to one or more rare diseases.
  (b) Topics for Consultation.--Topics for consultation 
pursuant to this section may include--
          (1) rare diseases;
          (2) the severity of rare diseases;
          (3) the unmet medical need associated with rare 
        diseases;
          (4) the willingness and ability of individuals with a 
        rare disease to participate in clinical trials;
          (5) an assessment of the benefits and risks of 
        therapies to treat rare diseases;
          (6) the general design of clinical trials for rare 
        disease populations and subpopulations; and
          (7) the demographics and the clinical description of 
        patient populations.
  (c) Classification as Special Government Employees.--The 
external experts who are consulted under this section may be 
considered special government employees, as defined under 
section 202 of title 18, United States Code.
  (d) Protection of Confidential Information and Trade 
Secrets.--
          (1) Rule of construction.--Nothing in this section 
        shall be construed to alter the protections offered by 
        laws, regulations, and policies governing disclosure of 
        confidential commercial or trade secret information, 
        and any other information exempt from disclosure 
        pursuant to section 552(b) of title 5, United States 
        Code, as such provisions would be applied to 
        consultation with individuals and organizations prior 
        to the date of enactment of this section.
          (2) Consent required for disclosure.--The Secretary 
        shall not disclose confidential commercial or trade 
        secret information to an expert consulted under this 
        section without the written consent of the sponsor 
        unless the expert is a special government employee (as 
        defined under section 202 of title 18, United States 
        Code) or the disclosure is otherwise authorized by law.
  (e) Other Consultation.--Nothing in this section shall be 
construed to limit the ability of the Secretary to consult with 
individuals and organizations as authorized prior to the date 
of enactment of this section.
  (f) No Right or Obligation.--
          (1) No right to consultation.--Nothing in this 
        section shall be construed to create a legal right for 
        a consultation on any matter or require the Secretary 
        to meet with any particular expert or stakeholder.
          (2) No altering of goals.--Nothing in this section 
        shall be construed to alter agreed upon goals and 
        procedures identified in the letters described in 
        section 101(b) of the Prescription Drug User Fee 
        Amendments of 2012.
          (3) No change to number of review cycles.--Nothing in 
        this section is intended to increase the number of 
        review cycles as in effect before the date of enactment 
        of this section.
  (g) No Delay in Product Review.--Prior to a consultation with 
an external expert, as described in this section, relating to 
an investigational new drug application under section 505(i), a 
new drug application under section 505(b), or a biologics 
license application under section 351 of the Public Health 
Service Act, the Director of the Center for Drug Evaluation and 
Research or the Director of the Center for Biologics Evaluation 
and Research (or appropriate Division Director), as 
appropriate, shall determine that--
          (1) such consultation will--
                  (A) facilitate the Secretary's ability to 
                complete the Secretary's review;
                  (B) address outstanding deficiencies in the 
                application; and
                  (C) increase the likelihood of an approval 
                decision in the current review cycle; or
          (2) the sponsor authorized such consultation.

           *       *       *       *       *       *       *


                      Subchapter G--Medical Gases

SEC. 575. DEFINITIONS.

  In this subchapter:
          (1) The term ``designated medical gas'' means any of 
        the following:
                  (A) Oxygen that meets the standards set forth 
                in an official compendium.
                  (B) Nitrogen that meets the standards set 
                forth in an official compendium.
                  (C) Nitrous oxide that meets the standards 
                set forth in an official compendium.
                  (D) Carbon dioxide that meets the standards 
                set forth in an official compendium.
                  (E) Helium that meets the standards set forth 
                in an official compendium.
                  (F) Carbon monoxide that meets the standards 
                set forth in an official compendium.
                  (G) Medical air that meets the standards set 
                forth in an official compendium.
                  (H) Any other medical gas deemed appropriate 
                by the Secretary, after taking into account any 
                investigational new drug application or 
                investigational new animal drug application for 
                the same medical gas submitted in accordance 
                with regulations applicable to such 
                applications in title 21 of the Code of Federal 
                Regulations, unless any period of exclusivity 
                under section 505(c)(3)(E)(ii) or section 
                505(j)(5)(F)(ii), or the extension of any such 
                period under section 505A, applicable to such 
                medical gas has not expired.
          (2) The term ``medical gas'' means a drug that--
                  (A) is manufactured or stored in a liquefied, 
                nonliquefied, or cryogenic state; and
                  (B) is administered as a gas.

SEC. 576. REGULATION OF MEDICAL GASES.

  (a) Certification of Designated Medical Gases.--
          (1) Submission.--Beginning 180 days after the date of 
        enactment of this section, any person may file with the 
        Secretary a request for certification of a medical gas 
        as a designated medical gas. Any such request shall 
        contain the following information:
                  (A) A description of the medical gas.
                  (B) The name and address of the sponsor.
                  (C) The name and address of the facility or 
                facilities where the medical gas is or will be 
                manufactured.
                  (D) Any other information deemed appropriate 
                by the Secretary to determine whether the 
                medical gas is a designated medical gas.
          (2) Grant of certification.--The certification 
        requested under paragraph (1) is deemed to be granted 
        unless, within 60 days of the filing of such request, 
        the Secretary finds that--
                  (A) the medical gas subject to the 
                certification is not a designated medical gas;
                  (B) the request does not contain the 
                information required under paragraph (1) or 
                otherwise lacks sufficient information to 
                permit the Secretary to determine that the 
                medical gas is a designated medical gas; or
                  (C) denying the request is necessary to 
                protect the public health.
          (3) Effect of certification.--
                  (A) In general.--
                          (i) Approved uses.--A designated 
                        medical gas for which a certification 
                        is granted under paragraph (2) is 
                        deemed, alone or in combination, as 
                        medically appropriate, with another 
                        designated medical gas or gases for 
                        which a certification or certifications 
                        have been granted, to have in effect an 
                        approved application under section 505 
                        or 512, subject to all applicable post-
                        approval requirements, for the 
                        following indications for use:
                                  (I) In the case of oxygen, 
                                the treatment or prevention of 
                                hypoxemia or hypoxia.
                                  (II) In the case of nitrogen, 
                                use in hypoxic challenge 
                                testing.
                                  (III) In the case of nitrous 
                                oxide, analgesia.
                                  (IV) In the case of carbon 
                                dioxide, use in extracorporeal 
                                membrane oxygenation therapy or 
                                respiratory stimulation.
                                  (V) In the case of helium, 
                                the treatment of upper airway 
                                obstruction or increased airway 
                                resistance.
                                  (VI) In the case of medical 
                                air, to reduce the risk of 
                                hyperoxia.
                                  (VII) In the case of carbon 
                                monoxide, use in lung diffusion 
                                testing.
                                  (VIII) Any other indication 
                                for use for a designated 
                                medical gas or combination of 
                                designated medical gases deemed 
                                appropriate by the Secretary, 
                                unless any period of 
                                exclusivity under clause (iii) 
                                or (iv) of section 
                                505(c)(3)(E), clause (iii) or 
                                (iv) of section 505(j)(5)(F), 
                                or section 527, or the 
                                extension of any such period 
                                under section 505A, applicable 
                                to such indication for use for 
                                such gas or combination of 
                                gases has not expired.
                          (ii) Labeling.--The requirements of 
                        sections 503(b)(4) and 502(f) are 
                        deemed to have been met for a 
                        designated medical gas if the labeling 
                        on final use container for such medical 
                        gas bears--
                                  (I) the information required 
                                by section 503(b)(4);
                                  (II) a warning statement 
                                concerning the use of the 
                                medical gas as determined by 
                                the Secretary by regulation; 
                                and
                                  (III) appropriate directions 
                                and warnings concerning storage 
                                and handling.
                  (B) Inapplicability of exclusivity 
                provisions.--
                          (i) No exclusivity for a certified 
                        medical gas.--No designated medical gas 
                        deemed under subparagraph (A)(i) to 
                        have in effect an approved application 
                        is eligible for any period of 
                        exclusivity under section 505(c), 
                        505(j), or 527, or the extension of any 
                        such period under section 505A, on the 
                        basis of such deemed approval.
                          (ii) Effect on certification.--No 
                        period of exclusivity under section 
                        505(c), 505(j), or section 527, or the 
                        extension of any such period under 
                        section 505A, with respect to an 
                        application for a drug product shall 
                        prohibit, limit, or otherwise affect 
                        the submission, grant, or effect of a 
                        certification under this section, 
                        except as provided in subsection 
                        (a)(3)(A)(i)(VIII) and section 
                        575(1)(H).
          (4) Withdrawal, suspension, or revocation of 
        approval.--
                  (A) Withdrawal, suspension of approval.--
                Nothing in this subchapter limits the 
                Secretary's authority to withdraw or suspend 
                approval of a drug product, including a 
                designated medical gas deemed under this 
                section to have in effect an approved 
                application under section 505 or section 512 of 
                this Act.
                  (B) Revocation of certification.--The 
                Secretary may revoke the grant of a 
                certification under paragraph (2) if the 
                Secretary determines that the request for 
                certification contains any material omission or 
                falsification.
  (b) Prescription Requirement.--
          (1) In general.--A designated medical gas shall be 
        subject to the requirements of section 503(b)(1) unless 
        the Secretary exercises the authority provided in 
        section 503(b)(3) to remove such medical gas from the 
        requirements of section 503(b)(1), the gas is approved 
        for use without a prescription pursuant to an 
        application under section 505 or 512, or the use in 
        question is authorized pursuant to another provision of 
        this Act relating to use of medical products in 
        emergencies.
          (2) Oxygen.--
                  (A) No prescription required for certain 
                uses.--Notwithstanding paragraph (1), oxygen 
                may be provided without a prescription for the 
                following uses:
                          (i) For use in the event of 
                        depressurization or other environmental 
                        oxygen deficiency.
                          (ii) For oxygen deficiency or for use 
                        in emergency resuscitation, when 
                        administered by properly trained 
                        personnel.
                  (B) Labeling.--For oxygen provided pursuant 
                to subparagraph (A), the requirements of 
                section 503(b)(4) shall be deemed to have been 
                met if its labeling bears a warning that the 
                oxygen can be used for emergency use only and 
                for all other medical applications a 
                prescription is required.

SEC. 577. INAPPLICABILITY OF DRUG FEES TO DESIGNATED MEDICAL GASES.

  A designated medical gas, alone or in combination with 
another designated gas or gases (as medically appropriate) 
deemed under section 576 to have in effect an approved 
application shall not be assessed fees under section 736(a) on 
the basis of such deemed approval.

           *       *       *       *       *       *       *


                     CHAPTER VII--GENERAL AUTHORITY

            Subchapter A--General Administrative Provisions

                        REGULATIONS AND HEARINGS

  Sec. 701. (a) * * *

           *       *       *       *       *       *       *

  (h)(1)(A) * * *

           *       *       *       *       *       *       *

  [(C) For guidance documents that set forth initial 
interpretations of a statute or regulation, changes in 
interpretation or policy that are of more than a minor nature, 
complex scientific issues, or highly controversial issues, the 
Secretary shall ensure public participation prior to 
implementation of guidance documents, unless the Secretary 
determines that such prior public participation is not feasible 
or appropriate. In such cases, the Secretary shall provide for 
public comment upon implementation and take such comment into 
account.]
                  (C) For any guidance document that sets forth 
                initial interpretations of a statute or 
                regulation, sets forth changes in 
                interpretation or policy that are of more than 
                a minor nature, includes complex scientific 
                issues, or covers highly controversial issues--
                          (i) the Secretary--
                                  (I) at least 30 days before 
                                issuance of a draft of such 
                                guidance document, shall 
                                publish notice in the Federal 
                                Register of the Secretary's 
                                intent to prepare such guidance 
                                document; and
                                  (II) during preparation and 
                                before issuance of such 
                                guidance document, may meet 
                                with interested stakeholders, 
                                including industry, medical, 
                                and scientific experts and 
                                others, and solicit public 
                                comment;
                          (ii) if the Secretary for good cause 
                        finds that, with respect to such 
                        guidance document, compliance with 
                        clause (i) is impracticable, 
                        unnecessary, or contrary to the public 
                        interest--
                                  (I) the Secretary shall 
                                publish such finding and a 
                                brief statement of the reasons 
                                for such finding in the Federal 
                                Register;
                                  (II) clause (i) shall not 
                                apply with respect to such 
                                guidance document; and
                                  (III) during a 90-day period 
                                beginning not later than the 
                                date of issuance of the draft 
                                of such guidance document, the 
                                Secretary may meet with 
                                interested stakeholders, 
                                including industry, medical, 
                                and scientific experts and 
                                others, and shall solicit 
                                public comment;
                          (iii) beginning on the date of 
                        enactment of the Food and Drug 
                        Administration Reform Act of 2012, upon 
                        issuance of a draft guidance document 
                        under clause (i) or (ii), the Secretary 
                        shall--
                                  (I) designate the document as 
                                draft or final; and
                                  (II) not later than 18 months 
                                after the close of the comment 
                                period for such guidance, issue 
                                a final version of such 
                                guidance document in accordance 
                                with clauses (i) and (ii);
                          (iv) the Secretary may extend the 
                        deadline for issuing final guidance 
                        under clause (iii)(II) by not more than 
                        180 days upon submission by the 
                        Secretary of a notification of such 
                        extension in the Federal Register;
                          (v) if the Secretary issues a draft 
                        guidance document and fails to finalize 
                        the draft by the deadline determined 
                        under clause (iii)(II), as extended 
                        under clause (iv), the Secretary shall, 
                        beginning on the date of such deadline, 
                        treat the draft as null and void; and
                          (vi) not less than every 5 years 
                        after the issuance of a final guidance 
                        document in accordance with clause 
                        (iii), the Secretary shall--
                                  (I) conduct a retrospective 
                                analysis of such guidance 
                                document to ensure it is not 
                                outmoded, ineffective, 
                                insufficient, or excessively 
                                burdensome; and
                                  (II) based on such analysis, 
                                modify, streamline, expand, or 
                                repeal the guidance document in 
                                accordance with what has been 
                                learned.
                  (D) With respect to devices, a notice to 
                industry guidance letter, a notice to industry 
                advisory letter, and any similar notice that 
                sets forth initial interpretations of a statute 
                or regulation or sets forth changes in 
                interpretation or policy shall be treated as a 
                guidance document for purposes of subparagraph 
                (C).
                  (E) The following shall not be treated as a 
                guidance document for purposes of subparagraph 
                (C):
                          (i) Any document that does not set 
                        forth an initial interpretation or a 
                        reinterpretation of a statute or 
                        regulation.
                          (ii) Any document that sets forth or 
                        changes a policy relating to internal 
                        procedures of the Food and Drug 
                        Administration.
                          (iii) Agency reports, general 
                        information documents provided to 
                        consumers or health professionals, 
                        speeches, journal articles and 
                        editorials, media interviews, press 
                        materials, warning letters, memoranda 
                        of understanding, or communications 
                        directed to individual persons or 
                        firms.

           *       *       *       *       *       *       *


                           FACTORY INSPECTION

  Sec. 704. (a)(1) * * *

           *       *       *       *       *       *       *

  (4)(A) Any records or other information that the Secretary 
may inspect under this section from a person that owns or 
operates an establishment that is engaged in the manufacture, 
preparation, propagation, compounding, or processing of a drug 
shall, upon the request of the Secretary, be provided to the 
Secretary by such person, in advance of or in lieu of an 
inspection, within a reasonable timeframe, within reasonable 
limits, and in a reasonable manner, and in either electronic or 
physical form, at the expense of such person. The Secretary's 
request shall include a sufficient description of the records 
requested.
  (B) Upon receipt of the records requested under subparagraph 
(A), the Secretary shall provide to the person confirmation of 
receipt.
  (C) Nothing in this paragraph supplants the authority of the 
Secretary to conduct inspections otherwise permitted under this 
Act in order to ensure compliance with this Act.

           *       *       *       *       *       *       *

  (g)(1) * * *

           *       *       *       *       *       *       *

  (11) The authority provided by this subsection terminates on 
[October 1, 2012] October 1, 2017.

           *       *       *       *       *       *       *


                        CONFIDENTIAL INFORMATION

  Sec. 708. [The Secretary may provide] (a) Contractors.--The 
Secretary may provide any information which is exempt from 
disclosure pursuant to subsection (a) of section 552 of title 
5, United States Code, by reason of subsection (b)(4) of such 
section to a person other than an officer or employee of the 
Department if the Secretary determines such other person 
requires the information in connection with an activity which 
is undertaken under contract with the Secretary, which relates 
to the administration of this Act, and with respect to which 
the Secretary (or an officer or employee of the Department) is 
not prohibited from using such information. The Secretary shall 
require as a condition to the provision of information under 
this section that the person receiving it take such security 
precautions respecting the information as the Secretary may by 
regulation prescribe.
  (b) Ability To Receive and Protect Confidential 
Information.--Except pursuant to an order of a court of the 
United States, the Secretary shall not be required to disclose 
under section 552 of title 5, United States Code, or any other 
provision of law, any information relating to drugs obtained 
from a Federal, State, or local government agency, or from a 
foreign government agency, if the agency has requested that the 
information be kept confidential. For purposes of section 552 
of title 5, United States Code, this subsection shall be 
considered a statute described in section 552(b)(3)(B).
  (c) Authority To Enter Into Memoranda of Understanding for 
Purposes of Information Exchange.--The Secretary may enter into 
written agreements regarding the exchange of information 
referenced in section 301(j) subject to the following criteria:
          (1) Certification.--The Secretary may only enter into 
        written agreements under this subsection with foreign 
        governments that the Secretary has certified as having 
        the authority and demonstrated ability to protect trade 
        secret information from disclosure. Responsibility for 
        this certification shall not be delegated to any 
        officer or employee other than the Commissioner of Food 
        and Drugs.
          (2) Written agreement.--The written agreement under 
        this subsection shall include a commitment by the 
        foreign government to protect information exchanged 
        under this subsection from disclosure unless and until 
        the sponsor gives written permission for disclosure or 
        the Secretary makes a declaration of a public health 
        emergency pursuant to section 319 of the Public Health 
        Service Act that is relevant to the information.
          (3) Information exchange.--The Secretary may provide 
        to a foreign government that has been certified under 
        paragraph (1), and that has executed a written 
        agreement under paragraph (2), information referenced 
        in section 301(j) in the following circumstances:
                  (A) Information concerning the inspection of 
                a facility may be provided if--
                          (i) the Secretary reasonably 
                        believes, or the written agreement 
                        described in paragraph (2) establishes, 
                        that the government has authority to 
                        otherwise obtain such information; and
                          (ii) the written agreement executed 
                        under paragraph (2) limits the 
                        recipient's use of the information to 
                        the recipient's civil regulatory 
                        purposes.
                  (B) Information not described in subparagraph 
                (A) may be provided as part of an 
                investigation, or to alert the foreign 
                government to the potential need for an 
                investigation, if the Secretary has reasonable 
                grounds to believe that a drug has a reasonable 
                probability of causing serious adverse health 
                consequences or death.
  (d) No Limitation on Authority.--This section shall not 
affect the authority of the Secretary to provide or disclose 
information under any other provision of law.

           *       *       *       *       *       *       *


SEC. 712. CONFLICTS OF INTEREST.

  (a) * * *
  [(b) Appointments to Advisory Committees.--
          [(1) Recruitment.--
                  [(A) In general.--The Secretary shall--
                          [(i) develop and implement strategies 
                        on effective outreach to potential 
                        members of advisory committees at 
                        universities, colleges, other academic 
                        research centers, professional and 
                        medical societies, and patient and 
                        consumer groups;
                          [(ii) seek input from professional 
                        medical and scientific societies to 
                        determine the most effective 
                        informational and recruitment 
                        activities; and
                          [(iii) take into account the advisory 
                        committees with the greatest number of 
                        vacancies.
                  [(B) Recruitment activities.--The recruitment 
                activities under subparagraph (A) may include--
                          [(i) advertising the process for 
                        becoming an advisory committee member 
                        at medical and scientific society 
                        conferences;
                          [(ii) making widely available, 
                        including by using existing electronic 
                        communications channels, the contact 
                        information for the Food and Drug 
                        Administration point of contact 
                        regarding advisory committee 
                        nominations; and
                          [(iii) developing a method through 
                        which an entity receiving funding from 
                        the National Institutes of Health, the 
                        Agency for Healthcare Research and 
                        Quality, the Centers for Disease 
                        Control and Prevention, or the Veterans 
                        Health Administration can identify a 
                        person who the Food and Drug 
                        Administration can contact regarding 
                        the nomination of individuals to serve 
                        on advisory committees.
          [(2) Evaluation and criteria.--When considering a 
        term appointment to an advisory committee, the 
        Secretary shall review the expertise of the individual 
        and the financial disclosure report filed by the 
        individual pursuant to the Ethics in Government Act of 
        1978 for each individual under consideration for the 
        appointment, so as to reduce the likelihood that an 
        appointed individual will later require a written 
        determination as referred to in section 208(b)(1) of 
        title 18, United States Code, a written certification 
        as referred to in section 208(b)(3) of title 18, United 
        States Code, or a waiver as referred to in subsection 
        (c)(2) of this section for service on the committee at 
        a meeting of the committee.
  [(c) Disclosures; Prohibitions on Participation; Waivers.--
          [(1) Disclosure of financial interest.--Prior to a 
        meeting of an advisory committee regarding a 
        ``particular matter'' (as that term is used in section 
        208 of title 18, United States Code), each member of 
        the committee who is a full-time Government employee or 
        special Government employee shall disclose to the 
        Secretary financial interests in accordance with 
        subsection (b) of such section 208.
          [(2) Prohibitions and waivers on participation.--
                  [(A) In general.--Except as provided under 
                subparagraph (B), a member of an advisory 
                committee may not participate with respect to a 
                particular matter considered in an advisory 
                committee meeting if such member (or an 
                immediate family member of such member) has a 
                financial interest that could be affected by 
                the advice given to the Secretary with respect 
                to such matter, excluding interests exempted in 
                regulations issued by the Director of the 
                Office of Government Ethics as too remote or 
                inconsequential to affect the integrity of the 
                services of the Government officers or 
                employees to which such regulations apply.
                  [(B) Waiver.--If the Secretary determines it 
                necessary to afford the advisory committee 
                essential expertise, the Secretary may grant a 
                waiver of the prohibition in subparagraph (A) 
                to permit a member described in such 
                subparagraph to--
                          [(i) participate as a non-voting 
                        member with respect to a particular 
                        matter considered in a committee 
                        meeting; or
                          [(ii) participate as a voting member 
                        with respect to a particular matter 
                        considered in a committee meeting.
                  [(C) Limitation on waivers and other 
                exceptions.--
                          [(i) Definition.--For purposes of 
                        this subparagraph, the term 
                        ``exception'' means each of the 
                        following with respect to members of 
                        advisory committees:
                                  [(I) A waiver under section 
                                505(n)(4) (as in effect on the 
                                day before the date of the 
                                enactment of the Food and Drug 
                                Administration Amendments Act 
                                of 2007).
                                  [(II) A written determination 
                                under section 208(b) of title 
                                18, United States Code.
                                  [(III) A written 
                                certification under section 
                                208(b)(3) of such title.
                          [(ii) Determination of total number 
                        of members slots and member exceptions 
                        during fiscal year 2007.--The Secretary 
                        shall determine--
                                  [(I)(aa) for each meeting 
                                held by any advisory committee 
                                during fiscal year 2007, the 
                                number of members who 
                                participated in the meeting; 
                                and
                                  [(bb) the sum of the 
                                respective numbers determined 
                                under item (aa) (referred to in 
                                this subparagraph as the 
                                ``total number of 2007 meeting 
                                slots''); and
                                  [(II)(aa) for each meeting 
                                held by any advisory committee 
                                during fiscal year 2007, the 
                                number of members who received 
                                an exception for the meeting; 
                                and
                                  [(bb) the sum of the 
                                respective numbers determined 
                                under item (aa) (referred to in 
                                this subparagraph as the 
                                ``total number of 2007 meeting 
                                exceptions'').
                          [(iii) Determination of percentage 
                        regarding exceptions during fiscal year 
                        2007.--The Secretary shall determine 
                        the percentage constituted by--
                                  [(I) the total number of 2007 
                                meeting exceptions; divided by
                                  [(II) the total number of 
                                2007 meeting slots.
                          [(iv) Limitation for fiscal years 
                        2008 through 2012.--The number of 
                        exceptions at the Food and Drug 
                        Administration for members of advisory 
                        committees for a fiscal year may not 
                        exceed the following:
                                  [(I) For fiscal year 2008, 95 
                                percent of the percentage 
                                determined under clause (iii) 
                                (referred to in this clause as 
                                the ``base percentage'').
                                  [(II) For fiscal year 2009, 
                                90 percent of the base 
                                percentage.
                                  [(III) For fiscal year 2010, 
                                85 percent of the base 
                                percentage.
                                  [(IV) For fiscal year 2011, 
                                80 percent of the base 
                                percentage.
                                  [(V) For fiscal year 2012, 75 
                                percent of the base percentage.
                          [(v) Allocation of exceptions.--The 
                        exceptions authorized under clause (iv) 
                        for a fiscal year may be allocated 
                        within the centers or other 
                        organizational units of the Food and 
                        Drug Administration as determined 
                        appropriate by the Secretary.
          [(3) Disclosure of waiver.--Notwithstanding section 
        107(a)(2) of the Ethics in Government Act (5 U.S.C. 
        App.), the following shall apply:
                  [(A) 15 or more days in advance.--As soon as 
                practicable, but (except as provided in 
                subparagraph (B)) not later than 15 days prior 
                to a meeting of an advisory committee to which 
                a written determination as referred to in 
                section 208(b)(1) of title 18, United States 
                Code, a written certification as referred to in 
                section 208(b)(3) of title 18, United States 
                Code, or a waiver as referred to in paragraph 
                (2)(B) applies, the Secretary shall disclose 
                (other than information exempted from 
                disclosure under section 552 of title 5, United 
                States Code, and section 552a of title 5, 
                United States Code (popularly known as the 
                Freedom of Information Act and the Privacy Act 
                of 1974, respectively)) on the Internet Web 
                site of the Food and Drug Administration--
                          [(i) the type, nature, and magnitude 
                        of the financial interests of the 
                        advisory committee member to which such 
                        determination, certification, or waiver 
                        applies; and
                          [(ii) the reasons of the Secretary 
                        for such determination, certification, 
                        or waiver.
                  [(B) Less than 30 days in advance.--In the 
                case of a financial interest that becomes known 
                to the Secretary less than 30 days prior to a 
                meeting of an advisory committee to which a 
                written determination as referred to in section 
                208(b)(1) of title 18, United States Code, a 
                written certification as referred to in section 
                208(b)(3) of title 18, United States Code, or a 
                waiver as referred to in paragraph (2)(B) 
                applies, the Secretary shall disclose (other 
                than information exempted from disclosure under 
                section 552 of title 5, United States Code, and 
                section 552a of title 5, United States Code) on 
                the Internet Web site of the Food and Drug 
                Administration, the information described in 
                clauses (i) and (ii) of subparagraph (A) as 
                soon as practicable after the Secretary makes 
                such determination, certification, or waiver, 
                but in no case later than the date of such 
                meeting.]
  (b) Recruitment for Advisory Committees.--
          (1) In general.--The Secretary shall--
                  (A) develop and implement strategies on 
                effective outreach to potential members of 
                advisory committees at universities, colleges, 
                other academic research centers, professional 
                and medical societies, and patient and consumer 
                groups;
                  (B) seek input from professional medical and 
                scientific societies to determine the most 
                effective informational and recruitment 
                activities;
                  (C) at least every 180 days, request 
                referrals for potential members of advisory 
                committees from a variety of stakeholders, 
                including--
                          (i) product developers, patient 
                        groups, and disease advocacy 
                        organizations; and
                          (ii) relevant--
                                  (I) professional societies;
                                  (II) medical societies;
                                  (III) academic organizations; 
                                and
                                  (IV) governmental 
                                organizations; and
                  (D) in carrying out subparagraphs (A) and 
                (B), take into account the levels of activity 
                (including the numbers of annual meetings) and 
                the numbers of vacancies of the advisory 
                committees.
          (2) Recruitment activities.--The recruitment 
        activities under paragraph (1) may include--
                  (A) advertising the process for becoming an 
                advisory committee member at medical and 
                scientific society conferences;
                  (B) making widely available, including by 
                using existing electronic communications 
                channels, the contact information for the Food 
                and Drug Administration point of contact 
                regarding advisory committee nominations; and
                  (C) developing a method through which an 
                entity receiving funding from the National 
                Institutes of Health, the Agency for Healthcare 
                Research and Quality, the Centers for Disease 
                Control and Prevention, or the Veterans Health 
                Administration can identify a person whom the 
                Food and Drug Administration can contact 
                regarding the nomination of individuals to 
                serve on advisory committees.
          (3) Expertise.--In carrying out this subsection, the 
        Secretary shall seek to ensure that the Secretary has 
        access to the most current expert advice.
  (c) Disclosure of Determinations and Certifications.--
Notwithstanding section 107(a)(2) of the Ethics in Government 
Act of 1978, the following shall apply:
          (1) 15 or more days in advance.--As soon as 
        practicable, but (except as provided in paragraph (2)) 
        not later than 15 days prior to a meeting of an 
        advisory committee to which a written determination as 
        referred to in section 208(b)(1) of title 18, United 
        States Code, or a written certification as referred to 
        in section 208(b)(3) of such title, applies, the 
        Secretary shall disclose (other than information 
        exempted from disclosure under section 552 or section 
        552a of title 5, United States Code (popularly known as 
        the Freedom of Information Act and the Privacy Act of 
        1974, respectively)) on the Internet Website of the 
        Food and Drug Administration--
                  (A) the type, nature, and magnitude of the 
                financial interests of the advisory committee 
                member to which such determination or 
                certification applies; and
                  (B) the reasons of the Secretary for such 
                determination or certification, including, as 
                appropriate, the public health interest in 
                having the expertise of the member with respect 
                to the particular matter before the advisory 
                committee.
          (2) Less than 30 days in advance.--In the case of a 
        financial interest that becomes known to the Secretary 
        less than 30 days prior to a meeting of an advisory 
        committee to which a written determination as referred 
        to in section 208(b)(1) of title 18, United States 
        Code, or a written certification as referred to in 
        section 208(b)(3) of such title applies, the Secretary 
        shall disclose (other than information exempted from 
        disclosure under section 552 or 552a of title 5, United 
        States Code) on the Internet Website of the Food and 
        Drug Administration, the information described in 
        subparagraphs (A), (B), and (C) of paragraph (1) as 
        soon as practicable after the Secretary makes such 
        determination or certification, but in no case later 
        than the date of such meeting.
  (d) Public Record.--The Secretary shall ensure that the 
public record and transcript of each meeting of an advisory 
committee includes the disclosure required under [subsection 
(c)(3)] subsection (c) (other than information exempted from 
disclosure under section 552 of title 5, United States Code, 
and section 552a of title 5, United States Code).
  [(e) Annual Report.--Not later than February 1 of each year, 
the Secretary shall submit to the Committee on Appropriations 
and the Committee on Health, Education, Labor, and Pensions of 
the Senate, and the Committee on Appropriations and the 
Committee on Energy and Commerce of the House of 
Representatives a report that describes--
          [(1) with respect to the fiscal year that ended on 
        September 30 of the previous year, the number of 
        vacancies on each advisory committee, the number of 
        nominees received for each committee, and the number of 
        such nominees willing to serve;
          [(2) with respect to such year, the aggregate number 
        of disclosures required under subsection (c)(3) for 
        each meeting of each advisory committee and the 
        percentage of individuals to whom such disclosures did 
        not apply who served on such committee for each such 
        meeting;
          [(3) with respect to such year, the number of times 
        the disclosures required under subsection (c)(3) 
        occurred under subparagraph (B) of such subsection; and
          [(4) how the Secretary plans to reduce the number of 
        vacancies reported under paragraph (1) during the 
        fiscal year following such year, and mechanisms to 
        encourage the nomination of individuals for service on 
        an advisory committee, including those who are 
        classified by the Food and Drug Administration as 
        academicians or practitioners.]
  (e) Annual Report.--
          (1) In general.--Not later than February 1 of each 
        year, the Secretary shall submit to the Committee on 
        Appropriations and the Committee on Health, Education, 
        Labor, and Pensions of the Senate, and the Committee on 
        Appropriations and the Committee on Energy and Commerce 
        of the House of Representatives, a report that 
        describes--
                  (A) with respect to the fiscal year that 
                ended on September 30 of the previous year, the 
                number of persons nominated for participation 
                at meetings for each advisory committee, the 
                number of persons so nominated, and willing to 
                serve, the number of vacancies on each advisory 
                committee, and the number of persons contacted 
                for service as members on each advisory 
                committee meeting for each advisory committee 
                who did not participate because of the 
                potential for such participation to constitute 
                a disqualifying financial interest under 
                section 208 of title 18, United States Code;
                  (B) with respect to such year, the number of 
                persons contacted for services as members for 
                each advisory committee meeting for each 
                advisory committee who did not participate 
                because of reasons other than the potential for 
                such participation to constitute a 
                disqualifying financial interest under section 
                208 of title 18, United States Code;
                  (C) with respect to such year, the number of 
                members attending meetings for each advisory 
                committee; and
                  (D) with respect to such year, the aggregate 
                number of disclosures required under subsection 
                (d) and the percentage of individuals to whom 
                such disclosures did not apply who served on 
                such committee.
          (2) Public availability.--Not later than 30 days 
        after submitting any report under paragraph (1) to the 
        committees specified in such paragraph, the Secretary 
        shall make each such report available to the public.
  (f) Periodic Review of Guidance.--Not less than once every 5 
years, the Secretary [shall review guidance of the Food and 
Drug Administration regarding conflict of interest waiver 
determinations with respect to advisory committees and update 
such guidance as necessary.] shall--
          (1) review guidance of the Food and Drug 
        Administration with respect to advisory committees 
        regarding disclosure of conflicts of interest and the 
        application of section 208 of title 18, United States 
        Code; and
          (2) update such guidance as necessary to ensure that 
        the Food and Drug Administration receives appropriate 
        access to needed scientific expertise, with due 
        consideration of the requirements of such section 208.

           *       *       *       *       *       *       *


SEC. 714. STREAMLINED HIRING AUTHORITY.

  (a) In General.--In addition to any other personnel 
authorities under other provisions of law, the Secretary may, 
without regard to the provisions of title 5, United States 
Code, governing appointments in the competitive service, 
appoint employees to positions in the Food and Drug 
Administration to perform, administer, or support activities 
described in subsection (b), if the Secretary determines that 
such appointments are needed to achieve the objectives 
specified in subsection (c).
  (b) Activities Described.--The activities described in this 
subsection are--
          (1) activities under this Act related to the process 
        for the review of device applications (as defined in 
        section 737(8)); and
          (2) activities under this Act related to human 
        generic drug activities (as defined in section 744A).
  (c) Objectives Specified.--The objectives specified in this 
subsection are--
          (1) with respect to the activities under subsection 
        (b)(1), the goals referred to in section 738A(a)(1); 
        and
          (2) with respect to the activities under subsection 
        (b)(2), the goals referred to in section 744C(a).
  (d) Internal Controls.--The Secretary shall institute 
appropriate internal controls for appointments under this 
section.
  (e) Sunset.--The authority to appoint employees under this 
section shall terminate on the date that is three years after 
the date of enactment of this section.

           *       *       *       *       *       *       *


Subchapter C--Fees

           *       *       *       *       *       *       *


                     PART 2--FEES RELATING TO DRUGS

SEC. 735. DEFINITIONS.

  For purposes of this part:
          (1) The term ``human drug application'' means an 
        application for--
                  (A) * * *
                  (B) licensure of a biological product under 
                subsection (a) [or (k)] of section 351 of the 
                Public Health Service Act.

           *       *       *       *       *       *       *

          (7) The term ``costs of resources allocated for the 
        process for the review of human drug applications'' 
        means the [expenses incurred in connection with] 
        expenses in connection with the process for the review 
        of human drug applications for--
                  (A) * * *

           *       *       *       *       *       *       *


SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.

  (a) Types of Fees.--Beginning in [fiscal year 2008] fiscal 
year 2013, the Secretary shall assess and collect fees in 
accordance with this section as follows:
          (1) Human drug application and supplement fee.--
                  (A) In general.--Each person that submits, on 
                or after September 1, 1992, a human drug 
                application or a supplement shall be subject to 
                a fee as follows:
                          (i) A fee established under 
                        subsection [(c)(5)] (c)(4) for a human 
                        drug application for which clinical 
                        data (other than bioavailability or 
                        bioequivalence studies) with respect to 
                        safety or effectiveness are required 
                        for approval.
                          (ii) A fee established under 
                        subsection [(c)(5)] (c)(4) for a human 
                        drug application for which clinical 
                        data with respect to safety or 
                        effectiveness are not required or a 
                        supplement for which clinical data 
                        (other than bioavailability or 
                        bioequivalence studies) with respect to 
                        safety or effectiveness are required. 
                        Such fee shall be half of the amount of 
                        the fee established under clause (i).

           *       *       *       *       *       *       *

          (2) Prescription drug establishment fee.--
                  (A) In general.--Except as provided in 
                subparagraphs (B) and (C), each person that--
                          (i) is named as the applicant in a 
                        human drug application; and
                          (ii) after September 1, 1992, had 
                        pending before the Secretary a human 
                        drug application or supplement,
                shall be assessed an annual fee established 
                under subsection [(c)(5)] (c)(4) for each 
                prescription drug establishment listed in its 
                approved human drug application as an 
                establishment that manufactures the 
                prescription drug product named in the 
                application. The annual establishment fee shall 
                be assessed in each fiscal year in which the 
                prescription drug product named in the 
                application is assessed a fee under paragraph 
                (3) unless the prescription drug establishment 
                listed in the application does not engage in 
                the manufacture of the prescription drug 
                product during the fiscal year. The 
                establishment fee shall be [payable on or 
                before October 1 of each year] due on the later 
                of the first business day on or after October 1 
                of such fiscal year or the first business day 
                after the enactment of an appropriations Act 
                providing for the collection and obligation of 
                fees for such fiscal year under this section. 
                Each such establishment shall be assessed only 
                one fee per establishment, notwithstanding the 
                number of prescription drug products 
                manufactured at the establishment. In the event 
                an establishment is listed in a human drug 
                application by more than one applicant, the 
                establishment fee for the fiscal year shall be 
                divided equally and assessed among the 
                applicants whose prescription drug products are 
                manufactured by the establishment during the 
                fiscal year and assessed product fees under 
                paragraph (3).

           *       *       *       *       *       *       *

          (3) Prescription drug product fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B), each person who is named as 
                the applicant in a human drug application, and 
                who, after September 1, 1992, had pending 
                before the Secretary a human drug application 
                or supplement, shall pay for each such 
                prescription drug product the annual fee 
                established under [subsection (c)(5)] 
                subsection (c)(4). Such fee shall be [payable 
                on or before October 1 of each year.] due on 
                the later of the first business day on or after 
                October 1 of each such fiscal year or the first 
                business day after the enactment of an 
                appropriations Act providing for the collection 
                and obligation of fees for each such fiscal 
                year under this section. Such fee shall be paid 
                only once for each product for a fiscal year in 
                which the fee is payable.
                  [(B) Exception.--A prescription drug product 
                shall not be assessed a fee under subparagraph 
                (A) if such product is identified on the list 
                compiled under section 505(j)(7)(A) with a 
                potency described in terms of per 100 mL, or if 
                such product is the same product as another 
                product approved under an application filed 
                under section 505(b) or 505(j), under an 
                abbreviated application filed under section 507 
                (as in effect on the day before the date of 
                enactment of the Food and Drug Administration 
                Modernization Act of 1997), or under an 
                abbreviated new drug application pursuant to 
                regulations in effect prior to the 
                implementation of the Drug Price Competition 
                and Patent Term Restoration Act of 1984.]
                  (B) Exception.--A prescription drug product 
                shall not be assessed a fee under subparagraph 
                (A) if such product is--
                          (i) identified on the list compiled 
                        under section 505(j)(7)(A) with a 
                        potency described in terms of per 100 
                        mL;
                          (ii) the same product as another 
                        product that--
                                  (I) was approved under an 
                                application filed under section 
                                505(b) or 505(j); and
                                  (II) is not in the list of 
                                discontinued products compiled 
                                under section 505(j)(7)(A);
                          (iii) the same product as another 
                        product that was approved under an 
                        abbreviated application filed under 
                        section 507 (as in effect on the day 
                        before the date of enactment of the 
                        Food and Drug Administration 
                        Modernization Act of 1997); or
                          (iv) the same product as another 
                        product that was approved under an 
                        abbreviated new drug application 
                        pursuant to regulations in effect prior 
                        to the implementation of the Drug Price 
                        Competition and Patent Term Restoration 
                        Act of 1984.
  (b) Fee Revenue Amounts.--
          (1) In general.--For each of the [fiscal years 2008 
        through 2012] fiscal years 2013 through 2017, fees 
        under subsection (a) shall, except as provided in 
        subsections (c), (d), (f), and (g), be established to 
        generate a total revenue amount under such subsection 
        that is equal to the sum of--
                  (A) [$392,783,000; and] $693,099,000;
                  [(B) an amount equal to the modified workload 
                adjustment factor for fiscal year 2007 (as 
                determined under paragraph (3)).]
                  (B) the dollar amount equal to the inflation 
                adjustment for fiscal year 2013 (as determined 
                under paragraph (3)(A)); and
                  (C) the dollar amount equal to the workload 
                adjustment for fiscal year 2013 (as determined 
                under paragraph (3)(B)).

           *       *       *       *       *       *       *

          [(3) Modified workload adjustment factor for fiscal 
        year 2007.--For purposes of paragraph (1)(B), the 
        Secretary shall determine the modified workload 
        adjustment factor by determining the dollar amount that 
        results from applying the methodology that was in 
        effect under subsection (c)(2) for fiscal year 2007 to 
        the amount $354,893,000, except that, with respect to 
        the portion of such determination that is based on the 
        change in the total number of commercial 
        investigational new drug applications, the Secretary 
        shall count the number of such applications that were 
        active during the most recent 12-month period for which 
        data on such submissions is available.
          [(4) Additional fee revenues for drug safety.--
                  [(A) In general.--For each of the fiscal 
                years 2008 through 2012, paragraph (1)(A) shall 
                be applied by substituting the amount 
                determined under subparagraph (B) for 
                ``$392,783,000''.
                  [(B) Amount determined.--For each of the 
                fiscal years 2008 through 2012, the amount 
                determined under this subparagraph is the sum 
                of--
                          [(i) $392,783,000; plus
                          [(ii)(I) for fiscal year 2008, 
                        $25,000,000;
                          [(II) for fiscal year 2009, 
                        $35,000,000;
                          [(III) for fiscal year 2010, 
                        $45,000,000;
                          [(IV) for fiscal year 2011, 
                        $55,000,000; and
                          [(V) for fiscal year 2012, 
                        $65,000,000.
  [(c) Adjustments.--
          [(1) Inflation adjustment.--For fiscal year 2009 and 
        subsequent fiscal years, the revenues established in 
        subsection (b) shall be adjusted by the Secretary by 
        notice, published in the Federal Register, for a fiscal 
        year to reflect the greater of--
                  [(A) the total percentage change that 
                occurred in the Consumer Price Index for all 
                urban consumers (all items; U.S. city average) 
                for the 12 month period ending June 30 
                preceding the fiscal year for which fees are 
                being established,
                  [(B) the total percentage change for the 
                previous fiscal year in basic pay under the 
                General Schedule in accordance with section 
                5332 of title 5, United States Code, as 
                adjusted by any locality-based comparability 
                payment pursuant to section 5304 of such title 
                for Federal employees stationed in the District 
                of Columbia, or
                  [(C) the average annual change in the cost, 
                per full-time equivalent position of the Food 
                and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 5 years of the 
                preceding 6 fiscal years.
        The adjustment made each fiscal year by this subsection 
        will be added on a compounded basis to the sum of all 
        adjustments made each fiscal year after fiscal year 
        2008 under this subsection.
          [(2) Workload adjustment.--For fiscal year 2009 and 
        subsequent fiscal years, after the fee revenues 
        established in subsection (b) are adjusted for a fiscal 
        year for inflation in accordance with paragraph (1), 
        the fee revenues shall be adjusted further for such 
        fiscal year to reflect changes in the workload of the 
        Secretary for the process for the review of human drug 
        applications. With respect to such adjustment:
                  [(A) The adjustment shall be determined by 
                the Secretary based on a weighted average of 
                the change in the total number of human drug 
                applications (adjusted for changes in review 
                activities, as described in the notice that the 
                Secretary is required to publish in the Federal 
                Register under this subparagraph), efficacy 
                supplements, and manufacturing supplements 
                submitted to the Secretary, and the change in 
                the total number of active commercial 
                investigational new drug applications (adjusted 
                for changes in review activities, as so 
                described) during the most recent 12-month 
                period for which data on such submissions is 
                available. The Secretary shall publish in the 
                Federal Register the fee revenues and fees 
                resulting from the adjustment and the 
                supporting methodologies.
                  [(B) Under no circumstances shall the 
                adjustment result in fee revenues for a fiscal 
                year that are less than the fee revenues for 
                the fiscal year established in subsection (b), 
                as adjusted for inflation under paragraph (1). 
                Any adjustment for changes in review activities 
                made in setting fees and revenue amounts for 
                fiscal year 2009 may not result in the total 
                workload adjustment being more than 2 
                percentage points higher than it would have 
                been in the absence of the adjustment for 
                changes in review activities.
                  [(C) The Secretary shall contract with an 
                independent accounting firm to study the 
                adjustment for changes in review activities 
                applied in setting fees and revenue amounts for 
                fiscal year 2009 and to make recommendations, 
                if warranted, for future changes in the 
                methodology for calculating the adjustment. 
                After review of the recommendations, the 
                Secretary shall, if warranted, make appropriate 
                changes to the methodology, and the changes 
                shall be effective for each of the fiscal years 
                2010 through 2012. The Secretary shall not make 
                any adjustment for changes in review activities 
                for any fiscal year after 2009 unless such 
                study has been completed.
          [(3) Rent and rent-related cost adjustment.--For 
        fiscal year 2010 and each subsequent fiscal year, the 
        Secretary shall, before making adjustments under 
        paragraphs (1) and (2), decrease the fee revenue amount 
        established in subsection (b) if actual costs paid for 
        rent and rent-related expenses for the preceding fiscal 
        year are less than estimates made for such year in 
        fiscal year 2006. Any reduction made under this 
        paragraph shall not exceed the amount by which such 
        costs fall below the estimates made in fiscal year 2006 
        for such fiscal year, and shall not exceed $11,721,000 
        for any fiscal year.
          [(4) Final year adjustment.--
                  [(A) Increase in fees.--For fiscal year 2012, 
                the Secretary may, in addition to adjustments 
                under this paragraph and paragraphs (1), (2), 
                and (3), further increase the fee revenues and 
                fees established in subsection (b) if such an 
                adjustment is necessary to provide for not more 
                than 3 months of operating reserves of 
                carryover user fees for the process for the 
                review of human drug applications for the first 
                3 months of fiscal year 2013. If such an 
                adjustment is necessary, the rationale for the 
                amount of the increase shall be contained in 
                the annual notice establishing fee revenues and 
                fees for fiscal year 2012. If the Secretary has 
                carryover balances for such process in excess 
                of 3 months of such operating reserves, the 
                adjustment under this subparagraph shall not be 
                made.
                  [(B) Decrease in fees.--
                          [(i) In general.--For fiscal year 
                        2012, the Secretary may, in addition to 
                        adjustments under this paragraph and 
                        paragraphs (1), (2), and (3), decrease 
                        the fee revenues and fees established 
                        in subsection (b) by the amount 
                        determined in clause (ii), if, for 
                        fiscal year 2009 or 2010--
                                  [(I) the amount of the total 
                                appropriations for the Food and 
                                Drug Administration for such 
                                fiscal year (excluding the 
                                amount of fees appropriated for 
                                such fiscal year) exceeds the 
                                amount of the total 
                                appropriations for the Food and 
                                Drug Administration for fiscal 
                                year 2008 (excluding the amount 
                                of fees appropriated for such 
                                fiscal year), adjusted as 
                                provided under paragraph (1); 
                                and
                                  [(II) the amount of the total 
                                appropriations expended for the 
                                process for the review of human 
                                drug applications at the Food 
                                and Drug Administration for 
                                such fiscal year (excluding the 
                                amount of fees appropriated for 
                                such fiscal year) exceeds the 
                                amount of appropriations 
                                expended for the process for 
                                the review of human drug 
                                applications at the Food and 
                                Drug Administration for fiscal 
                                year 2008 (excluding the amount 
                                of fees appropriated for such 
                                fiscal year), adjusted as 
                                provided under paragraph (1).
                          [(ii) Amount of decrease.--The amount 
                        determined in this clause is the lesser 
                        of--
                                  [(I) the amount equal to the 
                                sum of the amounts that, for 
                                each of fiscal years 2009 and 
                                2010, is the lesser of--
                                          [(aa) the excess 
                                        amount described in 
                                        clause (i)(II) for such 
                                        fiscal year; or
                                          [(bb) the amount 
                                        specified in subsection 
                                        (b)(4)(B)(ii) for such 
                                        fiscal year; or
                                  [(II) $65,000,000.
                          [(iii) Limitations.--
                                  [(I) Fiscal year condition.--
                                In making the determination 
                                under clause (ii), an amount 
                                described in subclause (I) of 
                                such clause for fiscal year 
                                2009 or 2010 shall be taken 
                                into account only if subclauses 
                                (I) and (II) of clause (i) 
                                apply to such fiscal year.
                                  [(II) Relation to 
                                subparagraph (A).--The 
                                Secretary shall limit any 
                                decrease under this paragraph 
                                if such a limitation is 
                                necessary to provide for the 3 
                                months of operating reserves 
                                described in subparagraph (A).
          [(5) Annual fee setting.--The Secretary shall, 60 
        days before the start of each fiscal year that begins 
        after September 30, 2007, establish, for the next 
        fiscal year, application, product, and establishment 
        fees under subsection (a), based on the revenue amounts 
        established under subsection (b) and the adjustments 
        provided under this subsection.
          [(6) Limit.--The total amount of fees charged, as 
        adjusted under this subsection, for a fiscal year may 
        not exceed the total costs for such fiscal year for the 
        resources allocated for the process for the review of 
        human drug applications.]
          (3) Fiscal year 2013 inflation and workload 
        adjustments.--For purposes of paragraph (1), the dollar 
        amount of the inflation and workload adjustments for 
        fiscal year 2013 shall be determined as follows:
                  (A) Inflation adjustment.--The inflation 
                adjustment for fiscal year 2013 shall be the 
                sum of--
                          (i) $652,709,000 multiplied by the 
                        result of an inflation adjustment 
                        calculation determined using the 
                        methodology described in subsection 
                        (c)(1)(B); and
                          (ii) $652,709,000 multiplied by the 
                        result of an inflation adjustment 
                        calculation determined using the 
                        methodology described in subsection 
                        (c)(1)(C).
                  (B) Workload adjustment.--Subject to 
                subparagraph (C), the workload adjustment for 
                fiscal 2013 shall be--
                          (i) $652,709,000 plus the amount of 
                        the inflation adjustment calculated 
                        under subparagraph (A); multiplied by
                          (ii) the amount (if any) by which a 
                        percentage workload adjustment for 
                        fiscal year 2013, as determined using 
                        the methodology described in subsection 
                        (c)(2)(A), would exceed the percentage 
                        workload adjustment (as so determined) 
                        for fiscal year 2012, if both such 
                        adjustment percentages were calculated 
                        using the 5-year base period consisting 
                        of fiscal years 2003 through 2007.
                  (C) Limitation.--Under no circumstances shall 
                the adjustment under subparagraph (B) result in 
                fee revenues for fiscal year 2013 that are less 
                than the sum of the amount under paragraph 
                (1)(A) and the amount under paragraph (1)(B).
  (c) Adjustments.--
          (1) Inflation adjustment.--For fiscal year 2014 and 
        subsequent fiscal years, the revenues established in 
        subsection (b) shall be adjusted by the Secretary by 
        notice, published in the Federal Register, for a fiscal 
        year by the amount equal to the sum of--
                  (A) one;
                  (B) the average annual percent change in the 
                cost, per full-time equivalent position of the 
                Food and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 3 years of the 
                preceding 4 fiscal years, multiplied by the 
                proportion of personnel compensation and 
                benefits costs to total costs of the process 
                for the review of human drug applications (as 
                defined in section 735(6)) for the first 3 
                years of the preceding 4 fiscal years, and
                  (C) the average annual percent change that 
                occurred in the Consumer Price Index for urban 
                consumers (Washington-Baltimore, DC-MD-VA-WV; 
                Not Seasonally Adjusted; All items; Annual 
                Index) for the first 3 years of the preceding 4 
                years of available data multiplied by the 
                proportion of all costs other than personnel 
                compensation and benefits costs to total costs 
                of the process for the review of human drug 
                applications (as defined in section 735(6)) for 
                the first 3 years of the preceding 4 fiscal 
                years.
        The adjustment made each fiscal year under this 
        paragraph shall be added on a compounded basis to the 
        sum of all adjustments made each fiscal year after 
        fiscal year 2013 under this paragraph.
          (2) Workload adjustment.--For fiscal year 2014 and 
        subsequent fiscal years, after the fee revenues 
        established in subsection (b) are adjusted for a fiscal 
        year for inflation in accordance with paragraph (1), 
        the fee revenues shall be adjusted further for such 
        fiscal year to reflect changes in the workload of the 
        Secretary for the process for the review of human drug 
        applications. With respect to such adjustment:
                  (A) The adjustment shall be determined by the 
                Secretary based on a weighted average of the 
                change in the total number of human drug 
                applications (adjusted for changes in review 
                activities, as described in the notice that the 
                Secretary is required to publish in the Federal 
                Register under this subparagraph), efficacy 
                supplements, and manufacturing supplements 
                submitted to the Secretary, and the change in 
                the total number of active commercial 
                investigational new drug applications (adjusted 
                for changes in review activities, as so 
                described) during the most recent 12-month 
                period for which data on such submissions is 
                available. The Secretary shall publish in the 
                Federal Register the fee revenues and fees 
                resulting from the adjustment and the 
                supporting methodologies.
                  (B) Under no circumstances shall the 
                adjustment result in fee revenues for a fiscal 
                year that are less than the sum of the amount 
                under subsection (b)(1)(A) and the amount under 
                subsection (b)(1)(B), as adjusted for inflation 
                under paragraph (1).
                  (C) The Secretary shall contract with an 
                independent accounting or consulting firm to 
                periodically review the adequacy of the 
                adjustment and publish the results of those 
                reviews. The first review shall be conducted 
                and published by the end of fiscal year 2013 
                (to examine the performance of the adjustment 
                since fiscal year 2009), and the second review 
                shall be conducted and published by the end of 
                fiscal year 2015 (to examine the continued 
                performance of the adjustment). The reports 
                shall evaluate whether the adjustment 
                reasonably represents actual changes in 
                workload volume and complexity and present 
                options to discontinue, retain, or modify any 
                elements of the adjustment. The reports shall 
                be published for public comment. After review 
                of the reports and receipt of public comments, 
                the Secretary shall, if warranted, adopt 
                appropriate changes to the methodology. If the 
                Secretary adopts changes to the methodology 
                based on the first report, the changes shall be 
                effective for the first fiscal year for which 
                fees are set after the Secretary adopts such 
                changes and each subsequent fiscal year.
          (3) Final year adjustment.--For fiscal year 2017, the 
        Secretary may, in addition to adjustments under this 
        paragraph and paragraphs (1) and (2), further increase 
        the fee revenues and fees established in subsection (b) 
        if such an adjustment is necessary to provide for not 
        more than 3 months of operating reserves of carryover 
        user fees for the process for the review of human drug 
        applications for the first 3 months of fiscal year 
        2018. If such an adjustment is necessary, the rationale 
        for the amount of the increase shall be contained in 
        the annual notice establishing fee revenues and fees 
        for fiscal year 2017. If the Secretary has carryover 
        balances for such process in excess of 3 months of such 
        operating reserves, the adjustment under this 
        subparagraph shall not be made.
          (4) Annual fee setting.--The Secretary shall, not 
        later than 60 days before the start of each fiscal year 
        that begins after September 30, 2012, establish, for 
        the next fiscal year, application, product, and 
        establishment fees under subsection (a), based on the 
        revenue amounts established under subsection (b) and 
        the adjustments provided under this subsection.
          (5) Limit.--The total amount of fees charged, as 
        adjusted under this subsection, for a fiscal year may 
        not exceed the total costs for such fiscal year for the 
        resources allocated for the process for the review of 
        human drug applications.

           *       *       *       *       *       *       *

  (g) Crediting and Availability of Fees.--
          (1) In general.--[Fees authorized] Subject to 
        paragraph (2)(C), fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance in 
        appropriations Acts. Such fees are authorized to remain 
        available until expended. Such sums as may be necessary 
        may be transferred from the Food and Drug 
        Administration salaries and expenses appropriation 
        account without fiscal year limitation to such 
        appropriation account for salaries and expenses with 
        such fiscal year limitation. The sums transferred shall 
        be available solely for the process for the review of 
        human drug applications.
          (2) Collections and appropriation acts.--
                  (A) In general.--The fees authorized by this 
                section--
                          (i) [shall be retained] shall be 
                        collected and available in each fiscal 
                        year in an amount not to exceed the 
                        amount specified in appropriation Acts, 
                        or otherwise made available for 
                        obligation, for such fiscal year, and
                          (ii) [shall only be collected and 
                        available] shall be available to defray 
                        increases in the costs of the resources 
                        allocated for the process for the 
                        review of human drug applications 
                        (including increases in such costs for 
                        an additional number of full-time 
                        equivalent positions in the Department 
                        of Health and Human Services to be 
                        engaged in such process) over such 
                        costs, excluding costs paid from fees 
                        collected under this section, for 
                        fiscal year 1997 multiplied by the 
                        adjustment factor.

           *       *       *       *       *       *       *

                  (C) Provision for early payments.--Payment of 
                fees authorized under this section for a fiscal 
                year, prior to the due date for such fees, may 
                be accepted by the Secretary in accordance with 
                authority provided in advance in a prior year 
                appropriations Act.
          (3) Authorization of appropriations.--For each of the 
        [fiscal years 2008 through 2012] fiscal years 2013 
        through 2017, there is authorized to be appropriated 
        for fees under this section an amount equal to the 
        total revenue amount determined under subsection (b) 
        for the fiscal year, as adjusted or otherwise affected 
        under subsection (c) and paragraph (4) of this 
        subsection.
          (4) Offset.--If the sum of the cumulative amount of 
        fees collected under this section for the [fiscal years 
        2008 through 2010] fiscal years 2013 through 2015 and 
        the amount of fees estimated to be collected under this 
        section for [fiscal year 2011] fiscal year 2016 exceeds 
        the cumulative amount appropriated under paragraph (3) 
        for the fiscal years 2008 through 2011, the excess 
        shall be credited to the appropriation account of the 
        Food and Drug Administration as provided in paragraph 
        (1), and shall be subtracted from the amount of fees 
        that would otherwise be authorized to be collected 
        under this section pursuant to appropriation Acts for 
        [fiscal year 2012] fiscal year 2017.

           *       *       *       *       *       *       *


[Effective October 1, 2017, section 105(a) of H.R. 5651 provides for a 
       repeal of sections 735 and 736 (as amended by the bill).]

[SEC. 735. DEFINITIONS.

  [For purposes of this part:
          [(1) The term ``human drug application'' means an 
        application for--
                  [(A) approval of a new drug submitted under 
                section 505(b), or
                  [(B) licensure of a biological product under 
                subsection (a) of section 351 of the Public 
                Health Service Act.
        Such term does not include a supplement to such an 
        application, does not include an application with 
        respect to whole blood or a blood component for 
        transfusion, does not include an application with 
        respect to a bovine blood product for topical 
        application licensed before September 1, 1992, an 
        allergenic extract product, or an in vitro diagnostic 
        biologic product licensed under section 351 of the 
        Public Health Service Act, does not include an 
        application with respect to a large volume parenteral 
        drug product approved before September 1, 1992, does 
        not include an application for a licensure of a 
        biological product for further manufacturing use only, 
        and does not include an application or supplement 
        submitted by a State or Federal Government entity for a 
        drug that is not distributed commercially. Such term 
        does include an application for licensure, as described 
        in subparagraph (B), of a large volume biological 
        product intended for single dose injection for 
        intravenous use or infusion.
          [(2) The term ``supplement'' means a request to the 
        Secretary to approve a change in a human drug 
        application which has been approved.
          [(3) The term ``prescription drug product'' means a 
        specific strength or potency of a drug in final dosage 
        form--
                  [(A) for which a human drug application has 
                been approved,
                  [(B) which may be dispensed only under 
                prescription pursuant to section 503(b), and
                  [(C) which is on the list of products 
                described in section 505(j)(7)(A) (not 
                including the discontinued section of such 
                list) or is on a list created and maintained by 
                the Secretary of products approved under human 
                drug applications under section 351 of the 
                Public Health Service Act (not including the 
                discontinued section of such list).
        Such term does not include whole blood or a blood 
        component for transfusion, does not include a bovine 
        blood product for topical application licensed before 
        September 1, 1992, an allergenic extract product, or an 
        in vitro diagnostic biologic product licensed under 
        section 351 of the Public Health Service Act. Such term 
        does not include a biological product that is licensed 
        for further manufacturing use only, and does not 
        include a drug that is not distributed commercially and 
        is the subject of an application or supplement 
        submitted by a State or Federal Government entity. Such 
        term does include a large volume biological product 
        intended for single dose injection for intravenous use 
        or infusion.
          [(4) The term ``final dosage form'' means, with 
        respect to a prescription drug product, a finished 
        dosage form which is approved for administration to a 
        patient without substantial further manufacturing (such 
        as capsules, tablets, or lyophilized products before 
        reconstitution).
          [(5) The term ``prescription drug establishment'' 
        means a foreign or domestic place of business which is 
        at one general physical location consisting of one or 
        more buildings all of which are within five miles of 
        each other and at which one or more prescription drug 
        products are manufactured in final dosage form. For 
        purposes of this paragraph, the term ``manufactured'' 
        does not include packaging.
          [(6) The term ``process for the review of human drug 
        applications'' means the following activities of the 
        Secretary with respect to the review of human drug 
        applications and supplements:
                  [(A) The activities necessary for the review 
                of human drug applications and supplements.
                  [(B) The issuance of action letters which 
                approve human drug applications or which set 
                forth in detail the specific deficiencies in 
                such applications and, where appropriate, the 
                actions necessary to place such applications in 
                condition for approval.
                  [(C) The inspection of prescription drug 
                establishments and other facilities undertaken 
                as part of the Secretary's review of pending 
                human drug applications and supplements.
                  [(D) Activities necessary for the review of 
                applications for licensure of establishments 
                subject to section 351 of the Public Health 
                Service Act and for the release of lots of 
                biologics under such section.
                  [(E) Monitoring of research conducted in 
                connection with the review of human drug 
                applications.
                  [(F) Postmarket safety activities with 
                respect to drugs approved under human drug 
                applications or supplements, including the 
                following activities:
                          [(i) Collecting, developing, and 
                        reviewing safety information on 
                        approved drugs, including adverse event 
                        reports.
                          [(ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology 
                        systems.
                          [(iii) Developing and using improved 
                        analytical tools to assess potential 
                        safety problems, including access to 
                        external data bases.
                          [(iv) Implementing and enforcing 
                        section 505(o) (relating to 
                        postapproval studies and clinical 
                        trials and labeling changes) and 
                        section 505(p) (relating to risk 
                        evaluation and mitigation strategies).
                          [(v) Carrying out section 505(k)(5) 
                        (relating to adverse event reports and 
                        postmarket safety activities).
          [(7) The term ``costs of resources allocated for the 
        process for the review of human drug applications'' 
        means the expenses in connection with the process for 
        the review of human drug applications for--
                  [(A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                and committees and to contracts with such 
                contractors,
                  [(B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources,
                  [(C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies, and
                  [(D) collecting fees under section 736 and 
                accounting for resources allocated for the 
                review of human drug applications and 
                supplements.
          [(8) The term ``adjustment factor'' applicable to a 
        fiscal year is the Consumer Price Index for all urban 
        consumers (all items; United States city average) for 
        October of the preceding fiscal year divided by such 
        Index for October 1996.
          [(9) The term ``person'' includes an affiliate 
        thereof.
          [(10) The term ``active'', with respect to a 
        commercial investigational new drug application, means 
        such an application to which information was submitted 
        during the relevant period.
          [(11) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  [(A) one business entity controls, or has the 
                power to control, the other business entity; or
                  [(B) a third party controls, or has power to 
                control, both of the business entities.

[SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.

  [(a) Types of Fees.--Beginning infiscal year 2013, the 
Secretary shall assess and collect fees in accordance with this 
section as follows:
          [(1) Human drug application and supplement fee.--
                  [(A) In general.--Each person that submits, 
                on or after September 1, 1992, a human drug 
                application or a supplement shall be subject to 
                a fee as follows:
                          [(i) A fee established under 
                        subsection for a human drug application 
                        for which clinical data (other than 
                        bioavailability or bioequivalence 
                        studies) with respect to safety or 
                        effectiveness are required for 
                        approval.
                          [(ii) A fee established under 
                        subsection for a human drug application 
                        for which clinical data with respect to 
                        safety or effectiveness are not 
                        required or a supplement for which 
                        clinical data (other than 
                        bioavailability or bioequivalence 
                        studies) with respect to safety or 
                        effectiveness are required. Such fee 
                        shall be half of the amount of the fee 
                        established under clause (i).
                  [(B) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the application or supplement.
                  [(C) Exception for previously filed 
                application or supplement.--If a human drug 
                application or supplement was submitted by a 
                person that paid the fee for such application 
                or supplement, was accepted for filing, and was 
                not approved or was withdrawn (without a 
                waiver), the submission of a human drug 
                application or a supplement for the same 
                product by the same person (or the person's 
                licensee, assignee, or successor) shall not be 
                subject to a fee under subparagraph (A).
                  [(D) Refund of fee if application refused for 
                filing or withdrawn before filing.--The 
                Secretary shall refund 75 percent of the fee 
                paid under subparagraph (B) for any application 
                or supplement which is refused for filing or 
                withdrawn without a waiver before filing.
                  [(E) Fees for applications previously refused 
                for filing or withdrawn before filing.--A human 
                drug application or supplement that was 
                submitted but was refused for filing, or was 
                withdrawn before being accepted or refused for 
                filing, shall be subject to the full fee under 
                subparagraph (A) upon being resubmitted or 
                filed over protest, unless the fee is waived or 
                reduced under subsection (d).
                  [(F) Exception for designated orphan drug or 
                indication.--A human drug application for a 
                prescription drug product that has been 
                designated as a drug for a rare disease or 
                condition pursuant to section 526 shall not be 
                subject to a fee under subparagraph (A), unless 
                the human drug application includes an 
                indication for other than a rare disease or 
                condition. A supplement proposing to include a 
                new indication for a rare disease or condition 
                in a human drug application shall not be 
                subject to a fee under subparagraph (A), if the 
                drug has been designated pursuant to section 
                526 as a drug for a rare disease or condition 
                with regard to the indication proposed in such 
                supplement.
                  [(G) Refund of fee if application 
                withdrawn.--If an application or supplement is 
                withdrawn after the application or supplement 
                was filed, the Secretary may refund the fee or 
                a portion of the fee if no substantial work was 
                performed on the application or supplement 
                after the application or supplement was filed. 
                The Secretary shall have the sole discretion to 
                refund a fee or a portion of the fee under this 
                subparagraph. A determination by the Secretary 
                concerning a refund under this paragraph shall 
                not be reviewable.
          [(2) Prescription drug establishment fee.--
                  [(A) In general.--Except as provided in 
                subparagraphs (B) and (C), each person that--
                          [(i) is named as the applicant in a 
                        human drug application; and
                          [(ii) after September 1, 1992, had 
                        pending before the Secretary a human 
                        drug application or supplement,
                shall be assessed an annual fee established 
                under subsection (c)(4) for each prescription 
                drug establishment listed in its approved human 
                drug application as an establishment that 
                manufactures the prescription drug product 
                named in the application. The annual 
                establishment fee shall be assessed in each 
                fiscal year in which the prescription drug 
                product named in the application is assessed a 
                fee under paragraph (3) unless the prescription 
                drug establishment listed in the application 
                does not engage in the manufacture of the 
                prescription drug product during the fiscal 
                year. The establishment fee shall be due on the 
                later of the first business day on or after 
                October 1 of such fiscal year or the first 
                business day after the enactment of an 
                appropriations Act providing for the collection 
                and obligation of fees for such fiscal year 
                under this section. Each such establishment 
                shall be assessed only one fee per 
                establishment, notwithstanding the number of 
                prescription drug products manufactured at the 
                establishment. In the event an establishment is 
                listed in a human drug application by more than 
                one applicant, the establishment fee for the 
                fiscal year shall be divided equally and 
                assessed among the applicants whose 
                prescription drug products are manufactured by 
                the establishment during the fiscal year and 
                assessed product fees under paragraph (3).
                  [(B) Exception.--If, during the fiscal year, 
                an applicant initiates or causes to be 
                initiated the manufacture of a prescription 
                drug product at an establishment listed in its 
                human drug application--
                          [(i) that did not manufacture the 
                        product in the previous fiscal year; 
                        and
                          [(ii) for which the full 
                        establishment fee has been assessed in 
                        the fiscal year at a time before 
                        manufacture of the prescription drug 
                        product was begun;
                the applicant will not be assessed a share of 
                the establishment fee for the fiscal year in 
                which the manufacture of the product began.
                  [(C) Special rules for positron emission 
                tomography drugs.--
                          [(i) In general.--Except as provided 
                        in clause (ii), each person who is 
                        named as the applicant in an approved 
                        human drug application for a positron 
                        emission tomography drug shall be 
                        subject under subparagraph (A) to one-
                        sixth of an annual establishment fee 
                        with respect to each such establishment 
                        identified in the application as 
                        producing positron emission tomography 
                        drugs under the approved application.
                          [(ii) Exception from annual 
                        establishment fee.--Each person who is 
                        named as the applicant in an 
                        application described in clause (i) 
                        shall not be assessed an annual 
                        establishment fee for a fiscal year if 
                        the person certifies to the Secretary, 
                        at a time specified by the Secretary 
                        and using procedures specified by the 
                        Secretary, that--
                                  [(I) the person is a not-for-
                                profit medical center that has 
                                only 1 establishment for the 
                                production of positron emission 
                                tomography drugs; and
                                  [(II) at least 95 percent of 
                                the total number of doses of 
                                each positron emission 
                                tomography drug produced by 
                                such establishment during such 
                                fiscal year will be used within 
                                the medical center.
                          [(iii) Definition.--For purposes of 
                        this subparagraph, the term ``positron 
                        emission tomography drug'' has the 
                        meaning given to the term ``compounded 
                        positron emission tomography drug'' in 
                        section 201(ii), except that paragraph 
                        (1)(B) of such section shall not apply.
          [(3) Prescription drug product fee.--
                  [(A) In general.--Except as provided in 
                subparagraph (B), each person who is named as 
                the applicant in a human drug application, and 
                who, after September 1, 1992, had pending 
                before the Secretary a human drug application 
                or supplement, shall pay for each such 
                prescription drug product the annual fee 
                established under subsection (c)(4). Such fee 
                shall be due on the later of the first business 
                day on or after October 1 of each such fiscal 
                year or the first business day after the 
                enactment of an appropriations Act providing 
                for the collection and obligation of fees for 
                each such fiscal year under this section. Such 
                fee shall be paid only once for each product 
                for a fiscal year in which the fee is payable.
                  [(B) Exception.--A prescription drug product 
                shall not be assessed a fee under subparagraph 
                (A) if such product is--
                          [(i) identified on the list compiled 
                        under section 505(j)(7)(A) with a 
                        potency described in terms of per 100 
                        mL;
                          [(ii) the same product as another 
                        product that--
                                  [(I) was approved under an 
                                application filed under section 
                                505(b) or 505(j); and
                                  [(II) is not in the list of 
                                discontinued products compiled 
                                under section 505(j)(7)(A);
                          [(iii) the same product as another 
                        product that was approved under an 
                        abbreviated application filed under 
                        section 507 (as in effect on the day 
                        before the date of enactment of the 
                        Food and Drug Administration 
                        Modernization Act of 1997); or
                          [(iv) the same product as another 
                        product that was approved under an 
                        abbreviated new drug application 
                        pursuant to regulations in effect prior 
                        to the implementation of the Drug Price 
                        Competition and Patent Term Restoration 
                        Act of 1984.
  [(b) Fee Revenue Amounts.--
          [(1) In general.--For each of the fiscal years 2013 
        through 2017, fees under subsection (a) shall, except 
        as provided in subsections (c), (d), (f), and (g), be 
        established to generate a total revenue amount under 
        such subsection that is equal to the sum of--
                  [(A) $693,099,000;
                  [(B) the dollar amount equal to the inflation 
                adjustment for fiscal year 2013 (as determined 
                under paragraph (3)(A)); and
                  [(C) the dollar amount equal to the workload 
                adjustment for fiscal year 2013 (as determined 
                under paragraph (3)(B)).
          [(2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--
                  [(A) one-third shall be derived from fees 
                under subsection (a)(1) (relating to human drug 
                applications and supplements);
                  [(B) one-third shall be derived from fees 
                under subsection (a)(2) (relating to 
                prescription drug establishments); and
                  [(C) one-third shall be derived from fees 
                under subsection (a)(3) (relating to 
                prescription drug products).
          [(3) Fiscal year 2013 inflation and workload 
        adjustments.--For purposes of paragraph (1), the dollar 
        amount of the inflation and workload adjustments for 
        fiscal year 2013 shall be determined as follows:
                  [(A) Inflation adjustment.--The inflation 
                adjustment for fiscal year 2013 shall be the 
                sum of--
                          [(i) $652,709,000 multiplied by the 
                        result of an inflation adjustment 
                        calculation determined using the 
                        methodology described in subsection 
                        (c)(1)(B); and
                          [(ii) $652,709,000 multiplied by the 
                        result of an inflation adjustment 
                        calculation determined using the 
                        methodology described in subsection 
                        (c)(1)(C).
                  [(B) Workload adjustment.--Subject to 
                subparagraph (C), the workload adjustment for 
                fiscal 2013 shall be--
                          [(i) $652,709,000 plus the amount of 
                        the inflation adjustment calculated 
                        under subparagraph (A); multiplied by
                          [(ii) the amount (if any) by which a 
                        percentage workload adjustment for 
                        fiscal year 2013, as determined using 
                        the methodology described in subsection 
                        (c)(2)(A), would exceed the percentage 
                        workload adjustment (as so determined) 
                        for fiscal year 2012, if both such 
                        adjustment percentages were calculated 
                        using the 5-year base period consisting 
                        of fiscal years 2003 through 2007.
                  [(C) Limitation.--Under no circumstances 
                shall the adjustment under subparagraph (B) 
                result in fee revenues for fiscal year 2013 
                that are less than the sum of the amount under 
                paragraph (1)(A) and the amount under paragraph 
                (1)(B).
  [(c) Adjustments.--
          [(1) Inflation adjustment.--For fiscal year 2014 and 
        subsequent fiscal years, the revenues established in 
        subsection (b) shall be adjusted by the Secretary by 
        notice, published in the Federal Register, for a fiscal 
        year by the amount equal to the sum of--
                  [(A) one;
                  [(B) the average annual percent change in the 
                cost, per full-time equivalent position of the 
                Food and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 3 years of the 
                preceding 4 fiscal years, multiplied by the 
                proportion of personnel compensation and 
                benefits costs to total costs of the process 
                for the review of human drug applications (as 
                defined in section 735(6)) for the first 3 
                years of the preceding 4 fiscal years, and
                  [(C) the average annual percent change that 
                occurred in the Consumer Price Index for urban 
                consumers (Washington-Baltimore, DC-MD-VA-WV; 
                Not Seasonally Adjusted; All items; Annual 
                Index) for the first 3 years of the preceding 4 
                years of available data multiplied by the 
                proportion of all costs other than personnel 
                compensation and benefits costs to total costs 
                of the process for the review of human drug 
                applications (as defined in section 735(6)) for 
                the first 3 years of the preceding 4 fiscal 
                years.
        The adjustment made each fiscal year under this 
        paragraph shall be added on a compounded basis to the 
        sum of all adjustments made each fiscal year after 
        fiscal year 2013 under this paragraph.
          [(2) Workload adjustment.--For fiscal year 2014 and 
        subsequent fiscal years, after the fee revenues 
        established in subsection (b) are adjusted for a fiscal 
        year for inflation in accordance with paragraph (1), 
        the fee revenues shall be adjusted further for such 
        fiscal year to reflect changes in the workload of the 
        Secretary for the process for the review of human drug 
        applications. With respect to such adjustment:
                  [(A) The adjustment shall be determined by 
                the Secretary based on a weighted average of 
                the change in the total number of human drug 
                applications (adjusted for changes in review 
                activities, as described in the notice that the 
                Secretary is required to publish in the Federal 
                Register under this subparagraph), efficacy 
                supplements, and manufacturing supplements 
                submitted to the Secretary, and the change in 
                the total number of active commercial 
                investigational new drug applications (adjusted 
                for changes in review activities, as so 
                described) during the most recent 12-month 
                period for which data on such submissions is 
                available. The Secretary shall publish in the 
                Federal Register the fee revenues and fees 
                resulting from the adjustment and the 
                supporting methodologies.
                  [(B) Under no circumstances shall the 
                adjustment result in fee revenues for a fiscal 
                year that are less than the sum of the amount 
                under subsection (b)(1)(A) and the amount under 
                subsection (b)(1)(B), as adjusted for inflation 
                under paragraph (1).
                  [(C) The Secretary shall contract with an 
                independent accounting or consulting firm to 
                periodically review the adequacy of the 
                adjustment and publish the results of those 
                reviews. The first review shall be conducted 
                and published by the end of fiscal year 2013 
                (to examine the performance of the adjustment 
                since fiscal year 2009), and the second review 
                shall be conducted and published by the end of 
                fiscal year 2015 (to examine the continued 
                performance of the adjustment). The reports 
                shall evaluate whether the adjustment 
                reasonably represents actual changes in 
                workload volume and complexity and present 
                options to discontinue, retain, or modify any 
                elements of the adjustment. The reports shall 
                be published for public comment. After review 
                of the reports and receipt of public comments, 
                the Secretary shall, if warranted, adopt 
                appropriate changes to the methodology. If the 
                Secretary adopts changes to the methodology 
                based on the first report, the changes shall be 
                effective for the first fiscal year for which 
                fees are set after the Secretary adopts such 
                changes and each subsequent fiscal year.
          [(3) Final year adjustment.--For fiscal year 2017, 
        the Secretary may, in addition to adjustments under 
        this paragraph and paragraphs (1) and (2), further 
        increase the fee revenues and fees established in 
        subsection (b) if such an adjustment is necessary to 
        provide for not more than 3 months of operating 
        reserves of carryover user fees for the process for the 
        review of human drug applications for the first 3 
        months of fiscal year 2018. If such an adjustment is 
        necessary, the rationale for the amount of the increase 
        shall be contained in the annual notice establishing 
        fee revenues and fees for fiscal year 2017. If the 
        Secretary has carryover balances for such process in 
        excess of 3 months of such operating reserves, the 
        adjustment under this subparagraph shall not be made.
          [(4) Annual fee setting.--The Secretary shall, not 
        later than 60 days before the start of each fiscal year 
        that begins after September 30, 2012, establish, for 
        the next fiscal year, application, product, and 
        establishment fees under subsection (a), based on the 
        revenue amounts established under subsection (b) and 
        the adjustments provided under this subsection.
          [(5) Limit.--The total amount of fees charged, as 
        adjusted under this subsection, for a fiscal year may 
        not exceed the total costs for such fiscal year for the 
        resources allocated for the process for the review of 
        human drug applications.
  [(d) Fee Waiver or Reduction.--
          [(1) In general.--The Secretary shall grant to a 
        person who is named as the applicant in a human drug 
        application a waiver from or a reduction of one or more 
        fees assessed to that person under subsection (a) where 
        the Secretary finds that--
                  [(A) such waiver or reduction is necessary to 
                protect the public health,
                  [(B) the assessment of the fee would present 
                a significant barrier to innovation because of 
                limited resources available to such person or 
                other circumstances,
                  [(C) the fees to be paid by such person will 
                exceed the anticipated present and future costs 
                incurred by the Secretary in conducting the 
                process for the review of human drug 
                applications for such person, or
                  [(D) the applicant involved is a small 
                business submitting its first human drug 
                application to the Secretary for review.
          [(2) Considerations.--In determining whether to grant 
        a waiver or reduction of a fee under paragraph (1), the 
        Secretary shall consider only the circumstances and 
        assets of the applicant involved and any affiliate of 
        the applicant.
          [(3) Use of standard costs.--In making the finding in 
        paragraph (1)(C), the Secretary may use standard costs.
          [(4) Rules relating to small businesses.--
                  [(A) Definition.--In paragraph (1)(D), the 
                term ``small business'' means an entity that 
                has fewer than 500 employees, including 
                employees of affiliates, and that does not have 
                a drug product that has been approved under a 
                human drug application and introduced or 
                delivered for introduction into interstate 
                commerce.
                  [(B) Waiver of application fee.--The 
                Secretary shall waive under paragraph (1)(D) 
                the application fee for the first human drug 
                application that a small business or its 
                affiliate submits to the Secretary for review. 
                After a small business or its affiliate is 
                granted such a waiver, the small business or 
                its affiliate shall pay--
                          [(i) application fees for all 
                        subsequent human drug applications 
                        submitted to the Secretary for review 
                        in the same manner as an entity that 
                        does not qualify as a small business; 
                        and
                          [(ii) all supplement fees for all 
                        supplements to human drug applications 
                        submitted to the Secretary for review 
                        in the same manner as an entity that 
                        does not qualify as a small business.
  [(e) Effect of Failure To Pay Fees.--A human drug application 
or supplement submitted by a person subject to fees under 
subsection (a) shall be considered incomplete and shall not be 
accepted for filing by the Secretary until all fees owed by 
such person have been paid.
  [(f) Limitations.--
          [(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 
        1997 unless appropriations for salaries and expenses of 
        the Food and Drug Administration for such fiscal year 
        (excluding the amount of fees appropriated for such 
        fiscal year) are equal to or greater than the amount of 
        appropriations for the salaries and expenses of the 
        Food and Drug Administration for the fiscal year 1997 
        (excluding the amount of fees appropriated for such 
        fiscal year) multiplied by the adjustment factor 
        applicable to the fiscal year involved.
          [(2) Authority.--If the Secretary does not assess 
        fees under subsection (a) during any portion of a 
        fiscal year because of paragraph (1) and if at a later 
        date in such fiscal year the Secretary may assess such 
        fees, the Secretary may assess and collect such fees, 
        without any modification in the rate, for human drug 
        applications and supplements, prescription drug 
        establishments, and prescription drug products at any 
        time in such fiscal year notwithstanding the provisions 
        of subsection (a) relating to the date fees are to be 
        paid.
  [(g) Crediting and Availability of Fees.--
          [(1) In general.--Subject to paragraph (2)(C), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the 
        amount provided in advance in appropriations Acts. Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for the process for the 
        review of human drug applications.
          [(2) Collections and appropriation acts.--
                  [(A) In general.--The fees authorized by this 
                section--
                          [(i) shall be collected and available 
                        in each fiscal year in an amount not to 
                        exceed the amount specified in 
                        appropriation Acts, or otherwise made 
                        available for obligation, for such 
                        fiscal year, and
                          [(ii) shall be available to defray 
                        increases in the costs of the resources 
                        allocated for the process for the 
                        review of human drug applications 
                        (including increases in such costs for 
                        an additional number of full-time 
                        equivalent positions in the Department 
                        of Health and Human Services to be 
                        engaged in such process) over such 
                        costs, excluding costs paid from fees 
                        collected under this section, for 
                        fiscal year 1997 multiplied by the 
                        adjustment factor.
                  [(B) Compliance.--The Secretary shall be 
                considered to have met the requirements of 
                subparagraph (A)(ii) in any fiscal year if the 
                costs funded by appropriations and allocated 
                for the process for the review of human drug 
                applications--
                          [(i) are not more than 3 percent 
                        below the level specified in 
                        subparagraph (A)(ii); or
                          [(ii)(I) are more than 3 percent 
                        below the level specified in 
                        subparagraph (A)(ii), and fees assessed 
                        for the fiscal year following the 
                        subsequent fiscal year are decreased by 
                        the amount in excess of 3 percent by 
                        which such costs fell below the level 
                        specified in such subparagraph; and
                          [(II) such costs are not more than 5 
                        percent below the level specified in 
                        such subparagraph.
                  [(C) Provision for early payments.--Payment 
                of fees authorized under this section for a 
                fiscal year, prior to the due date for such 
                fees, may be accepted by the Secretary in 
                accordance with authority provided in advance 
                in a prior year appropriations Act.
          [(3) Authorization of appropriations.--For each of 
        the fiscal years 2013 through 2017, there is authorized 
        to be appropriated for fees under this section an 
        amount equal to the total revenue amount determined 
        under subsection (b) for the fiscal year, as adjusted 
        or otherwise affected under subsection (c) and 
        paragraph (4) of this subsection.
          [(4) Offset.--If the sum of the cumulative amount of 
        fees collected under this section for the fiscal years 
        2013 through 2015 and the amount of fees estimated to 
        be collected under this section for fiscal year 2016 
        exceeds the cumulative amount appropriated under 
        paragraph (3) for the fiscal years 2008 through 2011, 
        the excess shall be credited to the appropriation 
        account of the Food and Drug Administration as provided 
        in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation 
        Acts for fiscal year 2017.
  [(h) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  [(i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under 
subsection (d), or for a refund of any fee collected in 
accordance with subsection (a), a person shall submit to the 
Secretary a written request for such waiver, reduction, or 
refund not later than 180 days after such fee is due.
  [(j) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in the process 
of the review of human drug applications, be reduced to offset 
the number of officers, employees, and advisory committees so 
engaged.
  [(k) Orphan Drugs.--
          [(1) Exemption.--A drug designated under section 526 
        for a rare disease or condition and approved under 
        section 505 or under section 351 of the Public Health 
        Service Act shall be exempt from product and 
        establishment fees under this section, if the drug 
        meets all of the following conditions:
                  [(A) The drug meets the public health 
                requirements contained in this Act as such 
                requirements are applied to requests for 
                waivers for product and establishment fees.
                  [(B) The drug is owned or licensed and is 
                marketed by a company that had less than 
                $50,000,000 in gross worldwide revenue during 
                the previous year.
          [(2) Evidence of qualification.--An exemption under 
        paragraph (1) applies with respect to a drug only if 
        the applicant involved submits a certification that its 
        gross annual revenues did not exceed $50,000,000 for 
        the preceding 12 months before the exemption was 
        requested.]

           *       *       *       *       *       *       *


SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.

  [(a) Performance Report.--Beginning with fiscal year 2008, 
not later than 120 days after the end of each fiscal year for 
which fees are collected under this part, the Secretary shall 
prepare and submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report 
concerning the progress of the Food and Drug Administration in 
achieving the goals identified in the letters described in 
section 101(c) of the Food and Drug Administration Amendments 
Act of 2007 during such fiscal year and the future plans of the 
Food and Drug Administration for meeting the goals. The report 
for a fiscal year shall include information on all previous 
cohorts for which the Secretary has not given a complete 
response on all human drug applications and supplements in the 
cohort.]
  (a) Performance Report.--
          (1) In general.--Beginning with fiscal year 2013, not 
        later than 120 days after the end of each fiscal year 
        for which fees are collected under this part, the 
        Secretary shall prepare and submit to the Committee on 
        Energy and Commerce of the House of Representatives and 
        the Committee on Health, Education, Labor, and Pensions 
        of the Senate a report concerning--
                  (A) the progress of the Food and Drug 
                Administration in achieving the goals 
                identified in the letters described in section 
                101(b) of the Prescription Drug User Fee 
                Amendments of 2012 during such fiscal year and 
                the future plans of the Food and Drug 
                Administration for meeting the goals, including 
                the status of the independent assessment 
                described in such letters; and
                  (B) the progress of the Center for Drug 
                Evaluation and Research and the Center for 
                Biologics Evaluation and Research in achieving 
                the goals, and future plans for meeting the 
                goals, including, for each review division--
                          (i) the number of original standard 
                        new drug applications and biologics 
                        license applications filed per fiscal 
                        year for each review division;
                          (ii) the number of original priority 
                        new drug applications and biologics 
                        license applications filed per fiscal 
                        year for each review division;
                          (iii) the number of standard efficacy 
                        supplements filed per fiscal year for 
                        each review division;
                          (iv) the number of priority efficacy 
                        supplements filed per fiscal year for 
                        each review division;
                          (v) the number of applications filed 
                        for review under accelerated approval 
                        per fiscal year for each review 
                        division;
                          (vi) the number of applications filed 
                        for review as fast track products per 
                        fiscal year for each review division; 
                        and
                          (vii) the number of applications 
                        filed for orphan-designated products 
                        per fiscal year for each review 
                        division.
          (2) Inclusion.--The report under this subsection for 
        a fiscal year shall include information on all previous 
        cohorts for which the Secretary has not given a 
        complete response on all human drug applications and 
        supplements in the cohort.
  (b) Fiscal Report.--Beginning with fiscal year [2008] 2013, 
not later than 120 days after the end of each fiscal year for 
which fees are collected under this part, the Secretary shall 
prepare and submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report on the 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year.

           *       *       *       *       *       *       *

  (d) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and 
        plans for meeting the goals, for the process for the 
        review of human drug applications for the first 5 
        fiscal years after fiscal year [2012] 2017, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  (A) * * *

           *       *       *       *       *       *       *

          (5) Transmittal of recommendations.--Not later than 
        January 15, [2012] 2017, the Secretary shall transmit 
        to the Congress the revised recommendations under 
        paragraph (4), a summary of the views and comments 
        received under such paragraph, and any changes made to 
        the recommendations in response to such views and 
        comments.

           *       *       *       *       *       *       *


[Effective January 31, 2018, section 105(b) of H.R. 5651 provides for a 
           repeal of section 736B (as amended by the bill).]

[SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS.

  [(a) Performance Report.--
          [(1) In general.--Beginning with fiscal year 2013, 
        not later than 120 days after the end of each fiscal 
        year for which fees are collected under this part, the 
        Secretary shall prepare and submit to the Committee on 
        Energy and Commerce of the House of Representatives and 
        the Committee on Health, Education, Labor, and Pensions 
        of the Senate a report concerning--
                  [(A) the progress of the Food and Drug 
                Administration in achieving the goals 
                identified in the letters described in section 
                101(b) of the Prescription Drug User Fee 
                Amendments of 2012 during such fiscal year and 
                the future plans of the Food and Drug 
                Administration for meeting the goals, including 
                the status of the independent assessment 
                described in such letters; and
                  [(B) the progress of the Center for Drug 
                Evaluation and Research and the Center for 
                Biologics Evaluation and Research in achieving 
                the goals, and future plans for meeting the 
                goals, including, for each review division--
                          [(i) the number of original standard 
                        new drug applications and biologics 
                        license applications filed per fiscal 
                        year for each review division;
                          [(ii) the number of original priority 
                        new drug applications and biologics 
                        license applications filed per fiscal 
                        year for each review division;
                          [(iii) the number of standard 
                        efficacy supplements filed per fiscal 
                        year for each review division;
                          [(iv) the number of priority efficacy 
                        supplements filed per fiscal year for 
                        each review division;
                          [(v) the number of applications filed 
                        for review under accelerated approval 
                        per fiscal year for each review 
                        division;
                          [(vi) the number of applications 
                        filed for review as fast track products 
                        per fiscal year for each review 
                        division; and
                          [(vii) the number of applications 
                        filed for orphan-designated products 
                        per fiscal year for each review 
                        division.
          [(2) Inclusion.--The report under this subsection for 
        a fiscal year shall include information on all previous 
        cohorts for which the Secretary has not given a 
        complete response on all human drug applications and 
        supplements in the cohort.
  [(b) Fiscal Report.--Beginning with fiscal year, not later 
than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report on the implementation of 
the authority for such fees during such fiscal year and the 
use, by the Food and Drug Administration, of the fees collected 
for such fiscal year.
  [(c) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  [(d) Reauthorization.--
          [(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and 
        plans for meeting the goals, for the process for the 
        review of human drug applications for the first 5 
        fiscal years after fiscal year, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  [(A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  [(B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  [(C) scientific and academic experts;
                  [(D) health care professionals;
                  [(E) representatives of patient and consumer 
                advocacy groups; and
                  [(F) the regulated industry.
          [(2) Prior public input.--Prior to beginning 
        negotiations with the regulated industry on the 
        reauthorization of this part, the Secretary shall--
                  [(A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                  [(B) hold a public meeting at which the 
                public may present its views on the 
                reauthorization, including specific suggestions 
                for changes to the goals referred to in 
                subsection (a);
                  [(C) provide a period of 30 days after the 
                public meeting to obtain written comments from 
                the public suggesting changes to this part; and
                  [(D) publish the comments on the Food and 
                Drug Administration's Internet Web site.
          [(3) Periodic consultation.--Not less frequently than 
        once every month during negotiations with the regulated 
        industry, the Secretary shall hold discussions with 
        representatives of patient and consumer advocacy groups 
        to continue discussions of their views on the 
        reauthorization and their suggestions for changes to 
        this part as expressed under paragraph (2).
          [(4) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  [(A) present the recommendations developed 
                under paragraph (1) to the Congressional 
                committees specified in such paragraph;
                  [(B) publish such recommendations in the 
                Federal Register;
                  [(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  [(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  [(E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          [(5) Transmittal of recommendations.--Not later than 
        January 15, 2017, the Secretary shall transmit to the 
        Congress the revised recommendations under paragraph 
        (4), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and comments.
          [(6) Minutes of negotiation meetings.--
                  [(A) Public availability.--Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to the Congress, the Secretary 
                shall make publicly available, on the public 
                Web site of the Food and Drug Administration, 
                minutes of all negotiation meetings conducted 
                under this subsection between the Food and Drug 
                Administration and the regulated industry.
                  [(B) Content.--The minutes described under 
                subparagraph (A) shall summarize any 
                substantive proposal made by any party to the 
                negotiations as well as significant 
                controversies or differences of opinion during 
                the negotiations and their resolution.]

           *       *       *       *       *       *       *


PART 3--FEES RELATING TO DEVICES

           *       *       *       *       *       *       *


SEC. 737. DEFINITIONS.

  For purposes of this part:
          (1) * * *

           *       *       *       *       *       *       *

          (9) The term ``costs of resources allocated for the 
        process for the review of device applications'' means 
        the expenses [incurred] in connection with the process 
        for the review of device applications for--
                  (A) * * *

           *       *       *       *       *       *       *

          (10) The term ``adjustment factor'' applicable to a 
        fiscal year is the Consumer Price Index for all urban 
        consumers (all items; United States city average) for 
        October of the preceding fiscal year divided by such 
        Index for [October 2001] October 2011.

           *       *       *       *       *       *       *

          (13) The term ``establishment subject to a 
        registration fee'' means an establishment that [is 
        required to register with the Secretary under section 
        510 and is one of the following types of 
        establishments:
                  [(A) Manufacturer.--An establishment that 
                makes by any means any article that is a 
                device, including an establishment that 
                sterilizes or otherwise makes such article for 
                or on behalf of a specification developer or 
                any other person.
                  [(B) Single-use device reprocessor.--An 
                establishment that, within the meaning of 
                section 201(ll)(2)(A), performs additional 
                processing and manufacturing operations on a 
                single-use device that has previously been used 
                on a patient.
                  [(C) Specification developer.--An 
                establishment that develops specifications for 
                a device that is distributed under the 
                establishment's name but which performs no 
                manufacturing, including an establishment that, 
                in addition to developing specifications, also 
                arranges for the manufacturing of devices 
                labeled with another establishment's name by a 
                contract manufacturer.] is registered (or is 
                required to register) with the Secretary under 
                section 510 because such establishment is 
                engaged in the manufacture, preparation, 
                propagation, compounding, or processing of a 
                device.

SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

  (a) Types of Fees.--
          (1) In general.--Beginning in [fiscal year 2008] 
        fiscal year 2013, the Secretary shall assess and 
        collect fees in accordance with this section.
          (2) Premarket application, premarket report, 
        supplement, and submission fee, and annual fee for 
        periodic reporting concerning a class iii device.--
                  (A) In general.--Except as provided in 
                subparagraph (B) and [subsections (d) and (e)] 
                subsections (d), (e), and (f), each person who 
                submits any of the following, on or after 
                [October 1, 2002] October 1, 2012, shall be 
                subject to a fee established under [subsection 
                (c)(1)] subsection (c) for the fiscal year 
                involved in accordance with the following:
                          (i) * * *

           *       *       *       *       *       *       *

                          (viii) For a premarket notification 
                        submission, a fee equal to [1.84] 2 
                        percent of the fee that applies under 
                        clause (i).

           *       *       *       *       *       *       *

          (3) Annual establishment registration fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B) and subsection (f), each 
                establishment subject to a registration fee 
                shall be subject to a fee for each initial or 
                annual registration under section 510 beginning 
                with its registration for fiscal year 2008.

           *       *       *       *       *       *       *

                  (C) Payment.--The fee required under 
                subparagraph (A) shall be due once each fiscal 
                year, upon the [initial registration of the 
                establishment or upon the annual registration 
                under section 510.] later of--
                          (i) the initial or annual 
                        registration (as applicable) of the 
                        establishment under section 510; or
                          (ii) the first business day after the 
                        date of enactment of an appropriations 
                        Act providing for the collection and 
                        obligation of fees for such year under 
                        this section.
  [(b) Fee Amounts.--Except as provided in subsections (c), 
(d), (e), and (h) the fees under subsection (a) shall be based 
on the following fee amounts:


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        [Fee Type                          Year 2008  Year 2009  Year 2010  Year 2011  Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $185,000   $200,725   $217,787   $236,298   $256,384
Establishment Registration...............................     $1,706     $1,851     $2,008     $2,179   $2,364.]
----------------------------------------------------------------------------------------------------------------

  (b) Fee Amounts.--
          (1) In general.--Subject to subsections (c), (d), 
        (e), (f), and (i), for each of fiscal years 2013 
        through 2017, fees under subsection (a) shall be 
        derived from the base fee amounts specified in 
        paragraph (2), to generate the total revenue amounts 
        specified in paragraph (3).
          (2) Base fee amounts specified.--For purposes of 
        paragraph (1), the base fee amounts specified in this 
        paragraph are as follows:


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                         Fee Type                          Year 2013  Year 2014  Year 2015  Year 2016  Year 2017
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $248,000   $252,960   $258,019   $263,180   $268,443
Establishment Registration...............................     $2,575     $3,200     $3,750     $3,872     $3,872
----------------------------------------------------------------------------------------------------------------

          (3) Total revenue amounts.--For purposes of paragraph 
        (1), the total revenue amounts specified in this 
        paragraph are as follows:
                  (A) $97,722,301 for fiscal year 2013.
                  (B) $112,580,497 for fiscal year 2014.
                  (C) $125,767,107 for fiscal year 2015.
                  (D) $129,339,949 for fiscal year 2016.
                  (E) $130,184,348 for fiscal year 2017.
  (c) Annual Fee Setting; Adjustments.--
          [(1) In general.--The Secretary shall, 60 days before 
        the start of each fiscal year after September 30, 2002, 
        publish in the Federal Register fees under subsection 
        (a).
          [(2) Adjustment.--
                  [(A) In general.--When setting fees for 
                fiscal year 2010, the Secretary may increase 
                the fee under subsection (a)(3)(A) (applicable 
                to establishments subject to registration) only 
                if the Secretary estimates that the number of 
                establishments submitting fees for fiscal year 
                2009 is fewer than 12,250. The percentage 
                increase shall be the percentage by which the 
                estimate of establishments submitting fees in 
                fiscal year 2009 is fewer than 12,750, but in 
                no case may the percentage increase be more 
                than 8.5 percent over that specified in 
                subsection (b) for fiscal year 2010. If the 
                Secretary makes any adjustment to the fee under 
                subsection (a)(3)(A) for fiscal year 2010, then 
                such fee for fiscal years 2011 and 2012 shall 
                be adjusted so that such fee for fiscal year 
                2011 is equal to the adjusted fee for fiscal 
                year 2010 increased by 8.5 percent, and such 
                fee for fiscal year 2012 is equal to the 
                adjusted fee for fiscal year 2011 increased by 
                8.5 percent.
                  [(B) Publication.--For any adjustment made 
                under subparagraph (A), the Secretary shall 
                publish in the Federal Register the Secretary's 
                determination to make the adjustment and the 
                rationale for the determination.]
          (1) In general.--The Secretary shall, 60 days before 
        the start of each fiscal year after September 30, 2012, 
        establish fees under subsection (a), based on amounts 
        specified under subsection (b) and the adjustments 
        provided under this subsection, and publish such fees, 
        and the rationale for any adjustments to such fees, in 
        the Federal Register.
          (2) Inflation adjustments.--
                  (A) Adjustment to total revenue amounts.--For 
                fiscal year 2014 and each subsequent fiscal 
                year, the Secretary shall adjust the total 
                revenue amount specified in subsection (b)(3) 
                for such fiscal year by multiplying such amount 
                by the applicable inflation adjustment under 
                subparagraph (B) for such year.
                  (B) Applicable inflation adjustment to total 
                revenue amounts.--The applicable inflation 
                adjustment for a fiscal year is--
                          (i) for fiscal year 2014, the base 
                        inflation adjustment under subparagraph 
                        (C) for such fiscal year; and
                          (ii) for fiscal year 2015 and each 
                        subsequent fiscal year, the product 
                        of--
                                  (I) the base inflation 
                                adjustment under subparagraph 
                                (C) for such fiscal year; and
                                  (II) the product of the base 
                                inflation adjustment under 
                                subparagraph (C) for each of 
                                the fiscal years preceding such 
                                fiscal year, beginning with 
                                fiscal year 2014.
                  (C) Base inflation adjustment to total 
                revenue amounts.--
                          (i) In general.--Subject to further 
                        adjustment under clause (ii), the base 
                        inflation adjustment for a fiscal year 
                        is the sum of one plus--
                                  (I) the average annual 
                                percent change in the cost, per 
                                full-time equivalent position 
                                of the Food and Drug 
                                Administration, of all 
                                personnel compensation and 
                                benefits paid with respect to 
                                such positions for the first 3 
                                years of the preceding 4 fiscal 
                                years, multiplied by 0.60; and
                                  (II) the average annual 
                                percent change that occurred in 
                                the Consumer Price Index for 
                                urban consumers (Washington-
                                Baltimore, DC-MD-VA-WV; Not 
                                Seasonally Adjusted; All items; 
                                Annual Index) for the first 3 
                                years of the preceding 4 years 
                                of available data multiplied by 
                                0.40.
                          (ii) Limitations.--For purposes of 
                        subparagraph (B), if the base inflation 
                        adjustment for a fiscal year under 
                        clause (i)--
                                  (I) is less than 1, such 
                                adjustment shall be considered 
                                to be equal to 1; or
                                  (II) is greater than 1.04, 
                                such adjustment shall be 
                                considered to be equal to 1.04.
                  (D) Adjustment to base fee amounts.--For each 
                of fiscal years 2014 through 2017, the base fee 
                amounts specified in subsection (b)(2) shall be 
                adjusted as needed, on a uniform proportionate 
                basis, to generate the total revenue amounts 
                under subsection (b)(3), as adjusted for 
                inflation under subparagraph (A).
          (3) Volume-based adjustments to establishment 
        registration base fees.--For each of fiscal years 2014 
        through 2017, after the base fee amounts specified in 
        subsection (b)(2) are adjusted under paragraph (2)(D), 
        the base establishment registration fee amounts 
        specified in such subsection shall be further adjusted, 
        as the Secretary estimates is necessary in order for 
        total fee collections for such fiscal year to generate 
        the total revenue amounts, as adjusted under paragraph 
        (2).
          [(3)] (4) Limit.--The total amount of fees charged, 
        as adjusted under this subsection, for a fiscal year 
        may not exceed the total costs for such fiscal year for 
        the resources allocated for the process for the review 
        of device applications.
          [(4)] (5) Supplement.--
                  (A) * * *

           *       *       *       *       *       *       *

  (f) Fee Waiver or Reduction.--
          (1) In general.--The Secretary may, at the 
        Secretary's sole discretion, grant a waiver or 
        reduction of fees under subsection (a)(2) or (a)(3) if 
        the Secretary finds that such waiver or reduction is in 
        the interest of public health.
          (2) Limitation.--The sum of all fee waivers or 
        reductions granted by the Secretary in any fiscal year 
        under paragraph (1) shall not exceed 2 percent of the 
        total fee revenue amounts established for such year 
        under subsection (c).
          (3) Duration.--The authority provided by this 
        subsection terminates October 1, 2017.
  [(f)] (g) Effect of Failure To Pay Fees.--
          (1) * * *

           *       *       *       *       *       *       *

  [(g)] (h) Conditions.--
          (1) Performance goals; termination of program.--With 
        respect to the amount that, under the salaries and 
        expenses account of the Food and Drug Administration, 
        is appropriated for a fiscal year for devices and 
        radiological products, fees may not be assessed under 
        subsection (a) for the fiscal year, and the Secretary 
        is not expected to meet any performance goals 
        identified for the fiscal year, if--
                  (A) the amount so appropriated for the fiscal 
                year, excluding the amount of fees appropriated 
                for the fiscal year, is more than 1 percent 
                less than [$205,720,000] $280,587,000 
                multiplied by the adjustment factor applicable 
                to such fiscal year; or

           *       *       *       *       *       *       *

  [(h)] (i) Crediting and Availability of Fees.--
          (1) In general.--[Fees authorized] Subject to 
        paragraph (2)(C), fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance in 
        appropriation Acts. Such fees are authorized to be 
        appropriated to remain available until expended. Such 
        sums as may be necessary may be transferred from the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for the process for the 
        review of device applications.
          (2) Collections and appropriation acts.--
                  (A) In general.--The fees authorized by this 
                section--
                          (i) [shall be retained] subject to 
                        subparagraph (C), shall be collected 
                        and available in each fiscal year in an 
                        amount not to exceed the amount 
                        specified in appropriation Acts, or 
                        otherwise made available for 
                        obligation, for such fiscal year, and
                          (ii) shall only be [collected and] 
                        available to defray increases in the 
                        costs of the resources allocated for 
                        the process for the review of device 
                        applications (including increases in 
                        such costs for an additional number of 
                        full-time equivalent positions in the 
                        Department of Health and Human Services 
                        to be engaged in such process) over 
                        such costs, excluding costs paid from 
                        fees collected under this section, for 
                        [fiscal year 2002] fiscal year 2009 
                        multiplied by the adjustment factor.

           *       *       *       *       *       *       *

                  (C) Provision for early year payments.--
                Payment of fees authorized under this section 
                for a fiscal year, prior to the due date for 
                such fees, may be accepted by the Secretary in 
                accordance with authority provided in advance 
                in a prior year appropriations Act.
          [(3) Authorizations of appropriations.--There are 
        authorized to be appropriated for fees under this 
        section--
                  [(A) $48,431,000 for fiscal year 2008;
                  [(B) $52,547,000 for fiscal year 2009;
                  [(C) $57,014,000 for fiscal year 2010;
                  [(D) $61,860,000 for fiscal year 2011; and
                  [(E) $67,118,000 for fiscal year 2012.]
          (3) Authorizations of appropriations.--For each of 
        the fiscal years 2013 through 2017, there is authorized 
        to be appropriated for fees under this section an 
        amount equal to the total revenue amount specified 
        under subsection (b)(3) for the fiscal year, as 
        adjusted under subsection (c) and, for fiscal year 2017 
        only, as further adjusted under paragraph (4).
          (4) Offset.--If the cumulative amount of fees 
        collected during [fiscal years 2008, 2009, and 2010] 
        fiscal years 2013, 2014, and 2015, added to the amount 
        estimated to be collected for [fiscal year 2011] fiscal 
        year 2016, which estimate shall be based upon the 
        amount of fees received by the Secretary through [June 
        30, 2011] June 30, 2016, exceeds [the amount of fees 
        specified in aggregate in] the cumulative amount 
        appropriated pursuant to paragraph (3) for these four 
        fiscal years, the [aggregate amount in] excess shall be 
        credited to the appropriation account of the Food and 
        Drug Administration as provided in paragraph (1), and 
        shall be subtracted from the amount of fees that would 
        otherwise be authorized to be collected under this 
        section pursuant to appropriation Acts for [fiscal year 
        2012] fiscal year 2017.
  [(i)] (j) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  [(j)] (k) Written Requests for Refunds.--To qualify for 
consideration for a refund under subsection (a)(2)(D), a person 
shall submit to the Secretary a written request for such refund 
not later than 180 days after such fee is due.
  [(k)] (l) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employees, and advisory committees not engaged in the process 
of the review of device applications, be reduced to offset the 
number of officers, employees, and advisory committees so 
engaged.

SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Reports.--
          [(1) Performance report.--For fiscal years 2008 
        through 2012, not later than 120 days after the end of 
        each fiscal year during which fees are collected under 
        this part, the Secretary shall prepare and submit to 
        the Committee on Health, Education, Labor, and Pensions 
        of the Senate and the Committee on Energy and Commerce 
        of the House of Representatives, a report concerning 
        the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described 
        in section 201(c) of the Food and Drug Administration 
        Amendments Act of 2007 during such fiscal year and the 
        future plans of the Food and Drug Administration for 
        meeting the goals. The report for a fiscal year shall 
        include information on all previous cohorts for which 
        the Secretary has not given a complete response on all 
        device premarket applications and reports, supplements, 
        and premarket notifications in the cohort.]
          (1) Performance report.--
                  (A) In general.--Beginning with fiscal year 
                2013, for each fiscal year for which fees are 
                collected under this part, the Secretary shall 
                prepare and submit to the Committee on Health, 
                Education, Labor, and Pensions of the Senate 
                and the Committee on Energy and Commerce of the 
                House of Representatives annual reports 
                concerning the progress of the Food and Drug 
                Administration in achieving the goals 
                identified in the letters described in section 
                201(b) of the Medical Device User Fee 
                Amendments of 2012 during such fiscal year and 
                the future plans of the Food and Drug 
                Administration for meeting the goals.
                  (B) Publication.--With regard to information 
                to be reported by the Food and Drug 
                Administration to industry on a quarterly and 
                annual basis pursuant to the letters described 
                in section 201(b) of the Medical Device User 
                Fee Amendments Act of 2012, the Secretary shall 
                make such information publicly available on the 
                Internet Website of the Food and Drug 
                Administration not later than 60 days after the 
                end of each quarter or 120 days after the end 
                of each fiscal year, respectively, to which 
                such information applies. This information 
                shall include the status of the independent 
                assessment identified in the letters described 
                in such section 201(b).
                  (C) Updates.--The Secretary shall include in 
                each report under subparagraph (A) information 
                on all previous cohorts for which the Secretary 
                has not given a complete response on all device 
                premarket applications and reports, 
                supplements, and premarket notifications in the 
                cohort.
          (2) Fiscal report.--For fiscal years [2008 through 
        2012] 2013 through 2017, not later than 120 days after 
        the end of each fiscal year during which fees are 
        collected under this part, the Secretary shall prepare 
        and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on 
        Energy and Commerce of the House of Representatives, a 
        report on the implementation of the authority for such 
        fees during such fiscal year and the use, by the Food 
        and Drug Administration, of the fees collected during 
        such fiscal year for which the report is made.

           *       *       *       *       *       *       *

  (b) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and 
        plans for meeting the goals, for the process for the 
        review of device applications for the first 5 fiscal 
        years after fiscal year [2012] 2017, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  (A) * * *

           *       *       *       *       *       *       *

          (5) Transmittal of recommendations.--Not later than 
        January 15, [2012] 2017, the Secretary shall transmit 
        to Congress the revised recommendations under paragraph 
        (4), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and comments.

           *       *       *       *       *       *       *


[Effective January 31, 2018, section 207(a) of H.R. 5651 provides for a 
           repeal of section 738A (as amended by the bill).]

[SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.

  [(a) Reports.--
          [(1) Performance report.--
                  [(A) In general.--Beginning with fiscal year 
                2013, for each fiscal year for which fees are 
                collected under this part, the Secretary shall 
                prepare and submit to the Committee on Health, 
                Education, Labor, and Pensions of the Senate 
                and the Committee on Energy and Commerce of the 
                House of Representatives annual reports 
                concerning the progress of the Food and Drug 
                Administration in achieving the goals 
                identified in the letters described in section 
                201(b) of the Medical Device User Fee 
                Amendments of 2012 during such fiscal year and 
                the future plans of the Food and Drug 
                Administration for meeting the goals.
                  [(B) Publication.--With regard to information 
                to be reported by the Food and Drug 
                Administration to industry on a quarterly and 
                annual basis pursuant to the letters described 
                in section 201(b) of the Medical Device User 
                Fee Amendments Act of 2012, the Secretary shall 
                make such information publicly available on the 
                Internet Website of the Food and Drug 
                Administration not later than 60 days after the 
                end of each quarter or 120 days after the end 
                of each fiscal year, respectively, to which 
                such information applies. This information 
                shall include the status of the independent 
                assessment identified in the letters described 
                in such section 201(b).
                  [(C) Updates.--The Secretary shall include in 
                each report under subparagraph (A) information 
                on all previous cohorts for which the Secretary 
                has not given a complete response on all device 
                premarket applications and reports, 
                supplements, and premarket notifications in the 
                cohort.
          [(2) Fiscal report.--For fiscal years 2013 through 
        2017, not later than 120 days after the end of each 
        fiscal year during which fees are collected under this 
        part, the Secretary shall prepare and submit to the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate and the Committee on Energy and Commerce of 
        the House of Representatives, a report on the 
        implementation of the authority for such fees during 
        such fiscal year and the use, by the Food and Drug 
        Administration, of the fees collected during such 
        fiscal year for which the report is made.
          [(3) Public availability.--The Secretary shall make 
        the reports required under paragraphs (1) and (2) 
        available to the public on the Internet Web site of the 
        Food and Drug Administration.
  [(b) Reauthorization.--
          [(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and 
        plans for meeting the goals, for the process for the 
        review of device applications for the first 5 fiscal 
        years after fiscal year 2017, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  [(A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  [(B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  [(C) scientific and academic experts;
                  [(D) health care professionals;
                  [(E) representatives of patient and consumer 
                advocacy groups; and
                  [(F) the regulated industry.
          [(2) Prior public input.--Prior to beginning 
        negotiations with the regulated industry on the 
        reauthorization of this part, the Secretary shall--
                  [(A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                  [(B) hold a public meeting at which the 
                public may present its views on the 
                reauthorization, including specific suggestions 
                for changes to the goals referred to in 
                subsection (a)(1);
                  [(C) provide a period of 30 days after the 
                public meeting to obtain written comments from 
                the public suggesting changes to this part; and
                  [(D) publish the comments on the Food and 
                Drug Administration's Internet Web site.
          [(3) Periodic consultation.--Not less frequently than 
        once every month during negotiations with the regulated 
        industry, the Secretary shall hold discussions with 
        representatives of patient and consumer advocacy groups 
        to continue discussions of their views on the 
        reauthorization and their suggestions for changes to 
        this part as expressed under paragraph (2).
          [(4) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  [(A) present the recommendations developed 
                under paragraph (1) to the Congressional 
                committees specified in such paragraph;
                  [(B) publish such recommendations in the 
                Federal Register;
                  [(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  [(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  [(E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          [(5) Transmittal of recommendations.--Not later than 
        January 15, 2017, the Secretary shall transmit to 
        Congress the revised recommendations under paragraph 
        (4), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and comments.
          [(6) Minutes of negotiation meetings.--
                  [(A) Public availability.--Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to the Congress, the Secretary 
                shall make publicly available, on the public 
                Web site of the Food and Drug Administration, 
                minutes of all negotiation meetings conducted 
                under this subsection between the Food and Drug 
                Administration and the regulated industry.
                  [(B) Content.--The minutes described under 
                subparagraph (A) shall summarize any 
                substantive proposal made by any party to the 
                negotiations as well as significant 
                controversies or differences of opinion during 
                the negotiations and their resolution.]

           *       *       *       *       *       *       *


                 PART 7--FEES RELATING TO GENERIC DRUGS

SEC. 744A. DEFINITIONS.

  For purposes of this part:
          (1) The term ``abbreviated new drug application''--
                  (A) means an application submitted under 
                section 505(j), an abbreviated application 
                submitted under section 507 (as in effect on 
                the day before the date of enactment of the 
                Food and Drug Administration Modernization Act 
                of 1997), or an abbreviated new drug 
                application submitted pursuant to regulations 
                in effect prior to the implementation of the 
                Drug Price Competition and Patent Term 
                Restoration Act of 1984; and
                  (B) does not include an application for a 
                positron emission tomography drug.
          (2) The term ``active pharmaceutical ingredient'' 
        means--
                  (A) a substance, or a mixture when the 
                substance is unstable or cannot be transported 
                on its own, intended--
                          (i) to be used as a component of a 
                        drug; and
                          (ii) to furnish pharmacological 
                        activity or other direct effect in the 
                        diagnosis, cure, mitigation, treatment, 
                        or prevention of disease, or to affect 
                        the structure or any function of the 
                        human body; or
                  (B) a substance intended for final 
                crystallization, purification, or salt 
                formation, or any combination of those 
                activities, to become a substance or mixture 
                described in subparagraph (A).
          (3) The term ``adjustment factor'' means a factor 
        applicable to a fiscal year that is the Consumer Price 
        Index for all urban consumers (all items; United States 
        city average) for October of the preceding fiscal year 
        divided by such Index for October 2011.
          (4) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  (A) one business entity controls, or has the 
                power to control, the other business entity; or
                  (B) a third party controls, or has power to 
                control, both of the business entities.
          (5)(A) The term ``facility''--
                  (i) means a business or other entity--
                          (I) under one management, either 
                        direct or indirect; and
                          (II) at one geographic location or 
                        address engaged in manufacturing or 
                        processing an active pharmaceutical 
                        ingredient or a finished dosage form; 
                        and
                  (ii) does not include a business or other 
                entity whose only manufacturing or processing 
                activities are one or more of the following: 
                repackaging, relabeling, or testing.
          (B) For purposes of subparagraph (A), separate 
        buildings within close proximity are considered to be 
        at one geographic location or address if the activities 
        in them are--
                  (i) closely related to the same business 
                enterprise;
                  (ii) under the supervision of the same local 
                management; and
                  (iii) capable of being inspected by the Food 
                and Drug Administration during a single 
                inspection.
          (C) If a business or other entity would meet the 
        definition of a facility under this paragraph but for 
        being under multiple management, the business or other 
        entity is deemed to constitute multiple facilities, one 
        per management entity, for purposes of this paragraph.
          (6) The term ``finished dosage form'' means--
                  (A) a drug product in the form in which it 
                will be administered to a patient, such as a 
                tablet, capsule, solution, or topical 
                application;
                  (B) a drug product in a form in which 
                reconstitution is necessary prior to 
                administration to a patient, such as oral 
                suspensions or lyophilized powders; or
                  (C) any combination of an active 
                pharmaceutical ingredient with another 
                component of a drug product for purposes of 
                production of a drug product described in 
                subparagraph (A) or (B).
          (7) The term ``generic drug submission'' means an 
        abbreviated new drug application, an amendment to an 
        abbreviated new drug application, or a prior approval 
        supplement to an abbreviated new drug application.
          (8) The term ``human generic drug activities'' means 
        the following activities of the Secretary associated 
        with generic drugs and inspection of facilities 
        associated with generic drugs:
                  (A) The activities necessary for the review 
                of generic drug submissions, including review 
                of drug master files referenced in such 
                submissions.
                  (B) The issuance of--
                          (i) approval letters which approve 
                        abbreviated new drug applications or 
                        supplements to such applications; or
                          (ii) complete response letters which 
                        set forth in detail the specific 
                        deficiencies in such applications and, 
                        where appropriate, the actions 
                        necessary to place such applications in 
                        condition for approval.
                  (C) The issuance of letters related to Type 
                II active pharmaceutical drug master files 
                which--
                          (i) set forth in detail the specific 
                        deficiencies in such submissions, and 
                        where appropriate, the actions 
                        necessary to resolve those 
                        deficiencies; or
                          (ii) document that no deficiencies 
                        need to be addressed.
                  (D) Inspections related to generic drugs.
                  (E) Monitoring of research conducted in 
                connection with the review of generic drug 
                submissions and drug master files.
                  (F) Postmarket safety activities with respect 
                to drugs approved under abbreviated new drug 
                applications or supplements, including the 
                following activities:
                          (i) Collecting, developing, and 
                        reviewing safety information on 
                        approved drugs, including adverse event 
                        reports.
                          (ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology 
                        systems.
                          (iii) Developing and using improved 
                        analytical tools to assess potential 
                        safety problems, including access to 
                        external data bases.
                          (iv) Implementing and enforcing 
                        section 505(o) (relating to 
                        postapproval studies and clinical 
                        trials and labeling changes) and 
                        section 505(p) (relating to risk 
                        evaluation and mitigation strategies) 
                        insofar as those activities relate to 
                        abbreviated new drug applications.
                          (v) Carrying out section 505(k)(5) 
                        (relating to adverse-event reports and 
                        postmarket safety activities).
                  (G) Regulatory science activities related to 
                generic drugs.
          (9) The term ``positron emission tomography drug'' 
        has the meaning given to the term ``compounded positron 
        emission tomography drug'' in section 201(ii), except 
        that paragraph (1)(B) of such section shall not apply.
          (10) The term ``prior approval supplement'' means a 
        request to the Secretary to approve a change in the 
        drug substance, drug product, production process, 
        quality controls, equipment, or facilities covered by 
        an approved abbreviated new drug application when that 
        change has a substantial potential to have an adverse 
        effect on the identity, strength, quality, purity, or 
        potency of the drug product as these factors may relate 
        to the safety or effectiveness of the drug product.
          (11) The term ``resources allocated for human generic 
        drug activities'' means the expenses for--
                  (A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers and 
                employees and to contracts with such 
                contractors;
                  (B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  (C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  (D) collecting fees under subsection (a) and 
                accounting for resources allocated for the 
                review of abbreviated new drug applications and 
                supplements and inspection related to generic 
                drugs.
          (12) The term ``Type II active pharmaceutical 
        ingredient drug master file'' means a submission of 
        information to the Secretary by a person that intends 
        to authorize the Food and Drug Administration to 
        reference the information to support approval of a 
        generic drug submission without the submitter having to 
        disclose the information to the generic drug submission 
        applicant.

SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

  (a) Types of Fees.--Beginning in fiscal year 2013, the 
Secretary shall assess and collect fees in accordance with this 
section as follows:
          (1) One-time backlog fee for abbreviated new drug 
        applications pending on october 1, 2012.--
                  (A) In general.--Each person that owns an 
                abbreviated new drug application that is 
                pending on October 1, 2012, and that has not 
                received a tentative approval prior to that 
                date, shall be subject to a fee for each such 
                application, as calculated under subparagraph 
                (B).
                  (B) Method of fee amount calculation.--The 
                amount of each one-time backlog fee shall be 
                calculated by dividing $50,000,000 by the total 
                number of abbreviated new drug applications 
                pending on October 1, 2012, that have not 
                received a tentative approval as of that date.
                  (C) Notice.--Not later than October 31, 2012, 
                the Secretary shall cause to be published in 
                the Federal Register a notice announcing the 
                amount of the fee required by subparagraph (A).
                  (D) Fee due date.--The fee required by 
                subparagraph (A) shall be due no later than 30 
                calendar days after the date of the publication 
                of the notice specified in subparagraph (C).
          (2) Drug master file fee.--
                  (A) In general.--Each person that owns a Type 
                II active pharmaceutical ingredient drug master 
                file that is referenced on or after October 1, 
                2012, in a generic drug submission by any 
                initial letter of authorization shall be 
                subject to a drug master file fee.
                  (B) One-time payment.--If a person has paid a 
                drug master file fee for a Type II active 
                pharmaceutical ingredient drug master file, the 
                person shall not be required to pay a 
                subsequent drug master file fee when that Type 
                II active pharmaceutical ingredient drug master 
                file is subsequently referenced in generic drug 
                submissions.
                  (C) Notice.--
                          (i) Fiscal year 2013.--Not later than 
                        October 31, 2012, the Secretary shall 
                        cause to be published in the Federal 
                        Register a notice announcing the amount 
                        of the drug master file fee for fiscal 
                        year 2013.
                          (ii) Fiscal year 2014 through 2017.--
                        Not later than 60 days before the start 
                        of each of fiscal years 2014 through 
                        2017, the Secretary shall cause to be 
                        published in the Federal Register the 
                        amount of the drug master file fee 
                        established by this paragraph for such 
                        fiscal year.
                  (D) Availability for reference.--
                          (i) In general.--Subject to 
                        subsection (g)(2)(C), for a generic 
                        drug submission to reference a Type II 
                        active pharmaceutical ingredient drug 
                        master file, the drug master file must 
                        be deemed available for reference by 
                        the Secretary.
                          (ii) Conditions.--A drug master file 
                        shall be deemed available for reference 
                        by the Secretary if--
                                  (I) the person that owns a 
                                Type II active pharmaceutical 
                                ingredient drug master file has 
                                paid the fee required under 
                                subparagraph (A) within 20 
                                calendar days after the 
                                applicable due date under 
                                subparagraph (E); and
                                  (II) the drug master file has 
                                not failed an initial 
                                completeness assessment by the 
                                Secretary, in accordance with 
                                criteria to be published by the 
                                Secretary.
                          (iii) List.--The Secretary shall make 
                        publicly available on the Internet Web 
                        site of the Food and Drug 
                        Administration a list of the drug 
                        master file numbers that correspond to 
                        drug master files that have 
                        successfully undergone an initial 
                        completeness assessment, in accordance 
                        with criteria to be published by the 
                        Secretary, and are available for 
                        reference.
                  (E) Fee due date.--
                          (i) In general.--Subject to clause 
                        (ii), a drug master file fee shall be 
                        due no later than the date on which the 
                        first generic drug submission is 
                        submitted that references the 
                        associated Type II active 
                        pharmaceutical ingredient drug master 
                        file.
                          (ii) Limitation.--No fee shall be due 
                        under subparagraph (A) for a fiscal 
                        year until the later of--
                                  (I) 30 calendar days after 
                                publication of the notice 
                                provided for in clause (i) or 
                                (ii) of subparagraph (C), as 
                                applicable; or
                                  (II) 30 calendar days after 
                                the date of enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees under this 
                                section.
          (3) Abbreviated new drug application and prior 
        approval supplement filing fee.--
                  (A) In general.--Each applicant that submits, 
                on or after October 1, 2012, an abbreviated new 
                drug application or a prior approval supplement 
                to an abbreviated new drug application shall be 
                subject to a fee for each such submission in 
                the amount established under subsection (d).
                  (B) Notice.--
                          (i) Fiscal year 2013.--Not later than 
                        October 31, 2012, the Secretary shall 
                        cause to be published in the Federal 
                        Register a notice announcing the amount 
                        of the fees under subparagraph (A) for 
                        fiscal year 2013.
                          (ii) Fiscal years 2014 through 
                        2017.--Not later than 60 days before 
                        the start of each of fiscal years 2014 
                        through 2017, the Secretary shall cause 
                        to be published in the Federal Register 
                        the amount of the fees under 
                        subparagraph (A) for such fiscal year.
                  (C) Fee due date.--
                          (i) In general.--Except as provided 
                        in clause (ii), the fees required by 
                        subparagraphs (A) and (F) shall be due 
                        no later than the date of submission of 
                        the abbreviated new drug application or 
                        prior approval supplement for which 
                        such fee applies.
                          (ii) Special rule for 2013.--For 
                        fiscal year 2013, such fees shall be 
                        due on the later of--
                                  (I) the date on which the fee 
                                is due under clause (i);
                                  (II) 30 calendar days after 
                                publication of the notice 
                                referred to in subparagraph 
                                (B)(i); or
                                  (III) if an appropriations 
                                Act is not enacted providing 
                                for the collection and 
                                obligation of fees under this 
                                section by the date of 
                                submission of the application 
                                or prior approval supplement 
                                for which the fees under 
                                subparagraphs (A) and (F) 
                                apply, 30 calendar days after 
                                the date that such an 
                                appropriations Act is enacted.
                  (D) Refund of fee if abbreviated new drug 
                application is not considered to have been 
                received.--The Secretary shall refund 75 
                percent of the fee paid under subparagraph (A) 
                for any abbreviated new drug application or 
                prior approval supplement to an abbreviated new 
                drug application that the Secretary considers 
                not to have been received within the meaning of 
                section 505(j)(5)(A) for a cause other than 
                failure to pay fees.
                  (E) Fee for an application the secretary 
                considers not to have been received, or that 
                has been withdrawn.--An abbreviated new drug 
                application or prior approval supplement that 
                was submitted on or after October 1, 2012, and 
                that the Secretary considers not to have been 
                received, or that has been withdrawn, shall, 
                upon resubmission of the application or a 
                subsequent new submission following the 
                applicant's withdrawal of the application, be 
                subject to a full fee under subparagraph (A).
                  (F) Additional fee for active pharmaceutical 
                ingredient information not included by 
                reference to type ii active pharmaceutical 
                ingredient drug master file.--An applicant that 
                submits a generic drug submission on or after 
                October 1, 2012, shall pay a fee, in the amount 
                determined under subsection (d)(3), in addition 
                to the fee required under subparagraph (A), 
                if--
                          (i) such submission contains 
                        information concerning the manufacture 
                        of an active pharmaceutical ingredient 
                        at a facility by means other than 
                        reference by a letter of authorization 
                        to a Type II active pharmaceutical drug 
                        master file; and
                          (ii) a fee in the amount equal to the 
                        drug master file fee established in 
                        paragraph (2) has not been previously 
                        paid with respect to such information.
          (4) Generic drug facility fee and active 
        pharmaceutical ingredient facility fee.--
                  (A) In general.--Facilities identified, or 
                intended to be identified, in at least one 
                generic drug submission that is pending or 
                approved to produce a finished dosage form of a 
                human generic drug or an active pharmaceutical 
                ingredient contained in a human generic drug 
                shall be subject to fees as follows:
                          (i) Generic drug facility.--Each 
                        person that owns a facility which is 
                        identified or intended to be identified 
                        in at least one generic drug submission 
                        that is pending or approved to produce 
                        one or more finished dosage forms of a 
                        human generic drug shall be assessed an 
                        annual fee for each such facility.
                          (ii) Active pharmaceutical ingredient 
                        facility.--Each person that owns a 
                        facility which produces, or which is 
                        pending review to produce, one or more 
                        active pharmaceutical ingredients 
                        identified, or intended to be 
                        identified, in at least one generic 
                        drug submission that is pending or 
                        approved or in a Type II active 
                        pharmaceutical ingredient drug master 
                        file referenced in such a generic drug 
                        submission, shall be assessed an annual 
                        fee for each such facility.
                          (iii) Facilities producing both 
                        active pharmaceutical ingredients and 
                        finished dosage forms.--Each person 
                        that owns a facility identified, or 
                        intended to be identified, in at least 
                        one generic drug submission that is 
                        pending or approved to produce both one 
                        or more finished dosage forms subject 
                        to clause (i) and one or more active 
                        pharmaceutical ingredients subject to 
                        clause (ii) shall be subject to fees 
                        under both such clauses for that 
                        facility.
                  (B) Amount.--The amount of fees established 
                under subparagraph (A) shall be established 
                under subsection (d).
                  (C) Notice.--
                          (i) Fiscal year 2013.--For fiscal 
                        year 2013, the Secretary shall cause to 
                        be published in the Federal Register a 
                        notice announcing the amount of the 
                        fees provided for in subparagraph (A) 
                        within the timeframe specified in 
                        subsection (d)(1)(B).
                          (ii) Fiscal years 2014 through 
                        2017.--Within the timeframe specified 
                        in subsection (d)(2), the Secretary 
                        shall cause to be published in the 
                        Federal Register the amount of the fees 
                        under subparagraph (A) for such fiscal 
                        year.
                  (D) Fee due date.--
                          (i) Fiscal year 2013.--For fiscal 
                        year 2013, the fees under subparagraph 
                        (A) shall be due on the later of--
                                  (I) not later than 45 days 
                                after the publication of the 
                                notice under subparagraph (B); 
                                or
                                  (II) if an appropriations Act 
                                is not enacted providing for 
                                the collection and obligation 
                                of fees under this section by 
                                the date of the publication of 
                                such notice, 30 days after the 
                                date that such an 
                                appropriations Act is enacted.
                          (ii) Fiscal years 2014 through 
                        2017.--For each of fiscal years 2014 
                        through 2017, the fees under 
                        subparagraph (A) for such fiscal year 
                        shall be due on the later of--
                                  (I) the first business day on 
                                or after October 1 of each such 
                                year; or
                                  (II) the first business day 
                                after the enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees under this 
                                section for such year.
          (5) Date of submission.--For purposes of this part, a 
        generic drug submission or Type II pharmaceutical 
        master file is deemed to be ``submitted'' to the Food 
        and Drug Administration--
                  (A) if it is submitted via a Food and Drug 
                Administration electronic gateway, on the day 
                when transmission to that electronic gateway is 
                completed, except that a submission or master 
                file that arrives on a weekend, Federal 
                holiday, or day when the Food and Drug 
                Administration office that will review that 
                submission is not otherwise open for business 
                shall be deemed to be submitted on the next day 
                when that office is open for business; and
                  (B) if it is submitted in physical media 
                form, on the day it arrives at the appropriate 
                designated document room of the Food and Drug 
                Administration.
  (b) Fee Revenue Amounts.--
          (1) In general.--
                  (A) Fiscal year 2013.--For fiscal year 2013, 
                fees under subsection (a) shall be established 
                to generate a total estimated revenue amount 
                under such subsection of $299,000,000. Of that 
                amount--
                          (i) $50,000,000 shall be generated by 
                        the one-time backlog fee for generic 
                        drug applications pending on October 1, 
                        2012, established in subsection (a)(1); 
                        and
                          (ii) $249,000,000 shall be generated 
                        by the fees under paragraphs (2) 
                        through (4) of subsection (a).
                  (B) Fiscal years 2014 through 2017.--For each 
                of the fiscal years 2014 through 2017, fees 
                under paragraphs (2) through (4) of subsection 
                (a) shall be established to generate a total 
                estimated revenue amount under such subsection 
                that is equal to $299,000,000, as adjusted 
                pursuant to subsection (c).
          (2) Types of fees.--In establishing fees under 
        paragraph (1) to generate the revenue amounts specified 
        in paragraph (1)(A)(ii) for fiscal year 2013 and 
        paragraph (1)(B) for each of fiscal years 2014 through 
        2017, such fees shall be derived from the fees under 
        paragraphs (2) through (4) of subsection (a) as 
        follows:
                  (A) 6 percent shall be derived from fees 
                under subsection (a)(2) (relating to drug 
                master files).
                  (B) 24 percent shall be derived from fees 
                under subsection (a)(3) (relating to 
                abbreviated new drug applications and 
                supplements). The amount of a fee for a prior 
                approval supplement shall be half the amount of 
                the fee for an abbreviated new drug 
                application.
                  (C) 56 percent shall be derived from fees 
                under subsection (a)(4)(A)(i) (relating to 
                generic drug facilities). The amount of the fee 
                for a facility located outside the United 
                States and its territories and possessions 
                shall be not less than $15,000 and not more 
                than $30,000 higher than the amount of the fee 
                for a facility located in the United States and 
                its territories and possessions, as determined 
                by the Secretary on the basis of data 
                concerning the difference in cost between 
                inspections of facilities located in the United 
                States, including its territories and 
                possessions, and those located outside of the 
                United States and its territories and 
                possessions.
                  (D) 14 percent shall be derived from fees 
                under subsection (a)(4)(A)(ii) (relating to 
                active pharmaceutical ingredient facilities). 
                The amount of the fee for a facility located 
                outside the United States and its territories 
                and possessions shall be not less than $15,000 
                and not more than $30,000 higher than the 
                amount of the fee for a facility located in the 
                United States, including its territories and 
                possessions, as determined by the Secretary on 
                the basis of data concerning the difference in 
                cost between inspections of facilities located 
                in the United States and its territories and 
                possessions and those located outside of the 
                United States and its territories and 
                possessions.
  (c) Adjustments.--
          (1) Inflation adjustment.-- For fiscal year 2014 and 
        subsequent fiscal years, the revenues established in 
        subsection (b) shall be adjusted by the Secretary by 
        notice, published in the Federal Register, for a fiscal 
        year, by an amount equal to the sum of--
                  (A) one;
                  (B) the average annual percent change in the 
                cost, per full-time equivalent position of the 
                Food and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 3 years of the 
                preceding 4 fiscal years multiplied by the 
                proportion of personnel compensation and 
                benefits costs to total costs of human generic 
                drug activities for the first 3 years of the 
                preceding 4 fiscal years; and
                  (C) the average annual percent change that 
                occurred in the Consumer Price Index for urban 
                consumers (Washington-Baltimore, DC-MD-VA-WV; 
                Not Seasonally Adjusted; All items; Annual 
                Index) for the first 3 years of the preceding 4 
                years of available data multiplied by the 
                proportion of all costs other than personnel 
                compensation and benefits costs to total costs 
                of human generic drug activities for the first 
                3 years of the preceding 4 fiscal years.
        The adjustment made each fiscal year under this 
        subsection shall be added on a compounded basis to the 
        sum of all adjustments made each fiscal year after 
        fiscal year 2013 under this subsection.
          (2) Final year adjustment.--For fiscal year 2017, the 
        Secretary may, in addition to adjustments under 
        paragraph (1), further increase the fee revenues and 
        fees established in subsection (b) if such an 
        adjustment is necessary to provide for not more than 3 
        months of operating reserves of carryover user fees for 
        human generic drug activities for the first 3 months of 
        fiscal year 2018. Such fees may only be used in fiscal 
        year 2018. If such an adjustment is necessary, the 
        rationale for the amount of the increase shall be 
        contained in the annual notice establishing fee 
        revenues and fees for fiscal year 2017. If the 
        Secretary has carryover balances for such activities in 
        excess of 3 months of such operating reserves, the 
        adjustment under this subparagraph shall not be made.
  (d) Annual Fee Setting.--
          (1) Fiscal year 2013.--For fiscal year 2013--
                  (A) the Secretary shall establish, by October 
                31, 2012, the one-time generic drug backlog fee 
                for generic drug applications pending on 
                October 1, 2012, the drug master file fee, the 
                abbreviated new drug application fee, and the 
                prior approval supplement fee under subsection 
                (a), based on the revenue amounts established 
                under subsection (b); and
                  (B) the Secretary shall establish, not later 
                than 45 days after the date to comply with the 
                requirement for identification of facilities in 
                subsection (f)(2), the generic drug facility 
                fee and active pharmaceutical ingredient 
                facility fee under subsection (a) based on the 
                revenue amounts established under subsection 
                (b).
          (2) Fiscal years 2014 through 2017.--Not more than 60 
        days before the first day of each of fiscal years 2014 
        through 2017, the Secretary shall establish the drug 
        master file fee, the abbreviated new drug application 
        fee, the prior approval supplement fee, the generic 
        drug facility fee, and the active pharmaceutical 
        ingredient facility fee under subsection (a) for such 
        fiscal year, based on the revenue amounts established 
        under subsection (b) and the adjustments provided under 
        subsection (c).
          (3) Fee for active pharmaceutical ingredient 
        information not included by reference to type ii active 
        pharmaceutical ingredient drug master file.--In 
        establishing the fees under paragraphs (1) and (2), the 
        amount of the fee under subsection (a)(3)(F) shall be 
        determined by multiplying--
                  (A) the sum of--
                          (i) the total number of such active 
                        pharmaceutical ingredients in such 
                        submission; and
                          (ii) for each such ingredient that is 
                        manufactured at more than one such 
                        facility, the total number of such 
                        additional facilities; and
                  (B) the amount equal to the drug master file 
                fee established in subsection (a)(2) for such 
                submission.
  (e) Limit.--The total amount of fees charged, as adjusted 
under subsection (c), for a fiscal year may not exceed the 
total costs for such fiscal year for the resources allocated 
for human generic drug activities.
  (f) Identification of Facilities.--
          (1) Publication of notice; deadline for compliance.--
        Not later than October 1, 2012, the Secretary shall 
        cause to be published in the Federal Register a notice 
        requiring each person that owns a facility described in 
        subsection (a)(4)(A), or a site or organization 
        required to be identified by paragraph (4), to submit 
        to the Secretary information on the identity of each 
        such facility, site, or organization. The notice 
        required by this paragraph shall specify the type of 
        information to be submitted and the means and format 
        for submission of such information.
          (2) Required submission of facility identification.--
        Each person that owns a facility described in 
        subsection (a)(4)(A) or a site or organization required 
        to be identified by paragraph (4) shall submit to the 
        Secretary the information required under this 
        subsection each year. Such information shall--
                  (A) for fiscal year 2013, be submitted not 
                later than 60 days after the publication of the 
                notice under paragraph (1); and
                  (B) for each subsequent fiscal year, be 
                submitted, updated, or reconfirmed on or before 
                June 1 of the previous year.
          (3) Contents of notice.--At a minimum, the submission 
        required by paragraph (2) shall include for each such 
        facility--
                  (A) identification of a facility identified 
                or intended to be identified in an approved or 
                pending generic drug submission;
                  (B) whether the facility manufactures active 
                pharmaceutical ingredients or finished dosage 
                forms, or both;
                  (C) whether or not the facility is located 
                within the United States and its territories 
                and possessions;
                  (D) whether the facility manufactures 
                positron emission tomography drugs solely, or 
                in addition to other drugs; and
                  (E) whether the facility manufactures drugs 
                that are not generic drugs.
          (4) Certain sites and organizations.--
                  (A) In general.--Any person that owns or 
                operates a site or organization described in 
                subparagraph (B) shall submit to the Secretary 
                information concerning the ownership, name, and 
                address of the site or organization.
                  (B) Sites and organizations.--A site or 
                organization is described in this subparagraph 
                if it is identified in a generic drug 
                submission and is--
                          (i) a site in which a bioanalytical 
                        study is conducted;
                          (ii) a clinical research 
                        organization;
                          (iii) a contract analytical testing 
                        site; or
                          (iv) a contract repackager site.
                  (C) Notice.--The Secretary may, by notice 
                published in the Federal Register, specify the 
                means and format for submission of the 
                information under subparagraph (A) and may 
                specify, as necessary for purposes of this 
                section, any additional information to be 
                submitted.
                  (D) Inspection authority.--The Secretary's 
                inspection authority under section 704(a)(1) 
                shall extend to all such sites and 
                organizations.
  (g) Effect of Failure To Pay Fees.--
          (1) Generic drug backlog fee.--Failure to pay the fee 
        under subsection (a)(1) shall result in the Secretary 
        placing the person that owns the abbreviated new drug 
        application subject to that fee on an arrears list, 
        such that no new abbreviated new drug applications or 
        supplement submitted on or after October 1, 2012, from 
        that person, or any affiliate of that person, will be 
        received within the meaning of section 505(j)(5)(A) 
        until such outstanding fee is paid.
          (2) Drug master file fee.--
                  (A) Failure to pay the fee under subsection 
                (a)(2) within 20 calendar days after the 
                applicable due date under subparagraph (E) of 
                such subsection (as described in subsection 
                (a)(2)(D)(ii)(I)) shall result in the Type II 
                active pharmaceutical ingredient drug master 
                file not being deemed available for reference.
                  (B)(i) Any generic drug submission submitted 
                on or after October 1, 2012, that references, 
                by a letter of authorization, a Type II active 
                pharmaceutical ingredient drug master file that 
                has not been deemed available for reference 
                shall not be received within the meaning of 
                section 505(j)(5)(A) unless the condition 
                specified in clause (ii) is met.
                  (ii) The condition specified in this clause 
                is that the fee established under subsection 
                (a)(2) has been paid within 20 calendar days of 
                the Secretary providing the notification to the 
                sponsor of the abbreviated new drug application 
                or supplement of the failure of the owner of 
                the Type II active pharmaceutical ingredient 
                drug master file to pay the drug master file 
                fee as specified in subparagraph (C).
                  (C)(i) If an abbreviated new drug application 
                or supplement to an abbreviated new drug 
                application references a Type II active 
                pharmaceutical ingredient drug master file for 
                which a fee under subsection (a)(2)(A) has not 
                been paid by the applicable date under 
                subsection (a)(2)(E), the Secretary shall 
                notify the sponsor of the abbreviated new drug 
                application or supplement of the failure of the 
                owner of the Type II active pharmaceutical 
                ingredient drug master file to pay the 
                applicable fee.
                  (ii) If such fee is not paid within 20 
                calendar days of the Secretary providing the 
                notification, the abbreviated new drug 
                application or supplement to an abbreviated new 
                drug application shall not be received within 
                the meaning of 505(j)(5)(A).
          (3) Abbreviated new drug application fee and prior 
        approval supplement fee.--Failure to pay a fee under 
        subparagraph (A) or (F) of subsection (a)(3) within 20 
        calendar days of the applicable due date under 
        subparagraph (C) of such subsection shall result in the 
        abbreviated new drug application or the prior approval 
        supplement to an abbreviated new drug application not 
        being received within the meaning of section 
        505(j)(5)(A) until such outstanding fee is paid.
          (4) Generic drug facility fee and active 
        pharmaceutical ingredient facility fee.--
                  (A) In general.--Failure to pay the fee under 
                subsection (a)(4) within 20 calendar days of 
                the due date as specified in subparagraph (D) 
                of such subsection shall result in the 
                following:
                          (i) The Secretary shall place the 
                        facility on a publicly available 
                        arrears list, such that no new 
                        abbreviated new drug application or 
                        supplement submitted on or after 
                        October 1, 2012, from the person that 
                        is responsible for paying such fee, or 
                        any affiliate of that person, will be 
                        received within the meaning of section 
                        505(j)(5)(A).
                          (ii) Any new generic drug submission 
                        submitted on or after October 1, 2012, 
                        that references such a facility shall 
                        not be received, within the meaning of 
                        section 505(j)(5)(A) if the outstanding 
                        facility fee is not paid within 20 
                        calendar days of the Secretary 
                        providing the notification to the 
                        sponsor of the failure of the owner of 
                        the facility to pay the facility fee 
                        under subsection (a)(4)(C).
                          (iii) All drugs or active 
                        pharmaceutical ingredients manufactured 
                        in such a facility or containing an 
                        ingredient manufactured in such a 
                        facility shall be deemed misbranded 
                        under section 502(aa).
                  (B) Application of penalties.--The penalties 
                under this paragraph shall apply until the fee 
                established by subsection (a)(4) is paid or the 
                facility is removed from all generic drug 
                submissions that refer to the facility.
                  (C) Nonreceival for nonpayment.--
                          (i) Notice.--If an abbreviated new 
                        drug application or supplement to an 
                        abbreviated new drug application 
                        submitted on or after October 1, 2012, 
                        references a facility for which a 
                        facility fee has not been paid by the 
                        applicable date under subsection 
                        (a)(4)(C), the Secretary shall notify 
                        the sponsor of the generic drug 
                        submission of the failure of the owner 
                        of the facility to pay the facility 
                        fee.
                          (ii) Nonreceival.--If the facility 
                        fee is not paid within 20 calendar days 
                        of the Secretary providing the 
                        notification under clause (i), the 
                        abbreviated new drug application or 
                        supplement to an abbreviated new drug 
                        application shall not be received 
                        within the meaning of section 
                        505(j)(5)(A).
  (h) Limitations.--
          (1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 
        2012, unless appropriations for salaries and expenses 
        of the Food and Drug Administration for such fiscal 
        year (excluding the amount of fees appropriated for 
        such fiscal year) are equal to or greater than the 
        amount of appropriations for the salaries and expenses 
        of the Food and Drug Administration for the fiscal year 
        2009 (excluding the amount of fees appropriated for 
        such fiscal year) multiplied by the adjustment factor 
        (as defined in section 744A) applicable to the fiscal 
        year involved.
          (2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal 
        year and if at a later date in such fiscal year the 
        Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification 
        in the rate, for Type II active pharmaceutical 
        ingredient drug master files, abbreviated new drug 
        applications and prior approval supplements, and 
        generic drug facilities and active pharmaceutical 
        ingredient facilities at any time in such fiscal year 
        notwithstanding the provisions of subsection (a) 
        relating to the date fees are to be paid.
  (i) Crediting and Availability of Fees.--
          (1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to 
        the extent and in the amount provided in advance in 
        appropriations Acts, subject to paragraph (2). Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for human generic drug 
        activities.
          (2) Collections and appropriation acts.--
                  (A) In general.--The fees authorized by this 
                section--
                          (i) subject to subparagraphs (C) and 
                        (D), shall be collected and available 
                        in each fiscal year in an amount not to 
                        exceed the amount specified in 
                        appropriation Acts, or otherwise made 
                        available for obligation for such 
                        fiscal year; and
                          (ii) shall be available for a fiscal 
                        year beginning after fiscal year 2012 
                        to defray the costs of human generic 
                        drug activities (including such costs 
                        for an additional number of full-time 
                        equivalent positions in the Department 
                        of Health and HumanServices to be 
                        engaged in such activities), only if 
                        the Secretary allocates for such 
                        purpose an amount for such fiscal year 
                        (excluding amounts from fees collected 
                        under this section) no less than 
                        $97,000,000 multiplied by the 
                        adjustment factor defined in section 
                        744A(3) applicable to the fiscal year 
                        involved.
                  (B) Compliance.--The Secretary shall be 
                considered to have met the requirements of 
                subparagraph (A)(ii) in any fiscal year if the 
                costs funded by appropriations and allocated 
                for human generic activities are not more than 
                10 percent below the level specified in such 
                subparagraph.
                  (C) Fee collection during first program 
                year.--Until the date of enactment of an Act 
                making appropriations through September 30, 
                2013 for the salaries and expenses account of 
                the Food and Drug Administration, fees 
                authorized by this section for fiscal year 
                2013, may be collected and shall be credited to 
                such account and remain available until 
                expended.
                  (D) Provision for early payments in 
                subsequent years.--Payment of fees authorized 
                under this section for a fiscal year (after 
                fiscal year 2013), prior to the due date for 
                such fees, may be accepted by the Secretary in 
                accordance with authority provided in advance 
                in a prior year appropriations Act.
          (3) Authorization of appropriations.--For each of the 
        fiscal years 2013 through 2017, there is authorized to 
        be appropriated for fees under this section an amount 
        equivalent to the total revenue amount determined under 
        subsection (b) for the fiscal year, as adjusted under 
        subsection (c), if applicable, or as otherwise affected 
        under paragraph (2) of this subsection.
  (j) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 calendar days after it is due, such 
fee shall be treated as a claim of the United States Government 
subject to subchapter II of chapter 37 of title 31, United 
States Code.
  (k) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employees, and advisory committees not engaged in human generic 
drug activities, be reduced to offset the number of officers, 
employees, and advisory committees so engaged.
  (l) Positron Emission Tomography Drugs.--
          (1) Exemption from fees.--Submission of an 
        application for a positron emission tomography drug or 
        active pharmaceutical ingredient for a positron 
        emission tomography drug shall not require the payment 
        of any fee under this section. Facilities that solely 
        produce positron emission tomography drugs shall not be 
        required to pay a facility fee as established in 
        subsection (a)(4).
          (2) Identification requirement.--Facilities that 
        produce positron emission tomography drugs or active 
        pharmaceutical ingredients of such drugs are required 
        to be identified pursuant to subsection (f).
  (m) Disputes Concerning Fees.--To qualify for the return of a 
fee claimed to have been paid in error under this section, a 
person shall submit to the Secretary a written request 
justifying such return within 180 calendar days after such fee 
was paid.
  (n) Substantially Complete Applications.--An abbreviated new 
drug application that is not considered to be received within 
the meaning of section 505(j)(5)(A) because of failure to pay 
an applicable fee under this provision within the time period 
specified in subsection (g) shall be deemed not to have been 
``substantially complete'' on the date of its submission within 
the meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbreviated 
new drug application that is not substantially complete on the 
date of its submission solely because of failure to pay an 
applicable fee under the preceding sentence shall be deemed 
substantially complete and received within the meaning of 
section 505(j)(5)(A) as of the date such applicable fee is 
received.

SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Report.--
          (1) In general.--Beginning with fiscal year 2013, not 
        later than 120 days after the end of each fiscal year 
        for which fees are collected under this part, the 
        Secretary shall prepare and submit to the Committee on 
        Energy and Commerce of the House of Representatives and 
        the Committee on Health, Education, Labor, and Pensions 
        of the Senate a report concerning the progress of the 
        Food and Drug Administration in achieving the goals 
        identified in the letters described in section 301(b) 
        of the Generic Drug User Fee Amendments of 2012 during 
        such fiscal year and the future plans of the Food and 
        Drug Administration for meeting the goals.
          (2) Regulatory science accountability metrics.--The 
        report required by paragraph (1) shall describe the 
        amounts spent, data generated, and activities 
        undertaken, including any FDA Advisory Committee 
        consideration, by the Secretary for each of the local 
        acting bioequivalence topics (Topics 1-3) in the 
        Regulatory Science Plan described in the letters 
        described in section 301(b) of the Generic Drug User 
        Fee Amendments of 2012.
  (b) Fiscal Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which 
fees are collected under this part, the Secretary shall prepare 
and submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year.
  (c) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  (d) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and 
        plans for meeting the goals, for human generic drug 
        activities for the first 5 fiscal years after fiscal 
        year 2017, and for the reauthorization of this part for 
        such fiscal years, the Secretary shall consult with--
                  (A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (C) scientific and academic experts;
                  (D) health care professionals;
                  (E) representatives of patient and consumer 
                advocacy groups; and
                  (F) the generic drug industry.
          (2) Prior public input.--Prior to beginning 
        negotiations with the generic drug industry on the 
        reauthorization of this part, the Secretary shall--
                  (A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                  (B) hold a public meeting at which the public 
                may present its views on the reauthorization, 
                including specific suggestions for changes to 
                the goals referred to in subsection (a);
                  (C) provide a period of 30 days after the 
                public meeting to obtain written comments from 
                the public suggesting changes to this part; and
                  (D) publish the comments on the Food and Drug 
                Administration's Internet Web site.
          (3) Periodic consultation.--Not less frequently than 
        once every month during negotiations with the generic 
        drug industry, the Secretary shall hold discussions 
        with representatives of patient and consumer advocacy 
        groups to continue discussions of their views on the 
        reauthorization and their suggestions for changes to 
        this part as expressed under paragraph (2).
          (4) Public review of recommendations.--After 
        negotiations with the generic drug industry, the 
        Secretary shall--
                  (A) present the recommendations developed 
                under paragraph (1) to the congressional 
                committees specified in such paragraph;
                  (B) publish such recommendations in the 
                Federal Register;
                  (C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  (D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  (E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          (5) Transmittal of recommendations.--Not later than 
        January 15, 2017, the Secretary shall transmit to the 
        Congress the revised recommendations under paragraph 
        (4), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and comments.
          (6) Minutes of negotiation meetings.--
                  (A) Public availability.--Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to the Congress, the Secretary 
                shall make publicly available, on the Internet 
                Web site of the Food and Drug Administration, 
                minutes of all negotiation meetings conducted 
                under this subsection between the Food and Drug 
                Administration and the generic drug industry.
                  (B) Content.--The minutes described under 
                subparagraph (A) shall summarize any 
                substantive proposal made by any party to the 
                negotiations as well as significant 
                controversies or differences of opinion during 
                the negotiations and their resolution.

[Effective October 1, 2017, section 304(a) of H.R. 5651 provides for a 
       repeal of sections 744A and 744B (as added by the bill).]

[SEC. 744A. DEFINITIONS.

  [For purposes of this part:
          [(1) The term ``abbreviated new drug application''--
                  [(A) means an application submitted under 
                section 505(j), an abbreviated application 
                submitted under section 507 (as in effect on 
                the day before the date of enactment of the 
                Food and Drug Administration Modernization Act 
                of 1997), or an abbreviated new drug 
                application submitted pursuant to regulations 
                in effect prior to the implementation of the 
                Drug Price Competition and Patent Term 
                Restoration Act of 1984; and
                  [(B) does not include an application for a 
                positron emission tomography drug.
          [(2) The term ``active pharmaceutical ingredient'' 
        means--
                  [(A) a substance, or a mixture when the 
                substance is unstable or cannot be transported 
                on its own, intended--
                          [(i) to be used as a component of a 
                        drug; and
                          [(ii) to furnish pharmacological 
                        activity or other direct effect in the 
                        diagnosis, cure, mitigation, treatment, 
                        or prevention of disease, or to affect 
                        the structure or any function of the 
                        human body; or
                  [(B) a substance intended for final 
                crystallization, purification, or salt 
                formation, or any combination of those 
                activities, to become a substance or mixture 
                described in subparagraph (A).
          [(3) The term ``adjustment factor'' means a factor 
        applicable to a fiscal year that is the Consumer Price 
        Index for all urban consumers (all items; United States 
        city average) for October of the preceding fiscal year 
        divided by such Index for October 2011.
          [(4) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  [(A) one business entity controls, or has the 
                power to control, the other business entity; or
                  [(B) a third party controls, or has power to 
                control, both of the business entities.
          [(5)(A) The term ``facility''--
                  [(i) means a business or other entity--
                          [(I) under one management, either 
                        direct or indirect; and
                          [(II) at one geographic location or 
                        address engaged in manufacturing or 
                        processing an active pharmaceutical 
                        ingredient or a finished dosage form; 
                        and
                  [(ii) does not include a business or other 
                entity whose only manufacturing or processing 
                activities are one or more of the following: 
                repackaging, relabeling, or testing.
          [(B) For purposes of subparagraph (A), separate 
        buildings within close proximity are considered to be 
        at one geographic location or address if the activities 
        in them are--
                  [(i) closely related to the same business 
                enterprise;
                  [(ii) under the supervision of the same local 
                management; and
                  [(iii) capable of being inspected by the Food 
                and Drug Administration during a single 
                inspection.
          [(C) If a business or other entity would meet the 
        definition of a facility under this paragraph but for 
        being under multiple management, the business or other 
        entity is deemed to constitute multiple facilities, one 
        per management entity, for purposes of this paragraph.
          [(6) The term ``finished dosage form'' means--
                  [(A) a drug product in the form in which it 
                will be administered to a patient, such as a 
                tablet, capsule, solution, or topical 
                application;
                  [(B) a drug product in a form in which 
                reconstitution is necessary prior to 
                administration to a patient, such as oral 
                suspensions or lyophilized powders; or
                  [(C) any combination of an active 
                pharmaceutical ingredient with another 
                component of a drug product for purposes of 
                production of a drug product described in 
                subparagraph (A) or (B).
          [(7) The term ``generic drug submission'' means an 
        abbreviated new drug application, an amendment to an 
        abbreviated new drug application, or a prior approval 
        supplement to an abbreviated new drug application.
          [(8) The term ``human generic drug activities'' means 
        the following activities of the Secretary associated 
        with generic drugs and inspection of facilities 
        associated with generic drugs:
                  [(A) The activities necessary for the review 
                of generic drug submissions, including review 
                of drug master files referenced in such 
                submissions.
                  [(B) The issuance of--
                          [(i) approval letters which approve 
                        abbreviated new drug applications or 
                        supplements to such applications; or
                          [(ii) complete response letters which 
                        set forth in detail the specific 
                        deficiencies in such applications and, 
                        where appropriate, the actions 
                        necessary to place such applications in 
                        condition for approval.
                  [(C) The issuance of letters related to Type 
                II active pharmaceutical drug master files 
                which--
                          [(i) set forth in detail the specific 
                        deficiencies in such submissions, and 
                        where appropriate, the actions 
                        necessary to resolve those 
                        deficiencies; or
                          [(ii) document that no deficiencies 
                        need to be addressed.
                  [(D) Inspections related to generic drugs.
                  [(E) Monitoring of research conducted in 
                connection with the review of generic drug 
                submissions and drug master files.
                  [(F) Postmarket safety activities with 
                respect to drugs approved under abbreviated new 
                drug applications or supplements, including the 
                following activities:
                          [(i) Collecting, developing, and 
                        reviewing safety information on 
                        approved drugs, including adverse event 
                        reports.
                          [(ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology 
                        systems.
                          [(iii) Developing and using improved 
                        analytical tools to assess potential 
                        safety problems, including access to 
                        external data bases.
                          [(iv) Implementing and enforcing 
                        section 505(o) (relating to 
                        postapproval studies and clinical 
                        trials and labeling changes) and 
                        section 505(p) (relating to risk 
                        evaluation and mitigation strategies) 
                        insofar as those activities relate to 
                        abbreviated new drug applications.
                          [(v) Carrying out section 505(k)(5) 
                        (relating to adverse-event reports and 
                        postmarket safety activities).
                  [(G) Regulatory science activities related to 
                generic drugs.
          [(9) The term ``positron emission tomography drug'' 
        has the meaning given to the term ``compounded positron 
        emission tomography drug'' in section 201(ii), except 
        that paragraph (1)(B) of such section shall not apply.
          [(10) The term ``prior approval supplement'' means a 
        request to the Secretary to approve a change in the 
        drug substance, drug product, production process, 
        quality controls, equipment, or facilities covered by 
        an approved abbreviated new drug application when that 
        change has a substantial potential to have an adverse 
        effect on the identity, strength, quality, purity, or 
        potency of the drug product as these factors may relate 
        to the safety or effectiveness of the drug product.
          [(11) The term ``resources allocated for human 
        generic drug activities'' means the expenses for--
                  [(A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers and 
                employees and to contracts with such 
                contractors;
                  [(B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  [(C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  [(D) collecting fees under subsection (a) and 
                accounting for resources allocated for the 
                review of abbreviated new drug applications and 
                supplements and inspection related to generic 
                drugs.
          [(12) The term ``Type II active pharmaceutical 
        ingredient drug master file'' means a submission of 
        information to the Secretary by a person that intends 
        to authorize the Food and Drug Administration to 
        reference the information to support approval of a 
        generic drug submission without the submitter having to 
        disclose the information to the generic drug submission 
        applicant.

[SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

  [(a) Types of Fees.--Beginning in fiscal year 2013, the 
Secretary shall assess and collect fees in accordance with this 
section as follows:
          [(1) One-time backlog fee for abbreviated new drug 
        applications pending on october 1, 2012.--
                  [(A) In general.--Each person that owns an 
                abbreviated new drug application that is 
                pending on October 1, 2012, and that has not 
                received a tentative approval prior to that 
                date, shall be subject to a fee for each such 
                application, as calculated under subparagraph 
                (B).
                  [(B) Method of fee amount calculation.--The 
                amount of each one-time backlog fee shall be 
                calculated by dividing $50,000,000 by the total 
                number of abbreviated new drug applications 
                pending on October 1, 2012, that have not 
                received a tentative approval as of that date.
                  [(C) Notice.--Not later than October 31, 
                2012, the Secretary shall cause to be published 
                in the Federal Register a notice announcing the 
                amount of the fee required by subparagraph (A).
                  [(D) Fee due date.--The fee required by 
                subparagraph (A) shall be due no later than 30 
                calendar days after the date of the publication 
                of the notice specified in subparagraph (C).
          [(2) Drug master file fee.--
                  [(A) In general.--Each person that owns a 
                Type II active pharmaceutical ingredient drug 
                master file that is referenced on or after 
                October 1, 2012, in a generic drug submission 
                by any initial letter of authorization shall be 
                subject to a drug master file fee.
                  [(B) One-time payment.--If a person has paid 
                a drug master file fee for a Type II active 
                pharmaceutical ingredient drug master file, the 
                person shall not be required to pay a 
                subsequent drug master file fee when that Type 
                II active pharmaceutical ingredient drug master 
                file is subsequently referenced in generic drug 
                submissions.
                  [(C) Notice.--
                          [(i) Fiscal year 2013.--Not later 
                        than October 31, 2012, the Secretary 
                        shall cause to be published in the 
                        Federal Register a notice announcing 
                        the amount of the drug master file fee 
                        for fiscal year 2013.
                          [(ii) Fiscal year 2014 through 
                        2017.--Not later than 60 days before 
                        the start of each of fiscal years 2014 
                        through 2017, the Secretary shall cause 
                        to be published in the Federal Register 
                        the amount of the drug master file fee 
                        established by this paragraph for such 
                        fiscal year.
                  [(D) Availability for reference.--
                          [(i) In general.--Subject to 
                        subsection (g)(2)(C), for a generic 
                        drug submission to reference a Type II 
                        active pharmaceutical ingredient drug 
                        master file, the drug master file must 
                        be deemed available for reference by 
                        the Secretary.
                          [(ii) Conditions.--A drug master file 
                        shall be deemed available for reference 
                        by the Secretary if--
                                  [(I) the person that owns a 
                                Type II active pharmaceutical 
                                ingredient drug master file has 
                                paid the fee required under 
                                subparagraph (A) within 20 
                                calendar days after the 
                                applicable due date under 
                                subparagraph (E); and
                                  [(II) the drug master file 
                                has not failed an initial 
                                completeness assessment by the 
                                Secretary, in accordance with 
                                criteria to be published by the 
                                Secretary.
                          [(iii) List.--The Secretary shall 
                        make publicly available on the Internet 
                        Web site of the Food and Drug 
                        Administration a list of the drug 
                        master file numbers that correspond to 
                        drug master files that have 
                        successfully undergone an initial 
                        completeness assessment, in accordance 
                        with criteria to be published by the 
                        Secretary, and are available for 
                        reference.
                  [(E) Fee due date.--
                          [(i) In general.--Subject to clause 
                        (ii), a drug master file fee shall be 
                        due no later than the date on which the 
                        first generic drug submission is 
                        submitted that references the 
                        associated Type II active 
                        pharmaceutical ingredient drug master 
                        file.
                          [(ii) Limitation.-- No fee shall be 
                        due under subparagraph (A) for a fiscal 
                        year until the later of--
                                  [(I) 30 calendar days after 
                                publication of the notice 
                                provided for in clause (i) or 
                                (ii) of subparagraph (C), as 
                                applicable; or
                                  [(II) 30 calendar days after 
                                the date of enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees under this 
                                section.
          [(3) Abbreviated new drug application and prior 
        approval supplement filing fee.--
                  [(A) In general.--Each applicant that 
                submits, on or after October 1, 2012, an 
                abbreviated new drug application or a prior 
                approval supplement to an abbreviated new drug 
                application shall be subject to a fee for each 
                such submission in the amount established under 
                subsection (d).
                  [(B) Notice.--
                          [(i) Fiscal year 2013.--Not later 
                        than October 31, 2012, the Secretary 
                        shall cause to be published in the 
                        Federal Register a notice announcing 
                        the amount of the fees under 
                        subparagraph (A) for fiscal year 2013.
                          [(ii) Fiscal years 2014 through 
                        2017.--Not later than 60 days before 
                        the start of each of fiscal years 2014 
                        through 2017, the Secretary shall cause 
                        to be published in the Federal Register 
                        the amount of the fees under 
                        subparagraph (A) for such fiscal year.
                  [(C) Fee due date.--
                          [(i) In general.--Except as provided 
                        in clause (ii), the fees required by 
                        subparagraphs (A) and (F) shall be due 
                        no later than the date of submission of 
                        the abbreviated new drug application or 
                        prior approval supplement for which 
                        such fee applies.
                          [(ii) Special rule for 2013.--For 
                        fiscal year 2013, such fees shall be 
                        due on the later of--
                                  [(I) the date on which the 
                                fee is due under clause (i);
                                  [(II) 30 calendar days after 
                                publication of the notice 
                                referred to in subparagraph 
                                (B)(i); or
                                  [(III) if an appropriations 
                                Act is not enacted providing 
                                for the collection and 
                                obligation of fees under this 
                                section by the date of 
                                submission of the application 
                                or prior approval supplement 
                                for which the fees under 
                                subparagraphs (A) and (F) 
                                apply, 30 calendar days after 
                                the date that such an 
                                appropriations Act is enacted.
                  [(D) Refund of fee if abbreviated new drug 
                application is not considered to have been 
                received.--The Secretary shall refund 75 
                percent of the fee paid under subparagraph (A) 
                for any abbreviated new drug application or 
                prior approval supplement to an abbreviated new 
                drug application that the Secretary considers 
                not to have been received within the meaning of 
                section 505(j)(5)(A) for a cause other than 
                failure to pay fees.
                  [(E) Fee for an application the secretary 
                considers not to have been received, or that 
                has been withdrawn.--An abbreviated new drug 
                application or prior approval supplement that 
                was submitted on or after October 1, 2012, and 
                that the Secretary considers not to have been 
                received, or that has been withdrawn, shall, 
                upon resubmission of the application or a 
                subsequent new submission following the 
                applicant's withdrawal of the application, be 
                subject to a full fee under subparagraph (A).
                  [(F) Additional fee for active pharmaceutical 
                ingredient information not included by 
                reference to type ii active pharmaceutical 
                ingredient drug master file.--An applicant that 
                submits a generic drug submission on or after 
                October 1, 2012, shall pay a fee, in the amount 
                determined under subsection (d)(3), in addition 
                to the fee required under subparagraph (A), 
                if--
                          [(i) such submission contains 
                        information concerning the manufacture 
                        of an active pharmaceutical ingredient 
                        at a facility by means other than 
                        reference by a letter of authorization 
                        to a Type II active pharmaceutical drug 
                        master file; and
                          [(ii) a fee in the amount equal to 
                        the drug master file fee established in 
                        paragraph (2) has not been previously 
                        paid with respect to such information.
          [(4) Generic drug facility fee and active 
        pharmaceutical ingredient facility fee.--
                  [(A) In general.--Facilities identified, or 
                intended to be identified, in at least one 
                generic drug submission that is pending or 
                approved to produce a finished dosage form of a 
                human generic drug or an active pharmaceutical 
                ingredient contained in a human generic drug 
                shall be subject to fees as follows:
                          [(i) Generic drug facility.--Each 
                        person that owns a facility which is 
                        identified or intended to be identified 
                        in at least one generic drug submission 
                        that is pending or approved to produce 
                        one or more finished dosage forms of a 
                        human generic drug shall be assessed an 
                        annual fee for each such facility.
                          [(ii) Active pharmaceutical 
                        ingredient facility.--Each person that 
                        owns a facility which produces, or 
                        which is pending review to produce, one 
                        or more active pharmaceutical 
                        ingredients identified, or intended to 
                        be identified, in at least one generic 
                        drug submission that is pending or 
                        approved or in a Type II active 
                        pharmaceutical ingredient drug master 
                        file referenced in such a generic drug 
                        submission, shall be assessed an annual 
                        fee for each such facility.
                          [(iii) Facilities producing both 
                        active pharmaceutical ingredients and 
                        finished dosage forms.--Each person 
                        that owns a facility identified, or 
                        intended to be identified, in at least 
                        one generic drug submission that is 
                        pending or approved to produce both one 
                        or more finished dosage forms subject 
                        to clause (i) and one or more active 
                        pharmaceutical ingredients subject to 
                        clause (ii) shall be subject to fees 
                        under both such clauses for that 
                        facility.
                  [(B) Amount.--The amount of fees established 
                under subparagraph (A) shall be established 
                under subsection (d).
                  [(C) Notice.--
                          [(i) Fiscal year 2013.--For fiscal 
                        year 2013, the Secretary shall cause to 
                        be published in the Federal Register a 
                        notice announcing the amount of the 
                        fees provided for in subparagraph (A) 
                        within the timeframe specified in 
                        subsection (d)(1)(B).
                          [(ii) Fiscal years 2014 through 
                        2017.--Within the timeframe specified 
                        in subsection (d)(2), the Secretary 
                        shall cause to be published in the 
                        Federal Register the amount of the fees 
                        under subparagraph (A) for such fiscal 
                        year.
                  [(D) Fee due date.--
                          [(i) Fiscal year 2013.--For fiscal 
                        year 2013, the fees under subparagraph 
                        (A) shall be due on the later of--
                                  [(I) not later than 45 days 
                                after the publication of the 
                                notice under subparagraph (B); 
                                or
                                  [(II) if an appropriations 
                                Act is not enacted providing 
                                for the collection and 
                                obligation of fees under this 
                                section by the date of the 
                                publication of such notice, 30 
                                days after the date that such 
                                an appropriations Act is 
                                enacted.
                          [(ii) Fiscal years 2014 through 
                        2017.--For each of fiscal years 2014 
                        through 2017, the fees under 
                        subparagraph (A) for such fiscal year 
                        shall be due on the later of--
                                  [(I) the first business day 
                                on or after October 1 of each 
                                such year; or
                                  [(II) the first business day 
                                after the enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees under this 
                                section for such year.
          [(5) Date of submission.--For purposes of this part, 
        a generic drug submission or Type II pharmaceutical 
        master file is deemed to be ``submitted'' to the Food 
        and Drug Administration--
                  [(A) if it is submitted via a Food and Drug 
                Administration electronic gateway, on the day 
                when transmission to that electronic gateway is 
                completed, except that a submission or master 
                file that arrives on a weekend, Federal 
                holiday, or day when the Food and Drug 
                Administration office that will review that 
                submission is not otherwise open for business 
                shall be deemed to be submitted on the next day 
                when that office is open for business; and
                  [(B) if it is submitted in physical media 
                form, on the day it arrives at the appropriate 
                designated document room of the Food and Drug 
                Administration.
  [(b) Fee Revenue Amounts.--
          [(1) In general.--
                  [(A) Fiscal year 2013.--For fiscal year 2013, 
                fees under subsection (a) shall be established 
                to generate a total estimated revenue amount 
                under such subsection of $299,000,000. Of that 
                amount--
                          [(i) $50,000,000 shall be generated 
                        by the one-time backlog fee for generic 
                        drug applications pending on October 1, 
                        2012, established in subsection (a)(1); 
                        and
                          [(ii) $249,000,000 shall be generated 
                        by the fees under paragraphs (2) 
                        through (4) of subsection (a).
                  [(B) Fiscal years 2014 through 2017.--For 
                each of the fiscal years 2014 through 2017, 
                fees under paragraphs (2) through (4) of 
                subsection (a) shall be established to generate 
                a total estimated revenue amount under such 
                subsection that is equal to $299,000,000, as 
                adjusted pursuant to subsection (c).
          [(2) Types of fees.--In establishing fees under 
        paragraph (1) to generate the revenue amounts specified 
        in paragraph (1)(A)(ii) for fiscal year 2013 and 
        paragraph (1)(B) for each of fiscal years 2014 through 
        2017, such fees shall be derived from the fees under 
        paragraphs (2) through (4) of subsection (a) as 
        follows:
                  [(A) 6 percent shall be derived from fees 
                under subsection (a)(2) (relating to drug 
                master files).
                  [(B) 24 percent shall be derived from fees 
                under subsection (a)(3) (relating to 
                abbreviated new drug applications and 
                supplements). The amount of a fee for a prior 
                approval supplement shall be half the amount of 
                the fee for an abbreviated new drug 
                application.
                  [(C) 56 percent shall be derived from fees 
                under subsection (a)(4)(A)(i) (relating to 
                generic drug facilities). The amount of the fee 
                for a facility located outside the United 
                States and its territories and possessions 
                shall be not less than $15,000 and not more 
                than $30,000 higher than the amount of the fee 
                for a facility located in the United States and 
                its territories and possessions, as determined 
                by the Secretary on the basis of data 
                concerning the difference in cost between 
                inspections of facilities located in the United 
                States, including its territories and 
                possessions, and those located outside of the 
                United States and its territories and 
                possessions.
                  [(D) 14 percent shall be derived from fees 
                under subsection (a)(4)(A)(ii) (relating to 
                active pharmaceutical ingredient facilities). 
                The amount of the fee for a facility located 
                outside the United States and its territories 
                and possessions shall be not less than $15,000 
                and not more than $30,000 higher than the 
                amount of the fee for a facility located in the 
                United States, including its territories and 
                possessions, as determined by the Secretary on 
                the basis of data concerning the difference in 
                cost between inspections of facilities located 
                in the United States and its territories and 
                possessions and those located outside of the 
                United States and its territories and 
                possessions.
  [(c) Adjustments.--
          [(1) Inflation adjustment.-- For fiscal year 2014 and 
        subsequent fiscal years, the revenues established in 
        subsection (b) shall be adjusted by the Secretary by 
        notice, published in the Federal Register, for a fiscal 
        year, by an amount equal to the sum of--
                  [(A) one;
                  [(B) the average annual percent change in the 
                cost, per full-time equivalent position of the 
                Food and Drug Administration, of all personnel 
                compensation and benefits paid with respect to 
                such positions for the first 3 years of the 
                preceding 4 fiscal years multiplied by the 
                proportion of personnel compensation and 
                benefits costs to total costs of human generic 
                drug activities for the first 3 years of the 
                preceding 4 fiscal years; and
                  [(C) the average annual percent change that 
                occurred in the Consumer Price Index for urban 
                consumers (Washington-Baltimore, DC-MD-VA-WV; 
                Not Seasonally Adjusted; All items; Annual 
                Index) for the first 3 years of the preceding 4 
                years of available data multiplied by the 
                proportion of all costs other than personnel 
                compensation and benefits costs to total costs 
                of human generic drug activities for the first 
                3 years of the preceding 4 fiscal years.
        The adjustment made each fiscal year under this 
        subsection shall be added on a compounded basis to the 
        sum of all adjustments made each fiscal year after 
        fiscal year 2013 under this subsection.
          [(2) Final year adjustment.--For fiscal year 2017, 
        the Secretary may, in addition to adjustments under 
        paragraph (1), further increase the fee revenues and 
        fees established in subsection (b) if such an 
        adjustment is necessary to provide for not more than 3 
        months of operating reserves of carryover user fees for 
        human generic drug activities for the first 3 months of 
        fiscal year 2018. Such fees may only be used in fiscal 
        year 2018. If such an adjustment is necessary, the 
        rationale for the amount of the increase shall be 
        contained in the annual notice establishing fee 
        revenues and fees for fiscal year 2017. If the 
        Secretary has carryover balances for such activities in 
        excess of 3 months of such operating reserves, the 
        adjustment under this subparagraph shall not be made.
  [(d) Annual Fee Setting.--
          [(1) Fiscal year 2013.--For fiscal year 2013--
                  [(A) the Secretary shall establish, by 
                October 31, 2012, the one-time generic drug 
                backlog fee for generic drug applications 
                pending on October 1, 2012, the drug master 
                file fee, the abbreviated new drug application 
                fee, and the prior approval supplement fee 
                under subsection (a), based on the revenue 
                amounts established under subsection (b); and
                  [(B) the Secretary shall establish, not later 
                than 45 days after the date to comply with the 
                requirement for identification of facilities in 
                subsection (f)(2), the generic drug facility 
                fee and active pharmaceutical ingredient 
                facility fee under subsection (a) based on the 
                revenue amounts established under subsection 
                (b).
          [(2) Fiscal years 2014 through 2017.--Not more than 
        60 days before the first day of each of fiscal years 
        2014 through 2017, the Secretary shall establish the 
        drug master file fee, the abbreviated new drug 
        application fee, the prior approval supplement fee, the 
        generic drug facility fee, and the active 
        pharmaceutical ingredient facility fee under subsection 
        (a) for such fiscal year, based on the revenue amounts 
        established under subsection (b) and the adjustments 
        provided under subsection (c).
          [(3) Fee for active pharmaceutical ingredient 
        information not included by reference to type ii active 
        pharmaceutical ingredient drug master file.--In 
        establishing the fees under paragraphs (1) and (2), the 
        amount of the fee under subsection (a)(3)(F) shall be 
        determined by multiplying--
                  [(A) the sum of--
                          [(i) the total number of such active 
                        pharmaceutical ingredients in such 
                        submission; and
                          [(ii) for each such ingredient that 
                        is manufactured at more than one such 
                        facility, the total number of such 
                        additional facilities; and
                  [(B) the amount equal to the drug master file 
                fee established in subsection (a)(2) for such 
                submission.
  [(e) Limit.-- The total amount of fees charged, as adjusted 
under subsection (c), for a fiscal year may not exceed the 
total costs for such fiscal year for the resources allocated 
for human generic drug activities.
  [(f) Identification of Facilities.--
          [(1) Publication of notice; deadline for 
        compliance.--Not later than October 1, 2012, the 
        Secretary shall cause to be published in the Federal 
        Register a notice requiring each person that owns a 
        facility described in subsection (a)(4)(A), or a site 
        or organization required to be identified by paragraph 
        (4), to submit to the Secretary information on the 
        identity of each such facility, site, or organization. 
        The notice required by this paragraph shall specify the 
        type of information to be submitted and the means and 
        format for submission of such information.
          [(2) Required submission of facility 
        identification.--Each person that owns a facility 
        described in subsection (a)(4)(A) or a site or 
        organization required to be identified by paragraph (4) 
        shall submit to the Secretary the information required 
        under this subsection each year. Such information 
        shall--
                  [(A) for fiscal year 2013, be submitted not 
                later than 60 days after the publication of the 
                notice under paragraph (1); and
                  [(B) for each subsequent fiscal year, be 
                submitted, updated, or reconfirmed on or before 
                June 1 of the previous year.
          [(3) Contents of notice.--At a minimum, the 
        submission required by paragraph (2) shall include for 
        each such facility--
                  [(A) identification of a facility identified 
                or intended to be identified in an approved or 
                pending generic drug submission;
                  [(B) whether the facility manufactures active 
                pharmaceutical ingredients or finished dosage 
                forms, or both;
                  [(C) whether or not the facility is located 
                within the United States and its territories 
                and possessions;
                  [(D) whether the facility manufactures 
                positron emission tomography drugs solely, or 
                in addition to other drugs; and
                  [(E) whether the facility manufactures drugs 
                that are not generic drugs.
          [(4) Certain sites and organizations.--
                  [(A) In general.--Any person that owns or 
                operates a site or organization described in 
                subparagraph (B) shall submit to the Secretary 
                information concerning the ownership, name, and 
                address of the site or organization.
                  [(B) Sites and organizations.--A site or 
                organization is described in this subparagraph 
                if it is identified in a generic drug 
                submission and is--
                          [(i) a site in which a bioanalytical 
                        study is conducted;
                          [(ii) a clinical research 
                        organization;
                          [(iii) a contract analytical testing 
                        site; or
                          [(iv) a contract repackager site.
                  [(C) Notice.--The Secretary may, by notice 
                published in the Federal Register, specify the 
                means and format for submission of the 
                information under subparagraph (A) and may 
                specify, as necessary for purposes of this 
                section, any additional information to be 
                submitted.
                  [(D) Inspection authority.--The Secretary's 
                inspection authority under section 704(a)(1) 
                shall extend to all such sites and 
                organizations.
  [(g) Effect of Failure To Pay Fees.--
          [(1) Generic drug backlog fee.--Failure to pay the 
        fee under subsection (a)(1) shall result in the 
        Secretary placing the person that owns the abbreviated 
        new drug application subject to that fee on an arrears 
        list, such that no new abbreviated new drug 
        applications or supplement submitted on or after 
        October 1, 2012, from that person, or any affiliate of 
        that person, will be received within the meaning of 
        section 505(j)(5)(A) until such outstanding fee is 
        paid.
          [(2) Drug master file fee.--
                  [(A) Failure to pay the fee under subsection 
                (a)(2) within 20 calendar days after the 
                applicable due date under subparagraph (E) of 
                such subsection (as described in subsection 
                (a)(2)(D)(ii)(I)) shall result in the Type II 
                active pharmaceutical ingredient drug master 
                file not being deemed available for reference.
                  [(B)(i) Any generic drug submission submitted 
                on or after October 1, 2012, that references, 
                by a letter of authorization, a Type II active 
                pharmaceutical ingredient drug master file that 
                has not been deemed available for reference 
                shall not be received within the meaning of 
                section 505(j)(5)(A) unless the condition 
                specified in clause (ii) is met.
                  [(ii) The condition specified in this clause 
                is that the fee established under subsection 
                (a)(2) has been paid within 20 calendar days of 
                the Secretary providing the notification to the 
                sponsor of the abbreviated new drug application 
                or supplement of the failure of the owner of 
                the Type II active pharmaceutical ingredient 
                drug master file to pay the drug master file 
                fee as specified in subparagraph (C).
                  [(C)(i) If an abbreviated new drug 
                application or supplement to an abbreviated new 
                drug application references a Type II active 
                pharmaceutical ingredient drug master file for 
                which a fee under subsection (a)(2)(A) has not 
                been paid by the applicable date under 
                subsection (a)(2)(E), the Secretary shall 
                notify the sponsor of the abbreviated new drug 
                application or supplement of the failure of the 
                owner of the Type II active pharmaceutical 
                ingredient drug master file to pay the 
                applicable fee.
                  [(ii) If such fee is not paid within 20 
                calendar days of the Secretary providing the 
                notification, the abbreviated new drug 
                application or supplement to an abbreviated new 
                drug application shall not be received within 
                the meaning of 505(j)(5)(A).
          [(3) Abbreviated new drug application fee and prior 
        approval supplement fee.--Failure to pay a fee under 
        subparagraph (A) or (F) of subsection (a)(3) within 20 
        calendar days of the applicable due date under 
        subparagraph (C) of such subsection shall result in the 
        abbreviated new drug application or the prior approval 
        supplement to an abbreviated new drug application not 
        being received within the meaning of section 
        505(j)(5)(A) until such outstanding fee is paid.
          [(4) Generic drug facility fee and active 
        pharmaceutical ingredient facility fee.--
                  [(A) In general.--Failure to pay the fee 
                under subsection (a)(4) within 20 calendar days 
                of the due date as specified in subparagraph 
                (D) of such subsection shall result in the 
                following:
                          [(i) The Secretary shall place the 
                        facility on a publicly available 
                        arrears list, such that no new 
                        abbreviated new drug application or 
                        supplement submitted on or after 
                        October 1, 2012, from the person that 
                        is responsible for paying such fee, or 
                        any affiliate of that person, will be 
                        received within the meaning of section 
                        505(j)(5)(A).
                          [(ii) Any new generic drug submission 
                        submitted on or after October 1, 2012, 
                        that references such a facility shall 
                        not be received, within the meaning of 
                        section 505(j)(5)(A) if the outstanding 
                        facility fee is not paid within 20 
                        calendar days of the Secretary 
                        providing the notification to the 
                        sponsor of the failure of the owner of 
                        the facility to pay the facility fee 
                        under subsection (a)(4)(C).
                          [(iii) All drugs or active 
                        pharmaceutical ingredients manufactured 
                        in such a facility or containing an 
                        ingredient manufactured in such a 
                        facility shall be deemed misbranded 
                        under section 502(aa).
                  [(B) Application of penalties.--The penalties 
                under this paragraph shall apply until the fee 
                established by subsection (a)(4) is paid or the 
                facility is removed from all generic drug 
                submissions that refer to the facility.
                  [(C) Nonreceival for nonpayment.--
                          [(i) Notice.--If an abbreviated new 
                        drug application or supplement to an 
                        abbreviated new drug application 
                        submitted on or after October 1, 2012, 
                        references a facility for which a 
                        facility fee has not been paid by the 
                        applicable date under subsection 
                        (a)(4)(C), the Secretary shall notify 
                        the sponsor of the generic drug 
                        submission of the failure of the owner 
                        of the facility to pay the facility 
                        fee.
                          [(ii) Nonreceival.--If the facility 
                        fee is not paid within 20 calendar days 
                        of the Secretary providing the 
                        notification under clause (i), the 
                        abbreviated new drug application or 
                        supplement to an abbreviated new drug 
                        application shall not be received 
                        within the meaning of section 
                        505(j)(5)(A).
  [(h) Limitations.--
          [(1) In general.--Fees under subsection (a) shall be 
        refunded for a fiscal year beginning after fiscal year 
        2012, unless appropriations for salaries and expenses 
        of the Food and Drug Administration for such fiscal 
        year (excluding the amount of fees appropriated for 
        such fiscal year) are equal to or greater than the 
        amount of appropriations for the salaries and expenses 
        of the Food and Drug Administration for the fiscal year 
        2009 (excluding the amount of fees appropriated for 
        such fiscal year) multiplied by the adjustment factor 
        (as defined in section 744A) applicable to the fiscal 
        year involved.
          [(2) Authority.--If the Secretary does not assess 
        fees under subsection (a) during any portion of a 
        fiscal year and if at a later date in such fiscal year 
        the Secretary may assess such fees, the Secretary may 
        assess and collect such fees, without any modification 
        in the rate, for Type II active pharmaceutical 
        ingredient drug master files, abbreviated new drug 
        applications and prior approval supplements, and 
        generic drug facilities and active pharmaceutical 
        ingredient facilities at any time in such fiscal year 
        notwithstanding the provisions of subsection (a) 
        relating to the date fees are to be paid.
  [(i) Crediting and Availability of Fees.--
          [(1) In general.--Fees authorized under subsection 
        (a) shall be collected and available for obligation 
        only to the extent and in the amount provided in 
        advance in appropriations Acts, subject to paragraph 
        (2). Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be 
        transferred from the Food and Drug Administration 
        salaries and expenses appropriation account without 
        fiscal year limitation to such appropriation account 
        for salaries and expenses with such fiscal year 
        limitation. The sums transferred shall be available 
        solely for human generic drug activities.
          [(2) Collections and appropriation acts.--
                  [(A) In general.--The fees authorized by this 
                section--
                          [(i) subject to subparagraphs (C) and 
                        (D), shall be collected and available 
                        in each fiscal year in an amount not to 
                        exceed the amount specified in 
                        appropriation Acts, or otherwise made 
                        available for obligation for such 
                        fiscal year; and
                          [(ii) shall be available for a fiscal 
                        year beginning after fiscal year 2012 
                        to defray the costs of human generic 
                        drug activities (including such costs 
                        for an additional number of full-time 
                        equivalent positions in the Department 
                        of Health and HumanServices to be 
                        engaged in such activities), only if 
                        the Secretary allocates for such 
                        purpose an amount for such fiscal year 
                        (excluding amounts from fees collected 
                        under this section) no less than 
                        $97,000,000 multiplied by the 
                        adjustment factor defined in section 
                        744A(3) applicable to the fiscal year 
                        involved.
                  [(B) Compliance.--The Secretary shall be 
                considered to have met the requirements of 
                subparagraph (A)(ii) in any fiscal year if the 
                costs funded by appropriations and allocated 
                for human generic activities are not more than 
                10 percent below the level specified in such 
                subparagraph.
                  [(C) Fee collection during first program 
                year.--Until the date of enactment of an Act 
                making appropriations through September 30, 
                2013 for the salaries and expenses account of 
                the Food and Drug Administration, fees 
                authorized by this section for fiscal year 
                2013, may be collected and shall be credited to 
                such account and remain available until 
                expended.
                  [(D) Provision for early payments in 
                subsequent years.--Payment of fees authorized 
                under this section for a fiscal year (after 
                fiscal year 2013), prior to the due date for 
                such fees, may be accepted by the Secretary in 
                accordance with authority provided in advance 
                in a prior year appropriations Act.
          [(3) Authorization of appropriations.--For each of 
        the fiscal years 2013 through 2017, there is authorized 
        to be appropriated for fees under this section an 
        amount equivalent to the total revenue amount 
        determined under subsection (b) for the fiscal year, as 
        adjusted under subsection (c), if applicable, or as 
        otherwise affected under paragraph (2) of this 
        subsection.
  [(j) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 calendar days after it is due, such 
fee shall be treated as a claim of the United States Government 
subject to subchapter II of chapter 37 of title 31, United 
States Code.
  [(k) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employees, and advisory committees not engaged in human generic 
drug activities, be reduced to offset the number of officers, 
employees, and advisory committees so engaged.
  [(l) Positron Emission Tomography Drugs.--
          [(1) Exemption from fees.--Submission of an 
        application for a positron emission tomography drug or 
        active pharmaceutical ingredient for a positron 
        emission tomography drug shall not require the payment 
        of any fee under this section. Facilities that solely 
        produce positron emission tomography drugs shall not be 
        required to pay a facility fee as established in 
        subsection (a)(4).
          [(2) Identification requirement.--Facilities that 
        produce positron emission tomography drugs or active 
        pharmaceutical ingredients of such drugs are required 
        to be identified pursuant to subsection (f).
  [(m) Disputes Concerning Fees.--To qualify for the return of 
a fee claimed to have been paid in error under this section, a 
person shall submit to the Secretary a written request 
justifying such return within 180 calendar days after such fee 
was paid.
  [(n) Substantially Complete Applications.--An abbreviated new 
drug application that is not considered to be received within 
the meaning of section 505(j)(5)(A) because of failure to pay 
an applicable fee under this provision within the time period 
specified in subsection (g) shall be deemed not to have been 
``substantially complete'' on the date of its submission within 
the meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbreviated 
new drug application that is not substantially complete on the 
date of its submission solely because of failure to pay an 
applicable fee under the preceding sentence shall be deemed 
substantially complete and received within the meaning of 
section 505(j)(5)(A) as of the date such applicable fee is 
received.]

[Effective January 31, 2018, section 304(b) of H.R. 5651 provides for a 
            repeal of section 744C (as added by the bill).]

[SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

  [(a) Performance Report.--
          [(1) In general.--Beginning with fiscal year 2013, 
        not later than 120 days after the end of each fiscal 
        year for which fees are collected under this part, the 
        Secretary shall prepare and submit to the Committee on 
        Energy and Commerce of the House of Representatives and 
        the Committee on Health, Education, Labor, and Pensions 
        of the Senate a report concerning the progress of the 
        Food and Drug Administration in achieving the goals 
        identified in the letters described in section 301(b) 
        of the Generic Drug User Fee Amendments of 2012 during 
        such fiscal year and the future plans of the Food and 
        Drug Administration for meeting the goals.
          [(2) Regulatory science accountability metrics.--The 
        report required by paragraph (1) shall describe the 
        amounts spent, data generated, and activities 
        undertaken, including any FDA Advisory Committee 
        consideration, by the Secretary for each of the local 
        acting bioequivalence topics (Topics 1-3) in the 
        Regulatory Science Plan described in the letters 
        described in section 301(b) of the Generic Drug User 
        Fee Amendments of 2012.
  [(b) Fiscal Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which 
fees are collected under this part, the Secretary shall prepare 
and submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the 
implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, 
of the fees collected for such fiscal year.
  [(c) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  [(d) Reauthorization.--
          [(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals, and 
        plans for meeting the goals, for human generic drug 
        activities for the first 5 fiscal years after fiscal 
        year 2017, and for the reauthorization of this part for 
        such fiscal years, the Secretary shall consult with--
                  [(A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  [(B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  [(C) scientific and academic experts;
                  [(D) health care professionals;
                  [(E) representatives of patient and consumer 
                advocacy groups; and
                  [(F) the generic drug industry.
          [(2) Prior public input.--Prior to beginning 
        negotiations with the generic drug industry on the 
        reauthorization of this part, the Secretary shall--
                  [(A) publish a notice in the Federal Register 
                requesting public input on the reauthorization;
                  [(B) hold a public meeting at which the 
                public may present its views on the 
                reauthorization, including specific suggestions 
                for changes to the goals referred to in 
                subsection (a);
                  [(C) provide a period of 30 days after the 
                public meeting to obtain written comments from 
                the public suggesting changes to this part; and
                  [(D) publish the comments on the Food and 
                Drug Administration's Internet Web site.
          [(3) Periodic consultation.--Not less frequently than 
        once every month during negotiations with the generic 
        drug industry, the Secretary shall hold discussions 
        with representatives of patient and consumer advocacy 
        groups to continue discussions of their views on the 
        reauthorization and their suggestions for changes to 
        this part as expressed under paragraph (2).
          [(4) Public review of recommendations.--After 
        negotiations with the generic drug industry, the 
        Secretary shall--
                  [(A) present the recommendations developed 
                under paragraph (1) to the congressional 
                committees specified in such paragraph;
                  [(B) publish such recommendations in the 
                Federal Register;
                  [(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  [(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  [(E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          [(5) Transmittal of recommendations.--Not later than 
        January 15, 2017, the Secretary shall transmit to the 
        Congress the revised recommendations under paragraph 
        (4), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and comments.
          [(6) Minutes of negotiation meetings.--
                  [(A) Public availability.--Before presenting 
                the recommendations developed under paragraphs 
                (1) through (5) to the Congress, the Secretary 
                shall make publicly available, on the Internet 
                Web site of the Food and Drug Administration, 
                minutes of all negotiation meetings conducted 
                under this subsection between the Food and Drug 
                Administration and the generic drug industry.
                  [(B) Content.--The minutes described under 
                subparagraph (A) shall summarize any 
                substantive proposal made by any party to the 
                negotiations as well as significant 
                controversies or differences of opinion during 
                the negotiations and their resolution.]

           *       *       *       *       *       *       *


        PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 744G. DEFINITIONS.

  For purposes of this part:
          (1) The term ``adjustment factor'' applicable to a 
        fiscal year that is the Consumer Price Index for all 
        urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not 
        Seasonally Adjusted; All items) of the preceding fiscal 
        year divided by such Index for September 2011.
          (2) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  (A) one business entity controls, or has the 
                power to control, the other business entity; or
                  (B) a third party controls, or has power to 
                control, both of the business entities.
          (3) The term ``biosimilar biological product'' means 
        a product for which a biosimilar biological product 
        application has been approved.
          (4)(A) Subject to subparagraph (B), the term 
        ``biosimilar biological product application'' means an 
        application for licensure of a biological product under 
        section 351(k) of the Public Health Service Act.
          (B) Such term does not include--
                  (i) a supplement to such an application;
                  (ii) an application filed under section 
                351(k) of the Public Health Service Act that 
                cites as the reference product a bovine blood 
                product for topical application licensed before 
                September 1, 1992, or a large volume parenteral 
                drug product approved before such date;
                  (iii) an application filed under section 
                351(k) of the Public Health Service Act with 
                respect to--
                          (I) whole blood or a blood component 
                        for transfusion;
                          (II) an allergenic extract product;
                          (III) an in vitro diagnostic 
                        biological product; or
                          (IV) a biological product for further 
                        manufacturing use only; or
                  (iv) an application for licensure under 
                section 351(k) of the Public Health Service Act 
                that is submitted by a State or Federal 
                Government entity for a product that is not 
                distributed commercially.
          (5) The term ``biosimilar biological product 
        development meeting'' means any meeting, other than a 
        biosimilar initial advisory meeting, regarding the 
        content of a development program, including a proposed 
        design for, or data from, a study intended to support a 
        biosimilar biological product application.
          (6) The term ``biosimilar biological product 
        development program'' means the program under this part 
        for expediting the process for the review of 
        submissions in connection with biosimilar biological 
        product development.
          (7)(A) The term ``biosimilar biological product 
        establishment'' means a foreign or domestic place of 
        business--
                  (i) that is at one general physical location 
                consisting of one or more buildings, all of 
                which are within five miles of each other; and
                  (ii) at which one or more biosimilar 
                biological products are manufactured in final 
                dosage form.
          (B) For purposes of subparagraph (A)(ii), the term 
        ``manufactured'' does not include packaging.
          (8) The term ``biosimilar initial advisory 
        meeting''--
                  (A) means a meeting, if requested, that is 
                limited to--
                          (i) a general discussion regarding 
                        whether licensure under section 351(k) 
                        of the Public Health Service Act may be 
                        feasible for a particular product; and
                          (ii) if so, general advice on the 
                        expected content of the development 
                        program; and
                  (B) does not include any meeting that 
                involves substantive review of summary data or 
                full study reports.
          (9) The term ``costs of resources allocated for the 
        process for the review of biosimilar biological product 
        applications'' means the expenses in connection with 
        the process for the review of biosimilar biological 
        product applications for--
                  (A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers employees 
                and committees and to contracts with such 
                contractors;
                  (B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  (C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  (D) collecting fees under section 744H and 
                accounting for resources allocated for the 
                review of submissions in connection with 
                biosimilar biological product development, 
                biosimilar biological product applications, and 
                supplements.
          (10) The term ``final dosage form'' means, with 
        respect to a biosimilar biological product, a finished 
        dosage form which is approved for administration to a 
        patient without substantial further manufacturing (such 
        as lyophilized products before reconstitution).
          (11) The term ``financial hold''--
                  (A) means an order issued by the Secretary to 
                prohibit the sponsor of a clinical 
                investigation from continuing the investigation 
                if the Secretary determines that the 
                investigation is intended to support a 
                biosimilar biological product application and 
                the sponsor has failed to pay any fee for the 
                product required under subparagraph (A), (B), 
                or (D) of section 744H(a)(1); and
                  (B) does not mean that any of the bases for a 
                ``clinical hold'' under section 505(i)(3) have 
                been determined by the Secretary to exist 
                concerning the investigation.
          (12) The term ``person'' includes an affiliate of 
        such person.
          (13) The term ``process for the review of biosimilar 
        biological product applications'' means the following 
        activities of the Secretary with respect to the review 
        of submissions in connection with biosimilar biological 
        product development, biosimilar biological product 
        applications, and supplements:
                  (A) The activities necessary for the review 
                of submissions in connection with biosimilar 
                biological product development, biosimilar 
                biological product applications, and 
                supplements.
                  (B) Actions related to submissions in 
                connection with biosimilar biological product 
                development, the issuance of action letters 
                which approve biosimilar biological product 
                applications or which set forth in detail the 
                specific deficiencies in such applications, and 
                where appropriate, the actions necessary to 
                place such applications in condition for 
                approval.
                  (C) The inspection of biosimilar biological 
                product establishments and other facilities 
                undertaken as part of the Secretary's review of 
                pending biosimilar biological product 
                applications and supplements.
                  (D) Activities necessary for the release of 
                lots of biosimilar biological products under 
                section 351(k) of the Public Health Service 
                Act.
                  (E) Monitoring of research conducted in 
                connection with the review of biosimilar 
                biological product applications.
                  (F) Postmarket safety activities with respect 
                to biologics approved under biosimilar 
                biological product applications or supplements, 
                including the following activities:
                          (i) Collecting, developing, and 
                        reviewing safety information on 
                        biosimilar biological products, 
                        including adverse-event reports.
                          (ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology 
                        systems.
                          (iii) Developing and using improved 
                        analytical tools to assess potential 
                        safety problems, including access to 
                        external data bases.
                          (iv) Implementing and enforcing 
                        section 505(o) (relating to 
                        postapproval studies and clinical 
                        trials and labeling changes) and 
                        section 505(p) (relating to risk 
                        evaluation and mitigation strategies).
                          (v) Carrying out section 505(k)(5) 
                        (relating to adverse-event reports and 
                        postmarket safety activities).
          (14) The term ``supplement'' means a request to the 
        Secretary to approve a change in a biosimilar 
        biological product application which has been approved, 
        including a supplement requesting that the Secretary 
        determine that the biosimilar biological product meets 
        the standards for interchangeability described in 
        section 351(k)(4) of the Public Health Service Act.

SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT 
                    FEES.

  (a) Types of Fees.--Beginning in fiscal year 2013, the 
Secretary shall assess and collect fees in accordance with this 
section as follows:
          (1) Biosimilar development program fees.--
                  (A) Initial biosimilar biological product 
                development fee.--
                          (i) In general.--Each person that 
                        submits to the Secretary a meeting 
                        request described under clause (ii) or 
                        a clinical protocol for an 
                        investigational new drug protocol 
                        described under clause (iii) shall pay 
                        for the product named in the meeting 
                        request or the investigational new drug 
                        application the initial biosimilar 
                        biological product development fee 
                        established under subsection (b)(1)(A).
                          (ii) Meeting request.--The meeting 
                        request defined in this clause is a 
                        request for a biosimilar biological 
                        product development meeting for a 
                        product.
                          (iii) Clinical protocol for ind.--A 
                        clinical protocol for an 
                        investigational new drug protocol 
                        described in this clause is a clinical 
                        protocol consistent with the provisions 
                        of section 505(i), including any 
                        regulations promulgated under section 
                        505(i), (referred to in this section as 
                        ``investigational new drug 
                        application'') describing an 
                        investigation that the Secretary 
                        determines is intended to support a 
                        biosimilar biological product 
                        application for a product.
                          (iv) Due date.--The initial 
                        biosimilar biological product 
                        development fee shall be due by the 
                        earlier of the following:
                                  (I) Not later than 5 days 
                                after the Secretary grants a 
                                request for a biosimilar 
                                biological product development 
                                meeting.
                                  (II) The date of submission 
                                of an investigational new drug 
                                application describing an 
                                investigation that the 
                                Secretary determines is 
                                intended to support a 
                                biosimilar biological product 
                                application.
                          (v) Transition rule.--Each person 
                        that has submitted an investigational 
                        new drug application prior to the date 
                        of enactment of the Biosimilars User 
                        Fee Act of 2012 shall pay the initial 
                        biosimilar biological product 
                        development fee by the earlier of the 
                        following:
                                  (I) Not later than 60 days 
                                after the date of the enactment 
                                of the Biosimilars User Fee Act 
                                of 2012, if the Secretary 
                                determines that the 
                                investigational new drug 
                                application describes an 
                                investigation that is intended 
                                to support a biosimilar 
                                biological product application.
                                  (II) Not later than 5 days 
                                after the Secretary grants a 
                                request for a biosimilar 
                                biological product development 
                                meeting.
                  (B) Annual biosimilar biological product 
                development fee.--
                          (i) In general.--A person that pays 
                        an initial biosimilar biological 
                        product development fee for a product 
                        shall pay for such product, beginning 
                        in the fiscal year following the fiscal 
                        year in which the initial biosimilar 
                        biological product development fee was 
                        paid, an annual fee established under 
                        subsection (b)(1)(B) for biosimilar 
                        biological product development 
                        (referred to in this section as 
                        ``annual biosimilar biological product 
                        development fee'').
                          (ii) Due date.--The annual biosimilar 
                        biological product development program 
                        fee for each fiscal year will be due on 
                        the later of--
                                  (I) the first business day on 
                                or after October 1 of each such 
                                year; or
                                  (II) the first business day 
                                after the enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees for such 
                                year under this section.
                          (iii) Exception.--The annual 
                        biosimilar development program fee for 
                        each fiscal year will be due on the 
                        date specified in clause (ii), unless 
                        the person has--
                                  (I) submitted a marketing 
                                application for the biological 
                                product that was accepted for 
                                filing; or
                                  (II) discontinued 
                                participation in the biosimilar 
                                biological product development 
                                program for the product under 
                                subparagraph (C).
                  (C) Discontinuation of fee obligation.--A 
                person may discontinue participation in the 
                biosimilar biological product development 
                program for a product effective October 1 of a 
                fiscal year by, not later than August 1 of the 
                preceding fiscal year--
                          (i) if no investigational new drug 
                        application concerning the product has 
                        been submitted, submitting to the 
                        Secretary a written declaration that 
                        the person has no present intention of 
                        further developing the product as a 
                        biosimilar biological product; or
                          (ii) if an investigational new drug 
                        application concerning the product has 
                        been submitted, by withdrawing the 
                        investigational new drug application in 
                        accordance with part 312 of title 21, 
                        Code of Federal Regulations (or any 
                        successor regulations).
                  (D) Reactivation fee.--
                          (i) In general.--A person that has 
                        discontinued participation in the 
                        biosimilar biological product 
                        development program for a product under 
                        subparagraph (C) shall pay a fee 
                        (referred to in this section as 
                        ``reactivation fee'') by the earlier of 
                        the following:
                                  (I) Not later than 5 days 
                                after the Secretary grants a 
                                request for a biosimilar 
                                biological product development 
                                meeting for the product (after 
                                the date on which such 
                                participation was 
                                discontinued).
                                  (II) Upon the date of 
                                submission (after the date on 
                                which such participation was 
                                discontinued) of an 
                                investigational new drug 
                                application describing an 
                                investigation that the 
                                Secretary determines is 
                                intended to support a 
                                biosimilar biological product 
                                application for that product.
                          (ii) Application of annual fee.--A 
                        person that pays a reactivation fee for 
                        a product shall pay for such product, 
                        beginning in the next fiscal year, the 
                        annual biosimilar biological product 
                        development fee under subparagraph (B).
                  (E) Effect of failure to pay biosimilar 
                development program fees.--
                          (i) No biosimilar biological product 
                        development meetings.--If a person has 
                        failed to pay an initial or annual 
                        biosimilar biological product 
                        development fee as required under 
                        subparagraph (A) or (B), or a 
                        reactivation fee as required under 
                        subparagraph (D), the Secretary shall 
                        not provide a biosimilar biological 
                        product development meeting relating to 
                        the product for which fees are owed.
                          (ii) No receipt of investigational 
                        new drug applications.--Except in 
                        extraordinary circumstances, the 
                        Secretary shall not consider an 
                        investigational new drug application to 
                        have been received under section 
                        505(i)(2) if--
                                  (I) the Secretary determines 
                                that the investigation is 
                                intended to support a 
                                biosimilar biological product 
                                application; and
                                  (II) the sponsor has failed 
                                to pay an initial or annual 
                                biosimilar biological product 
                                development fee for the product 
                                as required under subparagraph 
                                (A) or (B), or a reactivation 
                                fee as required under 
                                subparagraph (D).
                          (iii) Financial hold.--
                        Notwithstanding section 505(i)(2), 
                        except in extraordinary circumstances, 
                        the Secretary shall prohibit the 
                        sponsor of a clinical investigation 
                        from continuing the investigation if--
                                  (I) the Secretary determines 
                                that the investigation is 
                                intended to support a 
                                biosimilar biological product 
                                application; and
                                  (II) the sponsor has failed 
                                to pay an initial or annual 
                                biosimilar biological product 
                                development fee for the product 
                                as required under subparagraph 
                                (A) or (B), or a reactivation 
                                fee for the product as required 
                                under subparagraph (D).
                          (iv) No acceptance of biosimilar 
                        biological product applications or 
                        supplements.--If a person has failed to 
                        pay an initial or annual biosimilar 
                        biological product development fee as 
                        required under subparagraph (A) or (B), 
                        or a reactivation fee as required under 
                        subparagraph (D), any biosimilar 
                        biological product application or 
                        supplement submitted by that person 
                        shall be considered incomplete and 
                        shall not be accepted for filing by the 
                        Secretary until all such fees owed by 
                        such person have been paid.
                  (F) Limits regarding biosimilar development 
                program fees.--
                          (i) No refunds.--The Secretary shall 
                        not refund any initial or annual 
                        biosimilar biological product 
                        development fee paid under subparagraph 
                        (A) or (B), or any reactivation fee 
                        paid under subparagraph (D).
                          (ii) No waivers, exemptions, or 
                        reductions.--The Secretary shall not 
                        grant a waiver, exemption, or reduction 
                        of any initial or annual biosimilar 
                        biological product development fee due 
                        or payable under subparagraph (A) or 
                        (B), or any reactivation fee due or 
                        payable under subparagraph (D).
          (2) Biosimilar biological product application and 
        supplement fee.--
                  (A) In general.--Each person that submits, on 
                or after October 1, 2012, a biosimilar 
                biological product application or a supplement 
                shall be subject to the following fees:
                          (i) A fee for a biosimilar biological 
                        product application that is equal to--
                                  (I) the amount of the fee 
                                established under subsection 
                                (b)(1)(D) for a biosimilar 
                                biological product application; 
                                minus
                                  (II) the cumulative amount of 
                                fees paid, if any, under 
                                subparagraphs (A), (B), and (D) 
                                of paragraph (1) for the 
                                product that is the subject of 
                                the application.
                          (ii) A fee for a biosimilar 
                        biological product application for 
                        which clinical data (other than 
                        comparative bioavailability studies) 
                        with respect to safety or effectiveness 
                        are not required, that is equal to--
                                  (I) half of the amount of the 
                                fee established under 
                                subsection (b)(1)(D) for a 
                                biosimilar biological product 
                                application; minus
                                  (II) the cumulative amount of 
                                fees paid, if any, under 
                                subparagraphs (A), (B), and (D) 
                                of paragraph (1) for that 
                                product.
                          (iii) A fee for a supplement for 
                        which clinical data (other than 
                        comparative bioavailability studies) 
                        with respect to safety or effectiveness 
                        are required, that is equal to half of 
                        the amount of the fee established under 
                        subsection (b)(1)(D) for a biosimilar 
                        biological product application.
                  (B) Reduction in fees.--Notwithstanding 
                section 404 of the Biosimilars User Fee Act of 
                2012, any person who pays a fee under 
                subparagraph (A), (B), or (D) of paragraph (1) 
                for a product before October 1, 2017, but 
                submits a biosimilar biological product 
                application for that product after such date, 
                shall be entitled to the reduction of any 
                biosimilar biological product application fees 
                that may be assessed at the time when such 
                biosimilar biological product application is 
                submitted, by the cumulative amount of fees 
                paid under subparagraphs (A), (B), and (D) of 
                paragraph (1) for that product.
                  (C) Payment due date.--Any fee required by 
                subparagraph (A) shall be due upon submission 
                of the application or supplement for which such 
                fee applies.
                  (D) Exception for previously filed 
                application or supplement.--If a biosimilar 
                biological product application or supplement 
                was submitted by a person that paid the fee for 
                such application or supplement, was accepted 
                for filing, and was not approved or was 
                withdrawn (without a waiver), the submission of 
                a biosimilar biological product application or 
                a supplement for the same product by the same 
                person (or the person's licensee, assignee, or 
                successor) shall not be subject to a fee under 
                subparagraph (A).
                  (E) Refund of application fee if application 
                refused for filing or withdrawn before 
                filing.--The Secretary shall refund 75 percent 
                of the fee paid under this paragraph for any 
                application or supplement which is refused for 
                filing or withdrawn without a waiver before 
                filing.
                  (F) Fees for applications previously refused 
                for filing or withdrawn before filing.--A 
                biosimilar biological product application or 
                supplement that was submitted but was refused 
                for filing, or was withdrawn before being 
                accepted or refused for filing, shall be 
                subject to the full fee under subparagraph (A) 
                upon being resubmitted or filed over protest, 
                unless the fee is waived under subsection (c).
          (3) Biosimilar biological product establishment 
        fee.--
                  (A) In general.--Except as provided in 
                subparagraph (E), each person that is named as 
                the applicant in a biosimilar biological 
                product application shall be assessed an annual 
                fee established under subsection (b)(1)(E) for 
                each biosimilar biological product 
                establishment that is listed in the approved 
                biosimilar biological product application as an 
                establishment that manufactures the biosimilar 
                biological product named in such application.
                  (B) Assessment in fiscal years.--The 
                establishment fee shall be assessed in each 
                fiscal year for which the biosimilar biological 
                product named in the application is assessed a 
                fee under paragraph (4) unless the biosimilar 
                biological product establishment listed in the 
                application does not engage in the manufacture 
                of the biosimilar biological product during 
                such fiscal year.
                  (C) Due date.--The establishment fee for a 
                fiscal year shall be due on the later of--
                          (i) the first business day on or 
                        after October 1 of such fiscal year; or
                          (ii) the first business day after the 
                        enactment of an appropriations Act 
                        providing for the collection and 
                        obligation of fees for such fiscal year 
                        under this section.
                  (D) Application to establishment.--
                          (i) Each biosimilar biological 
                        product establishment shall be assessed 
                        only one fee per biosimilar biological 
                        product establishment, notwithstanding 
                        the number of biosimilar biological 
                        products manufactured at the 
                        establishment, subject to clause (ii).
                          (ii) In the event an establishment is 
                        listed in a biosimilar biological 
                        product application by more than one 
                        applicant, the establishment fee for 
                        the fiscal year shall be divided 
                        equally and assessed among the 
                        applicants whose biosimilar biological 
                        products are manufactured by the 
                        establishment during the fiscal year 
                        and assessed biosimilar biological 
                        product fees under paragraph (4).
                  (E) Exception for new products.--If, during 
                the fiscal year, an applicant initiates or 
                causes to be initiated the manufacture of a 
                biosimilar biological product at an 
                establishment listed in its biosimilar 
                biological product application--
                          (i) that did not manufacture the 
                        biosimilar biological product in the 
                        previous fiscal year; and
                          (ii) for which the full biosimilar 
                        biological product establishment fee 
                        has been assessed in the fiscal year at 
                        a time before manufacture of the 
                        biosimilar biological product was 
                        begun,
                the applicant shall not be assessed a share of 
                the biosimilar biological product establishment 
                fee for the fiscal year in which the 
                manufacture of the product began.
          (4) Biosimilar biological product fee.--
                  (A) In general.--Each person who is named as 
                the applicant in a biosimilar biological 
                product application shall pay for each such 
                biosimilar biological product the annual fee 
                established under subsection (b)(1)(F).
                  (B) Due date.--The biosimilar biological 
                product fee for a fiscal year shall be due on 
                the later of--
                          (i) the first business day on or 
                        after October 1 of each such year; or
                          (ii) the first business day after the 
                        enactment of an appropriations Act 
                        providing for the collection and 
                        obligation of fees for such year under 
                        this section.
                  (C) One fee per product per year.--The 
                biosimilar biological product fee shall be paid 
                only once for each product for each fiscal 
                year.
  (b) Fee Setting and Amounts.--
          (1) In general.--Subject to paragraph (2), the 
        Secretary shall, 60 days before the start of each 
        fiscal year that begins after September 30, 2012, 
        establish, for the next fiscal year, the fees under 
        subsection (a). Except as provided in subsection (c), 
        such fees shall be in the following amounts:
                  (A) Initial biosimilar biological product 
                development fee.--The initial biosimilar 
                biological product development fee under 
                subsection (a)(1)(A) for a fiscal year shall be 
                equal to 10 percent of the amount established 
                under section 736(c)(4) for a human drug 
                application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                  (B) Annual biosimilar biological product 
                development fee.--The annual biosimilar 
                biological product development fee under 
                subsection (a)(1)(B) for a fiscal year shall be 
                equal to 10 percent of the amount established 
                under section 736(c)(4) for a human drug 
                application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                  (C) Reactivation fee.--The reactivation fee 
                under subsection (a)(1)(D) for a fiscal year 
                shall be equal to 20 percent of the amount of 
                the fee established under section 736(c)(4) for 
                a human drug application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                  (D) Biosimilar biological product application 
                fee.--The biosimilar biological product 
                application fee under subsection (a)(2) for a 
                fiscal year shall be equal to the amount 
                established under section 736(c)(4) for a human 
                drug application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                  (E) Biosimilar biological product 
                establishment fee.--The biosimilar biological 
                product establishment fee under subsection 
                (a)(3) for a fiscal year shall be equal to the 
                amount established under section 736(c)(4) for 
                a prescription drug establishment for that 
                fiscal year.
                  (F) Biosimilar biological product fee.--The 
                biosimilar biological product fee under 
                subsection (a)(4) for a fiscal year shall be 
                equal to the amount established under section 
                736(c)(4) for a prescription drug product for 
                that fiscal year.
          (2) Limit.--The total amount of fees charged for a 
        fiscal year under this section may not exceed the total 
        amount for such fiscal year of the costs of resources 
        allocated for the process for the review of biosimilar 
        biological product applications.
  (c) Application Fee Waiver for Small Business.--
          (1) Waiver of application fee.--The Secretary shall 
        grant to a person who is named in a biosimilar 
        biological product application a waiver from the 
        application fee assessed to that person under 
        subsection (a)(2)(A) for the first biosimilar 
        biological product application that a small business or 
        its affiliate submits to the Secretary for review. 
        After a small business or its affiliate is granted such 
        a waiver, the small business or its affiliate shall 
        pay--
                  (A) application fees for all subsequent 
                biosimilar biological product applications 
                submitted to the Secretary for review in the 
                same manner as an entity that is not a small 
                business; and
                  (B) all supplement fees for all supplements 
                to biosimilar biological product applications 
                submitted to the Secretary for review in the 
                same manner as an entity that is not a small 
                business.
          (2) Considerations.--In determining whether to grant 
        a waiver of a fee under paragraph (1), the Secretary 
        shall consider only the circumstances and assets of the 
        applicant involved and any affiliate of the applicant.
          (3) Small business defined.--In this subsection, the 
        term ``small business'' means an entity that has fewer 
        than 500 employees, including employees of affiliates, 
        and does not have a drug product that has been approved 
        under a human drug application (as defined in section 
        735) or a biosimilar biological product application (as 
        defined in section 744G(4)) and introduced or delivered 
        for introduction into interstate commerce.
  (d) Effect of Failure To Pay Fees.--A biosimilar biological 
product application or supplement submitted by a person subject 
to fees under subsection (a) shall be considered incomplete and 
shall not be accepted for filing by the Secretary until all 
fees owed by such person have been paid.
  (e) Crediting and Availability of Fees.--
          (1) In general.--Subject to paragraph (2), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the 
        amount provided in advance in appropriations Acts. Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for the process for the 
        review of biosimilar biological product applications.
          (2) Collections and appropriation acts.--
                  (A) In general.--Subject to subparagraphs (C) 
                and (D), the fees authorized by this section 
                shall be collected and available in each fiscal 
                year in an amount not to exceed the amount 
                specified in appropriation Acts, or otherwise 
                made available for obligation for such fiscal 
                year.
                  (B) Use of fees and limitation.--The fees 
                authorized by this section shall be available 
                for a fiscal year beginning after fiscal year 
                2012 to defray the costs of the process for the 
                review of biosimilar biological product 
                applications (including such costs for an 
                additional number of full-time equivalent 
                positions in the Department of Health and Human 
                Services to be engaged in such process), only 
                if the Secretary allocates for such purpose an 
                amount for such fiscal year (excluding amounts 
                from fees collected under this section) no less 
                than $20,000,000, multiplied by the adjustment 
                factor applicable to the fiscal year involved.
                  (C) Fee collection during first program 
                year.--Until the date of enactment of an Act 
                making appropriations through September 30, 
                2013, for the salaries and expenses account of 
                the Food and Drug Administration, fees 
                authorized by this section for fiscal year 2013 
                may be collected and shall be credited to such 
                account and remain available until expended.
                  (D) Provision for early payments in 
                subsequent years.--Payment of fees authorized 
                under this section for a fiscal year (after 
                fiscal year 2013), prior to the due date for 
                such fees, may be accepted by the Secretary in 
                accordance with authority provided in advance 
                in a prior year appropriations Act.
          (3) Authorization of appropriations.--For each of 
        fiscal years 2013 through 2017, there is authorized to 
        be appropriated for fees under this section an amount 
        equivalent to the total amount of fees assessed for 
        such fiscal year under this section.
  (f) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  (g) Written Requests for Waivers and Refunds.--To qualify for 
consideration for a waiver under subsection (c), or for a 
refund of any fee collected in accordance with subsection 
(a)(2)(A), a person shall submit to the Secretary a written 
request for such waiver or refund not later than 180 days after 
such fee is due.
  (h) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in the process 
of the review of biosimilar biological product applications, be 
reduced to offset the number of officers, employees, and 
advisory committees so engaged.

SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

  (a) Performance Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which 
fees are collected under this part, the Secretary shall prepare 
and submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report concerning the 
progress of the Food and Drug Administration in achieving the 
goals identified in the letters described in section 401(b) of 
the Biosimilar User Fee Act of 2012 during such fiscal year and 
the future plans of the Food and Drug Administration for 
meeting such goals. The report for a fiscal year shall include 
information on all previous cohorts for which the Secretary has 
not given a complete response on all biosimilar biological 
product applications and supplements in the cohort.
  (b) Fiscal Report.--Not later than 120 days after the end of 
fiscal year 2013 and each subsequent fiscal year for which fees 
are collected under this part, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report on the implementation of 
the authority for such fees during such fiscal year and the 
use, by the Food and Drug Administration, of the fees collected 
for such fiscal year.
  (c) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  (d) Study.--
          (1) In general.--The Secretary shall contract with an 
        independent accounting or consulting firm to study the 
        workload volume and full costs associated with the 
        process for the review of biosimilar biological product 
        applications.
          (2) Interim results.--Not later than June 1, 2015, 
        the Secretary shall publish, for public comment, 
        interim results of the study described under paragraph 
        (1).
          (3) Final results.--Not later than September 30, 
        2016, the Secretary shall publish, for public comment, 
        the final results of the study described under 
        paragraph (1).
  (e) Reauthorization.--
          (1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals 
        described in subsection (a), and plans for meeting the 
        goals, for the process for the review of biosimilar 
        biological product applications for the first 5 fiscal 
        years after fiscal year 2017, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  (A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (C) scientific and academic experts;
                  (D) health care professionals;
                  (E) representatives of patient and consumer 
                advocacy groups; and
                  (F) the regulated industry.
          (2) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  (A) present the recommendations developed 
                under paragraph (1) to the congressional 
                committees specified in such paragraph;
                  (B) publish such recommendations in the 
                Federal Register;
                  (C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  (D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  (E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          (3) Transmittal of recommendations.--Not later than 
        January 15, 2017, the Secretary shall transmit to the 
        Congress the revised recommendations under paragraph 
        (2), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and comments.

[Effective October 1, 2017, section 404(a) of H.R. 5651 provides for a 
       repeal of sections 744G and 744H (as added by the bill).]

[SEC. 744G. DEFINITIONS.

  [For purposes of this part:
          [(1) The term ``adjustment factor'' applicable to a 
        fiscal year that is the Consumer Price Index for all 
        urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not 
        Seasonally Adjusted; All items) of the preceding fiscal 
        year divided by such Index for September 2011.
          [(2) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  [(A) one business entity controls, or has the 
                power to control, the other business entity; or
                  [(B) a third party controls, or has power to 
                control, both of the business entities.
          [(3) The term ``biosimilar biological product'' means 
        a product for which a biosimilar biological product 
        application has been approved.
          [(4)(A) Subject to subparagraph (B), the term 
        ``biosimilar biological product application'' means an 
        application for licensure of a biological product under 
        section 351(k) of the Public Health Service Act.
          [(B) Such term does not include--
                  [(i) a supplement to such an application;
                  [(ii) an application filed under section 
                351(k) of the Public Health Service Act that 
                cites as the reference product a bovine blood 
                product for topical application licensed before 
                September 1, 1992, or a large volume parenteral 
                drug product approved before such date;
                  [(iii) an application filed under section 
                351(k) of the Public Health Service Act with 
                respect to--
                          [(I) whole blood or a blood component 
                        for transfusion;
                          [(II) an allergenic extract product;
                          [(III) an in vitro diagnostic 
                        biological product; or
                          [(IV) a biological product for 
                        further manufacturing use only; or
                  [(iv) an application for licensure under 
                section 351(k) of the Public Health Service Act 
                that is submitted by a State or Federal 
                Government entity for a product that is not 
                distributed commercially.
          [(5) The term ``biosimilar biological product 
        development meeting'' means any meeting, other than a 
        biosimilar initial advisory meeting, regarding the 
        content of a development program, including a proposed 
        design for, or data from, a study intended to support a 
        biosimilar biological product application.
          [(6) The term ``biosimilar biological product 
        development program'' means the program under this part 
        for expediting the process for the review of 
        submissions in connection with biosimilar biological 
        product development.
          [(7)(A) The term ``biosimilar biological product 
        establishment'' means a foreign or domestic place of 
        business--
                  [(i) that is at one general physical location 
                consisting of one or more buildings, all of 
                which are within five miles of each other; and
                  [(ii) at which one or more biosimilar 
                biological products are manufactured in final 
                dosage form.
          [(B) For purposes of subparagraph (A)(ii), the term 
        ``manufactured'' does not include packaging.
          [(8) The term ``biosimilar initial advisory 
        meeting''--
                  [(A) means a meeting, if requested, that is 
                limited to--
                          [(i) a general discussion regarding 
                        whether licensure under section 351(k) 
                        of the Public Health Service Act may be 
                        feasible for a particular product; and
                          [(ii) if so, general advice on the 
                        expected content of the development 
                        program; and
                  [(B) does not include any meeting that 
                involves substantive review of summary data or 
                full study reports.
          [(9) The term ``costs of resources allocated for the 
        process for the review of biosimilar biological product 
        applications'' means the expenses in connection with 
        the process for the review of biosimilar biological 
        product applications for--
                  [(A) officers and employees of the Food and 
                Drug Administration, contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers employees 
                and committees and to contracts with such 
                contractors;
                  [(B) management of information, and the 
                acquisition, maintenance, and repair of 
                computer resources;
                  [(C) leasing, maintenance, renovation, and 
                repair of facilities and acquisition, 
                maintenance, and repair of fixtures, furniture, 
                scientific equipment, and other necessary 
                materials and supplies; and
                  [(D) collecting fees under section 744H and 
                accounting for resources allocated for the 
                review of submissions in connection with 
                biosimilar biological product development, 
                biosimilar biological product applications, and 
                supplements.
          [(10) The term ``final dosage form'' means, with 
        respect to a biosimilar biological product, a finished 
        dosage form which is approved for administration to a 
        patient without substantial further manufacturing (such 
        as lyophilized products before reconstitution).
          [(11) The term ``financial hold''--
                  [(A) means an order issued by the Secretary 
                to prohibit the sponsor of a clinical 
                investigation from continuing the investigation 
                if the Secretary determines that the 
                investigation is intended to support a 
                biosimilar biological product application and 
                the sponsor has failed to pay any fee for the 
                product required under subparagraph (A), (B), 
                or (D) of section 744H(a)(1); and
                  [(B) does not mean that any of the bases for 
                a ``clinical hold'' under section 505(i)(3) 
                have been determined by the Secretary to exist 
                concerning the investigation.
          [(12) The term ``person'' includes an affiliate of 
        such person.
          [(13) The term ``process for the review of biosimilar 
        biological product applications'' means the following 
        activities of the Secretary with respect to the review 
        of submissions in connection with biosimilar biological 
        product development, biosimilar biological product 
        applications, and supplements:
                  [(A) The activities necessary for the review 
                of submissions in connection with biosimilar 
                biological product development, biosimilar 
                biological product applications, and 
                supplements.
                  [(B) Actions related to submissions in 
                connection with biosimilar biological product 
                development, the issuance of action letters 
                which approve biosimilar biological product 
                applications or which set forth in detail the 
                specific deficiencies in such applications, and 
                where appropriate, the actions necessary to 
                place such applications in condition for 
                approval.
                  [(C) The inspection of biosimilar biological 
                product establishments and other facilities 
                undertaken as part of the Secretary's review of 
                pending biosimilar biological product 
                applications and supplements.
                  [(D) Activities necessary for the release of 
                lots of biosimilar biological products under 
                section 351(k) of the Public Health Service 
                Act.
                  [(E) Monitoring of research conducted in 
                connection with the review of biosimilar 
                biological product applications.
                  [(F) Postmarket safety activities with 
                respect to biologics approved under biosimilar 
                biological product applications or supplements, 
                including the following activities:
                          [(i) Collecting, developing, and 
                        reviewing safety information on 
                        biosimilar biological products, 
                        including adverse-event reports.
                          [(ii) Developing and using improved 
                        adverse-event data-collection systems, 
                        including information technology 
                        systems.
                          [(iii) Developing and using improved 
                        analytical tools to assess potential 
                        safety problems, including access to 
                        external data bases.
                          [(iv) Implementing and enforcing 
                        section 505(o) (relating to 
                        postapproval studies and clinical 
                        trials and labeling changes) and 
                        section 505(p) (relating to risk 
                        evaluation and mitigation strategies).
                          [(v) Carrying out section 505(k)(5) 
                        (relating to adverse-event reports and 
                        postmarket safety activities).
          [(14) The term ``supplement'' means a request to the 
        Secretary to approve a change in a biosimilar 
        biological product application which has been approved, 
        including a supplement requesting that the Secretary 
        determine that the biosimilar biological product meets 
        the standards for interchangeability described in 
        section 351(k)(4) of the Public Health Service Act.

[SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR BIOLOGICAL PRODUCT 
                    FEES.

  [(a) Types of Fees.--Beginning in fiscal year 2013, the 
Secretary shall assess and collect fees in accordance with this 
section as follows:
          [(1) Biosimilar development program fees.--
                  [(A) Initial biosimilar biological product 
                development fee.--
                          [(i) In general.--Each person that 
                        submits to the Secretary a meeting 
                        request described under clause (ii) or 
                        a clinical protocol for an 
                        investigational new drug protocol 
                        described under clause (iii) shall pay 
                        for the product named in the meeting 
                        request or the investigational new drug 
                        application the initial biosimilar 
                        biological product development fee 
                        established under subsection (b)(1)(A).
                          [(ii) Meeting request.--The meeting 
                        request defined in this clause is a 
                        request for a biosimilar biological 
                        product development meeting for a 
                        product.
                          [(iii) Clinical protocol for ind.--A 
                        clinical protocol for an 
                        investigational new drug protocol 
                        described in this clause is a clinical 
                        protocol consistent with the provisions 
                        of section 505(i), including any 
                        regulations promulgated under section 
                        505(i), (referred to in this section as 
                        ``investigational new drug 
                        application'') describing an 
                        investigation that the Secretary 
                        determines is intended to support a 
                        biosimilar biological product 
                        application for a product.
                          [(iv) Due date.--The initial 
                        biosimilar biological product 
                        development fee shall be due by the 
                        earlier of the following:
                                  [(I) Not later than 5 days 
                                after the Secretary grants a 
                                request for a biosimilar 
                                biological product development 
                                meeting.
                                  [(II) The date of submission 
                                of an investigational new drug 
                                application describing an 
                                investigation that the 
                                Secretary determines is 
                                intended to support a 
                                biosimilar biological product 
                                application.
                          [(v) Transition rule.--Each person 
                        that has submitted an investigational 
                        new drug application prior to the date 
                        of enactment of the Biosimilars User 
                        Fee Act of 2012 shall pay the initial 
                        biosimilar biological product 
                        development fee by the earlier of the 
                        following:
                                  [(I) Not later than 60 days 
                                after the date of the enactment 
                                of the Biosimilars User Fee Act 
                                of 2012, if the Secretary 
                                determines that the 
                                investigational new drug 
                                application describes an 
                                investigation that is intended 
                                to support a biosimilar 
                                biological product application.
                                  [(II) Not later than 5 days 
                                after the Secretary grants a 
                                request for a biosimilar 
                                biological product development 
                                meeting.
                  [(B) Annual biosimilar biological product 
                development fee.--
                          [(i) In general.--A person that pays 
                        an initial biosimilar biological 
                        product development fee for a product 
                        shall pay for such product, beginning 
                        in the fiscal year following the fiscal 
                        year in which the initial biosimilar 
                        biological product development fee was 
                        paid, an annual fee established under 
                        subsection (b)(1)(B) for biosimilar 
                        biological product development 
                        (referred to in this section as 
                        ``annual biosimilar biological product 
                        development fee'').
                          [(ii) Due date.--The annual 
                        biosimilar biological product 
                        development program fee for each fiscal 
                        year will be due on the later of--
                                  [(I) the first business day 
                                on or after October 1 of each 
                                such year; or
                                  [(II) the first business day 
                                after the enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees for such 
                                year under this section.
                          [(iii) Exception.--The annual 
                        biosimilar development program fee for 
                        each fiscal year will be due on the 
                        date specified in clause (ii), unless 
                        the person has--
                                  [(I) submitted a marketing 
                                application for the biological 
                                product that was accepted for 
                                filing; or
                                  [(II) discontinued 
                                participation in the biosimilar 
                                biological product development 
                                program for the product under 
                                subparagraph (C).
                  [(C) Discontinuation of fee obligation.--A 
                person may discontinue participation in the 
                biosimilar biological product development 
                program for a product effective October 1 of a 
                fiscal year by, not later than August 1 of the 
                preceding fiscal year--
                          [(i) if no investigational new drug 
                        application concerning the product has 
                        been submitted, submitting to the 
                        Secretary a written declaration that 
                        the person has no present intention of 
                        further developing the product as a 
                        biosimilar biological product; or
                          [(ii) if an investigational new drug 
                        application concerning the product has 
                        been submitted, by withdrawing the 
                        investigational new drug application in 
                        accordance with part 312 of title 21, 
                        Code of Federal Regulations (or any 
                        successor regulations).
                  [(D) Reactivation fee.--
                          [(i) In general.--A person that has 
                        discontinued participation in the 
                        biosimilar biological product 
                        development program for a product under 
                        subparagraph (C) shall pay a fee 
                        (referred to in this section as 
                        ``reactivation fee'') by the earlier of 
                        the following:
                                  [(I) Not later than 5 days 
                                after the Secretary grants a 
                                request for a biosimilar 
                                biological product development 
                                meeting for the product (after 
                                the date on which such 
                                participation was 
                                discontinued).
                                  [(II) Upon the date of 
                                submission (after the date on 
                                which such participation was 
                                discontinued) of an 
                                investigational new drug 
                                application describing an 
                                investigation that the 
                                Secretary determines is 
                                intended to support a 
                                biosimilar biological product 
                                application for that product.
                          [(ii) Application of annual fee.--A 
                        person that pays a reactivation fee for 
                        a product shall pay for such product, 
                        beginning in the next fiscal year, the 
                        annual biosimilar biological product 
                        development fee under subparagraph (B).
                  [(E) Effect of failure to pay biosimilar 
                development program fees.--
                          [(i) No biosimilar biological product 
                        development meetings.--If a person has 
                        failed to pay an initial or annual 
                        biosimilar biological product 
                        development fee as required under 
                        subparagraph (A) or (B), or a 
                        reactivation fee as required under 
                        subparagraph (D), the Secretary shall 
                        not provide a biosimilar biological 
                        product development meeting relating to 
                        the product for which fees are owed.
                          [(ii) No receipt of investigational 
                        new drug applications.--Except in 
                        extraordinary circumstances, the 
                        Secretary shall not consider an 
                        investigational new drug application to 
                        have been received under section 
                        505(i)(2) if--
                                  [(I) the Secretary determines 
                                that the investigation is 
                                intended to support a 
                                biosimilar biological product 
                                application; and
                                  [(II) the sponsor has failed 
                                to pay an initial or annual 
                                biosimilar biological product 
                                development fee for the product 
                                as required under subparagraph 
                                (A) or (B), or a reactivation 
                                fee as required under 
                                subparagraph (D).
                          [(iii) Financial hold.--
                        Notwithstanding section 505(i)(2), 
                        except in extraordinary circumstances, 
                        the Secretary shall prohibit the 
                        sponsor of a clinical investigation 
                        from continuing the investigation if--
                                  [(I) the Secretary determines 
                                that the investigation is 
                                intended to support a 
                                biosimilar biological product 
                                application; and
                                  [(II) the sponsor has failed 
                                to pay an initial or annual 
                                biosimilar biological product 
                                development fee for the product 
                                as required under subparagraph 
                                (A) or (B), or a reactivation 
                                fee for the product as required 
                                under subparagraph (D).
                          [(iv) No acceptance of biosimilar 
                        biological product applications or 
                        supplements.--If a person has failed to 
                        pay an initial or annual biosimilar 
                        biological product development fee as 
                        required under subparagraph (A) or (B), 
                        or a reactivation fee as required under 
                        subparagraph (D), any biosimilar 
                        biological product application or 
                        supplement submitted by that person 
                        shall be considered incomplete and 
                        shall not be accepted for filing by the 
                        Secretary until all such fees owed by 
                        such person have been paid.
                  [(F) Limits regarding biosimilar development 
                program fees.--
                          [(i) No refunds.--The Secretary shall 
                        not refund any initial or annual 
                        biosimilar biological product 
                        development fee paid under subparagraph 
                        (A) or (B), or any reactivation fee 
                        paid under subparagraph (D).
                          [(ii) No waivers, exemptions, or 
                        reductions.--The Secretary shall not 
                        grant a waiver, exemption, or reduction 
                        of any initial or annual biosimilar 
                        biological product development fee due 
                        or payable under subparagraph (A) or 
                        (B), or any reactivation fee due or 
                        payable under subparagraph (D).
          [(2) Biosimilar biological product application and 
        supplement fee.--
                  [(A) In general.--Each person that submits, 
                on or after October 1, 2012, a biosimilar 
                biological product application or a supplement 
                shall be subject to the following fees:
                          [(i) A fee for a biosimilar 
                        biological product application that is 
                        equal to--
                                  [(I) the amount of the fee 
                                established under subsection 
                                (b)(1)(D) for a biosimilar 
                                biological product application; 
                                minus
                                  [(II) the cumulative amount 
                                of fees paid, if any, under 
                                subparagraphs (A), (B), and (D) 
                                of paragraph (1) for the 
                                product that is the subject of 
                                the application.
                          [(ii) A fee for a biosimilar 
                        biological product application for 
                        which clinical data (other than 
                        comparative bioavailability studies) 
                        with respect to safety or effectiveness 
                        are not required, that is equal to--
                                  [(I) half of the amount of 
                                the fee established under 
                                subsection (b)(1)(D) for a 
                                biosimilar biological product 
                                application; minus
                                  [(II) the cumulative amount 
                                of fees paid, if any, under 
                                subparagraphs (A), (B), and (D) 
                                of paragraph (1) for that 
                                product.
                          [(iii) A fee for a supplement for 
                        which clinical data (other than 
                        comparative bioavailability studies) 
                        with respect to safety or effectiveness 
                        are required, that is equal to half of 
                        the amount of the fee established under 
                        subsection (b)(1)(D) for a biosimilar 
                        biological product application.
                  [(B) Reduction in fees.--Notwithstanding 
                section 404 of the Biosimilars User Fee Act of 
                2012, any person who pays a fee under 
                subparagraph (A), (B), or (D) of paragraph (1) 
                for a product before October 1, 2017, but 
                submits a biosimilar biological product 
                application for that product after such date, 
                shall be entitled to the reduction of any 
                biosimilar biological product application fees 
                that may be assessed at the time when such 
                biosimilar biological product application is 
                submitted, by the cumulative amount of fees 
                paid under subparagraphs (A), (B), and (D) of 
                paragraph (1) for that product.
                  [(C) Payment due date.--Any fee required by 
                subparagraph (A) shall be due upon submission 
                of the application or supplement for which such 
                fee applies.
                  [(D) Exception for previously filed 
                application or supplement.--If a biosimilar 
                biological product application or supplement 
                was submitted by a person that paid the fee for 
                such application or supplement, was accepted 
                for filing, and was not approved or was 
                withdrawn (without a waiver), the submission of 
                a biosimilar biological product application or 
                a supplement for the same product by the same 
                person (or the person's licensee, assignee, or 
                successor) shall not be subject to a fee under 
                subparagraph (A).
                  [(E) Refund of application fee if application 
                refused for filing or withdrawn before 
                filing.--The Secretary shall refund 75 percent 
                of the fee paid under this paragraph for any 
                application or supplement which is refused for 
                filing or withdrawn without a waiver before 
                filing.
                  [(F) Fees for applications previously refused 
                for filing or withdrawn before filing.--A 
                biosimilar biological product application or 
                supplement that was submitted but was refused 
                for filing, or was withdrawn before being 
                accepted or refused for filing, shall be 
                subject to the full fee under subparagraph (A) 
                upon being resubmitted or filed over protest, 
                unless the fee is waived under subsection (c).
          [(3) Biosimilar biological product establishment 
        fee.--
                  [(A) In general.--Except as provided in 
                subparagraph (E), each person that is named as 
                the applicant in a biosimilar biological 
                product application shall be assessed an annual 
                fee established under subsection (b)(1)(E) for 
                each biosimilar biological product 
                establishment that is listed in the approved 
                biosimilar biological product application as an 
                establishment that manufactures the biosimilar 
                biological product named in such application.
                  [(B) Assessment in fiscal years.--The 
                establishment fee shall be assessed in each 
                fiscal year for which the biosimilar biological 
                product named in the application is assessed a 
                fee under paragraph (4) unless the biosimilar 
                biological product establishment listed in the 
                application does not engage in the manufacture 
                of the biosimilar biological product during 
                such fiscal year.
                  [(C) Due date.--The establishment fee for a 
                fiscal year shall be due on the later of--
                          [(i) the first business day on or 
                        after October 1 of such fiscal year; or
                          [(ii) the first business day after 
                        the enactment of an appropriations Act 
                        providing for the collection and 
                        obligation of fees for such fiscal year 
                        under this section.
                  [(D) Application to establishment.--
                          [(i) Each biosimilar biological 
                        product establishment shall be assessed 
                        only one fee per biosimilar biological 
                        product establishment, notwithstanding 
                        the number of biosimilar biological 
                        products manufactured at the 
                        establishment, subject to clause (ii).
                          [(ii) In the event an establishment 
                        is listed in a biosimilar biological 
                        product application by more than one 
                        applicant, the establishment fee for 
                        the fiscal year shall be divided 
                        equally and assessed among the 
                        applicants whose biosimilar biological 
                        products are manufactured by the 
                        establishment during the fiscal year 
                        and assessed biosimilar biological 
                        product fees under paragraph (4).
                  [(E) Exception for new products.--If, during 
                the fiscal year, an applicant initiates or 
                causes to be initiated the manufacture of a 
                biosimilar biological product at an 
                establishment listed in its biosimilar 
                biological product application--
                          [(i) that did not manufacture the 
                        biosimilar biological product in the 
                        previous fiscal year; and
                          [(ii) for which the full biosimilar 
                        biological product establishment fee 
                        has been assessed in the fiscal year at 
                        a time before manufacture of the 
                        biosimilar biological product was 
                        begun,
                the applicant shall not be assessed a share of 
                the biosimilar biological product establishment 
                fee for the fiscal year in which the 
                manufacture of the product began.
          [(4) Biosimilar biological product fee.--
                  [(A) In general.--Each person who is named as 
                the applicant in a biosimilar biological 
                product application shall pay for each such 
                biosimilar biological product the annual fee 
                established under subsection (b)(1)(F).
                  [(B) Due date.--The biosimilar biological 
                product fee for a fiscal year shall be due on 
                the later of--
                          [(i) the first business day on or 
                        after October 1 of each such year; or
                          [(ii) the first business day after 
                        the enactment of an appropriations Act 
                        providing for the collection and 
                        obligation of fees for such year under 
                        this section.
                  [(C) One fee per product per year.--The 
                biosimilar biological product fee shall be paid 
                only once for each product for each fiscal 
                year.
  [(b) Fee Setting and Amounts.--
          [(1) In general.--Subject to paragraph (2), the 
        Secretary shall, 60 days before the start of each 
        fiscal year that begins after September 30, 2012, 
        establish, for the next fiscal year, the fees under 
        subsection (a). Except as provided in subsection (c), 
        such fees shall be in the following amounts:
                  [(A) Initial biosimilar biological product 
                development fee.--The initial biosimilar 
                biological product development fee under 
                subsection (a)(1)(A) for a fiscal year shall be 
                equal to 10 percent of the amount established 
                under section 736(c)(4) for a human drug 
                application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                  [(B) Annual biosimilar biological product 
                development fee.--The annual biosimilar 
                biological product development fee under 
                subsection (a)(1)(B) for a fiscal year shall be 
                equal to 10 percent of the amount established 
                under section 736(c)(4) for a human drug 
                application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                  [(C) Reactivation fee.--The reactivation fee 
                under subsection (a)(1)(D) for a fiscal year 
                shall be equal to 20 percent of the amount of 
                the fee established under section 736(c)(4) for 
                a human drug application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                  [(D) Biosimilar biological product 
                application fee.--The biosimilar biological 
                product application fee under subsection (a)(2) 
                for a fiscal year shall be equal to the amount 
                established under section 736(c)(4) for a human 
                drug application described in section 
                736(a)(1)(A)(i) for that fiscal year.
                  [(E) Biosimilar biological product 
                establishment fee.--The biosimilar biological 
                product establishment fee under subsection 
                (a)(3) for a fiscal year shall be equal to the 
                amount established under section 736(c)(4) for 
                a prescription drug establishment for that 
                fiscal year.
                  [(F) Biosimilar biological product fee.--The 
                biosimilar biological product fee under 
                subsection (a)(4) for a fiscal year shall be 
                equal to the amount established under section 
                736(c)(4) for a prescription drug product for 
                that fiscal year.
          [(2) Limit.--The total amount of fees charged for a 
        fiscal year under this section may not exceed the total 
        amount for such fiscal year of the costs of resources 
        allocated for the process for the review of biosimilar 
        biological product applications.
  [(c) Application Fee Waiver for Small Business.--
          [(1) Waiver of application fee.--The Secretary shall 
        grant to a person who is named in a biosimilar 
        biological product application a waiver from the 
        application fee assessed to that person under 
        subsection (a)(2)(A) for the first biosimilar 
        biological product application that a small business or 
        its affiliate submits to the Secretary for review. 
        After a small business or its affiliate is granted such 
        a waiver, the small business or its affiliate shall 
        pay--
                  [(A) application fees for all subsequent 
                biosimilar biological product applications 
                submitted to the Secretary for review in the 
                same manner as an entity that is not a small 
                business; and
                  [(B) all supplement fees for all supplements 
                to biosimilar biological product applications 
                submitted to the Secretary for review in the 
                same manner as an entity that is not a small 
                business.
          [(2) Considerations.--In determining whether to grant 
        a waiver of a fee under paragraph (1), the Secretary 
        shall consider only the circumstances and assets of the 
        applicant involved and any affiliate of the applicant.
          [(3) Small business defined.--In this subsection, the 
        term ``small business'' means an entity that has fewer 
        than 500 employees, including employees of affiliates, 
        and does not have a drug product that has been approved 
        under a human drug application (as defined in section 
        735) or a biosimilar biological product application (as 
        defined in section 744G(4)) and introduced or delivered 
        for introduction into interstate commerce.
  [(d) Effect of Failure To Pay Fees.--A biosimilar biological 
product application or supplement submitted by a person subject 
to fees under subsection (a) shall be considered incomplete and 
shall not be accepted for filing by the Secretary until all 
fees owed by such person have been paid.
  [(e) Crediting and Availability of Fees.--
          [(1) In general.--Subject to paragraph (2), fees 
        authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the 
        amount provided in advance in appropriations Acts. Such 
        fees are authorized to remain available until expended. 
        Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to 
        such appropriation account for salaries and expenses 
        with such fiscal year limitation. The sums transferred 
        shall be available solely for the process for the 
        review of biosimilar biological product applications.
          [(2) Collections and appropriation acts.--
                  [(A) In general.--Subject to subparagraphs 
                (C) and (D), the fees authorized by this 
                section shall be collected and available in 
                each fiscal year in an amount not to exceed the 
                amount specified in appropriation Acts, or 
                otherwise made available for obligation for 
                such fiscal year.
                  [(B) Use of fees and limitation.--The fees 
                authorized by this section shall be available 
                for a fiscal year beginning after fiscal year 
                2012 to defray the costs of the process for the 
                review of biosimilar biological product 
                applications (including such costs for an 
                additional number of full-time equivalent 
                positions in the Department of Health and Human 
                Services to be engaged in such process), only 
                if the Secretary allocates for such purpose an 
                amount for such fiscal year (excluding amounts 
                from fees collected under this section) no less 
                than $20,000,000, multiplied by the adjustment 
                factor applicable to the fiscal year involved.
                  [(C) Fee collection during first program 
                year.--Until the date of enactment of an Act 
                making appropriations through September 30, 
                2013, for the salaries and expenses account of 
                the Food and Drug Administration, fees 
                authorized by this section for fiscal year 2013 
                may be collected and shall be credited to such 
                account and remain available until expended.
                  [(D) Provision for early payments in 
                subsequent years.--Payment of fees authorized 
                under this section for a fiscal year (after 
                fiscal year 2013), prior to the due date for 
                such fees, may be accepted by the Secretary in 
                accordance with authority provided in advance 
                in a prior year appropriations Act.
          [(3) Authorization of appropriations.--For each of 
        fiscal years 2013 through 2017, there is authorized to 
        be appropriated for fees under this section an amount 
        equivalent to the total amount of fees assessed for 
        such fiscal year under this section.
  [(f) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 days after it is due, such fee shall 
be treated as a claim of the United States Government subject 
to subchapter II of chapter 37 of title 31, United States Code.
  [(g) Written Requests for Waivers and Refunds.--To qualify 
for consideration for a waiver under subsection (c), or for a 
refund of any fee collected in accordance with subsection 
(a)(2)(A), a person shall submit to the Secretary a written 
request for such waiver or refund not later than 180 days after 
such fee is due.
  [(h) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in the process 
of the review of biosimilar biological product applications, be 
reduced to offset the number of officers, employees, and 
advisory committees so engaged.]

[Effective January 31, 2018, section 404(b) of H.R. 5651 provides for a 
            repeal of section 744I (as added by the bill).]

[SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

  [(a) Performance Report.--Beginning with fiscal year 2013, 
not later than 120 days after the end of each fiscal year for 
which fees are collected under this part, the Secretary shall 
prepare and submit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report 
concerning the progress of the Food and Drug Administration in 
achieving the goals identified in the letters described in 
section 401(b) of the Biosimilar User Fee Act of 2012 during 
such fiscal year and the future plans of the Food and Drug 
Administration for meeting such goals. The report for a fiscal 
year shall include information on all previous cohorts for 
which the Secretary has not given a complete response on all 
biosimilar biological product applications and supplements in 
the cohort.
  [(b) Fiscal Report.--Not later than 120 days after the end of 
fiscal year 2013 and each subsequent fiscal year for which fees 
are collected under this part, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report on the implementation of 
the authority for such fees during such fiscal year and the 
use, by the Food and Drug Administration, of the fees collected 
for such fiscal year.
  [(c) Public Availability.-- The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the Internet Web site of the Food and Drug 
Administration.
  [(d) Study.--
          [(1) In general.--The Secretary shall contract with 
        an independent accounting or consulting firm to study 
        the workload volume and full costs associated with the 
        process for the review of biosimilar biological product 
        applications.
          [(2) Interim results.--Not later than June 1, 2015, 
        the Secretary shall publish, for public comment, 
        interim results of the study described under paragraph 
        (1).
          [(3) Final results.--Not later than September 30, 
        2016, the Secretary shall publish, for public comment, 
        the final results of the study described under 
        paragraph (1).
  [(e) Reauthorization.--
          [(1) Consultation.--In developing recommendations to 
        present to the Congress with respect to the goals 
        described in subsection (a), and plans for meeting the 
        goals, for the process for the review of biosimilar 
        biological product applications for the first 5 fiscal 
        years after fiscal year 2017, and for the 
        reauthorization of this part for such fiscal years, the 
        Secretary shall consult with--
                  [(A) the Committee on Energy and Commerce of 
                the House of Representatives;
                  [(B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  [(C) scientific and academic experts;
                  [(D) health care professionals;
                  [(E) representatives of patient and consumer 
                advocacy groups; and
                  [(F) the regulated industry.
          [(2) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary 
        shall--
                  [(A) present the recommendations developed 
                under paragraph (1) to the congressional 
                committees specified in such paragraph;
                  [(B) publish such recommendations in the 
                Federal Register;
                  [(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                  [(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                  [(E) after consideration of such public views 
                and comments, revise such recommendations as 
                necessary.
          [(3) Transmittal of recommendations.--Not later than 
        January 15, 2017, the Secretary shall transmit to the 
        Congress the revised recommendations under paragraph 
        (2), a summary of the views and comments received under 
        such paragraph, and any changes made to the 
        recommendations in response to such views and 
        comments.]

           *       *       *       *       *       *       *


Subchapter D--Information and Education

           *       *       *       *       *       *       *


SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.

  (a) Drugs and Biologics.--
          (1) In general.--Beginning no earlier than 24 months 
        after the issuance of a final guidance issued after 
        public notice and opportunity for comment, submissions 
        under subsection (b), (i), or (j) of section 505 of 
        this Act or subsection (a) or (k) of section 351 of the 
        Public Health Service Act shall be submitted in such 
        electronic format as specified by the Secretary in such 
        guidance.
          (2) Guidance contents.--In the guidance under 
        paragraph (1), the Secretary may--
                  (A) provide a timetable for establishment by 
                the Secretary of further standards for 
                electronic submission as required by such 
                paragraph; and
                  (B) set forth criteria for waivers of and 
                exemptions from the requirements of this 
                subsection.
          (3) Exception.--This subsection shall not apply to 
        submissions described in section 561.
  (b) Devices.--
          (1) In general.--Beginning after the issuance of 
        final guidance implementing this paragraph, pre-
        submissions and submissions for devices under section 
        510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 
        520(m), or 564 of this Act or section 351 of the Public 
        Health Service Act, and any supplements to such pre-
        submissions or submissions, shall include an electronic 
        copy of such pre-submissions or submissions.
          (2) Guidance contents.--In the guidance under 
        paragraph (1), the Secretary may--
                  (A) provide standards for the electronic copy 
                required under such paragraph; and
                  (B) set forth criteria for waivers of and 
                exemptions from the requirements of this 
                subsection.

           *       *       *       *       *       *       *


                   CHAPTER VIII--IMPORTS AND EXPORTS

                          IMPORTS AND EXPORTS

  Sec. 801. (a) The Secretary of the Treasury shall deliver to 
the Secretary of Health and Human Services, upon his request, 
samples of food, drugs, devices, tobacco products, and 
cosmetics which are being imported or offered for import into 
the United States, giving notice thereof, except as otherwise 
described in the sixth and seventh sentences of this 
subsection, to the owner or consignee, who may appear before 
the Secretary of Health and Human Services and have the right 
to introduce testimony. The Secretary of Health and Human 
Services shall furnish to the Secretary of the Treasury a list 
of establishments registered pursuant to subsection (i) of 
section 510 or section 905(h) and shall request that if any 
drugs, devices, or tobacco products manufactured, prepared, 
propagated, compounded, or processed in an establishment not so 
registered are imported or offered for import into the United 
States, samples of such drugs, devices, or tobacco products be 
delivered to the Secretary of Health and Human Services, with 
notice of such delivery to the owner or consignee, who may 
appear before the Secretary of Health and Human Services and 
have the right to introduce testimony. If it appears from the 
examination of such samples or otherwise that (1) such article 
has been manufactured, processed, or packed under insanitary 
conditions or, in the case of a device, the methods used in, or 
the facilities or controls used for, the manufacture, packing, 
storage, or installation of the device do not conform to the 
requirements of section 520(f), or (2) such article is 
forbidden or restricted in sale in the country in which it was 
produced or from which it was exported, or (3) such article is 
adulterated, misbranded, or in violation of section 505, or 
prohibited from introduction or delivery for introduction into 
interstate commerce under section 301(ll), or (4) the 
recordkeeping requirements under section 204 of the FDA Food 
Safety Modernization Act (other than the requirements under 
subsection (f) of such section) have not been complied with 
regarding such article, or (5) for an article that is a drug, 
the appropriate unique facility identifiers under subsection 
(s) (relating to commercial importers) and section 510(i) 
(relating to foreign establishments), as specified by the 
Secretary, are not provided, then such article shall be refused 
admission, except as provided in subsection (b) of this 
section. With respect to an article of food, if importation of 
such food is subject to, but not compliant with, the 
requirement under subsection (q) that such food be accompanied 
by a certification or other assurance that the food meets 
applicable requirements of this Act, then such article shall be 
refused admission. If such article is subject to a requirement 
under section 760 or 761 and if the Secretary has credible 
evidence or information indicating that the responsible person 
(as defined in such section 760 or 761) has not complied with a 
requirement of such section 760 or 761 with respect to any such 
article, or has not allowed access to records described in such 
section 760 or 761, then such article shall be refused 
admission, except as provided in subsection (b) of this 
section. The Secretary of the Treasury shall cause the 
destruction of any such article refused admission unless such 
article is exported, under regulations prescribed by the 
Secretary of the Treasury, within ninety days of the date of 
notice of such refusal or within such additional time as may be 
permitted pursuant to such regulations, except that the 
Secretary of Health and Human Services, in consultation with 
the Secretary of Homeland Security, may cause the destruction, 
without the opportunity for export, of any drug refused 
admission that has reasonable probability of causing serious 
adverse health consequences or death, as determined by the 
Secretary of Health and Human Services, or that is valued at an 
amount that is $2,000 or less (or such higher amount as the 
Secretary of Homeland Security may set by regulation pursuant 
to section 1498 of title 19, United States Code). The Secretary 
of Health and Human Services shall issue regulations providing 
for notice and an opportunity for a hearing on the destruction 
of a drug under the previous sentence. For a drug with a value 
less than and or equal to $2,000 (or, as described in the sixth 
sentence of this subsection, such higher amount as the 
Secretary of Homeland Security may set by regulation pursuant 
to section 1498 of title 19, United States Code) the 
regulations under the previous sentence shall provide for 
prompt notice and an opportunity for a hearing for the owner or 
consignee before or after the destruction has occurred. For a 
drug with a value greater than $2,000 (or, as described in the 
sixth sentence of this subsection, such higher amount as the 
Secretary of Homeland Security may set by regulation pursuant 
to section 1498 of title 19, United States Code) that has 
reasonable probability of causing serious adverse health 
consequences or death as determined by the Secretary of Health 
and Human Services, the regulations under the seventh sentence 
of this subsection shall provide for notice and an opportunity 
for a hearing to the owner or consignee before the destruction 
occurs. Clause (2) of the third sentence of this paragraph 
shall not be construed to prohibit the admission of narcotic 
drugs the importation of which is permitted under the 
Controlled Substances Import and Export Act.

           *       *       *       *       *       *       *

  (r) Documentation.--
          (1) Submission.--The Secretary may require, in 
        consultation with the Secretary of Homeland Security 
        acting through U.S. Customs and Border Protection as 
        determined appropriate by the Secretary, the submission 
        of documentation or other information for a drug that 
        is imported or offered for import into the United 
        States.
          (2) Refusal of admission.--A drug imported or offered 
        for import into the United States shall be refused 
        admission unless all documentation and information the 
        Secretary requires under this Act, the Public Health 
        Service Act, or both, as appropriate, for such article 
        is submitted.
          (3) Regulations.--
                  (A) Documents and information.--The Secretary 
                shall issue a regulation to specify the 
                documentation or other information that is 
                described in paragraph (1). Such information 
                may include--
                          (i) information demonstrating the 
                        regulatory status of the drug, such as 
                        the new drug application, abbreviated 
                        new drug application, or 
                        investigational new drug or Drug Master 
                        File number;
                          (ii) facility information, such as 
                        proof of registration and the unique 
                        facility identifier; and
                          (iii) indication of compliance with 
                        current good manufacturing practice, 
                        such as satisfactory testing results, 
                        certifications relating to satisfactory 
                        inspections, and compliance with the 
                        country of export regulations.
                  (B) Exemption.--The Secretary may, by 
                regulation, exempt drugs imported for research 
                purposes only and other types of drug imports 
                from some or all of the requirements of this 
                subsection.
          (4) Effective date.--The final rule under paragraph 
        (3)(A) shall take effect not less than 180 days after 
        the Secretary promulgates such final rule.
  (s) Registration of Commercial Importers.--
          (1) Registration.--The Secretary shall require a 
        commercial importer of drugs--
                  (A) to be registered with the Secretary in a 
                form and manner specified by the Secretary; and
                  (B) consistent with the guidance under 
                section 510(q), to submit, at the time of 
                registration, a unique identifier for the 
                principal place of business for which the 
                importer is required to register under this 
                subsection.
          (2) Regulations.--
                  (A) In general.--The Secretary, in 
                consultation with the Secretary of Homeland 
                Security acting through U.S. Customs and Border 
                Protection, shall promulgate regulations to 
                establish good importer practices that specify 
                the measures an importer shall take to ensure 
                imported drugs are in compliance with the 
                requirements of this Act and the Public Health 
                Service Act.
                  (B) Expedited clearance for certain 
                importers.--In promulgating good importer 
                practice regulations under subparagraph (A), 
                the Secretary may, as appropriate, take into 
                account differences among importers and types 
                of imports, and, based on the level of risk 
                posed by the imported drug, provide for 
                expedited clearance for those importers that 
                volunteer to participate in partnership 
                programs for highly compliant companies.
          (3) Discontinuance of registration.--The Secretary 
        shall discontinue the registration of any commercial 
        importer of drugs that fails to comply with the 
        regulations promulgated under this subsection.
          (4) Exemptions.--The Secretary, by notice in the 
        Federal Register, may establish exemptions from the 
        requirements of this subsection.

           *       *       *       *       *       *       *


                   OFFICE OF INTERNATIONAL RELATIONS

  Sec. 803. (a) * * *

           *       *       *       *       *       *       *

  (c)(1) * * *

           *       *       *       *       *       *       *

  (3)(A) The Secretary shall regularly participate in meetings 
with representatives of other foreign governments to discuss 
and reach agreement on methods and approaches to harmonize 
regulatory requirements.
  (B) In carrying out subparagraph (A), the Secretary may 
participate in appropriate fora, including the International 
Medical Device Regulators Forum, and may--
          (i) provide guidance to such fora on strategies, 
        policies, directions, membership, and other activities 
        of a forum as appropriate;
          (ii) to the extent appropriate, solicit, review, and 
        consider comments from industry, academia, health care 
        professionals, and patient groups regarding the 
        activities of such fora; and
          (iii) to the extent appropriate, inform the public of 
        the Secretary's activities within such fora, and share 
        with the public any documentation relating to a forum's 
        strategies, policies, and other activities of such 
        fora.
  [(4) The Secretary shall, not later than 180 days after the 
date of enactment of the Food and Drug Administration 
Modernization Act of 1997, make public a plan that establishes 
a framework for achieving mutual recognition of good 
manufacturing practices inspections.]
  (4) With respect to devices, the Secretary may, when 
appropriate, enter into arrangements with nations regarding 
methods and approaches to harmonizing regulatory requirements 
for activities, including inspections and common international 
labeling symbols

           *       *       *       *       *       *       *

                              ----------                              


             PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007



           *       *       *       *       *       *       *
TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

           *       *       *       *       *       *       *


[SEC. 106. SUNSET DATES.

  [(a) Authorization.--The amendments made by sections 102, 
103, and 104 cease to be effective October 1, 2012.
  [(b) Reporting Requirements.--The amendment made by section 
105 ceases to be effective January 31, 2013.]

           *       *       *       *       *       *       *

                              ----------                              


  SECTION 508 OF THE PRESCRIPTION DRUG USER FEE AMENDMENTS ACT OF 2002

[SEC. 508. EFFECTIVE DATE.

  [The amendments made by this subtitle shall take effect 
October 1, 2002.]
                              ----------                              


 SECTION 107 OF THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 
                                  1997

[SEC. 107. TERMINATION OF EFFECTIVENESS.

  [The amendments made by sections 102 and 103 cease to be 
effective October 1, 2002, and section 104 ceases to be 
effective 120 days after such date.]
                              ----------                              


       SECTION 105 OF THE PRESCRIPTION DRUG USER FEE ACT OF 1992

[SEC. 105. SUNSET.

  [The amendments made by section 103 shall not be in effect 
after October 1, 1997 and section 104 shall not be in effect 
after 120 days after such date.]
                              ----------                              


               MEDICAL DEVICE USER FEE AMENDMENTS OF 2007



           *       *       *       *       *       *       *
TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

           *       *       *       *       *       *       *


Subtitle A--Fees Related to Medical Devices

           *       *       *       *       *       *       *


[SEC. 217. SUNSET CLAUSE.

  [The amendments made by this subtitle cease to be effective 
October 1, 2012, except that section 738A of the Federal Food, 
Drug, and Cosmetic Act (regarding annual performance and 
financial reports) ceases to be effective January 31, 2013.]
                              ----------                              


         MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002



           *       *       *       *       *       *       *
TITLE I--FEES RELATED TO MEDICAL DEVICES

           *       *       *       *       *       *       *


[SEC. 107. SUNSET CLAUSE.

  [The amendments made by this title cease to be effective 
October 1, 2007, except that section 103 with respect to annual 
reports ceases to be effective January 31, 2008.]

           *       *       *       *       *       *       *

                              ----------                              


                       PUBLIC HEALTH SERVICE ACT



           *       *       *       *       *       *       *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *


    Part F--Licensing--Biological Products and Clinical Laboratories

                     Subpart 1--Biological Products

                   REGULATION OF BIOLOGICAL PRODUCTS

  Sec. 351. (a) * * *

           *       *       *       *       *       *       *

  (m) Pediatric Studies.--
          (1) Application of certain provisions.--The 
        provisions of subsections (a), (d), (e), [(f), (i), 
        (j), (k), (l), (p), and (q)] (f), (h), (i), (j), (k), 
        (l), (n), and (p) of section 505A of the Federal Food, 
        Drug, and Cosmetic Act shall apply with respect to the 
        extension of a period under paragraphs (2) and (3) to 
        the same extent and in the same manner as such 
        provisions apply with respect to the extension of a 
        period under subsection (b) or (c) of section 505A of 
        the Federal Food, Drug, and Cosmetic Act.

           *       *       *       *       *       *       *


TITLE IV--NATIONAL RESEARCH INSTITUTES

           *       *       *       *       *       *       *


Part B--General Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *


SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

  (a)  * * *

           *       *       *       *       *       *       *

  (c) Process for Proposed Pediatric Study Requests and 
Labeling Changes.--
          (1) Submission of proposed pediatric study request.--
        The Director of the National Institutes of Health 
        shall, as appropriate, submit proposed pediatric study 
        requests for consideration by the Commissioner of Food 
        and Drugs for pediatric studies of a specific pediatric 
        indication identified under subsection (a). Such a 
        proposed pediatric study request shall be made in a 
        manner equivalent to a written request made under 
        subsection (b) or (c) of section 505A of the Federal 
        Food, Drug, and Cosmetic Act, or section 351(m) of this 
        Act, including with respect to the information provided 
        on the pediatric studies to be conducted pursuant to 
        the request. The Director of the National Institutes of 
        Health may submit a proposed pediatric study request 
        for a drug for which--
                  (A)(i) there is an approved application under 
                section 505(j) of the Federal Food, Drug, and 
                Cosmetic Act or section 351(k) of this Act; or

           *       *       *       *       *       *       *

                  [(B) there is no patent protection or market 
                exclusivity protection for at least one form of 
                the drug under the Federal Food, Drug, and 
                Cosmetic Act; and]
                  (B)(i) there remains no patent listed 
                pursuant to section 505(b)(1) of the Federal 
                Food, Drug, and Cosmetic Act; and
                  (ii) every three-year and five-year period 
                referred to in subsection (c)(3)(E)(ii), 
                (c)(3)(E)(iii), (c)(3)(E(iv), (j)(5)(F)(ii), 
                (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 
                of the Federal Food, Drug and Cosmetic Act, or 
                applicable twelve-year period referred to in 
                section 351(k)(7) of this Act, and any seven-
                year period referred to in section 527 of the 
                Federal Food, Drug, and Cosmetic Act, has ended 
                for at least one form of the drug; and

           *       *       *       *       *       *       *

          (2) Written request to holders of approved 
        applications [for drugs lacking exclusivity].--The 
        Commissioner of Food and Drugs, in consultation with 
        the Director of the National Institutes of Health, may 
        issue a written request based on the proposed pediatric 
        study request for the indication or indications 
        submitted pursuant to paragraph (1) (which shall 
        include a timeframe for negotiations for an agreement) 
        for pediatric studies concerning a drug identified 
        under subsection (a) to all holders of an approved 
        application for the drug [under section 505 of the 
        Federal Food, Drug, and Cosmetic Act]. Such a written 
        request shall be made in a manner equivalent to the 
        manner in which a written request is made under 
        subsection (b) or (c) of section [505A of such Act] 
        505A of the Federal Food, Drug, and Cosmetic Act or 
        section 351(m) of this Act, including with respect to 
        information provided on the pediatric studies to be 
        conducted pursuant to the request and using appropriate 
        formulations for each age group for which the study is 
        requested.

           *       *       *       *       *       *       *

  (e) Authorization of Appropriations.--
          (1) In general.--There are authorized to be 
        appropriated [to carry out this section--
                  [(A) $200,000,000 for fiscal year 2008; and
                  [(B) such sums as are necessary for each of 
                the four succeeding fiscal years.] $25,000,000 
                for each of fiscal years 2013 through 2017.

           *       *       *       *       *       *       *


        PART I--FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH

SEC. 499. ESTABLISHMENT AND DUTIES OF FOUNDATION.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Certain Activities of Foundation.--
          (1) In general.--In carrying out subsection (b), the 
        Foundation may solicit and accept gifts, grants, and 
        other donations, establish accounts, and invest and 
        expend funds in support of the following activities 
        with respect to the purpose described in such 
        subsection:
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) A program to collect funds for pediatric 
                pharmacologic research and studies [for which 
                the Secretary issues a certification in the 
                affirmative under section 505A(n)(1)(A) of the 
                Federal Food, Drug, and Cosmetic Act].

           *       *       *       *       *       *       *

                              ----------                              


                 BEST PHARMACEUTICALS FOR CHILDREN ACT



           *       *       *       *       *       *       *
SEC. 6. OFFICE OF PEDIATRIC THERAPEUTICS.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Staff.--The staff of the Office of Pediatric Therapeutics 
shall coordinate with employees of the Department of Health and 
Human Services who exercise responsibilities relating to 
pediatric therapeutics and shall include--
          (1) one or more additional individuals with expertise 
        concerning ethical issues presented by the conduct of 
        clinical research in the pediatric population; [and]
          (2) one or more additional individuals with expertise 
        in neonatology;
          (3) one or more additional individuals with expertise 
        in pediatric epidemiology; and
          [(2)] (4) one or more additional individuals with 
        expertise in pediatrics as may be necessary to perform 
        the activities described in subsection (b).

           *       *       *       *       *       *       *


SEC. 14. PEDIATRIC ADVISORY COMMITTEE.

  (a)  * * *

           *       *       *       *       *       *       *

  (d) Continuation of Operation of Committee.--Notwithstanding 
section 14 of the Federal Advisory Committee Act, the advisory 
committee shall continue to operate [during the five-year 
period beginning on the date of the enactment of the Best 
Pharmaceuticals for Children Act of 2007] to carry out the 
advisory committee's responsibilities under sections 505A, 
505B, and 520(m) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355a, 355c, and 360j(m)).

           *       *       *       *       *       *       *


SEC. 15. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY 
                    COMMITTEE.

  (a) Clarification of Authorities.--
          (1) In general.--The Pediatric Subcommittee of the 
        Oncologic Drugs Advisory Committee (referred to in this 
        section as the ``Subcommittee''), in carrying out the 
        mission of reviewing and evaluating the data concerning 
        the safety and effectiveness of marketed and 
        investigational human drug products for use in the 
        treatment of pediatric cancers, shall--
                  (A)  * * *

           *       *       *       *       *       *       *

                  (D) provide recommendations to the internal 
                review committee created under [section 
                505B(f)] section 505C of the Federal Food, 
                Drug, and Cosmetic Act regarding the 
                implementation of amendments to sections 505A 
                and 505B of the Federal Food, Drug, and 
                Cosmetic Act with respect to the treatment of 
                pediatric cancers.

           *       *       *       *       *       *       *

          (3) Continuation of operation of subcommittee.--
        Notwithstanding section 14 of the Federal Advisory 
        Committee Act, the Subcommittee shall continue to 
        operate [during the five-year period beginning on the 
        date of the enactment of the Best Pharmaceuticals for 
        Children Act of 2007] to carry out the Subcommittee's 
        responsibilities under this section.

           *       *       *       *       *       *       *

                              ----------                              


SECTION 305 OF THE PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT 
                                OF 2007

SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE 
                    AVAILABILITY.

  (a)  * * *

           *       *       *       *       *       *       *

  (e) Authorization of Appropriations.--There are authorized to 
be appropriated to carry out this section $6,000,000 for each 
of fiscal years [2008 through 2012] 2013 through 2017.
                              ----------                              


                            ORPHAN DRUG ACT



           *       *       *       *       *       *       *
  GRANTS AND CONTRACTS FOR DEVELOPMENT OF DRUGS FOR RARE DISEASES AND 
                               CONDITIONS

  Sec. 5. (a) * * *
  (b) For purposes of subsection (a):
          (1) The term ``qualified testing'' means--
                  (A) human clinical testing--
                          (i) * * *
                          (ii) which occurs [after the date 
                        such drug is designated under section 
                        526 of such Act and] before the date on 
                        which an application with respect to 
                        such drug is submitted under section 
                        505(b) of such Act or under section 351 
                        of the Public Health Service Act; and

           *       *       *       *       *       *       *

  [(c) For grants and contracts under subsection (a), there is 
authorized to be appropriated $30,000,000 for each of fiscal 
years 2008 through 2012.]
  (c) Authorization of Appropriations.--For grants and 
contracts under subsection (a), there is authorized to be 
appropriated $30,000,000 for each of fiscal years 2013 through 
2017.

           *       *       *       *       *       *       *

                              ----------                              


                       CONTROLLED SUBSTANCES ACT

TITLE II--CONTROL AND ENFORCEMENT

           *       *       *       *       *       *       *


Part C--Registration of Manufacturers, Distributors, and Dispensers of 
Controlled Substances; Piperidine Reporting

           *       *       *       *       *       *       *


                QUOTAS APPLICABLE TO CERTAIN SUBSTANCES

  Sec. 306. (a) * * *

           *       *       *       *       *       *       *

  (h)(1) Not later than 30 days after the receipt of a request 
described in paragraph (2), the Attorney General shall--
          (A) complete review of such request; and
          (B)(i) as necessary to address a shortage of a 
        controlled substance, increase the aggregate and 
        individual production quotas under this section 
        applicable to such controlled substance and any 
        ingredient therein to the level requested; or
          (ii) if the Attorney General determines that the 
        level requested is not necessary to address a shortage 
        of a controlled substance, the Attorney General shall 
        provide a written response detailing the basis for the 
        Attorney General's determination.
The Secretary shall make the written response provided under 
subparagraph (B)(ii) available to the public on the Web site of 
the Food and Drug Administration.
  (2) A request is described in this paragraph if--
          (A) the request pertains to a controlled substance on 
        the list of drugs in shortage maintained under section 
        506D of the Federal Food, Drug, and Cosmetic Act;
          (B) the request is submitted by the manufacturer of 
        the controlled substance; and
          (C) the controlled substance is in schedule II.

           *       *       *       *       *       *       *