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[From the U.S. Government Publishing Office]


114th Congress      }                               {     Rept. 114-41
                        HOUSE OF REPRESENTATIVES
 1st Session        }                               {      Part 1
======================================================================
 
    IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT

                                _______
                                

March  16, 2015.--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. 639]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 639) to amend the Controlled Substances Act with 
respect to drug scheduling recommendations by the Secretary of 
Health and Human Services, and with respect to registration of 
manufacturers and distributors seeking to conduct clinical 
testing, having considered the same, report favorably thereon 
with amendments and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     4
Background and Need for Legislation..............................     5
Hearings.........................................................     6
Committee Consideration..........................................     6
Committee Votes..................................................     6
Committee Oversight Findings.....................................     6
Statement of General Performance Goals and Objectives............     6
New Budget Authority, Entitlement Authority, and Tax Expenditures     7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     7
Committee Cost Estimate..........................................     7
Congressional Budget Office Estimate.............................     7
Federal Mandates Statement.......................................     7
Duplication of Federal Programs..................................     7
Disclosure of Directed Rule Makings..............................     7
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     8
Changes in Existing Law Made by the Bill, as Reported............     8
Exchange of Letters with Additional Committees of Referral.......   132

    The amendments are as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Improving Regulatory Transparency for 
New Medical Therapies Act''.

SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED DRUGS.

  (a) Effective Date of Approval.--
          (1) Effective date of drug approval.--Section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended 
        by adding at the end the following:
  ``(x) Date of Approval in the Case of Recommended Controls Under the 
CSA.--
          ``(1) In general.--In the case of an application under 
        subsection (b) with respect to a drug for which the Secretary 
        provides notice to the sponsor that the Secretary intends to 
        recommend controls under the Controlled Substances Act, 
        approval of such application shall not take effect until the 
        interim final rule controlling the drug is issued in accordance 
        with section 201(j) of the Controlled Substances Act.
          ``(2) Date of approval.--For purposes of this section, with 
        respect to an application described in paragraph (1), the term 
        `date of approval' shall mean the later of--
                  ``(A) the date an application under subsection (b) is 
                approved under subsection (c); or
                  ``(B) the date of issuance of the interim final rule 
                controlling the drug.''.
          (2) Effective date of approval of biological products.--
        Section 351 of the Public Health Service Act (42 U.S.C. 262) is 
        amended by adding at the end the following:
  ``(n) Date of Approval in the Case of Recommended Controls Under the 
CSA.--
          ``(1) In general.--In the case of an application under 
        subsection (a) with respect to a biological product for which 
        the Secretary provides notice to the sponsor that the Secretary 
        intends to recommend controls under the Controlled Substances 
        Act, approval of such application shall not take effect until 
        the interim final rule controlling the biological product is 
        issued in accordance with section 201(j) of the Controlled 
        Substances Act.
          ``(2) Date of approval.--For purposes of this section, with 
        respect to an application described in paragraph (1), 
        references to the date of approval of such application, or 
        licensure of the product subject to such application, shall 
        mean the later of--
                  ``(A) the date an application is approved under 
                subsection (a); or
                  ``(B) the date of issuance of the interim final rule 
                controlling the biological product.''.
          (3) Effective date of approval of animal drugs.--
                  (A) In general.--Section 512 of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by 
                adding at the end the following:
  ``(q) Date of Approval in the Case of Recommended Controls Under the 
CSA.--
          ``(1) In general.--In the case of an application under 
        subsection (b) with respect to a drug for which the Secretary 
        provides notice to the sponsor that the Secretary intends to 
        recommend controls under the Controlled Substances Act, 
        approval of such application shall not take effect until the 
        interim final rule controlling the drug is issued in accordance 
        with section 201(j) of the Controlled Substances Act.
          ``(2) Date of approval.--For purposes of this section, with 
        respect to an application described in paragraph (1), the term 
        `date of approval' shall mean the later of--
                  ``(A) the date an application under subsection (b) is 
                approved under subsection (c); or
                  ``(B) the date of issuance of the interim final rule 
                controlling the drug.''.
                  (B) Conditional approval.--Section 571(d) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                360ccc(d)) is amended by adding at the end the 
                following:
          ``(4)(A) In the case of an application under subsection (a) 
        with respect to a drug for which the Secretary provides notice 
        to the sponsor that the Secretary intends to recommend controls 
        under the Controlled Substances Act, conditional approval of 
        such application shall not take effect until the interim final 
        rule controlling the drug is issued in accordance with section 
        201(j) of the Controlled Substances Act.
          ``(B) For purposes of this section, with respect to an 
        application described in subparagraph (A), the term `date of 
        approval' shall mean the later of--
                  ``(i) the date an application under subsection (a) is 
                conditionally approved under subsection (b); or
                  ``(ii) the date of issuance of the interim final rule 
                controlling the drug.''.
                  (C) Indexing of legally marketed unapproved new 
                animal drugs.--Section 572 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360ccc-1) is amended by 
                adding at the end the following:
  ``(k) In the case of a request under subsection (d) to add a drug to 
the index under subsection (a) with respect to a drug for which the 
Secretary provides notice to the person filing the request that the 
Secretary intends to recommend controls under the Controlled Substances 
Act, a determination to grant the request to add such drug to the index 
shall not take effect, and the Secretary shall not list the drug on 
such index, until the interim final rule controlling the drug is issued 
in accordance with section 201(j) of the Controlled Substances Act.''.
          (4) Date of approval for designated new animal drugs.--
        Section 573(c) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360ccc-2(c)) is amended by adding at the end the 
        following:
          ``(3) For purposes of determining the 7-year period of 
        exclusivity under paragraph (1) for a drug for which the 
        Secretary intends to recommend controls under the Controlled 
        Substances Act, the drug shall not be considered approved or 
        conditionally approved until the date that the interim final 
        rule controlling the drug is issued in accordance with section 
        201(j) of the Controlled Substances Act.''.
  (b) Scheduling of Newly Approved Drugs.--Section 201 of the 
Controlled Substances Act (21 U.S.C. 811) is amended by inserting after 
subsection (i) the following:
  ``(j)(1) With respect to a drug referred to in subsection (f), if the 
Secretary of Health and Human Services recommends that the Attorney 
General add the drug to schedule II, III, IV, or V pursuant to 
subsections (a) and (b), the Attorney General shall, not later than 90 
days after the date described in paragraph (2), issue an interim final 
rule controlling the drug in accordance with such subsections and 
section 202(b) using the procedures described in paragraph (3).
  ``(2) The date described in this paragraph shall be the later of--
          ``(A) the date on which the Attorney General receives the 
        scientific and medical evaluation and recommendations from the 
        Secretary of Health and Human Services in accordance with 
        subsection (b); or
          ``(B) the date on which the Attorney General receives 
        notification from the Secretary of Health and Human Services 
        that the Secretary has approved an application under section 
        505(c), 512, 571, or 572 of the Federal Food, Drug, and 
        Cosmetic Act or section 351(a) of the Public Health Service Act 
        with respect to the drug described in paragraph (1).
  ``(3) A rule issued by the Attorney General under paragraph (1) shall 
be in accordance with the procedures provided in subsection (a), except 
that the rule shall become immediately effective as an interim final 
rule without requiring the Attorney General to demonstrate good cause 
therefor. After publication of the interim final rule, the Attorney 
General shall issue a final rule in accordance with the procedures 
provided in subsection (a).''.
  (c) Extension of Patent Term.--Section 156 of title 35, United States 
Code, is amended--
          (1) in subsection (d)(1), in the matter preceding 
        subparagraph (A), by inserting ``, or in the case of a drug 
        product described in subsection (i) within the sixty-day period 
        beginning on the covered date (as defined in subsection (i))'' 
        after ``marketing or use''; and
          (2) by adding at the end the following:
  ``(i)(1) For purposes of this section, if the Secretary of Health and 
Human Services provides notice to the sponsor of an application or 
request for approval, conditional approval, or indexing of a drug 
product for which the Secretary intends to recommend controls under the 
Controlled Substances Act, beginning on the covered date, the drug 
product shall be considered to--
          ``(A) have been approved; and
          ``(B) have permission for commercial marketing or use.
  ``(2) In this subsection, the term `covered date' means the later 
of--
          ``(A) the date an application is approved--
                  ``(i) under section 351(a)(2)(C) of the Public Health 
                Service Act; or
                  ``(ii) under section 505(b) or 512(c) of the Federal 
                Food, Drug, and Cosmetic Act;
          ``(B) the date an application is conditionally approved under 
        section 571(b) of the Federal Food, Drug, and Cosmetic Act;
          ``(C) the date a request for indexing is granted under 
        section 572(d) of the Federal Food, Drug, and Cosmetic Act; or
          ``(D) the date of issuance of the interim final rule 
        controlling the drug under section 201(j) of the Controlled 
        Substances Act.''.

SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.

  Section 303 of the Controlled Substances Act (21 U.S.C. 823) is 
amended by adding at the end the following:
  ``(i)(1) For purposes of registration to manufacture a controlled 
substance under subsection (d) for use only in a clinical trial, the 
Attorney General shall register the applicant, or serve an order to 
show cause upon the applicant in accordance with section 304(c), not 
later than 180 days after the date on which the application is accepted 
for filing.
  ``(2) For purposes of registration to manufacture a controlled 
substance under subsection (a) for use only in a clinical trial, the 
Attorney General shall, in accordance with the regulations issued by 
the Attorney General, issue a notice of application not later than 90 
days after the application is accepted for filing. Not later than 90 
days after the date on which the period for comment pursuant to such 
notice ends, the Attorney General shall register the applicant, or 
serve an order to show cause upon the applicant in accordance with 
section 304(c), unless the Attorney General has granted a hearing on 
the application under section 1008(i) of the Controlled Substances 
Import and Export Act.''.

    Amend the title so as to read:
    A bill to amend the Controlled Substances Act with respect 
to drug scheduling recommendations by the Secretary of Health 
and Human Services, and with respect to registration of 
manufacturers and distributors seeking to conduct clinical 
testing, and for other purposes.

                          Purpose and Summary

    H.R. 639 would amend the Controlled Substances Act (CSA) to 
require the Drug Enforcement Administration (DEA) to issue an 
interim final rule to place a drug that has both not been 
marketed previously in the United States and has abuse 
potential in a CSA schedule within ninety days of when the drug 
was approved by the Food and Drug Administration (FDA) or 
within ninety days of when FDA, through the Assistant Secretary 
of the Department of Health and Human Services (HHS), sends a 
scheduling recommendation to the DEA, whichever comes later. 
Because the Administrative Procedure Act provides that an 
interim final rule is a final agency action, an interim final 
rule scheduling a newly approved FDA product would constitute a 
``final scheduling decision,'' allowing a manufacturer to begin 
marketing the product upon its issuance.
    FDA's recommendations on medical and scientific matters 
would continue to be binding on the DEA, and, if FDA recommends 
that a previously scheduled drug be decontrolled, the DEA would 
no longer control the drug.
    In addition, for purposes of calculating a new drug's 
exclusivity and patent term restoration periods under the 
Hatch-Waxman Act, H.R. 639 would clarify that for a new drug 
that has been recommended to be scheduled by the FDA, the 
effective date of approval would be the later of FDA approval 
of the drug product or the issuance of an interim final rule by 
DEA scheduling the new drug. H.R. 639 also would make similar 
changes to treatment of animal drugs and biologics.
    Finally, under 21 CFR 1301.14, the DEA must accept a 
complete application for filing or, if the application is found 
defective, the agency must notify the applicant within ten days 
of receipt that the application is defective, including a 
statement for the reason for not accepting the application for 
filing. For registration applications related to Schedule III, 
IV, and V drugs that will only be used in clinical trials, H.R. 
639 would require the DEA to register the applicant or serve an 
order to show cause why the applicant shall not be registered 
within 180 days of the filing of the application. For drugs in 
Schedule I or II that will only be used in clinical trials, the 
DEA would be required to issue a notice of application not 
later than ninety days after an application is accepted for 
filing. Ninety days after the end of the comment period 
pursuant to the notice, H.R. 639 would require the DEA to 
register the applicant or serve an order to show cause on why 
the registrant should not be registered.

                  Background and Need for Legislation

    During the new drug approval process, FDA examines whether 
the new drug has abuse potential and, if so, makes a scheduling 
recommendation through the Assistant Secretary of HHS to the 
DEA. In formulating its recommendation, the FDA uses an eight 
part test outlined in section 201(c) of the CSA. Scientific and 
medical matters related to the scheduling recommendation by the 
FDA are binding on the DEA. The DEA uses the same eight part 
test outlined in Section 201(c), but given the binding nature 
of FDA's findings on scientific and medical matters, the DEA's 
primary examination rests in three areas: the actual or 
relative potential for abuse; its history or current patterns 
of abuse; and the scope, duration, and significance of abuse. 
Since 1996, the DEA has not made any scheduling decision for a 
new drug that was contrary to the FDA recommendation.
    When a new drug is approved by the FDA, a company can begin 
marketing the product upon its approval. However, for the 
subset of drugs that the FDA recommends to the DEA be 
scheduled, the FDA requires a company attest that they will not 
market the product until the DEA makes a ``final scheduling 
decision.'' The attestation is found on HHS Form 356(h). There 
is no schedule or deadline for the DEA to make a scheduling 
decision. As such, the FDA can approve a new drug as safe and 
effective, but patients and physicians must wait to access the 
newly approved therapy with no expectation of a reasonable 
timetable in which access will be granted. H.R. 639 would 
continue to allow DEA to conduct its own analysis, but would 
remove much of the uncertainty from the process.
    The Hatch-Waxman Act of 1984 provided a new drug with five 
years of data exclusivity after it has been approved as well as 
eligibility for patent term restoration to compensate for the 
time taken to receive regulatory approval. The exclusivity 
starts and the patent term restoration is calculated based on 
the date of approval for the product. H.R. 639 would clarify 
that for a new drug that has been recommended to be scheduled 
by the FDA, the effective date of approval would be the later 
of the date of FDA approval of the drug product or the date of 
issuance of an interim final rule by DEA scheduling the new 
drug. H.R. 639 also would make similar changes to the treatment 
of animal drugs and biologics. These changes would align the 
exclusivity and patent term restoration periods with other 
products that do not need to be scheduled prior to marketing.
    Inconsistency and lengthy review times at DEA are not 
limited to scheduling decisions for new drugs, but also apply 
to the review of registration applications submitted by 
companies in advance of conducting clinical trials. The DEA 
registration does not distinguish between the manufacturing of 
a controlled substance for marketing and the manufacturing of a 
controlled substance for the use in clinical trials. There is 
no timetable for the DEA to grant approval of registration 
applications, and there is not a transparent process for the 
applicant to determine the reasons for a delay in the 
application. H.R. 639 would bring transparency and 
predictability to the registration process so companies can 
properly plan clinical trial schedules for new therapies.

                                Hearings

    The Committee on Energy and Commerce held a hearing on 
January 27, 2015.\1\ The Subcommittee received testimony from:
---------------------------------------------------------------------------
    \1\H.R. 471 is a reintroduced version of H.R. 4069, the ``Ensuring 
Patient Access and Effective Drug Enforcement of 2013.''
---------------------------------------------------------------------------
      Mr. Ben D. Chlapek, Deputy Chief, Central Jackson 
County Fire, Blue Springs, Missouri;
      Mr. John L. Eadie, Director, Prescription Drug 
Monitoring Program Center of Excellence, Brandeis University;
      Dr. Blaine Enderson, Department of Surgery, 
University of Tennessee Medical Center;
      Dr. Nathan Fountain, Professor of Neurology, 
University of Virginia; and,
      Mr. Linden Barber, Partner and Director, DEA 
Compliance Operations, Quarles & Brady.

                        Committee Consideration

    On February 4, 2015, the Subcommittee on Health met in open 
markup session to consider H.R. 639 and forwarded the bill to 
the full Committee, as amended, by a voice vote. On February 11 
and 12, 2015, the full Committee met in open markup session to 
consider H.R. 639 and ordered the bill favorably reported to 
the House, as amended, by a voice vote.

                            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. 
There were no record votes taken in connection with ordering 
H.R. 639. A motion by Mr. Upton to order H.R. 639 reported to 
the House, as amended, was agreed to by a voice vote.

                      Committee Oversight Findings

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

         Statement of General Performance Goals and Objectives

    The objective of this legislation is to facilitate patient 
access to new therapies in an efficient and transparent manner, 
while ensuring appropriate controls are in place under the CSA.

   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. 
639 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    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. 639 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. At the 
time this report was filed, the estimate was not available.

                  Congressional Budget Office Estimate

    At the time this report was filed, the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 1974 
was not available.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 639 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 639 specifically 
directs to be completed zero specific rule makings within the 
meaning of 5 U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  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


Section 1: Short title

    Section 1 provides that the bill may be cited as the 
``Improving Regulatory Transparency for New Medical Therapies 
Act.''

Section 2: Scheduling of substances includes in new FDA-approved drugs

    Paragraph (a) amends section 505 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA) to state that, for new drugs the 
Assistant Secretary of Department of Health and Human Services 
(HHS) recommends to be scheduled by the Drug Enforcement 
Administration (DEA) under the Controlled Substances Act (CSA), 
the effective date of approval of the drug shall be the later 
of the date the application is approved by the Food and Drug 
Administration (FDA) or the date of the issuance of an Interim 
Final Rule (IFR) by the DEA controlling the drug. This would 
align the effective date of approval of the application to when 
the drug could be marketed.
    Paragraph (a) makes similar changes related to biologic 
license application under section 351 of the Public Health 
Service Act, animal drugs under section 512 of the FFDCA, minor 
use/minor species animal drugs under section 571 of the FFDCA, 
indexed animal drugs under section 572 of the FFDCA. For each 
of these sections, the effective date of approval of these 
products would be the later of when the product is approved by 
FDA or the issuance of an Interim Final Rule scheduling the 
drug.
    Paragraph (b) of section 2 amends the CSA to require the 
DEA to issue an IFR scheduling a drug the FDA has recommended 
to be scheduled not later than 90 days of the later of: 1) the 
date on which DEA receives FDA recommendation or 2) the date on 
which the FDA approves new drug application or biologic drug 
application.
    Paragraph (c) of section 2 amends 35 U.S.C. 156 to align a 
company's patent term restoration to when the company can begin 
marketing the product.

Section 3: Enhancing new drug development

    Section 3 amends the CSA to provide more predictability for 
when companies will receive a registration to manufacture a 
drug that will be used in a clinical trial. For Schedule III, 
IV, or V drugs, the DEA will be required to register an 
applicant or serve an order to show cause on why they cannot 
register an applicant within 180 days of the application being 
accepted for filing. For Schedule I or II drugs, the DEA will 
be required to issue a notice of application within 90 days 
after the application is accepted for filing. Not later than 90 
days after the comment period is closed, the DEA will be 
required to register the applicant or serve an order to show 
cause on why the applicant shall not be registered.

         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 V--DRUGS AND DEVICES


Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *



                               new drugs

  Sec. 505. (a) No person shall introduce or deliver for 
introduction into interstate commerce any new drug, unless an 
approval of an application filed pursuant to subsection (b) or 
(j) is effective with respect to such drug.
  (b)(1) Any person may file with the Secretary an application 
with respect to any drug subject to the provisions of 
subsection (a). Such persons shall submit to the Secretary as a 
part of the application (A) full reports of investigations 
which have been made to show whether or not such drug is safe 
for use and whether such drug is effective in use; (B) a full 
list of the articles used as components of such drug; (C) a 
full statement of the composition of such drug; (D) a full 
description of the methods used in, and the facilities and 
controls used for, the manufacture, processing, and packing of 
such drug; (E) such samples of such drug and of the articles 
used as components thereof as the Secretary may require; (F) 
specimens of the labeling proposed to be used for such drug, 
and (G) any assessments required under section 505B. The 
applicant shall file with the application the patent number and 
the expiration date of any patent which claims the drug for 
which the applicant submitted the application or which claims a 
method of using such drug and with respect to which a claim of 
patent infringement could reasonably be asserted if a person 
not licensed by the owner engaged in the manufacture use, or 
sale of the drug. If a application is filed under this 
subsection for a drug and a patent which claims such drug or a 
method of using such drug is issued after the filing date but 
before approval of the application, the applicant shall amend 
the application to include the information required by the 
preceding sentence. Upon approval of the application, the 
Secretary shall publish information submitted under the two 
preceding sentences. The Secretary shall, in consultation with 
the Director of the National Institutes of Health and with 
representatives of the drug manufacturing industry, review and 
develop guidance, as appropriate, on the inclusion of women and 
minorities in clinical trials required by clause (A).
  (2) An application submitted under paragraph (1) for a drug 
for which the investigations described in clause (A) of such 
paragraph and relied upon by the applicant for approval of the 
application were not conducted by or for the applicant and for 
which the applicant has not obtained a right of reference or 
use from the person by or for whom the investigations were 
conducted shall also include--
          (A) a certification, in the opinion of the applicant 
        and to the best of his knowledge, with respect to each 
        patent which claims the drug for which such 
        investigations were conducted or which claims a use for 
        such drug for which the applicant is seeking approval 
        under this subsection and for which information is 
        required to be filed under paragraph (1) or subsection 
        (c)--
                  (i) that such patent information has not been 
                filed,
                  (ii) that such patent has expired,
                  (iii) of the date on which such patent will 
                expire, or
                  (iv) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new drug for which the application is 
                submitted; and
          (B) if with respect to the drug for which 
        investigations described in paragraph (1)(A) were 
        conducted information was filed under paragraph (1) or 
        subsection (c) for a method of use patent which does 
        not claim a use for which the applicant is seeking 
        approval under this subsection, a statement that the 
        method of use patent does not claim such a use.
  (3) Notice of opinion that patent is invalid or will not be 
infringed.--
          (A) Agreement to give notice.--An applicant that 
        makes a certification described in paragraph (2)(A)(iv) 
        shall include in the application a statement that the 
        applicant will give notice as required by this 
        paragraph.
          (B) Timing of notice.--An applicant that makes a 
        certification described in paragraph (2)(A)(iv) shall 
        give notice as required under this paragraph--
                  (i) if the certification is in the 
                application, not later than 20 days after the 
                date of the postmark on the notice with which 
                the Secretary informs the applicant that the 
                application has been filed; or
                  (ii) if the certification is in an amendment 
                or supplement to the application, at the time 
                at which the applicant submits the amendment or 
                supplement, regardless of whether the applicant 
                has already given notice with respect to 
                another such certification contained in the 
                application or in an amendment or supplement to 
                the application.
          (C) Recipients of notice.--An applicant required 
        under this paragraph to give notice shall give notice 
        to--
                  (i) each owner of the patent that is the 
                subject of the certification (or a 
                representative of the owner designated to 
                receive such a notice); and
                  (ii) the holder of the approved application 
                under this subsection for the drug that is 
                claimed by the patent or a use of which is 
                claimed by the patent (or a representative of 
                the holder designated to receive such a 
                notice).
          (D) Contents of notice.--A notice required under this 
        paragraph shall--
                  (i) state that an application that contains 
                data from bioavailability or bioequivalence 
                studies has been submitted under this 
                subsection for the drug with respect to which 
                the certification is made to obtain approval to 
                engage in the commercial manufacture, use, or 
                sale of the drug before the expiration of the 
                patent referred to in the certification; and
                  (ii) include a detailed statement of the 
                factual and legal basis of the opinion of the 
                applicant that the patent is invalid or will 
                not be infringed.
  (4)(A) An applicant may not amend or supplement an 
application referred to in paragraph (2) to seek approval of a 
drug that is a different drug than the drug identified in the 
application as submitted to the Secretary.
  (B) With respect to the drug for which such an application is 
submitted, nothing in this subsection or subsection (c)(3) 
prohibits an applicant from amending or supplementing the 
application to seek approval of a different strength.
  (5)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1) or under 
section 351 of the Public Health Service Act, which shall 
relate to promptness in conducting the review, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards, and which 
shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection or section 351 of the Public Health Service Act 
if the sponsor or applicant makes a reasonable written request 
for a meeting for the purpose of reaching agreement on the 
design and size--
          (i)(I) of clinical trials intended to form the 
        primary basis of an effectiveness claim; or
          (II) in the case where human efficacy studies are not 
        ethical or feasible, of animal and any associated 
        clinical trials which, in combination, are intended to 
        form the primary basis of an effectiveness claim; or
          (ii) with respect to an application for approval of a 
        biological product under section 351(k) of the Public 
        Health Service Act, of any necessary clinical study or 
        studies.
The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of the 
clinical trials. Minutes of any such meeting shall be prepared 
by the Secretary and made available to the sponsor or applicant 
upon request.
  (C) Any agreement regarding the parameters of the design and 
size of clinical trials of a new drug under this paragraph that 
is reached between the Secretary and a sponsor or applicant 
shall be reduced to writing and made part of the administrative 
record by the Secretary. Such agreement shall not be changed 
after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing 
        division, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug 
        has been identified after the testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director will document the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance division personnel unless such field or 
compliance division personnel demonstrate to the reviewing 
division why such decision should be modified.
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (G) For purposes of this paragraph, the reviewing division is 
the division responsible for the review of an application for 
approval of a drug under this subsection or section 351 of the 
Public Health Service Act (including all scientific and medical 
matters, chemistry, manufacturing, and controls).
          (6) An application submitted under this subsection 
        shall be accompanied by the certification required 
        under section 402(j)(5)(B) of the Public Health Service 
        Act. Such certification shall not be considered an 
        element of such application.
  (c)(1) Within one hundred and eighty days after the filing of 
an application under subsection (b), or such additional period 
as may be agreed upon by the Secretary and the applicant, the 
Secretary shall either--
          (A) approve the application if he then finds that 
        none of the grounds for denying approval specified in 
        subsection (d) applies, or
          (B) give the applicant notice of an opportunity for a 
        hearing before the Secretary under subsection (d) on 
        the question whether such application is approvable. If 
        the applicant elects to accept the opportunity for 
        hearing by written request within thirty days after 
        such notice, such hearing shall commence not more than 
        ninety days after the expiration of such thirty days 
        unless the Secretary and the applicant otherwise agree. 
        Any such hearing shall thereafter be conducted on an 
        expedited basis and the Secretary's order thereon shall 
        be issued within ninety days after the date fixed by 
        the Secretary for filing final briefs.
  (2) If the patent information described in subsection (b) 
could not be filed with the submission of an application under 
subsection (b) because the application was filed before the 
patent information was required under subsection (b) or a 
patent was issued after the application was approved under such 
subsection, the holder of an approved application shall file 
with the Secretary, the patent number and the expiration date 
of any patent which claims the drug for which the application 
was submitted or which claims a method of using such drug and 
with respect to which a claim of patent infringement could 
reasonably be asserted if a person not licensed by the owner 
engaged in the manufacture, use, or sale of the drug. If the 
holder of an approved application could not file patent 
information under subsection (b) because it was not required at 
the time the application was approved, the holder shall file 
such information under this subsection not later than thirty 
days after the date of the enactment of this sentence, and if 
the holder of an approved application could not file patent 
information under subsection (b) because no patent had been 
issued when an application was filed or approved, the holder 
shall file such information under this subsection not later 
than thirty days after after the date the patent involved is 
issued. Upon the submission of patent information under this 
subsection, the Secretary shall publish it.
  (3) The approval of an application filed under subsection (b) 
which contains a certification required by paragraph (2) of 
such subsection shall be made effective on the last applicable 
date determined by applying the following to each certification 
made under subsection (b)(2)(A):
          (A) If the applicant only made a certification 
        described in clause (i) or (ii) of subsection (b)(2)(A) 
        or in both such clauses, the approval may be made 
        effective immediately.
          (B) If the applicant made a certification described 
        in clause (iii) of subsection (b)(2)(A), the approval 
        may be made effective on the date certified under 
        clause (iii).
          (C) If the applicant made a certification described 
        in clause (iv) of subsection (b)(2)(A), the approval 
        shall be made effective immediately unless, before the 
        expiration of 45 days after the date on which the 
        notice described in subsection (b)(3) is received, an 
        action is brought for infringement of the patent that 
        is the subject of the certification and for which 
        information was submitted to the Secretary under 
        paragraph (2) or subsection (b)(1) before the date on 
        which the application (excluding an amendment or 
        supplement to the application) was submitted. If such 
        an action is brought before the expiration of such 
        days, the approval may be made effective upon the 
        expiration of the thirty-month period beginning on the 
        date of the receipt of the notice provided under 
        subsection (b)(3) or such shorter or longer period as 
        the court may order because either party to the action 
        failed to reasonably cooperate in expediting the 
        action, except that--
                  (i) if before the expiration of such period 
                the district court decides that the patent is 
                invalid or not infringed (including any 
                substantive determination that there is no 
                cause of action for patent infringement or 
                invalidity), the approval shall be made 
                effective on--
                          (I) the date on which the court 
                        enters judgment reflecting the 
                        decision; or
                          (II) the date of a settlement order 
                        or consent decree signed and entered by 
                        the court stating that the patent that 
                        is the subject of the certification is 
                        invalid or not infringed;
                  (ii) if before the expiration of such period 
                the district court decides that the patent has 
                been infringed--
                          (I) if the judgment of the district 
                        court is appealed, the approval shall 
                        be made effective on--
                                  (aa) the date on which the 
                                court of appeals decides that 
                                the patent is invalid or not 
                                infringed (including any 
                                substantive determination that 
                                there is no cause of action for 
                                patent infringement or 
                                invalidity); or
                                  (bb) the date of a settlement 
                                order or consent decree signed 
                                and entered by the court of 
                                appeals stating that the patent 
                                that is the subject of the 
                                certification is invalid or not 
                                infringed; or
                          (II) if the judgment of the district 
                        court is not appealed or is affirmed, 
                        the approval shall be made effective on 
                        the date specified by the district 
                        court in a court order under section 
                        271(e)(4)(A) of title 35, United States 
                        Code;
                  (iii) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent is invalid or not 
                infringed, the approval shall be made effective 
                as provided in clause (i); or
                  (iv) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent has been infringed, 
                the approval shall be made effective as 
                provided in clause (ii).
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action.
          (D) Civil action to obtain patent certainty.--
                  (i) Declaratory judgment absent infringement 
                action.--
                          (I) In general.--No action may be 
                        brought under section 2201 of title 28, 
                        United States Code, by an applicant 
                        referred to in subsection (b)(2) for a 
                        declaratory judgment with respect to a 
                        patent which is the subject of the 
                        certification referred to in 
                        subparagraph (C) unless--
                                  (aa) the 45-day period 
                                referred to in such 
                                subparagraph has expired;
                                  (bb) neither the owner of 
                                such patent nor the holder of 
                                the approved application under 
                                subsection (b) for the drug 
                                that is claimed by the patent 
                                or a use of which is claimed by 
                                the patent brought a civil 
                                action against the applicant 
                                for infringement of the patent 
                                before the expiration of such 
                                period; and
                                  (cc) in any case in which the 
                                notice provided under paragraph 
                                (2)(B) relates to 
                                noninfringement, the notice was 
                                accompanied by a document 
                                described in subclause (III).
                          (II) Filing of civil action.--If the 
                        conditions described in items (aa), 
                        (bb), and as applicable, (cc) of 
                        subclause (I) have been met, the 
                        applicant referred to in such subclause 
                        may, in accordance with section 2201 of 
                        title 28, United States Code, bring a 
                        civil action under such section against 
                        the owner or holder referred to in such 
                        subclause (but not against any owner or 
                        holder that has brought such a civil 
                        action against the applicant, unless 
                        that civil action was dismissed without 
                        prejudice) for a declaratory judgment 
                        that the patent is invalid or will not 
                        be infringed by the drug for which the 
                        applicant seeks approval, except that 
                        such civil action may be brought for a 
                        declaratory judgment that the patent 
                        will not be infringed only in a case in 
                        which the condition described in 
                        subclause (I)(cc) is applicable. A 
                        civil action referred to in this 
                        subclause shall be brought in the 
                        judicial district where the defendant 
                        has its principal place of business or 
                        a regular and established place of 
                        business.
                          (III) Offer of confidential access to 
                        application.--For purposes of subclause 
                        (I)(cc), the document described in this 
                        subclause is a document providing an 
                        offer of confidential access to the 
                        application that is in the custody of 
                        the applicant referred to in subsection 
                        (b)(2) for the purpose of determining 
                        whether an action referred to in 
                        subparagraph (C) should be brought. The 
                        document providing the offer of 
                        confidential access shall contain such 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, as would 
                        apply had a protective order been 
                        entered for the purpose of protecting 
                        trade secrets and other confidential 
                        business information. A request for 
                        access to an application under an offer 
                        of confidential access shall be 
                        considered acceptance of the offer of 
                        confidential access with the 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, contained 
                        in the offer of confidential access, 
                        and those restrictions and other terms 
                        of the offer of confidential access 
                        shall be considered terms of an 
                        enforceable contract. Any person 
                        provided an offer of confidential 
                        access shall review the application for 
                        the sole and limited purpose of 
                        evaluating possible infringement of the 
                        patent that is the subject of the 
                        certification under subsection 
                        (b)(2)(A)(iv) and for no other purpose, 
                        and may not disclose information of no 
                        relevance to any issue of patent 
                        infringement to any person other than a 
                        person provided an offer of 
                        confidential access. Further, the 
                        application may be redacted by the 
                        applicant to remove any information of 
                        no relevance to any issue of patent 
                        infringement.
                  (ii) Counterclaim to infringement action.--
                          (I) In general.--If an owner of the 
                        patent or the holder of the approved 
                        application under subsection (b) for 
                        the drug that is claimed by the patent 
                        or a use of which is claimed by the 
                        patent brings a patent infringement 
                        action against the applicant, the 
                        applicant may assert a counterclaim 
                        seeking an order requiring the holder 
                        to correct or delete the patent 
                        information submitted by the holder 
                        under subsection (b) or this subsection 
                        on the ground that the patent does not 
                        claim either--
                                  (aa) the drug for which the 
                                application was approved; or
                                  (bb) an approved method of 
                                using the drug.
                          (II) No independent cause of 
                        action.--Subclause (I) does not 
                        authorize the assertion of a claim 
                        described in subclause (I) in any civil 
                        action or proceeding other than a 
                        counterclaim described in subclause 
                        (I).
                  (iii) No damages.--An applicant shall not be 
                entitled to damages in a civil action under 
                clause (i) or a counterclaim under clause (ii).
          (E)(i) If an application (other than an abbreviated 
        new drug application) submitted under subsection (b) 
        for a drug, no active ingredient (including any ester 
        or salt of the active ingredient) of which has been 
        approved in any other application under subsection (b), 
        was approved during the period beginning January 1, 
        1982, and ending on the date of the enactment of this 
        subsection, the Secretary may not make the approval of 
        another application for a drug for which the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and for which the applicant has not obtained 
        a right of reference or use from the person by or for 
        whom the investigations were conducted effective before 
        the expiration of ten years from the date of the 
        approval of the application previously approved under 
        subsection (b).
          (ii) If an application submitted under subsection (b) 
        for a drug, no active ingredient (including any ester 
        or salt of the active ingredient) of which has been 
        approved in any other application under subsection (b), 
        is approved after the date of the enactment of this 
        clause, no application which refers to the drug for 
        which the subsection (b) application was submitted and 
        for which the investigations described in clause (A) of 
        subsection (b)(1) and relied upon by the applicant for 
        approval of the application were not conducted by or 
        for the applicant and for which the applicant has not 
        obtained a right of reference or use from the person by 
        or for whom the investigations were conducted may be 
        submitted under subsection (b) before the expiration of 
        five years from the date of the approval of the 
        application under subsection (b), except that such an 
        application may be submitted under subsection (b) after 
        the expiration of four years from the date of the 
        approval of the subsection (b) application if it 
        contains a certification of patent invalidity or 
        noninfringement described in clause (iv) of subsection 
        (b)(2)(A). The approval of such an application shall be 
        made effective in accordance with this paragraph except 
        that, if an action for patent infringement is commenced 
        during the one-year period beginning forty-eight months 
        after the date of the approval of the subsection (b) 
        application, the thirty-month period referred to in 
        subparagraph (C) shall be extended by such amount of 
        time (if any) which is required for seven and one-half 
        years to have elapsed from the date of approval of the 
        subsection (b) application.
          (iii) If an application submitted under subsection 
        (b) for a drug, which includes an active ingredient 
        (including any ester or salt of the active ingredient) 
        that has been approved in another application approved 
        under subsection (b), is approved after the date of the 
        enactment of this clause and if such application 
        contains reports of new clinical investigations (other 
        than bioavailability studies) essential to the approval 
        of the application and conducted or sponsored by the 
        applicant, the Secretary may not make the approval of 
        an application submitted under subsection (b) for the 
        conditions of approval of such drug in the approved 
        subsection (b) application effective before the 
        expiration of three years from the date of the approval 
        of the application under subsection (b) if the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and if the applicant has not obtained a right 
        of reference or use from the person by or for whom the 
        investigations were conducted.
          (iv) If a supplement to an application approved under 
        subsection (b) is approved after the date of enactment 
        of this clause and the supplement contains reports of 
        new clinical investigations (other than bioavailabilty 
        studies) essential to the approval of the supplement 
        and conducted or sponsored by the person submitting the 
        supplement, the Secretary may not make the approval of 
        an application submitted under subsection (b) for a 
        change approved in the supplement effective before the 
        expiration of three years from the date of the approval 
        of the supplement under subsection (b) if the 
        investigations described in clause (A) of subsection 
        (b)(1) and relied upon by the applicant for approval of 
        the application were not conducted by or for the 
        applicant and if the applicant has not obtained a right 
        of reference or use from the person by or for whom the 
        investigations were conducted.
          (v) If an application (or supplement to an 
        application) submitted under subsection (b) for a drug, 
        which includes an active ingredient (including any 
        ester or salt of the active ingredient) that has been 
        approved in another application under subsection (b), 
        was approved during the period beginning January 1, 
        1982, and ending on the date of the enactment of this 
        clause, the Secretary may not make the approval of an 
        application submitted under this subsection and for 
        which the investigations described in clause (A) of 
        subsection (b)(1) and relied upon by the applicant for 
        approval of the application were not conducted by or 
        for the applicant and for which the applicant has not 
        obtained a right of reference or use from the person by 
        or for whom the investigations were conducted and which 
        refers to the drug for which the subsection (b) 
        application was submitted effective before the 
        expiration of two years from the date of enactment of 
        this clause.
  (4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
drug and to obtain approval for the drug prior to manufacture 
of the drug in a larger facility, unless the Secretary makes a 
determination that a full scale production facility is 
necessary to ensure the safety or effectiveness of the drug.
  (d) If the Secretary finds, after due notice to the applicant 
in accordance with subsection (c) and giving him an opportunity 
for a hearing, in accordance with said subsection, that (1) the 
investigations, reports of which are required to be submitted 
to the Secretary pursuant to subsection (b), do not include 
adequate tests by all methods reasonably applicable to show 
whether or not such drug is safe for use under the conditions 
prescribed, recommended, or suggested in the proposed labeling 
thereof; (2) the results of such tests show that such drug is 
unsafe for use under such conditions or do not show that such 
drug is safe for use under such conditions; (3) the methods 
used in, and the facilities and controls used for, the 
manufacture, processing, and packing of such drug are 
inadequate to preserve its identity, strength, quality, and 
purity; (4) upon the basis of the information submitted to him 
as part of the application, or upon the basis of any other 
information before him with respect to such drug, he has 
insufficient information to determine whether such drug is safe 
for use under such conditions; or (5) evaluated on the basis of 
the information submitted to him as part of the application and 
any other information before him with respect to such drug, 
there is a lack of substantial evidence that the drug will have 
the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
proposed labeling thereof; or (6) the application failed to 
contain the patent information prescribed by subsection (b); or 
(7) based on a fair evaluation of all material facts, such 
labeling is false or misleading in any particular; he shall 
issue an order refusing to approve the application. If, after 
such notice and opportunity for hearing, the Secretary finds 
that clauses (1) through (6) do not apply, he shall issue an 
order approving the application. As used in this subsection and 
subsection (e), the term ``substantial evidence'' means 
evidence consisting of adequate and well-controlled 
investigations, including clinical investigations, by experts 
qualified by scientific training and experience to evaluate the 
effectiveness of the drug involved, on the basis of which it 
could fairly and responsibly be concluded by such experts that 
the drug will have the effect it purports or is represented to 
have under the conditions of use prescribed, recommended, or 
suggested in the labeling or proposed labeling thereof. If the 
Secretary determines, based on relevant science, that data from 
one adequate and well-controlled clinical investigation and 
confirmatory evidence (obtained prior to or after such 
investigation) are sufficient to establish effectiveness, the 
Secretary may consider such data and evidence to constitute 
substantial evidence for purposes of the preceding sentence. 
The Secretary shall implement a structured risk-benefit 
assessment framework in the new drug approval process to 
facilitate the balanced consideration of benefits and risks, a 
consistent and systematic approach to the discussion and 
regulatory decisionmaking, and the communication of the 
benefits and risks of new drugs. Nothing in the preceding 
sentence shall alter the criteria for evaluating an application 
for premarket approval of a drug.
  (e) The Secretary shall, after due notice and opportunity for 
hearing to the applicant, withdraw approval of an application 
with respect to any drug under this section if the Secretary 
finds (1) that clinical or other experience, tests, or other 
scientific data show that such drug is unsafe for use under the 
conditions of use upon the basis of which the application was 
approved; (2) that new evidence of clinical experience, not 
contained in such application or not available to the Secretary 
until after such application was approved, or tests by new 
methods, or tests by methods not deemed reasonably applicable 
when such application was approved, evaluated together with the 
evidence available to the Secretary when the application was 
approved, shows that such drug is not shown to be safe for use 
under the conditions of use upon the basis of which the 
application was approved; or (3) on the basis of new 
information before him with respect to such drug, evaluated 
together with the evidence available to him when the 
application was approved, that there is a lack of substantial 
evidence that the drug will have the effect it purports or is 
represented to have under the conditions of use prescribed, 
recommended, or suggested in the labeling thereof; or (4) the 
patent information prescribed by subsection (c) was not filed 
within thirty days after the receipt of written notice from the 
Secretary specifying the failure to file such information; or 
(5) that the application contains any untrue statement of a 
material fact: Provided, That if the Secretary (or in his 
absence the officer acting as Secretary) finds that there is an 
imminent hazard to the public health, he may suspend the 
approval of such application immediately, and give the 
applicant prompt notice of his action and afford the applicant 
the opportunity for an expedited hearing under this subsection; 
but the authority conferred by this proviso to suspend the 
approval of an application shall not be delegated. The 
Secretary may also, after due notice and opportunity for 
hearing to the applicant, withdraw the approval of an 
application submitted under subsection (b) or (j) with respect 
to any drug under this section if the Secretary finds (1) that 
the applicant has failed to establish a system for maintaining 
required records, or has repeatedly or deliberately failed to 
maintain such records or to make required reports, in 
accordance with a regulation or order under subsection (k) or 
to comply with the notice requirements of section 510(k)(2), or 
the applicant has refused to permit access to, or copying or 
verification of, such records as required by paragraph (2) of 
such subsection; or (2) that on the basis of new information 
before him, evaluated together with the evidence before him 
when the application was approved, the methods used in, or the 
facilities and controls used for, the manufacture, processing, 
and packing of such drug are inadequate to assure and preserve 
its identity, strength, quality, and purity and were not made 
adequate within a reasonable time after receipt of written 
notice from the Secretary specifying the matter complained of; 
or (3) that on the basis of new information before him, 
evaluated together with the evidence before him when the 
application was approved, the labeling of such drug, based on a 
fair evaluation of all material facts, is false or misleading 
in any particular and was not corrected within a reasonable 
time after receipt of written notice from the Secretary 
specifying the matter complained of. Any order under this 
subsection shall state the findings upon which it is based. The 
Secretary may withdraw the approval of an application submitted 
under this section, or suspend the approval of such an 
application, as provided under this subsection, without first 
ordering the applicant to submit an assessment of the approved 
risk evaluation and mitigation strategy for the drug under 
section 505-1(g)(2)(D).
  (f) Whenever the Secretary finds that the facts so require, 
he shall revoke any previous order under subsection (d) or (e) 
refusing, withdrawing, or suspending approval of an application 
and shall approve such application or reinstate such approval, 
as may be appropriate.
  (g) Orders of the Secretary issued under this section shall 
be served (1) in person by any officer or employee of the 
Department designated by the Secretary or (2) by mailing the 
order by registered mail or by certified mail addressed to the 
applicant or respondent at his last-known address in the 
records of the Secretary.
  (h) An appeal may be taken by the applicant from an order of 
the Secretary refusing or withdrawing approval of an 
application under this section. Such appeal shall be taken by 
filing in the United States court of appeals for the circuit 
wherein such applicant resides or has his principal place of 
business, or in the United States Court of Appeals for the 
District of Columbia Circuit, within sixty days after the entry 
of such order, a written petition praying that the order of the 
Secretary be set aside. A copy of such petition shall be 
forthwith transmitted by the clerk of the court to the 
Secretary, or any officer designated by him for that purpose, 
and thereupon the Secretary shall certify and file in the court 
the record upon which the order complained of was entered, as 
provided in section 2112 of title 28, United States Code. Upon 
the filing of such petition such court shall have exclusive 
jurisdiction to affirm or set aside such order, except that 
until the filing of the record the Secretary may modify or set 
aside his order. No objection to the order of the Secretary 
shall be considered by the court unless such objection shall 
have been urged before the Secretary or unless there were 
reasonable grounds for failure so to do. The finding of the 
Secretary as to the facts, if supported by substantial 
evidence, shall be conclusive. If any person shall apply to the 
court for leave to adduce additional evidence, and shall show 
to the satisfaction of the court that such additional evidence 
is material and that there were reasonable grounds for failure 
to adduce such evidence in the proceeding before the Secretary, 
the court may order such additional evidence to be taken before 
the Secretary and to be adduced upon the hearing in such manner 
and upon such terms and conditions as to the court may seem 
proper. The Secretary may modify his findings as to the facts 
by reason of the additional evidence so taken, and he shall 
file with the court such modified findings which, if supported 
by substantial evidence, shall be conclusive, and his 
recommendation, if any, for the setting aside of the original 
order. The judgment of the court affirming or setting aside any 
such order of the Secretary shall be final, subject to review 
by the Supreme Court of the United States upon certiorari or 
certification as provided in section 1254 of title 28 of the 
United States Code. The commencement of proceedings under this 
subsection shall not, unless specifically ordered by the court 
to the contrary, operate as a stay of the Secretary's order.
  (i)(1) The Secretary shall promulgate regulations for 
exempting from the operation of the foregoing subsections of 
this section drugs intended solely for investigational use by 
experts qualified by scientific training and experience to 
investigate the safety and effectiveness of drugs. Such 
regulations may, within the discretion of the Secretary, among 
other conditions relating to the protection of the public 
health, provide for conditioning such exemption upon--
          (A) the submission to the Secretary, before any 
        clinical testing of a new drug is undertaken, of 
        reports, by the manufacturer or the sponsor of the 
        investigation of such drug, or preclinical tests 
        (including tests on animals) of such drug adequate to 
        justify the proposed clinical testing;
          (B) the manufacturer or the sponsor of the 
        investigation of a new drug proposed to be distributed 
        to investigators for clinical testing obtaining a 
        signed agreement from each of such investigators that 
        patients to whom the drug is administered will be under 
        his personal supervision, or under the supervision of 
        investigators responsible to him, and that he will not 
        supply such drug to any other investigator, or to 
        clinics, for administration to human beings;
          (C) the establishment and maintenance of such 
        records, and the making of such reports to the 
        Secretary, by the manufacturer or the sponsor of the 
        investigation of such drug, of data (including but not 
        limited to analytical reports by investigators) 
        obtained as the result of such investigational use of 
        such drug, as the Secretary finds will enable him to 
        evaluate the safety and effectiveness of such drug in 
        the event of the filing of an application pursuant to 
        subsection (b); and
                  (D) the submission to the Secretary by the 
                manufacturer or the sponsor of the 
                investigation of a new drug of a statement of 
                intent regarding whether the manufacturer or 
                sponsor has plans for assessing pediatric 
                safety and efficacy.
  (2) Subject to paragraph (3), a clinical investigation of a 
new drug may begin 30 days after the Secretary has received 
from the manufacturer or sponsor of the investigation a 
submission containing such information about the drug and the 
clinical investigation, including--
          (A) information on design of the investigation and 
        adequate reports of basic information, certified by the 
        applicant to be accurate reports, necessary to assess 
        the safety of the drug for use in clinical 
        investigation; and
          (B) adequate information on the chemistry and 
        manufacturing of the drug, controls available for the 
        drug, and primary data tabulations from animal or human 
        studies.
  (3)(A) At any time, the Secretary may prohibit the sponsor of 
an investigation from conducting the investigation (referred to 
in this paragraph as a ``clinical hold'') if the Secretary 
makes a determination described in subparagraph (B). The 
Secretary shall specify the basis for the clinical hold, 
including the specific information available to the Secretary 
which served as the basis for such clinical hold, and confirm 
such determination in writing.
  (B) For purposes of subparagraph (A), a determination 
described in this subparagraph with respect to a clinical hold 
is that--
          (i) the drug involved represents an unreasonable risk 
        to the safety of the persons who are the subjects of 
        the clinical investigation, taking into account the 
        qualifications of the clinical investigators, 
        information about the drug, the design of the clinical 
        investigation, the condition for which the drug is to 
        be investigated, and the health status of the subjects 
        involved; or
          (ii) the clinical hold should be issued for such 
        other reasons as the Secretary may by regulation 
        establish (including reasons established by regulation 
        before the date of the enactment of the Food and Drug 
        Administration Modernization Act of 1997).
  (C) Any written request to the Secretary from the sponsor of 
an investigation that a clinical hold be removed shall receive 
a decision, in writing and specifying the reasons therefor, 
within 30 days after receipt of such request. Any such request 
shall include sufficient information to support the removal of 
such clinical hold.
  (4) Regulations under paragraph (1) shall provide that such 
exemption shall be conditioned upon the manufacturer, or the 
sponsor of the investigation, requiring that experts using such 
drugs for investigational purposes certify to such manufacturer 
or sponsor that they will inform any human beings to whom such 
drugs, or any controls used in connection therewith, are being 
administered, or their representatives, that such drugs are 
being used for investigational purposes and will obtain the 
consent of such human beings or their representatives, except 
where it is not feasible or it is contrary to the best 
interests of such human beings. Nothing in this subsection 
shall be construed to require any clinical investigator to 
submit directly to the Secretary reports on the investigational 
use of drugs. The Secretary shall update such regulations to 
require inclusion in the informed consent documents and process 
a statement that clinical trial information for such clinical 
investigation has been or will be submitted for inclusion in 
the registry data bank pursuant to subsection (j) of section 
402 of the Public Health Service Act.
  (j)(1) Any person may file with the Secretary an abbreviated 
application for the approval of a new drug.
  (2)(A) An abbreviated application for a new drug shall 
contain--
          (i) information to show that the conditions of use 
        prescribed, recommended, or suggested in the labeling 
        proposed for the new drug have been previously approved 
        for a drug listed under paragraph (7) (hereinafter in 
        this subsection referred to as a ``listed drug'');
          (ii)(I) if the listed drug referred to in clause (i) 
        has only one active ingredient, information to show 
        that the active ingredient of the new drug is the same 
        as that of the listed drug;
          (II) if the listed drug referred to in clause (i) has 
        more than one active ingredient, information to show 
        that the active ingredients of the new drug are the 
        same as those of the listed drug, or
          (III) if the listed drug referred to in clause (i) 
        has more than one active ingredient and if one of the 
        active ingredients of the new drug is different and the 
        application is filed pursuant to the approval of a 
        petition filed under subparagraph (C), information to 
        show that the other active ingredients of the new drug 
        are the same as the active ingredients of the listed 
        drug, information to show that the different active 
        ingredient is an active ingredient of a listed drug or 
        of a drug which does not meet the requirements of 
        section 201(p), and such other information respecting 
        the different active ingredient with respect to which 
        the petition was filed as the Secretary may require;
          (iii) information to show that the route of 
        administration, the dosage form, and the strength of 
        the new drug are the same as those of the listed drug 
        referred to in clause (i) or, if the route of 
        administration, the dosage form, or the strength of the 
        new drug is different and the application is filed 
        pursuant to the approval of a petition filed under 
        subparagraph (C), such information respecting the route 
        of administration, dosage form, or strength with 
        respect to which the petition was filed as the 
        Secretary may require;
          (iv) information to show that the new drug is 
        bioequivalent to the listed drug referred to in clause 
        (i), except that if the application is filed pursuant 
        to the approval of a petition filed under subparagraph 
        (C), information to show that the active ingredients of 
        the new drug are of the same pharmacological or 
        therapeutic class as those of the listed drug referred 
        to in clause (i) and the new drug can be expected to 
        have the same therapeutic effect as the listed drug 
        when administered to patients for a condition of use 
        referred to in clause (i);
          (v) information to show that the labeling proposed 
        for the new drug is the same as the labeling approved 
        for the listed drug referred to in clause (i) except 
        for changes required because of differences approved 
        under a petition filed under subparagraph (C) or 
        because the new drug and the listed drug are produced 
        or distributed by different manufacturers;
          (vi) the items specified in clauses (B) through (F) 
        of subsection (b)(1);
          (vii) a certification, in the opinion of the 
        applicant and to the best of his knowledge, with 
        respect to each patent which claims the listed drug 
        referred to in clause (i) or which claims a use for 
        such listed drug for which the applicant is seeking 
        approval under this subsection and for which 
        information is required to be filed under subsection 
        (b) or (c)--
                  (I) that such patent information has not been 
                filed,
                  (II) that such patent has expired,
                  (III) of the date on which such patent will 
                expire, or
                  (IV) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new drug for which the application is 
                submitted; and
          (viii) if with respect to the listed drug referred to 
        in clause (i) information was filed under subsection 
        (b) or (c) for a method of use patent which does not 
        claim a use for which the applicant is seeking approval 
        under this subsection, a statement that the method of 
        use patent does not claim such a use.
The Secretary may not require that an abbreviated application 
contain information in addition to that required by clauses (i) 
through (viii).
  (B) Notice of opinion that patent is invalid or will not be 
infringed.--
          (i) Agreement to give notice.--An applicant that 
        makes a certification described in subparagraph 
        (A)(vii)(IV) shall include in the application a 
        statement that the applicant will give notice as 
        required by this subparagraph.
          (ii) Timing of notice.--An applicant that makes a 
        certification described in subparagraph (A)(vii)(IV) 
        shall give notice as required under this subparagraph--
                  (I) if the certification is in the 
                application, not later than 20 days after the 
                date of the postmark on the notice with which 
                the Secretary informs the applicant that the 
                application has been filed; or
                  (II) if the certification is in an amendment 
                or supplement to the application, at the time 
                at which the applicant submits the amendment or 
                supplement, regardless of whether the applicant 
                has already given notice with respect to 
                another such certification contained in the 
                application or in an amendment or supplement to 
                the application.
          (iii) Recipients of notice.--An applicant required 
        under this subparagraph to give notice shall give 
        notice to--
                  (I) each owner of the patent that is the 
                subject of the certification (or a 
                representative of the owner designated to 
                receive such a notice); and
                  (II) the holder of the approved application 
                under subsection (b) for the drug that is 
                claimed by the patent or a use of which is 
                claimed by the patent (or a representative of 
                the holder designated to receive such a 
                notice).
          (iv) Contents of notice.--A notice required under 
        this subparagraph shall--
                  (I) state that an application that contains 
                data from bioavailability or bioequivalence 
                studies has been submitted under this 
                subsection for the drug with respect to which 
                the certification is made to obtain approval to 
                engage in the commercial manufacture, use, or 
                sale of the drug before the expiration of the 
                patent referred to in the certification; and
                  (II) include a detailed statement of the 
                factual and legal basis of the opinion of the 
                applicant that the patent is invalid or will 
                not be infringed.
  (C) If a person wants to submit an abbreviated application 
for a new drug which has a different active ingredient or whose 
route of administration, dosage form, or strength differ from 
that of a listed drug, such person shall submit a petition to 
the Secretary seeking permission to file such an application. 
The Secretary shall approve or disapprove a petition submitted 
under this subparagraph within ninety days of the date the 
petition is submitted. The Secretary shall approve such a 
petition unless the Secretary finds--
          (i) that investigations must be conducted to show the 
        safety and effectiveness of the drug or of any of its 
        active ingredients, the route of administration, the 
        dosage form, or strength which differ from the listed 
        drug; or
          (ii) that any drug with a different active ingredient 
        may not be adequately evaluated for approval as safe 
        and effective on the basis of the information required 
        to be submitted in an abbreviated application.
  (D)(i) An applicant may not amend or supplement an 
application to seek approval of a drug referring to a different 
listed drug from the listed drug identified in the application 
as submitted to the Secretary.
  (ii) With respect to the drug for which an application is 
submitted, nothing in this subsection prohibits an applicant 
from amending or supplementing the application to seek approval 
of a different strength.
  (iii) Within 60 days after the date of the enactment of the 
Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003, the Secretary shall issue guidance defining the term 
``listed drug'' for purposes of this subparagraph.
  (3)(A) The Secretary shall issue guidance for the individuals 
who review applications submitted under paragraph (1), which 
shall relate to promptness in conducting the review, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards, and which 
shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection if the sponsor or applicant makes a reasonable 
written request for a meeting for the purpose of reaching 
agreement on the design and size of bioavailability and 
bioequivalence studies needed for approval of such application. 
The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of such 
studies. Minutes of any such meeting shall be prepared by the 
Secretary and made available to the sponsor or applicant.
  (C) Any agreement regarding the parameters of design and size 
of bioavailability and bioequivalence studies of a drug under 
this paragraph that is reached between the Secretary and a 
sponsor or applicant shall be reduced to writing and made part 
of the administrative record by the Secretary. Such agreement 
shall not be changed after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the reviewing 
        division, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug 
        has been identified after the testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director will document the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance office personnel unless such field or 
compliance office personnel demonstrate to the reviewing 
division why such decision should be modified.
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (G) For purposes of this paragraph, the reviewing division is 
the division responsible for the review of an application for 
approval of a drug under this subsection (including scientific 
matters, chemistry, manufacturing, and controls).
  (4) Subject to paragraph (5), the Secretary shall approve an 
application for a drug unless the Secretary finds--
          (A) the methods used in, or the facilities and 
        controls used for, the manufacture, processing, and 
        packing of the drug are inadequate to assure and 
        preserve its identity, strength, quality, and purity;
          (B) information submitted with the application is 
        insufficient show that each of the proposed conditions 
        of use have been previously approved for the listed 
        drug referred to in the application;
          (C)(i) if the listed drug has only one active 
        ingredient, information submitted with the application 
        is insufficient to show that the active ingredient is 
        the same as that of the listed drug;
          (ii) if the listed drug has more than one active 
        ingredient, information submitted with the application 
        is insufficient to show that the active ingredients are 
        the same as the active ingredients of the listed drug, 
        or
          (iii) if the listed drug has more than one active 
        ingredient and if the application is for a drug which 
        has an active ingredient different from the listed 
        drug, information submitted with the application is 
        insufficient to show--
                  (I) that the other active ingredients are the 
                same as the active ingredients of the listed 
                drug, or
                  (II) that the different active ingredient is 
                an active ingredient of a listed drug or a drug 
                which does not meet the requirements of section 
                201(p),
        or no petition to file an application for the drug with 
        the different ingredient was approved under paragraph 
        (2)(C);
          (D)(i) if the application is for a drug whose route 
        of administration, dosage form, or strength of the drug 
        is the same as the route of administration, dosage 
        form, or strength of the listed drug referred to in the 
        application, information submitted in the application 
        is insufficient to show that the route of 
        administration, dosage form, or strength is the same as 
        that of the listed drug, or
          (ii) if the application is for a drug whose route of 
        administration, dosage form, or strength of the drug is 
        different from that of the listed drug referred to in 
        the application, no petition to file an application for 
        the drug with the different route of administration, 
        dosage form, or strength was approved under paragraph 
        (2)(C);
          (E) if the application was filed pursuant to the 
        approval of a petition under paragraph (2)(C), the 
        application did not contain the information required by 
        the Secretary respecting the active ingredient, route 
        of administration, dosage form, or strength which is 
        not the same;
          (F) information submitted in the application is 
        insufficient to show that the drug is bioequivalent to 
        the listed drug referred to in the application or, if 
        the application was filed pursuant to a petition 
        approved under paragraph (2)(C), information submitted 
        in the application is insufficient to show that the 
        active ingredients of the new drug are of the same 
        pharmacological or therapeutic class as those of the 
        listed drug referred to in paragraph (2)(A)(i) and that 
        the new drug can be expected to have the same 
        therapeutic effect as the listed drug when administered 
        to patients for a condition of use referred to in such 
        paragraph;
          (G) information submitted in the application is 
        insufficient to show that the labeling proposed for the 
        drug is the same as the labeling approved for the 
        listed drug referred to in the application except for 
        changes required because of differences approved under 
        a petition filed under paragraph (2)(C) or because the 
        drug and the listed drug are produced or distributed by 
        different manufacturers;
          (H) information submitted in the application or any 
        other information available to the Secretary shows that 
        (i) the inactive ingredients of the drug are unsafe for 
        use under the conditions prescribed, recommended, or 
        suggested in the labeling proposed for the drug, or 
        (ii) the composition of the drug is unsafe under such 
        conditions because of the type or quantity of inactive 
        ingredients included or the manner in which the 
        inactive ingredients are included;
          (I) the approval under subsection (c) of the listed 
        drug referred to in the application under this 
        subsection has been withdrawn or suspended for grounds 
        described in the first sentence of subsection (e), the 
        Secretary has published a notice of opportunity for 
        hearing to withdraw approval of the listed drug under 
        subsection (c) for grounds described in the first 
        sentence of subsection (e), the approval under this 
        subsection of the listed drug referred to in the 
        application under this subsection has been withdrawn or 
        suspended under paragraph (6), or the Secretary has 
        determined that the listed drug has been withdrawn from 
        sale for safety or effectiveness reasons;
          (J) the application does not meet any other 
        requirement of paragraph (2)(A); or
          (K) the application contains an untrue statement of 
        material fact.
  (5)(A) Within one hundred and eighty days of the initial 
receipt of an application under paragraph (2) or within such 
additional period as may be agreed upon by the Secretary and 
the applicant, the Secretary shall approve or disapprove the 
application.
  (B) The approval of an application submitted under paragraph 
(2) shall be made effective on the last applicable date 
determined by applying the following to each certification made 
under paragraph (2)(A)(vii):
          (i) If the applicant only made a certification 
        described in subclause (I) or (II) of paragraph 
        (2)(A)(vii) or in both such subclauses, the approval 
        may be made effective immediately.
          (ii) If the applicant made a certification described 
        in subclause (III) of paragraph (2)(A)(vii), the 
        approval may be made effective on the date certified 
        under subclause (III).
          (iii) If the applicant made a certification described 
        in subclause (IV) of paragraph (2)(A)(vii), the 
        approval shall be made effective immediately unless, 
        before the expiration of 45 days after the date on 
        which the notice described in paragraph (2)(B) is 
        received, an action is brought for infringement of the 
        patent that is the subject of the certification and for 
        which information was submitted to the Secretary under 
        subsection (b)(1) or (c)(2) before the date on which 
        the application (excluding an amendment or supplement 
        to the application), which the Secretary later 
        determines to be substantially complete, was submitted. 
        If such an action is brought before the expiration of 
        such days, the approval shall be made effective upon 
        the expiration of the thirty-month period beginning on 
        the date of the receipt of the notice provided under 
        paragraph (2)(B)(i) or such shorter or longer period as 
        the court may order because either party to the action 
        failed to reasonably cooperate in expediting the 
        action, except that--
                  (I) if before the expiration of such period 
                the district court decides that the patent is 
                invalid or not infringed (including any 
                substantive determination that there is no 
                cause of action for patent infringement or 
                invalidity), the approval shall be made 
                effective on--
                          (aa) the date on which the court 
                        enters judgment reflecting the 
                        decision; or
                          (bb) the date of a settlement order 
                        or consent decree signed and entered by 
                        the court stating that the patent that 
                        is the subject of the certification is 
                        invalid or not infringed;
                  (II) if before the expiration of such period 
                the district court decides that the patent has 
                been infringed--
                          (aa) if the judgment of the district 
                        court is appealed, the approval shall 
                        be made effective on--
                                  (AA) the date on which the 
                                court of appeals decides that 
                                the patent is invalid or not 
                                infringed (including any 
                                substantive determination that 
                                there is no cause of action for 
                                patent infringement or 
                                invalidity); or
                                  (BB) the date of a settlement 
                                order or consent decree signed 
                                and entered by the court of 
                                appeals stating that the patent 
                                that is the subject of the 
                                certification is invalid or not 
                                infringed; or
                          (bb) if the judgment of the district 
                        court is not appealed or is affirmed, 
                        the approval shall be made effective on 
                        the date specified by the district 
                        court in a court order under section 
                        271(e)(4)(A) of title 35, United States 
                        Code;
                  (III) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent is invalid or not 
                infringed, the approval shall be made effective 
                as provided in subclause (I); or
                  (IV) if before the expiration of such period 
                the court grants a preliminary injunction 
                prohibiting the applicant from engaging in the 
                commercial manufacture or sale of the drug 
                until the court decides the issues of patent 
                validity and infringement and if the court 
                decides that such patent has been infringed, 
                the approval shall be made effective as 
                provided in subclause (II).
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action.
          (iv)  180-day exclusivity period.--
                  (I) Effectiveness of application.--Subject to 
                subparagraph (D), if the application contains a 
                certification described in paragraph 
                (2)(A)(vii)(IV) and is for a drug for which a 
                first applicant has submitted an application 
                containing such a certification, the 
                application shall be made effective on the date 
                that is 180 days after the date of the first 
                commercial marketing of the drug (including the 
                commercial marketing of the listed drug) by any 
                first applicant.
                  (II) Definitions.--In this paragraph:
                          (aa)  180-day exclusivity period.--
                        The term ``180-day exclusivity period'' 
                        means the 180-day period ending on the 
                        day before the date on which an 
                        application submitted by an applicant 
                        other than a first applicant could 
                        become effective under this clause.
                          (bb) First applicant.--As used in 
                        this subsection, the term ``first 
                        applicant'' means an applicant that, on 
                        the first day on which a substantially 
                        complete application containing a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) is submitted for 
                        approval of a drug, submits a 
                        substantially complete application that 
                        contains and lawfully maintains a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) for the drug.
                          (cc) Substantially complete 
                        application.--As used in this 
                        subsection, the term ``substantially 
                        complete application'' means an 
                        application under this subsection that 
                        on its face is sufficiently complete to 
                        permit a substantive review and 
                        contains all the information required 
                        by paragraph (2)(A).
                          (dd) Tentative approval.--
                                  (AA) In general.--The term 
                                ``tentative approval'' means 
                                notification to an applicant by 
                                the Secretary that an 
                                application under this 
                                subsection meets the 
                                requirements of paragraph 
                                (2)(A), but cannot receive 
                                effective approval because the 
                                application does not meet the 
                                requirements of this 
                                subparagraph, there is a period 
                                of exclusivity for the listed 
                                drug under subparagraph (F) or 
                                section 505A, or there is a 7-
                                year period of exclusivity for 
                                the listed drug under section 
                                527.
                                  (BB) Limitation.--A drug that 
                                is granted tentative approval 
                                by the Secretary is not an 
                                approved drug and shall not 
                                have an effective approval 
                                until the Secretary issues an 
                                approval after any necessary 
                                additional review of the 
                                application.
          (C) Civil action to obtain patent certainty.--
                  (i) Declaratory judgment absent infringement 
                action.--
                          (I) In general.--No action may be 
                        brought under section 2201 of title 28, 
                        United States Code, by an applicant 
                        under paragraph (2) for a declaratory 
                        judgment with respect to a patent which 
                        is the subject of the certification 
                        referred to in subparagraph (B)(iii) 
                        unless--
                                  (aa) the 45-day period 
                                referred to in such 
                                subparagraph has expired;
                                  (bb) neither the owner of 
                                such patent nor the holder of 
                                the approved application under 
                                subsection (b) for the drug 
                                that is claimed by the patent 
                                or a use of which is claimed by 
                                the patent brought a civil 
                                action against the applicant 
                                for infringement of the patent 
                                before the expiration of such 
                                period; and
                                  (cc) in any case in which the 
                                notice provided under paragraph 
                                (2)(B) relates to 
                                noninfringement, the notice was 
                                accompanied by a document 
                                described in subclause (III).
                          (II) Filing of civil action.--If the 
                        conditions described in items (aa), 
                        (bb), and as applicable, (cc) of 
                        subclause (I) have been met, the 
                        applicant referred to in such subclause 
                        may, in accordance with section 2201 of 
                        title 28, United States Code, bring a 
                        civil action under such section against 
                        the owner or holder referred to in such 
                        subclause (but not against any owner or 
                        holder that has brought such a civil 
                        action against the applicant, unless 
                        that civil action was dismissed without 
                        prejudice) for a declaratory judgment 
                        that the patent is invalid or will not 
                        be infringed by the drug for which the 
                        applicant seeks approval, except that 
                        such civil action may be brought for a 
                        declaratory judgment that the patent 
                        will not be infringed only in a case in 
                        which the condition described in 
                        subclause (I)(cc) is applicable. A 
                        civil action referred to in this 
                        subclause shall be brought in the 
                        judicial district where the defendant 
                        has its principal place of business or 
                        a regular and established place of 
                        business.
                          (III) Offer of confidential access to 
                        application.--For purposes of subclause 
                        (I)(cc), the document described in this 
                        subclause is a document providing an 
                        offer of confidential access to the 
                        application that is in the custody of 
                        the applicant under paragraph (2) for 
                        the purpose of determining whether an 
                        action referred to in subparagraph 
                        (B)(iii) should be brought. The 
                        document providing the offer of 
                        confidential access shall contain such 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, as would 
                        apply had a protective order been 
                        entered for the purpose of protecting 
                        trade secrets and other confidential 
                        business information. A request for 
                        access to an application under an offer 
                        of confidential access shall be 
                        considered acceptance of the offer of 
                        confidential access with the 
                        restrictions as to persons entitled to 
                        access, and on the use and disposition 
                        of any information accessed, contained 
                        in the offer of confidential access, 
                        and those restrictions and other terms 
                        of the offer of confidential access 
                        shall be considered terms of an 
                        enforceable contract. Any person 
                        provided an offer of confidential 
                        access shall review the application for 
                        the sole and limited purpose of 
                        evaluating possible infringement of the 
                        patent that is the subject of the 
                        certification under paragraph 
                        (2)(A)(vii)(IV) and for no other 
                        purpose, and may not disclose 
                        information of no relevance to any 
                        issue of patent infringement to any 
                        person other than a person provided an 
                        offer of confidential access. Further, 
                        the application may be redacted by the 
                        applicant to remove any information of 
                        no relevance to any issue of patent 
                        infringement.
                  (ii) Counterclaim to infringement action.--
                          (I) In general.--If an owner of the 
                        patent or the holder of the approved 
                        application under subsection (b) for 
                        the drug that is claimed by the patent 
                        or a use of which is claimed by the 
                        patent brings a patent infringement 
                        action against the applicant, the 
                        applicant may assert a counterclaim 
                        seeking an order requiring the holder 
                        to correct or delete the patent 
                        information submitted by the holder 
                        under subsection (b) or (c) on the 
                        ground that the patent does not claim 
                        either--
                                  (aa) the drug for which the 
                                application was approved; or
                                  (bb) an approved method of 
                                using the drug.
                          (II) No independent cause of 
                        action.--Subclause (I) does not 
                        authorize the assertion of a claim 
                        described in subclause (I) in any civil 
                        action or proceeding other than a 
                        counterclaim described in subclause 
                        (I).
                  (iii) No damages.--An applicant shall not be 
                entitled to damages in a civil action under 
                clause (i) or a counterclaim under clause (ii).
          (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) Failure to market.--The first 
                        applicant fails to market the drug by 
                        the later of--
                                  (aa) the earlier of the date 
                                that is--
                                          (AA) 75 days after 
                                        the date on which the 
                                        approval of the 
                                        application of the 
                                        first applicant is made 
                                        effective under 
                                        subparagraph (B)(iii); 
                                        or
                                          (BB) 30 months after 
                                        the date of submission 
                                        of the application of 
                                        the first applicant; or
                                  (bb) with respect to the 
                                first applicant or any other 
                                applicant (which other 
                                applicant has received 
                                tentative approval), the date 
                                that is 75 days after the date 
                                as of which, as to each of the 
                                patents with respect to which 
                                the first applicant submitted 
                                and lawfully maintained a 
                                certification qualifying the 
                                first applicant for the 180-day 
                                exclusivity period under 
                                subparagraph (B)(iv), at least 
                                1 of the following has 
                                occurred:
                                          (AA) In an 
                                        infringement action 
                                        brought against that 
                                        applicant with respect 
                                        to the patent or in a 
                                        declaratory judgment 
                                        action brought by that 
                                        applicant with respect 
                                        to the patent, a court 
                                        enters a final decision 
                                        from which no appeal 
                                        (other than a petition 
                                        to the Supreme Court 
                                        for a writ of 
                                        certiorari) has been or 
                                        can be taken that the 
                                        patent is invalid or 
                                        not infringed.
                                          (BB) In an 
                                        infringement action or 
                                        a declaratory judgment 
                                        action described in 
                                        subitem (AA), a court 
                                        signs a settlement 
                                        order or consent decree 
                                        that enters a final 
                                        judgment that includes 
                                        a finding that the 
                                        patent is invalid or 
                                        not infringed.
                                          (CC) The patent 
                                        information submitted 
                                        under subsection (b) or 
                                        (c) is withdrawn by the 
                                        holder of the 
                                        application approved 
                                        under subsection (b).
                          (II) Withdrawal of application.--The 
                        first applicant withdraws the 
                        application or the Secretary considers 
                        the application to have been withdrawn 
                        as a result of a determination by the 
                        Secretary that the application does not 
                        meet the requirements for approval 
                        under paragraph (4).
                          (III) Amendment of certification.--
                        The first applicant amends or withdraws 
                        the certification for all of the 
                        patents with respect to which that 
                        applicant submitted a certification 
                        qualifying the applicant for the 180-
                        day exclusivity period.
                          (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.
                          (V) Agreement with another applicant, 
                        the listed drug application holder, or 
                        a patent owner.--The first applicant 
                        enters into an agreement with another 
                        applicant under this subsection for the 
                        drug, the holder of the application for 
                        the listed drug, or an owner of the 
                        patent that is the subject of the 
                        certification under paragraph 
                        (2)(A)(vii)(IV), the Federal Trade 
                        Commission or the Attorney General 
                        files a complaint, and there is a final 
                        decision of the Federal Trade 
                        Commission or the court with regard to 
                        the complaint from which no appeal 
                        (other than a petition to the Supreme 
                        Court for a writ of certiorari) has 
                        been or can be taken that the agreement 
                        has violated the antitrust laws (as 
                        defined in section 1 of the Clayton Act 
                        (15 U.S.C. 12), except that the term 
                        includes section 5 of the Federal Trade 
                        Commission Act (15 U.S.C. 45) to the 
                        extent that that section applies to 
                        unfair methods of competition).
                          (VI) Expiration of all patents.--All 
                        of the patents as to which the 
                        applicant submitted a certification 
                        qualifying it for the 180-day 
                        exclusivity period have expired.
                  (ii) Forfeiture.--The 180-day exclusivity 
                period described in subparagraph (B)(iv) shall 
                be forfeited by a first applicant if a 
                forfeiture event occurs with respect to that 
                first applicant.
                  (iii) Subsequent applicant.--If all first 
                applicants forfeit the 180-day exclusivity 
                period under clause (ii)--
                          (I) approval of any application 
                        containing a certification described in 
                        paragraph (2)(A)(vii)(IV) shall be made 
                        effective in accordance with 
                        subparagraph (B)(iii); and
                          (II) no applicant shall be eligible 
                        for a 180-day exclusivity period.
  (E) If the Secretary decides to disapprove an application, 
the Secretary shall give the applicant notice of an opportunity 
for a hearing before the Secretary on the question of whether 
such application is approvable. If the applicant elects to 
accept the opportunity for hearing by written request within 
thirty days after such notice, such hearing shall commence not 
more than ninety days after the expiration of such thirty days 
unless the Secretary and the applicant otherwise agree. Any 
such hearing shall thereafter be conducted on an expedited 
basis and the Secretary's order thereon shall be issued within 
ninety days after the date fixed by the Secretary for filing 
final briefs.
  (F)(i) If an application (other than an abbreviated new drug 
application) submitted under subsection (b) for a drug, no 
active ingredient (including any ester or salt of the active 
ingredient) of which has been approved in any other application 
under subsection (b), was approved during the period beginning 
January 1, 1982, and ending on the date of the enactment of 
this subsection, the Secretary may not make the approval of an 
application submitted under this subsection which refers to the 
drug for which the subsection (b) application was submitted 
effective before the expiration of ten years from the date of 
the approval of the application under subsection (b).
  (ii) If an application submitted under subsection (b) for a 
drug, no active ingredient (including any ester or salt of the 
active ingredient) of which has been approved in any other 
application under subsection (b), is approved after the date of 
the enactment of this subsection, no application may be 
submitted under this subsection which refers to the drug for 
which the subsection (b) application was submitted before the 
expiration of five years from the date of the approval of the 
application under subsection (b), except that such an 
application may be submitted under this subsection after the 
expiration of four years from the date of the approval of the 
subsection (b) application if it contains a certification of 
patent invalidity or noninfringement described in subclause 
(IV) of paragraph (2)(A)(vii). The approval of such an 
application shall be made effective in accordance with 
subparagraph (B) except that, if an action for patent 
infringement is commenced during the one-year period beginning 
forty-eight months after the date of the approval of the 
subsection (b) application, the thirty-month period referred to 
in subparagraph (B)(iii) shall be extended by such amount of 
time (if any) which is required for seven and one-half years to 
have elapsed from the date of approval of the subsection (b) 
application.
  (iii) If an application submitted under subsection (b) for a 
drug, which includes an active ingredient (including any ester 
or salt of the active ingredient) that has been approved in 
another application approved under subsection (b), is approved 
after the date of enactment of this subsection and if such 
application contains reports of new clinical investigations 
(other than bioavailability studies) essential to the approval 
of the application and conducted or sponsored by the applicant, 
the Secretary may not make the approval of an application 
submitted under this subsection for the conditions of approval 
of such drug in the subsection (b) application effective before 
the expiration of three years from the date of the approval of 
the application under subsection (b) for such drug.
  (iv) If a supplement to an application approved under 
subsection (b) is approved after the date of enactment of this 
subsection and the supplement contains reports of new clinical 
investigations (other than bioavailability studies) essential 
to the approval of the supplement and conducted or sponsored by 
the person submitting the supplement, the Secretary may not 
make the approval of an application submitted under this 
subsection for a change approved in the supplement effective 
before the expiration of three years from the date of the 
approval of the supplement under subsection (b).
  (v) If an application (or supplement to an application) 
submitted under subsection (b) for a drug, which includes an 
active ingredient (including any ester or salt of the active 
ingredient) that has been approved in another application under 
subsection (b), was approved during the period beginning 
January 1, 1982, and ending on the date of the enactment of 
this subsection, the Secretary may not make the approval of an 
application submitted under this subsection which refers to the 
drug for which the subsection (b) application was submitted or 
which refers to a change approved in a supplement to the 
subsection (b) application effective before the expiration of 
two years from the date of enactment of this subsection.
  (6) If a drug approved under this subsection refers in its 
approved application to a drug the approval of which was 
withdrawn or suspended for grounds described in the first 
sentence of subsection (e) or was withdrawn or suspended under 
this paragraph or which, as determined by the Secretary, has 
been withdrawn from sale for safety or effectiveness reasons, 
the approval of the drug under this subsection shall be 
withdrawn or suspended--
          (A) for the same period as the withdrawal or 
        suspension under subsection (e) or this paragraph, or
          (B) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
  (7)(A)(i) Within sixty days of the date of the enactment of 
this subsection, the Secretary shall publish and make available 
to the public--
          (I) a list in alphabetical order of the official and 
        proprietary name of each drug which has been approved 
        for safety and effectiveness under subsection (c) 
        before the date of the enactment of this subsection;
          (II) the date of approval if the drug is approved 
        after 1981 and the number of the application which was 
        approved; and
          (III) whether in vitro or in vivo bioequivalence 
        studies, or both such studies, are required for 
        applications filed under this subsection which will 
        refer to the drug published.
  (ii) Every thirty days after the publication of the first 
list under clause (i) the Secretary shall revise the list to 
include each drug which has been approved for safety and 
effectiveness under subsection (c) or approved under this 
subsection during the thirty-day period.
  (iii) When patent information submitted under subsection (b) 
or (c) respecting a drug included on the list is to be 
published by the Secretary, the Secretary shall, in revisions 
made under clause (ii), include such information for such drug.
  (B) A drug approved for safety and effectiveness under 
subsection (c) or approved under this subsection shall, for 
purposes of this subsection, be considered to have been 
published under subparagraph (A) on the date of its approval or 
the date of enactment, whichever is later.
  (C) If the approval of a drug was withdrawn or suspended for 
grounds described in the first sentence of subsection (e) or 
was withdrawn or suspended under paragraph (6) or if the 
Secretary determines that a drug has been withdrawn from sale 
for safety or effectiveness reasons, it may not be published in 
the list under subparagraph (A) or, if the withdrawal or 
suspension occurred after its publication in such list, it 
shall be immediately removed from such list--
          (i) for the same period as the withdrawal or 
        suspension under subsection (e) or paragraph (6), or
          (ii) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
A notice of the removal shall be published in the Federal 
Register.
  (8) For purposes of this subsection:
          (A)(i) The term ``bioavailability'' means the rate 
        and extent to which the active ingredient or 
        therapeutic ingredient is absorbed from a drug and 
        becomes available at the site of drug action.
          (ii) For a drug that is not intended to be absorbed 
        into the bloodstream, the Secretary may assess 
        bioavailability by scientifically valid measurements 
        intended to reflect the rate and extent to which the 
        active ingredient or therapeutic ingredient becomes 
        available at the site of drug action.
          (B) A drug shall be considered to be bioequivalent to 
        a listed drug if--
                  (i) the rate and extent of absorption of the 
                drug do not show a significant difference from 
                the rate and extent of absorption of the listed 
                drug when administered at the same molar dose 
                of the therapeutic ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses; or
                  (ii) the extent of absorption of the drug 
                does not show a significant difference from the 
                extent of absorption of the listed drug when 
                administered at the same molar dose of the 
                therapeutic ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses and the difference from the 
                listed drug in the rate of absorption of the 
                drug is intentional, is reflected in its 
                proposed labeling, is not essential to the 
                attainment of effective body drug 
                concentrations on chronic use, and is 
                considered medically insignificant for the 
                drug.
          (C) For a drug that is not intended to be absorbed 
        into the bloodstream, the Secretary may establish 
        alternative, scientifically valid methods to show 
        bioequivalence if the alternative methods are expected 
        to detect a significant difference between the drug and 
        the listed drug in safety and therapeutic effect.
  (9) The Secretary shall, with respect to each application 
submitted under this subsection, maintain a record of--
          (A) the name of the applicant,
          (B) the name of the drug covered by the application,
          (C) the name of each person to whom the review of the 
        chemistry of the application was assigned and the date 
        of such assignment, and
          (D) the name of each person to whom the 
        bioequivalence review for such application was assigned 
        and the date of such assignment.
The information the Secretary is required to maintain under 
this paragraph with respect to an application submitted under 
this subsection shall be made available to the public after the 
approval of such application.
  (10)(A) If the proposed labeling of a drug that is the 
subject of an application under this subsection differs from 
the listed drug due to a labeling revision described under 
clause (i), the drug that is the subject of such application 
shall, notwithstanding any other provision of this Act, be 
eligible for approval and shall not be considered misbranded 
under section 502 if--
          (i) the application is otherwise eligible for 
        approval under this subsection but for expiration of 
        patent, an exclusivity period, or of a delay in 
        approval described in paragraph (5)(B)(iii), and a 
        revision to the labeling of the listed drug has been 
        approved by the Secretary within 60 days of such 
        expiration;
          (ii) the labeling revision described under clause (i) 
        does not include a change to the ``Warnings'' section 
        of the labeling;
          (iii) the sponsor of the application under this 
        subsection agrees to submit revised labeling of the 
        drug that is the subject of such application not later 
        than 60 days after the notification of any changes to 
        such labeling required by the Secretary; and
          (iv) such application otherwise meets the applicable 
        requirements for approval under this subsection.
  (B) If, after a labeling revision described in subparagraph 
(A)(i), the Secretary determines that the continued presence in 
interstate commerce of the labeling of the listed drug (as in 
effect before the revision described in subparagraph (A)(i)) 
adversely impacts the safe use of the drug, no application 
under this subsection shall be eligible for approval with such 
labeling.
  (k)(1) In the case of any drug for which an approval of an 
application filed under subsection (b) or (j) is in effect, the 
applicant shall establish and maintain such records, and make 
such reports to the Secretary, of data relating to clinical 
experience and other data or information, received or otherwise 
obtained by such applicant with respect to such drug, as the 
Secretary may by general regulation, or by order with respect 
to such application, prescribe on the basis of a finding that 
such records and reports are necessary in order to enable the 
Secretary to determine, or facilitate a determination, whether 
there is or may be ground for invoking subsection (e) of this 
section. Regulations and orders issued under this subsection 
and under subsection (i) shall have due regard for the 
professional ethics of the medical profession and the interests 
of patients and shall provide, where the Secretary deems it to 
be appropriate, for the examination, upon request, by the 
persons to whom such regulations or orders are applicable, of 
similar information received or otherwise obtained by the 
Secretary.
  (2) Every person required under this section to maintain 
records, and every person in charge or custody thereof, shall, 
upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to have access to and copy and verify such records.
          (3) Active postmarket risk identification.--
                  (A) Definition.--In this paragraph, the term 
                ``data'' refers to information with respect to 
                a drug approved under this section or under 
                section 351 of the Public Health Service Act, 
                including claims data, patient survey data, 
                standardized analytic files that allow for the 
                pooling and analysis of data from disparate 
                data environments, and any other data deemed 
                appropriate by the Secretary.
                  (B) Development of postmarket risk 
                identification and analysis methods.--The 
                Secretary shall, not later than 2 years after 
                the date of the enactment of the Food and Drug 
                Administration Amendments Act of 2007, in 
                collaboration with public, academic, and 
                private entities--
                          (i) develop methods to obtain access 
                        to disparate data sources including the 
                        data sources specified in subparagraph 
                        (C);
                          (ii) develop validated methods for 
                        the establishment of a postmarket risk 
                        identification and analysis system to 
                        link and analyze safety data from 
                        multiple sources, with the goals of 
                        including, in aggregate--
                                  (I) at least 25,000,000 
                                patients by July 1, 2010; and
                                  (II) at least 100,000,000 
                                patients by July 1, 2012; and
                          (iii) convene a committee of experts, 
                        including individuals who are 
                        recognized in the field of protecting 
                        data privacy and security, to make 
                        recommendations to the Secretary on the 
                        development of tools and methods for 
                        the ethical and scientific uses for, 
                        and communication of, postmarketing 
                        data specified under subparagraph (C), 
                        including recommendations on the 
                        development of effective research 
                        methods for the study of drug safety 
                        questions.
                  (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) for risk identification 
                                and analysis based on 
                                electronic health data, in 
                                compliance with the regulations 
                                promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability 
                                Act of 1996, and in a manner 
                                that does not disclose 
                                individually identifiable 
                                health information in violation 
                                of paragraph (4)(B);
                                  (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) to provide for active 
                                adverse event surveillance 
                                using the following data 
                                sources, as available:
                                          (aa) Federal health-
                                        related electronic data 
                                        (such as data from the 
                                        Medicare program and 
                                        the health systems of 
                                        the Department of 
                                        Veterans Affairs);
                                          (bb) private sector 
                                        health-related 
                                        electronic data (such 
                                        as pharmaceutical 
                                        purchase data and 
                                        health insurance claims 
                                        data); and
                                          (cc) other data as 
                                        the Secretary deems 
                                        necessary to create a 
                                        robust system to 
                                        identify adverse events 
                                        and potential drug 
                                        safety signals;
                                  (IV) to identify certain 
                                trends and patterns with 
                                respect to data accessed by the 
                                system;
                                  (V) 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) to enable the program to 
                                export data in a form 
                                appropriate for further 
                                aggregation, statistical 
                                analysis, and reporting.
                          (ii) Timeliness of reporting.--The 
                        procedures established under clause (i) 
                        shall ensure that such data are 
                        accessed, analyzed, and reported in a 
                        timely, routine, and systematic manner, 
                        taking into consideration the need for 
                        data completeness, coding, cleansing, 
                        and standardized analysis and 
                        transmission.
                          (iii) Private sector resources.--To 
                        ensure the establishment of the active 
                        postmarket risk identification and 
                        analysis system under this subsection 
                        not later than 1 year after the 
                        development of the risk identification 
                        and analysis methods under subparagraph 
                        (B), as required under clause (i), the 
                        Secretary may, on a temporary or 
                        permanent basis, implement systems or 
                        products developed by private entities.
                          (iv) Complementary approaches.--To 
                        the extent the active postmarket risk 
                        identification and analysis system 
                        under this subsection is not sufficient 
                        to gather data and information relevant 
                        to a priority drug safety question, the 
                        Secretary shall develop, support, and 
                        participate in complementary approaches 
                        to gather and analyze such data and 
                        information, including--
                                  (I) approaches that are 
                                complementary with respect to 
                                assessing the safety of use of 
                                a drug in domestic populations 
                                not included, or 
                                underrepresented, in the trials 
                                used to approve the drug (such 
                                as older people, people with 
                                comorbidities, pregnant women, 
                                or children); and
                                  (II) existing approaches such 
                                as the Vaccine Adverse Event 
                                Reporting System and the 
                                Vaccine Safety Datalink or 
                                successor databases.
                          (v) Authority for contracts.--The 
                        Secretary may enter into contracts with 
                        public and private entities to fulfill 
                        the requirements of this subparagraph.
          (4) Advanced analysis of drug safety data.--
                  (A) Purpose.--The Secretary shall establish 
                collaborations with public, academic, and 
                private entities, which may include the Centers 
                for Education and Research on Therapeutics 
                under section 912 of the Public Health Service 
                Act, to provide for advanced analysis of drug 
                safety data described in paragraph (3)(C) and 
                other information that is publicly available or 
                is provided by the Secretary, in order to--
                          (i) improve the quality and 
                        efficiency of postmarket drug safety 
                        risk-benefit analysis;
                          (ii) provide the Secretary with 
                        routine access to outside expertise to 
                        study advanced drug safety questions; 
                        and
                          (iii) enhance the ability of the 
                        Secretary to make timely assessments 
                        based on drug safety data.
                  (B) Privacy.--Such analysis shall not 
                disclose individually identifiable health 
                information when presenting such drug safety 
                signals and trends or when responding to 
                inquiries regarding such drug safety signals 
                and trends.
                  (C) Public process for priority questions.--
                At least biannually, the Secretary shall seek 
                recommendations from the Drug Safety and Risk 
                Management Advisory Committee (or any successor 
                committee) and from other advisory committees, 
                as appropriate, to the Food and Drug 
                Administration on--
                          (i) priority drug safety questions; 
                        and
                          (ii) mechanisms for answering such 
                        questions, including through--
                                  (I) active risk 
                                identification under paragraph 
                                (3); and
                                  (II) when such risk 
                                identification is not 
                                sufficient, postapproval 
                                studies and clinical trials 
                                under subsection (o)(3).
                  (D) Procedures for the development of drug 
                safety collaborations.--
                          (i) In general.--Not later than 180 
                        days after the date of the 
                        establishment of the active postmarket 
                        risk identification and analysis system 
                        under this subsection, the Secretary 
                        shall establish and implement 
                        procedures under which the Secretary 
                        may routinely contract with one or more 
                        qualified entities to--
                                  (I) classify, analyze, or 
                                aggregate data described in 
                                paragraph (3)(C) and 
                                information that is publicly 
                                available or is provided by the 
                                Secretary;
                                  (II) allow for prompt 
                                investigation of priority drug 
                                safety questions, including--
                                          (aa) unresolved 
                                        safety questions for 
                                        drugs or classes of 
                                        drugs; and
                                          (bb) for a newly-
                                        approved drugs, safety 
                                        signals from clinical 
                                        trials used to approve 
                                        the drug and other 
                                        preapproval trials; 
                                        rare, serious drug side 
                                        effects; and the safety 
                                        of use in domestic 
                                        populations not 
                                        included, or 
                                        underrepresented, in 
                                        the trials used to 
                                        approve the drug (such 
                                        as older people, people 
                                        with comorbidities, 
                                        pregnant women, or 
                                        children);
                                  (III) perform advanced 
                                research and analysis on 
                                identified drug safety risks;
                                  (IV) focus postapproval 
                                studies and clinical trials 
                                under subsection (o)(3) more 
                                effectively on cases for which 
                                reports under paragraph (1) and 
                                other safety signal detection 
                                is not sufficient to resolve 
                                whether there is an elevated 
                                risk of a serious adverse event 
                                associated with the use of a 
                                drug; and
                                  (V) carry out other 
                                activities as the Secretary 
                                deems necessary to carry out 
                                the purposes of this paragraph.
                          (ii) Request for specific 
                        methodology.--The procedures described 
                        in clause (i) shall permit the 
                        Secretary to request that a specific 
                        methodology be used by the qualified 
                        entity. The qualified entity shall work 
                        with the Secretary to finalize the 
                        methodology to be used.
                  (E) Use of analyses.--The Secretary shall 
                provide the analyses described in this 
                paragraph, including the methods and results of 
                such analyses, about a drug to the sponsor or 
                sponsors of such drug.
                  (F) Qualified entities.--
                          (i) In general.--The Secretary shall 
                        enter into contracts with a sufficient 
                        number of qualified entities to develop 
                        and provide information to the 
                        Secretary in a timely manner.
                          (ii) Qualification.--The Secretary 
                        shall enter into a contract with an 
                        entity under clause (i) only if the 
                        Secretary determines that the entity 
                        has a significant presence in the 
                        United States and has one or more of 
                        the following qualifications:
                                  (I) The research, 
                                statistical, epidemiologic, or 
                                clinical capability and 
                                expertise to conduct and 
                                complete the activities under 
                                this paragraph, including the 
                                capability and expertise to 
                                provide the Secretary de-
                                identified data consistent with 
                                the requirements of this 
                                subsection.
                                  (II) An information 
                                technology infrastructure in 
                                place to support electronic 
                                data and operational standards 
                                to provide security for such 
                                data.
                                  (III) Experience with, and 
                                expertise on, the development 
                                of drug safety and 
                                effectiveness research using 
                                electronic population data.
                                  (IV) An understanding of drug 
                                development or risk/benefit 
                                balancing in a clinical 
                                setting.
                                  (V) Other expertise which the 
                                Secretary deems necessary to 
                                fulfill the activities under 
                                this paragraph.
                  (G) Contract requirements.--Each contract 
                with a qualified entity under subparagraph 
                (F)(i) shall contain the following 
                requirements:
                          (i) Ensuring privacy.--The qualified 
                        entity shall ensure that the entity 
                        will not use data under this subsection 
                        in a manner that--
                                  (I) violates the regulations 
                                promulgated under section 
                                264(c) of the Health Insurance 
                                Portability and Accountability 
                                Act of 1996;
                                  (II) violates sections 552 or 
                                552a of title 5, United States 
                                Code, with regard to the 
                                privacy of individually-
                                identifiable beneficiary health 
                                information; or
                                  (III) discloses individually 
                                identifiable health information 
                                when presenting drug safety 
                                signals and trends or when 
                                responding to inquiries 
                                regarding drug safety signals 
                                and trends.
                        Nothing in this clause prohibits lawful 
                        disclosure for other purposes.
                          (ii) Component of another 
                        organization.--If a qualified entity is 
                        a component of another organization--
                                  (I) the qualified entity 
                                shall establish appropriate 
                                security measures to maintain 
                                the confidentiality and privacy 
                                of such data; and
                                  (II) the entity shall not 
                                make an unauthorized disclosure 
                                of such data to the other 
                                components of the organization 
                                in breach of such 
                                confidentiality and privacy 
                                requirement.
                          (iii) Termination or nonrenewal.--If 
                        a contract with a qualified entity 
                        under this subparagraph is terminated 
                        or not renewed, the following 
                        requirements shall apply:
                                  (I) Confidentiality and 
                                privacy protections.--The 
                                entity shall continue to comply 
                                with the confidentiality and 
                                privacy requirements under this 
                                paragraph with respect to all 
                                data disclosed to the entity.
                                  (II) Disposition of data.--
                                The entity shall return any 
                                data disclosed to such entity 
                                under this subsection to which 
                                it would not otherwise have 
                                access or, if returning the 
                                data is not practicable, 
                                destroy the data.
                  (H) Competitive procedures.--The Secretary 
                shall use competitive procedures (as defined in 
                section 4(5) of the Federal Procurement Policy 
                Act) to enter into contracts under subparagraph 
                (G).
                  (I) Review of contract in the event of a 
                merger or acquisition.--The Secretary shall 
                review the contract with a qualified entity 
                under this paragraph in the event of a merger 
                or acquisition of the entity in order to ensure 
                that the requirements under this paragraph will 
                continue to be met.
                  (J) Coordination.--In carrying out this 
                paragraph, the Secretary shall provide for 
                appropriate communications to the public, 
                scientific, public health, and medical 
                communities, and other key stakeholders, and to 
                the extent practicable shall coordinate with 
                the activities of private entities, 
                professional associations, or other entities 
                that may have sources of drug safety data.
          (5) The Secretary shall--
                  (A) conduct regular, bi-weekly screening of 
                the Adverse Event Reporting System database and 
                post a quarterly report on the Adverse Event 
                Reporting System Web site of any new safety 
                information or potential signal of a serious 
                risk identified by Adverse Event Reporting 
                System within the last quarter;
                  (B) report to Congress not later than 2 year 
                after the date of the enactment of the Food and 
                Drug Administration Amendments Act of 2007 on 
                procedures and processes of the Food and Drug 
                Administration for addressing ongoing post 
                market safety issues identified by the Office 
                of Surveillance and Epidemiology and how 
                recommendations of the Office of Surveillance 
                and Epidemiology are handled within the agency; 
                and
                  (C) on an annual basis, review the entire 
                backlog of postmarket safety commitments to 
                determine which commitments require revision or 
                should be eliminated, report to the Congress on 
                these determinations, and assign start dates 
                and estimated completion dates for such 
                commitments.
  (l)(1) Safety and effectiveness data and information which 
has been submitted in an application under subsection (b) for a 
drug and which has not previously been disclosed to the public 
shall be made available to the public, upon request, unless 
extraordinary circumstances are shown--
          (A) if no work is being or will be undertaken to have 
        the application approved,
          (B) if the Secretary has determined that the 
        application is not approvable and all legal appeals 
        have been exhausted,
          (C) if approval of the application under subsection 
        (c) is withdrawn and all legal appeals have been 
        exhausted,
          (D) if the Secretary has determined that such drug is 
        not a new drug, or
          (E) upon the effective date of the approval of the 
        first application under subsection (j) which refers to 
        such drug or upon the date upon which the approval of 
        an application under subsection (j) which refers to 
        such drug could be made effective if such an 
        application had been submitted.
  (2) Action Package for Approval.--
          (A) Action package.--The Secretary shall publish the 
        action package for approval of an application under 
        subsection (b) or section 351 of the Public Health 
        Service Act on the Internet Web site of the Food and 
        Drug Administration--
                  (i) not later than 30 days after the date of 
                approval of such application for a drug no 
                active ingredient (including any ester or salt 
                of the active ingredient) of which has been 
                approved in any other application under this 
                section or section 351 of the Public Health 
                Service Act; and
                  (ii) not later than 30 days after the third 
                request for such action package for approval 
                received under section 552 of title 5, United 
                States Code, for any other drug.
          (B) Immediate publication of summary review.--
        Notwithstanding subparagraph (A), the Secretary shall 
        publish, on the Internet Web site of the Food and Drug 
        Administration, the materials described in subparagraph 
        (C)(iv) not later than 48 hours after the date of 
        approval of the drug, except where such materials 
        require redaction by the Secretary.
          (C) Contents.--An action package for approval of an 
        application under subparagraph (A) shall be dated and 
        shall include the following:
                  (i) Documents generated by the Food and Drug 
                Administration related to review of the 
                application.
                  (ii) Documents pertaining to the format and 
                content of the application generated during 
                drug development.
                  (iii) Labeling submitted by the applicant.
                  (iv) A summary review that documents 
                conclusions from all reviewing disciplines 
                about the drug, noting any critical issues and 
                disagreements with the applicant and within the 
                review team and how they were resolved, 
                recommendations for action, and an explanation 
                of any nonconcurrence with review conclusions.
                  (v) The Division Director and Office 
                Director's decision document which includes--
                          (I) a brief statement of concurrence 
                        with the summary review;
                          (II) a separate review or addendum to 
                        the review if disagreeing with the 
                        summary review; and
                          (III) a separate review or addendum 
                        to the review to add further analysis.
                  (vi) Identification by name of each officer 
                or employee of the Food and Drug Administration 
                who--
                          (I) participated in the decision to 
                        approve the application; and
                          (II) consents to have his or her name 
                        included in the package.
          (D) Review.--A scientific review of an application is 
        considered the work of the reviewer and shall not be 
        altered by management or the reviewer once final.
          (E) Confidential information.--This paragraph does 
        not authorize the disclosure of any trade secret, 
        confidential commercial or financial information, or 
        other matter listed in section 552(b) of title 5, 
        United States Code.
  (m) For purposes of this section, the term ``patent'' means a 
patent issued by the United States Patent and Trademark Office.
  (n)(1) For the purpose of providing expert scientific advice 
and recommendations to the Secretary regarding a clinical 
investigation of a drug or the approval for marketing of a drug 
under section 505 or section 351 of the Public Health Service 
Act, the Secretary shall establish panels of experts or use 
panels of experts established before the date of enactment of 
the Food and Drug Administration Modernization Act of 1997, or 
both.
  (2) The Secretary may delegate the appointment and oversight 
authority granted under section 1004 to a director of a center 
or successor entity within the Food and Drug Administration.
  (3) The Secretary shall make appointments to each panel 
established under paragraph (1) so that each panel shall 
consist of--
          (A) members who are qualified by training and 
        experience to evaluate the safety and effectiveness of 
        the drugs to be referred to the panel and who, to the 
        extent feasible, possess skill and experience in the 
        development, manufacture, or utilization of such drugs;
          (B) members with diverse expertise in such fields as 
        clinical and administrative medicine, pharmacy, 
        pharmacology, pharmacoeconomics, biological and 
        physical sciences, and other related professions;
          (C) a representative of consumer interests, and a 
        representative of interests of the drug manufacturing 
        industry not directly affected by the matter to be 
        brought before the panel; and
          (D) two or more members who are specialists or have 
        other expertise in the particular disease or condition 
        for which the drug under review is proposed to be 
        indicated.
Scientific, trade, and consumer organizations shall be afforded 
an opportunity to nominate individuals for appointment to the 
panels. No individual who is in the regular full-time employ of 
the United States and engaged in the administration of this Act 
may be a voting member of any panel. The Secretary shall 
designate one of the members of each panel to serve as chairman 
thereof.
  (4) The Secretary shall, as appropriate, provide education 
and training to each new panel member before such member 
participates in a panel's activities, including education 
regarding requirements under this Act and related regulations 
of the Secretary, and the administrative processes and 
procedures related to panel meetings.
  (5) Panel members (other than officers or employees of the 
United States), while attending meetings or conferences of a 
panel or otherwise engaged in its business, shall be entitled 
to receive compensation for each day so engaged, including 
traveltime, at rates to be fixed by the Secretary, but not to 
exceed the daily equivalent of the rate in effect for positions 
classified above grade GS-15 of the General Schedule. While 
serving away from their homes or regular places of business, 
panel members may be allowed travel expenses (including per 
diem in lieu of subsistence) as authorized by section 5703 of 
title 5, United States Code, for persons in the Government 
service employed intermittently.
  (6) The Secretary shall ensure that scientific advisory 
panels meet regularly and at appropriate intervals so that any 
matter to be reviewed by such a panel can be presented to the 
panel not more than 60 days after the matter is ready for such 
review. Meetings of the panel may be held using electronic 
communication to convene the meetings.
  (7) Within 90 days after a scientific advisory panel makes 
recommendations on any matter under its review, the Food and 
Drug Administration official responsible for the matter shall 
review the conclusions and recommendations of the panel, and 
notify the affected persons of the final decision on the 
matter, or of the reasons that no such decision has been 
reached. Each such final decision shall be documented including 
the rationale for the decision.
  (o) Postmarket Studies and Clinical Trials; Labeling.--
          (1) In general.--A responsible person may not 
        introduce or deliver for introduction into interstate 
        commerce the new drug involved if the person is in 
        violation of a requirement established under paragraph 
        (3) or (4) with respect to the drug.
          (2) Definitions.--For purposes of this subsection:
                  (A) Responsible person.--The term 
                ``responsible person'' means a person who--
                          (i) has submitted to the Secretary a 
                        covered application that is pending; or
                          (ii) is the holder of an approved 
                        covered application.
                  (B) Covered application.--The term ``covered 
                application'' means--
                          (i) an application under subsection 
                        (b) for a drug that is subject to 
                        section 503(b); and
                          (ii) an application under section 351 
                        of the Public Health Service Act.
                  (C) New safety information; serious risk.--
                The terms ``new safety information'', ``serious 
                risk'', and ``signal of a serious risk'' have 
                the meanings given such terms in section 505-
                1(b).
          (3) Studies and clinical trials.--
                  (A) In general.--For any or all of the 
                purposes specified in subparagraph (B), the 
                Secretary may, subject to subparagraph (D), 
                require a responsible person for a drug to 
                conduct a postapproval study or studies of the 
                drug, or a postapproval clinical trial or 
                trials of the drug, on the basis of scientific 
                data deemed appropriate by the Secretary, 
                including information regarding chemically-
                related or pharmacologically-related drugs.
                  (B) Purposes of study or clinical trial.--The 
                purposes referred to in this subparagraph with 
                respect to a postapproval study or postapproval 
                clinical trial are the following:
                          (i) To assess a known serious risk 
                        related to the use of the drug 
                        involved.
                          (ii) To assess signals of serious 
                        risk related to the use of the drug.
                          (iii) To identify an unexpected 
                        serious risk when available data 
                        indicates the potential for a serious 
                        risk.
                  (C) Establishment of requirement after 
                approval of covered application.--The Secretary 
                may require a postapproval study or studies or 
                postapproval clinical trial or trials for a 
                drug for which an approved covered application 
                is in effect as of the date on which the 
                Secretary seeks to establish such requirement 
                only if the Secretary becomes aware of new 
                safety information.
                  (D) Determination by secretary.--
                          (i) Postapproval studies.--The 
                        Secretary may not require the 
                        responsible person to conduct a study 
                        under this paragraph, unless the 
                        Secretary makes a determination that 
                        the reports under subsection (k)(1) and 
                        the active postmarket risk 
                        identification and analysis system as 
                        available under subsection (k)(3) will 
                        not be sufficient to meet the purposes 
                        set forth in subparagraph (B).
                          (ii) Postapproval clinical trials.--
                        The Secretary may not require the 
                        responsible person to conduct a 
                        clinical trial under this paragraph, 
                        unless the Secretary makes a 
                        determination that a postapproval study 
                        or studies will not be sufficient to 
                        meet the purposes set forth in 
                        subparagraph (B).
                  (E) Notification; timetables; periodic 
                reports.--
                          (i) Notification.--The Secretary 
                        shall notify the responsible person 
                        regarding a requirement under this 
                        paragraph to conduct a postapproval 
                        study or clinical trial by the target 
                        dates for communication of feedback 
                        from the review team to the responsible 
                        person regarding proposed labeling and 
                        postmarketing study commitments as set 
                        forth in the letters described in 
                        section 101(c) of the Food and Drug 
                        Administration Amendments Act of 2007.
                          (ii) Timetable; periodic reports.--
                        For each study or clinical trial 
                        required to be conducted under this 
                        paragraph, the Secretary shall require 
                        that the responsible person submit a 
                        timetable for completion of the study 
                        or clinical trial. With respect to each 
                        study required to be conducted under 
                        this paragraph or otherwise undertaken 
                        by the responsible person to 
                        investigate a safety issue, the 
                        Secretary shall require the responsible 
                        person to periodically report to the 
                        Secretary on the status of such study 
                        including whether any difficulties in 
                        completing the study have been 
                        encountered. With respect to each 
                        clinical trial required to be conducted 
                        under this paragraph or otherwise 
                        undertaken by the responsible person to 
                        investigate a safety issue, the 
                        Secretary shall require the responsible 
                        person to periodically report to the 
                        Secretary on 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 the requirements under section 
                        402(j) of the Public Health Service 
                        Act. If the responsible person fails to 
                        comply with such timetable or violates 
                        any other requirement of this 
                        subparagraph, the responsible person 
                        shall be considered in violation of 
                        this subsection, unless the responsible 
                        person demonstrates good cause for such 
                        noncompliance or such other violation. 
                        The Secretary shall determine what 
                        constitutes good cause under the 
                        preceding sentence.
                  (F) Dispute resolution.--The responsible 
                person may appeal a requirement to conduct a 
                study or clinical trial under this paragraph 
                using dispute resolution procedures established 
                by the Secretary in regulation and guidance.
          (4) Safety labeling changes requested by secretary.--
                  (A) New safety information.--If the Secretary 
                becomes aware of new safety information that 
                the Secretary believes should be included in 
                the labeling of the drug, the Secretary shall 
                promptly notify the responsible person or, if 
                the same drug approved under section 505(b) is 
                not currently marketed, the holder of an 
                approved application under 505(j).
                  (B) Response to notification.--Following 
                notification pursuant to subparagraph (A), the 
                responsible person or the holder of the 
                approved application under section 505(j) shall 
                within 30 days--
                          (i) submit a supplement proposing 
                        changes to the approved labeling to 
                        reflect the new safety information, 
                        including changes to boxed warnings, 
                        contraindications, warnings, 
                        precautions, or adverse reactions; or
                          (ii) notify the Secretary that the 
                        responsible person or the holder of the 
                        approved application under section 
                        505(j) does not believe a labeling 
                        change is warranted and submit a 
                        statement detailing the reasons why 
                        such a change is not warranted.
                  (C) Review.--Upon receipt of such supplement, 
                the Secretary shall promptly review and act 
                upon such supplement. If the Secretary 
                disagrees with the proposed changes in the 
                supplement or with the statement setting forth 
                the reasons why no labeling change is 
                necessary, the Secretary shall initiate 
                discussions to reach agreement on whether the 
                labeling for the drug should be modified to 
                reflect the new safety information, and if so, 
                the contents of such labeling changes.
                  (D) Discussions.--Such discussions shall not 
                extend for more than 30 days after the response 
                to the notification under subparagraph (B), 
                unless the Secretary determines an extension of 
                such discussion period is warranted.
                  (E) Order.--Within 15 days of the conclusion 
                of the discussions under subparagraph (D), the 
                Secretary may issue an order directing the 
                responsible person or the holder of the 
                approved application under section 505(j) to 
                make such a labeling change as the Secretary 
                deems appropriate to address the new safety 
                information. Within 15 days of such an order, 
                the responsible person or the holder of the 
                approved application under section 505(j) shall 
                submit a supplement containing the labeling 
                change.
                  (F) Dispute resolution.--Within 5 days of 
                receiving an order under subparagraph (E), the 
                responsible person or the holder of the 
                approved application under section 505(j) may 
                appeal using dispute resolution procedures 
                established by the Secretary in regulation and 
                guidance.
                  (G) Violation.--If the responsible person or 
                the holder of the approved application under 
                section 505(j) has not submitted a supplement 
                within 15 days of the date of such order under 
                subparagraph (E), and there is no appeal or 
                dispute resolution proceeding pending, the 
                responsible person or holder shall be 
                considered to be in violation of this 
                subsection. If at the conclusion of any dispute 
                resolution procedures the Secretary determines 
                that a supplement must be submitted and such a 
                supplement is not submitted within 15 days of 
                the date of that determination, the responsible 
                person or holder shall be in violation of this 
                subsection.
                  (H) Public health threat.--Notwithstanding 
                subparagraphs (A) through (F), if the Secretary 
                concludes that such a labeling change is 
                necessary to protect the public health, the 
                Secretary may accelerate the timelines in such 
                subparagraphs.
                  (I) Rule of construction.--This paragraph 
                shall not be construed to affect the 
                responsibility of the responsible person or the 
                holder of the approved application under 
                section 505(j) to maintain its label in 
                accordance with existing requirements, 
                including subpart B of part 201 and sections 
                314.70 and 601.12 of title 21, Code of Federal 
                Regulations (or any successor regulations).
          (5) Non-delegation.--Determinations by the Secretary 
        under this subsection for a drug shall be made by 
        individuals at or above the level of individuals 
        empowered to approve a drug (such as division directors 
        within the Center for Drug Evaluation and Research).
  (p) Risk Evaluation and Mitigation Strategy.--
          (1) In general.--A person may not introduce or 
        deliver for introduction into interstate commerce a new 
        drug if--
                  (A)(i) the application for such drug is 
                approved under subsection (b) or (j) and is 
                subject to section 503(b); or
                  (ii) the application for such drug is 
                approved under section 351 of the Public Health 
                Service Act; and
                  (B) a risk evaluation and mitigation strategy 
                is required under section 505-1 with respect to 
                the drug and the person fails to maintain 
                compliance with the requirements of the 
                approved strategy or with other requirements 
                under section 505-1, including requirements 
                regarding assessments of approved strategies.
          (2) Certain postmarket studies.--The failure to 
        conduct a postmarket study under section 506, subpart H 
        of part 314, or subpart E of part 601 of title 21, Code 
        of Federal Regulations (or any successor regulations), 
        is deemed to be a violation of paragraph (1).
  (q) Petitions and Civil Actions Regarding Approval of Certain 
Applications.--
          (1) In general.--
                  (A) Determination.--The Secretary shall not 
                delay approval of a pending application 
                submitted under subsection (b)(2) or (j) of 
                this section or section 351(k) of the Public 
                Health Service Act because of any request to 
                take any form of action relating to the 
                application, either before or during 
                consideration of the request, unless--
                          (i) the request is in writing and is 
                        a petition submitted to the Secretary 
                        pursuant to section 10.30 or 10.35 of 
                        title 21, Code of Federal Regulations 
                        (or any successor regulations); and
                          (ii) the Secretary determines, upon 
                        reviewing the petition, that a delay is 
                        necessary to protect the public health.
                Consideration of the petition shall be separate 
                and apart from review and approval of any 
                application.
                  (B) Notification.--If the Secretary 
                determines under subparagraph (A) that a delay 
                is necessary with respect to an application, 
                the Secretary shall provide to the applicant, 
                not later than 30 days after making such 
                determination, the following information:
                          (i) Notification of the fact that a 
                        determination under subparagraph (A) 
                        has been made.
                          (ii) If applicable, any clarification 
                        or additional data that the applicant 
                        should submit to the docket on the 
                        petition to allow the Secretary to 
                        review the petition promptly.
                          (iii) A brief summary of the specific 
                        substantive issues raised in the 
                        petition which form the basis of the 
                        determination.
                  (C) Format.--The information described in 
                subparagraph (B) shall be conveyed via either, 
                at the discretion of the Secretary--
                          (i) a document; or
                          (ii) a meeting with the applicant 
                        involved.
                  (D) Public disclosure.--Any information 
                conveyed by the Secretary under subparagraph 
                (C) shall be considered part of the application 
                and shall be subject to the disclosure 
                requirements applicable to information in such 
                application.
                  (E) Denial based on intent to delay.--If the 
                Secretary determines that a petition or a 
                supplement to the petition was submitted with 
                the primary purpose of delaying the approval of 
                an application and the petition does not on its 
                face raise valid scientific or regulatory 
                issues, the Secretary may deny the petition at 
                any point based on such determination. The 
                Secretary may issue guidance to describe the 
                factors that will be used to determine under 
                this subparagraph whether a petition is 
                submitted with the primary purpose of delaying 
                the approval of an application.
                  (F) Final agency action.--The Secretary shall 
                take final agency action on a petition not 
                later than 150 days after the date on which the 
                petition is submitted. The Secretary shall not 
                extend such period for any reason, including--
                          (i) any determination made under 
                        subparagraph (A);
                          (ii) the submission of comments 
                        relating to the petition or 
                        supplemental information supplied by 
                        the petitioner; or
                          (iii) the consent of the petitioner.
                  (G) Extension of 30-month 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 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.
                  (H) Certification.--The Secretary shall not 
                consider a petition for review unless the party 
                submitting such petition does so in written 
                form and the subject document is signed and 
                contains the following certification: ``I 
                certify that, to my best knowledge and belief: 
                (a) this petition includes all information and 
                views upon which the petition relies; (b) this 
                petition includes representative data and/or 
                information known to the petitioner which are 
                unfavorable to the petition; and (c) I have 
                taken reasonable steps to ensure that any 
                representative data and/or information which 
                are unfavorable to the petition were disclosed 
                to me. I further certify that the information 
                upon which I have based the action requested 
                herein first became known to the party on whose 
                behalf this petition is submitted on or about 
                the following date: __________. If I received 
                or expect to receive payments, including cash 
                and other forms of consideration, to file this 
                information or its contents, I received or 
                expect to receive those payments from the 
                following persons or organizations: 
                _____________. I verify under penalty of 
                perjury that the foregoing is true and correct 
                as of the date of the submission of this 
                petition.'', with the date on which such 
                information first became known to such party 
                and the names of such persons or organizations 
                inserted in the first and second blank space, 
                respectively.
                  (I) Verification.--The Secretary shall not 
                accept for review any supplemental information 
                or comments on a petition unless the party 
                submitting such information or comments does so 
                in written form and the subject document is 
                signed and contains the following verification: 
                ``I certify that, to my best knowledge and 
                belief: (a) I have not intentionally delayed 
                submission of this document or its contents; 
                and (b) the information upon which I have based 
                the action requested herein first became known 
                to me on or about __________. If I received or 
                expect to receive payments, including cash and 
                other forms of consideration, to file this 
                information or its contents, I received or 
                expect to receive those payments from the 
                following persons or organizations: _____. I 
                verify under penalty of perjury that the 
                foregoing is true and correct as of the date of 
                the submission of this petition.'', with the 
                date on which such information first became 
                known to the party and the names of such 
                persons or organizations inserted in the first 
                and second blank space, respectively.
          (2) Exhaustion of administrative remedies.--
                  (A) Final agency action within 150 days.--The 
                Secretary shall be considered to have taken 
                final agency action on a petition if--
                          (i) during the 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
                          (ii) such period expires without the 
                        Secretary having made such a final 
                        decision.
                  (B) Dismissal of certain civil actions.--If a 
                civil action is filed against the Secretary 
                with respect to any issue raised in the 
                petition before the Secretary has taken final 
                agency action on the petition within the 
                meaning of subparagraph (A), the court shall 
                dismiss without prejudice the action for 
                failure to exhaust administrative remedies.
                  (C) Administrative record.--For purposes of 
                judicial review related to the approval of an 
                application for which a petition under 
                paragraph (1) was submitted, the administrative 
                record regarding any issue raised by the 
                petition shall include--
                          (i) the petition filed under 
                        paragraph (1) and any supplements and 
                        comments thereto;
                          (ii) the Secretary's response to such 
                        petition, if issued; and
                          (iii) other information, as 
                        designated by the Secretary, related to 
                        the Secretary's determinations 
                        regarding the issues raised in such 
                        petition, as long as the information 
                        was considered by the agency no later 
                        than the date of final agency action as 
                        defined under subparagraph (2)(A), and 
                        regardless of whether the Secretary 
                        responded to the petition at or before 
                        the approval of the application at 
                        issue in the petition.
          (3) Annual report on delays in approvals per 
        petitions.--The Secretary shall annually submit to the 
        Congress a report that specifies--
                  (A) the number of applications that were 
                approved during the preceding 12-month period;
                  (B) the number of such applications whose 
                effective dates were delayed by petitions 
                referred to in paragraph (1) during such 
                period;
                  (C) the number of days by which such 
                applications were so delayed; and
                  (D) the number of such petitions that were 
                submitted during such period.
          (4) Exceptions.--
                  (A) This subsection does not apply to--
                          (i) a petition that relates solely to 
                        the timing of the approval of an 
                        application pursuant to subsection 
                        (j)(5)(B)(iv); or
                          (ii) a petition that is made by the 
                        sponsor of an application and that 
                        seeks only to have the Secretary take 
                        or refrain from taking any form of 
                        action with respect to that 
                        application.
                  (B) Paragraph (2) does not apply to a 
                petition addressing issues concerning an 
                application submitted pursuant to section 
                351(k) of the Public Health Service Act.
          (5) Definitions.--
                  (A) Application.--For purposes of this 
                subsection, the term ``application'' means an 
                application submitted under subsection (b)(2) 
                or (j) of the Act or 351(k) of the Public 
                Health Service Act.
                  (B) Petition.--For purposes of this 
                subsection, other than paragraph (1)(A)(i), the 
                term ``petition'' means a request described in 
                paragraph (1)(A)(i).
  (r) Postmarket Drug Safety Information for Patients and 
Providers.--
          (1) Establishment.--Not later than 1 year after the 
        date of the enactment of the Food and Drug 
        Administration Amendments Act of 2007, the Secretary 
        shall improve the transparency of information about 
        drugs and allow patients and health care providers 
        better access to information about drugs by developing 
        and maintaining an Internet Web site that--
                  (A) provides links to drug safety information 
                listed in paragraph (2) for prescription drugs 
                that are approved under this section or 
                licensed under section 351 of the Public Health 
                Service Act; and
                  (B) improves communication of drug safety 
                information to patients and providers.
          (2) Internet web site.--The Secretary shall carry out 
        paragraph (1) by--
                  (A) developing and maintaining an accessible, 
                consolidated Internet Web site with easily 
                searchable drug safety information, including 
                the information found on United States 
                Government Internet Web sites, such as the 
                United States National Library of Medicine's 
                Daily Med and Medline Plus Web sites, in 
                addition to other such Web sites maintained by 
                the Secretary;
                  (B) ensuring that the information provided on 
                the Internet Web site is comprehensive and 
                includes, when available and appropriate--
                          (i) patient labeling and patient 
                        packaging inserts;
                          (ii) a link to a list of each drug, 
                        whether approved under this section or 
                        licensed under such section 351, for 
                        which a Medication Guide, as provided 
                        for under part 208 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations), is required;
                          (iii) a link to the registry and 
                        results data bank provided for under 
                        subsections (i) and (j) of section 402 
                        of the Public Health Service Act;
                          (iv) the most recent safety 
                        information and alerts issued by the 
                        Food and Drug Administration for drugs 
                        approved by the Secretary under this 
                        section, such as product recalls, 
                        warning letters, and import alerts;
                          (v) publicly available information 
                        about implemented RiskMAPs and risk 
                        evaluation and mitigation strategies 
                        under subsection (o);
                          (vi) guidance documents and 
                        regulations related to drug safety; and
                          (vii) other material determined 
                        appropriate by the Secretary;
                  (C) providing access to summaries of the 
                assessed and aggregated data collected from the 
                active surveillance infrastructure under 
                subsection (k)(3) to provide information of 
                known and serious side-effects for drugs 
                approved under this section or licensed under 
                such section 351;
                  (D) preparing, by 18 months after approval of 
                a drug or after use of the drug by 10,000 
                individuals, whichever is later, a summary 
                analysis of the adverse drug reaction reports 
                received for the drug, including identification 
                of any new risks not previously identified, 
                potential new risks, or known risks reported in 
                unusual number;
                  (E) enabling patients, providers, and drug 
                sponsors to submit adverse event reports 
                through the Internet Web site;
                  (F) providing educational materials for 
                patients and providers about the appropriate 
                means of disposing of expired, damaged, or 
                unusable medications; and
                  (G) supporting initiatives that the Secretary 
                determines to be useful to fulfill the purposes 
                of the Internet Web site.
          (3) Posting of drug labeling.--The Secretary shall 
        post on the Internet Web site established under 
        paragraph (1) the approved professional labeling and 
        any required patient labeling of a drug approved under 
        this section or licensed under such section 351 not 
        later than 21 days after the date the drug is approved 
        or licensed, including in a supplemental application 
        with respect to a labeling change.
          (4) Private sector resources.--To ensure development 
        of the Internet Web site by the date described in 
        paragraph (1), the Secretary may, on a temporary or 
        permanent basis, implement systems or products 
        developed by private entities.
          (5) Authority for contracts.--The Secretary may enter 
        into contracts with public and private entities to 
        fulfill the requirements of this subsection.
          (6) Review.--The Advisory Committee on Risk 
        Communication under section 567 shall, on a regular 
        basis, perform a comprehensive review and evaluation of 
        the types of risk communication information provided on 
        the Internet Web site established under paragraph (1) 
        and, through other means, shall identify, clarify, and 
        define the purposes and types of information available 
        to facilitate the efficient flow of information to 
        patients and providers, and shall recommend ways for 
        the Food and Drug Administration to work with outside 
        entities to help facilitate the dispensing of risk 
        communication information to patients and providers.
  (s) Referral to Advisory Committee.--Prior to the approval of 
a drug no active ingredient (including any ester or salt of the 
active ingredient) of which has been approved in any other 
application under this section or section 351 of the Public 
Health Service Act, the Secretary shall--
          (1) refer such drug to a Food and Drug Administration 
        advisory committee for review at a meeting of such 
        advisory committee; or
          (2) if the Secretary does not refer such a drug to a 
        Food and Drug Administration advisory committee prior 
        to the approval of the drug, provide in the action 
        letter on the application for the drug a summary of the 
        reasons why the Secretary did not refer the drug to an 
        advisory committee prior to approval.
  (t) Database for Authorized Generic Drugs.--
          (1) In general.--
                  (A) Publication.--The Commissioner shall--
                          (i) not later than 9 months after the 
                        date of the enactment of the Food and 
                        Drug Administration Amendments Act of 
                        2007, publish a complete list on the 
                        Internet Web site of the Food and Drug 
                        Administration of all authorized 
                        generic drugs (including drug trade 
                        name, brand company manufacturer, and 
                        the date the authorized generic drug 
                        entered the market); and
                          (ii) update the list quarterly to 
                        include each authorized generic drug 
                        included in an annual report submitted 
                        to the Secretary by the sponsor of a 
                        listed drug during the preceding 3-
                        month period.
                  (B) Notification.--The Commissioner shall 
                notify relevant Federal agencies, including the 
                Centers for Medicare & Medicaid Services and 
                the Federal Trade Commission, when the 
                Commissioner first publishes the information 
                described in subparagraph (A) that the 
                information has been published and that the 
                information will be updated quarterly.
          (2) Inclusion.--The Commissioner shall include in the 
        list described in paragraph (1) each authorized generic 
        drug included in an annual report submitted to the 
        Secretary by the sponsor of a listed drug after January 
        1, 1999.
          (3) Authorized generic drug.--In this section, the 
        term ``authorized generic drug'' means a listed drug 
        (as that term is used in subsection (j)) that--
                  (A) has been approved under subsection (c); 
                and
                  (B) is marketed, sold, or distributed 
                directly or indirectly to retail class of trade 
                under a different labeling, packaging (other 
                than repackaging as the listed drug in blister 
                packs, unit doses, or similar packaging for use 
                in institutions), product code, labeler code, 
                trade name, or trade mark than the listed drug.
  (u) Certain Drugs Containing Single Enantiomers.--
          (1) In general.--For purposes of subsections 
        (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is 
        submitted under subsection (b) for a non-racemic drug 
        containing as an active ingredient (including any ester 
        or salt of the active ingredient) a single enantiomer 
        that is contained in a racemic drug approved in another 
        application under subsection (b), the applicant may, in 
        the application for such non-racemic drug, elect to 
        have the single enantiomer not be considered the same 
        active ingredient as that contained in the approved 
        racemic drug, if--
                  (A)(i) the single enantiomer has not been 
                previously approved except in the approved 
                racemic drug; and
                  (ii) the application submitted under 
                subsection (b) for such non-racemic drug--
                          (I) includes full reports of new 
                        clinical investigations (other than 
                        bioavailability studies)--
                                  (aa) necessary for the 
                                approval of the application 
                                under subsections (c) and (d); 
                                and
                                  (bb) conducted or sponsored 
                                by the applicant; and
                          (II) does not rely on any clinical 
                        investigations that are part of an 
                        application submitted under subsection 
                        (b) for approval of the approved 
                        racemic drug; and
                  (B) the application submitted under 
                subsection (b) for such non-racemic drug is not 
                submitted for approval of a condition of use--
                          (i) in a therapeutic category in 
                        which the approved racemic drug has 
                        been approved; or
                          (ii) for which any other enantiomer 
                        of the racemic drug has been approved.
          (2) Limitation.--
                  (A) No approval in certain therapeutic 
                categories.--Until the date that is 10 years 
                after the date of approval of a non-racemic 
                drug described in paragraph (1) and with 
                respect to which the applicant has made the 
                election provided for by such paragraph, the 
                Secretary shall not approve such non-racemic 
                drug for any condition of use in the 
                therapeutic category in which the racemic drug 
                has been approved.
                  (B) Labeling.--If applicable, the labeling of 
                a non-racemic drug described in paragraph (1) 
                and with respect to which the applicant has 
                made the election provided for by such 
                paragraph shall include a statement that the 
                non-racemic drug is not approved, and has not 
                been shown to be safe and effective, for any 
                condition of use of the racemic drug.
          (3) Definition.--
                  (A) In general.--For purposes of this 
                subsection, the term ``therapeutic category'' 
                means a therapeutic category identified in the 
                list developed by the United States 
                Pharmacopeia pursuant to section 1860D-
                4(b)(3)(C)(ii) of the Social Security Act and 
                as in effect on the date of the enactment of 
                this subsection.
                  (B) Publication by secretary.--The Secretary 
                shall publish the list described in 
                subparagraph (A) and may amend such list by 
                regulation.
          (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, 
        2017.
  (v) Antibiotic Drugs Submitted Before November 21, 1997.--
          (1) Antibiotic drugs approved before november 21, 
        1997.--
                  (A) In general.--Notwithstanding any 
                provision of the Food and Drug Administration 
                Modernization Act of 1997 or any other 
                provision of law, a sponsor of a drug that is 
                the subject of an application described in 
                subparagraph (B)(i) shall be eligible for, with 
                respect to the drug, the 3-year exclusivity 
                period referred to under clauses (iii) and (iv) 
                of subsection (c)(3)(E) and under clauses (iii) 
                and (iv) of subsection (j)(5)(F), subject to 
                the requirements of such clauses, as 
                applicable.
                  (B) Application; antibiotic drug described.--
                          (i) Application.--An application 
                        described in this clause is an 
                        application for marketing submitted 
                        under this section after the date of 
                        the enactment of this subsection in 
                        which the drug that is the subject of 
                        the application contains an antibiotic 
                        drug described in clause (ii).
                          (ii) Antibiotic drug.--An antibiotic 
                        drug described in this clause is an 
                        antibiotic drug that was the subject of 
                        an application approved by the 
                        Secretary under section 507 of this Act 
                        (as in effect before November 21, 
                        1997).
          (2) Antibiotic drugs submitted before november 21, 
        1997, but not approved.--
                  (A) In general.--Notwithstanding any 
                provision of the Food and Drug Administration 
                Modernization Act of 1997 or any other 
                provision of law, a sponsor of a drug that is 
                the subject of an application described in 
                subparagraph (B)(i) may elect to be eligible 
                for, with respect to the drug--
                          (i)(I) the 3-year exclusivity period 
                        referred to under clauses (iii) and 
                        (iv) of subsection (c)(3)(E) and under 
                        clauses (iii) and (iv) of subsection 
                        (j)(5)(F), subject to the requirements 
                        of such clauses, as applicable; and
                          (II) the 5-year exclusivity period 
                        referred to under clause (ii) of 
                        subsection (c)(3)(E) and under clause 
                        (ii) of subsection (j)(5)(F), subject 
                        to the requirements of such clauses, as 
                        applicable; or
                          (ii) a patent term extension under 
                        section 156 of title 35, United States 
                        Code, subject to the requirements of 
                        such section.
                  (B) Application; antibiotic drug described.--
                          (i) Application.--An application 
                        described in this clause is an 
                        application for marketing submitted 
                        under this section after the date of 
                        the enactment of this subsection in 
                        which the drug that is the subject of 
                        the application contains an antibiotic 
                        drug described in clause (ii).
                          (ii) Antibiotic drug.--An antibiotic 
                        drug described in this clause is an 
                        antibiotic drug that was the subject of 
                        1 or more applications received by the 
                        Secretary under section 507 of this Act 
                        (as in effect before November 21, 
                        1997), none of which was approved by 
                        the Secretary under such section.
          (3) Limitations.--
                  (A) Exclusivities and extensions.--Paragraphs 
                (1)(A) and (2)(A) shall not be construed to 
                entitle a drug that is the subject of an 
                approved application described in subparagraphs 
                (1)(B)(i) or (2)(B)(i), as applicable, to any 
                market exclusivities or patent extensions other 
                than those exclusivities or extensions 
                described in paragraph (1)(A) or (2)(A).
                  (B) Conditions of use.--Paragraphs (1)(A) and 
                (2)(A)(i) shall not apply to any condition of 
                use for which the drug referred to in 
                subparagraph (1)(B)(i) or (2)(B)(i), as 
                applicable, was approved before the date of the 
                enactment of this subsection.
          (4) Application of certain provisions.--
        Notwithstanding section 125, or any other provision, of 
        the Food and Drug Administration Modernization Act of 
        1997, or any other provision of law, and subject to the 
        limitations in paragraphs (1), (2), and (3), the 
        provisions of the Drug Price Competition and Patent 
        Term Restoration Act of 1984 shall apply to any drug 
        subject to paragraph (1) or any drug with respect to 
        which an election is made under paragraph (2)(A).
  (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.
  (x) Date of Approval in the Case of Recommended Controls 
Under the CSA.--
          (1) In general.--In the case of an application under 
        subsection (b) with respect to a drug for which the 
        Secretary provides notice to the sponsor that the 
        Secretary intends to recommend controls under the 
        Controlled Substances Act, approval of such application 
        shall not take effect until the interim final rule 
        controlling the drug is issued in accordance with 
        section 201(j) of the Controlled Substances Act.
          (2) Date of approval.--For purposes of this section, 
        with respect to an application described in paragraph 
        (1), the term ``date of approval'' shall mean the later 
        of--
                  (A) the date an application under subsection 
                (b) is approved under subsection (c); or
                  (B) the date of issuance of the interim final 
                rule controlling the drug.

           *       *       *       *       *       *       *


                            new animal drugs

  Sec. 512. (a)
  (1) A new animal drug shall, with respect to any particular 
use or intended use of such drug, be deemed unsafe for purposes 
of section 501(a)(5) and section 402(a)(2)(C)(ii) unless--
          (A) there is in effect an approval of an application 
        filed pursuant to subsection (b) with respect to such 
        use or intended use of such drug, and such drug, its 
        labeling, and such use conform to such approved 
        application;
          (B) there is in effect a conditional approval of an 
        application filed pursuant to section 571 with respect 
        to such use or intended use of such drug, and such 
        drug, its labeling, and such use conform to such 
        conditionally approved application; or
          (C) there is in effect an index listing pursuant to 
        section 572 with respect to such use or intended use of 
        such drug in a minor species, and such drug, its 
        labeling, and such use conform to such index listing.
A new animal drug shall also be deemed unsafe for such purposes 
in the event of removal from the establishment of a 
manufacturer, packer, or distributor of such drug for use in 
the manufacture of animal feed in any State unless at the time 
of such removal such manufacturer, packer, or distributor has 
an unrevoked written statement from the consignee of such drug, 
or notice from the Secretary, to the effect that, with respect 
to the use of such drug in animal feed, such consignee (i) 
holds a license issued under subsection (m) and has in its 
possession current approved labeling for such drug in animal 
feed; or (ii) will, if the consignee is not a user of the drug, 
ship such drug only to a holder of a license issued under 
subsection (m).
  (2) An animal feed bearing or containing a new animal drug 
shall, with respect to any particular use or intended use of 
such animal feed be deemed unsafe for purposes of section 
501(a)(6) unless--
          (A) there is in effect--
                  (i) an approval of an application filed 
                pursuant to subsection (b) with respect to such 
                drug, as used in such animal feed, and such 
                animal feed and its labeling, distribution, 
                holding, and use conform to such approved 
                application;
                  (ii) a conditional approval of an application 
                filed pursuant to section 571 with respect to 
                such drug, as used in such animal feed, and 
                such animal feed and its labeling, 
                distribution, holding, and use conform to such 
                conditionally approved application; or
                  (iii) an index listing pursuant to section 
                572 with respect to such drug, as used in such 
                animal feed, and such animal feed and its 
                labeling, distribution, holding, and use 
                conform to such index listing; and
          (B) such animal feed is manufactured at a site for 
        which there is in effect a license issued pursuant to 
        subsection (m)(1) to manufacture such animal feed.
  (3) A new animal drug or an animal feed bearing or containing 
a new animal drug shall not be deemed unsafe for the purposes 
of section 501(a)(5) or (6) if such article is for 
investigational use and conforms to the terms of an exemption 
in effect with respect thereto under section 512(j).
  (4)(A) Except as provided in subparagraph (B), if an approval 
of an application filed under subsection (b) is in effect with 
respect to a particular use or intended use of a new animal 
drug, the drug shall not be deemed unsafe for the purposes of 
paragraph (1) and shall be exempt from the requirements of 
section 502(f) with respect to a different use or intended use 
of the drug, other than a use in or on animal feed, if such use 
or intended use--
          (i) is by or on the lawful written or oral order of a 
        licensed veterinarian within the context of a 
        veterinarian-client-patient relationship, as defined by 
        the Secretary; and
          (ii) is in compliance with regulations promulgated by 
        the Secretary that establish the conditions for such 
        different use or intended use.
The regulations promulgated by the Secretary under clause (ii) 
may prohibit particular uses of an animal drug and shall not 
permit such different use of an animal drug if the labeling of 
another animal drug that contains the same active ingredient 
and which is in the same dosage form and concentration provides 
for such different use.
  (B) If the Secretary finds that there is a reasonable 
probability that a use of an animal drug authorized under 
subparagraph (A) may present a risk to the public health, the 
Secretary may--
          (i) establish a safe level for a residue of an animal 
        drug when it is used for such different use authorized 
        by subparagraph (A); and
          (ii) require the development of a practical, 
        analytical method for the detection of residues of such 
        drug above the safe level established under clause (i).
The use of an animal drug that results in residues exceeding a 
safe level established under clause (i) shall be considered an 
unsafe use of such drug under paragraph (1). Safe levels may be 
established under clause (i) either by regulation or order.
  (C) The Secretary may by general regulation provide access to 
the records of veterinarians to ascertain any use or intended 
use authorized under subparagraph (A) that the Secretary has 
determined may present a risk to the public health.
  (D) If the Secretary finds, after affording an opportunity 
for public comment, that a use of an animal drug authorized 
under subparagraph (A) presents a risk to the public health or 
that an analytical method required under subparagraph (B) has 
not been developed and submitted to the Secretary, the 
Secretary may, by order, prohibit any such use.
  (5) If the approval of an application filed under section 505 
is in effect, the drug under such application shall not be 
deemed unsafe for purposes of paragraph (1) and shall be exempt 
from the requirements of section 502(f) with respect to a use 
or intended use of the drug in animals if such use or intended 
use--
          (A) is by or on the lawful written or oral order of a 
        licensed veterinarian within the context of a 
        veterinarian-client-patient relationship, as defined by 
        the Secretary; and
          (B) is in compliance with regulations promulgated by 
        the Secretary that establish the conditions for the use 
        or intended use of the drug in animals.
  (6) For purposes of section 402(a)(2)(D), a use or intended 
use of a new animal drug shall not be deemed unsafe under this 
section if the Secretary establishes a tolerance for such drug 
and any edible portion of any animal imported into the United 
States does not contain residues exceeding such tolerance. In 
establishing such tolerance, the Secretary shall rely on data 
sufficient to 
demonstrate that a proposed tolerance is safe based on similar 
food safety criteria used by the Secretary to establish 
tolerances for applications for new animal drugs filed under 
subsection (b)(1). The Secretary may consider and rely on data 
submitted by the drug manufacturer, including data submitted to 
appropriate regulatory authorities in any country where the new 
animal drug is lawfully used or data available from a relevant 
international organization, to the extent such data are not 
inconsistent with the criteria used by the Secretary to 
establish a tolerance for applications for new animal drugs 
filed under subsection (b)(1). For purposes of this paragraph, 
``relevant international organization'' means the Codex 
Alimenterius Commission or other international organization 
deemed appropriate by the Secretary. The Secretary may, under 
procedures specified by regulation, revoke a tolerance 
established under this paragraph if information demonstrates 
that the use of the new animal drug under actual use conditions 
results in food being imported into the United States with 
residues exceeding the tolerance or if scientific evidence 
shows the tolerance to be unsafe.
  (b)(1) Any person may file with the Secretary an application 
with respect to any intended use or uses of a new animal drug. 
Such person shall submit to the Secretary as a part of the 
application (A) full reports of investigations which have been 
made to show whether or not such drug is safe and effective for 
use; (B) a full list of the articles used as components of such 
drug; (C) a full statement of the composition of such drug; (D) 
a full description of the methods used in, and the facilities 
and controls used for, the manufacture, processing, and packing 
of such drug; (E) such samples of such drug and of the articles 
used as components thereof, of any animal feed for use in or on 
which such drug is intended, and of the edible portions or 
products (before or after slaughter) of animals to which such 
drug (directly or in or on animal feed) is intended to be 
administered, as the Secretary may require; (F) specimens of 
the labeling proposed to be used for such drug, or in case such 
drug is intended for use in animal feed, proposed labeling 
appropriate for such use, and specimens of the labeling for the 
drug to be manufactured, packed, or distributed by the 
applicant; (G) a description of practicable methods for 
determining the quantity, if any, of such drug in or on food, 
and any substance formed in or on food, because of its use; and 
(H) the proposed tolerance or withdrawal period or other use 
restrictions for such drug if any tolerance or withdrawal 
period or other use restrictions are required in order to 
assure that the proposed use of such drug will be safe. The 
applicant shall file with the application the patent number and 
the expiration date of any patent which claims the new animal 
drug for which the applicant filed the application or which 
claims a method of using such drug and with respect to which a 
claim of patent infringement could reasonably be asserted if a 
person not licensed by the owner engaged in the manufacture, 
use, or sale of the drug. If an application is filed under this 
subsection for a drug and a patent which claims such drug or a 
method of using such drug is issued after the filing date but 
before approval of the application, the applicant shall amend 
the application to include the information required by the 
preceding sentence. Upon approval of the application, the 
Secretary shall publish information submitted under the two 
preceding sentences.
  (2) Any person may file with the Secretary an abbreviated 
application for the approval of a new animal drug. An 
abbreviated application shall contain the information required 
by subsection (n).
  (3) Any person intending to file an application under 
paragraph (1), section 571, or a request for an investigational 
exemption under subsection (j) shall be entitled to one or more 
conferences prior to such submission to reach an agreement 
acceptable to the Secretary establishing a submission or an 
investigational requirement, which may include a requirement 
for a field investigation. A decision establishing a submission 
or an investigational requirement shall bind the Secretary and 
the applicant or requestor unless (A) the Secretary and the 
applicant or requestor mutually agree to modify the 
requirement, or (B) the Secretary by written order determines 
that a substantiated scientific requirement essential to the 
determination of safety or effectiveness of the animal drug 
involved has appeared after the conference. No later than 25 
calendar days after each such conference, the Secretary shall 
provide a written order setting forth a scientific 
justification specific to the animal drug and intended uses 
under consideration if the agreement referred to in the first 
sentence requires more than one field investigation as being 
essential to provide substantial evidence of effectiveness for 
the intended uses of the drug. Nothing in this paragraph shall 
be construed as compelling the Secretary to require a field 
investigation.
  (c)(1) Within one hundred and eighty days after the filing of 
an application pursuant to subsection (b), or such additional 
period as may be agreed upon by the Secretary and the 
applicant, the Secretary shall either (A) issue an order 
approving the application if he then finds that none of the 
grounds for denying approval specified in subsection (d) 
applies, or (B) give the applicant notice of an opportunity for 
a hearing before the Secretary under subsection (d) on the 
question whether such application is approvable. If the 
applicant elects to accept the opportunity for a hearing by 
written request within thirty days after such notice, such 
hearing shall commence not more than ninety days after the 
expiration of such thirty days unless the Secretary and the 
applicant otherwise agree. Any such hearing shall thereafter be 
conducted on an expedited basis and the Secretary's order 
thereon shall be issued within ninety days after the date fixed 
by the Secretary for filing final briefs.
  (2)(A) Subject to subparagraph (C), the Secretary shall 
approve an abbreviated application for a drug unless the 
Secretary finds--
          (i) the methods used in, or the facilities and 
        controls used for, the manufacture, processing, and 
        packing of the drug are inadequate to assure and 
        preserve its identity, strength, quality, and purity;
          (ii) the conditions of use prescribed, recommended, 
        or suggested in the proposed labeling are not 
        reasonably certain to be followed in practice or, 
        except as provided in subparagraph (B), information 
        submitted with the application is insufficient to show 
        that each of the proposed conditions of use or similar 
        limitations (whether in the labeling or published 
        pursuant to subsection (i)) have been previously 
        approved for the approved new animal drug referred to 
        in the application;
          (iii) information submitted with the application is 
        insufficient to show that the active ingredients are 
        the same as those of the approved new animal drug 
        referred to in the application;
          (iv)(I) if the application is for a drug whose active 
        ingredients, route of administration, dosage form, 
        strength, or use with other animal drugs in animal feed 
        is the same as the active ingredients, route of 
        administration, dosage form, strength, or use with 
        other animal drugs in animal feed of the approved new 
        animal drug referred to in the application, information 
        submitted in the application is insufficient to show 
        that the active ingredients, route of administration, 
        dosage form, strength, or use with other animal drugs 
        in animal feed is the same as that of the approved new 
        animal drug, or
          (II) if the application is for a drug whose active 
        ingredients, route of administration, dosage form, 
        strength, or use with other animal drugs in animal feed 
        is different from that of the approved new animal drug 
        referred to in the application, no petition to file an 
        application for the drug with the different active 
        ingredients, route of administration, dosage form, 
        strength, or use with other animal drugs in animal feed 
        was approved under subsection (n)(3);
          (v) if the application was filed pursuant to the 
        approval of a petition under subsection (n)(3), the 
        application did not contain the information required by 
        the Secretary respecting the active ingredients, route 
        of administration, dosage form, strength, or use with 
        other animal drugs in animal feed which is not the 
        same;
          (vi) information submitted in the application is 
        insufficient to show that the drug is bioequivalent to 
        the approved new animal drug referred to in the 
        application, or if the application is filed under a 
        petition approved pursuant to subsection (n)(3), 
        information submitted in the application is 
        insufficient to show that the active ingredients of the 
        new animal drug are of the same pharmacological or 
        therapeutic class as the pharmacological or therapeutic 
        class of the approved new animal drug and that the new 
        animal drug can be expected to have the same 
        therapeutic effect as the approved new animal drug when 
        used in accordance with the labeling;
          (vii) information submitted in the application is 
        insufficient to show that the labeling proposed for the 
        drug is the same as the labeling approved for the 
        approved new animal drug referred to in the application 
        except for changes required because of differences 
        approved under a petition filed under subsection 
        (n)(3), because of a different withdrawal period, or 
        because the drug and the approved new animal drug are 
        produced or distributed by different manufacturers;
          (viii) information submitted in the application or 
        any other information available to the Secretary shows 
        that (I) the inactive ingredients of the drug are 
        unsafe for use under the conditions prescribed, 
        recommended, or suggested in the labeling proposed for 
        the drug, (II) the composition of the drug is unsafe 
        under such conditions because of the type or quantity 
        of inactive ingredients included or the manner in which 
        the inactive ingredients are included, or (III) in the 
        case of a drug for food producing animals, the inactive 
        ingredients of the drug or its composition may be 
        unsafe with respect to human food safety;
          (ix) the approval under subsection (b)(1) of the 
        approved new animal drug referred to in the application 
        filed under subsection (b)(2) has been withdrawn or 
        suspended for grounds described in paragraph (1) of 
        subsection (e), the Secretary has published a notice of 
        a hearing to withdraw approval of the approved new 
        animal drug for such grounds, the approval under this 
        paragraph of the new animal drug for which the 
        application under subsection (b)(2) was filed has been 
        withdrawn or suspended under subparagraph (G) for such 
        grounds, or the Secretary has determined that the 
        approved new animal drug has been withdrawn from sale 
        for safety or effectiveness reasons;
          (x) the application does not meet any other 
        requirement of subsection (n); or
          (xi) the application contains an untrue statement of 
        material fact.
  (B) If the Secretary finds that a new animal drug for which 
an application is submitted under subsection (b)(2) is 
bioequivalent to the approved new animal drug referred to in 
such application and that residues of the new animal drug are 
consistent with the tolerances established for such approved 
new animal drug but at a withdrawal period which is different 
than the withdrawal period approved for such approved new 
animal drug, the Secretary may establish, on the basis of 
information submitted, such different withdrawal period as the 
withdrawal period for the new animal drug for purposes of the 
approval of such application for such drug.
  (C) Within 180 days of the initial receipt of an application 
under subsection (b)(2) or within such additional period as may 
be agreed upon by the Secretary and the applicant, the 
Secretary shall approve or disapprove the application.
  (D) The approval of an application filed under subsection 
(b)(2) shall be made effective on the last applicable date 
determined under the following:
          (i) If the applicant only made a certification 
        described in clause (i) or (ii) of subsection (n)(1)(G) 
        or in both such clauses, the approval may be made 
        effective immediately.
          (ii) If the applicant made a certification described 
        in clause (iii) of subsection (n)(1)(G), the approval 
        may be made effective on the date certified under 
        clause (iii).
          (iii) If the applicant made a certification described 
        in clause (iv) of subsection (n)(1)(G), the approval 
        shall be made effective immediately unless an action is 
        brought for infringement of a patent which is the 
        subject of the certification before the expiration of 
        45 days from the date the notice provided under 
        subsection (n)(2)(B)(i) is received. If such an action 
        is brought before the expiration of such days, the 
        approval shall be made effective upon the expiration of 
        the 30 month period beginning on the date of the 
        receipt of the notice provided under subsection 
        (n)(2)(B) or such shorter or longer period as the court 
        may order because either party to the action failed to 
        reasonably cooperate in expediting the action, except 
        that if before the expiration of such period--
                  (I) the court decides that such patent is 
                invalid or not infringed, the approval shall be 
                made effective on the date of the court 
                decision,
                  (II) the court decides that such patent has 
                been infringed, the approval shall be made 
                effective on such date as the court orders 
                under section 271(e)(4)(A) of title 35, United 
                States Code, or
                  (III) the court grants a preliminary 
                injunction prohibiting the applicant from 
                engaging in the commercial manufacture or sale 
                of the drug until the court decides the issues 
                of patent validity and infringement and if the 
                court decides that such patent is invalid or 
                not infringed, the approval shall be made 
                effective on the date of such court decision.
        In such an action, each of the parties shall reasonably 
        cooperate in expediting the action. Until the 
        expiration of 45 days from the date the notice made 
        under subsection (n)(2)(B) is received, no action may 
        be brought under section 2201 of title 28, United 
        States Code, for a declaratory judgment with respect to 
        the patent. Any action brought under section 2201 shall 
        be brought in the judicial district where the defendant 
        has its principal place of business or a regular and 
        established place of business.
          (iv) If the application contains a certification 
        described in clause (iv) of subsection (n)(1)(G) and is 
        for a drug for which a previous application has been 
        filed under this subsection containing such a 
        certification, the application shall be made effective 
        not earlier than 180 days after--
                  (I) the date the Secretary receives notice 
                from the applicant under the previous 
                application of the first commercial marketing 
                of the drug under the previous application, or
                  (II) the date of a decision of a court in an 
                action described in subclause (III) holding the 
                patent which is the subject of the 
                certification to be invalid or not infringed,
        whichever is earlier.
  (E) If the Secretary decides to disapprove an application, 
the Secretary shall give the applicant notice of an opportunity 
for a hearing before the Secretary on the question of whether 
such application is approvable. If the applicant elects to 
accept the opportunity for hearing by written request within 30 
days after such notice, such hearing shall commence not more 
than 90 days after the expiration of such 30 days unless the 
Secretary and the applicant otherwise agree. Any such hearing 
shall thereafter be conducted on an expedited basis and the 
Secretary's order thereon shall be issued within 90 days after 
the date fixed by the Secretary for filing final briefs.
  (F)(i) If an application submitted under subsection (b)(1) 
for a drug, no active ingredient (including any ester or salt 
of the active ingredient) of which has been approved in any 
other application under subsection (b)(1), is approved after 
the date of the enactment of this paragraph, no application may 
be submitted under subsection (b)(2) which refers to the drug 
for which the subsection (b)(1) application was submitted 
before the expiration of 5 years from the date of the approval 
of the application under subsection (b)(1), except that such an 
application may be submitted under subsection (b)(2) after the 
expiration of 4 years from the date of the approval of the 
subsection (b)(1) application if it contains a certification of 
patent invalidity or noninfringement described in clause (iv) 
of subsection (n)(1)(G). The approval of such an application 
shall be made effective in accordance with subparagraph (B) 
except that, if an action for patent infringement is commenced 
during the one-year period beginning 48 months after the date 
of the approval of the subsection (b) application, the 30 month 
period referred to in subparagraph (D)(iii) shall be extended 
by such amount of time (if any) which is required for seven and 
one-half years to have elapsed from the date of approval of the 
subsection (b) application.
  (ii) If an application submitted under subsection (b)(1) for 
a drug, which includes an active ingredient (including any 
ester or salt of the active ingredient) that has been approved 
in another application approved under such subsection, is 
approved after the date of enactment of this paragraph and if 
such application contains substantial evidence of the 
effectiveness of the drug involved, any studies of animal 
safety, or, in the case of food producing animals, human food 
safety studies (other than bioequivalence studies or residue 
depletion studies, except residue depletion studies for minor 
uses or minor species) required for the approval of the 
application and conducted or sponsored by the applicant, the 
Secretary may not make the approval of an application submitted 
under subsection (b)(2) for the conditions of approval of such 
drug in the subsection (b)(1) application effective before the 
expiration of 3 years from the date of the approval of the 
application under subsection (b)(1) for such drug.
  (iii) If a supplement to an application approved under 
subsection (b)(1) is approved after the date of enactment of 
this paragraph and the supplement contains substantial evidence 
of the effectiveness of the drug involved, any studies of 
animal safety, or, in the case of food producing animals, human 
food safety studies (other than bioequivalence studies or 
residue depletion studies, except residue depletion studies for 
minor uses or minor species) required for the approval of the 
supplement and conducted or sponsored by the person submitting 
the supplement, the Secretary may not make the approval of an 
application submitted under subsection (b)(2) for a change 
approved in the supplement effective before the expiration of 3 
years from the date of the approval of the supplement.
  (iv) An applicant under subsection (b)(1) who comes within 
the provisions of clause (i) of this subparagraph as a result 
of an application which seeks approval for a use solely in non-
food producing animals, may elect, within 10 days of receiving 
such approval, to waive clause (i) of this subparagraph, in 
which event the limitation on approval of applications 
submitted under subsection (b)(2) set forth in clause (ii) of 
this subparagraph shall be applicable to the subsection (b)(1) 
application.
  (v) If an application (including any supplement to a new 
animal drug application) submitted under subsection (b)(1) for 
a new animal drug for a food-producing animal use, which 
includes an active ingredient (including any ester or salt of 
the active ingredient) which has been the subject of a waiver 
under clause (iv) is approved after the date of enactment of 
this paragraph, and if the application contains substantial 
evidence of the effectiveness of the drug involved, any studies 
of animal safety, or human food safety studies (other than 
bioequivalence studies or residue depletion studies, except 
residue depletion studies for minor uses or minor species) 
required for the new approval of the application and conducted 
or sponsored by the applicant, the Secretary may not make the 
approval of an application (including any supplement to such 
application) submitted under subsection (b)(2) for the new 
conditions of approval of such drug in the subsection (b)(1) 
application effective before the expiration of five years from 
the date of approval of the application under subsection (b)(1) 
for such drug. The provisions of this paragraph shall apply 
only to the first approval for a food-producing animal use for 
the same applicant after the waiver under clause (iv).
  (G) If an approved application submitted under subsection 
(b)(2) for a new animal drug refers to a drug the approval of 
which was withdrawn or suspended for grounds described in 
paragraph (1) or (2) of subsection (e) or was withdrawn or 
suspended under this subparagraph or which, as determined by 
the Secretary, has been withdrawn from sale for safety or 
effectiveness reasons, the approval of the drug under this 
paragraph shall be withdrawn or suspended--
          (i) for the same period as the withdrawal or 
        suspension under subsection (e) or this subparagraph, 
        or
          (ii) if the approved new animal drug has been 
        withdrawn from sale, for the period of withdrawal from 
        sale or, if earlier, the period ending on the date the 
        Secretary determines that the withdrawal from sale is 
        not for safety or effectiveness reasons.
  (H) For purposes of this paragraph:
          (i) The term ``bioequivalence'' means the rate and 
        extent to which the active ingredient or therapeutic 
        ingredient is absorbed from a new animal drug and 
        becomes available at the site of drug action.
          (ii) A new animal drug shall be considered to be 
        bioequivalent to the approved new animal drug referred 
        to in its application under subsection (n) if--
                  (I) the rate and extent of absorption of the 
                drug do not show a significant difference from 
                the rate and extent of absorption of the 
                approved new animal drug referred to in the 
                application when administered at the same dose 
                of the active ingredient under similar 
                experimental conditions in either a single dose 
                or multiple doses;
                  (II) the extent of absorption of the drug 
                does not show a significant difference from the 
                extent of absorption of the approved new animal 
                drug referred to in the application when 
                administered at the same dose of the active 
                ingredient under similar experimental 
                conditions in either a single dose or multiple 
                doses and the difference from the approved new 
                animal drug in the rate of absorption of the 
                drug is intentional, is reflected in its 
                proposed labeling, is not essential to the 
                attainment of effective drug concentrations in 
                use, and is considered scientifically 
                insignificant for the drug in attaining the 
                intended purposes of its use and preserving 
                human food safety; or
                  (III) in any case in which the Secretary 
                determines that the measurement of the rate and 
                extent of absorption or excretion of the new 
                animal drug in biological fluids is 
                inappropriate or impractical, an appropriate 
                acute pharmacological effects test or other 
                test of the new animal drug and, when deemed 
                scientifically necessary, of the approved new 
                animal drug referred to in the application in 
                the species to be tested or in an appropriate 
                animal model does not show a significant 
                difference between the new animal drug and such 
                approved new animal drug when administered at 
                the same dose under similar experimental 
                conditions.
        If the approved new animal drug referred to in the 
        application for a new animal drug under subsection (n) 
        is approved for use in more than one animal species, 
        the bioequivalency information described in subclauses 
        (I), (II), and (III) shall be obtained for one species, 
        or if the Secretary deems appropriate based on 
        scientific principles, shall be obtained for more than 
        one species. The Secretary may prescribe the dose to be 
        used in determining bioequivalency under subclause (I), 
        (II), or (III). To assure that the residues of the new 
        animal drug will be consistent with the established 
        tolerances for the approved new animal drug referred to 
        in the application under subsection (b)(2) upon the 
        expiration of the withdrawal period contained in the 
        application for the new animal drug, the Secretary 
        shall require bioequivalency data or residue depletion 
        studies of the new animal drug or such other data or 
        studies as the Secretary considers appropriate based on 
        scientific principles. If the Secretary requires one or 
        more residue studies under the preceding sentence, the 
        Secretary may not require that the assay methodology 
        used to determine the withdrawal period of the new 
        animal drug be more rigorous than the methodology used 
        to determine the withdrawal period for the approved new 
        animal drug referred to in the application. If such 
        studies are required and if the approved new animal 
        drug, referred to in the application for the new animal 
        drug for which such studies are required, is approved 
        for use in more than one animal species, such studies 
        shall be conducted for one species, or if the Secretary 
        deems appropriate based on scientific principles, shall 
        be conducted for more than one species.
  (3) If the patent information described in subsection (b)(1) 
could not be filed with the submission of an application under 
subsection (b)(1) because the application was filed before the 
patent information was required under subsection (b)(1) or a 
patent was issued after the application was approved under such 
subsection, the holder of an approved application shall file 
with the Secretary the patent number and the expiration date of 
any patent which claims the new animal drug for which the 
application was filed or which claims a method of using such 
drug and with respect to which a claim of patent infringement 
could reasonably be asserted if a person not licensed by the 
owner engaged in the manufacture, use, or sale of the drug. If 
the holder of an approved application could not file patent 
information under subsection (b)(1) because it was not required 
at the time the application was approved, the holder shall file 
such information under this subsection not later than 30 days 
after the date of the enactment of this sentence, and if the 
holder of an approved application could not file patent 
information under subsection (b)(1) because no patent had been 
issued when an application was filed or approved, the holder 
shall file such information under this subsection not later 
than 30 days after the date the patent involved is issued. Upon 
the submission of patent information under this subsection, the 
Secretary shall publish it.
  (4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
drug and to obtain approval for the drug prior to manufacture 
of the drug in a larger facility, unless the Secretary makes a 
determination that a full scale production facility is 
necessary to ensure the safety or effectiveness of the drug.
  (d)(1) If the Secretary finds, after due notice to the 
applicant in accordance with subsection (c) and giving him an 
opportunity for a hearing, in accordance with said subsection, 
that--
          (A) the investigations, reports of which are required 
        to be submitted to the Secretary pursuant to subsection 
        (b), do not include adequate tests by all methods 
        reasonably applicable to show whether or not such drug 
        is safe for use under the conditions prescribed, 
        recommended, or suggested in the proposed labeling 
        thereof;
          (B) the results of such tests show that such drug is 
        unsafe for use under such conditions or do not show 
        that such drug is safe for use under such conditions;
          (C) the methods used in, and the facilities and 
        controls used for, the manufacture, processing, and 
        packing of such drug are inadequate to preserve its 
        identity, strength, quality, and purity;
          (D) upon the basis of the information submitted to 
        him as part of the application, or upon the basis of 
        any other information before him with respect to such 
        drug, he has insufficient information to determine 
        whether such drug is safe for use under such 
        conditions;
          (E) evaluated on the basis of the information 
        submitted to him as part of the application and any 
        other information before him with respect to such drug, 
        there is a lack of substantial evidence that the drug 
        will have the effect it purports or is represented to 
        have under the conditions of use prescribed, 
        recommended, or suggested in the proposed labeling 
        thereof;
          (F) upon the basis of information submitted to the 
        Secretary as part of the application or any other 
        information before the Secretary with respect to such 
        drug, any use prescribed, recommended, or suggested in 
        labeling proposed for such drug will result in a 
        residue of such drug in excess of a tolerance found by 
        the Secretary to be safe for such drug;
          (G) the application failed to contain the patent 
        information prescribed by subsection (b)(1);
          (H) based on a fair evaluation of all material facts, 
        such labeling is false or misleading in any particular; 
        or
          (I) such drug induces cancer when ingested by man or 
        animal or, after tests which are appropriate for the 
        evaluation of the safety of such drug, induces cancer 
        in man or animal, except that the foregoing provisions 
        of this subparagraph shall not apply with respect to 
        such drug if the Secretary finds that, under the 
        conditions of use specified in proposed labeling and 
        reasonably certain to be followed in practice (i) such 
        drug will not adversely affect the animals for which it 
        is intended, and (ii) no residue of such drug will be 
        found (by methods of examination prescribed or approved 
        by the Secretary by regulations, which regulations 
        shall not be subject to subsections (c), (d), and (h)), 
        in any edible portion of such animals after slaughter 
        or in any food yielded by or derived from the living 
        animals;
he shall issue an order refusing to approve the application. 
If, after such notice and opportunity for hearing, the 
Secretary finds that subparagraphs (A) through (I) do not 
apply, he shall issue an order approving the application.
  (2) In determining whether such drug is safe for use under 
the conditions prescribed, recommended, or suggested in the 
proposed labeling thereof, the Secretary shall consider, among 
other relevant factors, (A) the probable consumption of such 
drug and of any substance formed in or on food because of the 
use of such drug, (B) the cumulative effect on man or animal of 
such drug, taking into account any chemically or 
pharmacologically related substance, (C) safety factors which 
in the opinion of experts, qualified by scientific training and 
experience to evaluate the safety of such drugs, are 
appropriate for the use of animal experimentation data, and (D) 
whether the conditions of use prescribed, recommended, or 
suggested in the proposed labeling are reasonably certain to be 
followed in practice. Any order issued under this subsection 
refusing to approve an application shall state the findings 
upon which it is based.
  (3) As used in this section, the term ``substantial 
evidence'' means evidence consisting of one or more adequate 
and well controlled investigations, such as--
          (A) a study in a target species;
          (B) a study in laboratory animals;
          (C) any field investigation that may be required 
        under this section and that meets the requirements of 
        subsection (b)(3) if a presubmission conference is 
        requested by the applicant;
          (D) a bioequivalence study; or
          (E) an in vitro study;
by experts qualified by scientific training and experience to 
evaluate the effectiveness of the drug involved, on the basis 
of which it could fairly and reasonably be concluded by such 
experts that the drug will have the effect it purports or is 
represented to have under the conditions of use prescribed, 
recommended, or suggested in the labeling or proposed labeling 
thereof.
  (4) In a case in which an animal drug contains more than one 
active ingredient, or the labeling of the drug prescribes, 
recommends, or suggests use of the drug in combination with one 
or more other animal drugs, and the active ingredients or drugs 
intended for use in the combination have previously been 
separately approved pursuant to an application submitted under 
section 512(b)(1) for particular uses and conditions of use for 
which they are intended for use in the combination--
          (A) the Secretary shall not issue an order under 
        paragraph (1)(A), (1)(B), or (1)(D) refusing to approve 
        the application for such combination on human food 
        safety grounds unless the Secretary finds that the 
        application fails to establish that--
                  (i) none of the active ingredients or drugs 
                intended for use in the combination, 
                respectively, at the longest withdrawal time of 
                any of the active ingredients or drugs in the 
                combination, respectively, exceeds its 
                established tolerance; or
                  (ii) none of the active ingredients or drugs 
                in the combination interferes with the methods 
                of analysis for another of the active 
                ingredients or drugs in the combination, 
                respectively;
          (B) the Secretary shall not issue an order under 
        paragraph (1)(A), (1)(B), or (1)(D) refusing to approve 
        the application for such combination on target animal 
        safety grounds unless the Secretary finds that--
                  (i)(I) there is a substantiated scientific 
                issue, specific to one or more of the active 
                ingredients or animal drugs in the combination, 
                that cannot adequately be evaluated based on 
                information contained in the application for 
                the combination (including any investigations, 
                studies, or tests for which the applicant has a 
                right of reference or use from the person by or 
                for whom the investigations, studies, or tests 
                were conducted); or
                  (II) there is a scientific issue raised by 
                target animal observations contained in studies 
                submitted to the 
                Secretary as part of the application; and
                  (ii) based on the Secretary's evaluation of 
                the information contained in the application 
                with respect to the issues identified in 
                clauses (i) (I) and (II), paragraph (1) (A), 
                (B), or (D) apply;
          (C) except in the case of a combination that contains 
        a nontopical antibacterial ingredient or animal drug, 
        the 
        Secretary shall not issue an order under paragraph 
        (1)(E) refusing to approve an application for a 
        combination animal drug intended for use other than in 
        animal feed or drinking water unless the Secretary 
        finds that the application fails to demonstrate that--
                  (i) there is substantial evidence that any 
                active ingredient or animal drug intended only 
                for the same use as another active ingredient 
                or animal drug in the combination makes a 
                contribution to labeled effectiveness;
                  (ii) each active ingredient or animal drug 
                intended for at least one use that is different 
                from all other active ingredients or animal 
                drugs used in the combination 
                provides appropriate concurrent use for the 
                intended target population; or
                  (iii) where based on scientific information 
                the 
                Secretary has reason to believe the active 
                ingredients or animal drugs may be physically 
                incompatible or have disparate dosing regimens, 
                such active ingredients or 
                animal drugs are physically compatible or do 
                not have disparate dosing regimens; and
          (D) the Secretary shall not issue an order under 
        paragraph (1)(E) refusing to approve an application for 
        a combination animal drug intended for use in animal 
        feed or drinking water unless the Secretary finds that 
        the application fails to demonstrate that--
                  (i) there is substantial evidence that any 
                active ingredient or animal drug intended only 
                for the same use as another active ingredient 
                or animal drug in the combination makes a 
                contribution to the labeled effectiveness;
                  (ii) each of the active ingredients or animal 
                drugs intended for at least one use that is 
                different from all other active ingredients or 
                animal drugs used in the combination provides 
                appropriate concurrent use for the intended 
                target population;
                  (iii) where a combination contains more than 
                one nontopical antibacterial ingredient or 
                animal drug, there is substantial evidence that 
                each of the nontopical antibacterial 
                ingredients or animal drugs makes a 
                contribution to the labeled effectiveness, 
                except that for purposes of this clause, 
                antibacterial ingredient or animal drug does 
                not include the ionophore or arsenical classes 
                of animal drugs; or
                  (iv) where based on scientific information 
                the Secretary has reason to believe the active 
                ingredients or animal drugs intended for use in 
                drinking water may be physically incompatible, 
                such active ingredients or animal drugs 
                intended for use in drinking water are 
                physically compatible.
          (5) In reviewing an application that proposes a 
        change to add an intended use for a minor use or a 
        minor species to an approved new animal drug 
        application, the Secretary shall reevaluate only the 
        relevant information in the approved application to 
        determine whether the application for the minor use or 
        minor species can be approved. A decision to approve 
        the application for the minor use or minor species is 
        not, implicitly or explicitly, a reaffirmation of the 
        approval of the original application.
  (e)(1) The Secretary shall, after due notice and opportunity 
for hearing to the applicant, issue an order withdrawing 
approval of an application filed pursuant to subsection (b) 
with respect to any new animal drug if the Secretary finds--
          (A) that experience or scientific data show that such 
        drug is unsafe for use under the conditions of use upon 
        the basis of which the application was approved or the 
        condition of use authorized under subsection (a)(4)(A);
          (B) that new evidence not contained in such 
        application or not available to the Secretary until 
        after such application was approved, or tests by new 
        methods, or tests by methods not deemed reasonably 
        applicable when such application was approved, 
        evaluated together with the evidence available to the 
        Secretary when the application was approved, shows that 
        such drug is not shown to be safe for use under the 
        conditions of use upon the basis of which the 
        application was approved or that subparagraph (I) of 
        paragraph (1) of subsection (d) applies to such drug;
          (C) on the basis of new information before him with 
        respect to such drug, evaluated together with the 
        evidence available to him when the application was 
        approved, that there is a lack of substantial evidence 
        that such drug will have the effect it purports or is 
        represented to have under the conditions of use 
        prescribed, recommended, or suggested in the labeling 
        thereof;
          (D) the patent information prescribed by subsection 
        (c)(3) was not filed within 30 days after the receipt 
        of written notice from the Secretary specifying the 
        failure to file such information;
          (E) that the application contains any untrue 
        statement of a material fact; or
          (F) that the applicant has made any changes from the 
        standpoint of safety or effectiveness beyond the 
        variations provided for in the application unless he 
        has supplemented the application by filing with the 
        Secretary adequate information respecting all such 
        changes and unless there is in effect an approval of 
        the supplemental application. The supplemental 
        application shall be treated in the same manner as the 
        original application.
If the Secretary (or in his absence the officer acting as 
Secretary) finds that there is an imminent hazard to the health 
of man or of the animals for which such drug is intended, he 
may suspend the approval of such application immediately, and 
give the applicant prompt notice of his action and afford the 
applicant the opportunity for an expedited hearing under this 
subsection; but the authority conferred by this sentence to 
suspend the approval of an application shall not be delegated.
  (2) The Secretary may also, after due notice and opportunity 
for hearing to the applicant, issue an order withdrawing the 
approval of an application with respect to any new animal drug 
under this section if the Secretary finds--
          (A) that the applicant has failed to establish a 
        system for maintaining required records, or has 
        repeatedly or deliberately failed to maintain such 
        records or to make required reports in accordance with 
        a regulation or order under subsection (l), or the 
        applicant has refused to permit access to, or copying 
        or verification of, such records as required by 
        paragraph (2) of such subsection;
          (B) that on the basis of new information before him, 
        evaluated together with the evidence before him when 
        the application was approved, the methods used in, or 
        the facilities and controls used for, the manufacture, 
        processing, and packing of such drug are inadequate to 
        assure and preserve its identity, strength, quality, 
        and purity and were not made adequate within a 
        reasonable time after receipt of written notice from 
        the Secretary specifying the matter complained of; or
          (C) that on the basis of new information before him, 
        evaluated together with the evidence before him when 
        the application was approved, the labeling of such 
        drug, based on a fair evaluation of all material facts, 
        is false or misleading in any particular and was not 
        corrected within a reasonable time after receipt of 
        written notice from the Secretary specifying the matter 
        complained of.
  (3) Any order under this subsection shall state the findings 
upon which it is based.
  (f) Whenever the Secretary finds that the facts so require, 
he shall revoke any previous order under subsection (d), (e), 
or (m), or section 571 (c), (d), or (e) refusing, withdrawing, 
or suspending approval of an application and shall approve such 
application or reinstate such approval, as may be appropriate.
  (g) Orders of the Secretary issued under this section, or 
section 571 (other than orders issuing, amending, or repealing 
regulations) shall be served (1) in person by any officer or 
employee of the department designated by the Secretary or (2) 
by mailing the order by registered mail or by certified mail 
addressed to the applicant or respondent at his last known 
address in the records of the Secretary.
  (h) An appeal may be taken by the applicant from an order of 
the Secretary refusing or withdrawing approval of an 
application filed under subsection (b) or (m) of this section. 
The provisions of subsection (h) of section 505 of this Act 
shall govern any such appeal.
  (i) When a new animal drug application filed pursuant to 
subsection (b) or section 571 is approved, the Secretary shall 
by notice, which upon publication shall be effective as a 
regulation, publish in the Federal Register the name and 
address of the applicant and the conditions and indications of 
use of the new animal drug covered by such application, 
including any tolerance and withdrawal period or other use 
restrictions and, if such new animal drug is intended for use 
in animal feed, appropriate purposes and conditions of use 
(including special labeling requirements and any requirement 
that an animal feed bearing or containing the new animal drug 
be limited to use under the professional supervision of a 
licensed veterinarian) applicable to any animal feed for use in 
which such drug is approved, and such other information, upon 
the basis of which such application was approved, as the 
Secretary deems necessary to assure the safe and effective use 
of such drug. Upon withdrawal of approval of such new animal 
drug application or upon its suspension or upon failure to 
renew a conditional approval under section 571, the Secretary 
shall forthwith revoke or suspend, as the case may be, the 
regulation published pursuant to this subsection (i) insofar as 
it is based on the approval of such application.
  (j) To the extent consistent with the public health, the 
Secretary shall promulgate regulations for exempting from the 
operation of this section new animal drugs, and animal feeds 
bearing or containing new animal drugs, intended solely for 
investigational use by experts qualified by scientific training 
and experience to investigate the safety and effectiveness of 
animal drugs. Such regulations may, in the discretion of the 
Secretary, among other conditions relating to the protection of 
the public health, provide for conditioning such exemption upon 
the establishment and maintenance of such records, and the 
making of such reports to the Secretary, by the manufacturer or 
the sponsor of the investigation of such article, of data 
(including but not limited to analytical reports by 
investigators) obtained as a result of such investigational use 
of such article, as the Secretary finds will enable him to 
evaluate the safety and effectiveness of such article in the 
event of the filing of an application pursuant to this section. 
Such regulations, among other things, shall set forth the 
conditions (if any) upon which animals treated with such 
articles, and any products of such animals (before or after 
slaughter), may be marketed for food use.
  (k) While approval of an application for a new animal drug is 
effective, a food shall not, by reason of bearing or containing 
such drug or any substance formed in or on the food because of 
its use in accordance with such application (including the 
conditions and indications of use prescribed pursuant to 
subsection (i)), be considered adulterated within the meaning 
of clause (1) of section 402(a).
  (l)(1) In the case of any new animal drug for which an 
approval of an application filed pursuant to subsection (b) or 
section 571 is in effect, the applicant shall establish and 
maintain such records, and make such reports to the Secretary, 
of data relating to experience, including experience with uses 
authorized under subsection (a)(4)(A), and other data or 
information, received or otherwise obtained by such applicant 
with respect to such drug, or with respect to animal feeds 
bearing or containing such drug, as the Secretary may by 
general regulation, or by order with respect to such 
application, prescribe on the basis of a finding that such 
records and reports are necessary in order to enable the 
Secretary to determine, or facilitate a determination, whether 
there is or may be ground for invoking subsection (e) or 
subsection (m)(4) of this section. Such regulation or order 
shall provide, where the Secretary deems it to be appropriate, 
for the examination, upon request, by the persons to whom such 
regulation or order is applicable, of similar information 
received or otherwise obtained by the Secretary.
  (2) Every person required under this subsection to maintain 
records, and every person in charge or custody thereof, shall, 
upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to have access to and copy and verify such records.
  (3)(A) In the case of each new animal drug described in 
paragraph (1) that contains an antimicrobial active ingredient, 
the sponsor of the drug shall submit an annual report to the 
Secretary on the amount of each antimicrobial active ingredient 
in the drug that is sold or distributed for use in food-
producing animals, including information on any distributor-
labeled product.
  (B) Each report under this paragraph shall specify the amount 
of each antimicrobial active ingredient--
          (i) by container size, strength, and dosage form;
          (ii) by quantities distributed domestically and 
        quantities exported; and
          (iii) by dosage form, including, for each such dosage 
        form, a listing of the target animals, indications, and 
        production classes that are specified on the approved 
        label of the product.
  (C) Each report under this paragraph shall--
          (i) be submitted not later than March 31 each year;
          (ii) cover the period of the preceding calendar year; 
        and
          (iii) include separate information for each month of 
        such calendar year.
  (D) The Secretary may share information reported under this 
paragraph with the Antimicrobial Resistance Task Force 
established under section 319E of the Public Health Service 
Act.
  (E) The Secretary shall make summaries of the information 
reported under this paragraph publicly available, except that--
          (i) the summary data shall be reported by 
        antimicrobial class, and no class with fewer than 3 
        distinct sponsors of approved applications shall be 
        independently reported; and
          (ii) the data shall be reported in a manner 
        consistent with protecting both national security and 
        confidential business information.
  (m)(1) Any person may file with the Secretary an application 
for a license to manufacture animal feeds bearing or containing 
new animal drugs. Such person shall submit to the Secretary as 
part of the application (A) a full statement of the business 
name and address of the specific facility at which the 
manufacturing is to take place and the facility's registration 
number, (B) the name and signature of the responsible 
individual or individuals for that facility, (C) a 
certification that the animal feeds bearing or containing new 
animal drugs are manufactured and labeled in accordance with 
the applicable regulations published pursuant to subsection (i) 
or for indexed new animal drugs in accordance with the index 
listing published pursuant to section 572(e)(2) and the 
labeling requirements set forth in section 572(h), and (D) a 
certification that the methods used in, and the facilities and 
controls used for, manufacturing, processing, packaging, and 
holding such animal feeds are in conformity with current good 
manufacturing practice as described in section 501(a)(2)(B).
  (2) Within 90 days after the filing of an application 
pursuant to paragraph (1), or such additional period as may be 
agreed upon by the Secretary and the applicant, the Secretary 
shall (A) issue an order approving the application if the 
Secretary then finds that none of the grounds for denying 
approval specified in paragraph (3) applies, or (B) give the 
applicant notice of an opportunity for a hearing before the 
Secretary under paragraph (3) on the question whether such 
application is approvable. The procedure governing such a 
hearing shall be the procedure set forth in the last two 
sentences of subsection (c)(1).
  (3) If the Secretary, after due notice to the applicant in 
accordance with paragraph (2) and giving the applicant an 
opportunity for a hearing in accordance with such paragraph, 
finds, on the basis of information submitted to the Secretary 
as part of the application, on the basis of a preapproval 
inspection, or on the basis of any other information before the 
Secretary--
          (A) that the application is incomplete, false, or 
        misleading in any particular;
          (B) that the methods used in, and the facilities and 
        controls used for, the manufacture, processing, and 
        packing of such animal feed are inadequate to preserve 
        the identity, strength, quality, and purity of the new 
        animal drug therein; or
          (C) that the facility manufactures animal feeds 
        bearing or containing new animal drugs in a manner that 
        does not accord with the specifications for manufacture 
        or labels animal feeds bearing or containing new animal 
        drugs in a manner that does not accord with the 
        conditions or indications of use that are published 
        pursuant to subsection (i) or an index listing pursuant 
        to section 572(e),
the Secretary shall issue an order refusing to approve the 
application. If, after such notice and opportunity for hearing, 
the Secretary finds that subparagraphs (A) through (C) do not 
apply, the Secretary shall issue an order approving the 
application. An order under this subsection approving an 
application for a license to manufacture animal feeds bearing 
or containing new animal drugs shall permit a facility to 
manufacture only those animal feeds bearing or containing new 
animal drugs for which there are in effect regulations pursuant 
to subsection (i) or an index listing pursuant to section 
572(e) relating to the use of such drugs in or on such animal 
feed.
  (4)(A) The Secretary shall, after due notice and opportunity 
for hearing to the applicant, revoke a license to manufacture 
animal feeds bearing or containing new animal drugs under this 
subsection if the Secretary finds--
          (i) that the application for such license contains 
        any untrue statement of a material fact; or
          (ii) that the applicant has made changes that would 
        cause the application to contain any untrue statements 
        of material fact or that would affect the safety or 
        effectiveness of the animal feeds manufactured at the 
        facility unless the applicant has supplemented the 
        application by filing with the Secretary adequate 
        information respecting all such changes and unless 
        there is in effect an approval of the supplemental 
        application.
If the Secretary (or in the Secretary's absence the officer 
acting as the Secretary) finds that there is an imminent hazard 
to the health of humans or of the animals for which such animal 
feed is intended, the Secretary may suspend the license 
immediately, and give the applicant prompt notice of the action 
and afford the applicant the opportunity for an expedited 
hearing under this subsection; but the authority conferred by 
this sentence shall not be delegated.
  (B) The Secretary may also, after due notice and opportunity 
for hearing to the applicant, revoke a license to manufacture 
animal feed under this subsection if the Secretary finds--
          (i) that the applicant has failed to establish a 
        system for maintaining required records, or has 
        repeatedly or deliberately failed to maintain such 
        records or to make required reports in accordance with 
        a regulation or order under paragraph (5)(A) of this 
        subsection or section 504(a)(3)(A), or the applicant 
        has refused to permit access to, or copying or 
        verification of, such records as required by 
        subparagraph (B) of such paragraph or section 
        504(a)(3)(B);
          (ii) that on the basis of new information before the 
        Secretary, evaluated together with the evidence before 
        the Secretary when such license was issued, the methods 
        used in, or the facilities and controls used for, the 
        manufacture, processing, packing, and holding of such 
        animal feed are inadequate to assure and preserve the 
        identity, strength, quality, and purity of the new 
        animal drug therein, and were not made adequate within 
        a reasonable time after receipt of written notice from 
        the Secretary, specifying the matter complained of;
          (iii) that on the basis of new information before the 

        Secretary, evaluated together with the evidence before 
        the Secretary when such license was issued, the 
        labeling of any animal feeds, based on a fair 
        evaluation of all material facts, is false or 
        misleading in any particular and was not corrected 
        within a reasonable time after receipt of written 
        notice from the Secretary specifying the matter 
        complained of; or
          (iv) that on the basis of new information before the 
        Secretary, evaluated together with the evidence before 
        the Secretary when such license was issued, the 
        facility has manufactured, processed, packed, or held 
        animal feed bearing or containing a new animal drug 
        adulterated under section 501(a)(6) and the facility 
        did not discontinue the manufacture, processing, 
        packing, or holding of such animal feed within a 
        reasonable time after receipt of written notice from 
        the 
        Secretary specifying the matter complained of.
  (C) The Secretary may also revoke a license to manufacture 
animal feeds under this subsection if an applicant gives notice 
to the Secretary of intention to discontinue the manufacture of 
all animal feed covered under this subsection and waives an 
opportunity for a hearing on the matter.
  (D) Any order under this paragraph shall state the findings 
upon which it is based.
  (5) When a license to manufacture animal feeds bearing or 
containing new animal drugs has been issued--
          (A) the applicant shall establish and maintain such 
        records, and make such reports to the Secretary, or (at 
        the option of the Secretary) to the appropriate person 
        or persons holding an approved application filed under 
        subsection (b), as the Secretary may by general 
        regulation, or by order with respect to such 
        application, prescribe on the basis of a finding that 
        such records and reports are necessary in order to 
        enable the Secretary to determine, or facilitate a 
        determination, whether there is or may be ground for 
        invoking subsection (e) or paragraph (4); and
          (B) every person required under this subsection to 
        maintain records, and every person in charge or custody 
        thereof, shall, upon request of an officer or employee 
        designated by the Secretary, permit such officer or 
        employee at all reasonable times to have access to and 
        copy and verify such records.
  (6) To the extent consistent with the public health, the 
Secretary may promulgate regulations for exempting from the 
operation of this subsection facilities that manufacture, 
process, pack, or hold animal feeds bearing or containing new 
animal drugs.
  (n)(1) An abbreviated application for a new animal drug shall 
contain--
          (A)(i) except as provided in clause (ii), information 
        to show that the conditions of use or similar 
        limitations (whether in the labeling or published 
        pursuant to subsection (i)) prescribed, recommended, or 
        suggested in the labeling proposed for the new animal 
        drug have been previously approved for a new animal 
        drug listed under paragraph (4) (hereinafter in this 
        subsection referred to as an ``approved new animal 
        drug''), and
          (ii) information to show that the withdrawal period 
        at which residues of the new animal drug will be 
        consistent with the tolerances established for the 
        approved new animal drug is the same as the withdrawal 
        period previously established for the approved new 
        animal drug or, if the withdrawal period is proposed to 
        be different, information showing that the residues of 
        the new animal drug at the proposed different 
        withdrawal period will be consistent with the 
        tolerances established for the approved new animal 
        drug;
          (B)(i) information to show that the active 
        ingredients of the new animal drug are the same as 
        those of the approved new animal drug, and
          (ii) if the approved new animal drug has more than 
        one active ingredient, and if one of the active 
        ingredients of the new animal drug is different from 
        one of the active ingredients of the approved new 
        animal drug and the application is filed pursuant to 
        the approval of a petition filed under paragraph (3)--
                  (I) information to show that the other active 
                ingredients of the new animal drug are the same 
                as the active ingredients of the approved new 
                animal drug,
                  (II) information to show either that the 
                different active ingredient is an active 
                ingredient of another approved new animal drug 
                or of an animal drug which does not meet the 
                requirements of section 201(v), and
                  (III) such other information respecting the 
                different active ingredients as the Secretary 
                may require;
          (C)(i) if the approved new animal drug is permitted 
        to be used with one or more animal drugs in animal 
        feed, information to show that the proposed uses of the 
        new animal drug with other animal drugs in animal feed 
        are the same as the uses of the approved new animal 
        drug, and
          (ii) if the approved new animal drug is permitted to 
        be used with one or more other animal drugs in animal 
        feed, and one of the other animal drugs proposed for 
        use with the new animal drug in animal feed is 
        different from one of the other animal drugs permitted 
        to be used in animal feed with the approved new animal 
        drug, and the application is filed pursuant to the 
        approval of a petition filed under paragraph (3)--
                  (I) information to show either that the 
                different animal drug proposed for use with the 
                approved new animal drug in animal feed is an 
                approved new animal drug permitted to be used 
                in animal feed or does not meet the 
                requirements of section 201(v) when used with 
                another animal drug in animal feed,
                  (II) information to show that other animal 
                drugs proposed for use with the new animal drug 
                in animal feed are the same as the other animal 
                drugs permitted to be used with the approved 
                new animal drug, and
                  (III) such other information respecting the 
                different animal drug or combination with 
                respect to which the petition was filed as the 
                Secretary may require,
          (D) information to show that the route of 
        administration, the dosage form, and the strength of 
        the new animal drug are the same as those of the 
        approved new animal drug or, if the route of 
        administration, the dosage form, or the strength of the 
        new animal drug is different and the application is 
        filed pursuant to the approval of a petition filed 
        under paragraph (3), such information respecting the 
        route of administration, dosage form, or strength with 
        respect to which the petition was filed as the 
        Secretary may require;
          (E) information to show that the new animal drug is 
        bioequivalent to the approved new animal drug, except 
        that if the application is filed pursuant to the 
        approval of a petition filed under paragraph (3) for 
        the purposes described in subparagraph (B) or (C), 
        information to show that the active ingredients of the 
        new animal drug are of the same pharmacological or 
        therapeutic class as the pharmacological or therapeutic 
        class of the approved new animal drug and that the new 
        animal drug can be expected to have the same 
        therapeutic effect as the approved new animal drug when 
        used in accordance with the labeling;
          (F) information to show that the labeling proposed 
        for the new animal drug is the same as the labeling 
        approved for the approved new animal drug except for 
        changes required because of differences approved under 
        a petition filed under paragraph (3), because of a 
        different withdrawal period, or because the new animal 
        drug and the approved new animal drug are produced or 
        distributed by different manufacturers;
          (G) the items specified in clauses (B) through (F) of 
        subsection (b)(1);
          (H) a certification, in the opinion of the applicant 
        and to the best of his knowledge, with respect to each 
        patent which claims the approved new animal drug or 
        which claims a use for such approved new animal drug 
        for which the applicant is seeking approval under this 
        subsection and for which information is required to be 
        filed under subsection (b)(1) or (c)(3)--
                  (i) that such patent information has not been 
                filed,
                  (ii) that such patent has expired,
                  (iii) of the date on which such patent will 
                expire, or
                  (iv) that such patent is invalid or will not 
                be infringed by the manufacture, use, or sale 
                of the new animal drug for which the 
                application is filed; and
          (I) if with respect to the approved new animal drug 
        information was filed under subsection (b)(1) or (c)(3) 
        for a method of use patent which does not claim a use 
        for which the applicant is seeking approval of an 
        application under subsection (c)(2), a statement that 
        the method of use patent does not claim such a use.
The Secretary may not require that an abbreviated application 
contain information in addition to that required by 
subparagraphs (A) through (I).
  (2)(A) An applicant who makes a certification described in 
paragraph (1)(G)(iv) shall include in the application a 
statement that the applicant will give the notice required by 
subparagraph (B) to--
          (i) each owner of the patent which is the subject of 
        the certification or the representative of such owner 
        designated to receive such notice, and
          (ii) the holder of the approved application under 
        subsection (c)(1) for the drug which is claimed by the 
        patent or a use of which is claimed by the patent or 
        the representative of such holder designated to receive 
        such notice.
  (B) The notice referred to in subparagraph (A) shall state 
that an application, which contains data from bioequivalence 
studies, has been filed under this subsection for the drug with 
respect to which the certification is made to obtain approval 
to engage in the commercial manufacture, use, or sale of such 
drug before the expiration of the patent referred to in the 
certification. Such notice shall include a detailed statement 
of the factual and legal basis of the applicant's opinion that 
the patent is not valid or will not be infringed.
  (C) If an application is amended to include a certification 
described in paragraph (1)(G)(iv), the notice required by 
subparagraph (B) shall be given when the amended application is 
filed.
  (3) If a person wants to submit an abbreviated application 
for a new animal drug--
          (A) whose active ingredients, route of 
        administration, dosage form, or strength differ from 
        that of an approved new animal drug, or
          (B) whose use with other animal drugs in animal feed 
        differs from that of an approved new animal drug,
such person shall submit a petition to the Secretary seeking 
permission to file such an application. The Secretary shall 
approve a petition for a new animal drug unless the Secretary 
finds that--
          (C) investigations must be conducted to show the 
        safety and effectiveness, in animals to be treated with 
        the drug, of the active ingredients, route of 
        administration, dosage form, strength, or use with 
        other animal drugs in animal feed which differ from the 
        approved new animal drug, or
          (D) investigations must be conducted to show the 
        safety for human consumption of any residues in food 
        resulting from the proposed active ingredients, route 
        of administration, dosage form, strength, or use with 
        other animal drugs in animal feed for the new animal 
        drug which is different from the active ingredients, 
        route of administration, dosage form, strength, or use 
        with other animal drugs in animal feed of the approved 
        new animal drug.
The Secretary shall approve or disapprove a petition submitted 
under this paragraph within 90 days of the date the petition is 
submitted.
  (4)(A)(i) Within 60 days of the date of the enactment of this 
subsection, the Secretary shall publish and make available to 
the public a list in alphabetical order of the official and 
proprietary name of each new animal drug which has been 
approved for safety and effectiveness before the date of the 
enactment of this subsection.
  (ii) Every 30 days after the publication of the first list 
under clause (i) the Secretary shall revise the list to include 
each new animal drug which has been approved for safety and 
effectiveness under subsection (c) during the 30 day period.
  (iii) When patent information submitted under subsection 
(b)(1) or (c)(3) respecting a new animal drug included on the 
list is to be published by the Secretary, the Secretary shall, 
in revisions made under clause (ii), include such information 
for such drug.
  (B) A new animal drug approved for safety and effectiveness 
before the date of the enactment of this subsection or approved 
for safety and effectiveness under subsection (c) shall, for 
purposes of this subsection, be considered to have been 
published under subparagraph (A) on the date of its approval or 
the date of enactment, whichever is later.
  (C) If the approval of a new animal drug was withdrawn or 
suspended under subsection (c)(2)(G) or for grounds described 
in subsection (e) or if the Secretary determines that a drug 
has been withdrawn from sale for safety or effectiveness 
reasons, it may not be published in the list under subparagraph 
(A) or, if the withdrawal or suspension occurred after its 
publication in such list, it shall be immediately removed from 
such list--
          (i) for the same period as the withdrawal or 
        suspension under subsection (c)(2)(G) or (e), or
          (ii) if the listed drug has been withdrawn from sale, 
        for the period of withdrawal from sale or, if earlier, 
        the period ending on the date the Secretary determines 
        that the withdrawal from sale is not for safety or 
        effectiveness reasons.
A notice of the removal shall be published in the Federal 
Register.
  (5) If an application contains the information required by 
clauses (A), (G), and (H) of subsection (b)(1) and such 
information--
          (A) is relied on by the applicant for the approval of 
        the application, and
          (B) is not information derived either from 
        investigations, studies, or tests conducted by or for 
        the applicant or for which the applicant had obtained a 
        right of reference or use from the person by or for 
        whom the investigations, studies, or tests were 
        conducted,
such application shall be considered to be an application filed 
under subsection (b)(2).
  (o) For purposes of this section, the term ``patent'' means a 
patent issued by the United States Patent and Trademark Office.
  (p)(1) Safety and effectiveness data and information which 
has been submitted in an application filed under subsection 
(b)(1) or section 571(a) for a drug and which has not 
previously been disclosed to the public shall be made available 
to the public, upon request, unless extraordinary circumstances 
are shown--
          (A) if no work is being or will be undertaken to have 
        the application approved,
          (B) if the Secretary has determined that the 
        application is not approvable and all legal appeals 
        have been exhausted,
          (C) if approval of the application under subsection 
        (c) is withdrawn and all legal appeals have been 
        exhausted,
          (D) if the Secretary has determined that such drug is 
        not a new drug, or
          (E) upon the effective date of the approval of the 
        first application filed under subsection (b)(2) which 
        refers to such drug or upon the date upon which the 
        approval of an application filed under subsection 
        (b)(2) which refers to such drug could be made 
        effective if such an application had been filed.
  (2) Any request for data and information pursuant to 
paragraph (1) shall include a verified statement by the person 
making the request that any data or information received under 
such paragraph shall not be disclosed by such person to any 
other person--
          (A) for the purpose of, or as part of a plan, scheme, 
        or device for, obtaining the right to make, use, or 
        market, or making, using, or marketing, outside the 
        United States, the drug identified in the application 
        filed under subsection (b)(1) or section 571(a), and
          (B) without obtaining from any person to whom the 
        data and information are disclosed an identical 
        verified statement, a copy of which is to be provided 
        by such person to the Secretary, which meets the 
        requirements of this paragraph.
  (q) Date of Approval in the Case of Recommended Controls 
Under the CSA.--
          (1) In general.--In the case of an application under 
        subsection (b) with respect to a drug for which the 
        Secretary provides notice to the sponsor that the 
        Secretary intends to recommend controls under the 
        Controlled Substances Act, approval of such application 
        shall not take effect until the interim final rule 
        controlling the drug is issued in accordance with 
        section 201(j) of the Controlled Substances Act.
          (2) Date of approval.--For purposes of this section, 
        with respect to an application described in paragraph 
        (1), the term ``date of approval'' shall mean the later 
        of--
                  (A) the date an application under subsection 
                (b) is approved under subsection (c); or
                  (B) the date of issuance of the interim final 
                rule controlling the drug.

           *       *       *       *       *       *       *


     Subchapter F--New Animal Drugs for Minor Use and Minor Species

SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR MINOR USE AND 
                    MINOR SPECIES.

  (a)(1) Except as provided in paragraph (3) of this section, 
any person may file with the Secretary an application for 
conditional approval of a new animal drug intended for a minor 
use or a minor species. Such an application may not be a 
supplement to an application approved under section 512. Such 
application must comply in all respects with the provisions of 
section 512 of this Act except sections 512(a)(4), 512(b)(2), 
512(c)(1), 512(c)(2), 512(c)(3), 512(d)(1), 512(e), 512(h), and 
512(n) unless otherwise stated in this section, and any 
additional provisions of this section. New animal drugs are 
subject to application of the same safety standards that would 
be applied to such drugs under section 512(d) (including, for 
antimicrobial new animal drugs, with respect to antimicrobial 
resistance).
  (2) The applicant shall submit to the Secretary as part of an 
application for the conditional approval of a new animal drug--
          (A) all information necessary to meet the 
        requirements of section 512(b)(1) except section 
        512(b)(1)(A);
          (B) full reports of investigations which have been 
        made to show whether or not such drug is safe under 
        section 512(d) (including, for an antimicrobial new 
        animal drug, with respect to antimicrobial resistance) 
        and there is a reasonable expectation of effectiveness 
        for use;
          (C) data for establishing a conditional dose;
          (D) projections of expected need and the 
        justification for that expectation based on the best 
        information available;
          (E) information regarding the quantity of drug 
        expected to be distributed on an annual basis to meet 
        the expected need; and
          (F) a commitment that the applicant will conduct 
        additional investigations to meet the requirements for 
        the full demonstration of effectiveness under section 
        512(d)(1)(E) within 5 years.
  (3) A person may not file an application under paragraph (1) 
if--
          (A) the application seeks conditional approval of a 
        new animal drug that is contained in, or is a product 
        of, a transgenic animal.
          (B) the person has previously filed an application 
        for conditional approval under paragraph (1) for the 
        same drug in the same dosage form for the same intended 
        use whether or not subsequently conditionally approved 
        by the Secretary under subsection (b), or
          (C) the person obtained the application, or data or 
        other information contained therein, directly or 
        indirectly from the person who filed for conditional 
        approval under paragraph (1) for the same drug in the 
        same dosage form for the same intended use whether or 
        not subsequently conditionally approved by the 
        Secretary under subsection (b).
  (b) Within 180 days after the filing of an application 
pursuant to subsection (a), or such additional period as may be 
agreed upon by the Secretary and the applicant, the Secretary 
shall either--
          (1) issue an order, effective for one year, 
        conditionally approving the application if the 
        Secretary finds that none of the grounds for denying 
        conditional approval, specified in subsection (c) of 
        this section applies and publish a Federal Register 
        notice of the conditional approval, or
          (2) give the applicant notice of an opportunity for 
        an informal hearing on the question whether such 
        application can be conditionally approved.
  (c) If the Secretary finds, after giving the applicant notice 
and an opportunity for an informal hearing, that--
          (1) any of the provisions of section 512(d)(1) (A) 
        through (D) or (F) through (I) are applicable;
          (2) the information submitted to the Secretary as 
        part of the application and any other information 
        before the Secretary with respect to such drug, is 
        insufficient to show that there is a reasonable 
        expectation that the drug will have the effect it 
        purports or is represented to have under the conditions 
        of use prescribed, recommended, or suggested in the 
        proposed labeling thereof; or
          (3) another person has received approval under 
        section 512 for the same drug in the same dosage form 
        for the same intended use, and that person is able to 
        assure the availability of sufficient quantities of the 
        drug to meet the needs for which the drug is intended;
the Secretary shall issue an order refusing to conditionally 
approve the application. If, after such notice and opportunity 
for an informal hearing, the Secretary finds that paragraphs 
(1) through (3) do not apply, the Secretary shall issue an 
order conditionally approving the application effective for one 
year and publish a Federal Register notice of the conditional 
approval. Any order issued under this subsection refusing to 
conditionally approve an application shall state the findings 
upon which it is based.
  (d) A conditional approval under this section is effective 
for a 1-year period and is thereafter renewable by the 
Secretary annually for up to 4 additional 1-year terms. A 
conditional approval shall be in effect for no more than 5 
years from the date of approval under subsection (b)(1) or (c) 
of this section unless extended as provided for in subsection 
(h) of this section. The following shall also apply:
          (1) No later than 90 days from the end of the 1-year 
        period for which the original or renewed conditional 
        approval is effective, the applicant may submit a 
        request to renew a conditional approval for an 
        additional 1-year term.
          (2) A conditional approval shall be deemed renewed at 
        the end of the 1-year period, or at the end of a 90-day 
        extension that the Secretary may, at the Secretary's 
        discretion, grant by letter in order to complete review 
        of the renewal request, unless the Secretary determines 
        before the expiration of the 1-year period or the 90-
        day extension that--
                  (A) the applicant failed to submit a timely 
                renewal request;
                  (B) the request fails to contain sufficient 
                information to show that--
                          (i) the applicant is making 
                        sufficient progress toward meeting 
                        approval requirements under section 
                        512(d)(1)(E), and is likely to be able 
                        to fulfill those requirements and 
                        obtain an approval under section 512 
                        before the expiration of the 5-year 
                        maximum term of the conditional 
                        approval;
                          (ii) the quantity of the drug that 
                        has been distributed is consistent with 
                        the conditionally approved intended use 
                        and conditions of use, unless there is 
                        adequate explanation that ensures that 
                        the drug is only used for its intended 
                        purpose; or
                          (iii) the same drug in the same 
                        dosage form for the same intended use 
                        has not received approval under section 
                        512, or if such a drug has been 
                        approved, that the holder of the 
                        approved application is unable to 
                        assure the availability of sufficient 
                        quantities of the drug to meet the 
                        needs for which the drug is intended; 
                        or
                  (C) any of the provisions of section 
                512(e)(1) (A) through (B) or (D) through (F) 
                are applicable.
          (3) If the Secretary determines before the end of the 
        1-year period or the 90-day extension, if granted, that 
        a conditional approval should not be renewed, the 
        Secretary shall issue an order refusing to renew the 
        conditional approval, and such conditional approval 
        shall be deemed withdrawn and no longer in effect. The 
        Secretary shall thereafter provide an opportunity for 
        an informal hearing to the applicant on the issue 
        whether the conditional approval shall be reinstated.
          (4)(A) In the case of an application under subsection 
        (a) with respect to a drug for which the Secretary 
        provides notice to the sponsor that the Secretary 
        intends to recommend controls under the Controlled 
        Substances Act, conditional approval of such 
        application shall not take effect until the interim 
        final rule controlling the drug is issued in accordance 
        with section 201(j) of the Controlled Substances Act.
          (B) For purposes of this section, with respect to an 
        application described in subparagraph (A), the term 
        ``date of approval'' shall mean the later of--
                  (i) the date an application under subsection 
                (a) is conditionally approved under subsection 
                (b); or
                  (ii) the date of issuance of the interim 
                final rule controlling the drug.
  (e)(1) The Secretary shall issue an order withdrawing 
conditional approval of an application filed pursuant to 
subsection (a) if the Secretary finds that another person has 
received approval under section 512 for the same drug in the 
same dosage form for the same intended use and that person is 
able to assure the availability of sufficient quantities of the 
drug to meet the needs for which the drug is intended.
  (2) The Secretary shall, after due notice and opportunity for 
an informal hearing to the applicant, issue an order 
withdrawing conditional approval of an application filed 
pursuant to subsection (a) if the Secretary finds that--
          (A) any of the provisions of section 512(e)(1) (A) 
        through (B) or (D) through (F) are applicable; or
          (B) on the basis of new information before the 
        Secretary with respect to such drug, evaluated together 
        with the evidence available to the Secretary when the 
        application was conditionally approved, that there is 
        not a reasonable expectation that such drug will have 
        the effect it purports or is represented to have under 
        the conditions of use prescribed, recommended, or 
        suggested in the labeling thereof.
  (3) The Secretary may also, after due notice and opportunity 
for an informal hearing to the applicant, issue an order 
withdrawing conditional approval of an application filed 
pursuant to subsection (a) if the Secretary finds that any of 
the provisions of section 512(e)(2) are applicable.
  (f)(1) The label and labeling of a new animal drug with a 
conditional approval under this section shall--
          (A) bear the statement, ``conditionally approved by 
        FDA pending a full demonstration of effectiveness under 
        application number''; and
          (B) contain such other information as prescribed by 
        the Secretary.
  (2) An intended use that is the subject of a conditional 
approval under this section shall not be included in the same 
product label with any intended use approved under section 512.
  (g) A conditionally approved new animal drug application may 
not be amended or supplemented to add indications for use.
  (h) 180 days prior to the termination date established under 
subsection (d) of this section, an applicant shall have 
submitted all the information necessary to support a complete 
new animal drug application in accordance with section 
512(b)(1) or the conditional approval issued under this section 
is no longer in effect. Following review of this information, 
the Secretary shall either--
          (1) issue an order approving the application under 
        section 512(c) if the Secretary finds that none of the 
        grounds for denying approval specified in section 
        512(d)(1) applies, or
          (2) give the applicant an opportunity for a hearing 
        before the Secretary under section 512(d) on the 
        question whether such application can be approved.
Upon issuance of an order approving the application, product 
labeling and administrative records of approval shall be 
modified accordingly. If the Secretary has not issued an order 
under section 512(c) approving such application prior to the 
termination date established under subsection (d) of this 
section, the conditional approval issued under this section is 
no longer in effect unless the Secretary grants an extension of 
an additional 180-day period so that the Secretary can complete 
review of the application. The decision to grant an extension 
is committed to the discretion of the Secretary and not subject 
to judicial review.
  (i) The decision of the Secretary under subsection (c), (d), 
or (e) of this section refusing or withdrawing conditional 
approval of an application shall constitute final agency action 
subject to judicial review.
  (j) In this section and section 572, the term ``transgenic 
animal'' means an animal whose genome contains a nucleotide 
sequence that has been intentionally modified in vitro, and the 
progeny of such an animal; Provided that the term ``transgenic 
animal'' does not include an animal of which the nucleotide 
sequence of the genome has been modified solely by selective 
breeding.

SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR 
                    MINOR SPECIES.

  (a)(1) The Secretary shall establish an index limited to--
          (A) new animal drugs intended for use in a minor 
        species for which there is a reasonable certainty that 
        the animal or edible products from the animal will not 
        be consumed by humans or food-producing animals; and
          (B) new animal drugs intended for use only in a 
        hatchery, tank, pond, or other similar contained man-
        made structure in an early, non-food life stage of a 
        food-producing minor species, where safety for humans 
        is demonstrated in accordance with the standard of 
        section 512(d) (including, for an antimicrobial new 
        animal drug, with respect to antimicrobial resistance).
  (2) The index shall not include a new animal drug that is 
contained in or a product of a transgenic animal.
  (b) Any person intending to file a request under this section 
shall be entitled to one or more conferences to discuss the 
requirements for indexing a new animal drug.
  (c)(1) Any person may submit a request to the Secretary for a 
determination whether a new animal drug may be eligible for 
inclusion in the index. Such a request shall include--
          (A) information regarding the need for the new animal 
        drug, the species for which the new animal drug is 
        intended, the proposed intended use and conditions of 
        use, and anticipated annual distribution;
          (B) information to support the conclusion that the 
        proposed use meets the conditions of subparagraph (A) 
        or (B) of subsection (a)(1) of this section;
          (C) information regarding the components and 
        composition of the new animal drug;
          (D) a description of the methods used in, and the 
        facilities and controls used for, the manufacture, 
        processing, and packing of such new animal drug;
          (E) an environmental assessment that meets the 
        requirements of the National Environmental Policy Act 
        of 1969, as amended, and as defined in 21 CFR Part 25, 
        as it appears on the date of enactment of this 
        provision and amended thereafter or information to 
        support a categorical exclusion from the requirement to 
        prepare an environmental assessment;
          (F) information sufficient to support the conclusion 
        that the proposed use of the new animal drug is safe 
        under section 512(d) with respect to individuals 
        exposed to the new animal drug through its manufacture 
        or use; and
          (G) such other information as the Secretary may deem 
        necessary to make this eligibility determination.
  (2) Within 90 days after the submission of a request for a 
determination of eligibility for indexing based on subsection 
(a)(1)(A) of this section, or 180 days for a request submitted 
based on subsection (a)(1)(B) of this section, the Secretary 
shall grant or deny the request, and notify the person who 
requested such determination of the Secretary's decision. The 
Secretary shall grant the request if the Secretary finds that--
          (A) the same drug in the same dosage form for the 
        same intended use is not approved or conditionally 
        approved;
          (B) the proposed use of the drug meets the conditions 
        of subparagraph (A) or (B) of subsection (a)(1), as 
        appropriate;
          (C) the person requesting the determination has 
        established appropriate specifications for the 
        manufacture and control of the new animal drug and has 
        demonstrated an understanding of the requirements of 
        current good manufacturing practices;
          (D) the new animal drug will not significantly affect 
        the human environment; and
          (E) the new animal drug is safe with respect to 
        individuals exposed to the new animal drug through its 
        manufacture or use.
If the Secretary denies the request, the Secretary shall 
thereafter provide due notice and an opportunity for an 
informal conference. A decision of the Secretary to deny an 
eligibility request following an informal conference shall 
constitute final agency action subject to judicial review.
  (d)(1) With respect to a new animal drug for which the 
Secretary has made a determination of eligibility under 
subsection (c), the person who made such a request may ask that 
the Secretary add the new animal drug to the index established 
under subsection (a). The request for addition to the index 
shall include--
          (A) a copy of the Secretary's determination of 
        eligibility issued under subsection (c);
          (B) a written report that meets the requirements in 
        subsection (d)(2) of this section;
          (C) a proposed index entry;
          (D) facsimile labeling;
          (E) anticipated annual distribution of the new animal 
        drug;
          (F) a written commitment to manufacture the new 
        animal drug and animal feeds bearing or containing such 
        new animal drug according to current good manufacturing 
        practices;
          (G) a written commitment to label, distribute, and 
        promote the new animal drug only in accordance with the 
        index entry;
          (H) upon specific request of the Secretary, 
        information submitted to the expert panel described in 
        paragraph (3); and
          (I) any additional requirements that the Secretary 
        may prescribe by general regulation or specific order.
  (2) The report required in paragraph (1) shall--
          (A) be authored by a qualified expert panel;
          (B) include an evaluation of all available target 
        animal safety and effectiveness information, including 
        anecdotal information;
          (C) state the expert panel's opinion regarding 
        whether the benefits of using the new animal drug for 
        the proposed use in a minor species outweigh its risks 
        to the target animal, taking into account the harm 
        being caused by the absence of an approved or 
        conditionally approved new animal drug for the minor 
        species in question;
          (D) include information from which labeling can be 
        written; and
          (E) include a recommendation regarding whether the 
        new animal drug should be limited to use under the 
        professional supervision of a licensed veterinarian.
  (3) A qualified expert panel, as used in this section, is a 
panel that--
          (A) is composed of experts qualified by scientific 
        training and experience to evaluate the target animal 
        safety and effectiveness of the new animal drug under 
        consideration;
          (B) operates external to FDA; and
          (C) is not subject to the Federal Advisory Committee 
        Act, 5 U.S.C. App. 2.
The Secretary shall define the criteria for selection of a 
qualified expert panel and the procedures for the operation of 
the panel by regulation.
  (4) Within 180 days after the receipt of a request for 
listing a new animal drug in the index, the Secretary shall 
grant or deny the request. The Secretary shall grant the 
request if the request for indexing continues to meet the 
eligibility criteria in subsection (a) and the Secretary finds, 
on the basis of the report of the qualified expert panel and 
other information available to the Secretary, that the benefits 
of using the new animal drug for the proposed use in a minor 
species outweigh its risks to the target animal, taking into 
account the harm caused by the absence of an approved or 
conditionally-approved new animal drug for the minor species in 
question. If the Secretary denies the request, the Secretary 
shall thereafter provide due notice and the opportunity for an 
informal conference. The decision of the Secretary following an 
informal conference shall constitute final agency action 
subject to judicial review.
  (e)(1) The index established under subsection (a) shall 
include the following information for each listed drug--
          (A) the name and address of the person who holds the 
        index listing;
          (B) the name of the drug and the intended use and 
        conditions of use for which it is being indexed;
          (C) product labeling; and
          (D) conditions and any limitations that the Secretary 
        deems necessary regarding use of the drug.
  (2) The Secretary shall publish the index, and revise it 
periodically.
  (3) The Secretary may establish by regulation a process for 
reporting changes in the conditions of manufacturing or 
labeling of indexed products.
  (f)(1) If the Secretary finds, after due notice to the person 
who requested the index listing and an opportunity for an 
informal conference, that--
          (A) the expert panel failed to meet the requirements 
        as set forth by the Secretary by regulation;
          (B) on the basis of new information before the 
        Secretary, evaluated together with the evidence 
        available to the Secretary when the new animal drug was 
        listed in the index, the benefits of using the new 
        animal drug for the indexed use do not outweigh its 
        risks to the target animal;
          (C) the conditions of subsection (c)(2) of this 
        section are no longer satisfied;
          (D) the manufacture of the new animal drug is not in 
        accordance with current good manufacturing practices;
          (E) the labeling, distribution, or promotion of the 
        new animal drug is not in accordance with the index 
        entry;
          (F) the conditions and limitations of use associated 
        with the index listing have not been followed; or
          (G) the request for indexing contains any untrue 
        statement of material fact,
the Secretary shall remove the new animal drug from the index. 
The decision of the Secretary following an informal conference 
shall constitute final agency action subject to judicial 
review.
  (2) If the Secretary finds that there is a reasonable 
probability that the use of the drug would present a risk to 
the health of humans or other animals, the Secretary may--
          (A) suspend the listing of such drug immediately;
          (B) give the person listed in the index prompt notice 
        of the Secretary's action; and
          (C) afford that person the opportunity for an 
        informal conference.
The decision of the Secretary following an informal conference 
shall constitute final agency action subject to judicial 
review.
  (g) For purposes of indexing new animal drugs under this 
section, to the extent consistent with the public health, the 
Secretary shall promulgate regulations for exempting from the 
operation of section 512 minor species new animal drugs and 
animal feeds bearing or containing new animal drugs intended 
solely for investigational use by experts qualified by 
scientific training and experience to investigate the safety 
and effectiveness of minor species animal drugs. Such 
regulations may, at the discretion of the Secretary, among 
other conditions relating to the protection of the public 
health, provide for conditioning such exemption upon the 
establishment and maintenance of such records, and the making 
of such reports to the Secretary, by the manufacturer or the 
sponsor of the investigation of such article, of data 
(including but not limited to analytical reports by 
investigators) obtained as a result of such investigational use 
of such article, as the Secretary finds will enable the 
Secretary to evaluate the safety and effectiveness of such 
article in the event of the filing of a request for an index 
listing pursuant to this section.
  (h) The labeling of a new animal drug that is the subject of 
an index listing shall state, prominently and conspicuously--
          (1) ``Not approved by fda.--Legally marketed as an 
        FDA indexed product. Extra-label use is prohibited.'';
          (2) except in the case of new animal drugs indexed 
        for use in an early life stage of a food-producing 
        animal, ``This product is not to be used in animals 
        intended for use as food for humans or other 
        animals.''; and
          (3) such other information as may be prescribed by 
        the Secretary in the index listing.
  (i)(1) In the case of any new animal drug for which an index 
listing pursuant to subsection (a) is in effect, the person who 
has an index listing shall establish and maintain such records, 
and make such reports to the Secretary, of data relating to 
experience, and other data or information, received or 
otherwise obtained by such person with respect to such drug, or 
with respect to animal feeds bearing or containing such drug, 
as the Secretary may by general regulation, or by order with 
respect to such listing, prescribe on the basis of a finding 
that such records and reports are necessary in order to enable 
the Secretary to determine, or facilitate a determination, 
whether there is or may be ground for invoking subsection (f). 
Such regulation or order shall provide, where the Secretary 
deems it to be appropriate, for the examination, upon request, 
by the persons to whom such regulation or order is applicable, 
of similar information received or otherwise obtained by the 
Secretary.
  (2) Every person required under this subsection to maintain 
records, and every person in charge or custody thereof, shall, 
upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to have access to and copy and verify such records.
  (j)(1) Safety and effectiveness data and information which 
has been submitted in support of a request for a new animal 
drug to be indexed under this section and which has not been 
previously disclosed to the public shall be made available to 
the public, upon request, unless extraordinary circumstances 
are shown--
          (A) if no work is being or will be undertaken to have 
        the drug indexed in accordance with the request,
          (B) if the Secretary has determined that such drug 
        cannot be indexed and all legal appeals have been 
        exhausted,
          (C) if the indexing of such drug is terminated and 
        all legal appeals have been exhausted, or
          (D) if the Secretary has determined that such drug is 
        not a new animal drug.
  (2) Any request for data and information pursuant to 
paragraph (1) shall include a verified statement by the person 
making the request that any data or information received under 
such paragraph shall not be disclosed by such person to any 
other person--
          (A) for the purpose of, or as part of a plan, scheme, 
        or device for, obtaining the right to make, use, or 
        market, or making, using, or marketing, outside the 
        United States, the drug identified in the request for 
        indexing; and
          (B) without obtaining from any person to whom the 
        data and information are disclosed an identical 
        verified statement, a copy of which is to be provided 
        by such person to the Secretary, which meets the 
        requirements of this paragraph.
  (k) In the case of a request under subsection (d) to add a 
drug to the index under subsection (a) with respect to a drug 
for which the Secretary provides notice to the person filing 
the request that the Secretary intends to recommend controls 
under the Controlled Substances Act, a determination to grant 
the request to add such drug to the index shall not take 
effect, and the Secretary shall not list the drug on such 
index, until the interim final rule controlling the drug is 
issued in accordance with section 201(j) of the Controlled 
Substances Act.

SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR MINOR SPECIES.

  (a) Designation.--
          (1) The manufacturer or the sponsor of a new animal 
        drug for a minor use or use in a minor species may 
        request that the Secretary declare that drug a 
        ``designated new animal drug''. A request for 
        designation of a new animal drug shall be made before 
        the submission of an application under section 512(b) 
        or section 571 for the new animal drug.
          (2) The Secretary may declare a new animal drug a 
        ``designated new animal drug'' if--
                  (A) it is intended for a minor use or use in 
                a minor species; and
                  (B) the same drug in the same dosage form for 
                the same intended use is not approved under 
                section 512 or 571 or designated under this 
                section at the time the request is made.
          (3) Regarding the termination of a designation--
                  (A) the sponsor of a new animal drug shall 
                notify the Secretary of any decision to 
                discontinue active pursuit of approval under 
                section 512 or 571 of an application for a 
                designated new animal drug. The Secretary shall 
                terminate the designation upon such 
                notification;
                  (B) the Secretary may also terminate 
                designation if the Secretary independently 
                determines that the sponsor is not actively 
                pursuing approval under section 512 or 571 with 
                due diligence;
                  (C) the sponsor of an approved designated new 
                animal drug shall notify the Secretary of any 
                discontinuance of the manufacture of such new 
                animal drug at least one year before 
                discontinuance. The Secretary shall terminate 
                the designation upon such notification; and
                  (D) the designation shall terminate upon the 
                expiration of any applicable exclusivity period 
                under subsection (c).
          (4) Notice respecting the designation or termination 
        of designation of a new animal drug shall be made 
        available to the public.
  (b) Grants and Contracts for Development of Designated New 
Animal Drugs.--
          (1) The Secretary may make grants to and enter into 
        contracts with public and private entities and 
        individuals to assist in defraying the costs of 
        qualified safety and effectiveness testing expenses and 
        manufacturing expenses incurred in connection with the 
        development of designated new animal drugs.
          (2) For purposes of paragraph (1) of this section--
                  (A) The term ``qualified safety and 
                effectiveness testing'' means testing--
                          (i) which occurs after the date such 
                        new animal drug is designated under 
                        this section and before the date on 
                        which an application with respect to 
                        such drug is submitted under section 
                        512; and
                          (ii) which is carried out under an 
                        investigational exemption under section 
                        512(j).
                  (B) The term ``manufacturing expenses'' means 
                expenses incurred in developing processes and 
                procedures associated with manufacture of the 
                designated new animal drug which occur after 
                the new animal drug is designated under this 
                section and before the date on which an 
                application with respect to such new animal 
                drug is submitted under section 512 or 571.
  (c) Exclusivity for Designated New Animal Drugs.--
          (1) Except as provided in subsection (c)(2), if the 
        Secretary approves or conditionally approves an 
        application for a designated new animal drug, the 
        Secretary may not approve or conditionally approve 
        another application submitted for such new animal drug 
        with the same intended use as the designated new animal 
        drug for another applicant before the expiration of 
        seven years from the date of approval or conditional 
        approval of the application.
          (2) If an application filed pursuant to section 512 
        or section 571 is approved for a designated new animal 
        drug, the Secretary may, during the 7-year exclusivity 
        period beginning on the date of the application 
        approval or conditional approval, approve or 
        conditionally approve another application under section 
        512 or section 571 for such drug for such minor use or 
        minor species for another applicant if--
                  (A) the Secretary finds, after providing the 
                holder of such an approved application notice 
                and opportunity for the submission of views, 
                that in the granted exclusivity period the 
                holder of the approved application cannot 
                assure the availability of sufficient 
                quantities of the drug to meet the needs for 
                which the drug was designated; or
                  (B) such holder provides written consent to 
                the Secretary for the approval or conditional 
                approval of other applications before the 
                expiration of such exclusivity period.
          (3) For purposes of determining the 7-year period of 
        exclusivity under paragraph (1) for a drug for which 
        the Secretary intends to recommend controls under the 
        Controlled Substances Act, the drug shall not be 
        considered approved or conditionally approved until the 
        date that the interim final rule controlling the drug 
        is issued in accordance with section 201(j) of the 
        Controlled Substances Act.

           *       *       *       *       *       *       *

                              ----------                              


                       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)(1) No person shall introduce or deliver for 
introduction into interstate commerce any biological product 
unless--
          (A) a biologics license under this subsection or 
        subsection (k) is in effect for the biological product; 
        and
          (B) each package of the biological product is plainly 
        marked with--
                  (i) the proper name of the biological product 
                contained in the package;
                  (ii) the name, address, and applicable 
                license number of the manufacturer of the 
                biological product; and
                  (iii) the expiration date of the biological 
                product.
  (2)(A) The Secretary shall establish, by regulation, 
requirements for the approval, suspension, and revocation of 
biologics licenses.
          (B) Pediatric studies.--A person that submits an 
        application for a license under this paragraph shall 
        submit to the Secretary as part of the application any 
        assessments required under section 505B of the Federal 
        Food, Drug, and Cosmetic Act.
  (C) The Secretary shall approve a biologics license 
application--
          (i) on the basis of a demonstration that--
                  (I) the biological product that is the 
                subject of the application is safe, pure, and 
                potent; and
                  (II) the facility in which the biological 
                product is manufactured, processed, packed, or 
                held meets standards designed to assure that 
                the biological product continues to be safe, 
                pure, and potent; and
          (ii) if the applicant (or other appropriate person) 
        consents to the inspection of the facility that is the 
        subject of the application, in accordance with 
        subsection (c).
  (D) Postmarket Studies and Clinical Trials; Labeling; Risk 
Evaluation and Mitigation Strategy.--A person that submits an 
application for a license under this paragraph is subject to 
sections 505(o), 505(p), and 505-1 of the Federal Food, Drug, 
and Cosmetic Act.
  (3) The Secretary shall prescribe requirements under which a 
biological product undergoing investigation shall be exempt 
from the requirements of paragraph (1).
  (b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark 
on the package or container of the biological product so as to 
falsify the label or mark.
  (c) Any officer, agent, or employee of the Department of 
Health and Human Services, authorized by the Secretary for the 
purpose, may during all reasonable hours enter and inspect any 
establishment for the propagation or manufacture and 
preparation of any biological product.
  (d)(1) Upon a determination that a batch, lot, or other 
quantity of a product licensed under this section presents an 
imminent or substantial hazard to the public health, the 
Secretary shall issue an order immediately ordering the recall 
of such batch, lot, or other quantity of such product. An order 
under this paragraph shall be issued in accordance with section 
554 of title 5, United States Code.
  (2) Any violation of paragraph (1) shall subject the violator 
to a civil penalty of up to $100,000 per day of violation. The 
amount of a civil penalty under this paragraph shall, effective 
December 1 of each year beginning 1 year after the effective 
date of this paragraph, be increased by the percent change in 
the Consumer Price Index for the base quarter of such year over 
the Consumer Price Index for the base quarter of the preceding 
year, adjusted to the nearest \1/10\ of 1 percent. For purposes 
of this paragraph, the term ``base quarter'', as used with 
respect to a year, means the calendar quarter ending on 
September 30 of such year and the price index for a base 
quarter is the arithmetical mean of such index for the 3 months 
comprising such quarter.
  (e) No person shall interfere with any officer, agent, or 
employee of the Service in the performance of any duty imposed 
upon him by this section or by regulations made by authority 
thereof.
  (f) Any person who shall violate, or aid or abet in 
violating, any of the provisions of this section shall be 
punished upon conviction by a fine not exceeding $500 or by 
imprisonment not exceeding one year, or by both such fine and 
imprisonment, in the discretion of the court.
  (g) Nothing contained in this Act shall be construed as in 
any way affecting, modifying, repealing, or superseding the 
provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C., 
1940 edition, title 21, ch. 9).
  (h) A partially processed biological product which--
          (1) is not in a form applicable to the prevention, 
        treatment, or cure of diseases or injuries of man;
          (2) is not intended for sale in the United States; 
        and
          (3) is intended for further manufacture into final 
        dosage form outside the United States,
shall be subject to no restriction on the export of the product 
under this Act or the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et. seq.) if the product is manufactured, processed, 
packaged, and held in conformity with current good 
manufacturing practice requirements or meets international 
manufacturing standards as certified by an international 
standards organization recognized by the Secretary and meets 
the requirements of section 801(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(e)).
  (i) In this section:
          (1) The term ``biological product'' means a virus, 
        therapeutic serum, toxin, antitoxin, vaccine, blood, 
        blood component or derivative, allergenic product, 
        protein (except any chemically synthesized 
        polypeptide), or analogous product, or arsphenamine or 
        derivative of arsphenamine (or any other trivalent 
        organic arsenic compound), applicable to the 
        prevention, treatment, or cure of a disease or 
        condition of human beings.
          (2) The term ``biosimilar'' or ``biosimilarity'', in 
        reference to a biological product that is the subject 
        of an application under subsection (k), means--
                  (A) that the biological product is highly 
                similar to the reference product 
                notwithstanding minor differences in clinically 
                inactive components; and
                  (B) there are no clinically meaningful 
                differences between the biological product and 
                the reference product in terms of the safety, 
                purity, and potency of the product.
          (3) The term ``interchangeable'' or 
        ``interchangeability'', in reference to a biological 
        product that is shown to meet the standards described 
        in subsection (k)(4), means that the biological product 
        may be substituted for the reference product without 
        the intervention of the health care provider who 
        prescribed the reference product.
          (4) The term ``reference product'' means the single 
        biological product licensed under subsection (a) 
        against which a biological product is evaluated in an 
        application submitted under subsection (k).
  (j) The Federal Food, Drug, and Cosmetic Act, including the 
requirements under sections 505(o), 505(p), and 505-1 of such 
Act, applies to a biological product subject to regulation 
under this section, except that a product for which a license 
has been approved under subsection (a) shall not be required to 
have an approved application under section 505 of such Act.
  (k) Licensure of Biological Products as Biosimilar or 
Interchangeable.--
          (1) In general.--Any person may submit an application 
        for licensure of a biological product under this 
        subsection.
          (2) Content.--
                  (A) In general.--
                          (i) Required information.--An 
                        application submitted under this 
                        subsection shall include information 
                        demonstrating that--
                                  (I) the biological product is 
                                biosimilar to a reference 
                                product based upon data derived 
                                from--
                                          (aa) analytical 
                                        studies that 
                                        demonstrate that the 
                                        biological product is 
                                        highly similar to the 
                                        reference product 
                                        notwithstanding minor 
                                        differences in 
                                        clinically inactive 
                                        components;
                                          (bb) animal studies 
                                        (including the 
                                        assessment of 
                                        toxicity); and
                                          (cc) a clinical study 
                                        or studies (including 
                                        the assessment of 
                                        immunogenicity and 
                                        pharmacokinetics or 
                                        pharmacodynamics) that 
                                        are sufficient to 
                                        demonstrate safety, 
                                        purity, and potency in 
                                        1 or more appropriate 
                                        conditions of use for 
                                        which the reference 
                                        product is licensed and 
                                        intended to be used and 
                                        for which licensure is 
                                        sought for the 
                                        biological product;
                                  (II) the biological product 
                                and reference product utilize 
                                the same mechanism or 
                                mechanisms of action for the 
                                condition or conditions of use 
                                prescribed, recommended, or 
                                suggested in the proposed 
                                labeling, but only to the 
                                extent the mechanism or 
                                mechanisms of action are known 
                                for the reference product;
                                  (III) the condition or 
                                conditions of use prescribed, 
                                recommended, or suggested in 
                                the labeling proposed for the 
                                biological product have been 
                                previously approved for the 
                                reference product;
                                  (IV) the route of 
                                administration, the dosage 
                                form, and the strength of the 
                                biological product are the same 
                                as those of the reference 
                                product; and
                                  (V) the facility in which the 
                                biological product is 
                                manufactured, processed, 
                                packed, or held meets standards 
                                designed to assure that the 
                                biological product continues to 
                                be safe, pure, and potent.
                          (ii) Determination by secretary.--The 
                        Secretary may determine, in the 
                        Secretary's discretion, that an element 
                        described in clause (i)(I) is 
                        unnecessary in an application submitted 
                        under this subsection.
                          (iii) Additional information.--An 
                        application submitted under this 
                        subsection--
                                  (I) shall include publicly-
                                available information regarding 
                                the Secretary's previous 
                                determination that the 
                                reference product is safe, 
                                pure, and potent; and
                                  (II) may include any 
                                additional information in 
                                support of the application, 
                                including publicly-available 
                                information with respect to the 
                                reference product or another 
                                biological product.
                  (B) Interchangeability.--An application (or a 
                supplement to an application) submitted under 
                this subsection may include information 
                demonstrating that the biological product meets 
                the standards described in paragraph (4).
          (3) Evaluation by secretary.--Upon review of an 
        application (or a supplement to an application) 
        submitted under this subsection, the Secretary shall 
        license the biological product under this subsection 
        if--
                  (A) the Secretary determines that the 
                information submitted in the application (or 
                the supplement) is sufficient to show that the 
                biological product--
                          (i) is biosimilar to the reference 
                        product; or
                          (ii) meets the standards described in 
                        paragraph (4), and therefore is 
                        interchangeable with the reference 
                        product; and
                  (B) the applicant (or other appropriate 
                person) consents to the inspection of the 
                facility that is the subject of the 
                application, in accordance with subsection (c).
          (4) Safety standards for determining 
        interchangeability.--Upon review of an application 
        submitted under this subsection or any supplement to 
        such application, the Secretary shall determine the 
        biological product to be interchangeable with the 
        reference product if the Secretary determines that the 
        information submitted in the application (or a 
        supplement to such application) is sufficient to show 
        that--
                  (A) the biological product--
                          (i) is biosimilar to the reference 
                        product; and
                          (ii) can be expected to produce the 
                        same clinical result as the reference 
                        product in any given patient; and
                  (B) for a biological product that is 
                administered more than once to an individual, 
                the risk in terms of safety or diminished 
                efficacy of alternating or switching between 
                use of the biological product and the reference 
                product is not greater than the risk of using 
                the reference product without such alternation 
                or switch.
          (5) General rules.--
                  (A) One reference product per application.--A 
                biological product, in an application submitted 
                under this subsection, may not be evaluated 
                against more than 1 reference product.
                  (B) Review.--An application submitted under 
                this subsection shall be reviewed by the 
                division within the Food and Drug 
                Administration that is responsible for the 
                review and approval of the application under 
                which the reference product is licensed.
                  (C) Risk evaluation and mitigation 
                strategies.--The authority of the Secretary 
                with respect to risk evaluation and mitigation 
                strategies under the Federal Food, Drug, and 
                Cosmetic Act shall apply to biological products 
                licensed under this subsection in the same 
                manner as such authority applies to biological 
                products licensed under subsection (a).
          (6) Exclusivity for first interchangeable biological 
        product.--Upon review of an application submitted under 
        this subsection relying on the same reference product 
        for which a prior biological product has received a 
        determination of interchangeability for any condition 
        of use, the Secretary shall not make a determination 
        under paragraph (4) that the second or subsequent 
        biological product is interchangeable for any condition 
        of use until the earlier of--
                  (A) 1 year after the first commercial 
                marketing of the first interchangeable 
                biosimilar biological product to be approved as 
                interchangeable for that reference product;
                  (B) 18 months after--
                          (i) a final court decision on all 
                        patents in suit in an action instituted 
                        under subsection (l)(6) against the 
                        applicant that submitted the 
                        application for the first approved 
                        interchangeable biosimilar biological 
                        product; or
                          (ii) the dismissal with or without 
                        prejudice of an action instituted under 
                        subsection (l)(6) against the applicant 
                        that submitted the application for the 
                        first approved interchangeable 
                        biosimilar biological product; or
                  (C)(i) 42 months after approval of the first 
                interchangeable biosimilar biological product 
                if the applicant that submitted such 
                application has been sued under subsection 
                (l)(6) and such litigation is still ongoing 
                within such 42-month period; or
                  (ii) 18 months after approval of the first 
                interchangeable biosimilar biological product 
                if the applicant that submitted such 
                application has not been sued under subsection 
                (l)(6).
        For purposes of this paragraph, the term ``final court 
        decision'' means a final decision of a court from which 
        no appeal (other than a petition to the United States 
        Supreme Court for a writ of certiorari) has been or can 
        be taken.
          (7) Exclusivity for reference product.--
                  (A) Effective date of biosimilar application 
                approval.--Approval of an application under 
                this subsection may not be made effective by 
                the Secretary until the date that is 12 years 
                after the date on which the reference product 
                was first licensed under subsection (a).
                  (B) Filing period.--An application under this 
                subsection may not be submitted to the 
                Secretary until the date that is 4 years after 
                the date on which the reference product was 
                first licensed under subsection (a).
                  (C) First licensure.--Subparagraphs (A) and 
                (B) shall not apply to a license for or 
                approval of--
                          (i) a supplement for the biological 
                        product that is the reference product; 
                        or
                          (ii) a subsequent application filed 
                        by the same sponsor or manufacturer of 
                        the biological product that is the 
                        reference product (or a licensor, 
                        predecessor in interest, or other 
                        related entity) for--
                                  (I) a change (not including a 
                                modification to the structure 
                                of the biological product) that 
                                results in a new indication, 
                                route of administration, dosing 
                                schedule, dosage form, delivery 
                                system, delivery device, or 
                                strength; or
                                  (II) a modification to the 
                                structure of the biological 
                                product that does not result in 
                                a change in safety, purity, or 
                                potency.
          (8) Guidance documents.--
                  (A) In general.--The Secretary may, after 
                opportunity for public comment, issue guidance 
                in accordance, except as provided in 
                subparagraph (B)(i), with section 701(h) of the 
                Federal Food, Drug, and Cosmetic Act with 
                respect to the licensure of a biological 
                product under this subsection. Any such 
                guidance may be general or specific.
                  (B) Public comment.--
                          (i) In general.--The Secretary shall 
                        provide the public an opportunity to 
                        comment on any proposed guidance issued 
                        under subparagraph (A) before issuing 
                        final guidance.
                          (ii) Input regarding most valuable 
                        guidance.--The Secretary shall 
                        establish a process through which the 
                        public may provide the Secretary with 
                        input regarding priorities for issuing 
                        guidance.
                  (C) No requirement for application 
                consideration.--The issuance (or non-issuance) 
                of guidance under subparagraph (A) shall not 
                preclude the review of, or action on, an 
                application submitted under this subsection.
                  (D) Requirement for product class-specific 
                guidance.--If the Secretary issues product 
                class-specific guidance under subparagraph (A), 
                such guidance shall include a description of--
                          (i) the criteria that the Secretary 
                        will use to determine whether a 
                        biological product is highly similar to 
                        a reference product in such product 
                        class; and
                          (ii) the criteria, if available, that 
                        the Secretary will use to determine 
                        whether a biological product meets the 
                        standards described in paragraph (4).
                  (E) Certain product classes.--
                          (i) Guidance.--The Secretary may 
                        indicate in a guidance document that 
                        the science and experience, as of the 
                        date of such guidance, with respect to 
                        a product or product class (not 
                        including any recombinant protein) does 
                        not allow approval of an application 
                        for a license as provided under this 
                        subsection for such product or product 
                        class.
                          (ii) Modification or reversal.--The 
                        Secretary may issue a subsequent 
                        guidance document under subparagraph 
                        (A) to modify or reverse a guidance 
                        document under clause (i).
                          (iii) No effect on ability to deny 
                        license.--Clause (i) shall not be 
                        construed to require the Secretary to 
                        approve a product with respect to which 
                        the Secretary has not indicated in a 
                        guidance document that the science and 
                        experience, as described in clause (i), 
                        does not allow approval of such an 
                        application.
  (l) Patents.--
          (1) Confidential access to subsection (k) 
        application.--
                  (A) Application of paragraph.--Unless 
                otherwise agreed to by a person that submits an 
                application under subsection (k) (referred to 
                in this subsection as the ``subsection (k) 
                applicant'') and the sponsor of the application 
                for the reference product (referred to in this 
                subsection as the ``reference product 
                sponsor''), the provisions of this paragraph 
                shall apply to the exchange of information 
                described in this subsection.
                  (B) In general.--
                          (i) Provision of confidential 
                        information.--When a subsection (k) 
                        applicant submits an application under 
                        subsection (k), such applicant shall 
                        provide to the persons described in 
                        clause (ii), subject to the terms of 
                        this paragraph, confidential access to 
                        the information required to be produced 
                        pursuant to paragraph (2) and any other 
                        information that the subsection (k) 
                        applicant determines, in its sole 
                        discretion, to be appropriate (referred 
                        to in this subsection as the 
                        ``confidential information'').
                          (ii) Recipients of information.--The 
                        persons described in this clause are 
                        the following:
                                  (I) Outside counsel.--One or 
                                more attorneys designated by 
                                the reference product sponsor 
                                who are employees of an entity 
                                other than the reference 
                                product sponsor (referred to in 
                                this paragraph as the ``outside 
                                counsel''), provided that such 
                                attorneys do not engage, 
                                formally or informally, in 
                                patent prosecution relevant or 
                                related to the reference 
                                product.
                                  (II) In-house counsel.--One 
                                attorney that represents the 
                                reference product sponsor who 
                                is an employee of the reference 
                                product sponsor, provided that 
                                such attorney does not engage, 
                                formally or informally, in 
                                patent prosecution relevant or 
                                related to the reference 
                                product.
                          (iii) Patent owner access.--A 
                        representative of the owner of a patent 
                        exclusively licensed to a reference 
                        product sponsor with respect to the 
                        reference product and who has retained 
                        a right to assert the patent or 
                        participate in litigation concerning 
                        the patent may be provided the 
                        confidential information, provided that 
                        the representative informs the 
                        reference product sponsor and the 
                        subsection (k) applicant of his or her 
                        agreement to be subject to the 
                        confidentiality provisions set forth in 
                        this paragraph, including those under 
                        clause (ii).
                  (C) Limitation on disclosure.--No person that 
                receives confidential information pursuant to 
                subparagraph (B) shall disclose any 
                confidential information to any other person or 
                entity, including the reference product sponsor 
                employees, outside scientific consultants, or 
                other outside counsel retained by the reference 
                product sponsor, without the prior written 
                consent of the subsection (k) applicant, which 
                shall not be unreasonably withheld.
                  (D) Use of confidential information.--
                Confidential information shall be used for the 
                sole and exclusive purpose of determining, with 
                respect to each patent assigned to or 
                exclusively licensed by the reference product 
                sponsor, whether a claim of patent infringement 
                could reasonably be asserted if the subsection 
                (k) applicant engaged in the manufacture, use, 
                offering for sale, sale, or importation into 
                the United States of the biological product 
                that is the subject of the application under 
                subsection (k).
                  (E) Ownership of confidential information.--
                The confidential information disclosed under 
                this paragraph is, and shall remain, the 
                property of the subsection (k) applicant. By 
                providing the confidential information pursuant 
                to this paragraph, the subsection (k) applicant 
                does not provide the reference product sponsor 
                or the outside counsel any interest in or 
                license to use the confidential information, 
                for purposes other than those specified in 
                subparagraph (D).
                  (F) Effect of infringement action.--In the 
                event that the reference product sponsor files 
                a patent infringement suit, the use of 
                confidential information shall continue to be 
                governed by the terms of this paragraph until 
                such time as a court enters a protective order 
                regarding the information. Upon entry of such 
                order, the subsection (k) applicant may 
                redesignate confidential information in 
                accordance with the terms of that order. No 
                confidential information shall be included in 
                any publicly-available complaint or other 
                pleading. In the event that the reference 
                product sponsor does not file an infringement 
                action by the date specified in paragraph (6), 
                the reference product sponsor shall return or 
                destroy all confidential information received 
                under this paragraph, provided that if the 
                reference product sponsor opts to destroy such 
                information, it will confirm destruction in 
                writing to the subsection (k) applicant.
                  (G) Rule of construction.--Nothing in this 
                paragraph shall be construed--
                          (i) as an admission by the subsection 
                        (k) applicant regarding the validity, 
                        enforceability, or infringement of any 
                        patent; or
                          (ii) as an agreement or admission by 
                        the subsection (k) applicant with 
                        respect to the competency, relevance, 
                        or materiality of any confidential 
                        information.
                  (H) Effect of violation.--The disclosure of 
                any confidential information in violation of 
                this paragraph shall be deemed to cause the 
                subsection (k) applicant to suffer irreparable 
                harm for which there is no adequate legal 
                remedy and the court shall consider immediate 
                injunctive relief to be an appropriate and 
                necessary remedy for any violation or 
                threatened violation of this paragraph.
          (2) Subsection (k) application information.--Not 
        later than 20 days after the Secretary notifies the 
        subsection (k) applicant that the application has been 
        accepted for review, the subsection (k) applicant--
                  (A) shall provide to the reference product 
                sponsor a copy of the application submitted to 
                the Secretary under subsection (k), and such 
                other information that describes the process or 
                processes used to manufacture the biological 
                product that is the subject of such 
                application; and
                  (B) may provide to the reference product 
                sponsor additional information requested by or 
                on behalf of the reference product sponsor.
          (3) List and description of patents.--
                  (A) List by reference product sponsor.--Not 
                later than 60 days after the receipt of the 
                application and information under paragraph 
                (2), the reference product sponsor shall 
                provide to the subsection (k) applicant--
                          (i) a list of patents for which the 
                        reference product sponsor believes a 
                        claim of patent infringement could 
                        reasonably be asserted by the reference 
                        product sponsor, or by a patent owner 
                        that has granted an exclusive license 
                        to the reference product sponsor with 
                        respect to the reference product, if a 
                        person not licensed by the reference 
                        product sponsor engaged in the making, 
                        using, offering to sell, selling, or 
                        importing into the United States of the 
                        biological product that is the subject 
                        of the subsection (k) application; and
                          (ii) an identification of the patents 
                        on such list that the reference product 
                        sponsor would be prepared to license to 
                        the subsection (k) applicant.
                  (B) List and description by subsection (k) 
                applicant.--Not later than 60 days after 
                receipt of the list under subparagraph (A), the 
                subsection (k) applicant--
                          (i) may provide to the reference 
                        product sponsor a list of patents to 
                        which the subsection (k) applicant 
                        believes a claim of patent infringement 
                        could reasonably be asserted by the 
                        reference product sponsor if a person 
                        not licensed by the reference product 
                        sponsor engaged in the making, using, 
                        offering to sell, selling, or importing 
                        into the United States of the 
                        biological product that is the subject 
                        of the subsection (k) application;
                          (ii) shall provide to the reference 
                        product sponsor, with respect to each 
                        patent listed by the reference product 
                        sponsor under subparagraph (A) or 
                        listed by the subsection (k) applicant 
                        under clause (i)--
                                  (I) a detailed statement that 
                                describes, on a claim by claim 
                                basis, the factual and legal 
                                basis of the opinion of the 
                                subsection (k) applicant that 
                                such patent is invalid, 
                                unenforceable, or will not be 
                                infringed by the commercial 
                                marketing of the biological 
                                product that is the subject of 
                                the subsection (k) application; 
                                or
                                  (II) a statement that the 
                                subsection (k) applicant does 
                                not intend to begin commercial 
                                marketing of the biological 
                                product before the date that 
                                such patent expires; and
                          (iii) shall provide to the reference 
                        product sponsor a response regarding 
                        each patent identified by the reference 
                        product sponsor under subparagraph 
                        (A)(ii).
                  (C) Description by reference product 
                sponsor.--Not later than 60 days after receipt 
                of the list and statement under subparagraph 
                (B), the reference product sponsor shall 
                provide to the subsection (k) applicant a 
                detailed statement that describes, with respect 
                to each patent described in subparagraph 
                (B)(ii)(I), on a claim by claim basis, the 
                factual and legal basis of the opinion of the 
                reference product sponsor that such patent will 
                be infringed by the commercial marketing of the 
                biological product that is the subject of the 
                subsection (k) application and a response to 
                the statement concerning validity and 
                enforceability provided under subparagraph 
                (B)(ii)(I).
          (4) Patent resolution negotiations.--
                  (A) In general.--After receipt by the 
                subsection (k) applicant of the statement under 
                paragraph (3)(C), the reference product sponsor 
                and the subsection (k) applicant shall engage 
                in good faith negotiations to agree on which, 
                if any, patents listed under paragraph (3) by 
                the subsection (k) applicant or the reference 
                product sponsor shall be the subject of an 
                action for patent infringement under paragraph 
                (6).
                  (B) Failure to reach agreement.--If, within 
                15 days of beginning negotiations under 
                subparagraph (A), the subsection (k) applicant 
                and the reference product sponsor fail to agree 
                on a final and complete list of which, if any, 
                patents listed under paragraph (3) by the 
                subsection (k) applicant or the reference 
                product sponsor shall be the subject of an 
                action for patent infringement under paragraph 
                (6), the provisions of paragraph (5) shall 
                apply to the parties.
          (5) Patent resolution if no agreement.--
                  (A) Number of patents.--The subsection (k) 
                applicant shall notify the reference product 
                sponsor of the number of patents that such 
                applicant will provide to the reference product 
                sponsor under subparagraph (B)(i)(I).
                  (B) Exchange of patent lists.--
                          (i) In general.--On a date agreed to 
                        by the subsection (k) applicant and the 
                        reference product sponsor, but in no 
                        case later than 5 days after the 
                        subsection (k) applicant notifies the 
                        reference product sponsor under 
                        subparagraph (A), the subsection (k) 
                        applicant and the reference product 
                        sponsor shall simultaneously exchange--
                                  (I) the list of patents that 
                                the subsection (k) applicant 
                                believes should be the subject 
                                of an action for patent 
                                infringement under paragraph 
                                (6); and
                                  (II) the list of patents, in 
                                accordance with clause (ii), 
                                that the reference product 
                                sponsor believes should be the 
                                subject of an action for patent 
                                infringement under paragraph 
                                (6).
                          (ii) Number of patents listed by 
                        reference product sponsor.--
                                  (I) In general.--Subject to 
                                subclause (II), the number of 
                                patents listed by the reference 
                                product sponsor under clause 
                                (i)(II) may not exceed the 
                                number of patents listed by the 
                                subsection (k) applicant under 
                                clause (i)(I).
                                  (II) Exception.--If a 
                                subsection (k) applicant does 
                                not list any patent under 
                                clause (i)(I), the reference 
                                product sponsor may list 1 
                                patent under clause (i)(II).
          (6) Immediate patent infringement action.--
                  (A) Action if agreement on patent list.--If 
                the subsection (k) applicant and the reference 
                product sponsor agree on patents as described 
                in paragraph (4), not later than 30 days after 
                such agreement, the reference product sponsor 
                shall bring an action for patent infringement 
                with respect to each such patent.
                  (B) Action if no agreement on patent list.--
                If the provisions of paragraph (5) apply to the 
                parties as described in paragraph (4)(B), not 
                later than 30 days after the exchange of lists 
                under paragraph (5)(B), the reference product 
                sponsor shall bring an action for patent 
                infringement with respect to each patent that 
                is included on such lists.
                  (C) Notification and publication of 
                complaint.--
                          (i) Notification to secretary.--Not 
                        later than 30 days after a complaint is 
                        served to a subsection (k) applicant in 
                        an action for patent infringement 
                        described under this paragraph, the 
                        subsection (k) applicant shall provide 
                        the Secretary with notice and a copy of 
                        such complaint.
                          (ii) Publication by secretary.--The 
                        Secretary shall publish in the Federal 
                        Register notice of a complaint received 
                        under clause (i).
          (7) Newly issued or licensed patents.--In the case of 
        a patent that--
                  (A) is issued to, or exclusively licensed by, 
                the reference product sponsor after the date 
                that the reference product sponsor provided the 
                list to the subsection (k) applicant under 
                paragraph (3)(A); and
                  (B) the reference product sponsor reasonably 
                believes that, due to the issuance of such 
                patent, a claim of patent infringement could 
                reasonably be asserted by the reference product 
                sponsor if a person not licensed by the 
                reference product sponsor engaged in the 
                making, using, offering to sell, selling, or 
                importing into the United States of the 
                biological product that is the subject of the 
                subsection (k) application,
        not later than 30 days after such issuance or 
        licensing, the reference product sponsor shall provide 
        to the subsection (k) applicant a supplement to the 
        list provided by the reference product sponsor under 
        paragraph (3)(A) that includes such patent, not later 
        than 30 days after such supplement is provided, the 
        subsection (k) applicant shall provide a statement to 
        the reference product sponsor in accordance with 
        paragraph (3)(B), and such patent shall be subject to 
        paragraph (8).
          (8) Notice of commercial marketing and preliminary 
        injunction.--
                  (A) Notice of commercial marketing.--The 
                subsection (k) applicant shall provide notice 
                to the reference product sponsor not later than 
                180 days before the date of the first 
                commercial marketing of the biological product 
                licensed under subsection (k).
                  (B) Preliminary injunction.--After receiving 
                the notice under subparagraph (A) and before 
                such date of the first commercial marketing of 
                such biological product, the reference product 
                sponsor may seek a preliminary injunction 
                prohibiting the subsection (k) applicant from 
                engaging in the commercial manufacture or sale 
                of such biological product until the court 
                decides the issue of patent validity, 
                enforcement, and infringement with respect to 
                any patent that is--
                          (i) included in the list provided by 
                        the reference product sponsor under 
                        paragraph (3)(A) or in the list 
                        provided by the subsection (k) 
                        applicant under paragraph (3)(B); and
                          (ii) not included, as applicable, 
                        on--
                                  (I) the list of patents 
                                described in paragraph (4); or
                                  (II) the lists of patents 
                                described in paragraph (5)(B).
                  (C) Reasonable cooperation.--If the reference 
                product sponsor has sought a preliminary 
                injunction under subparagraph (B), the 
                reference product sponsor and the subsection 
                (k) applicant shall reasonably cooperate to 
                expedite such further discovery as is needed in 
                connection with the preliminary injunction 
                motion.
          (9) Limitation on declaratory judgment action.--
                  (A) Subsection (k) application provided.--If 
                a subsection (k) applicant provides the 
                application and information required under 
                paragraph (2)(A), neither the reference product 
                sponsor nor the subsection (k) applicant may, 
                prior to the date notice is received under 
                paragraph (8)(A), bring any action under 
                section 2201 of title 28, United States Code, 
                for a declaration of infringement, validity, or 
                enforceability of any patent that is described 
                in clauses (i) and (ii) of paragraph (8)(B).
                  (B) Subsequent failure to act by subsection 
                (k) applicant.--If a subsection (k) applicant 
                fails to complete an action required of the 
                subsection (k) applicant under paragraph 
                (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), 
                paragraph (7), or paragraph (8)(A), the 
                reference product sponsor, but not the 
                subsection (k) applicant, may bring an action 
                under section 2201 of title 28, United States 
                Code, for a declaration of infringement, 
                validity, or enforceability of any patent 
                included in the list described in paragraph 
                (3)(A), including as provided under paragraph 
                (7).
                  (C) Subsection (k) application not 
                provided.--If a subsection (k) applicant fails 
                to provide the application and information 
                required under paragraph (2)(A), the reference 
                product sponsor, but not the subsection (k) 
                applicant, may bring an action under section 
                2201 of title 28, United States Code, for a 
                declaration of infringement, validity, or 
                enforceability of any patent that claims the 
                biological product or a use of the biological 
                product.
  (m) Pediatric Studies.--
          (1) Application of certain provisions.--The 
        provisions of subsections (a), (d), (e), (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.
          (2) Market exclusivity for new biological products.--
        If, prior to approval of an application that is 
        submitted under subsection (a), the Secretary 
        determines that information relating to the use of a 
        new biological product in the pediatric population may 
        produce health benefits in that population, the 
        Secretary makes a written request for pediatric studies 
        (which shall include a timeframe for completing such 
        studies), the applicant agrees to the request, such 
        studies are completed using appropriate formulations 
        for each age group for which the study is requested 
        within any such timeframe, and the reports thereof are 
        submitted and accepted in accordance with section 
        505A(d)(3) of the Federal Food, Drug, and Cosmetic 
        Act--
                  (A) the periods for such biological product 
                referred to in subsection (k)(7) are deemed to 
                be 4 years and 6 months rather than 4 years and 
                12 years and 6 months rather than 12 years; and
                  (B) if the biological product is designated 
                under section 526 for a rare disease or 
                condition, the period for such biological 
                product referred to in section 527(a) is deemed 
                to be 7 years and 6 months rather than 7 years.
          (3) Market exclusivity for already-marketed 
        biological products.--If the Secretary determines that 
        information relating to the use of a licensed 
        biological product in the pediatric population may 
        produce health benefits in that population and makes a 
        written request to the holder of an approved 
        application under subsection (a) for pediatric studies 
        (which shall include a timeframe for completing such 
        studies), the holder agrees to the request, such 
        studies are completed using appropriate formulations 
        for each age group for which the study is requested 
        within any such timeframe, and the reports thereof are 
        submitted and accepted in accordance with section 
        505A(d)(3) of the Federal Food, Drug, and Cosmetic 
        Act--
                  (A) the periods for such biological product 
                referred to in subsection (k)(7) are deemed to 
                be 4 years and 6 months rather than 4 years and 
                12 years and 6 months rather than 12 years; and
                  (B) if the biological product is designated 
                under section 526 for a rare disease or 
                condition, the period for such biological 
                product referred to in section 527(a) is deemed 
                to be 7 years and 6 months rather than 7 years.
          (4) Exception.--The Secretary shall not extend a 
        period referred to in paragraph (2)(A), (2)(B), (3)(A), 
        or (3)(B) if the determination under section 505A(d)(3) 
        is made later than 9 months prior to the expiration of 
        such period.
  (n) Date of Approval in the Case of Recommended Controls 
Under the CSA.--
          (1) In general.--In the case of an application under 
        subsection (a) with respect to a biological product for 
        which the Secretary provides notice to the sponsor that 
        the Secretary intends to recommend controls under the 
        Controlled Substances Act, approval of such application 
        shall not take effect until the interim final rule 
        controlling the biological product is issued in 
        accordance with section 201(j) of the Controlled 
        Substances Act.
          (2) Date of approval.--For purposes of this section, 
        with respect to an application described in paragraph 
        (1), references to the date of approval of such 
        application, or licensure of the product subject to 
        such application, shall mean the later of--
                  (A) the date an application is approved under 
                subsection (a); or
                  (B) the date of issuance of the interim final 
                rule controlling the biological product.

           *       *       *       *       *       *       *

                              ----------                              


                       CONTROLLED SUBSTANCES ACT

TITLE II--CONTROL AND ENFORCEMENT

           *       *       *       *       *       *       *


         Part B--Authority To Control; Standards and Schedules

        authority and criteria for classification of substances

  Sec. 201. (a) The Attorney General shall apply the provisions 
of this title to the controlled substances listed in the 
schedules established by section 202 of this title and to any 
other drug or other substance added to such schedules under 
this title. Except as provided in subsections (d) and (e), the 
Attorney General may by rule--
          (1) add to such a schedule or transfer between such 
        schedules any drug or other substance if he--
                  (A) finds that such drug or other substance 
                has a potential for abuse, and
                  (B) makes with respect to such drug or other 
                substance the findings prescribed by subsection 
                (b) of section 202 for the schedule in which 
                such drug is to be placed; or
          (2) remove any drug or other substance from the 
        schedules if he finds that the drug or other substance 
        does not meet the requirements for inclusion in any 
        schedule.
Rules of the Attorney General under this subsection shall be 
made on the record after opportunity for a hearing pursuant to 
the rulemaking procedures prescribed by subchapter II of 
chapter 5 of title 5 of the United States Code. Proceedings for 
the issuance, amendment, or repeal of such rules may be 
initiated by the Attorney General (1) on his own motion, (2) at 
the request of the Secretary, or (3) on the petition of any 
interested party.
  (b) The Attorney General shall, before initiating proceedings 
under subsection (a) to control a drug or other substance or to 
remove a drug or other substance entirely from the schedules, 
and after gathering the necessary data, request from the 
Secretary a scientific and medical evaluation, and his 
recommendations, as to whether such drug or other substance 
should be so controlled or removed as a controlled substance. 
In making such evaluation and recommendations, the Secretary 
shall consider the factors listed in paragraphs (2), (3), (6), 
(7), and (8) of subsection (c) and any scientific or medical 
considerations involved in paragraphs (1), (4), and (5) of such 
subsection. The recommendations of the Secretary shall include 
recommendations with respect to the appropriate schedule, if 
any, under which such drug or other substance should be listed. 
The evaluation and the recommendations of the Secretary shall 
be made in writing and submitted to the Attorney General within 
a reasonable time. The recommendations of the Secretary to the 
Attorney General shall be binding on the Attorney General as to 
such scientific and medical matters, and if the Secretary 
recommends that a drug or other substance not be controlled, 
the Attorney General shall not control the drug or other 
substance. If the Attorney General determines that these facts 
and all other relevant data constitute substantial evidence of 
potential for abuse such as to warrant control or substantial 
evidence that the drug or other substance should be removed 
entirely from the schedules, he shall initiate proceedings for 
control or removal, as the case may be, under subsection (a).
  (c) In making any finding under subsection (a) of this 
section or under subsection (b) of section 202, the Attorney 
General shall consider the following factors with respect to 
each drug or other substance proposed to be controlled or 
removed from the schedules:
          (1) Its actual or relative potential for abuse.
          (2) Scientific evidence of its pharmacological 
        effect, if known.
          (3) The state of current scientific knowledge 
        regarding the drug or other substance.
          (4) Its history and current pattern of abuse.
          (5) The scope, duration, and significance of abuse.
          (6) What, if any, risk there is to the public health.
          (7) Its psychic or physiological dependence 
        liability.
          (8) Whether the substance is an immediate precursor 
        of a substance already controlled under this title.
  (d)(1) If control is required by United States obligations 
under international treaties, conventions, or protocols in 
effect on the effective date of this part, the Attorney General 
shall issue an order controlling such drug under the schedule 
he deems most appropriate to carry out such obligations, 
without regard to the findings required by subsection (a) of 
this section or section 202(b) and without regard to the 
procedures prescribed by subsections (a) and (b) of this 
section.
  (2) (A) Whenever the Secretary of State receives notification 
from the Secretary-General of the United Nations that 
information has been transmitted by or to the World Health 
Organization, pursuant to article 2 of the Convention on 
Psychotropic Substances, which may justify adding a drug or 
other substance to one of the schedules of the Convention, 
transferring a drug or substance from one schedule to another, 
or deleting it from the schedules, the Secretary of State shall 
immediately transmit the notice to the Secretary of Health, 
Education, and Welfare who shall publish it in the Federal 
Register and provide opportunity to interested persons to 
submit to him comments respecting the scientific and medical 
evaluations which he is to prepare respecting such drug or 
substance. The Secretary of Health, Education, and Welfare 
shall prepare for transmission through the Secretary of State 
to the World Health Organization such medical and scientific 
evaluations as may be appropriate regarding the possible action 
that could be proposed by the World Health Organization 
respecting the drug or substance with respect to which a notice 
was transmitted under this subparagraph.
  (B) Whenever the Secretary of State receives information that 
the Commission on Narcotic Drugs of the United Nations proposes 
to decide whether to add a drug or other substance to one of 
the schedules of the Convention, transfer a drug or substance 
from one schedule to another, or delete it from the schedules, 
the Secretary of State shall transmit timely notice to the 
Secretary of Health, Education, and Welfare of such information 
who shall publish a summary of such information in the Federal 
Register and provide opportunity to interested persons to 
submit to him comments respecting the recommendation which he 
is to furnish, pursuant to this subparagraph, respecting such 
proposal. The Secretary of Health, Education, and Welfare shall 
evaluate the proposal and furnish a recommendation to the 
Secretary of State which shall be binding on the representative 
of the United States in discussions and negotiations relating 
to the proposal.
  (3) When the United States receives notification of a 
scheduling decision pursuant to article 2 of the Convention on 
Psychotropic Substances that a drug or other substance has been 
added or transferred to a schedule specified in the 
notification or receives notification (referred to in this 
subsection as a ``schedule notice'') that existing legal 
controls applicable under this title to a drug or substance and 
the controls required by the Federal Food, Drug, and Cosmetic 
Act do not meet the requirements of the schedule of the 
Convention in which such drug or substance has been placed, the 
Secretary of Health, Education, and Welfare, after consultation 
with the Attorney General, shall first determine whether 
existing legal controls under this title applicable to the drug 
or substance and the controls required by the Federal Food, 
Drug, and Cosmetic Act, meet the requirements of the schedule 
specified in the notification or schedule notice and shall take 
the following action:
          (A) If such requirements are met by such existing 
        controls but the Secretary of Health, Education, and 
        Welfare nonetheless believes that more stringent 
        controls should be applied to the drug or substance, 
        the Secretary shall recommend to the Attorney General 
        that he initiate proceedings for scheduling the drug or 
        substance, pursuant to subsections (a) and (b) of this 
        section, to apply to such controls.
          (B) If such requirements are not met by such existing 
        controls and the Secretary of Health, Education, and 
        Welfare concurs in the scheduling decision or schedule 
        notice transmitted by the notification, the Secretary 
        shall recommend to the Attorney General that he 
        initiate proceedings for scheduling the drug or 
        substance under the appropriate schedule pursuant to 
        subsections (a) and (b) of this section.
          (C) If such requirements are not met by such existing 
        controls and the Secretary of Health, Education, and 
        Welfare does not concur in the scheduling decision or 
        schedule notice transmitted by the notification, the 
        Secretary shall--
                  (i) if he deems that additional controls are 
                necessary to protect the public health and 
                safety, recommend to the Attorney General that 
                he initiate proceedings for scheduling the drug 
                or substance pursuant to subsections (a) and 
                (b) of this section, to apply such additional 
                controls;
                  (ii) request the Secretary of State to 
                transmit a notice of qualified acceptance, 
                within the period specified in the Convention, 
                pursuant to paragraph 7 of article 2 of the 
                Convention, to the Secretary-General of the 
                United Nations;
                  (iii) request the Secretary of State to 
                transmit a notice of qualified acceptance as 
                prescribed in clause (ii) and request the 
                Secretary of State to ask for a review by the 
                Economic and Social Council of the United 
                Nations, in accordance with paragraph 8 of 
                article 2 of the Convention, of the scheduling 
                decision; or
                  (iv) in the case of a schedule notice, 
                request the Secretary of State to take 
                appropriate action under the Convention to 
                initiate proceedings to remove the drug or 
                substance from the schedules under the 
                Convention or to transfer the drug or substance 
                to a schedule under the Convention different 
                from the one specified in the schedule notice.
  (4)(A) If the Attorney General determines, after consultation 
with the Secretary of Health, Education, and Welfare, that 
proceedings initiated under recommendations made under 
paragraph (B) or (C)(i) of paragraph (3) will not be completed 
within the time period required by paragraph 7 of article 2 of 
the Convention, the Attorney General, after consultation with 
the Secretary and after providing interested persons 
opportunity to submit comments respecting the requirements of 
the temporary order to be issued under this sentence, shall 
issue a temporary order controlling the drug or substance under 
schedule IV or V, whichever is most appropriate to carry out 
the minimum United States obligations under paragraph 7 of 
article 2 of the Convention. As a part of such order, the 
Attorney General shall, after consultation with the Secretary, 
except such drug or substance from the application of any 
provision of part C of this title which he finds is not 
required to carry out the United States obligations under 
paragraph 7 of article 2 of the Convention. In the case of 
proceedings initiated under subparagraph (B) of paragraph (3), 
the Attorney General, concurrently with the issuance of such 
order, shall request the Secretary of State to transmit a 
notice of qualified acceptance to the Secretary-General of the 
United Nations pursuant to paragraph 7 of article 2 of the 
Convention. A temporary order issued under this subparagraph 
controlling a drug or other substance subject to proceedings 
initiated under subsections (a) and (b) of this section shall 
expire upon the effective date of the application to the drug 
or substance of the controls resulting from such proceedings.
  (B) After a notice of qualified acceptance of a scheduling 
decision with respect to a drug or other substance is 
transmitted to the Secretary-General of the United Nations in 
accordance with clause (ii) or (iii) of paragraph (3)(C) or 
after a request has been made under clause (iv) of such 
paragraph with respect to a drug or substance described in a 
schedule notice, the Attorney General, after consultation with 
the Secretary of Health, Education, and Welfare and after 
providing interested persons opportunity to submit comments 
respecting the requirements of the order to be issued under 
this sentence, shall issue an order controlling the drug or 
substance under schedule IV or V, whichever is most appropriate 
to carry out the minimum United States obligations under 
paragraph 7 of article 2 of the Convention in the case of a 
drug or substance for which a notice of qualified acceptance 
was transmitted or whichever the Attorney General determines is 
appropriate in the case of a drug or substance described in a 
schedule notice. As a part of such order, the Attorney General 
shall, after consultation with the Secretary, except such drug 
or substance from the application of any provision of part C of 
this title which he finds is not required to carry out the 
United States obligations under paragraph 7 of article 2 of the 
Convention. If, as a result of a review under paragraph 8 of 
article 2 of the Convention of the scheduling decision with 
respect to which a notice of qualified acceptance was 
transmitted in accordance with clause (ii) or (iii) of 
paragraph (3)(C)--
          (i) the decision is reversed, and
          (ii) the drug or substance subject to such decision 
        is not required to be controlled under schedule IV or V 
        to carry out the minimum United States obligations 
        under paragraph 7 of article 2 of the Convention,
the order issued under this subparagraph with respect to such 
drug or substance shall expire upon receipt by the United 
States of the review decision. If, as a result of action taken 
pursuant to action initiated under a request transmitted under 
clause (iv) of paragraph (3)(C), the drug or substance with 
respect to which such action was taken is not required to be 
controlled under schedule IV or V, the order issued under this 
paragraph with respect to such drug or substance shall expire 
upon receipt by the United States of a notice of the action 
taken with respect to such drug or substance under the 
Convention.
  (C) An order issued under subparagraph (A) or (B) may be 
issued without regard to the findings required by subsection 
(a) of this section or by section 202(b) and without regard to 
the procedures prescribed by subsection (a) or (b) of this 
section.
  (5) Nothing in the amendments made by the Psychotropic 
Substances Act of 1978 or the regulations or orders promulgated 
thereunder shall be construed to preclude requests by the 
Secretary of Health, Education, and Welfare or the Attorney 
General through the Secretary of State, pursuant to article 2 
or other applicable provisions of the Convention, for review of 
scheduling decisions under such Convention, based on new or 
additional information.
  (e) The Attorney General may, without regard to the findings 
required by subsection (a) of this section or section 202(b) 
and without regard to the procedures prescribed by subsections 
(a) and (b) of this section, place an immediate precursor in 
the same schedule in which the controlled substance of which it 
is an immediate precursor is placed or in any other schedule 
with a higher numerical designation. If the Attorney General 
designates a substance as an immediate precursor and places it 
in a schedule, other substances shall not be placed in a 
schedule solely because they are its precursors.
  (f) If, at the time a new-drug application is submitted to 
the Secretary for any drug having a stimulant, depressant, or 
hallucinogenic effect on the central nervous system, it appears 
that such drug has an abuse potential, such information shall 
be forwarded by the Secretary to the Attorney General.
  (g)(1) The Attorney General shall by regulation exclude any 
nonnarcotic drug which contains a controlled substance from the 
application of titles II and III of the Comprehensive Drug 
Abuse Prevention and Control Act (21 U.S.C. 802 et seq.) if 
such drug may, under the Federal Food, Drug, and Cosmetic Act, 
be lawfully sold over the counter without a prescription.
  (2) Dextromethorphan shall not be deemed to be included in 
any schedule by reason of enactment of this title unless 
controlled after the date of such enactment pursuant to the 
foregoing provisions of this section.
  (3) The Attorney General may, by regulation, exempt any 
compound, mixture, or preparation containing a controlled 
substance from the application of all or any part of this title 
if he finds such compound, mixture, or preparation meets the 
requirements of one of the following categories:
          (A) A mixture, or preparation containing a 
        nonnarcotic controlled substance, which mixture or 
        preparation is approved for prescription use, and which 
        contains one or more other active ingredients which are 
        not listed in any schedule and which are included there 
        in such combinations, quantity, proportion, or 
        concentration as to vitiate the potential for abuse.
          (B) A compound, mixture, or preparation which 
        contains any controlled substance, which is not for 
        administration to a human being or animal, and which is 
        packaged in such form or concentration, or with 
        adulterants or denaturants, so that as packaged it does 
        not present any significant potential for abuse.
          (C) Upon the recommendation of the Secretary of 
        Health and Human Services, a compound, mixture, or 
        preparation which contains any anabolic steroid, which 
        is intended for administration to a human being or an 
        animal, and which, because of its concentration, 
        preparation, formulation or delivery system, does not 
        present any significant potential for abuse.
  (h)(1) If the Attorney General finds that the scheduling of a 
substance in schedule I on a temporary basis is necessary to 
avoid an imminent hazard to the public safety, he may, by order 
and without regard to the requirements of subsection (b) 
relating to the Secretary of Health and Human Services, 
schedule such substance in schedule I if the substance is not 
listed in any other schedule in section 202 or if no exemption 
or approval is in effect for the substance under section 505 of 
the Federal Food, Drug, and Cosmetic Act. Such an order may not 
be issued before the expiration of thirty days from--
          (A) the date of the publication by the Attorney 
        General of a notice in the Federal Register of the 
        intention to issue such order and the grounds upon 
        which such order is to be issued, and
          (B) the date the Attorney General has transmitted the 
        notice required by paragraph (4).
  (2) The scheduling of a substance under this subsection shall 
expire at the end of 2 years from the date of the issuance of 
the order scheduling such substance, except that the Attorney 
General may, during the pendency of proceedings under 
subsection (a)(1) with respect to the substance, extend the 
temporary scheduling for up to 1 year.
  (3) When issuing an order under paragraph (1), the Attorney 
General shall be required to consider, with respect to the 
finding of an imminent hazard to the public safety, only those 
factors set forth in paragraphs (4), (5), and (6) of subsection 
(c), including actual abuse, diversion from legitimate 
channels, and clandestine importation, manufacture, or 
distribution.
  (4) The Attorney General shall transmit notice of an order 
proposed to be issued under paragraph (1) to the Secretary of 
Health and Human Services. In issuing an order under paragraph 
(1), the Attorney General shall take into consideration any 
comments submitted by the Secretary in response to a notice 
transmitted pursuant to this paragraph.
  (5) An order issued under paragraph (1) with respect to a 
substance shall be vacated upon the conclusion of a subsequent 
rulemaking proceeding initiated under subsection (a) with 
respect to such substance.
  (6) An order issued under paragraph (1) is not subject to 
judicial review.
  (i) Temporary and Permanent Scheduling of Recently Emerged 
Anabolic Steroids.--
          (1) The Attorney General may issue a temporary order 
        adding a drug or other substance to the definition of 
        anabolic steroids if the Attorney General finds that--
                  (A) the drug or other substance satisfies the 
                criteria for being considered an anabolic 
                steroid under section 102(41) but is not listed 
                in that section or by regulation of the 
                Attorney General as being an anabolic steroid; 
                and
                  (B) adding such drug or other substance to 
                the definition of anabolic steroids will assist 
                in preventing abuse or misuse of the drug or 
                other substance.
          (2) An order issued under paragraph (1) shall not 
        take effect until 30 days after the date of the 
        publication by the Attorney General of a notice in the 
        Federal Register of the intention to issue such order 
        and the grounds upon which such order is to be issued. 
        The order shall expire not later than 24 months after 
        the date it becomes effective, except that the Attorney 
        General may, during the pendency of proceedings under 
        paragraph (6), extend the temporary scheduling order 
        for up to 6 months.
          (3) The Attorney General shall transmit notice of an 
        order proposed to be issued under paragraph (1) to the 
        Secretary of Health and Human Services. In issuing an 
        order under paragraph (1), the Attorney General shall 
        take into consideration any comments submitted by the 
        Secretary in response to a notice transmitted pursuant 
        to this paragraph.
          (4) A temporary scheduling order issued under 
        paragraph (1) shall be vacated upon the issuance of a 
        permanent scheduling order under paragraph (6).
          (5) An order issued under paragraph (1) is not 
        subject to judicial review.
          (6) The Attorney General may, by rule, issue a 
        permanent order adding a drug or other substance to the 
        definition of anabolic steroids if such drug or other 
        substance satisfies the criteria for being considered 
        an anabolic steroid under section 102(41). Such 
        rulemaking may be commenced simultaneously with the 
        issuance of the temporary order issued under paragraph 
        (1).
  (j)(1) With respect to a drug referred to in subsection (f), 
if the Secretary of Health and Human Services recommends that 
the Attorney General add the drug to schedule II, III, IV, or V 
pursuant to subsections (a) and (b), the Attorney General 
shall, not later than 90 days after the date described in 
paragraph (2), issue an interim final rule controlling the drug 
in accordance with such subsections and section 202(b) using 
the procedures described in paragraph (3).
  (2) The date described in this paragraph shall be the later 
of--
          (A) the date on which the Attorney General receives 
        the scientific and medical evaluation and 
        recommendations from the Secretary of Health and Human 
        Services in accordance with subsection (b); or
          (B) the date on which the Attorney General receives 
        notification from the Secretary of Health and Human 
        Services that the Secretary has approved an application 
        under section 505(c), 512, 571, or 572 of the Federal 
        Food, Drug, and Cosmetic Act or section 351(a) of the 
        Public Health Service Act with respect to the drug 
        described in paragraph (1).
  (3) A rule issued by the Attorney General under paragraph (1) 
shall be in accordance with the procedures provided in 
subsection (a), except that the rule shall become immediately 
effective as an interim final rule without requiring the 
Attorney General to demonstrate good cause therefor. After 
publication of the interim final rule, the Attorney General 
shall issue a final rule in accordance with the procedures 
provided in subsection (a).

           *       *       *       *       *       *       *


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

           *       *       *       *       *       *       *


                       registration requirements

  Sec. 303. (a) The Attorney General shall register an 
applicant to manufacture controlled substances in schedule I or 
II if he determines that such registration is consistent with 
the public interest and with United States obligations under 
international treaties, conventions, or protocols in effect on 
the effective date of this part. In determining the public 
interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances and any 
        controlled substance in schedule I or II compounded 
        therefrom into other than legitimate medical, 
        scientific, research, or industrial channels, by 
        limiting the importation and bulk manufacture of such 
        controlled substances to a number of establishments 
        which can produce an adequate and uninterrupted supply 
        of these substances under adequately competitive 
        conditions for legitimate medical, scientific, 
        research, and industrial purposes;
          (2) compliance with applicable State and local law;
          (3) promotion of technical advances in the art of 
        manufacturing these substances and the development of 
        new substances;
          (4) prior conviction record of applicant under 
        Federal and State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (5) past experience in the manufacture of controlled 
        substances, and the existence in the establishment of 
        effective control against diversion; and
          (6) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (b) The Attorney General shall register an applicant to 
distribute a controlled substance in schedule I or II unless he 
determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances into 
        other than legitimate medical, scientific, and 
        industrial channels;
          (2) compliance with applicable State and local law;
          (3) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (4) past experience in the distribution of controlled 
        substances; and
          (5) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (c) Registration granted under subsections (a) and (b) of 
this section shall not entitle a registrant to (1) manufacture 
or distribute controlled substances in schedule I or II other 
than those specified in the registration, or (2) manufacture 
any quantity of those controlled substances in excess of the 
quota assigned pursuant to section 306.
  (d) The Attorney General shall register an applicant to 
manufacture controlled substances in schedule III, IV, or V, 
unless he determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances and any 
        controlled substance in schedule III, IV, or V 
        compounded therefrom into other than legitimate 
        medical, scientific, or industrial channels;
          (2) compliance with applicable State and local law;
          (3) promotion of technical advances in the art of 
        manufacturing these substances and the development of 
        new substances;
          (4) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (5) past experience in the manufacture, distribution, 
        and dispensing of controlled substances, and the 
        existence in the establishment of effective controls 
        against diversion; and
          (6) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (e) The Attorney General shall register an applicant to 
distribute controlled substances in schedule III, IV, or V, 
unless he determines that the issuance of such registration is 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) maintenance of effective controls against 
        diversion of particular controlled substances into 
        other than legitimate medical, scientific, and 
        industrial channels;
          (2) compliance with applicable State and local law;
          (3) prior conviction record of applicant under 
        Federal or State laws relating to the manufacture, 
        distribution, or dispensing of such substances;
          (4) past experience in the distribution of controlled 
        substances; and
          (5) such other factors as may be relevant to and 
        consistent with the public health and safety.
  (f) The Attorney General shall register practitioners 
(including pharmacies, as distinguished from pharmacists) to 
dispense, or conduct research with, controlled substances in 
schedule II, III, IV, or V and shall modify the registrations 
of pharmacies so registered to authorize them to dispense 
controlled substances by means of the Internet, if the 
applicant is authorized to dispense, or conduct research with 
respect to, controlled substances under the laws of the State 
in which he practices. The Attorney General may deny an 
application for such registration or such modification of 
registration if the Attorney General determines that the 
issuance of such registration or modification would be 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) The recommendation of the appropriate State 
        licensing board or professional disciplinary authority.
          (2) The applicant's experience in dispensing, or 
        conducting research with respect to controlled 
        substances.
          (3) The applicant's conviction record under Federal 
        or State laws relating to the manufacture, 
        distribution, or dispensing of controlled substances.
          (4) Compliance with applicable State, Federal, or 
        local laws relating to controlled substances.
          (5) Such other conduct which may threaten the public 
        health and safety.
Separate registration under this part for practitioners 
engaging in research with controlled substances in schedule II, 
III, IV, or V, who are already registered under this part in 
another capacity, shall not be required. Registration 
applications by practitioners wishing to conduct research with 
controlled substances in schedule I shall be referred to the 
Seretary, who shall determine the qualifications and competency 
of each practitioner requesting registration, as well as the 
merits of the research protocol. The Secretary, in determining 
the merits of each research protocol, shall consult with the 
Attorney General as to effective procedures to adequately 
safeguard against diversion of such controlled substances from 
legitimate medical or scientific use. Registration for the 
purpose of bona fide research with controlled substances in 
schedule I by a practitioner deemed qualified by the Secretary 
may be denied by the Attorney General only on a ground 
specified in section 304(a). Article 7 of the Convention on 
Psychotrophic Substances shall not be construed to prohibit, or 
impose additional restrictions upon, research involving drugs 
or other substances scheduled under the convention which is 
conducted in conformity with this subsection and other 
applicable provisions of this title.
  (g)(1) Except as provided in paragraph (2), practitioners who 
dispense narcotic drugs to individuals for maintenance 
treatment or detoxification treatment shall obtain annually a 
separate registration for that purpose. The Attorney General 
shall register an applicant to dispense narcotic drugs to 
individuals for maintenance treatment or detoxification 
treatment (or both)--
          (A) if the applicant is a practitioner who is 
        determined by the Secretary to be qualified (under 
        standards established by the Secretary) to engage in 
        the treatment with respect to which registration is 
        sought;
          (B) if the Attorney General determines that the 
        applicant will comply with standards established by the 
        Attorney General respecting (i) security of stocks of 
        narcotic drugs for such treatment, and (ii) the 
        maintenance of records (in accordance with section 307) 
        on such drugs; and
          (C) if the Secretary determines that the applicant 
        will comply with standards established by the Secretary 
        (after consultation with the Attorney General) 
        respecting the quantities of narcotic drugs which may 
        be provided for unsupervised use by individuals in such 
        treatment.
  (2)(A) Subject to subparagraphs (D) and (J), the requirements 
of paragraph (1) are waived in the case of the dispensing 
(including the prescribing), by a practitioner, of narcotic 
drugs in schedule III, IV, or V or combinations of such drugs 
if the practitioner meets the conditions specified in 
subparagraph (B) and the narcotic drugs or combinations of such 
drugs meet the conditions specified in subparagraph (C).
  (B) For purposes of subparagraph (A), the conditions 
specified in this subparagraph with respect to a practitioner 
are that, before the initial dispensing of narcotic drugs in 
schedule III, IV, or V or combinations of such drugs to 
patients for maintenance or detoxification treatment, the 
practitioner submit to the Secretary a notification of the 
intent of the practitioner to begin dispensing the drugs or 
combinations for such purpose, and that the notification 
contain the following certifications by the practitioner:
          (i) The practitioner is a qualifying physician (as 
        defined in subparagraph (G)).
          (ii) With respect to patients to whom the 
        practitioner will provide such drugs or combinations of 
        drugs, the practitioner has the capacity to refer the 
        patients for appropriate counseling and other 
        appropriate ancillary services.
          (iii) The total number of such patients of the 
        practitioner at any one time will not exceed the 
        applicable number. For purposes of this clause, the 
        applicable number is 30, unless, not sooner than 1 year 
        after the date on which the practitioner submitted the 
        initial notification, the practitioner submits a second 
        notification to the Secretary of the need and intent of 
        the practitioner to treat up to 100 patients. A second 
        notification under this clause shall contain the 
        certifications required by clauses (i) and (ii) of this 
        subparagraph. The Secretary may by regulation change 
        such total number.
  (C) For purposes of subparagraph (A), the conditions 
specified in this subparagraph with respect to narcotic drugs 
in schedule III, IV, or V or combinations of such drugs are as 
follows:
          (i) The drugs or combinations of drugs have, under 
        the Federal Food, Drug, and Cosmetic Act or section 351 
        of the Public Health Service Act, been approved for use 
        in maintenance or detoxification treatment.
          (ii) The drugs or combinations of drugs have not been 
        the subject of an adverse determination. For purposes 
        of this clause, an adverse determination is a 
        determination published in the Federal Register and 
        made by the Secretary, after consultation with the 
        Attorney General, that the use of the drugs or 
        combinations of drugs for maintenance or detoxification 
        treatment requires additional standards respecting the 
        qualifications of practitioners to provide such 
        treatment, or requires standards respecting the 
        quantities of the drugs that may be provided for 
        unsupervised use.
  (D)(i) A waiver under subparagraph (A) with respect to a 
practitioner is not in effect unless (in addition to conditions 
under subparagraphs (B) and (C)) the following conditions are 
met:
          (I) The notification under subparagraph (B) is in 
        writing and states the name of the practitioner.
          (II) The notification identifies the registration 
        issued for the practitioner pursuant to subsection (f).
          (III) If the practitioner is a member of a group 
        practice, the notification states the names of the 
        other practitioners in the practice and identifies the 
        registrations issued for the other practitioners 
        pursuant to subsection (f).
  (ii) Upon receiving a notification under subparagraph (B), 
the Attorney General shall assign the practitioner involved an 
identification number under this paragraph for inclusion with 
the registration issued for the practitioner pursuant to 
subsection (f). The identification number so assigned shall be 
appropriate to preserve the confidentiality of patients for 
whom the practitioner has dispensed narcotic drugs under a 
waiver under subparagraph (A).
  (iii) Not later than 45 days after the date on which the 
Secretary receives a notification under subparagraph (B), the 
Secretary shall make a determination of whether the 
practitioner involved meets all requirements for a waiver under 
subparagraph (B). If the Secretary fails to make such 
determination by the end of the such 45-day period, the 
Attorney General shall assign the physician an identification 
number described in clause (ii) at the end of such period.
  (E)(i) If a practitioner is not registered under paragraph 
(1) and, in violation of the conditions specified in 
subparagraphs (B) through (D), dispenses narcotic drugs in 
schedule III, IV, or V or combinations of such drugs for 
maintenance treatment or detoxification treatment, the Attorney 
General may, for purposes of section 304(a)(4), consider the 
practitioner to have committed an act that renders the 
registration of the practitioner pursuant to subsection (f) to 
be inconsistent with the public interest.
  (ii)(I) Upon the expiration of 45 days from the date on which 
the Secretary receives a notification under subparagraph (B), a 
practitioner who in good faith submits a notification under 
subparagraph (B) and reasonably believes that the conditions 
specified in subparagraphs (B) through (D) have been met shall, 
in dispensing narcotic drugs in schedule III, IV, or V or 
combinations of such drugs for maintenance treatment or 
detoxification treatment, be considered to have a waiver under 
subparagraph (A) until notified otherwise by the Secretary, 
except that such a practitioner may commence to prescribe or 
dispense such narcotic drugs for such purposes prior to the 
expiration of such 45-day period if it facilitates the 
treatment of an individual patient and both the Secretary and 
the Attorney General are notified by the practitioner of the 
intent to commence prescribing or dispensing such narcotic 
drugs.
  (II) For purposes of subclause (I), the publication in the 
Federal Register of an adverse determination by the Secretary 
pursuant to subparagraph (C)(ii) shall (with respect to the 
narcotic drug or combination involved) be considered to be a 
notification provided by the Secretary to practitioners, 
effective upon the expiration of the 30-day period beginning on 
the date on which the adverse determination is so published.
  (F)(i) With respect to the dispensing of narcotic drugs in 
schedule III, IV, or V or combinations of such drugs to 
patients for maintenance or detoxification treatment, a 
practitioner may, in his or her discretion, dispense such drugs 
or combinations for such treatment under a registration under 
paragraph (1) or a waiver under subparagraph (A) (subject to 
meeting the applicable conditions).
  (ii) This paragraph may not be construed as having any legal 
effect on the conditions for obtaining a registration under 
paragraph (1), including with respect to the number of patients 
who may be served under such a registration.
  (G) For purposes of this paragraph:
          (i) The term ``group practice'' has the meaning given 
        such term in section 1877(h)(4) of the Social Security 
        Act.
          (ii) The term ``qualifying physician'' means a 
        physician who is licensed under State law and who meets 
        one or more of the following conditions:
                  (I) The physician holds a subspecialty board 
                certification in addiction psychiatry from the 
                American Board of Medical Specialties.
                  (II) The physician holds an addiction 
                certification from the American Society of 
                Addiction Medicine.
                  (III) The physician holds a subspecialty 
                board certification in addiction medicine from 
                the American Osteopathic Association.
                  (IV) The physician has, with respect to the 
                treatment and management of opiate-dependent 
                patients, completed not less than eight hours 
                of training (through classroom situations, 
                seminars at professional society meetings, 
                electronic communications, or otherwise) that 
                is provided by the American Society of 
                Addiction Medicine, the American Academy of 
                Addiction Psychiatry, the American Medical 
                Association, the American Osteopathic 
                Association, the American Psychiatric 
                Association, or any other organization that the 
                Secretary determines is appropriate for 
                purposes of this subclause.
                  (V) The physician has participated as an 
                investigator in one or more clinical trials 
                leading to the approval of a narcotic drug in 
                schedule III, IV, or V for maintenance or 
                detoxification treatment, as demonstrated by a 
                statement submitted to the Secretary by the 
                sponsor of such approved drug.
                  (VI) The physician has such other training or 
                experience as the State medical licensing board 
                (of the State in which the physician will 
                provide maintenance or detoxification 
                treatment) considers to demonstrate the ability 
                of the physician to treat and manage opiate-
                dependent patients.
                  (VII) The physician has such other training 
                or experience as the Secretary considers to 
                demonstrate the ability of the physician to 
                treat and manage opiate-dependent patients. Any 
                criteria of the Secretary under this subclause 
                shall be established by regulation. Any such 
                criteria are effective only for 3 years after 
                the date on which the criteria are promulgated, 
                but may be extended for such additional 
                discrete 3-year periods as the Secretary 
                considers appropriate for purposes of this 
                subclause. Such an extension of criteria may 
                only be effectuated through a statement 
                published in the Federal Register by the 
                Secretary during the 30-day period preceding 
                the end of the 3-year period involved.
  (H)(i) In consultation with the Administrator of the Drug 
Enforcement Administration, the Administrator of the Substance 
Abuse and Mental Health Services Administration, the Director 
of the National Institute on Drug Abuse, and the Commissioner 
of Food and Drugs, the Secretary shall issue regulations 
(through notice and comment rulemaking) or issue practice 
guidelines to address the following:
          (I) Approval of additional credentialing bodies and 
        the responsibilities of additional credentialing 
        bodies.
          (II) Additional exemptions from the requirements of 
        this paragraph and any regulations under this 
        paragraph.
Nothing in such regulations or practice guidelines may 
authorize any Federal official or employee to exercise 
supervision or control over the practice of medicine or the 
manner in which medical services are provided.
  (ii) Not later than 120 days after the date of the enactment 
of the Drug Addiction Treatment Act of 2000, the Secretary 
shall issue a treatment improvement protocol containing best 
practice guidelines for the treatment and maintenance of 
opiate-dependent patients. The Secretary shall develop the 
protocol in consultation with the Director of the National 
Institute on Drug Abuse, the Administrator of the Drug 
Enforcement Administration, the Commissioner of Food and Drugs, 
the Administrator of the Substance Abuse and Mental Health 
Services Administration and other substance abuse disorder 
professionals. The protocol shall be guided by science.
  (I) During the 3-year period beginning on the date of the 
enactment of the Drug Addiction Treatment Act of 2000, a State 
may not preclude a practitioner from dispensing or prescribing 
drugs in schedule III, IV, or V, or combinations of such drugs, 
to patients for maintenance or detoxification treatment in 
accordance with this paragraph unless, before the expiration of 
that 3-year period, the State enacts a law prohibiting a 
practitioner from dispensing such drugs or combinations of 
drug.
  (J)(i) This paragraph takes effect on the date of the 
enactment of the Drug Addiction Treatment Act of 2000, and 
remains in effect thereafter.
  (ii) For purposes relating to clause (iii), the Secretary and 
the Attorney General may, during the 3-year period beginning on 
the date of the enactment of the Office of National Drug 
Control Policy Reauthorization Act of 2006, make determinations 
in accordance with the following:
          (I) The Secretary may make a determination of whether 
        treatments provided under waivers under subparagraph 
        (A) have been effective forms of maintenance treatment 
        and detoxification treatment in clinical settings; may 
        make a determination of whether such waivers have 
        significantly increased (relative to the beginning of 
        such period) the availability of maintenance treatment 
        and detoxification treatment; and may make a 
        determination of whether such waivers have adverse 
        consequences for the public health.
          (II) The Attorney General may make a determination of 
        the extent to which there have been violations of the 
        numerical limitations established under subparagraph 
        (B) for the number of individuals to whom a 
        practitioner may provide treatment; may make a 
        determination of whether waivers under subparagraph (A) 
        have increased (relative to the beginning of such 
        period) the extent to which narcotic drugs in schedule 
        III, IV, or V or combinations of such drugs are being 
        dispensed or possessed in violation of this Act; and 
        may make a determination of whether such waivers have 
        adverse consequences for the public health.
  (iii) If, before the expiration of the period specified in 
clause (ii), the Secretary or the Attorney General publishes in 
the Federal Register a decision, made on the basis of 
determinations under such clause, that subparagraph (B)(iii) 
should be applied by limiting the total number of patients a 
practitioner may treat to 30, then the provisions in such 
subparagraph (B)(iii) permitting more than 30 patients shall 
not apply, effective 60 days after the date on which the 
decision is so published. The Secretary shall in making any 
such decision consult with the Attorney General, and shall in 
publishing the decision in the Federal Register include any 
comments received from the Attorney General for inclusion in 
the publication. The Attorney General shall in making any such 
decision consult with the Secretary, and shall in publishing 
the decision in the Federal Register include any comments 
received from the Secretary for inclusion in the publication.
  (h) The Attorney General shall register an applicant to 
distribute a list I chemical unless the Attorney General 
determines that registration of the applicant is inconsistent 
with the public interest. Registration under this subsection 
shall not be required for the distribution of a drug product 
that is exempted under clause (iv) or (v) of section 
102(39)(A). In determining the public interest for the purposes 
of this subsection, the Attorney General shall consider--
          (1) maintenance by the applicant of effective 
        controls against diversion of listed chemicals into 
        other than legitimate channels;
          (2) compliance by the applicant with applicable 
        Federal, State, and local law;
          (3) any prior conviction record of the applicant 
        under Federal or State laws relating to controlled 
        substances or to chemicals controlled under Federal or 
        State law;
          (4) any past experience of the applicant in the 
        manufacture and distribution of chemicals; and
          (5) such other factors as are relevant to and 
        consistent with the public health and safety.
  (i)(1) For purposes of registration to manufacture a 
controlled substance under subsection (d) for use only in a 
clinical trial, the Attorney General shall register the 
applicant, or serve an order to show cause upon the applicant 
in accordance with section 304(c), not later than 180 days 
after the date on which the application is accepted for filing.
  (2) For purposes of registration to manufacture a controlled 
substance under subsection (a) for use only in a clinical 
trial, the Attorney General shall, in accordance with the 
regulations issued by the Attorney General, issue a notice of 
application not later than 90 days after the application is 
accepted for filing. Not later than 90 days after the date on 
which the period for comment pursuant to such notice ends, the 
Attorney General shall register the applicant, or serve an 
order to show cause upon the applicant in accordance with 
section 304(c), unless the Attorney General has granted a 
hearing on the application under section 1008(i) of the 
Controlled Substances Import and Export Act.

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                              ----------                              


                      TITLE 35, UNITED STATES CODE



           *       *       *       *       *       *       *
PART II--PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

           *       *       *       *       *       *       *


CHAPTER 14--ISSUE OF PATENT

           *       *       *       *       *       *       *


Sec. 156. Extension of patent term

  (a) The term of a patent which claims a product, a method of 
using a product, or a method of manufacturing a product shall 
be extended in accordance with this section from the original 
expiration date of the patent, which shall include any patent 
term adjustment granted under section 154(b), if--
          (1) the term of the patent has not expired before an 
        application is submitted under subsection (d)(1) for 
        its extension;
          (2) the term of the patent has never been extended 
        under subsection (e)(1) of this section;
          (3) an application for extension is submitted by the 
        owner of record of the patent or its agent and in 
        accordance with the requirements of paragraphs (1) 
        through (4) of subsection (d);
          (4) the product has been subject to a regulatory 
        review period before its commercial marketing or use;
          (5)(A) except as provided in subparagraph (B) or (C), 
        the permission for the commercial marketing or use of 
        the product after such regulatory review period is the 
        first permitted commercial marketing or use of the 
        product under the provision of law under which such 
        regulatory review period occurred;
          (B) in the case of a patent which claims a method of 
        manufacturing the product which primarily uses 
        recombinant DNA technology in the manufacture of the 
        product, the permission for the commercial marketing or 
        use of the product after such regulatory review period 
        is the first permitted commercial marketing or use of a 
        product manufactured under the process claimed in the 
        patent; or
          (C) for purposes of subparagraph (A), in the case of 
        a patent which--
                  (i) claims a new animal drug or a veterinary 
                biological product which (I) is not covered by 
                the claims in any other patent which has been 
                extended, and (II) has received permission for 
                the commercial marketing or use in non-food-
                producing animals and in food-producing 
                animals, and
                  (ii) was not extended on the basis of the 
                regulatory review period for use in non-food-
                producing animals,
        the permission for the commercial marketing or use of 
        the drug or product after the regulatory review period 
        for use in food-producing animals is the first 
        permitted commercial marketing or use of the drug or 
        product for administration to a food-producing animal.
The product referred to in paragraphs (4) and (5) is 
hereinafter in this section referred to as the ``approved 
product''.
  (b) Except as provided in subsection (d)(5)(F), the rights 
derived from any patent the term of which is extended under 
this section shall during the period during which the term of 
the patent is extended--
          (1) in the case of a patent which claims a product, 
        be limited to any use approved for the product--
                  (A) before the expiration of the term of the 
                patent--
                          (i) under the provision of law under 
                        which the applicable regulatory review 
                        occurred, or
                          (ii) under the provision of law under 
                        which any regulatory review described 
                        in paragraph (1), (4), or (5) of 
                        subsection (g) occurred, and
                  (B) on or after the expiration of the 
                regulatory review period upon which the 
                extension of the patent was based;
          (2) in the case of a patent which claims a method of 
        using a product, be limited to any use claimed by the 
        patent and approved for the product--
                  (A) before the expiration of the term of the 
                patent--
                          (i) under any provision of law under 
                        which an applicable regulatory review 
                        occurred, and
                          (ii) under the provision of law under 
                        which any regulatory review described 
                        in paragraph (1), (4), or (5) of 
                        subsection (g) occurred, and
                  (B) on or after the expiration of the 
                regulatory review period upon which the 
                extension of the patent was based; and
          (3) in the case of a patent which claims a method of 
        manufacturing a product, be limited to the method of 
        manufacturing as used to make--
                  (A) the approved product, or
                  (B) the product if it has been subject to a 
                regulatory review period described in paragraph 
                (1), (4), or (5) of subsection (g).
As used in this subsection, the term ``product'' includes an 
approved product.
  (c) The term of a patent eligible for extension under 
subsection (a) shall be extended by the time equal to the 
regulatory review period for the approved product which period 
occurs after the date the patent is issued, except that--
          (1) each period of the regulatory review period shall 
        be reduced by any period determined under subsection 
        (d)(2)(B) during which the applicant for the patent 
        extension did not act with due diligence during such 
        period of the regulatory review period;
          (2) after any reduction required by paragraph (1), 
        the period of extension shall include only one-half of 
        the time remaining in the periods described in 
        paragraphs (1)(B)(i), (2)(B)(i), (3)(B)(i), (4)(B)(i), 
        and (5)(B)(i) of subsection (g);
          (3) if the period remaining in the term of a patent 
        after the date of the approval of the approved product 
        under the provision of law under which such regulatory 
        review occurred when added to the regulatory review 
        period as revised under paragraphs (1) and (2) exceeds 
        fourteen years, the period of extension shall be 
        reduced so that the total of both such periods does not 
        exceed fourteen years; and
          (4) in no event shall more than one patent be 
        extended under subsection (e)(1) for the same 
        regulatory review period for any product.
  (d)(1) To obtain an extension of the term of a patent under 
this section, the owner of record of the patent or its agent 
shall submit an application to the Director. Except as provided 
in paragraph (5), such an application may only be submitted 
within the sixty-day period beginning on the date the product 
received permission under the provision of law under which the 
applicable regulatory review period occurred for commercial 
marketing or use, or in the case of a drug product described in 
subsection (i) within the sixty-day period beginning on the 
covered date (as defined in subsection (i)). The application 
shall contain--
          (A) the identity of the approved product and the 
        Federal statute under which regulatory review occurred;
          (B) the identity of the patent for which an extension 
        is being sought and the identity of each claim of such 
        patent which claims the approved product or a method of 
        using or manufacturing the approved product;
          (C) information to enable the Director to determine 
        under subsections (a) and (b) the eligibility of a 
        patent for extension and the rights that will be 
        derived from the extension and information to enable 
        the Director and the Secretary of Health and Human 
        Services or the Secretary of Agriculture to determine 
        the period of the extension under subsection (g);
          (D) a brief description of the activities undertaken 
        by the applicant during the applicable regulatory 
        review period with respect to the approved product and 
        the significant dates applicable to such activities; 
        and
          (E) such patent or other information as the Director 
        may require.
For purposes of determining the date on which a product 
receives permission under the second sentence of this 
paragraph, if such permission is transmitted after 4:30 P.M., 
Eastern Time, on a business day, or is transmitted on a day 
that is not a business day, the product shall be deemed to 
receive such permission on the next business day. For purposes 
of the preceding sentence, the term ``business day'' means any 
Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any 
legal holiday under section 6103 of title 5.
  (2)(A) Within 60 days of the submittal of an application for 
extension of the term of a patent under paragraph (1), the 
Director shall notify--
          (i) the Secretary of Agriculture if the patent claims 
        a drug product or a method of using or manufacturing a 
        drug product and the drug product is subject to the 
        Virus-Serum-Toxin Act, and
          (ii) the Secretary of Health and Human Services if 
        the patent claims any other drug product, a medical 
        device, or a food additive or color additive or a 
        method of using or manufacturing such a product, 
        device, or additive and if the product, device, and 
        additive are subject to the Federal Food, Drug, and 
        Cosmetic Act,
of the extension application and shall submit to the Secretary 
who is so notified a copy of the application. Not later than 30 
days after the receipt of an application from the Director, the 
Secretary receiving the application shall review the dates 
contained in the application pursuant to paragraph (1)(C) and 
determine the applicable regulatory review period, shall notify 
the Director of the determination, and shall publish in the 
Federal Register a notice of such determination.
  (B)(i) If a petition is submitted to the Secretary making the 
determination under subparagraph (A), not later than 180 days 
after the publication of the determination under subparagraph 
(A), upon which it may reasonably be determined that the 
applicant did not act with due diligence during the applicable 
regulatory review period, the Secretary making the 
determination shall, in accordance with regulations promulgated 
by such Secretary, determine if the applicant acted with due 
diligence during the applicable regulatory review period. The 
Secretary making the determination shall make such 
determination not later than 90 days after the receipt of such 
a petition. For a drug product, device, or additive subject to 
the Federal Food, Drug, and Cosmetic Act or the Public Health 
Service Act, the Secretary may not delegate the authority to 
make the determination prescribed by this clause to an office 
below the Office of the Director of Food and Drugs. For a 
product subject to the Virus-Serum-Toxin Act, the Secretary of 
Agriculture may not delegate the authority to make the 
determination prescribed by this clause to an office below the 
Office of the Assistant Secretary for Marketing and Inspection 
Services.
  (ii) The Secretary making a determination under clause (i) 
shall notify the Director of the determination and shall 
publish in the Federal Register a notice of such determination 
together with the factual and legal basis for such 
determination. Any interested person may request, within the 
60-day period beginning on the publication of a determination, 
the Secretary making the determination to hold an informal 
hearing on the determination. If such a request is made within 
such period, such Secretary shall hold such hearing not later 
than 30 days after the date of the request, or at the request 
of the person making the request, not later than 60 days after 
such date. The Secretary who is holding the hearing shall 
provide notice of the hearing to the owner of the patent 
involved and to any interested person and provide the owner and 
any interested person an opportunity to participate in the 
hearing. Within 30 days after the completion of the hearing, 
such Secretary shall affirm or revise the determination which 
was the subject of the hearing and shall notify the Director of 
any revision of the determination and shall publish any such 
revision in the Federal Register.
  (3) For the purposes of paragraph (2)(B), the term ``due 
diligence'' means that degree of attention, continuous directed 
effort, and timeliness as may reasonably be expected from, and 
are ordinarily exercised by, a person during a regulatory 
review period.
  (4) An application for the extension of the term of a patent 
is subject to the disclosure requirements prescribed by the 
Director.
  (5)(A) If the owner of record of the patent or its agent 
reasonably expects that the applicable regulatory review period 
described in paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii), 
(4)(B)(ii), or (5)(B)(ii) of subsection (g) that began for a 
product that is the subject of such patent may extend beyond 
the expiration of the patent term in effect, the owner or its 
agent may submit an application to the Director for an interim 
extension during the period beginning 6 months, and ending 15 
days, before such term is due to expire. The application shall 
contain--
          (i) the identity of the product subject to regulatory 
        review and the Federal statute under which such review 
        is occurring;
          (ii) the identity of the patent for which interim 
        extension is being sought and the identity of each 
        claim of such patent which claims the product under 
        regulatory review or a method of using or manufacturing 
        the product;
          (iii) information to enable the Director to determine 
        under subsection (a)(1), (2), and (3) the eligibility 
        of a patent for extension;
          (iv) a brief description of the activities undertaken 
        by the applicant during the applicable regulatory 
        review period to date with respect to the product under 
        review and the significant dates applicable to such 
        activities; and
          (v) such patent or other information as the Director 
        may require.
  (B) If the Director determines that, except for permission to 
market or use the product commercially, the patent would be 
eligible for an extension of the patent term under this 
section, the Director shall publish in the Federal Register a 
notice of such determination, including the identity of the 
product under regulatory review, and shall issue to the 
applicant a certificate of interim extension for a period of 
not more than 1 year.
  (C) The owner of record of a patent, or its agent, for which 
an interim extension has been granted under subparagraph (B), 
may apply for not more than 4 subsequent interim extensions 
under this paragraph, except that, in the case of a patent 
subject to subsection (g)(6)(C), the owner of record of the 
patent, or its agent, may apply for only 1 subsequent interim 
extension under this paragraph. Each such subsequent 
application shall be made during the period beginning 60 days 
before, and ending 30 days before, the expiration of the 
preceding interim extension.
  (D) Each certificate of interim extension under this 
paragraph shall be recorded in the official file of the patent 
and shall be considered part of the original patent.
  (E) Any interim extension granted under this paragraph shall 
terminate at the end of the 60-day period beginning on the date 
on which the product involved receives permission for 
commercial marketing or use, except that, if within that 60-day 
period the applicant notifies the Director of such permission 
and submits any additional information under paragraph (1) of 
this subsection not previously contained in the application for 
interim extension, the patent shall be further extended, in 
accordance with the provisions of this section--
          (i) for not to exceed 5 years from the date of 
        expiration of the original patent term; or
          (ii) if the patent is subject to subsection 
        (g)(6)(C), from the date on which the product involved 
        receives approval for commercial marketing or use.
  (F) The rights derived from any patent the term of which is 
extended under this paragraph shall, during the period of 
interim extension--
          (i) in the case of a patent which claims a product, 
        be limited to any use then under regulatory review;
          (ii) in the case of a patent which claims a method of 
        using a product, be limited to any use claimed by the 
        patent then under regulatory review; and
          (iii) in the case of a patent which claims a method 
        of manufacturing a product, be limited to the method of 
        manufacturing as used to make the product then under 
        regulatory review.
  (e)(1) A determination that a patent is eligible for 
extension may be made by the Director solely on the basis of 
the representations contained in the application for the 
extension. If the Director determines that a patent is eligible 
for extension under subsection (a) and that the requirements of 
paragraphs (1) through (4) of subsection (d) have been complied 
with, the Director shall issue to the applicant for the 
extension of the term of the patent a certificate of extension, 
under seal, for the period prescribed by subsection (c). Such 
certificate shall be recorded in the official file of the 
patent and shall be considered as part of the original patent.
  (2) If the term of a patent for which an application has been 
submitted under subsection (d)(1) would expire before a 
certificate of extension is issued or denied under paragraph 
(1) respecting the application, the Director shall extend, 
until such determination is made, the term of the patent for 
periods of up to one year if he determines that the patent is 
eligible for extension.
  (f) For purposes of this section:
          (1) The term ``product'' means:
                  (A) A drug product.
                  (B) Any medical device, food additive, or 
                color additive subject to regulation under the 
                Federal Food, Drug, and Cosmetic Act.
          (2) The term ``drug product'' means the active 
        ingredient of--
                  (A) a new drug, antibiotic drug, or human 
                biological product (as those terms are used in 
                the Federal Food, Drug, and Cosmetic Act and 
                the Public Health Service Act), or
                  (B) a new animal drug or veterinary 
                biological product (as those terms are used in 
                the Federal Food, Drug, and Cosmetic Act and 
                the Virus-Serum-Toxin Act) which is not 
                primarily manufactured using recombinant DNA, 
                recombinant RNA, hybridoma technology, or other 
                processes involving site specific genetic 
                manipulation techniques,
        including any salt or ester of the active ingredient, 
        as a single entity or in combination with another 
        active ingredient.
          (3) The term ``major health or environmental effects 
        test'' means a test which is reasonably related to the 
        evaluation of the health or environmental effects of a 
        product, which requires at least six months to conduct, 
        and the data from which is submitted to receive 
        permission for commercial marketing or use. Periods of 
        analysis or evaluation of test results are not to be 
        included in determining if the conduct of a test 
        required at least six months.
          (4)(A) Any reference to section 351 is a reference to 
        section 351 of the Public Health Service Act.
          (B) Any reference to section 503, 505, 512, or 515 is 
        a reference to section 503, 505, 512, or 515 of the 
        Federal Food, Drug, and Cosmetic Act.
          (C) Any reference to the Virus-Serum-Toxin Act is a 
        reference to the Act of March 4, 1913 (21 U.S.C. 151-
        158).
          (5) The term ``informal hearing'' has the meaning 
        prescribed for such term by section 201(y) of the 
        Federal Food, Drug, and Cosmetic Act.
          (6) The term ``patent'' means a patent issued by the 
        United States Patent and Trademark Office.
          (7) The term ``date of enactment'' as used in this 
        section means September 24, 1984, for a human drug 
        product, a medical device, food additive, or color 
        additive.
          (8) The term ``date of enactment'' as used in this 
        section means the date of enactment of the Generic 
        Animal Drug and Patent Term Restoration Act for an 
        animal drug or a veterinary biological product.
  (g) For purposes of this section, the term ``regulatory 
review period'' has the following meanings:
          (1)(A) In the case of a product which is a new drug, 
        antibiotic drug, or human biological product, the term 
        means the period described in subparagraph (B) to which 
        the limitation described in paragraph (6) applies.
          (B) The regulatory review period for a new drug, 
        antibiotic drug, or human biological product is the sum 
        of--
                  (i) the period beginning on the date an 
                exemption under subsection (i) of section 505 
                or subsection (d) of section 507 became 
                effective for the approved product and ending 
                on the date an application was initially 
                submitted for such drug product under section 
                351, 505, or 507, and
                  (ii) the period beginning on the date the 
                application was initially submitted for the 
                approved product under section 351, subsection 
                (b) of section 505, or section 507 and ending 
                on the date such application was approved under 
                such section.
          (2)(A) In the case of a product which is a food 
        additive or color additive, the term means the period 
        described in subparagraph (B) to which the limitation 
        described in paragraph (6) applies.
          (B) The regulatory review period for a food or color 
        additive is the sum of--
                  (i) the period beginning on the date a major 
                health or environmental effects test on the 
                additive was initiated and ending on the date a 
                petition was initially submitted with respect 
                to the product under the Federal Food, Drug, 
                and Cosmetic Act requesting the issuance of a 
                regulation for use of the product, and
                  (ii) the period beginning on the date a 
                petition was initially submitted with respect 
                to the product under the Federal Food, Drug, 
                and Cosmetic Act requesting the issuance of a 
                regulation for use of the product, and ending 
                on the date such regulation became effective 
                or, if objections were filed to such 
                regulation, ending on the date such objections 
                were resolved and commercial marketing was 
                permitted or, if commercial marketing was 
                permitted and later revoked pending further 
                proceedings as a result of such objections, 
                ending on the date such proceedings were 
                finally resolved and commercial marketing was 
                permitted.
          (3)(A) In the case of a product which is a medical 
        device, the term means the period described in 
        subparagraph (B) to which the limitation described in 
        paragraph (6) applies.
          (B) The regulatory review period for a medical device 
        is the sum of--
                  (i) the period beginning on the date a 
                clinical investigation on humans involving the 
                device was begun and ending on the date an 
                application was initially submitted with 
                respect to the device under section 515, and
                  (ii) the period beginning on the date an 
                application was initially submitted with 
                respect to the device under section 515 and 
                ending on the date such application was 
                approved under such Act or the period beginning 
                on the date a notice of completion of a product 
                development protocol was initially submitted 
                under section 515(f)(5) and ending on the date 
                the protocol was declared completed under 
                section 515(f)(6).
          (4)(A) In the case of a product which is a new animal 
        drug, the term means the period described in 
        subparagraph (B) to which the limitation described in 
        paragraph (6) applies.
          (B) The regulatory review period for a new animal 
        drug product is the sum of--
                  (i) the period beginning on the earlier of 
                the date a major health or environmental 
                effects test on the drug was initiated or the 
                date an exemption under subsection (j) of 
                section 512 became effective for the approved 
                new animal drug product and ending on the date 
                an application was initially submitted for such 
                animal drug product under section 512, and
                  (ii) the period beginning on the date the 
                application was initially submitted for the 
                approved animal drug product under subsection 
                (b) of section 512 and ending on the date such 
                application was approved under such section.
          (5)(A) In the case of a product which is a veterinary 
        biological product, the term means the period described 
        in subparagraph (B) to which the limitation described 
        in paragraph (6) applies.
          (B) The regulatory period for a veterinary biological 
        product is the sum of--
                  (i) the period beginning on the date the 
                authority to prepare an experimental biological 
                product under the Virus-Serum-Toxin Act became 
                effective and ending on the date an application 
                for a license was submitted under the Virus-
                Serum-Toxin Act, and
                  (ii) the period beginning on the date an 
                application for a license was initially 
                submitted for approval under the Virus-Serum-
                Toxin Act and ending on the date such license 
                was issued.
          (6) A period determined under any of the preceding 
        paragraphs is subject to the following limitations:
                  (A) If the patent involved was issued after 
                the date of the enactment of this section, the 
                period of extension determined on the basis of 
                the regulatory review period determined under 
                any such paragraph may not exceed five years.
                  (B) If the patent involved was issued before 
                the date of the enactment of this section and--
                          (i) no request for an exemption 
                        described in paragraph (1)(B) or (4)(B) 
                        was submitted and no request for the 
                        authority described in paragraph (5)(B) 
                        was submitted,
                          (ii) no major health or environmental 
                        effects test described in paragraph 
                        (2)(B) or (4)(B) was initiated and no 
                        petition for a regulation or 
                        application for registration described 
                        in such paragraph was submitted, or
                          (iii) no clinical investigation 
                        described in paragraph (3) was begun or 
                        product development protocol described 
                        in such paragraph was submitted,
                before such date for the approved product the 
                period of extension determined on the basis of 
                the regulatory review period determined under 
                any such paragraph may not exceed five years.
                  (C) If the patent involved was issued before 
                the date of the enactment of this section and 
                if an action described in subparagraph (B) was 
                taken before the date of the enactment of this 
                section with respect to the approved product 
                and the commercial marketing or use of the 
                product has not been approved before such date, 
                the period of extension determined on the basis 
                of the regulatory review period determined 
                under such paragraph may not exceed two years 
                or in the case of an approved product which is 
                a new animal drug or veterinary biological 
                product (as those terms are used in the Federal 
                Food, Drug, and Cosmetic Act or the Virus-
                Serum-Toxin Act), three years.
  (h) The Director may establish such fees as the Director 
determines appropriate to cover the costs to the Office of 
receiving and acting upon applications under this section.
  (i)(1) For purposes of this section, if the Secretary of 
Health and Human Services provides notice to the sponsor of an 
application or request for approval, conditional approval, or 
indexing of a drug product for which the Secretary intends to 
recommend controls under the Controlled Substances Act, 
beginning on the covered date, the drug product shall be 
considered to--
          (A) have been approved; and
          (B) have permission for commercial marketing or use.
  (2) In this subsection, the term ``covered date'' means the 
later of--
          (A) the date an application is approved--
                  (i) under section 351(a)(2)(C) of the Public 
                Health Service Act; or
                  (ii) under section 505(b) or 512(c) of the 
                Federal Food, Drug, and Cosmetic Act;
          (B) the date an application is conditionally approved 
        under section 571(b) of the Federal Food, Drug, and 
        Cosmetic Act;
          (C) the date a request for indexing is granted under 
        section 572(d) of the Federal Food, Drug, and Cosmetic 
        Act; or
          (D) the date of issuance of the interim final rule 
        controlling the drug under section 201(j) of the 
        Controlled Substances Act.

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