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114th Congress  }                                             {    Report
                        HOUSE OF REPRESENTATIVES
 2d Session     }                                             {   114-531

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



 
   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
               RELATED AGENCIES APPROPRIATIONS BILL, 2017

                                _______
                                

 April 26, 2016.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

          Mr. Aderholt, from the Committee on Appropriations, 
                        submitted the following

                              R E P O R T

                             together with

                    DISSENTING AND ADDITIONAL VIEWS

                        [To accompany H.R. 5054]

    The Committee on Appropriations submits the following 
report in explanation of the accompanying bill making 
appropriations for Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies for fiscal year 2017.

                                CONTENTS

                                                                   Page
Title I--Agricultural Programs...................................     4
Title II--Conservation Programs..................................    43
Title III--Rural Development Programs............................    46
Title IV--Domestic Food Programs.................................    55
Title V--Foreign Assistance and Related Programs.................    62
Title VI--Related Agencies and Food and Drug Administration......    65
Title VII--General Provisions....................................    82

                                OVERVIEW

    The Agriculture, Rural Development, Food and Drug 
Administration, and Related Agencies Subcommittee has 
jurisdiction over the U.S. Department of Agriculture (USDA), 
except for the Forest Service, the Food and Drug Administration 
(FDA), the Commodity Futures Trading Commission (CFTC), and the 
Farm Credit Administration (FCA). The Subcommittee's 
responsibility covers a vast and diverse group of agencies 
responsible for such things as promoting the production of a 
plentiful food supply; assisting farmers and ranchers across 
the country with sound production practices; improving the 
quality of life and vitality of communities in rural America; 
assisting indigent populations in the U.S. and abroad with 
basic nutritional needs; research and development in 
agriculture to improve productivity and stability; overseeing 
commodity markets that provide confidence for businesses, 
traders, investors, and the public; supporting a safe food 
supply; and safe and effective drugs and medical devices. The 
activities of these agencies impact every American every day of 
the year.
    The fiscal year 2017 discretionary spending in this bill 
totals $21,299,000,000, which is $451,000,000 below the fiscal 
year 2016 enacted level and $281,000,000 below the President's 
budget request for fiscal year 2017.
    The funding levels provided in this appropriations bill 
continue to demonstrate how seriously this Committee takes its 
responsibility to fund the highest priority programs and 
activities while helping to address the Nation's debt, deficit, 
and economic challenges.
    The Committee does not include funding to begin new 
programs and, except where specifically noted, does not provide 
additional funding for pay increases. The Committee identifies 
savings of almost $1,000,000,000 at USDA, provides relief for 
excessive leasing costs at the CFTC, and reins in regulatory 
overreach at the FDA, USDA, and CFTC.

                         Oversight and Hearings

    Consistent with the Committee on Appropriations Oversight 
Plan, as approved and transmitted to the Committee on Oversight 
and Government Reform and the Committee on House Administration 
in January 2015, the Subcommittee began the fiscal year 2017 
process committed to maintaining the Committee's focus on 
comprehensive oversight of federal discretionary spending under 
the Subcommittee's jurisdiction. In order to thoroughly review 
the President's budget request for fiscal year 2017 and examine 
how funds appropriated in previous years had been managed, the 
Subcommittee held 11 hearings for the mission areas, agencies, 
and programs of the USDA, the FDA, and the CFTC. The hearings 
included:
        Commodity Futures Trading Commission--February 10, 2016
        Secretary of Agriculture--February 11, 2016
        USDA Inspector General--February 12, 2016
        USDA Food, Nutrition, and Consumer Services--February 
        24, 2016
        USDA Food Safety--February 24, 2016
        Food and Drug Administration--February 25, 2016
        USDA Natural Resources and the Environment--February 
        26, 2016
        USDA Marketing and Regulatory Programs--March 3, 2016
        USDA Rural Development--March 15, 2016
        USDA Research, Education, and Economics--March 16, 2016
        USDA Farm and Foreign Agricultural Services--March 17, 
        2016
    As stewards of the taxpayer's dollar, the Subcommittee is 
responsible for ensuring that the funds under its jurisdiction 
are wisely invested and properly used. As such, the 
Subcommittee established four objectives to guide its hearings, 
oversight activities, and the development of its bill and 
report recommendations for fiscal year 2017. These objectives 
include increasing oversight, efficiency, and the need for 
effective outcomes; keeping rural America vibrant; supporting 
American farmers, ranchers, and producers; and protecting the 
health of people, plants, and animals.
    Through its oversight activities, the Subcommittee can 
accomplish the goal of improving the management of agencies and 
programs by identifying and reducing waste, fraud, and abuse. 
It is joined in this effort by USDA's Inspector General, CFTC's 
Inspector General, and the Inspector General's Office of the 
Department of Health and Human Services. During the hearing 
with USDA's Office of the Inspector General (OIG), the 
Subcommittee focused on USDA financial statements, improper 
payments, and how well USDA's agencies are managing their 
programs.
    The Subcommittee questioned the Secretary of Agriculture 
about spending reductions included in USDA's budget request 
that are proposed for some of USDA's most popular and 
successful programs, such as crop insurance, Animal and Plant 
Health Inspection Service (APHIS) pest and disease programs, 
and Rural Development loan and grant programs. The Subcommittee 
also discussed ways in which USDA can assist U.S. producers 
struggling to recover from citrus greening, highly pathogenic 
avian influenza (HPAI) and declining market prices.
    When it convened to review CFTC's increased budget request, 
the Subcommittee questioned the need for a 123 percent increase 
since the Financial Crisis of 2008 and continued to identify 
wasteful spending in the agency's excessive leasing costs. The 
Subcommittee made clear that it does not tolerate fraud, waste, 
or abuse in any program, knowing that these actions undermine 
support for all programs. The Subcommittee also examined the 
CFTC's regulations regarding the Swap Dealer de Minimis level.
    When the Subcommittee heard from the FDA, it focused on 
preventing burdensome regulations for producers and the 
American people, in addition to ongoing discussions of how the 
FDA is implementing the Food Safety Modernization Act (FSMA), 
the motivation for the generic drug labeling rule, and 
regulation of tobacco products. The FDA regulates over 20 
percent of every consumer dollar spent on products in the U.S., 
and so the Subcommittee reminded the FDA to be aware of the 
comprehensive economic impact of their regulatory decisions.
    The Subcommittee heard from USDA's Food, Nutrition, and 
Consumer Services mission area and reviewed implementation of 
school meal regulations as well as waste, fraud and abuse 
within nutrition programs. The Members discussed potential ways 
to identify and help beneficiaries of nutrition programs who 
showed indications of illegal drug use.
    During the hearing to review the USDA's Rural Development 
(RD) mission area, the Subcommittee focused on the shocking 
spike in the cost of the Rental Assistance program and support 
for rural broadband programs. Members also questioned the 
Administration on proposed funding cuts for rural housing 
programs necessary for the continued well-being of rural 
communities.
    During the hearing to review the USDA's Research, 
Education, and Economics mission area, the Subcommittee focused 
on the efficient use of limited research dollars and 
coordination of research efforts within USDA. The Subcommittee 
also expressed its interest in USDA's ongoing investigation of 
animal care at the Agricultural Research Service's (ARS) Meat 
Animal Research Center (MARC) in Clay Center, Nebraska.
    The Subcommittee discussed implementation of the 2014 farm 
bill and international, in-kind food aid during its hearing 
with USDA's Farm and Foreign Agricultural Services mission 
area. The Subcommittee also received an update on the farm bill 
directive to create an Under Secretary for Trade and Foreign 
Agricultural Affairs within USDA.
    During the hearing with USDA's Marketing and Regulatory 
Programs mission area, the Subcommittee focused on USDA's 
response to emerging threats to animal and plant health, 
particularly the recent outbreak of HPAI.
    Because the Subcommittee knows that it cannot fulfill all 
requests for funding, it focuses on those areas that are most 
effective, broadly supported, and capable of delivering 
positive outcomes and a substantial return on investment. The 
Subcommittee will monitor the issues identified by its 
constituents and other stakeholders, those issues discussed at 
the hearings, and other high priority matters relevant to the 
management of USDA, FDA, CFTC, and FCA. The Subcommittee will 
maintain its oversight efforts throughout the 114th Congress to 
ensure taxpayer dollars are wisely and prudently used on behalf 
of the American people.

                                TITLE I


                         AGRICULTURAL PROGRAMS


                 Production, Processing, and Marketing


                        Office of the Secretary


                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................       $45,555,000
2017 budget estimate..................................        64,403,000
Provided in the bill..................................        44,555,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................        19,848,000
 

    The following table reflects the amount provided by the 
Committee for each office and activity:

                         OFFICE OF THE SECRETARY
                         [Dollars in Thousands]
------------------------------------------------------------------------
                                          FY 2016    FY 2017   Committee
                                          enacted    estimate  provision
------------------------------------------------------------------------
Office of the Secretary................     $5,051    $10,178     $5,051
Office of Tribal Relations.............        502        755        502
Office of Homeland Security and              1,496      1,592      1,496
 Emergency Coordination................
Office of Advocacy and Outreach........      1,209     11,220      1,209
Office of the Assistant Secretary for          804        807        804
 Administration........................
Departmental Administration............     25,124     27,420     24,124
Office of the Assistant Secretary for        3,869      3,919      3,869
 Congressional Relations...............
Office of Communications...............      7,500      8,512      7,500
                                        --------------------------------
      Total............................    $45,555    $64,403    $44,555
------------------------------------------------------------------------

                          COMMITTEE PROVISIONS

    For the Office of the Secretary, the Committee provides an 
appropriation of $44,555,000. The Committee recommendation 
includes the following offices under the Office of the 
Secretary: immediate Office of the Secretary; Office of Tribal 
Relations; Office of Homeland Security and Emergency 
Coordination; Office of Advocacy and Outreach; Office of the 
Assistant Secretary for Administration; Departmental 
Administration; Office of the Assistant Secretary for 
Congressional Relations; and Office of Communications.
    Pay Cost.--The Committee does not include requested funding 
for a civilian pay increase across the Department. Should the 
President provide a civilian pay increase for fiscal year 2017, 
it is assumed that the cost of such a pay increase will be 
absorbed within existing appropriations for fiscal year 2017.
    Commodity Credit Corporation (CCC) Obligations and 
Commitments.--The Secretary is directed to notify the 
Committees on Appropriations of the House and Senate in writing 
15 days prior to the obligation or commitment of any emergency 
funds from the CCC.
    CCC Report.--The Committee directs the Secretary to provide 
a report on November 15, 2016, and May 16, 2017, on planned 
uses of funding under the authorities of Section 4 and Section 
11 of the CCC Charter Act.
    Crop Biotechnology & Biotech Ingredients.--Plants, food, 
and food ingredients developed using genetic engineering were 
introduced into the U.S. food supply in the 1990s. Public and 
private sector scientists knowledgeable in genetic engineering, 
toxicology, chemistry, nutrition, and other scientific areas 
have carefully evaluated and assessed the safety of these 
products and have determined that such products are safe for 
human and animal consumption. The Committee provides a total of 
$3,000,000 for the FDA to coordinate with USDA to provide 
education and outreach to the public on the safety and benefits 
of crop biotechnology and food and animal feed ingredients 
derived from biotechnology. The Committee expects this 
educational information to be posted on both agency websites 
and through other social media and communications platforms 
within 60 days of enactment of this Act.
    Federal Employee Conduct.--The federal government grants 
federal employees with tremendous responsibility and trust to 
carry out their duties. They must do so free from conflicts of 
interest and without seeking private gain. Employees are public 
servants charged with implementing federal programs in a legal 
and ethical manner. Federal employees are reminded that they 
shall not advance a personal agenda or give preferential 
treatment to any outside organization or individual within the 
government programs which they administer. Information that is 
received by the employee, including information from the 
employees, offices, or Committees of the Congress of the United 
States, should be handled in a professional and confidential 
manner according to the federal government's code of conduct, 
standards, regulations, and statutes. The Committee is aware of 
recent conduct in violation of these principles, and the 
Committee believes that it is incumbent upon agency officials 
to take immediate disciplinary action when they confirm such 
behavior.
    Nutrition Research Coordination.--The Committee seeks to 
bring more transparency and coordination to nutrition research 
and evaluation projects conducted by the Department. The 
Secretary is directed to ensure both the Research, Education, 
and Economics (REE) and the Food, Nutrition, and Consumer 
Services mission areas coordinate and finalize the Food and 
Nutrition Service (FNS) Research and Evaluation Plan submitted 
in fiscal year 2017 to prevent duplication of efforts and 
resources. The plan submitted for fiscal year 2017 shall 
include a brief description of the projects FNS expects to 
pursue and whether or not it was mandated by law.
    Section 732 states that FNS shall not receive any funding 
for new research and evaluation projects in fiscal year 2017 
until the Committees on Appropriations of the House and Senate 
receive the fiscal year 2017 Research and Evaluation Plan that 
has been developed in coordination with REE. In submitting the 
fiscal year 2018 budget justification, FNS is directed to 
provide its Research and Evaluation Plan simultaneously with 
its budget request. There is an expectation that this process 
will be followed in the future.
    Improper Payments, Unachieved Savings, and Financial 
Management.--The Committee remains concerned with the 
Department's overall management of crucial financial issues 
that result in savings and efficiencies for taxpayers. This 
includes its consistent lack of compliance with mandatory 
improper payments reporting information, failure to complete 
OIG recommendations that would total $801 million in savings, 
and delaying the submission of financial statements for the 
second consecutive year.
    The Department has made gradual progress on some of these 
issues. USDA has reduced the amount of unachieved savings 
identified by the IG slightly since fiscal year 2015, and 
certain agencies, including the Risk Management Agency (RMA), 
have reduced their improper payment rates. The Committee 
directs the Department to properly report information related 
to improper payments and continue to work to reduce unachieved 
savings. Finally, the Department is directed to work with the 
Office of Management and Budget to submit financial statements 
on schedule for fiscal year 2016 and correct deficiencies 
identified for fiscal year 2015.
    Avian Influenza.--The Committee appreciates the 
Department's response to the recent outbreak of HPAI, which 
caused considerable devastation to America's poultry industry 
and cost the economy well over $1,000,000,000 between the 
public and private sector. The Committee encourages the 
Department to continue its work with trading partners to reopen 
trade for poultry and poultry products to the greatest extent 
possible. The Committee will continue to closely monitor the 
situation and directs USDA to keep the Committee apprised of 
future developments.
    Congressional Relations Allocation Notification.--Within 30 
days of the enactment of this Act, the Secretary shall notify 
the Committees on Appropriations of the House and Senate on the 
allocation of the funds provided to the Assistant Secretary for 
Congressional Relations by USDA agency, along with an 
explanation for the agency-by-agency distribution of the funds.
    State Office Co-location.--The Committee continues to 
direct that any reallocation of resources related to the co-
location of state offices scheduled for fiscal year 2017 and 
subsequent years is subject to the Committee's reprogramming 
procedures required under law.
    Administrative Provision.--The Committee directs the 
Secretary to advise the Committees on Appropriations of the 
House and Senate, through the Office of Budget and Program 
Analysis (OBPA), of the status of all reports requested of the 
Department in this bill at the time of submission of the fiscal 
year 2018 budget request and monthly thereafter. The Department 
needs to improve its timeliness in adhering to this requirement 
as stated in the fiscal year 2015 and 2016 House Appropriations 
reports. The Committee reminds the Secretary that all 
correspondence related to the directives in this bill must be 
addressed to the Committee on Appropriations.
    Loan and Grant Programs.--The Committee directs the 
Department, through OBPA, to provide quarterly reports to the 
Committees on Appropriations of the House and Senate on the 
status of obligations and funds availability for the loan and 
grant programs provided in this bill.
    The Committee further directs that if an estimate of loan 
activity for any program funded in Titles I and III of this 
bill indicates that a limitation on authority to make 
commitments for a fiscal year will be reached before the end of 
that fiscal year, or in any event when 75 percent of the 
authority to make commitments has been utilized, the Secretary 
shall promptly notify the Committees on Appropriations of the 
House and Senate through OBPA.
    Communication from USDA.--The Department is reminded that 
the Members of the Committee must be informed of the 
activities, pending and proposed actions, and expenditures made 
by USDA and its respective agencies so that Congress can 
determine whether laws and programs are being implemented and 
carried out in accordance with the intent of Congress. A 
collaborative working relationship between the Committee and 
the agencies is necessary to ensure efficient and effective 
implementation of Congress' funding decisions. USDA is directed 
to ensure the Committee is notified of major changes to 
existing policies and any significant developments in its 
operations prior to providing non-governmental stakeholders 
such information.
    Late Reports.--The Committee reminds the Secretary that the 
timelines specified by the Committees on Appropriations of the 
House and Senate for fiscal year 2016 reports are deadlines 
that must be met. While the Committee notes that the Department 
has made progress since 2014, the Department still has several 
outstanding reports that are delayed due to long reviews and 
clearances, especially in the immediate Office of the 
Secretary. The Committee directs the Secretary to submit these 
overdue reports.
    Decentralized Rent and Homeland Security.--In fiscal year 
2015, the Committee provided the Department with authority to 
decentralize rent from the General Services Administration 
(GSA) and the Department of Homeland Security (DHS). The 
Secretary submitted this request ``as part of USDA's 
implementation of the President's `Freeze the Federal 
Footprint' initiative'' and to encourage efficiencies across 
the Department at individual agencies. On the contrary, USDA 
did not freeze, but expanded, its footprint by approximately 
141,000 square feet. Meanwhile, the Secretary has claimed 
savings of $25,200,000, while there will be a projected 
increase of $9,900,000 since fiscal year 2015.
    The Secretary is directed to find actual savings within the 
total estimated costs for fiscal year 2017, in accordance with 
the President's ``Reduce the Footprint'' initiative. If USDA 
does not find ways to reduce its physical footprint or the cost 
of its existing footprint, such increased costs will need to be 
absorbed by the agency to the detriment of the core missions of 
these agencies. Further, the Committee in fiscal year 2015 
directed that ``any future requests for increases to rent and 
security costs will need to be accompanied by detailed 
justifications.'' USDA has not provided such justification. The 
following table shows the increased costs, with the most 
recently available data as provided by USDA:

                         [Dollars in Thousands]
------------------------------------------------------------------------
                                                  GSA Rent
                     Year                         and DHS       Change
                                                   Costs
------------------------------------------------------------------------
2015..........................................     $209,436        - - -
2016..........................................      216,657       +7,221
2017..........................................     219,328*       +2,671
                                               -------------------------
      Total...................................  ...........     +$9,892
------------------------------------------------------------------------
*Amount does not include the Administration's request for $17,700,000 to
  support a move in FNCS.

    FSMA Implementation and Interagency Coordination.--The 
Committee provides the full amount requested, $5,000,000, for 
the National Institute for Food and Agriculture (NIFA) to be 
the sole agency providing education and technical assistance 
for farmers in implementing new requirements resulting from 
FSMA. The Committee commends NIFA's extension programs for the 
relationship they have built with our nation's producers, and 
hopes that they will continue to build this trust through FSMA 
implementation. However, USDA must clearly communicate their 
lead role in the collaborative partnership with the FDA to 
administer and manage the National Food Safety Training, 
Education, Extension, Outreach, and Technical Assistance 
Program. The Secretary is directed to work with the 
Commissioner of the FDA to ensure that there is no duplication 
of efforts and resources for FSMA education and training at the 
farm level.
    Design-Build.--The Committee encourages the Department to 
use the design-build method of project delivery when 
appropriate.
    Invasive Species.--The Committee recognizes the threats 
posed by invasive plant species and the need to protect, 
restore, and enhance native plants, including those that are 
endangered or threatened. The Committee encourages ARS, the 
Natural Resources Conservation Service (NRCS), and NIFA to 
support the research, education, and conservation of native 
plants.
    Flexibility in Loan and Loan Guarantee Levels.--The bill 
includes language to exceed the limitation on loan and loan 
guarantee levels by up to 25 percent without budget authority 
upon written notification to the Committees on Appropriations 
of the House and Senate.
    Scientific Integrity.--Pursuant to the President's 2009 
memorandum and as directed by the Office of Science and 
Technology Policy, USDA adopted a scientific integrity policy 
in 2011. It appears to conform to the President's directive by 
requiring the use of information based upon well-established 
scientific processes, including peer review where appropriate, 
making the Department's scientific findings and conclusions 
publicly available and ensuring a mechanism is in place to 
resolve disputes regarding scientific processes or the 
integrity of scientific information. The Committee directs the 
Secretary to ensure all USDA agencies are complying with the 
policy and using it as a requirement in their policy and 
regulatory decisions.
    Rural Poverty.--The Department has statutory authorities 
and programs designed to help break the multi-generational trap 
of poverty in rural counties. The Committee recognizes that 
USDA may utilize existing programs and funding within RD and 
FNS in order to assist families, create jobs, and develop a 
path towards independence and self-sufficiency. Other existing 
resources such as the extension service and public universities 
can be used for coordination and outreach activities. As of 
April 2016, the Committee has not received the detailed plan 
required to be submitted by the Secretary which would detail 
all funding resources and bundled services to combat rural 
poverty.
    StrikeForce Initiative.--The Committee appreciates the 
Department's efforts to target assistance to at-risk 
communities through the StrikeForce Initiative for Rural Growth 
and Opportunity. USDA, in collaboration with public and private 
partners, helps rural counties experiencing chronic poverty 
improve economic opportunities and quality of life for local 
residents. The Committee encourages USDA to place special 
emphasis on persistent poverty counties and continue to utilize 
a strategy of partnering public resources with local expertise 
to grow rural economies and create jobs in these poverty-
stricken areas.
    Administrative Savings.--The Secretary has repeatedly 
stated that USDA has achieved $1,400,000,000 in savings through 
the Blueprint for Stronger Service initiative. The Committee 
acknowledges that the Department has taken positive steps to 
cut costs and modernize operations, but USDA must also 
acknowledge that a majority of cost savings were made necessary 
by funding limitations instituted by Congress and at the 
direction from Congress. The Committee is still awaiting a 
detailed report describing each of the specific cost savings 
and the actions taken to achieve such savings for each agency 
in order to arrive at the estimated total.
    U.S.-Mexico Cooperation.--The Committee directs the 
Secretary of Agriculture to work with his Mexican counterpart 
to develop a U.S.-Mexico working group to increase cooperation 
between the two countries in a similar manner as the ``Beyond 
the Borders Initiative'' between the United States and Canada. 
The working group shall develop proposals and create potential 
solutions aimed at facilitating commerce through improvements 
in the efficiency of the inspection process on both sides of 
the border, integrating small and large producers into the 
trade supply chain, and improving border wait times and 
transportation costs, among others.In addition, the Secretary 
shall work with his Mexican counterpart to develop a program for U.S.-
Mexico academic exchanges for students in agriculture related fields of 
study and professional agriculture specialists. The Secretary shall 
brief the Committee within 180 days of the date of enactment on efforts 
in these areas.
    Urban Agriculture.--The Committee acknowledges the need for 
an expanded USDA role in support of urban agriculture in 
American cities. Support from the Department is lacking for 
urban producers who often have different needs than rural 
producers. Therefore, the Committee directs USDA to evaluate 
policies and programs and deliver a report to the Committees on 
Appropriations of the House and Senate explaining how to 
further advance urban agriculture.
    Conflict of Interest.--The Committee is aware of concerns 
within Congress and the agricultural community regarding 
conflict of interest issues with the consultants, academics, 
and other personnel contracted out by the Department. Such 
contracts may include parties in multiple roles who receive 
funding from the Department for legitimate activities who are 
simultaneously employed by advocacy or partisan-leaning 
research institutions. Such situations are particularly harmful 
to the Department's credibility when parties employed in 
advocacy or other roles opine on similar topics or products as 
those involved in the Department's contract. The Committee 
directs the Secretary to avoid such conflicts of interest in 
order to protect the credibility of the Department and the 
integrity of the programs and policies under the Department's 
purview.
    Cottonseed as an Oilseed.--Section 8702(10) of Title 7 of 
the U.S. Code states the Secretary of Agriculture may choose to 
define ``any oilseed as designated by the Secretary.'' The 
Committee notes that this law is explicit in its intent. The 
Secretary has publicly chosen not to exercise such authority 
regarding cottonseed, even given significant demand from 
Congress and its constituencies. The Committee recognizes the 
significant obstacles facing cotton producers who are in need 
of financial assistance and encourages the Secretary to use the 
authority he has in law, and has used recently, to provide such 
assistance.
    Under Secretary for Trade and Foreign Agricultural 
Affairs.--The Secretary is directed to complete the report 
regarding the establishment of an Under Secretary for Trade and 
Foreign Agricultural Affairs required by the 2014 farm bill, 
the 2015 Agriculture Appropriations Act, and the 2016 
Agriculture Appropriations Act. This report is two years 
overdue.
    USDA and EPA Cooperation.--Interagency Consultation.--The 
Department has a robust history of collecting and analyzing 
data related to agricultural economics and the environmental 
impact of farming practices upon the environment, including 
crop protection and pest management. Although several 
provisions in the Federal Insecticide, Fungicide, and 
Rodenticide Act require USDA and US EPA to consult and 
coordinate together, there has been a recent notable 
disconnect. Given the Department's expertise, the Committee 
directs the Secretary to ensure USDA experts consult with the 
US EPA on regulatory decisions impacting America's farmers.

                          Executive Operations


                     OFFICE OF THE CHIEF ECONOMIST

 
 
 
2016 appropriation....................................       $17,777,000
2017 budget estimate..................................        17,592,000
Provided in the bill..................................        16,777,000
Comparison:
    2016 appropriation................................        -1,000,000
    2017 budget estimate..............................          -815,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Chief Economist (OCE), the Committee 
provides an appropriation of $16,777,000.
    Drought Resilience.--The Committee is concerned about the 
extent and severity of the drought in the U.S. and recognizes 
the importance of understanding and being prepared for drought. 
The Committee encourages the OCE to continue research and work 
with partners on drought resilience efforts to better address 
the serious threat posed by drought in the U.S.
    Policy Research.--The Committee includes $4,000,000 for 
policy research under 7 U.S.C. 3155 for entities with existing 
institutional capacity, including staff, databases, models, and 
long-term, well-documented experience, to conduct complex 
economic and baseline analysis for the benefit of USDA, the 
Congressional Budget Office, and the Congress.

                       NATIONAL APPEALS DIVISION

 
 
 
2016 appropriation....................................       $13,317,000
2017 budget estimate..................................        13,481,000
Provided in the bill..................................        13,317,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................          -164,000
 

                          COMMITTEE PROVISIONS

    For the National Appeals Division, the Committee provides 
an appropriation of $13,317,000.

                 OFFICE OF BUDGET AND PROGRAM ANALYSIS

 
 
 
2016 appropriation....................................        $9,392,000
2017 budget estimate..................................         9,525,000
Provided in the bill..................................         9,392,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................          -133,000
 

                          COMMITTEE PROVISIONS

    For the Office of Budget and Program Analysis, the 
Committee provides an appropriation of $9,392,000.

                Office of the Chief Information Officer


 
 
 
2016 appropriation....................................       $44,538,000
2017 budget estimate..................................        65,716,000
Provided in the bill..................................        44,538,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................       -21,178,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Chief Information Officer (CIO), the 
Committee provides an appropriation of $44,538,000. This 
includes $28,000,000 for cybersecurity activities.
    IT Purchases and Oversight.--The Committee directs the CIO 
to comply with the spirit and letter of the Federal Information 
Technology Acquisition Reform Act and incorporate its 
principles into future planning and current oversight of IT 
activities across the Department and the performance plan 
required in H. Rpt. 113-468.

                 Office of the Chief Financial Officer


 
 
 
2016 appropriation....................................        $6,028,000
2017 budget estimate..................................         9,119,000
Provided in the bill..................................         6,028,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................        -3,091,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Chief Financial Officer (CFO), the 
Committee provides an appropriation of $6,028,000.
    Digital Accountability and Transparency Act (DATA).--The 
Committee supports the work of the CFO to bring the Department 
into compliance with the DATA.
    Shared Costs Report.--While the Committee notes that the 
Department did not find any increased costs in its Shared Costs 
Programs per the report required by the 2015 Appropriations 
Act, the Department also did not identify any savings. The 
Committee continues to direct the production of the report 
required in Public Law 113-235 and directs the agency to 
identify areas of savings and efficiencies.

           Office of the Assistant Secretary for Civil Rights


 
 
 
2016 appropriation....................................          $898,000
2017 budget estimate..................................           901,000
Provided in the bill..................................           898,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            -3,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Assistant Secretary for Civil Rights, 
the Committee provides an appropriation of $898,000.

                         Office of Civil Rights


 
 
 
2016 appropriation....................................       $24,070,000
2017 budget estimate..................................        24,750,000
Provided in the bill..................................        24,070,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................          -680,000
 

                          COMMITTEE PROVISIONS

    For the Office of Civil Rights, the Committee provides an 
appropriation of $24,070,000.

                  Agriculture Buildings and Facilities


                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................       $64,189,000
2017 budget estimate..................................        84,365,000
Provided in the bill..................................        84,189,000
Comparison:
    2016 appropriation................................       +20,000,000
    2017 budget estimate..............................          -176,000
 

                          COMMITTEE PROVISIONS

    For Agriculture Buildings and Facilities, the Committee 
provides an appropriation of $84,189,000.
    Report on Headquarters Modernization.--The Committee 
directs the Department to provide the report required in H. 
Rpt. 113-468. The Committee requests the report include an 
update on the establishment of the Nonrecurring Expense Fund 
through the authority provided in Public Law 113-235. This 
authority was provided to enable the Secretary to use funding 
from expired accounts to invest in the Department's 
infrastructure. The Committee is concerned the Department has 
failed to utilize this previously provided authority.

                     Hazardous Materials Management


                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................        $3,618,000
2017 budget estimate..................................         3,633,000
Provided in the bill..................................         3,618,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................           -15,000
 

                          COMMITTEE PROVISIONS

    For Hazardous Materials Management, the Committee provides 
an appropriation of $3,618,000.

                      Office of Inspector General


 
 
 
2016 appropriation....................................       $95,738,000
2017 budget estimate..................................       100,998,000
Provided in the bill..................................        96,040,000
Comparison:
    2016 appropriation................................          +302,000
    2017 budget estimate..............................        -4,958,000
 

                          COMMITTEE PROVISIONS

    For the Office of Inspector General, the Committee provides 
an appropriation of $96,040,000. This amount includes an 
increase for GSA rent.

                     Office of the General Counsel


 
 
 
2016 appropriation....................................       $44,383,000
2017 budget estimate..................................        49,599,000
Provided in the bill..................................        44,383,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................        -5,216,000
 

                          COMMITTEE PROVISIONS

    For the Office of the General Counsel, the Committee 
provides an appropriation of $44,383,000.

                            Office of Ethics


 
 
 
2016 appropriation....................................        $3,654,000
2017 budget estimate..................................         4,617,000
Provided in the bill..................................         4,556,000
Comparison:
    2016 appropriation................................          +902,000
    2017 budget estimate..............................           -61,000
 

                          COMMITTEE PROVISIONS

    For the Office of Ethics, the Committee provides an 
appropriation of $4,556,000.

  Office of the Under Secretary for Research, Education, and Economics


 
 
 
2016 appropriation....................................          $893,000
2017 budget estimate..................................           901,000
Provided in the bill..................................           893,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            -8,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Under Secretary for Research, 
Education, and Economics, the Committee provides an 
appropriation of $893,000.
    Administrative Reorganization.--The Committee does not 
concur with the agency's proposal to combine NIFA Research and 
Education Activities, Extension Activities, and Integrated 
Activities into one account. While the Committee supports 
greater efficiency in the management of limited federal 
research dollars, the proposal fails to demonstrate that such 
reorganization would result in significant savings or the 
improvement of programs offered through NIFA.
    Biological Research Stations.--The Committee directs USDA 
to provide a report within 120 days of enactment of this Act on 
the feasibility of establishing a new biological research 
station in association with a Historically Black College or 
University that has previously established partnerships in the 
conservation field. The report should examine the need for such 
a station, the economic and educational benefits, and 
associated costs.
    Coffee Plant Health.--The Committee appreciates ARS and 
NIFA's work to address existing and emerging challenges to 
coffee production in the United States and commends the 
agency's work with research partners and coffee grower groups. 
The Committee encourages ARS, NIFA, and its partners to 
maintain support for coffee plant health research.
    Office of Pest Management Policy.--The Committee commends 
the Office of Pest Management Policy for its work providing the 
Department, federal agencies, producers, and other interested 
stakeholders scientifically sound analysis of pest management 
issues important to agriculture, especially methyl bromide 
transition, pesticide resistance management, and the 
development of antimicrobials to combat citrus greening. The 
Committee encourages the Under Secretary to better utilize this 
office and directs ARS to continue to support its vital work.
    Pollinators and Colony Health Research.--The Committee 
recognizes that Colony Collapse Disorder and related colony 
health issues are a significant concern to beekeepers, honey 
producers, farmers, researchers, policymakers, and the public. 
It appreciates USDA's logical, scientifically based approach to 
studying these issues and directs the Department to continue to 
focus on the challenges facing pollinators.
    Potato Research.--The Committee supports research efforts 
to combat crop-threatening pest and disease pressures, 
including the potato cyst nematode. The Committee also 
recognizes the importance of research initiatives to identify 
and improve desired traits for new potato varieties and directs 
the Department to continue working with universities, industry 
and potato growers on these projects.
    Screening Technologies.--The Committee encourages the 
development of technologies that will provide rapid, portable, 
and facile screening of food fish species at port sites and 
wholesale and retail centers.

                       Economic Research Service


 
 
 
2016 appropriation....................................       $85,373,000
2017 budget estimate..................................        91,278,000
Provided in the bill..................................        86,000,000
Comparison:
    2016 appropriation................................          +627,000
    2017 budget estimate..............................        -5,278,000
 

                          COMMITTEE PROVISIONS

    For the Economic Research Service, the Committee provides 
an appropriation of $86,000,000, including $627,000 for 
cooperative agreements on groundwater modeling and drought 
resilience.

                National Agricultural Statistics Service


 
 
 
2016 appropriation....................................      $168,443,000
2017 budget estimate..................................       176,639,000
Provided in the bill..................................       168,443,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................        -8,196,000
 

                          COMMITTEE PROVISIONS

    For the National Agricultural Statistics Service (NASS), 
the Committee provides an appropriation of $168,443,000, of 
which $41,871,000 is for the Census of Agriculture.
    Pecan Data.--The Committee encourages NASS to restart 
surveys and reports for pecans, including publication of the 
2016 Noncitrus Fruits and Nuts Preliminary Summary.

                     Agricultural Research Service


                         SALARIES AND EXPENSES

 
 
 
2016 appropriation....................................    $1,143,825,000
2017 budget estimate..................................     1,161,340,000
Provided in the bill..................................     1,151,825,000
Comparison:
    2016 appropriation................................        +8,000,000
    2017 budget estimate..............................        -9,515,000
 

                          COMMITTEE PROVISIONS

    For Salaries and Expenses of the Agricultural Research 
Service, the Committee provides an appropriation of 
$1,151,825,000.
    The Committee does not concur with the agency's proposed 
redirections of research programs or increases for fiscal year 
2017.
    Agriculture Research Stations.--The Committee is concerned 
about the continued trend towards reductions in on-the-ground 
agriculture research through proposed cutbacks and 
consolidations without a clear plan to ensure that research 
which reflects the local needs and growing conditions 
continues. The Committee directs the ARS to prioritize funding 
for field stations and work directly with local growers as 
changes in local research offerings are considered.
    Animal Research.--The Committee expects the Department to 
keep the Committee informed on the progress of implementing 
changes to policies and procedures as a result of the January 
19, 2015, New York Times article titled ``U.S. Research Lab 
Lets Livestock Suffer in Quest for Profit'' about MARC in Clay 
Center, Nebraska.
    The Committee understands that some specific instances 
mentioned in the article may have been taken out of context and 
that others may have been exaggerated. It also believes that 
ARS scientists sincerely care about the animals they work with. 
The Committee recognizes the need for and value of animal 
research, but it demands that all animals be treated humanely 
and that the risk of premature death will be limited wherever 
possible. No type of abuse or mistreatment will be tolerated.
    Aerial Application Research.--The Committee recognizes the 
importance of the ARS Aerial Application Technology Program. 
The program conducts innovative research making aerial 
applications more efficient, effective, and precise. Research 
for aerial application serves the public good as a vital tool 
for the future, as agriculture strives to meet the food, fiber, 
and bio-energy demands of a growing population.
    Alfalfa Research.--The Committee supports research into 
alfalfa seed and forage systems, which hold the potential to 
maximize crop yields, increase milk production, and improve 
genetics.
    ARS Field Stations.--The Committee recognizes the 
successful utilization of authorities granted in previous 
annual appropriations Acts to further cooperation between 
industry and the ARS Canal Point, Florida Sugarcane Field 
Station. However, the Committee is concerned that this 
partnership is jeopardized by requirements that are outside the 
scope of the functionality of the facilities. The Committee 
directs ARS to resolve these issues, thus allowing this model 
partnership to continue. Additionally, the Committee recognizes 
Florida's importance as a sentinel state in studying invasive 
pests and diseases. With new species entering ports every week, 
it is critical that ARS devote attention to the need for 
research facilities to study these threats.
    Aquaculture Industry Coordination.--Nearly half the seafood 
consumed across the world is the product of aquaculture, and 
the aquaculture industry is a critical and growing part of the 
U.S. economy. However, less than one percent of worldwide 
production comes from U.S. producers. In January 2016, the 
National Oceanic and Atmospheric Administration's National 
Marine Fisheries Services issued a final rule to open the 
federal waters in the Gulf of Mexico to development of 
aquaculture. The Committee is concerned that vital seedstock 
required to implement this initiative will be sourced from 
foreign aquaculture producers. The Committee encourages the 
agency to support and protect the U.S. aquaculture industry by 
working collaboratively with U.S. aquaculture producers and 
research institutions that specialize in the development of 
aquaculture technologies.
    Aquatic Animal Health.--The Committee supports ARS' work 
with land-grant universities and other federal partners to 
develop solutions to aquatic animal pathogens including 
Aeromonas in catfish and viral hemorrhagic septicemia in 
finfish. ARS is encouraged to collaborate with industry 
stakeholders on the development of potential vaccines and 
therapeutants.
    Citrus Greening Disease Research.--The Committee commends 
ARS' research efforts on citrus greening disease and encourages 
the agency to continue working to develop methods to reduce 
transmission and enhance immunity in citrus trees and to work 
with industry, universities, growers, and other partners to 
develop effective control mechanisms. The Committee also 
encourages ARS to coordinate its efforts with the Huanglongbing 
Multi-Agency Coordination (HLB MAC) group.
    Co-Location of Researchers.--The Committee encourages ARS 
to develop a plan to maximize its investments in plant science 
facilities and research by taking advantage of the synergies 
and efficiencies realized through the co-location of USDA 
researchers in state-of-the-art facilities with university and 
other stakeholders.
    Cotton Ginning.--The Committee recognizes the importance of 
pollution abatement, improving fiber quality, ginning 
efficiency, cotton seed and other byproducts, and remains 
committed to expanding research in cotton ginning and 
innovation by existing laboratories.
    Cranberry Research.--The Committee recognizes the ongoing 
research needs of the cranberry sector, ranging from disease 
control to pesticide use to responsible management of water 
resources. The Committee urges ARS to continue these efforts.
    Domestic and Bighorn Sheep.--The Committee recognizes the 
challenges caused by infectious disease problems arising from 
wildlife-domestic animal agriculture interactions, particularly 
between domestic sheep and wild bighorn sheep. The Committee 
encourages ARS to work to determine the role of domestic sheep 
in causing die-offs of bighorn sheep from respiratory disease 
and to develop methods to reduce transmission and enhance 
immunity.
    Emerging Cereal Rust Diseases.--The Committee continues to 
be concerned about emerging cereal rust diseases, particularly 
Ug99, and the threat they pose to domestic and world food 
supplies. The Committee encourages ARS to continue its work on 
these diseases, including the development of Ug99-resistant 
wheat varieties.
    Forest Products Research.--The forest products sector is an 
important part of the U.S. economy. The Committee supports 
research on wood quality, forest product evaluation standards 
and valuation techniques, and ARS' continuing work with the 
Forest Products Laboratory.
    FOV Race 4 Cotton Research.--The Committee recognizes the 
serious threat that fusarium oxysporum f. sp. Vasinfectum 
(FOV), particularly the strain FOV Race 4, poses to the U.S. 
cotton industry. The Committee encourages ARS to continue 
research efforts to combat FOV Race 4 and to work with industry 
and other partners to develop effective control measures to 
eradicate this disease and prevent its spread nationwide.
    Germplasm Enhancement of Maize.--The Committee supports the 
germplasm enhancement of maize project and encourages continued 
cooperation between ARS and industry.
    Greenhouse Technology Research.--The Committee recognizes 
the importance of advancing greenhouse technology and exploring 
its capabilities to address the energy and water challenges 
inherent in four-season production systems, beginning in food 
insecure communities across the country. The Committee 
encourages ARS to work with the Department of Energy (DOE) for 
greenhouse technology research that explores how to integrate 
ongoing research projects at the various DOE National Labs to 
develop affordable, deployable, and energy- and water-efficient 
food production platforms for undernourished regions of the 
country. By working together, ARS and DOE can bring their 
respective strengths and resources to designing the most 
desirable, low-cost, and efficient production system.
    Horticultural Research and Education.--The Committee 
recognizes the importance of the U.S. National Arboretum and 
its role as a center for discovery and education, as well as a 
destination for more than 500,000 visitors every year. The 
Committee encourages the agency to continue to support the 
Arboretum.
    Human Nutrition Research.--There is strong evidence that 
nutrition plays a vital role in how a person ages, particularly 
its significance for preventative health care and degenerative 
and age-related diseases. Research is needed to address the 
needs of the rapidly growing number of older Americans. The 
Committee encourages ARS to continue research relating to the 
effect of nutrition on aging.
    Long-Term Agro-ecosystem Research Network.--The Committee 
recommendation includes an additional $1,000,000 above fiscal 
year 2016 for the Long-Term Agro-ecosystem Research (LTAR) 
network.
    Lower Mississippi River Basin.--The Committee recognizes 
the groundwater problems in the Lower Mississippi River Basin 
and encourages ARS to continue research to quantify how 
conservation practices and technology affect water quality and 
quantity.
    National Agricultural Library.--The Committee encourages 
ARS to maintain a focus on agricultural-related legal issues 
within the National Agricultural Library. The Committee notes 
that as the agriculture sector faces increasing financial 
stress, there is a necessity that agricultural-related legal 
issues be addressed on an increasingly frequent basis. Further, 
agricultural-related legal issues are increasingly complex, and 
the impact of these legal issues continues to broaden in scope. 
The Committee recommends that the National Agricultural Library 
play an important role in assisting all stakeholders with 
understanding these issues.
    Porcine Virus Research.--The Committee is aware of ongoing 
research to identify mechanisms of viral pathogenesis, 
transmission, and immunity to porcine epidemic diarrhea virus 
(PEDv) and encourages ARS to continue its efforts to identify 
the genetic virulence factors of PEDv, identify a protective 
immune response, including transmission of maternal antibodies 
through the milk, and evaluate new vaccine platforms for the 
development of improved PEDv vaccines.
    Pulse Health Initiative.--The Committee is aware of the 
need to investigate the ability of pulse crops, such as dry 
beans, dry peas, lentils, and chickpeas, to provide solutions 
to critical health issues and to improve the sustainability of 
crop rotations by improving the nitrogen-fixing abilities of 
pulse crops. The Committee encourages ARS to continue its work 
on these important issues.
    Safe and Abundant Water Supply.--The Committee supports 
technological development to address key agricultural water 
resource issues across the U.S. The Committee recommendation 
includes an additional $4,000,000 above fiscal year 2016 to 
conduct further research for Safe and Abundant Water Supplies 
to Support U.S. Agricultural Production.
    Sage Grouse.--The Committee is aware that listing the 
greater sage grouse as endangered under the Endangered Species 
Act has the potential to negatively affect rural communities in 
the 11 states that have sage brush ecosystems. The Committee 
encourages ARS to work with its partners on sage brush and 
related rangeland research that will help preserve the greater 
sage grouse and the other species that rely on the sage brush 
ecosystem.
    Sclerotinia Initiative.--The Committee is aware of the 
importance of controlling Sclerotinia in sunflowers, soybeans, 
canola, edible beans, peanuts, peas, lentils, and chickpeas and 
encourages ARS to continue its support of this initiative.
    Small Grain Genomics.--The Committee supports research on 
small grain genomics and recognizes its importance in improving 
crop traits and developing new cultivars. The Committee 
provides an increase of $1,000,000 above fiscal year 2016 to 
support the Small Grains Genomic Initiative.
    Sodium Consumption.--The Committee directs the ARS Human 
Nutrition Research Centers to provide a plan within 90 days of 
enactment of this Act for conducting a study on the levels of 
sodium consumption in school-aged children. The plan shall 
include the methodology and timeframes necessary to conduct 
such a study, focusing on whether the consumption levels are 
within or outside the usual range of consumption, both 
domestically and worldwide.
    Sorghum in Agriculture.--The Committee recognizes the 
growing significance of sorghum in agriculture due to water 
conservation traits and increased utilization. Funding is 
included to initiate gene flow research to advance the 
durability and sustainability of fitness traits in sorghum.
    U.S. Sheep Experiment Station (USSES).--The Committee 
recognizes the unique and valuable contributions the USSES 
makes toward increasing the production efficiency of sheep and 
improving sustainable rangeland ecosystems. The Committee also 
recognizes a unique opportunity to expand other research 
initiatives. The Committee encourages ARS to work with various 
stakeholders regarding efforts to propose mission improvements 
for the USSES.
    U.S. Wheat and Barley Scab (USWBS).--The Committee 
recognizes that fusarium head blight is a major threat to 
agriculture, inflicting substantial yield and quality losses 
throughout the U.S. The Committee supports research carried out 
through the USWBS initiative. The Committee recommendation 
includes an additional $2,000,000 above fiscal year 2016 to 
conduct further research for the USWBS initiative to enhance 
food safety and supply by reducing the impact of fusarium head 
blight on wheat and barley.

                        BUILDINGS AND FACILITIES

 
 
 
2016 appropriation....................................      $212,101,000
2017 budget estimate..................................        94,500,000
Provided in the bill..................................        99,600,000
Comparison:
    2016 appropriation................................      -112,501,000
    2017 budget estimate..............................        +5,100,000
 

                          COMMITTEE PROVISIONS

    For Agricultural Research Service, Buildings and 
Facilities, the Committee provides an appropriation of 
$99,600,000 for priorities identified in the USDA ARS Capital 
Investment Strategy, April 2012, including not less than 
$5,100,000 for planning and design purposes for the next 
highest priorities identified in the USDA ARS Capital 
Investment Strategy.

               National Institute of Food and Agriculture


                   RESEARCH AND EDUCATION ACTIVITIES

 
 
 
2016 appropriation....................................      $819,685,000
2017 budget estimate..................................       836,915,000
Provided in the bill..................................       832,860,000
Comparison:
    2016 appropriation................................       +13,175,000
    2017 budget estimate..............................        -4,055,000
 

                          COMMITTEE PROVISIONS

    For Research and Education Activities, the Committee 
provides an appropriation of $832,860,000.
    Agriculture and Food Research Initiative (AFRI).--The 
Committee recognizes the importance of the research conducted 
through AFRI and provides an increase of $25,000,000 for this 
competitive grant program. The Committee believes that each of 
the six AFRI Challenge Areas are of equal importance to the 
agricultural community and rejects the President's proposal 
that any increase to the AFRI program be available only to the 
Sustainable Bioenergy Challenge Area.
    Agricultural Research Enhancement Awards.--The Committee 
continues to direct that not less than 15 percent of the 
competitive research grant funds be used for USDA's agriculture 
research enhancement awards program, including USDA-EPSCoR, in 
accordance with 7 U.S.C. 450i.
    Budget Request for Fiscal Year 2018.--The Committee 
appreciates NIFA's efforts to provide additional information in 
its budget requests over the past three years. For the fiscal 
year 2018 budget request, the Committee is particularly 
interested in the request for the Agriculture and Food Research 
Initiative and requests that the agency provide greater detail 
on the levels proposed to be allocated to and the expected 
publication date, scope, and allocation level for each request 
for awards to be published under each priority area specified 
in section 2(b)(2) of the Competitive, Special, and Facilities 
Research Grant Act (7 U.S.C. 450i(b)(2)).
    Childhood Obesity.--Within the funds made available for 
AFRI, the Committee encourages NIFA to support innovative 
efforts to address the unique challenges faced in addressing 
childhood obesity through a combination of family education and 
clinical studies focused on early life influences on obesity 
risk; the development of eating behavior during infancy and 
early childhood; the role of sleep in the development of 
childhood obesity; and obesity prevention strategies for low-
income children in childcare and educational settings.
    Citrus Disease Research Program.--The 2014 farm bill 
established the Emergency Citrus Disease Research and Extension 
Program, which is intended to discover and develop tools for 
early detection, control, and eradication of diseases and pests 
that threaten domestic citrus production and processing, and 
provided $25,000,000 per year in mandatory funding for the 
program through the Specialty Crop Research Initiative. The 
Committee believes research projects funded under this 
authority should be prioritized based on the critical threat of 
citrus greening and encourages NIFA, to the maximum extent 
practicable, to follow the recommendations of the National 
Agricultural Research, Extension, and Education Advisory 
Board's citrus disease subcommittee and to collaborate with the 
HLB MAC group.
    Food Manufacturing Efficiencies.--The Committee is aware of 
many new and promising food manufacturing processes and 
technologies. The nation's food supply can be made safer, more 
secure, and more affordable through means such as automation of 
equipment and modifying processes along the entire supply chain 
to work more efficiently and use less water, energy and other 
resources. The Committee urges the Department to promote 
enhanced technology, processes, and data analysis throughout 
the food manufacturing industry.
    Livestock and Poultry Waste Research.--The Committee 
recognizes the benefits of improved methods of managing animal 
waste in livestock and poultry production and encourages NIFA 
to support research and development of innovative technologies, 
particularly those that are operationally and economically 
feasible and have a high probability of widespread 
implementation.
    Organic Agriculture.--The Committee encourages USDA to 
ensure that the needs of the U.S. organic sector are more fully 
addressed through AFRI. As USDA's flagship competitive 
agricultural research grant program, AFRI funding should be 
reflective of the needs of all aspects of U.S. agriculture, 
including organic. The Committee directs USDA to develop a plan 
for meeting this goal, including how the agency will ensure 
organic research conducted through AFRI is not duplicative of 
research conducted with mandatory funds through the Organic 
Agriculture Research and Extension Initiative and other 
research programs, and report back to the Committee within 60 
days of enactment of this Act.
    Research at Historically Black Colleges and Universities 
and Hispanic Serving Institutions.--The Committee encourages 
NIFA to continue to support biotechnology by promoting research 
at the land-grant colleges and universities, including the 
Historically Black Colleges and Universities and Hispanic 
Serving Institutions, and directs NIFA to encourage 
partnerships among universities and industry.
    Unmanned Aircraft Systems.--The rapidly evolving field of 
Unmanned Aircraft Systems (UAS) provides highly promising 
opportunities for timely collection of geospatial data that can 
be used to increase profitability for agricultural producers 
and improve environmental stewardship in a broad range of 
areas. The Committee believes that research, development, 
education, and extension programs are needed to help further 
develop the technology and educate farmers and natural resource 
managers on best practices and safe operation of UAS. The 
Committee encourages NIFA to support the research, development, 
education and training of techniques, sensor and imaging 
technology, data analytics tools, best practices, and the safe 
and efficient deployment of UAS for improved agriculture and 
environmental stewardship.
    Urban Agriculture.--The Committee acknowledges the need for 
expanded research in support of urban agriculture in American 
cities. Support from the Department is lacking for urban 
producers who often have different needs than rural producers. 
Therefore, the Committee directs USDA to evaluate its policies 
and programs and deliver a report to the Committee explaining 
how to further advance urban agriculture.
    Zoonotic Disease Research.--The eradication of zoonotic 
livestock diseases has been a priority of federal and state 
animal health officials, as was reflected in the 2014 farm 
bill. The Committee recognizes the need for this research and 
encourages NIFA to support the development of improved 
management tools for zoonotic livestock diseases that have 
significant wildlife reservoirs.
    The following table reflects the amount provided by the 
Committee:

                  NATIONAL INSTITUTE OF FOOD AND AGRICULTURE--RESEARCH AND EDUCATION ACTIVITIES
                                             [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                                       Committee
               Program/Activity                          Authorization              2016       2017
                                                                                  enacted    estimate  provision
----------------------------------------------------------------------------------------------------------------
Hatch Act....................................  7 U.S.C. 361a-i.................   $243,701   $243,701   $243,701
McIntire-Stennis Cooperative Forestry Act....  16 U.S.C. 582a through a-7......     33,961     33,961     33,961
Research at 1890 Institutions (Evans-Allen     7 U.S.C. 3222...................     54,185     58,000     54,185
 Program).
Payments to the 1994 Institutions............  7 U.S.C. 301 note...............      3,439      3,654      3,439
Education Grants for 1890 Institutions.......  7 U.S.C. 3152(b)................     19,336     20,410     19,336
1890s Capacity Coordination Initiative.......  ................................      - - -     10,000      - - -
Education Grants for Hispanic-Serving          7 U.S.C. 3241...................      9,219      9,219      9,219
 Institutions.
Education Grants for Alaska Native and Native  7 U.S.C. 3156...................      3,194      3,194      3,194
 Hawaiian-Serving Institutions.
Research Grants for 1994 Institutions........  7 U.S.C. 301 note...............      1,801      3,914      1,801
Capacity Building for Non Land-Grant Colleges  7 U.S.C. 3319i..................      5,000      - - -      - - -
 of Agriculture.
Grants for Insular Areas.....................  7 U.S.C. 3222b-2, 3362 and 3363.      2,000      1,800      1,800
Agriculture and Food Research Initiative.....  7 U.S.C. 450i(b)................    350,000    375,000    375,000
Veterinary Medicine Loan Repayment...........  7 U.S.C. 3151a..................      5,000      5,000      6,500
Veterinary Services Grant Program............  7 U.S.C. 3151b..................      2,500      - - -      2,500
Food and Agriculture Resiliency Program for    ................................      - - -      2,500      - - -
 Military Veterans.
Continuing Animal Health and Disease Research  7 U.S.C. 3195...................      4,000      - - -      4,000
 Program.
Supplemental and Alternative Crops...........  7 U.S.C. 3319d..................        825      - - -      - - -
Multicultural Scholars, Graduate Fellowship    7 U.S.C. 3152(b)................      9,000      - - -      9,000
 and Institution Challenge Grants.
Secondary and 2-year Post-Secondary Education  7 U.S.C. 3152(j)................        900      - - -        900
Aquaculture Centers..........................  7 U.S.C. 3322...................      4,000      - - -      4,000
Sustainable Agriculture Research and           7 U.S.C. 5811, 5812, 5831, and       24,667     29,967     24,667
 Education.                                     5832.
Farm Business Management.....................  7 U.S.C. 5925f..................      1,450      - - -      - - -
Sun Grant Program............................  7 U.S.C. 8114...................      2,500      - - -      - - -
Alfalfa and Forage Research Program..........  7 U.S.C. 5925...................      2,000      - - -      - - -
Minor Crop Pest Management (IR-4)............  7 U.S.C. 450i(c)................     11,913     11,913     11,913
Special Research Grants:.....................  7 U.S.C. 450i(c)................  .........  .........  .........
    Global Change/UV Monitoring..............  ................................      1,405      1,405      1,405
    Potato Research..........................  7 U.S.C. 450i(c)................      2,000      - - -      2,000
    Aquaculture Research.....................  7 U.S.C. 450i(c)................      1,350      - - -      - - -
                                                                                --------------------------------
        Total, Special Research Grants.......  ................................      4,755      1,405      3,405
Necessary Expenses of Research and Education
 Activities:
    Grants Management Systems................  ................................      7,830      9,790      7,830
    GSA Rent and DHS Security Expenses.......  ................................      5,960      5,960      5,960
    Federal Administration--Other Necessary    ................................      6,549      7,527      6,549
     Expenses.
                                                                                --------------------------------
        Total, Necessary Expenses............  ................................     20,339     23,277     20,339
                                                                                ================================
            Total, Research and Education      ................................   $819,685   $836,915   $832,860
             Activities.
----------------------------------------------------------------------------------------------------------------

              NATIVE AMERICAN INSTITUTIONS ENDOWMENT FUND

 
 
 
2016 appropriation....................................     ($11,880,000)
2017 budget estimate..................................      (11,880,000)
Provided in the bill..................................      (11,880,000)
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For the Native American Institutions Endowment Fund, the 
Committee provides $11,880,000.

                          EXTENSION ACTIVITIES

 
 
 
2016 appropriation....................................      $475,891,000
2017 budget estimate..................................       501,859,000
Provided in the bill..................................       477,391,000
Comparison:
    2016 appropriation................................        +1,500,000
    2017 budget estimate..............................       -24,468,000
 

                          COMMITTEE PROVISIONS

    For Extension Activities, the Committee provides an 
appropriation of $477,391,000.
    Rural Health and Safety Education Programs.--The opioid 
abuse epidemic is one of the greatest threats facing rural 
America today, and the Committee supports all efforts to 
address this problem through improved health and safety 
education and outreach. The Committee provides $3,000,000 for 
Rural Health and Safety Education Programs to combat opioid 
abuse in rural communities.
    The following table reflects the amount provided by the 
Committee:

               National Institute of Food and Agriculture


                                              EXTENSION ACTIVITIES
                                             [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                  FY 2016    FY 2017   Committee
               Program/Activity                          Authorization            enacted    estimate  provision
----------------------------------------------------------------------------------------------------------------
Smith-Lever Act, Section 3(b) and (c)          7 U.S.C. 343(b) and (c) and        $300,000   $300,000   $300,000
 programs and Cooperative Extension.            208(c) of P.L. 93-471.
Extension Services at 1890 Institutions......  7 U.S.C. 3221...................     45,620     48,350     45,620
Extension Services at 1994 Institutions......  7 U.S.C. 343(b)(3)..............      4,446      6,724      4,446
Facility Improvements at 1890 Institutions...  7 U.S.C. 3222b..................     19,730     21,703     19,730
Renewable Resources Extension Act............  16 U.S.C. 1671 et seq...........      4,060      4,060      4,060
Rural Health and Safety Education Programs...  7 U.S.C. 2662(i)................      1,500      - - -      3,000
Food Animal Residue Avoidance Database         7 U.S.C. 7642...................      1,250      - - -      1,250
 Program.
Women and Minorities in STEM Fields..........  7 U.S.C. 5925...................        400      - - -        400
Grants to Youth Organizations................  ................................      - - -      1,000      - - -
Food Safety Outreach Program.................  7 U.S.C. 7625...................      5,000      5,000      5,000
Smith-Lever Act, Section 3(d):...............  7 U.S.C. 343(d).................  .........  .........  .........
    Food and Nutrition Education.............  ................................     67,934     68,034     67,934
    Farm Safety and Youth Farm Safety          ................................      4,610      4,610      4,610
     Education Programs.
    New Technologies for Agricultural          ................................      1,550      - - -      1,550
     Extension.
    Children, Youth, and Families at Risk....  ................................      8,395      8,395      8,395
    Federally Recognized Tribes Extension      ................................      3,039      5,839      3,039
     Program.
    Home Visits for Remote Areas.............  ................................      - - -     20,000      - - -
                                                                                --------------------------------
        Total, Section 3(d)..................  ................................     85,528    106,878     85,528
Necessary Expenses of Extension Activities:
    Agriculture in the K-12 Classroom........  7 U.S.C. 3152(j)................        552      - - -        552
    Federal Administration--Other Necessary    ................................      7,805      8,144      7,805
     Expenses for Extension Activities.
                                                                                --------------------------------
        Total, Necessary Expenses............  ................................      8,357      8,144      8,357
                                                                                ================================
        Total, Extension Activities..........  ................................   $475,891   $501,859   $477,391
----------------------------------------------------------------------------------------------------------------

                         INTEGRATED ACTIVITIES

 
 
 
2016 appropriation....................................       $30,900,000
2017 budget estimate..................................        28,900,000
Provided in the bill..................................        30,900,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................        +2,000,000
 

                          COMMITTEE PROVISIONS

    For Integrated Activities, the Committee provides an 
appropriation of $30,900,000.
    Food and Agriculture Defense Initiative (FADI).--The 
Committee supports the important work being done through the 
diagnostic laboratory network and encourages NIFA to prioritize 
funding to strengthen animal health diagnostic laboratories 
operated and administered by Colleges of Veterinary Medicine at 
land grant institutions. NIFA should take into consideration 
the degree to which the capacity for surveillance, monitoring, 
response, and capacity is enhanced; the concentration of human 
and animal populations that are directly at risk; trade, 
tourism, and cultural considerations; geography, ecology, and 
climate; the strength of biomedical, agricultural, 
environmental, and public health expertise at the hosting land 
grant university; evidence of active collaboration with, and 
support of, the state department of agriculture; and evidence 
of stakeholder support and engagement.
    The following table reflects the amount provided by the 
Committee.

               National Institute of Food and Agriculture


                                              INTEGRATED ACTIVITIES
                                             [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                  FY 2016    FY 2017   Committee
               Program/Activity                          Authorization            enacted    estimate  provision
----------------------------------------------------------------------------------------------------------------
Methyl Bromide Transition Program............  7 U.S.C. 7626...................     $2,000     $- - -     $2,000
Organic Transition Program...................  7 U.S.C. 7626...................      4,000      4,000      4,000
Regional Rural Development Centers...........  7 U.S.C. 450i(c)................      1,000      1,000      1,000
Food and Agriculture Defense Initiative......  7 U.S.C. 3351...................      6,700     10,000      6,700
Crop Protection/Pest Management Program......  7 U.S.C. 7626...................     17,200     20,200     17,200
                                                                                --------------------------------
    Total, Integrated Activities.............  ................................    $30,900    $35,200    $30,900
----------------------------------------------------------------------------------------------------------------

  Office of the Under Secretary for Marketing and Regulatory Programs


 
 
 
2016 appropriation....................................          $893,000
2017 budget estimate..................................           901,000
Provided in the bill..................................           893,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            -8,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Under Secretary for Marketing and 
Regulatory Programs, the Committee provides an appropriation of 
$893,000.

               Animal and Plant Health Inspection Service


                         SALARIES AND EXPENSES

                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................      $894,415,000
2017 budget estimate..................................       901,196,000
Provided in the bill..................................       930,831,000
Comparison:
    2016 appropriation................................       +36,416,000
    2017 budget estimate..............................       +29,635,000
 

                          COMMITTEE PROVISIONS

    For the Animal and Plant Health Inspection Service, 
Salaries and Expenses, the Committee provides an appropriation 
of $930,831,000.
    Included in this funding level are increases of $21,000,000 
for Emergency Preparedness and Response; $9,916,000 for 
Zoonotic Disease Management; $9,500,000 for Specialty Crop 
Pests; $1,750,000 for the National Veterinary Stockpile; 
$1,500,000 for Equine, Cervid, and Small Ruminant Health; and 
$1,518,000 for Animal Health Technical Services. The Committee 
maintains recent increases for such functions as Avian Health; 
Overseas Technical and Trade Operations in order to help 
resolve sanitary and phytosanitary trade issues that could 
result in the opening of new markets and retaining and 
expanding existing market access for U.S. agricultural 
products; the National Animal Health Lab Network; the Citrus 
Health Response Program; and Wildlife Damage Management.
    Within the amount included for Specialty Crop Pests, the 
Committee includes increases of $1,500,000 for fruit fly 
exclusion and detection; $5,000,000 for the Citrus Health 
Response Program; $2,000,000 for the glassy-winged 
sharpshooter; and $1,000,000 for the light brown apple moth. 
Funding for the European grapevine moth should be no less than 
the amount provided in fiscal year 2016. The Committee 
continues to provide an additional $5,500,000 for citrus 
greening emergency response to the HLB MAC.
    The following table reflects the amounts provided by the 
Committee:

                         [Dollars in Thousands]
------------------------------------------------------------------------
                                                           Committee
                                                           provision
------------------------------------------------------------------------
Animal Health Technical Services.....................            $36,857
Aquatic Animal Health................................              2,253
Avian Health.........................................             55,340
Cattle Health........................................             91,500
Equine, Cervid, and Small Ruminant Health............             21,000
National Veterinary Stockpile........................              5,723
Swine Health.........................................             24,800
Veterinary Biologics.................................             16,417
Veterinary Diagnostics...............................             36,540
Zoonotic Disease Management..........................             19,439
                                                      ------------------
    Subtotal, Animal Health..........................            309,869
Agricultural Quarantine Inspection (Appropriated)....             27,900
Cotton Pests.........................................             11,520
Field Crop & Rangeland Ecosystem Pests...............              8,826
Pest Detection.......................................             27,446
Plant Protection Methods Development.................             20,686
Specialty Crop Pests.................................            167,500
Tree & Wood Pests....................................             45,933
                                                      ------------------
    Subtotal, Plant Health...........................            309,811
Wildlife Damage Management...........................            100,376
Wildlife Services Methods Development................             18,856
                                                      ------------------
    Subtotal, Wildlife Services......................            119,232
Animal & Plant Health Regulatory Enforcement.........             16,224
Biotechnology Regulatory Services....................             18,875
                                                      ------------------
    Subtotal, Regulatory Services....................             35,099
Contingency Fund.....................................                470
Emergency Preparedness & Response....................             37,966
                                                      ------------------
    Subtotal, Safeguarding and Emergency Preparedness             38,436
Agriculture Import/Export............................             15,099
Overseas Technical and Trade Operations..............             22,114
                                                      ------------------
    Subtotal, Safe Trade & International Technical                37,213
     Assistance......................................
Animal Welfare.......................................             28,510
Horse Protection.....................................                697
                                                      ------------------
    Subtotal, Animal Welfare.........................             29,207
APHIS Information Technology Infrastructure..........              4,251
Physical/Operational Security........................              5,146
GSA Rental and DHS Security Payments.................             42,567
    Subtotal, Agency Management......................             51,964
                                                      ------------------
        Total, Salaries & Expenses...................           $930,831
------------------------------------------------------------------------

    Animal Welfare.--The bill provides $28,510,000 for the 
Animal Welfare program in order to ensure that minimum 
standards of care and treatment are provided for certain 
animals bred for commercial sale, used in research, transported 
commercially, or exhibited to the public. The Committee 
provides $500,000 to support the renewal of a Memorandum of 
Understanding (MOU) between APHIS and ARS. The MOU is necessary 
for ARS to utilize the skills and expertise of APHIS' animal 
care staff and to help ARS address some of their recent 
failures to maintain high standards of care for animals used in 
ARS funded research. At a minimum, the MOU should ensure that 
ARS is adhering to its own standards and guidelines for 
research practices as required by the Humane Animal Care and 
Use policy, a policy that is closely aligned with the Animal 
Welfare Act; ensure that every ARS location engaging in 
research and testing on vertebrate animals has a fully 
functioning Institutional Animal Care and Use Committee (IACUC) 
in place; and, ensure that each IACUC produces a semi-annual 
report with a description of and the reasons for any major 
deviations from the requirements outlined in ARS policy.
    Antimicrobial Resistance.--There is currently no evidence 
to support the claim that agriculture is largely to blame for 
the increase in antibiotic-resistant strains of bacteria, and 
so the Committee supports funding to collect additional data 
that will inform policy related to the appropriate antibiotic 
use in all settings across agriculture and clinical medicine. 
The Committee provides $9,916,000 for on-farm surveillance and 
data collection to enhance the understanding of on-farm levels 
of antibiotic use and the impact on antimicrobial resistance 
levels. The information collected should clearly delineate 
between antibiotics used for food-producing and companion 
animals. Further, to avoid duplication with existing programs 
like the National Antimicrobial Resistance Monitoring System, 
the Committee expects surveys regarding on-farm usage to be 
limited to collecting information about the antibiotics used 
and should not be utilized for other regulatory purposes. In 
designing these surveys, the Committee expects the agency to 
work primarily with end-users of antibiotics and veterinarians 
providing care to the animals. APHIS will collect this 
information through its statistical unit under the Confidential 
Information Protection and Statistical Efficiency Act, which 
will guarantee that all information collected is protected from 
distribution in a manner that could identify an individual 
respondent for the full time the data is in existence. This 
information is needed for use in the larger National Strategy 
for Combatting Antibiotic Resistant Bacteria with other federal 
partners.
    Aquatic Animal Health.--Nearly half of the seafood consumed 
across the world is the product of aquaculture. In addition, 
the aquaculture industry is a critical and growing part of the 
U.S. economy. Unfortunately, the monitoring of aquatic animal 
health issues is not adequate to meet the needs of the growing 
industry. For example, the shrimp and catfish aquaculture 
industries are losing revenue due to the lack of tracking and 
monitoring of aquatic animal pathogens. These losses could have 
been prevented if the pathogens had been promptly identified 
and effective treatments or prevention procedures were 
developed and available. The Committee encourages the agency to 
support and protect this important industry. Collaborative 
efforts among the agency, industry, and other federal and state 
partners are essential to improving preparedness, surveillance, 
and response capabilities, as well as reducing the likelihood 
of disease spread. APHIS should collaborate with ARS' Aquatic 
Animal Health Research Unit as necessary to support its aquatic 
animal health efforts.
    Biotechnology Review Process.--The Committee is aware of an 
Administration-wide effort to modernize the regulatory system 
for biotechnology products. As noted by the White House Office 
of Science and Technology Policy memo on the subject dated July 
2, 2015, this regulatory system ``. . . must protect public 
health, welfare, safety, and our environment while promoting 
economic growth, innovation, competitiveness, and job 
creation.'' In moving forward, it should be noted that, since 
the establishment of the original coordinated framework over 
three decades ago, there are no known validated instances of 
harm to the environment, agriculture, or non-target organisms 
arising from the use of plants regulated by APHIS. The 
Committee encourages the agency to continue to maintain some of 
the benefits of the existing regulatory system, but find 
greater efficiencies and utilize this opportunity to include 
advances in biotechnology methodology. The agency should engage 
in a deliberative, science-based process devoid of political 
agendas and the baseless scare tactics used to disparage the 
industry.
    Cervid Health.--Data from 2007 indicates that the cervid 
industry in the United States accounts for 5,600 deer farms and 
1,900 elk farms, has an economic value of $894,000,000, and 
supports nearly 30,000 jobs. This industry continues to 
participate in the agency's national, voluntary Herd 
Certification Program (HCP) that supports the domestic and 
international marketability of U.S. cervid herds. The Committee 
encourages APHIS to maintain its commitment to the HCP and the 
cervid industry and directs the agency to spend no less than 
$3,500,000 for cervid health activities. Within the funds 
provided, the agency should give consideration to indemnity 
payments if warranted.
    Citrus Health Response Program (CHRP).--CHRP is a national 
effort to protect the U.S. citrus industry from the ravages of 
invasive pests and diseases. These funds are designed to 
partner with state departments of agriculture and industry 
groups to address the challenges of citrus pests and diseases. 
In addition to the funds provided in this account, the 
Committee encourages APHIS to utilize the funds available in 
the Plant Pest and Disease Management and Disaster Prevention 
Programs account to the greatest extent possible in an attempt 
to sustain the economic viability of the citrus industry.
    Cost Sharing with States and Other Cooperators.--The 
Committee directs APHIS to maximize the use of cost-sharing 
agreements or matching requirements with states, territories, 
producers, foreign governments, non-governmental organizations, 
and any other recipient of services in order to reduce the cost 
burden on the agency.
    Cotton Pests.--The Committee is concerned that every effort 
be made by APHIS and the cotton industry to ensure the boll 
weevil does not re-infest areas of the United States where it 
has been successfully eradicated. The Boll Weevil Eradication 
Program, an outstanding example of a public-private 
partnership, has successfully eradicated the boll weevil from 
all U.S. cotton-producing regions except for the extreme lower 
parts of Texas in the Lower Rio Grande Valley (LRGV) bordering 
Tamaulipas, Mexico. Growers in the LRGV, with assistance from 
APHIS and the support of the entire industry, continue to 
conduct an active program to eradicate the boll weevil. The 
LRGV serves as the barrier between boll weevil infested areas 
of Mexico and boll weevil-free areas of the United States. The 
Department is directed to work with the U.S. cotton industry to 
develop a plan of action to protect the United States from re-
infestation and to report its findings to the Committee not 
less than 120 days after enactment of this Act.
    Emergency Outbreaks.--The Committee continues to include 
specific language relating to the availability of funds to 
address emergencies related to the arrest and eradication of 
contagious or infectious diseases or pests of animals, poultry 
or plants. The Committee expects the Secretary to continue to 
use the authority provided in this bill to transfer funds from 
the CCC for the arrest and eradication of animal and plant 
pests and diseases that threaten American agriculture. By 
providing funds in this account, the Committee is enhancing, 
not replacing, the use of CCC funding for emergency outbreaks.
    Export Certification.--The Committee recognizes personnel 
constraints on the U.S.-Mexico border, with regard to 
phytosanitary inspections for exported goods. In the best 
interest of cross-border trade and agribusiness, the Committee 
encourages APHIS to ensure adequate levels of staffing to 
provide timely phytosanitary certification in support of 
exports.
    Feral Swine Management.--Feral swine are found in at least 
41 states with a population of more than 5,000,000 and cause 
more than $1,500,000,000 in damages and control costs in the 
United States each year, with at least $800,000,000 of this due 
to direct damage to agriculture. The Committee believes this 
damage assessment far underestimates the level of damage when 
considering the impact to the environment, native species, 
habitat, historic sites, and residential and commercial areas. 
The Committee supports APHIS' National Feral Swine Damage 
Management Program but has concerns that the currently budgeted 
amount does not provide sufficient funding to allow for the 
increasing demands in the areas of research, development, 
education, outreach, and coordination. Therefore, the Committee 
provides an increase of $3,000,000 above the funds provided in 
fiscal year 2016 and directs APHIS to use these funds to 
support its existing cooperative service agreement process, 
which identifies and develops unmet needs for feral swine 
control nationwide.
    Foreign Market Access Requests.--Increasingly, U.S. 
agriculture is facing non-tariff trade barriers, which are 
limiting the ability for U.S. agriculture to open and maintain 
access to key export markets. The Committee directs APHIS to 
review and update the list of foreign market access requests 
submitted by U.S. producers, producer groups, companies and/or 
non-government agencies. All efforts should be made to assign 
the appropriate agency resources to opening and maintaining 
access to foreign markets for U.S. products. By March 2017, the 
agency should provide an update to the Committee on the number 
of foreign market access requests that have been successfully 
granted for U.S. agriculture; export volumes; the number of 
foreign market access requests that have been granted for 
imports to the U.S. marketplace; and the number of outstanding 
requests and the length of time each request has been pending 
before the agency. The agency should identify the limitations 
in achieving and maintaining foreign market access for U.S. 
agriculture.
    Foreign Zoonotic Disease Response.--The Committee 
recognizes and commends APHIS for its efforts to address the 
challenges associated with eradicating foreign zoonotic 
diseases such as HPAI and FMD in a timely manner. In order to 
reduce the spread of disease outbreaks in the future, the 
Committee directs APHIS to use existing funds to undertake a 
review of existing protocols for foreign zoonotic disease 
eradication, including stamping-out policies, and to develop a 
strategy that improves agency, state and local, and industry 
responsiveness. This plan should take into consideration 
existing technology limitations, adverse weather, lack of 
water, and other issues that may hinder APHIS' eradication 
efforts in the event of future outbreaks. Furthermore, APHIS 
should consider funds available to states through the current 
cooperative agreements for surveillance testing and backyard 
flock surveillance; grant or cost share opportunities for 
farmers to give them the ability to enhance biosecurity 
measures at their operations; the need for veterinarian 
positions in states for biosecurity activities; and needs to 
address the unavailability of vaccine for FMD.
    Grapevine Import Regulations.--The Committee urges APHIS to 
update its import regulations for grapevines. The current 
regulatory review process and requirements for pathogen 
screening of imports are expensive, cumbersome and time-
consuming. Complying without the use of available technology 
can take in excess of thirteen years to complete. APHIS should 
issue new regulations that dramatically shorten the review 
timeline by using new technology and prioritize the approval of 
new grape varieties suited for colder, harsher climates.
    Horse Protection Act.--The Committee has continually 
encouraged APHIS to work more closely with stakeholders 
pursuant to the Horse Protection Act. Specifically, the agency 
has been directed to provide greater and more consistent 
transparency, to work more closely with stakeholders on rules 
and regulations, and to move away from the subjective nature of 
current inspection methods in favor of objective measurements. 
The Committee is disappointed that the agency has not worked in 
good faith to address the Committee's requests, which are 
intended to further the dual goals of the Horse Protection 
Act--to care for animals engaged in the trade and promote the 
industry in a safe manner. The Committee has become aware that 
APHIS intends to modify regulations associated with Horse 
Protection Act through rule-making actions and notes that any 
substantive changes to the statute or its intent should be made 
by Congress through the legislative process.
    Huanglongbing Emergency Response.--The Committee maintains 
the increased funding levels for Huanglongbing Emergency 
Response within the Specialty Crop Pests line item. The 
Committee encourages APHIS to allocate sufficient resources in 
order to continue vital management, control, and associated 
activities to address citrus greening. The disease, for which 
there is no cure, has caused a reduction in citrus production 
by over 60 percent since 2007 in Florida alone. All citrus 
producing counties in Texas are under quarantine, and 
California has found the Asian Citrus Psyllid, the vector of 
the disease, in some backyard trees. The spread of this disease 
has called the future of the domestic citrus industry into 
question, costing thousands of jobs and millions of dollars in 
lost revenue. In addition, the agency is encouraged to support 
priorities and strategies identified by the HLB MAC group to 
benefit the citrus industry. The agency should appropriately 
allocate resources based on critical need and maximum effect to 
the citrus industry.
    The Committee maintains the $2,000,000 increase from fiscal 
year 2016 for citrus health to support priorities and 
strategies identified by the HLB MAC group. The MAC is focused 
on short-term solutions to help the citrus industry, and the 
cooperative nature of federal, state, and industry 
representatives in this group is expected to result in the 
development of tools and techniques to address this devastating 
disease. Helping growers explore new possible solutions, the 
MAC has been an effective resource. The agency should 
appropriately allocate resources based on critical need and 
maximum impact to the citrus industry. These citrus health 
activities directly protect citrus production on approximately 
765,000 acres in the United States worth more than 
$3,300,000,000 for the 2014-2015 growing season.
    Light Brown Apple Moth.--The Committee encourages APHIS to 
engage state and international regulatory bodies to deregulate 
the light brown apple moth. The Committee is concerned that if 
APHIS simply withdraws federal regulation without the necessary 
work with other regulatory officials, APHIS will shift, not 
reduce, the regulatory burden. Should APHIS withdraw the 
federal order for light brown apple moth, it must take steps to 
reduce the overall burden on growers. The Committee includes an 
increase for the light brown apple moth to support the second 
phase of the Joint Forward Plan and urges the Department to 
develop initiatives for permanent, ongoing departmental 
regulatory partnerships while continuing to engage stakeholders 
and trading partners throughout North America.
    National Animal Health Laboratory Network (NAHLN).--The 
laboratories within the NAHLN network are on the frontline for 
detection of newly identified and reemerging animal diseases. 
NAHLN laboratories provide a critical contribution to animal 
and public health. The bill provides funding for NAHLN through 
both APHIS and NIFA at approximately $12,000,000 and 
$3,000,000, respectively, resulting in a total investment of 
$15,000,000 for fiscal year 2017.
    NAHLN laboratories were invaluable during the 2015 outbreak 
of HPAI, which significantly increased testing needs. At the 
same time, NAHLN laboratories must also continue testing for 
other animal diseases of concern. The Committee encourages 
NAHLN to consider partnering with other accredited private 
laboratories as necessary to assist with increased testing 
demands in order to prevent backlogs and provide results as 
quickly as possible.
    Orobanche Ramosa.--The Committee recognizes that APHIS-
funded efforts to control orobanche ramosa, also known as 
branched broomrape, in Texas were not completely successful and 
its spread is a threat to agriculture. As such, the Committee 
encourages APHIS to work with the appropriate Congressional 
Committees, along with states and local stakeholders to 
formulate a plan to manage branched broomrape.
    Phytopthora ramorum.--The Committee expects APHIS to 
continue its efforts to manage P. ramorum while minimizing 
disruption to the interstate movement of plant materials and 
commercial trade. The agency should use an appropriate portion 
of funds from the Specialty Crop Pests account to expeditiously 
implement the review of the Federal Order governing shipment of 
plant materials from quarantined and regulated counties as well 
as to continue its review of the efficacy of the pre-
notification requirements for western nurseries. APHIS also 
should continue efforts to partner with the regulated states to 
develop new best management practices regarding P. ramorum 
during the effective period of the Order.
    Potato Cyst Nematode Eradication.--The Committee includes 
funding to maintain resources for the potato cyst nematode 
eradication program at the fiscal year 2016 level in order to 
continue with successful efforts to eradicate this pest. If 
left untreated, this pest could spread, affecting other crops.
    Regional Biosecurity Plans.--The Secretary of Agriculture 
shall submit to the Committees on Appropriations of the House 
and Senate, at the time the President's budget for fiscal year 
2018 is submitted under section 1105(a) of title 31, United 
States Code, a report describing the steps USDA has taken to 
implement the Regional Biosecurity Plan for Micronesia and 
Hawaii, as developed jointly by the Department and other 
federal and non-federal entities. The report shall include an 
update on previous and upcoming implementation activities, 
including estimates of additional funding to be used or needed 
for planned activities.
    Vaccine for Foot-and-Mouth Disease.--FMD is a highly 
contagious viral disease eradicated from the U.S. in 1929, but 
it is still a threat since countries around the globe continue 
grappling with the disease. This disease could cause billions 
of dollars in damage to the economy if unchecked. APHIS has 
publicly stated that the FMD vaccine bank is insufficient to 
deal with a large scale FMD outbreak in the U.S. and that a 
larger vaccine bank is needed. APHIS has also noted that 
expanding the current FMD vaccine supply is an expensive 
investment. Having sufficient quantities of vaccine readily 
available and deployable to control an FMD outbreak would 
appear to be a critical part of the USDA APHIS mission. Rapid 
control of FMD protects the security of the U.S. food supply, 
limiting the economic damage from livestock losses due to the 
disease, and also shortens disruptions to trade and commerce 
that would occur as long as FMD goes uncontrolled due to a lack 
of vaccine. The Committee is concerned that this potential 
vaccine shortage could result in the compromised management of 
an FMD outbreak in the United States. In order that the 
Committee can better understand the budget implications 
required to address this vaccine shortage, APHIS is directed to 
report to the Committees on Appropriations of the House and 
Senate within 90 days of enactment of this Act on contingency 
plans to develop an expanded vaccine bank and the estimated 
funding necessary for implementation and maintenance.
    Wildlife Damage Management.--While receiving support from 
cooperators to conduct wildlife management operations, special 
emphasis should be placed on those areas such as oral rabies 
vaccination, livestock protection, predator damage management 
for avian predators such as the raven in Western states and 
cormorants in the south, and other such activities that will 
reduce or eliminate threats to agricultural industries. The 
Committee expects APHIS to provide no less than $28,000,000 for 
the national rabies control and surveillance efforts.
    Of particular concern is the continued and repeat 
depredation by wolves and packs in the Pacific Northwest. In 
certain states where state management plans require state 
agencies to utilize lethal control of wolves, it is important 
these actions are taken to protect livestock. As experts in the 
field of managing predators to prevent depredation, USDA has 
valuable knowledge, tools and resources that can assist states 
in managing the federally reintroduced wolves. The Committee 
directs USDA to prioritize and complete the documentation and 
processes needed to allow them to assist states and local 
livestock producers with managing this situation.

                        BUILDINGS AND FACILITIES

 
 
 
2016 appropriation....................................        $3,175,000
2017 budget estimate..................................         3,175,000
Provided in the bill..................................         3,175,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For Animal and Plant Health Inspection Service, Buildings 
and Facilities, the Committee provides an appropriation of 
$3,175,000.
    Facilities for Fruit Fly Eradication.--In Section 743, the 
Committee provides $30,000,000 for the improvement and repair 
of facilities and infrastructure related to the research and 
production of fruit fly eradication initiatives. Recent fruit 
fly contaminations have cost producers more than $1,100,000,000 
in economic loss. The Committee directs APHIS to provide a 
report and consult with the Committee on plans for construction 
and location of the new facilities.

                     Agricultural Marketing Service


                           MARKETING SERVICES

 
 
 
2016 appropriation....................................       $81,223,000
2017 budget estimate..................................        81,933,000
Provided in the bill..................................        82,223,000
Comparison:
    2016 appropriation................................        +1,000,000
    2017 budget estimate..............................          +290,000
 

                          COMMITTEE PROVISIONS

    For Marketing Services of the Agricultural Marketing 
Service, the Committee provides an appropriation of 
$82,223,000.The Committee notes the Department has the 
authority to include state organic program fees and transitional 
certification fees when administering the program under 7 U.S.C. 6523.
    Organic Integrity.--The Committee is aware that the 
National Organic Standards Board (NOSB) is conducting its 
sunset review process for reviewing substances on the National 
List. It is important that this process includes sound science 
and robust stakeholder participation. The Committee expects 
both the NOSB and USDA to fully consider all currently 
available scientific information during the sunset review and 
rulemaking procedures.
    Organic Rulemaking.--The Committee is aware that USDA 
released a proposed rule on April 7, 2016, titled ``National 
Organic Program: Organic Livestock and Poultry Practices.'' The 
Committee is concerned about the potential disruption to 
existing organic producers and their supply chains, as well as 
ensuring that animal health is fully protected. Before 
finalizing this regulation, the Committee directs USDA to 
conduct an additional, thorough assessment on the costs of 
compliance and alternatives for existing organic producers so 
that producers and supply chains directly impacted by the 
change in rules will be minimally impacted.
    Research and Promotion Programs.--The Committee notes that 
the commodity Research and Promotion boards that the agency 
oversees are not agencies of the federal government, nor are 
Research and Promotion programs funded with federal funds. The 
funding used to operate and carry out the activities of the 
various Research and Promotion programs is provided by 
producers and industry stakeholders, and employees of the 
boards are not federal employees. Therefore, the Committee 
urges USDA to recognize that such boards are not subject to the 
provisions of 5 U.S.C. Section 552.
    Rural Infrastructure.--Inadequate market access is a 
critical barrier to economic growth in rural and agricultural 
communities. The Committee provides $1,000,000 for the 
Transportation Services Division to continue working with other 
federal, state and local agencies, as well as producers and 
those involved in all sectors of agricultural transportation, 
to address rural infrastructure needs to ensure producers have 
domestic and international market access.

                 LIMITATION ON ADMINISTRATIVE EXPENSES

 
 
 
2016 limitation.......................................     ($60,982,000)
2017 budget limitation................................      (61,227,000)
Provided in the bill..................................      (61,227,000)
Comparison:
    2016 limitation...................................          +245,000
    2017 budget limitation............................             - - -
 

                          COMMITTEE PROVISIONS

    The Committee provides a limitation of $61,227,000 on 
Administrative Expenses of the Agricultural Marketing Service.

    FUNDS FOR STRENGTHENING MARKETS, INCOME, AND SUPPLY (SECTION 32)

                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................     ($20,489,000)
2017 budget estimate..................................      (20,705,000)
Provided in the bill..................................      (20,489,000)
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................          -216,000
 

                          COMMITTEE PROVISIONS

    For the Marketing Agreements and Orders Program, the 
Committee provides a transfer from Section 32 funds of 
$20,489,000.
    The following table reflects the status of this fund for 
fiscal years 2016 and 2017:

ESTIMATED TOTAL FUNDS AVAILABLE AND BALANCE CARRIED FORWARD FISCAL YEARS
                                2016-2017
                         [Dollars in Thousands]
------------------------------------------------------------------------
                                     FY 2016 enacted    FY 2017 estimate
------------------------------------------------------------------------
Appropriation (30% of Customs             $10,316,645        $10,929,841
 Receipts)........................
Less Transfers:
    Food & Nutrition Service......         -8,969,178         -9,462,665
    Commerce Department...........           -145,811
                                   ------------------------------145,175
        Total, Transfers..........         -9,114,989         -9,607,840
Prior Year Appropriation                      223,344            125,000
 Available, Start of Year.........
Unavailable for Obligations                         0                  0
 (recoveries & offsetting
 collections).....................
Transfer of Prior Year Funds to              -122,000           -125,000
 FNS (F&V;)........................
    Budget Authority:.............          1,303,000          1,322,000
Rescission of Current Year Funds..           -215,636           -231,443
Appropriations Temporarily                    -77,384            -79,557
 Reduced--Sequestration...........
Unavailable for Obligations (F&V;             -125,000           -125,000
 Transfer to FNS).................
                                   -------------------------------------
    Available for Obligation:.....            884,980            886,000
Less Obligations:
    Child Nutrition Programs                  465,000            465,000
     (Entitlement Commodities)....
    State Option Contract.........              5,000              5,000
    Removal of Defective                        2,500              2,500
     Commodities..................
    Emergency Surplus Removal.....            118,500                  0
    Small Business Support........                  0                  0
    Disaster Relief...............              5,000              5,000
    Additional Fruits, Vegetables,            107,500            206,000
     and Nuts Purchases...........
    Fresh Fruit and Vegetable                  40,000             44,000
     Program......................
    Estimated Future Needs........             87,192            102,571
                                   -------------------------------------
        Total, Commodity                      830,692            830,071
         Procurement..............
    Administrative Funds:
        Commodity Purchase Support             33,799             35,440
        Marketing Agreements and               20,489             20,489
         Orders...................
                                   -------------------------------------
            Total, Administrative              54,288             55,929
             Funds................
                                   -------------------------------------
    Total Obligations.............            884,980            886,000
Unobligated Balance, End of Year..                  0                  0
Unavailable for Obligations (F&V;              125,000            125,000
 Transfer to FNS).................
Balances, Collections, and                          0                  0
 Recoveries Not Available.........
                                   -------------------------------------
        Total, End of Year                   $125,000           $125,000
         Balances.................
------------------------------------------------------------------------

                   PAYMENTS TO STATES AND POSSESSIONS

 
 
 
2016 appropriation....................................        $1,235,000
2017 budget estimate..................................         1,235,000
Provided in the bill..................................         1,235,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For Payments to States and Possessions, the Committee 
provides an appropriation of $1,235,000.

        Grain Inspection, Packers and Stockyards Administration


                         SALARIES AND EXPENSES

 
 
 
2016 appropriation....................................       $43,057,000
2017 budget estimate..................................        43,482,000
Provided in the bill..................................        43,057,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................          -425,000
 

                          COMMITTEE PROVISIONS

    For the Grain Inspection, Packers and Stockyards 
Administration, the Committee provides $43,057,000.

        LIMITATION ON INSPECTION AND WEIGHING SERVICES EXPENSES

 
 
 
2016 limitation.......................................     ($55,000,000)
2017 budget limitation................................      (57,500,000)
Provided in the bill..................................      (55,000,000)
Comparison:
    2016 limitation...................................             - - -
    2017 budget limitation............................        -2,500,000
 

                          COMMITTEE PROVISIONS

    The Committee includes a limitation on inspection and 
weighing services expenses of $55,000,000. The Committee does 
not concur with the agency's proposal to eliminate the 
limitation on inspection and weighing services expenses. The 
agency has sufficient carryover balances in this account for 
these activities. Additionally, the bill includes authority to 
exceed by 10 percent the limitation on inspection and weighing 
services with notification to the Committees on Appropriations 
of the House and Senate.

             Office of the Under Secretary for Food Safety


 
 
 
2016 appropriation....................................          $816,000
2017 budget estimate..................................           819,000
Provided in the bill..................................           816,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            -3,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Under Secretary for Food Safety, the 
Committee provides an appropriation of $816,000.

                   Food Safety and Inspection Service


 
 
 
2016 appropriation....................................    $1,014,871,000
2017 budget estimate..................................     1,030,405,000
Provided in the bill..................................     1,030,405,000
Comparison:
    2016 appropriation................................       +15,534,000
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For the Food Safety and Inspection Service (FSIS), the 
Committee provides an appropriation of $1,030,405,000.
    The following table reflects the Committee's 
recommendations for fiscal year 2017:

                   FOOD SAFETY AND INSPECTION SERVICE
                         [Dollars in Thousands]
------------------------------------------------------------------------
                                                         Recommendation
------------------------------------------------------------------------
Federal Inspection....................................          $914,098
Public Health Data Communication Infrastructure System            34,580
International Food Safety and Inspection..............            16,487
State Food Safety and Inspection......................            61,568
Codex Alimentarius....................................             3,672
                                                       -----------------
    Total, Food Safety and Inspection Service.........        $1,030,405
------------------------------------------------------------------------

    Humane Methods of Slaughter.--FSIS shall ensure that 
inspectors hired with funding previously specified for 
enforcement under the Humane Methods of Slaughter Act focus 
their attention on overseeing compliance with humane handling 
rules for live animals as they arrive and are offloaded and 
handled in pens, chutes, and stunning areas, and that all 
inspectors receive robust national training, including on the 
Regulatory Essentials, Humane Animal Tracking System, and 
Public Health Information System.
    Siluriformes Inspection Report--Within 120 days of 
enactment, the Secretary shall report to the Committee the 
status of the implementation of the mandatory inspection 
program for siluriformes and catfish products. The report shall 
contain the dates of domestic public and technical meetings 
held to explain the new program and their locations; the dates 
of foreign technical meetings held to explain the new program 
and their locations; domestic catfish slaughter and processing 
facilities visited by inspection personnel broken down by state 
and the types of regulatory actions taken, if any; the names 
countries that notified the Department by March 1 of their 
intention to continue to export siluriformes to the U.S. and 
the number of establishments that would be eligible to export; 
the names of countries that notified the Department after March 
1 of their intention to continue to export siluriformes to the 
U.S. and the number of establishments that would be eligible to 
export; the number of pounds of siluriformes imported beginning 
on April 15, 2016 broken down by country; the number of pounds 
that were subject to TOIs broken down by country; the specific 
TOIs performed broken down by country; the number of chemical 
and microbiological samples taken by country; the types and 
numbers of regulatory violations found by country. The 
Secretary shall also report the number of field inspection 
personnel assigned to the domestic facilities and the number of 
field inspection personnel assigned to perform import 
inspection.
    Water Conserving Technologies.--The Committee continues to 
direct FSIS to utilize water conserving technologies that allow 
hand-washing facilities to be immediately activated and 
deactivated in a hands-free manner to reduce cross-
contamination.

    Office of the Under Secretary for Farm and Foreign Agricultural 
                                Services


 
 
 
2016 appropriation....................................          $898,000
2017 budget estimate..................................           901,000
Provided in the bill..................................           898,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            -3,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Under Secretary for Farm and Foreign 
Agricultural Services, the Committee provides an appropriation 
of $898,000.

                          Farm Service Agency


                         SALARIES AND EXPENSES

                     (INCLUDING TRANSFERS OF FUNDS)

----------------------------------------------------------------------------------------------------------------
                                                                              Transfer from
                                                           Appropriation     Program Accounts    Total, FSA S&E;
----------------------------------------------------------------------------------------------------------------
2016 appropriation.....................................     $1,200,180,000     ($309,880,000)   ($1,510,060,000)
2017 budget estimate...................................      1,209,751,000      (309,610,000)    (1,519,361,000)
Provided in the Bill...................................      1,200,180,000      (309,610,000)    (1,509,790,000)
Comparison:
    2016 appropriation.................................              - - -           -270,000         (-270,000)
    2017 budget estimate...............................        -$9,571,000             $- - -      (-$9,571,000)
----------------------------------------------------------------------------------------------------------------

                          COMMITTEE PROVISIONS

    For Salaries and Expenses of the Farm Service Agency (FSA), 
the Committee provides an appropriation of $1,200,180,000 and 
transfers of $309,610,000, for a total program level of 
$1,509,790,000.
    Oriental Fruit Fly.--The Committee strongly urges FSA to 
make funds available to those farmers who were negatively 
impacted by an Oriental Fruit Fly quarantine from October 2015 
through February 2016. The farmers, who were unable to bring 
their crop to market, sustained devastating losses, although 
the quarantine was necessary and successful in eradicating the 
Oriental Fruit Fly pest. Because crop insurance and other 
similar programs do not apply in instances of a state or 
federally declared quarantine, the impacted farmers are in need 
of relief. The Committee believes it is within FSA's purview to 
make funds available to the impacted farmers.
    FSA Farm Loan Levels.--The Committee does not agree with 
FSA's proposal to waive loan fees for certain groups of 
farmers. However, the Committee does recognize increased demand 
for overall loan levels and provides this relief in accordance 
with the President's budget request, including additional 
funding for Emergency Loans. In general, USDA data demonstrates 
that farmers are experiencing a significant decline in farm 
income and the cost of doing business is growing. As such, the 
need for larger individual loan limitations and flexibility may 
be increasing. The Department is directed to work with 
stakeholders to address these issues.
    Budgetary Reductions.--FSA has submitted consecutive 
proposals for significant annual budget savings through 
``operational efficiencies'' with little detail for achieving 
these goals. FSA proposed nearly $40,000,000 in reductions for 
fiscal year 2016. An additional $24,000,000 in IT savings is 
proposed for fiscal year 2017 through contractual savings. The 
Committee directs FSA to provide a report by the end of fiscal 
year 2016 detailing the specific contracts and amounts FSA 
proposes to achieve these savings from.
    Proposal to Close County Offices.--The Committee includes 
statutory language preventing the closure of county offices.
    FSA IT.--The agreement includes statutory language that 
allows FSA to release funds for farm program delivery IT 
projects only after the submission of a spending plan to the 
Committees on Appropriations of the House and Senate. The 
roadmap submitted by FSA in fiscal year 2015 and submission of 
a spend plan for review to the Government Accountability Office 
(GAO) in fiscal year 2016 were the first steps toward bringing 
accountability and guidance to almost a decade of mismanagement 
of the Modernize and Innovate the Delivery of Agricultural 
Systems (MIDAS) IT system. MIDAS was over budget by hundreds of 
millions of dollars, took years longer than expected, and only 
delivered a fraction of the promised results. While FSA has 
made some improvements in reforming the program, the Committee 
further directs the agency to provide a report within 90 days 
of enactment of this Act on its future plans for MIDAS-specific 
IT functions.
    Loan Deficiency Payments.--The Committee encourages the 
Secretary to work with producers who have already received a 
benefit under 7 U.S.C. 7935 with respect to the 2015 crop of a 
commodity prior to the availability of a benefit under 7 U.S.C. 
8286 as provided by amendments made by Public Law 114-113.
    Alternative Imaging Capabilities.--The Committee notes that 
space-based infrared and hyper-spectral satellites are ideally 
suited to managing and monitoring agricultural lands and 
waters. These commercially-available capabilities could do much 
toward more efficient use of agriculture resources. 
Accordingly, the Committee encourages the Department to examine 
the utility and cost of new, commercially-derived, space-based 
imaging data systems that can support the agriculture 
community, including ways that improve efficiencies within the 
Farm and Foreign Agricultural Services mission area.
    Economic Impact of Livestock and Conservation Reserve 
Program (CRP).--CRP is a federal program under FSA that pays a 
yearly rental payment in exchange for farmers and ranchers to 
remove environmentally sensitive land from agricultural 
production. Due to increasing enrollment in CRP in certain 
areas, livestock operations have been reduced. In an effort to 
focus on the economic impact of CRP in rural communities, 
specifically livestock production, the Committee directs FSA to 
submit a report within 60 days of enactment of this Act. 
Central facets of the report should focus on (1) the 
opportunities livestock production brings to rural communities; 
(2) determine the economic impact livestock production has on 
rural communities (feed sales, construction/fencing costs, 
management practice investments that increase revenue for local 
businesses); (3) explore the tax benefits for rural school 
districts resulting from property taxes and cash receipts due 
to livestock production; and (4) assess the ability for 
nutrients to be captured and soil quality maintained by grazing 
livestock (similar to the CRP program).

                         STATE MEDIATION GRANTS

 
 
 
2016 appropriation....................................        $3,404,000
2017 budget estimate..................................         3,404,000
Provided in the bill..................................         3,404,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For State Mediation Grants, the Committee provides an 
appropriation of $3,404,000.

               GRASSROOTS SOURCE WATER PROTECTION PROGRAM

 
 
 
2016 appropriation....................................        $6,500,000
2017 budget estimate..................................             - - -
Provided in the bill..................................         6,500,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................        +6,500,000
 

                          COMMITTEE PROVISIONS

    For the Grassroots Source Water Protection Program, the 
Committee provides an appropriation of $6,500,000.

                        DAIRY INDEMNITY PROGRAM

                     (INCLUDING TRANSFER OF FUNDS)

 
 
 
2016 appropriation....................................       \1\$500,000
2017 budget estimate..................................        \1\500,000
Provided in the bill..................................        \1\500,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            - - -
 
\1\Current indefinite appropriation.

                          COMMITTEE PROVISIONS

    For the Dairy Indemnity Program, the Committee provides an 
appropriation of such sums as may be necessary (estimated to be 
$500,000 in the President's fiscal year 2017 budget request).

           AGRICULTURAL CREDIT INSURANCE FUND PROGRAM ACCOUNT

                     (INCLUDING TRANSFERS OF FUNDS)

                         ESTIMATED LOAN LEVELS

 
 
 
2016 loan level.......................................    $6,402,114,000
2017 budget estimate..................................     6,655,053,000
Provided in the bill..................................     6,667,144,000
Comparison:
    2016 loan level...................................      +265,030,000
    2017 budget estimate..............................       +12,091,000
 

                          COMMITTEE PROVISIONS

    For the Agricultural Credit Insurance Fund program account, 
the Committee provides a loan level of $6,667,144,000.
    The following table reflects the loan levels for the 
Agricultural Credit Insurance Fund program account:

                                    AGRICULTURE CREDIT PROGRAMS--LOAN LEVELS
                                             [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                                   Committee
                                                       FY 2016  enacted    FY 2017  estimate       provision
----------------------------------------------------------------------------------------------------------------
Farm Loan Programs:
    Farm Ownership:
        Direct......................................          $1,500,000          $1,500,000          $1,500,000
        Unsubsidized Guaranteed.....................           2,000,000           2,000,000           2,000,000
    Farm Operating:
        Direct......................................           1,252,004           1,460,047           1,460,047
        Unsubsidized Guaranteed.....................           1,393,443           1,432,430           1,432,430
    Emergency Loans.................................              34,667              22,576              34,667
    Indian Tribe Land Acquisition Loans.............               2,000              20,000              20,000
    Conservation Loans:
        Unsubsidized Guaranteed.....................             150,000             150,000             150,000
    Indian Highly Fractionated Land.................              10,000              10,000              10,000
    Boll Weevil Eradication.........................              60,000              60,000              60,000
                                                     -----------------------------------------------------------
        Total.......................................          $6,402,114          $6,655,053          $6,667,144
----------------------------------------------------------------------------------------------------------------


                            ESTIMATED LOAN SUBSIDY AND ADMINISTRATIVE EXPENSES LEVELS
                                             [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                     Direct Loan     Guaranteed                  Administrative
                                                       subsidy      loan subsidy     Grants         expenses
----------------------------------------------------------------------------------------------------------------
2016 appropriation..............................           $53,961       $14,352        $- - -          $314,918
2017 budget estimate............................            62,198        15,327         1,500           317,068
Provided in the Bill............................            62,198        15,327         - - -           314,918
Comparison:
    2016 appropriation..........................            +8,237          +975         - - -             - - -
    2017 budget estimate........................           $ - - -       $ - - -       -$1,500           -$2,150
----------------------------------------------------------------------------------------------------------------

    The following table reflects the costs of loan programs 
under credit reform:

            AGRICULTURE CREDIT PROGRAMS--SUBSIDIES AND GRANTS
                         [Dollars in Thousands]
------------------------------------------------------------------------
                                   FY 2016       FY 2017      Committee
                                   enacted      estimate      provision
------------------------------------------------------------------------
Farm Loan Subsidies:
    Farm Operating:
        Direct................       $53,961       $62,198       $62,198
        Unsubsidized                  14,352        15,327        15,327
         Guaranteed...........
    Emergency Loans...........         1,262         1,262         1,938
    Indian Highly Fractionated         - - -         2,550         2,550
     Land.....................
    Individual Development             - - -         1,500         - - -
     Accounts.................
                               -----------------------------------------
        Total.................        69,575        82,837        82,013
ACIF Expenses:
    Salaries and Expenses.....       306,998       306,998       306,998
    Administrative Expenses...         7,920        10,070         7,920
                               -----------------------------------------
        Total, ACIF Expenses..      $314,918      $317,068      $314,918
------------------------------------------------------------------------

                         Risk Management Agency


                         SALARIES AND EXPENSES

 
 
 
2016 appropriation....................................       $74,829,000
2017 budget estimate..................................     \1\66,615,000
Provided in the bill..................................        74,829,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................       +8,214,000
 
\1\Does not include up to $20,000,000 transfer from mandatory crop
  insurance funding.

                          COMMITTEE PROVISIONS

    For the Risk Management Agency, the Committee provides an 
appropriation of $74,829,000.
    Standard Reinsurance Agreement (SRA) Discrepancies.--The 
Committee notes that stakeholders, including specialty crop 
insurance agents, are concerned about commissions received for 
their products as compared to other crops. In a manner 
consistent in law, the Committee encourages RMA to address this 
issue by working with all such stakeholders and involving them 
in any future negotiations of the SRA. The Committee directs 
RMA to provide a report to the Committee on the amount of 
commissions paid to crop insurance agents, broken down by 
state, year, and crop for fiscal years 2006 through 2015. The 
report shall also provide such information by insurance 
products subject to and not subject to the administrative and 
operating expenses limitation in the SRA and the 80 percent 
limitation on agent commissions by state.
    Crop Insurance in Drought Areas.--The Committee encourages 
the Secretary to be flexible in administering the Federal Crop 
Insurance program in areas impacted by natural disasters, 
including in drought-affected areas.

                              CORPORATIONS


                Federal Crop Insurance Corporation Fund


 
 
 
2016 appropriaion.....................................  \1\$7,857,970,00
                                                                       0
2017 budget estimate..................................  \1\8,839,089,000
Provided in the bill..................................  \1\8,839,089,000
Comparison:
    2016 appropriation................................      +981,119,000
    2017 budget estimate..............................            - - -
 
\1\Current indefinite appropriation.

                          COMMITTEE PROVISIONS

    For the Federal Crop Insurance Corporation Fund, the 
Committee provides an appropriation of such sums as may be 
necessary (estimated to be $8,839,089,000 in the President's 
fiscal year 2017 budget request).

                   Commodity Credit Corporation Fund


                 REIMBURSEMENT FOR NET REALIZED LOSSES

                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................  \1\$6,871,132,00
                                                                       0
2017 budget estimate..................................  \1\13,476,854,00
                                                                       0
Provided in the bill..................................  \1\13,476,854,00
                                                                       0
Comparison:
    2016 appropriation................................    +6,605,722,000
    2017 budget estimate..............................            - - -
 
\1\Current indefinite appropriation.

                          COMMITTEE PROVISIONS

    For Reimbursement for Net Realized Losses to the Commodity 
Credit Corporation, the Committee provides such sums as may be 
necessary to reimburse for net realized losses sustained but 
not previously reimbursed (estimated to be $13,476,854,000 in 
the President's fiscal year 2017 budget request).

                       HAZARDOUS WASTE MANAGEMENT

                        (LIMITATION ON EXPENSES)

 
 
 
2016 limitation.......................................      ($5,000,000)
2017 budget estimate..................................       (5,000,000)
Provided in the bill..................................       (5,000,000)
Comparison:
    2016 limitation...................................             - - -
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For Hazardous Waste Management, the Committee provides a 
limitation of $5,000,000.

                                TITLE II


                         CONSERVATION PROGRAMS


  Office of the Under Secretary for Natural Resources and Environment


 
 
 
2016 appropriation....................................          $898,000
2017 budget estimate..................................           901,000
Provided in the bill..................................           898,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            -3,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Under Secretary for Natural Resources 
and Environment, the Committee provides an appropriation of 
$898,000.

                 Natural Resources Conservation Service


                        CONSERVATION OPERATIONS

 
 
 
2016 appropriation....................................      $850,856,000
2017 budget estimate..................................       860,374,000
Provided in the bill..................................       855,256,000
Comparison:
    2016 appropriation................................        +4,400,000
    2017 budget estimate..............................        -5,118,000
 

                          COMMITTEE PROVISIONS

    For Conservation Operations, the Committee provides an 
appropriation of $855,256,000.
    The Committee provides $9,300,000 for the Snow Survey and 
Water Forecasting Program; $9,400,000 for the Plant Materials 
Centers; and $80,000,000 for the Soil Surveys Program. The 
Committee provides $756,556,000 for Conservation Technical 
Assistance and includes a $15,000,000 increase for written 
conservation plans and conservation program delivery. The 
Committee is pleased with the progress of the Conservation 
Effects Assessment Project and the Conservation Delivery 
Streamlining Initiative and directs NRCS to continue to invest 
in these programs.
    Administrative Reorganization.--The Committee commends NRCS 
for its organizational realignment of administrative functions 
and appreciates the savings this will generate. NRCS has worked 
to become a more efficient, accountable organization, and the 
Committee encourages NRCS to work with other agencies within 
USDA to do the same.
    Agricultural Conservation Easement Program.--Due to the 
unique ecological needs of each state, the Committee encourages 
NRCS to work with state and local partners to address these 
needs and to ensure the priority needs and projects in each 
state, such as those that are leveraged by public and private 
resources, are addressed.
    Cheat Grass Eradication.--The Committee encourages NRCS to 
continue to assist farmers and ranchers to eradicate, control, 
and reduce the fuel loads associated with cheat grass and to 
collaborate with ARS, as appropriate, on research related to 
cheat grass.
    Conservation Practice Standards.--The Committee is aware 
that NRCS has been pressured to modify its conservation 
practice standards in certain circumstances for purposes not 
related to the conservation of farm and ranch land. The 
Committee recognizes that conservation practice standards are 
science-based, undergo a thorough technical review, are open to 
the public for notice and comment, and reflect the best 
available knowledge on how to achieve the identified 
conservation and environmental objective. The Committee directs 
NRCS to maintain its long-standing process for developing and 
updating its conservation practice standards.
    Floodplain Buyouts.--The Committee commends the successful 
efforts of NRCS with voluntary floodplain homeowner buyout 
projects. The Committee encourages the NRCS to continue 
collaborative efforts with participating towns and counties to 
mitigate unintended consequences resulting from buyouts, such 
as utility cost increases for homeowners in these regions.
    Harmful Algal Blooms.--The Committee supports NRCS' ongoing 
work to prevent soil erosion leading to harmful algal blooms 
through the introduction of cover crops and encourages 
continued targeting of watersheds where harmful algal blooms 
pose a threat.
    Herbicide Resistance.--The Committee reminds NRCS of the 
challenges many producers are facing due to the spread of 
herbicide-resistant weeds and encourages it to ensure agency 
staff, partners, and producers are aware of conservation 
practice standards, conservation activity plans to address 
herbicide-resistant weeds, and financial assistance available 
through conservation programs to assist producers in their 
efforts to control these weeds.
    Irrigation Agriculture.--The Committee recognizes the 
importance of irrigation agriculture and commends efforts to 
expand irrigation systems in states and regions that have not 
previously irrigated. The Committee directs NRCS to study the 
benefits of waiving irrigation history requirements within the 
Environmental Quality Inventive Program (EQIP) as it has under 
the Regional Conservation Partnership Program (RCPP) and to 
submit a report within 60 days of enactment of this Act on 
actions it can take to prevent unnecessary barriers to states 
that would otherwise have access to funds for irrigation 
systems.
    Locally Led Conservation.--The Committee recognizes that 
locally led conservation is the foundation of the Nation's 
highly successful legacy of conservation and encourages NRCS to 
work with state, tribal, local, and other partners on voluntary 
stewardship projects that preserve working agricultural lands 
while protecting watersheds and wildlife habitat.
    Milkweed.--The Committee is concerned about the rapid 
decline in milkweed for monarch butterfly habitat. The 
Committee encourages NRCS consider the increased benefits of 
restoring milkweed for monarch habitat in fiscal year 2017.
    National Marine Sanctuaries.--The Committee urges the 
agency to continue the collaborative agreement with the Office 
of National Marine Sanctuaries to address sources of 
agricultural runoff, such as sediments, nitrates, and 
pesticides.
    Resource Conservation and Development Councils (RC&Ds;).--
The Committee recognizes RC&Ds; have been valuable partners in 
conservation and encourages NRCS to continue working with local 
councils, as appropriate, to ensure conservation programs meet 
local resource needs.
    Regional Conservation Partnership Program.--The Committee 
commends NRCS for the success of RCPP, through which NRCS 
provides assistance to producers through partnership 
agreements, program contracts, or easement agreements. These 
programs allow for diverse and innovative conservation projects 
which leverage both public and private funding. The Committee 
encourages NRCS to consider the needs of organic farmers, who 
implement a wide variety of creative methods to improve water 
quality and enhance the environment, while implementing RCPP.
    Sage Grouse Initiative.--The Committee supports NRCS' sage 
grouse conservation efforts. Through the initiative, NRCS 
provides technical and financial assistance to help landowners 
conserve sage grouse habitat on their land. The initiative is 
an integral part of efforts by federal agencies, several 
western states, and private landowners to help preclude the 
listing of the sage grouse as an endangered species.
    Water Use Efficiency.--The Committee is encouraged by the 
work being undertaken by the Bureau of Reclamation and NRCS 
under the California Bay-Delta Program Water Use Efficiency 
Grants Program, which coordinates the water use efficiency 
assistance authorized under the Secure Water Act. The Committee 
directs NRCS to work with Reclamation to identify and implement 
ways within existing authorities to extend the benefits of this 
collaborative effort.

                    WATERSHED REHABILITATION PROGRAM

 
 
 
2016 appropriation....................................       $12,000,000
2017 budget estimate..................................             - - -
Provided in the bill..................................        12,000,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................       +12,000,000
 

                          COMMITTEE PROVISIONS

    For the Watershed Rehabilitation Program, the Committee 
provides an appropriation of $12,000,000.

                               TITLE III


                       RURAL DEVELOPMENT PROGRAMS


          Office of the Under Secretary for Rural Development


 
 
 
2016 appropriation....................................          $893,000
2017 budget estimate..................................           896,000
Provided in the bill..................................           893,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            -3,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Under Secretary for Rural 
Development, the Committee provides an appropriation of 
$893,000.
    Resource Conservation and Development Councils.--The 
Committee recognizes that RC&Ds; have been valuable partners in 
rural economic development and encourages RD to continue 
working with local councils, as appropriate, to address local 
economic development needs.
    Reporting Requirements.--The Committee reminds RD that any 
action that relocates an office or employees and reorganizes 
offices, programs, or activities must be reported to the 
Committees on Appropriations of the House and Senate as 
required by law.
    StrikeForce Initiative.--The Committee appreciates the 
Department's efforts to target assistance to at-risk 
communities through the StrikeForce Initiative for Rural Growth 
and Opportunity. USDA, in collaboration with public and private 
partners, helps rural counties experiencing chronic poverty 
improve economic opportunities and quality of life for local 
residents. The Committee encourages USDA to place special 
emphasis on persistent poverty counties and continue to utilize 
a strategy of partnering public resources with local expertise 
to grow rural economies and create jobs in these poverty-
stricken areas.
    Persistent Poverty Areas.--The bill directs certain RD 
programs, including the Section 502 Single Family Housing 
Direct Loan Program, Mutual and Self-Help Housing Grants, Rural 
Community Facilities Program, Rural Business Program Account, 
Rural Cooperative Developments Grants, Rural Water and Waste 
Disposal Program, Rural Electrification and Telecommunications 
Loans Program, and the Distance Learning, Telemedicine, and 
Broadband Program, to provide at least 10 percent of the 
amounts provided to persistent poverty counties, defined as 
those areas that have 20 percent of their population living in 
poverty over the past 30 years.

                Rural Development Salaries and Expenses


                     (INCLUDING TRANSFERS OF FUNDS)

----------------------------------------------------------------------------------------------------------------
                                                                                                   Committee
                                                          FY 2016  enacted  FY 2017  estimate      provision
----------------------------------------------------------------------------------------------------------------
Appropriations.........................................       $225,835,000       $230,679,000       $225,835,000
Transfer from:
    Rural Housing Insurance Fund Program Account.......        417,854,000        426,821,000        410,086,000
    Rural Development Loan Fund Program Account........          4,468,000          4,564,000          3,495,000
    Rural Electrification and Telecommunications Loan           34,707,000         36,451,000         33,414,000
     Program Account...................................
                                                        --------------------------------------------------------
        Total, RD Salaries and Expenses................       $682,864,000       $698,515,000       $672,830,000
----------------------------------------------------------------------------------------------------------------

                          COMMITTEE PROVISIONS

    For Salaries and Expenses of the Rural Development mission 
area, the Committee provides an appropriation of $225,835,000.

                         Rural Housing Service


              RURAL HOUSING INSURANCE FUND PROGRAM ACCOUNT

                     (INCLUDING TRANSFERS OF FUNDS)

                                              [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                                 Administrative
                                                             Loan level       Subsidy level         expenses
----------------------------------------------------------------------------------------------------------------
2016 Appropriation.....................................        $25,148,531            $79,377           $417,854
2017 Budget Estimate...................................         25,233,208             81,963            426,821
Provided in the Bill...................................         25,305,132             89,302            410,086
Comparison:
    2016 Appropriation.................................           +156,601             +9,925             -7,768
    2017 Budget Estimate...............................           +$71,924            +$7,339           -$16,735
----------------------------------------------------------------------------------------------------------------

                          COMMITTEE PROVISIONS

    For the Rural Housing Insurance Fund program account, the 
Committee provides a loan level of $25,305,132,000.
    Section 502 Intermediary Pilot Program.--The bill directs 
the Secretary to continue and expand the pilot program for 
packaging section 502 direct loans. The pilot requires not less 
than ten non-profit organizations to prepare and review 
applications for single family loans, saving federal funds and 
staff time. The Committee expects the Rural Housing Service to 
expeditiously implement this program.
    Section 514 Loan Program.--The Farm Labor Housing program 
(Section 514) has been successful in assisting in the 
development of farm housing. The program presently only permits 
housing of certain farm workers and has not taken into 
consideration changes in the agricultural labor market. As a 
result, farmers are restricted on who can use the housing built 
with these funds to house the workers they need to prune and 
harvest their crops. USDA is directed to report to the 
Committees on Appropriations of the House and Senate within 90 
days of enactment of this Act regarding the feasibility and 
impacts of amending the program to expand the list of eligible 
tenants permitted to live in existing housing.
    Rural Definition.--Communities need transparency and 
deserve to understand the criteria that are evaluated when 
determining eligibility for RHS programs. The Committee directs 
RHS to submit a report listing the criteria used to define 
``rural in character'' in determining program eligibility.
    The following table reflects the loan levels for the Rural 
Housing Insurance Fund program account:

                                             [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                   FY 2017          Committee
                                                            FY 2016  enacted      estimate          provision
----------------------------------------------------------------------------------------------------------------
Rural Housing Insurance Fund Loans:
    Single Family Housing (sec. 502):
        Direct............................................          $900,000          $900,000        $1,000,000
        Unsubsidized Guaranteed...........................        24,000,000        24,000,000        24,000,000
    Housing Repair (sec. 504).............................            26,278            26,277            26,277
    Rental Housing (sec. 515).............................            28,398            33,074            35,000
    Multi-family Guaranteed (sec. 538)....................           150,000           230,000           200,000
    Site Development Loans................................             5,000             5,000             5,000
    Credit Sales of Acquired Property.....................            10,000            10,000            10,000
    Self-help Housing Land Development Fund...............             5,000             5,000             5,000
    Farm Labor Housing....................................            23,855            23,857            23,855
                                                           -----------------------------------------------------
        Total, Loan Authorization.........................       $25,148,531       $25,233,208       $25,305,132
----------------------------------------------------------------------------------------------------------------

    The following table reflects the costs of loan programs 
under credit reform:

        ESTIMATED LOAN SUBSIDY AND ADMINISTRATIVE EXPENSES LEVELS
                         [Dollars in Thousands]
------------------------------------------------------------------------
                                   FY 2016       FY 2017      Committee
                                   enacted      estimate      provision
------------------------------------------------------------------------
Rural Housing Insurance Fund
 Program Account (Loan
 Subsidies and Grants):
    Single Family Housing
     (sec. 502):
        Direct................       $60,750       $60,930       $67,700
    Housing Repair (sec. 504).         3,424         3,663         3,663
    Rental Housing (sec. 515).         8,414         9,790        10,360
    Farm Labor Housing........         6,789         7,052         7,051
    Site Development (sec.             - - -           111           111
     524).....................
    Self-Help Land (sec. 523).         - - -           417           417
        Total, Loan Subsidies.        79,377        81,963        89,302
    Farm Labor Housing Grants.         8,336         8,336         8,336
RHIF Expenses:
        Administrative              $417,854      $426,821      $410,086
         Expenses.............
------------------------------------------------------------------------

                       RENTAL ASSISTANCE PROGRAM

 
 
 
2016 appropriation....................................    $1,389,695,000
2017 budget estimate..................................     1,405,033,000
Provided in the bill..................................     1,405,033,000
Comparison:
    2016 appropriation................................       +15,338,000
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For the Rental Assistance Program, the Committee provides a 
program level of $1,405,033,000.

           MULTIFAMILY HOUSING REVITALIZATION PROGRAM ACCOUNT

 
 
 
2016 appropriation....................................       $37,000,000
2017 budget estimate..................................        37,362,000
Provided in the bill..................................        40,000,000
Comparison:
    2016 appropriation................................        +3,000,000
    2017 budget estimate..............................        +2,638,000
 

    For the Multifamily Housing Revitalization Program Account, 
the Committee provides an appropriation of $40,000,000, 
including $18,000,000 for the rural housing voucher program.

                  MUTUAL AND SELF-HELP HOUSING GRANTS

 
 
 
2016 appropriation....................................       $27,500,000
2017 budget estimate..................................        18,493,000
Provided in the bill..................................        30,000,000
Comparison:
    2016 appropriation................................        +2,500,000
    2017 budget estimate..............................       +11,507,000
 

                          COMMITTEE PROVISIONS

    For Mutual and Self-Help Housing Grants, the Committee 
provides an appropriation of $30,000,000.

                    RURAL HOUSING ASSISTANCE GRANTS

 
 
 
2016 appropriation....................................       $32,239,000
2017 budget estimate..................................        28,701,000
Provided in the bill..................................        33,701,000
Comparison:
    2016 appropriation................................        +1,462,000
    2017 budget estimate..............................        +5,000,000
 

                          COMMITTEE PROVISIONS

    For the Rural Housing Assistance Grants program, the 
Committee provides an appropriation of $33,701,000 including 
$5,000,000 for rural housing preservation grants.

               RURAL COMMUNITY FACILITIES PROGRAM ACCOUNT

                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................       $42,278,000
2017 budget estimate..................................        37,000,000
Provided in the bill..................................        47,100,000
Comparison:
    2016 appropriation................................        +4,822,000
    2017 budget estimate..............................       +10,100,000
 

                          COMMITTEE PROVISIONS

    For the Rural Community Facilities Program Account, the 
Committee provides an appropriation of $47,100,000.
    Power Plus.--In conjunction with the Administration's 
POWER+ initiative and Partnerships for Opportunity and 
Workforce and Economic Revitalization, the Committee encourages 
USDA to give consideration to Community Facility investments in 
coal communities that have been negatively impacted by changes 
in the coal industry and power sector.
    The following table provides the Committee's 
recommendations as compared to the budget request:

                                             [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                                   Committee
                                                       FY 2016  enacted    FY 2017  estimate       provision
----------------------------------------------------------------------------------------------------------------
Loan Levels:
    Community Facility Direct Loans.................        ($2,200,000)        ($2,200,000)        ($2,200,000)
    Community Facility Guaranteed Loans.............           (148,305)             (- - -)           (148,305)
Subsidy and Grants:
    Community Facility Guaranteed Loans.............               3,500               - - -               3,322
    Community Facility Grants.......................              25,000              25,000              30,000
    Rural Community Development Initiative..........               4,000               4,000               4,000
    Economic Impact Initiative......................               5,778               - - -               5,778
    Tribal College Grants...........................               4,000               8,000               4,000
                                                     -----------------------------------------------------------
        Total, Rural Community Facilities Program                $42,278             $37,000             $47,100
         Subsidy and Grants.........................
----------------------------------------------------------------------------------------------------------------

    The following is included in the bill for the Rural 
Community Facilities Program: $4,000,000 is for the Rural 
Community Development Initiative.

                   Rural Business-Cooperative Service


                     RURAL BUSINESS PROGRAM ACCOUNT

                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................       $74,000,000
2017 budget estimate..................................        81,444,000
Provided in the bill..................................        76,883,000
Comparison:
    2016 appropriation................................        +2,883,000
    2017 budget estimate..............................        -4,561,000
 

                          COMMITTEE PROVISIONS

    For the Rural Business Program Account, the Committee 
provides an appropriation of $76,883,000.
    The following table provides the Committee's 
recommendations as compared to the budget request:

                         [Dollars in Thousands]
------------------------------------------------------------------------
                                   FY 2016       FY 2017      Committee
                                   enacted      estimated     provision
------------------------------------------------------------------------
Loan Level:
    Business and Industry         ($919,768)    ($892,244)    ($919,768)
     Guaranteed Loans.........
Subsidy and Grants:
    Business and Industry             35,687        35,779        36,883
     Guaranteed Loans.........
    Rural Business Development        24,000        55,000        35,000
     Grants...................
    Delta Regional Authority/          3,000         - - -         5,000
     Appalachian Regional
     Commission...............
                               -----------------------------------------
        Total, Rural Business        $62,687       $90,779       $76,883
         Program Subsidy and
         Grants...............
------------------------------------------------------------------------

    The following programs are included in the bill for the 
Rural Business Program account: $500,000 for rural 
transportation technical assistance and $4,000,000 for 
Federally Recognized Native American Tribes, of which $250,000 
is for transportation technical assistance. The Committee notes 
that the 2014 farm bill consolidated the Rural Business 
Opportunity and Rural Business Enterprise grant programs.
    Rural Business Development Grants.--The Committee 
understands the important role that rural business development 
grants have in supporting the development or expansion of 
businesses in rural areas. However, the Committee is concerned 
that scarce grant monies are not always awarded to best 
stimulate small business through building upon other 
investments in technology infrastructure. The bill includes 
$10,000,000 for grants to businesses with proposals that have 
identified a community need that can be addressed through 
technology investment. The Committee encourages the Department 
to award grants to applicants with sound proposals and 
significant commercial potential.

              INTERMEDIARY RELENDING PROGRAM FUND ACCOUNT

                     (INCLUDING TRANSFER OF FUNDS)

                         [Dollars in Thousands]
------------------------------------------------------------------------
                                               Subsidy    Administrative
                               Loan level       level         expenses
------------------------------------------------------------------------
2016 appropriation..........       $18,889        $5,217         $4,468
2017 budget estimate........        18,889         5,476          4,564
Provided in the bill........        18,889         5,476          3,495
Comparison:
    2016 appropriation......         - - -          +259           -973
    2017 budget estimate....        $- - -        $- - -        -$1,069
------------------------------------------------------------------------

                          COMMITTEE PROVISIONS

    For the Intermediary Relending Program Fund Account, the 
Committee provides for a loan level of $18,889,000.
    For the loan subsidy, the Committee provides an 
appropriation of $5,476,000. In addition, the Committee 
provides $3,495,000 for administrative expenses.

            RURAL ECONOMIC DEVELOPMENT LOANS PROGRAM ACCOUNT

                    (INCLUDING RESCISSION OF FUNDS)

 
                                                           Loan Level
 
2016 appropriation....................................       $33,077,000
2017 budget estimate..................................        85,000,000
Provided in the bill..................................        50,000,000
Comparison:
    2016 appropriation................................       +16,923,000
    2017 budget estimate..............................      -$35,000,000
 

                          COMMITTEE PROVISIONS

    For the Rural Economic Development Loans Program Account, 
the Committee provides for a loan level of $50,000,000.
    Review and Selection Process.--The Committee recognizes 
demand for the Rural Economic Development Loan and Grant 
Program remains high. The Committee encourages the Rural 
Business-Cooperative Service to award funds on a first-come 
first-serve basis, after taking all other eligibility 
requirements into account, and not the prioritization system 
utilized in fiscal year 2016. The Committee supports utilizing 
a first-come first-serve award system as the most expeditious 
means to award funds to eligible projects.

                  RURAL COOPERATIVE DEVELOPMENT GRANTS

 
 
 
2016 appropriation....................................       $22,050,000
2017 budget estimate..................................        22,250,000
Provided in the bill..................................        26,550,000
Comparison:
    2016 appropriation................................        +4,500,000
    2017 budget estimate..............................        +4,300,000
 

                          COMMITTEE PROVISIONS

    For Rural Cooperative Development Grants, the Committee 
provides an appropriation of $26,550,000.
    The total includes $2,750,000 for a cooperative agreement 
for the Appropriate Technology Transfer for Rural Areas program 
and $15,000,000 for the value-added agricultural product market 
development grant program.
    The Committee notes that the 2014 farm bill provided 
mandatory funding for value-added agricultural product market 
development grants.

                    RURAL ENERGY FOR AMERICA PROGRAM

 
 
 
2016 appropriation....................................          $500,000
2017 budget estimate..................................        18,515,000
Provided in the bill..................................           464,000
Comparison:
    2016 appropriation................................           -36,000
    2017 budget estimate..............................       -18,051,000
 

                          COMMITTEE PROVISIONS

    For the Rural Energy for America Program, the Committee 
provides a loan level of $10,000,000 and an appropriation of 
$464,000 for the loan subsidy to make loans as authorized by 
section 9007 of the Farm Security and Rural Investment Act of 
2002 (7 U.S.C. 8107).
    The Committee notes that the 2014 farm bill provides 
mandatory funding for this program in fiscal year 2017.

                        Rural Utilities Service


             RURAL WATER AND WASTE DISPOSAL PROGRAM ACCOUNT

                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................      $522,365,000
2017 budget estimate..................................       461,593,000
Provided in the bill..................................       533,210,000
Comparison:
    2016 appropriation................................       +10,845,000
    2017 budget estimate..............................       +71,617,000
 

                          COMMITTEE PROVISIONS

    For the Rural Water and Waste Disposal Program Account, the 
Committee provides an appropriation of $533,210,000.
    Water Supplies for Very Small Communities.--The Committee 
is aware of concerns that Rural Utilities Service (RUS) grant 
programs do not adequately help small, disadvantaged, and 
severely disadvantaged communities access the funding and 
expertise necessary to develop sustainable water supplies or 
otherwise improve their wastewater systems, and it directs the 
agency to focus its efforts to assist these communities with 
predevelopment planning to help them address their water supply 
needs.
    Carryover Balances for AK, HI, and Colonias Grants.--The 
Committee is aware of significant carryover balances of 
unobligated funds provided in prior year appropriations for 
Water and Waste Disposal grants for Alaskan villages, Native 
American Tribes, Hawaiian Homelands, and the Colonias. The 
Committee urges the Department to work with state, local and 
tribal organization stakeholders to provide assistance via 
water and waste disposal grant programs as long as such 
assistance was requested by the respective groups in the year 
in which the funds were appropriated. The Department has 
flexibility to shift these prior year funds among the four 
areas through a reprogramming of funds. Further, the Committee 
provides flexibility in fiscal year 2017 to move funds to other 
water and waste disposal priorities in order to reduce the 
backlog of related needs nationwide.
    Open and Free Competition Policy.--The Committee supports 
the Department's underlying adherence to free and open 
competition on water and waste projects as contained in 7 CFR 
1780.70(b) and (d). The Committee supports efforts to eliminate 
arbitrary actions in the procurement process but is concerned 
that the Department is undermining the ability of local 
communities and the engineer of record to design water and 
wastewater projects in the manner that best serves the unique 
needs and considerations of local communities. In particular, 
the Committee is concerned about the May 17, 2012 memorandum 
and the implementation of pipe materials. The Committee 
believes that the Department must apply its policy uniformly to 
all building materials but is concerned with the Department 
requirements that would unnecessarily delay projects by 
including onerous approval processes. Communities and 
professional engineers are different and specify the pipe 
materials that best suit the needs of their community and 
project. These communities and engineers, therefore make 
different determinations depending on what is suited for a 
given community, including the existence of applicable federal, 
state, or local ordinances or standard specifications. The 
Committee encourages the Department to defer to the engineer of 
record in the selection of materials that meet nationally 
recognized standards, including pipe, absent extraordinary 
circumstances demonstrating arbitrary action.
    Domestic Preference.--The bill includes language specifying 
that funds made available for RUS' Rural Water and Waste 
Disposal program account shall use iron and steel products 
produced in the United States. RUS shall apply the 
Environmental Protection Agency's definition of public water 
systems while implementing the domestic preference provision.
    The following table provides the Committee's 
recommendations as compared to the budget request:

                                             [Dollars in Thousands]
----------------------------------------------------------------------------------------------------------------
                                                                                                   Committee
                                                        FY 2016 enacted    FY 2017 estimate        provision
----------------------------------------------------------------------------------------------------------------
Loan Levels:
    Water and Waste Direct Loans....................        ($1,200,000)          ($803,802)        ($1,200,000)
    Water and Waste Guaranteed Loans................            (50,000)               - - -            (50,000)
Subsidy and Grants:
    Direct Subsidy..................................              31,320              34,885              52,080
    Guaranteed Subsidy..............................                 275               - - -                 240
    Water and Waste Revolving Fund..................               1,000                 500               1,000
    Water Well System Grants........................                 993                 500                 993
    Grants for the Colonias and AK/HI...............              64,000              42,544              53,000
    Water and Waste Technical Assistance Grants.....              20,000              13,930              20,000
    Circuit Rider Program...........................              16,397              13,000              16,897
    Solid Waste Management Grants...................               4,000               1,000               4,000
    High Energy Cost Grants.........................              10,000               - - -               - - -
    Water and Waste Disposal Grants.................             364,380             350,234             375,000
    306A(i)(2) Grants...............................              10,000               5,000              10,000
                                                     -----------------------------------------------------------
        Total, Subsidies and Grants.................            $522,365            $461,593            $533,210
----------------------------------------------------------------------------------------------------------------

   RURAL ELECTRIFICATION AND TELECOMMUNICATIONS LOANS PROGRAM ACCOUNT

                     (INCLUDING TRANSFER OF FUNDS)

                         [Dollars in Thousands]
------------------------------------------------------------------------
                                               Subsidy    Administrative
                               Loan level       level        expenses
------------------------------------------------------------------------
2016 Appropriation..........    $6,940,000          $104        $34,707
2017 Budget Estimate........     7,190,056        14,071         36,451
Provided in the Bill........     6,940,000         3,071         33,414
Comparison:
    2016 Appropriation......         - - -        +2,967         -1,293
    2017 Budget Estimate....     -$250,056      -$11,000        -$3,037
------------------------------------------------------------------------

                          COMMITTEE PROVISIONS

    For the Rural Electrification and Telecommunications Loans 
Program Account, the Committee provides a loan level of 
$6,940,000,000. In addition, the Committee provides $33,414,000 
for administrative expenses.
    The following table reflects the loan levels for the Rural 
Electrification and Telecommunications Loans Program Account:

                         [Dollars in Thousands]
------------------------------------------------------------------------
                                   FY 2016       FY 2017      Committee
                                   enacted      estimate      provision
------------------------------------------------------------------------
Loan Authorizations:
Electric:
    Direct, FFB...............    $5,500,000    $6,500,000    $5,500,000
    Guaranteed Underwriting...       750,000         - - -       750,000
        Subtotal..............     6,250,000     6,500,000     6,250,000
Telecommunications:
    Direct, Treasury Rate.....       690,000       690,056       690,000
                               -----------------------------------------
        Total, Loan               $6,940,000    $7,190,056    $6,940,000
         Authorizations.......
------------------------------------------------------------------------

         DISTANCE LEARNING, TELEMEDICINE, AND BROADBAND PROGRAM

                         [Dollars in Thousands]
------------------------------------------------------------------------
                                   FY 2016       FY 2017      Committee
                                   enacted      estimate      provision
------------------------------------------------------------------------
Broadband Program:
    Loan Authorization........       $20,576         - - -       $20,000
    Loan Subsidy..............         4,500         - - -         4,560
    Grants....................        10,372        39,492        33,000
Distance Learning and
 Telemedicine:
    Grants....................        22,000        34,950        25,000
                               -----------------------------------------
        Total, Loan Subsidy          $36,872       $74,442       $62,560
         and Grants...........
------------------------------------------------------------------------

                          COMMITTEE PROVISIONS

    For the Distance Learning, Telemedicine, and Broadband 
Program, the Committee provides an appropriation of 
$62,560,000, which includes $25,000,000 for distance learning 
and telemedicine grants.
    Broadband Loan and Grant Program Priorities.--The Committee 
recognizes the advantages of extending broadband services, 
including the economic development opportunities and improved 
health care services that broadband technology provides. 
Funding provided for the broadband programs is intended to 
promote availability in those areas where there is not 
otherwise a business case for private investment in a broadband 
network. The Committee directs RUS to focus expenditures on 
projects that bring broadband service to underserved households 
and areas.
    Tribal Communities.--The Committee notes that tribal 
communities continue to struggle with gaining access to 
broadband service. The Committee encourages the Secretary to 
provide a report that identifies the specific challenges Indian 
Tribal Organizations (ITOs) have in gaining access to broadband 
service and provide a plan for addressing these challenges, 
including how the Community Connect program can assist ITOs.

                                TITLE IV


                         DOMESTIC FOOD PROGRAMS


    Office of the Under Secretary for Food, Nutrition, and Consumer 
                                Services


 
 
 
2016 appropriation....................................          $811,000
2017 budget estimate..................................           814,000
Provided in the bill..................................           811,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................            -3,000
 

                          COMMITTEE PROVISIONS

    For the Office of the Under Secretary for Food, Nutrition, 
and Consumer Services, the Committee provides an appropriation 
of $811,000.
    Communication from FNS.--The Committee recognizes the 
efforts made to increase communication and reduce delays by FNS 
in completing requested reports. Reports requested by the 
Committees on Appropriations of the House and Senate, as well 
as information regarding FNS programs, are an important part of 
the Committees' oversight responsibilities. The directives and 
issues that are specified in the House, Senate, or conference 
report are very important to the Committee and the dates 
specified are mandatory. FNS is expected to keep the Committee 
apprised of activities and issues, especially those mentioned 
in Committee reports. FNS is reminded that the Committee 
reserves the right to call before it any agency that does not 
submit reports on time.
    Public Release of Information.--The Committee directs FNS 
to continue making all policy documents related to the Special 
Supplemental Nutrition Program for Women, Infants, and Children 
(WIC) program (including, but not limited to, instructions, 
memoranda, guidance, and questions and answers) available to 
the public on the Internet within one week of their release to 
WIC state administrators.
    Program Eligibility.--The Committee directs FNS to work 
with states to ensure full compliance with the law mandating 
that every WIC and SNAP participant meet all program 
eligibility requirements. FNS is also directed to ensure these 
programs are not being promoted to ineligible individuals, 
which would increase program costs.
    Fruit and Vegetable Consumption.--The Committee continues 
to urge FNS to recognize in relevant agency publications and 
regulations related to all federal nutrition programs, 
including nutrition education programs and child nutrition 
programs, the nutritional benefits provided by all forms of 
fruits, vegetables, and beans, whether canned, dried, fresh, or 
frozen.

                       Food and Nutrition Service


                        CHILD NUTRITION PROGRAMS

                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................   $22,149,746,000
2017 budget estimate..................................    23,230,733,000
Provided in the bill..................................    23,175,679,000
Comparison:
    2016 appropriation................................    +1,025,933,000
    2017 budget estimate..............................       -55,054,000
 

                          COMMITTEE PROVISIONS

    For the Child Nutrition Programs, the Committee provides 
$23,175,679,000.
    School Meals.--The Committee remains concerned about the 
challenges and costs that local schools face in implementing 
the various regulations from the Healthy, Hunger-Free Kids Act 
of 2010. Some schools are continuing to have difficulty 
complying with the whole grain requirements that went into 
effect on July 1, 2014, and schools are increasingly concerned 
with further reductions in the sodium requirements. In order to 
provide schools with the certainty and flexibility they need 
for the 2017-2018 school year, the Committee continues to 
extend the whole grain waiver provision to those school food 
authorities demonstrating a hardship in implementing the whole 
grain standards.
    The Committee also continues a provision stating that 
sodium standards cannot be reduced below Target 1 until the 
latest scientific research establishes that the reduction is 
beneficial for children. According to information provided by 
USDA, the overwhelming majority of research that has been 
reviewed on this issue was conducted more than 10 years ago, 
with most research conducted in the 1980s and 1990s. The 
Committee notes that the requirement that the latest scientific 
research prove that further sodium reductions are beneficial 
for children has not been met.
    As schools seek to implement the school meal standards, the 
Committee encourages USDA to consider ways to assist schools 
with technical assistance and training, including the services 
of not-for-profit culinary institutions, to provide healthy, 
cost-effective foods that students will eat.
    Improper Payments.--The Committee remains concerned about 
the staggering error rates for the National School Lunch 
Program (NSLP) and School Breakfast Program (SBP), which were 
about 16 percent and 23 percent, respectively, in fiscal year 
2015. This amounts to $1,800,000,000 in improper payments for 
NSLP and $875,000,000 for SBP. While the error rate for SBP had 
a small decrease, there was a slight increase in the error rate 
for NSLP. OIG completed an audit report in May of 2015 that 
evaluated how FNS is attempting to lower the error rates, and 
the Committee acknowledges FNS is working to address this 
issue. The fiscal year 2016 explanatory statement directed FNS 
to provide a report addressing OIG's recommendations. The 
Committee expects this report by June 1, 2016.
    Potable Water.--The Committee is aware of the statutory 
requirement that schools and child care centers make potable 
water available to children free of charge during meal times in 
the place where meals are served. The Committee directs USDA to 
provide a report on the actions that have been taken to ensure 
that potable water is being provided in schools and child care 
centers.
    Technology Use in School Meal Programs.--The Committee 
supports increased use of technology as a strategy to combat 
waste, fraud and abuse in the school meal programs and urges 
USDA to continue to allow local control in the selection of 
technology platforms. The Committee directs USDA to clearly 
communicate to recipients of any funding that can be used for 
technology infrastructure in or for the support of school meal 
programs that the funds are intended to establish state systems 
that are capable of interoperability or interface with the 
technology platforms selected by school districts.
    The following table reflects the Committee recommendations 
for the child nutrition programs:

                         [Dollars in Thousands]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Child Nutrition Programs:
    School Lunch Program.............................        $12,756,627
    School Breakfast Program.........................          4,486,347
    Child and Adult Care Food Program................          3,446,278
    Summer Food Service Program......................            628,484
    Special Milk Program.............................              9,236
    State Administrative Expenses....................            279,058
    Commodity Procurement............................          1,428,089
    Food Safety Education............................              2,869
    Coordinated Review...............................             10,000
    Computer Support and Processing..................             11,876
    Training and Technical Assistance................             18,137
    CNP Studies and Evaluations......................             21,274
    CN Payment Accuracy..............................             10,974
    Farm to School Team..............................              3,426
    Team Nutrition...................................             15,504
    Healthier U.S. Schools Challenge.................              1,500
    School Meals Equipment Grants....................             25,000
    Summer EBT Demonstration.........................             21,000
                                                      ------------------
        Total........................................        $23,175,679
------------------------------------------------------------------------

SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN 
                                 (WIC)

 
 
 
2016 appropriation....................................    $6,350,000,000
2017 budget estimate..................................     6,350,000,000
Provided in the bill..................................     6,350,000,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For the Special Supplemental Nutrition Program for Women, 
Infants, and Children, the Committee provides an appropriation 
of $6,350,000,000. The Committee provides for continuation of 
the breastfeeding peer counselor program and infrastructure.
    USDA data shows that WIC participation rates have decreased 
steadily since fiscal year 2010. The President's budget request 
includes a projection of an average monthly participation rate 
of 8.1 million women, infants, and children for fiscal year 
2017. However, the average monthly participation rate was 8.0 
million for fiscal year 2015, and the current average for 
fiscal year 2016 is 7.9 million. Birth rates also remain at an 
all-time low according to the Centers for Disease Control and 
Prevention (CDC).
    USDA is estimating recovery and carryover funds to be much 
higher than average at more than $600,000,000. Furthermore, the 
Secretary has a sufficient WIC contingency reserve fund as a 
safety net to meet unexpected demand. With lower participation 
rates, higher carryover funds, and an ample reserve fund, the 
Committee provides funding that will ensure all eligible 
participants will be served. The Committee will continue to 
monitor WIC participation, carryover funds, and food costs and 
take additional action as necessary to ensure that funding 
provided in fiscal year 2017 remains sufficient to serve all 
eligible applicants.
    Income Eligibility Standards.--The Committee continues to 
monitor WIC income eligibility standards to ensure all 
procedures are followed by the WIC state and local agencies. 
FNS has been conducting Certification and Eligibility 
Management Evaluations on all state agencies and ITOs in order 
to ensure compliance and maintain program integrity in the 
participant certification process. USDA is directed to provide 
a report describing the results of these evaluations, detailing 
discrepancies found in determining participant eligibility and 
the certification process. The report should include steps FNS 
will take to ensure state agencies and ITOs adhere to the 
income verification procedures that the Department has 
implemented.
    Program Integrity and Fraudulent Activities.--The FNS WIC 
Program Integrity and Monitoring Branch plays a role in helping 
WIC state agencies address vendor management, cost containment, 
and fraudulent activities such as the online sale of WIC-
provided infant formula. The Committee remains concerned about 
fraud and abuse in the program and directs FNS to provide a 
report on this branch's efforts and results in addressing these 
areas.
    WIC Eligibility of Multivitamins.--The Committee encourages 
FNS to prepare a report assessing the inclusion of vitamins 
eligible for purchase as part of the supplemental foods under 
the special supplemental nutrition program for women, infants, 
and children (WIC). Such report shall include: whether there 
are dietary deficiencies within the WIC population that could 
be enhanced through such inclusion; considerations regarding 
the implementation and possible health impacts of such 
inclusion; cost considerations related to such inclusion. This 
report shall be submitted to the Committee not later than 90 
days after enactment of this Act.
    Zika Outreach and Education.--The Committee is supportive 
of ensuring pregnant women are educated on the various methods 
for preventing exposure to the Zika virus during pregnancy. The 
Committee directs the Department, in consultation with the 
Centers for Disease Control and Prevention, to continue its 
education and outreach efforts through the WIC program to 
provide pregnant women with the information they need to 
prevent Zika. During fiscal year 2017, the Department is 
directed to designate $10,000,000 to assist with Zika outreach 
and education, with priority given to States with the greatest 
need.

               SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM

 
 
 
2016 appropriation....................................   $80,849,383,000
2017 budget estimate..................................    81,689,168,000
Provided in the bill..................................    79,673,277,000
Comparison:
    2016 appropriation................................    -1,176,106,000
    2017 budget estimate..............................    -2,015,891,000
 

                          COMMITTEE PROVISIONS

    For the Supplemental Nutrition Assistance Program, the 
Committee provides $79,673,277,000. The total amount includes 
$3,000,000,000 for a contingency reserve to be used only in the 
amount necessary. Section 748 provides an additional 
$19,000,000 for the purchase of TEFAP commodities in order to 
maintain the fiscal year 2016 funding level.
    The Committee provides an increase of $4,000,000 for 
Nutrition Education and Program Information solely for SNAP 
Employment and Training technical assistance. The Committee is 
aware of coordinated attempts to circumvent the directive in 
the fiscal year 2016 explanatory statement in order to provide 
funding for existing Centers of Excellence. Therefore, 
consistent with the Consolidated Appropriations Act of 2016, 
the Committee does not provide funding for new or existing 
Centers of Excellence, which have not been authorized by 
Congress.
    Required Reporting for Out-of-State Moves.--The Committee 
remains committed to eliminating fraud and abuse within SNAP. 
Bill language is included to require SNAP participants to 
report to the state agency when they move outside of the state 
in which they are certified. This provision closes a loophole 
in order to prevent fraudulent SNAP participation in multiple 
states.
    SNAP Purchase Report.--The Committee is aware that FNS is 
preparing a report describing purchases made by SNAP recipients 
as compared to non-SNAP recipients. FNS is directed to complete 
this report as soon as practicable and make this report 
publicly available.
    SNAP Error Rates.--An OIG report issued in September of 
2015 reviewed the FNS quality control process for determining 
the SNAP error rate associated with benefits provided to 
recipients. OIG found vulnerabilities and inconsistencies in 
the methods used to determine the error rate and concluded FNS' 
quality control process resulted in an understatement of SNAP's 
error rates. The fiscal year 2016 explanatory statement 
directed the Department to provide a report on how FNS will 
address OIG's recommendations. The Committee expects this 
report no later than June 1, 2016.
    Recruitment Activities.--The Committee continues to direct 
USDA to ensure that Section 4018 of the 2014 farm bill is 
implemented and enforced in a manner consistent with the 
statute which prohibits USDA from conducting recruitment 
activities, advertising the program, or entering into 
agreements with foreign governments to promote SNAP benefits. 
The Committee continues to direct USDA to enforce this 
provision to ensure that state agencies are not reimbursed for 
such activities consistent with the statute.
    Issuance of SNAP Benefits.--The Committee notes that some 
states issue SNAP benefits to recipients in a compressed time 
frame, usually at the beginning of the month, which causes 
challenges for both SNAP participants and retailers. The 
Committee continues to direct FNS to work with those states 
with a compressed issuance schedule to provide benefits at 
least twice per month and to report to the Committees on 
Appropriations of the House and Senate progress made on this 
issue.
    Electronic Benefit Transfer (EBT) Equipment.--The Committee 
is aware that some farmers markets and farmers selling directly 
to consumers are interested in EBT equipment that operates for 
a variety of federal nutrition programs. FNS is encouraged to 
assist farmers markets and direct-selling farmers in obtaining 
EBT equipment that allows participation in other federal 
nutrition programs.
    The following table reflects the Committee recommendations 
for SNAP:

                         [Dollars in Thousands]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Supplemental Nutrition Assistance Program Account:
    Benefits..........................................       $68,801,122
    Contingency Reserve...............................         3,000,000
Administrative Costs:
    State Administrative Costs........................         4,348,604
    Nutrition Education and Obesity Prevention Grant             414,000
     Program..........................................
    Employment and Training...........................           465,680
    Mandatory Other Program Costs.....................           193,417
    Discretionary Other Program Costs.................               998
        Administrative Subtotal.......................         5,422,699
    Nutrition Assistance for Puerto Rico (NAP)........         1,965,415
    American Samoa....................................             7,893
    Food Distribution Program on Indian Reservations..           151,000
    TEFAP Commodities.................................           299,000
    Commonwealth of the Northern Mariana Islands......            12,148
    Community Food Project............................             9,000
    Program Access....................................             5,000
        Subtotal......................................         2,449,456
                                                       -----------------
            Total.....................................       $79,673,277
------------------------------------------------------------------------

                      COMMODITY ASSISTANCE PROGRAM

 
 
 
2016 appropriation....................................      $296,217,000
2017 budget estimate..................................       313,139,000
Provided in the bill..................................       315,139,000
Comparison:
    2016 appropriation................................       +18,922,000
    2017 budget estimate..............................        +2,000,000
 

                          COMMITTEE PROVISIONS

    The Committee provides an appropriation of $315,139,000 for 
the Commodity Assistance Program. The recommended funding level 
for the Commodity Supplemental Food Program is $236,120,000.
    The Committee recommendation includes $18,548,000 for the 
Farmers' Market Nutrition Program.
    The Committee has included $59,401,000 for administrative 
funding for The Emergency Food Assistance Program (TEFAP).
    For the Food Donations Programs, the Committee provides an 
appropriation of $1,070,000 for Pacific Island Assistance.
    TEFAP Handling and Distribution Costs.--In addition to 
grant funds supporting commodity handling and distribution 
costs, the bill permits states to use up to 10 percent of the 
funds provided for purchasing TEFAP commodities to help with 
the costs of storing, transporting, and distributing 
commodities. The Committee expects state agencies to consult 
with their emergency feeding organizations on the need for the 
conversion of such funds.

                   NUTRITION PROGRAMS ADMINISTRATION

 
 
 
2016 appropriation....................................      $150,824,000
2017 budget estimate..................................       179,447,000
Provided in the bill..................................       168,524,000
Comparison:
    2016 appropriation................................       +17,700,000
    2017 budget estimate..............................       -10,923,000
 

                          COMMITTEE PROVISIONS

    For Nutrition Programs Administration, the Committee 
provides $168,524,000. This funding level includes $1,000,000 
for FNS to contract for an independent study to identify the 
best means of efficiently consolidating Child Nutrition Program 
reporting requirements for school food authorities and state 
agencies. The Committee expects the study to be completed no 
later than 18 months from the date of enactment of this Act.

                                TITLE V


                FOREIGN ASSISTANCE AND RELATED PROGRAMS


                      Foreign Agricultural Service


                         SALARIES AND EXPENSES

                     (INCLUDING TRANSFERS OF FUNDS)

----------------------------------------------------------------------------------------------------------------
                                                                              Transfer from
                                                           Appropriation       export loan           Total
                                                                                 account
----------------------------------------------------------------------------------------------------------------
2016 appropriation.....................................       $191,566,000         $6,394,000       $197,960,000
2017 budget estimate...................................        196,571,000          6,074,000        202,645,000
Provided in the Bill...................................        194,566,000          6,074,000        200,640,000
Comparison:
    2016 appropriation.................................         +3,000,000           -320,000         +2,680,000
    2017 budget estimate...............................        -$2,005,000             $- - -        -$2,005,000
----------------------------------------------------------------------------------------------------------------

                          COMMITTEE PROVISIONS

    For the Foreign Agricultural Service, the Committee 
provides an appropriation of $194,566,000 and transfer of 
$6,074,000, for a total appropriation of $200,640,000.
    This amount includes a $3,000,000 increase above estimated 
amounts specifically for the Country Strategy Support Fund. 
This should be specifically targeted to increase U.S. exports 
and remove existing trade barriers.
    Farmer-to-Farmer.--The Farmer-to-Farmer program provides 
valuable outreach opportunities for U.S. agricultural exports. 
The program enhances agricultural efforts overseas and 
strengthens international ties. USDA should take a lead role in 
promoting and administering the program.

  Food for Peace Title I Direct Credit and Food for Progress Program 
                                Account


                     (INCLUDING TRANSFER OF FUNDS)

 
 
 
2016 appropriation....................................        $2,528,000
2017 budget estimate..................................           149,000
Provided in the bill..................................           149,000
Comparison:
    2016 appropriation................................        -2,379,000
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For administrative expenses to carry out the credit program 
of Food for Peace Title I, Food for Peace Act, and the Food for 
Progress Act, the Committee provides an appropriation of 
$149,000.

                     Food for Peace Title II Grants


 
 
 
2016 appropriation....................................    $1,466,000,000
2017 budget estimate..................................     1,350,000,000
Provided in the bill..................................     1,466,000,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................      +116,000,000
 

                          COMMITTEE PROVISIONS

    For Food for Peace Title II grants, the Committee provides 
$1,466,000,000, of which $350,000,000 is for non-emergency 
assistance. This is $116,000,000 above the President's request 
and includes statutory language that requires the U.S. Agency 
for International Development (USAID) to meet the level for 
non-emergency assistance using the funds appropriated for the 
Food for Peace Act (FFPA).
    Food Aid Funding and Reform.--The Committee provides 
$116,000,000 in funding above the President's budget request 
level. The Committee is concerned that U.S. commodity purchases 
and maritime sealift capabilities have been significantly 
reduced due to reforms and circumvention of the spirit of the 
FFPA. This lack of participation by key stakeholder and 
constituency groups has resulted in decreased demand and 
support for the Title II program as reflected in the levels 
proposed in the President's budget request for the past two 
years, the most recent of which is $116,000,000 below the 
fiscal year 2016 enacted level.
    In fiscal year 2014, approximately 15 percent, or 
$210,000,000, was spent on local and regional purchases, 
vouchers, cash and other delivery methods under reforms enacted 
in the 2014 farm bill and the Community Development Fund (CDF). 
These reforms have reduced the amount of U.S commodities since 
fiscal year 2011 from 45 percent to 25 percent of the program, 
while Internal Transportation, Storage, and Handling (ITSH) 
costs have increased by a similar amount.
    The Committee is concerned that no data has shown that the 
enactment of these reforms has produced increased feeding of 
beneficiaries and quicker food aid delivery as promised. These 
reforms have only resulted in decreased support and proposed 
funding for the program. USAID's IG audit report 7-962-16-003-P 
examined $23,000,000 in cash and voucher transfers under the 
Office of Food for Peace. The report found that ``None of the 
implementers completed distributions on time, the average delay 
being 3 months.'' In addition, one implementer predicted being 
able to feed 20,000 beneficiaries, but 6 months past the target 
date, had only reached approximately 6,000. This data is 
disturbing and significantly undermines the claims of benefits 
that would be achieved through the farm bill reforms and 
further changes proposed by the President's budget.
    Nonemergency Assistance.--In a recent legal opinion, GAO 
determined that ``USAID only obligated $261.6 million of the 
appropriation for nonemergency food assistance'' out of the 
$350 million required by the FFPA. While the Committee 
acknowledges that USAID was able to waive this level legally 
through ``notwithstanding'' authority in the FFPA for emergency 
funding purposes, the 2014 farm bill excluded the authority for 
USAID to waive the level for nonemergency assistance. 
Therefore, the Committee does not include the new bill language 
requested by USAID to credit funding from the CDF to the FFPA 
for nonemergency assistance. Instead, the Committee includes 
statutory language requiring USAID to meet the nonemergency 
assistance level for FY 2017 as intended by Congress. The 
Committee notes that USAID has access to the Bill Emerson 
Humanitarian Trust (BEHT) for emergency purposes, for which the 
Committee provided additional funding in FY 2016. USAID 
requested use of emergency funds from the BEHT as recently as 
2014 when USDA released $50 million from the BEHT to procure an 
estimated 67,400 metric tons of commodities, and this action 
was further supported by an additional $130 million from USDA's 
CCC for associated costs, including transportation and 
distribution.
    CCC Financial Statements.--The Committee directs the 
Department and USAID to address issues arising from 
deficiencies identified in USDA's delayed financial statements 
and the parent-child relationship between USDA and USAID. The 
Committee further directs both agencies to continue to update 
and ratify a written agreement that clearly defines roles and 
responsibilities for carrying out the Food for Peace Title II 
program.
    ITSH Costs.--The Committee directs the Department and USAID 
to provide a clear definition of these costs, how they are 
incurred, and how they differ from Inland Freight Costs. The 
Committee is concerned that these costs have increased 
significantly in recent years and seeks to understand the 
causes. The Committee also directs USAID to identify whether 
local and regional purchases, cash, and vouchers are counted as 
a part of these costs. USAID is directed to provide this 
information within 60 days of enactment of this Act.
    Central American Food Assistance.--The Administrator of 
USAID is directed to provide a report within 90 days of 
enactment of this Act on the amounts and types of food aid to 
Honduras, Guatemala, and El Salvador.

  MCGOVERN-DOLE INTERNATIONAL FOOD FOR EDUCATION AND CHILD NUTRITION 
                             PROGRAM GRANTS

 
 
 
2016 appropriation....................................      $201,626,000
2017 budget estimate..................................       182,045,000
Provided in the bill..................................       201,626,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................       +19,581,000
 

                          COMMITTEE PROVISIONS

    For McGovern-Dole International Food for Education and 
Child Nutrition Program Grants, the Committee provides an 
appropriation of $201,626,000.

              COMMODITY CREDIT CORPORATION EXPORT (LOANS)

                    CREDIT GUARANTEE PROGRAM ACCOUNT

                     (INCLUDING TRANSFERS OF FUNDS)

 
 
 
2016 appropriation....................................        $6,748,000
2017 budget estimate..................................         8,537,000
Provided in the bill..................................         8,537,000
Comparison:
    2016 appropriation................................        +1,789,000
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For administrative expenses of the Commodity Credit 
Corporation Export Loans Credit Guarantee Program Account, the 
Committee provides an appropriation of $8,537,000.

                                TITLE VI


           RELATED AGENCIES AND FOOD AND DRUG ADMINISTRATION


                DEPARTMENT OF HEALTH AND HUMAN SERVICES


                      Food and Drug Administration


                         SALARIES AND EXPENSES

                         [Dollars in Thousands]
------------------------------------------------------------------------
                                                             Total, FDA
                               Appropriation    User Fees        S&E;
------------------------------------------------------------------------
2016 appropriation...........     $2,720,808    $1,960,584    $4,681,392
2017 budget estimate.........      2,730,924     2,025,020     4,755,944
Provided in the bill.........      2,753,855     2,025,020     4,778,875
Comparison:
    2016 appropriation.......        +33,047       +64,436       +97,483
    2017 budget estimate.....       +$22,931        $- - -      +$22,931
------------------------------------------------------------------------

    The Committee provides an appropriation of $2,753,855,000 
in new budget authority for the FDA. In addition, the Committee 
recommends the following user fee amounts: $865,653,000--
prescription drugs; $144,859,000--medical devices; 
$324,085,000--human generic drugs; $22,079,000--biosimilar 
biologicals; $22,977,000--animal drugs; $10,367,000--animal 
generic drugs; $635,000,000--tobacco products; estimated 
$21,000,000--mammography quality standards; estimated 
$1,000,000--food and feed recalls; estimated $6,000,000--food 
reinspection; and, estimated $5,000,000--voluntary qualified 
importers. The combination of new budget authority and definite 
user fees provides the FDA with a total discretionary salaries 
and expenses level of $4,778,875,000. This total does not 
include permanent, indefinite user fees for mammography, 
pharmacy compounding, export, and color certification.
    The Committee recommendation does not include proposed user 
fees for Export and Color Certification, Food Facility 
Registration and Inspection, Food Import, International 
Courier, Cosmetics, or Food Contact Notification.
    The Committee does not include funding for a civilian pay 
increase across the agency. Should the President provide a 
civilian pay increase for fiscal year 2017, it is assumed that 
the cost of such a pay increase will be absorbed within 
existing appropriations for fiscal year 2017.
    The Committee recommendation maintains fiscal year 2016 
funding levels for the medical countermeasures initiative as 
well as recent funding increases for antimicrobial resistance, 
counterfeit drugs, food safety, foreign drug inspections, 
import safety, and pharmacy compounding.
    Funding for Food Safety.--The Committee includes increases 
of $33,152,000 for the implementation of FSMA. These increases 
include $19,139,000 for the National Integrated Food Safety 
System (NIFSS) and $14,013,000 for Import Safety. The increases 
provided in this bill and the increases provided since fiscal 
year 2011 should assist the FDA in preparation for the 
implementation of FSMA prior to the effective dates of the 
seven foundational proposed rules. While the FDA has not 
implemented the final rules, the Committee understands that 
most businesses will not need to comply with the two rules for 
preventive controls for human food and for animal food until 
August 2016 and that the other five rules will not be effective 
until fiscal year 2017 and later. Within the amount provided 
for NIFSS, the Committee includes $5,000,000 to allow for the 
development of a data exchange to maximize standardization and 
access to farm data across FDA and States.
    The Committee notes that with these increases, the 
estimated total funding for food safety since FSMA was signed 
into law on January 4, 2011, would be nearly $340,000,000. In 
addition to the increases for FSMA, the FDA utilizes base 
resources for its comprehensive food safety efforts. The 
Committee directs the FDA to provide a detailed accounting of 
its food safety resources in the fiscal year 2018 budget 
request, including which pre-2011 base resources are now 
repurposed for activities in support of FSMA and which 
resources are the result of appropriated increases from fiscal 
years 2011 to 2017, a detailed explanation of what the FDA has 
accomplished with increased food safety resources since fiscal 
year 2011, and how the aggregate total of these base resources 
for food safety will be utilized in fiscal year 2017.
    Medical Product Safety Funding.--The Committee provides an 
increase of $9,411,000 for medical product safety initiatives. 
Included in this amount is $2,911,000 for the Animal Drug and 
Medical Device Review; $2,000,000 for the Precision Medicine 
initiative, and $2,500,000 for the Pediatric Device Consortia 
Grant Program. According to the FDA's fiscal year 2017 budget 
request, the agency is spending approximately $41,700,000 on 
antimicrobial resistance activities in fiscal year 2016. In 
addition, the Committee provides an additional $2,000,000 for 
Orphan Product Grants as a result of administrative savings 
from the Office of the Commissioner.
    Foreign High Risk Inspections.--The bill provides an 
additional $2,500,000 and a total of $7,500,000 for the FDA's 
Office of Global Regulatory Operations and Policy to enhance 
the compliance of foreign manufacturers and exporters of food, 
medical devices and pharmaceuticals through on-site 
verification.
    Animal Drug Compounding.--The Committee is concerned that 
the FDA has proposed draft guidance for industry (#230) for 
animal drug compounding that applies Sections 503A and 503B of 
the FDCA to animal health even though these provisions were 
written in regard to compounding of human drugs. The Committee 
is concerned that this will result in confusion in the industry 
and may result in a misallocation of the resources Congress 
makes available to the FDA to oversee compounding activities. 
The Committee expects that any final guidance on animal drug 
compounding will reference statutory provisions that 
specifically relate to veterinary practices.
    Antibiotics.--The Committee urges the FDA to work to foster 
the development of new antibiotics by supporting greater 
collaboration between industry and the FDA around adaptive 
clinical trials and labeling changes. The President's Council 
of Advisors on Science and Technology has recommended this 
proposal to help support the type of robust drug development 
that will be needed to ensure patients are protected from 
bacterial resistance.
    Biological Products.--The Committee commends the FDA for 
issuing draft guidance to address the mixing, diluting, or 
repackaging of biological products outside the scope of an 
approved biologics license application. The Committee urges the 
FDA to finalize the guidance without delay following the public 
comment period and continues to emphasize the need for close 
FDA inspection and supervision of large-scale compounding and 
repackaging of sterile injectable drugs and biological 
products, particularly products that are administered into 
areas of the human body where there is tempered immunity, such 
as the eye or spinal column, to ensure that they are processed 
in keeping with current good manufacturing practice for sterile 
products, in particular 21 CFR 200.50 regarding ophthalmic 
preparations.
    Biosimilars.--The Committee recognizes that biosimilars 
offer an important opportunity for expanding the market and 
reducing costs for patients. The Committee urges the FDA to 
partner with external stakeholders including patient 
organizations on educating patients and professionals about 
biosimilars, with a focus on populations for which approved 
biosimilars are indicated.
    Blood Donor Policies.--The Committee commends the FDA on 
updating their blood donor policy in the December 2015 Guidance 
to Industry from a lifetime ban to a one year deferral, however 
it continues to encourage a permanent policy change based on 
scientifically supported risk factors and not time passed. The 
Committee remains concerned that certain questions on the FDA 
blood donor questionnaire are outdated and discriminatory. This 
questionnaire should not ask about sexual orientation, rather 
it should assess risk factors that might expose a potential 
blood donor to blood-borne illness. The Committee encourages 
FDA to find an adequate replacement question for the blood 
donor questionnaire that is cognitively appropriate and will 
maintain a safe donor pool without discrimination.
    Centers of Excellence.--The Committee is encouraged by the 
ongoing research and collaboration underway at the Centers of 
Excellence in Regulatory Science and Innovation (CERSI) 
program. The Committee believes that these programs will help 
the agency improve public health, address scientific challenges 
presented by revolutions in medical product development, and 
improve food safety and quality. The Committee commends the 
agency for launching this program in 2011 and expanding it in 
2014. For this reason, the Committee believes that the agency 
should continue to invest in the existing four locations in the 
CERSI network at their original funding level to ensure their 
efficacy and to capitalize on existing studies.
    Compassionate Use.--The Committee is aware of GAO's current 
plans to conduct a review of the FDA's work with patient 
stakeholder groups as it relates to Expanded Access or 
Compassionate Use of human drugs. The Committee encourages the 
FDA to work with GAO in order to provide them with all the 
necessary information they need to complete their review of the 
program.
    Continued FDA Approval of Drug Safety Labeling.--The 
Committee is deeply concerned with the FDA's failure to resolve 
issues with and finalize its proposed rule entitled 
``Supplemental Applications Proposing Labeling Changes for 
Approved Drugs and Biological Products.'' The proposed rule, as 
currently drafted, has the potential to threaten public health 
and create unprecedented patient and provider confusion by 
allowing multiple versions of safety labeling for the same 
bioequivalent product. The Committee urges the FDA to establish 
in the final rule a system where safety information in 
prescription drug labeling in a multisource environment (i.e., 
when there is both an innovator and a generic manufacturer or 
more than one generic manufacturer) is always FDA-approved, 
grounded in scientific evidence, and presents no opportunity 
for mismatched safety information between the innovator and 
generic versions of a drug. The FDA should be the final 
decision maker regarding whether a manufacturer should change 
its labeling in a multisource environment. The FDA is the only 
entity that possesses all of the clinical trial, safety, and 
post-marketing data submitted by all manufacturers. Only the 
agency has all of the necessary tools to make an informed 
decision when it comes to making safety labeling changes, and, 
as a result, consistent with the FDA's responsibility to 
approve drug applications and labeling prior to marketing, only 
the FDA should determine whether a safety labeling change 
should occur.
    Crop Biotechnology & Biotech Ingredients.--Plants, food, 
and food ingredients developed using genetic engineering were 
introduced into the U.S. food supply in the 1990s. Public and 
private sector scientists knowledgeable in genetic engineering, 
toxicology, chemistry, nutrition, and other scientific areas 
have carefully evaluated and assessed the safety of these 
products and have determined that such products are safe for 
human and animal consumption. The Committee provides a total of 
$3,000,000 for the FDA to coordinate with USDA to provide 
education and outreach to the public on the safety and benefits 
of crop biotechnology and food and animal feed ingredients 
derived from biotechnology. The Committee expects this 
educational information to be posted on both agency websites 
and through other social media and communications platforms 
within 60 days of enactment of this Act.
    Date Labels on Food.--The Committee is concerned by the 
amount of food waste resulting from consumer confusion around 
date labels on food. The Committee notes that there is 
currently no federal uniform system for food date labels, which 
are currently determined by the food company to indicate 
quality rather than the safety of the food. The Committee urges 
FDA to study current and potential date labeling language and 
formats to determine what language and/or format is most 
effective in reducing consumer confusion and communicate such 
voluntary options to food producers.
    Drug Compounding.--The Committee believes patient access to 
the right drug at the right time is of utmost importance. In 
instances where a commercially manufactured drug is not 
appropriate for a patient for a specific reason, a compounded 
drug may be the difference between life and death. Since 
passage of the Drug Quality and Security Act (DQSA) of 2013, 
the Committee has had concerns that the FDA interpreted 
provisions of Section 503A of the FDCA in a manner that might 
jeopardize the availability of compounded medications for 
``office use''. The practice of ``office use'' occurs when a 
compounder will compound a batch of drugs in anticipation of 
receiving patient-specific prescriptions at a later time. It 
may also be the case of a doctor in his or her office 
maintaining compounded drugs on site because it is unsafe or 
impractical to issue a traditional prescription. This practice 
is authorized in the vast majority of states and was intended 
to be allowable under DQSA. The Committee is aware that on 
April 15, 2016, FDA released a new Draft Guidance on the issue 
of ``office-use'' compounding. The Committee directs the FDA to 
issue a Final Guidance that provides for ``office-use'' 
compounding of drugs, in appropriate circumstances as well as 
including drugs compounded in anticipation of a prescription 
for an identified individual patient. Such ``anticipatory'' 
compounded drugs must be based on the history of previous valid 
compound prescription orders, and on an established history 
between the prescriber and the patient and the compounder.
    Drug Compounding Inspections.--The Committee understands 
that the FDA is interpreting provisions of Section 503A of the 
FDCA to inspect state-licensed compounding pharmacies under 
current Good Manufacturing Practices (cGMPs) instead of under 
the standards contained in the United States Pharmacopeial 
Convention (USP) for sterile and non-sterile pharmaceutical 
compounding or other applicable pharmacy inspection standards 
adopted by state law or regulation. The Committee reminds the 
FDA that compounding pharmacies are not drug manufacturers, but 
rather, are state licensed and regulated health care providers 
that are inspected by state boards of pharmacy pursuant to 
state laws and regulations that establish sterility and other 
standards for the pharmacies operating within their states. 
Compounding pharmacies are more appropriately inspected using 
USP standards or other pharmacy inspection standards adopted by 
state law or regulation in the state in which a pharmacy is 
licensed.
    Drug Compounding of Allergen Extracts.--The Committee is 
concerned that proposed changes to general chapter 797 of the 
USP contradicts the legislative intent of Section 503A of DQSA 
regarding the practice of ``office-use'' compounding of 
allergen extracts. The FDA recognizes USP general chapter 797 
as federal policy on the practice of drug compounding. The 
Committee is concerned that the proposed changes to USP general 
chapter 797 would be inconsistent with its legislative intent 
of Section 503A and with the agency's own previous positions on 
the practice of office-use compounding of allergen extracts. It 
is the sense of the committee that the practice of office-use 
compounding of allergen extracts by physicians is proven to be 
both safe and effective for the diagnosis and treatment of 
allergic conditions. The Committee suggests that the USP work 
with organizations from the physician and patient communities 
that represent physicians who regularly engage in office-use 
compounding of allergen extracts or patients who benefit from 
such compounding of allergen extracts, to ensure that any 
changes to USP general chapter 797 regarding office-use 
compounding of allergen extracts are reflective of the clear 
legislative intent of Section 503A of the DQSA.
    Duchenne Muscular Dystrophy.--The Committee is encouraged 
that the FDA has the tools, authorities, and latitude necessary 
to review and approve safe and effective treatments for rare 
diseases, such as Duchenne Muscular Dystrophy, as efficiently 
as possible. In particular, the Committee is aware that the use 
of intermediate clinical endpoints (ICE) may be an appropriate 
approach as it has been in similar deadly diseases with dire 
unmet needs, such as HIV and cancer.
    Emerging Public Health Threat Funding.--In order for the 
FDA to mount as rapid a response as possible to the spread of 
the Zika virus, the Committee reinforces its position that the 
agency obligate unobligated Ebola funds for the higher threat 
of Zika. The legislative text of the fiscal year 2015 emergency 
supplemental provided the FDA with such flexibility to deal 
with future public health emergencies such as those threats 
associated with the Zika viruses. Due to ongoing threats, the 
bill includes an appropriation of $10,000,000 to support needs 
related to work on Ebola and Zika, such as support for FDA 
staff conducting ongoing response activities; support for 
regulatory science research to develop the tools, standards, 
and approaches to characterize investigational medical product 
safety, efficacy, quality, and performance; and support to 
expedite the development and availability of medical products 
for Ebola and Zika.
    FDA and Centers for Medicare and Medicaid Services (CMS) 
Parallel Review Pilot.--The Committee directs the FDA to 
provide a report within 60 days of enactment of this Act on 
whether it plans to once again extend the pilot and steps the 
agency will take to encourage more manufacturers to utilize the 
pilot, including considerations for manufacturers choosing the 
510(k) approval pathway and for novel products deemed covered 
by CMS but that warrant evaluation to ensure the appropriate 
level of coverage. The Committee also directs the FDA to report 
on efforts to work with CMS to balance each agency's 
evidentiary needs with the burden on manufacturers, including 
the consideration and use of alternative trial designs.
    FDA Partnerships under FSMA.--The purpose of FSMA is to 
reform the nation's food safety laws to ensure a safe public 
food supply. As the FDA continues implementation of FSMA, the 
Committee encourages the FDA to work in partnership with 
existing government food safety programs, including the use of 
MOUs, to verify compliance with FSMA rules once they are 
finalized as a way to eliminate duplication of activities under 
the law. In addition, the Committee continues to provide 
$5,000,000 for the Food Safety Outreach Program under NIFA and 
expects that NIFA will serve as the sole agency providing food 
safety training, education, outreach, and technical assistance 
at the farm level.
    Federal Employee Conduct.--The federal government grants 
federal employees with tremendous responsibility and trust to 
carry out their duties. They must do so free from conflicts of 
interest and without seeking private gain. Employees are public 
servants charged with implementing federal programs in a legal 
and ethical manner. Federal employees are reminded that they 
shall not advance a personal agenda or give preferential 
treatment to any outside organization or individual within 
government programs in which they administer. Information that 
is received by the employee, including information from the 
employees, offices, or Committees of the Congress of the United 
States, should be handled in a professional and confidential 
manner according to the federal government's code of conduct, 
standards, regulations, and statutes. The Committee is aware of 
recent conduct in violation of these principles, and the 
Committee believes that it is incumbent upon agency officials 
to take immediate disciplinary action when they confirm such 
behavior.
    Food Contact Notification User Fees.--The funds made 
available by this Act include sufficient monies to fund the 
FDA's Food Contact Notification Program and shall be deemed to 
satisfy the requirements of 21 U.S.C. 348(h)(5)(A). The 
Committee recommendation does not include proposed user fees.
    Genomic Editing.--The Committee understands the potential 
benefits to society in the genetic modification of living 
organisms. However, researchers do not yet fully understand all 
the possible side effects of editing the genes of a human 
embryo. Editing of the human germ line may involve serious and 
unquantifiable safety and ethical issues. Federal and non-
federal organizations such as the National Academy of Sciences 
and National Academy of Medicine continue to understand the 
potential risks of genome editing and a broader public 
discussion of the societal and ethical implications of this 
technique is still ongoing. In accordance with the current 
policy at the National Institutes of Health, the Committee 
includes bill language that places a prohibition on the FDA's 
use of funds involving the genetic modification of a human 
embryo. The Committee continues to support a wide range of 
innovations in biomedical research, but will do so in a fashion 
that reflects well-established scientific and ethical 
principles.
    Harm Reduction.--It is the Committee recommendation that 
the FDA consider the benefits of harm reduction as part of 
evaluations under the Deeming regulations for tobacco products.
    Indoor Tanning Devices.--Last December, the FDA proposed 
two rules intended to prevent the use of sunlamp products, 
including tanning beds, by certain age groups, reduce the risks 
for adults using these devices, and require manufacturers to 
take additional safety precautions. While the Committee remains 
deeply concerned with the deadly threat of melanoma, it 
questions some elements of the proposed rules. In particular, 
the Committee requests that the FDA hold a meeting with 
industry officials as it begins to consider the final 
regulations to discuss such issues as the number of allowable 
visits by adults and other similar measures that could create 
an undue economic burden on the industry.
    Late Reports.--The Committee reminds the Commissioner that 
the timelines specified by the Committees on Appropriations of 
the House and Senate for fiscal year 2016 reports are deadlines 
that must be met. While the Committee notes that the FDA has 
made progress in providing more timely information and updates, 
the FDA still has several outstanding reports that are delayed 
due to long reviews and clearances. The Committee directs the 
Commissioner to submit these overdue reports.
    Local Port Cooperation.--The Committee directs the FDA to 
work with local governments at high volume ports of entry to 
explore activities which reduce the risk of food borne 
illnesses and enhance the capacity of local officials in 
dealing with food borne threats.
    Mammography Exam Reports.--More than four years ago, in 
November 2011, the National Mammography Quality Assurance 
Advisory Committee approved a change to the mammogram patient 
report and physician report to include information regarding an 
individual's breast density. This process has not been 
completed. The Committee urges the FDA to implement this change 
in an expedited manner and must report to Congress on the 
status of this change no more than 60 days from the enactment 
of this Act.
    Medical Countermeasures.--The Committee directs that not 
less than $24,552,000 shall be available for the FDA's Medical 
Countermeasures Initiative. This total is in addition to the 
unobligated funds remaining to support the FDA's emergency 
response to Ebola and related disease outbreaks.
    Medical Gas Rulemaking.--The Committee is significantly 
concerned that the FDA has not initiated rulemaking to address 
numerous longstanding regulatory issues for medical gases 
despite the statutory requirement in the Food and Drug 
Administration Safety and Innovation Act (FDASIA) to issue a 
final rulemaking addressing all necessary changes for medical 
gases by July 9, 2016. In fact, the FDA rulemaking on medical 
gases is not even listed in the most recent Unified Agenda as a 
priority. Designated medical gases are a unique class of drugs 
that differ significantly from traditional pharmaceuticals and 
therefore must be addressed in the federal drug regulations to 
prevent safety and enforcement issues caused by current 
regulations. The Committee disagrees with the FDA report to 
Congress sent on June 30, 2015, which stated that, despite 
decades of issues created by existing regulations, ``the 
current regulatory framework is adequate and sufficiently 
flexible to appropriately regulate medical gases.'' The bill 
includes language requiring the FDA to issue final regulations 
revising the federal drug regulations with respect to medical 
gases not later than July 9, 2016. If the Commissioner fails to 
issue final regulations with respect to medical gases by the 
statutory deadline, the Commissioner shall incorporate by 
reference voluntary consensus safety and labeling standards 
developed by an ANSI-accredited standard development 
organization until such time as the Commissioner issues final 
regulations consistent with Section 1112 of Public Law 112-144.
    Laboratories Near High Volume Ports.--The Committee directs 
the FDA to submit a report within 90 days of enactment of this 
Act on the potential for implementing pilot programs which will 
allow for public-private partnerships at high volume ports of 
entry in an effort to increase the number of FDA-certified 
public or private labs located near major ports of entry to 
provide services on weekends and holidays, reduce the risk of 
food borne illnesses, and enhance the capacity of local 
officials in dealing with foodborne threats.
    Laboratory Developed Tests.--The FDA's draft guidance 
issued on October 3, 2014, titled ``Framework for Regulatory 
Oversight of Laboratory Developed Tests'' (LDTs), puts forth a 
proposed regulatory framework that is a significant shift in 
the way LDTs are regulated. Such a shift deserves input from 
the public, and Congress has been working with stakeholders, 
constituencies, and the FDA to find common ground on regulating 
LDTs. The FDA's guidance circumvents the normal rulemaking 
process and changes expectations for patients, doctors, and 
laboratories for the first time since the Clinical Laboratory 
Improvement Amendments Act was passed in 1988. The Committee 
directs the FDA to suspend further efforts to finalize the LDT 
guidance and continue working with Congress to pass legislation 
that addresses a new pathway for regulation of LDTs in a 
transparent manner.
    Medical Device Facility Inspections.--The Committee is 
concerned about the lack of transparency and consistency with 
the medical device facility inspection process. This often 
leads to inefficiencies and inconsistencies in the inspection 
process. The Committee urges the agency to work with 
stakeholders and Congress to improve the facility inspection 
process. Potential process improvements may include, but are 
not necessarily limited to, more timely and frequent 
communications related to inspection observations and 
remediation plans, as well as changes to the way medical device 
Export Certificates (e.g., Certificate to Foreign Government, 
etc.) are affected by FDA Observational Findings following a 
facility inspection. In addition, the agency shall produce a 
report to the Committee by September 30, 2016, which provides 
information on the rates of inspection for facilities across 
districts and internationally and any FDA efforts to 
standardize rates of inspections across districts and 
internationally. The Committee understands that five days is 
typically sufficient for the FDA to complete an overseas 
inspection and determine the suitability of the location to 
provide product into the U.S. market while inspections inside 
the U.S. can take several weeks or months to complete the same 
assessment. These discrepancies lead to variations in 
inspection standards and potentially competitive advantages for 
those who choose to manufacture outside the U.S.
    Menu Labeling.--The Committee is concerned about the recent 
FDA final determination that increased the size and scope of 
those affected under restaurant menu labeling regulations. 
Specifically, the final rule attempts to regulate local grocery 
chains that typically do not qualify as restaurants. The 
Committee includes bill language which directs the FDA to 
implement the final rule no earlier than December 1, 2016, at 
least one-year following agency publication of related guidance 
to newly regulated stakeholders.
    Nanotechnology.--The Committee recognizes the increased 
capabilities that the FDA has developed to study environment, 
health, and safety of nanomaterials within the FDA's Jefferson 
Laboratory Campus, including the National Center for 
Toxicological Research, and its consolidated headquarters at 
White Oak, Maryland. The Committee recommends continued 
collaborative research with universities and industry on the 
toxicology of nanotechnology products and processes, in 
accordance with the National Nanotechnology Initiative 
Environment, Health, and Safety Research Strategy as updated in 
October 2011.
    Nutrient Content Claims.--The Committee expects the FDA to 
amend its ``healthy'' nutrient content claim regulation to be 
based upon significant scientific agreement. In addition, to 
ensure that food producers can make truthful and non-misleading 
statements about the healthfulness of products, the Committee 
directs the FDA to make such regulatory changes during the 
rulemaking process and issue guidance to industry no more than 
six months after the enactment of this Act providing for the 
use of the word ``healthy'' in food labeling statements.
    Nutrition Facts Label.--The Committee is concerned that 
proposed rules that have been issued to revise the Nutrition 
and Supplemental Facts labels may create confusion and 
misinformation among consumers. The FDA is encouraged to 
determine how the proposed new label disclosure statements 
regarding added sugars would be understood and interpreted by 
consumers before proceeding with a final rule. Additionally, 
the FDA should evaluate the consumer perception and impact on 
healthful nutrient dense foods that use added sugar to make the 
food more palatable.
    Office of Cosmetics and Colors.--The Committee 
recommendation includes not less than $11,700,000 for cosmetics 
activities, including not less than $7,200,000 for the Office 
of Cosmetics and Colors (OCAC) and other supporting offices 
within the Center for Food Safety and Applied Nutrition 
(CFSAN). Funding provided for CFSAN is for direct support of 
operation, staffing, compliance, research and international 
activities. The Committee notes that every year since fiscal 
year 2012 it has requested that OCAC respond to a citizen 
petition setting safety levels for trace amounts of lead in 
cosmetics. The Committee is disappointed that OCAC has not 
responded to these requests and urges OCAC to make this a 
priority. Therefore, the Committee directs OCAC to respond to 
the petition by September 15, 2016.
    The Committee appreciates OCAC's willingness to engage with 
China in 2016 for a cosmetics regulatory dialogue. In light of 
China's importance to U.S.-based manufacturers and consumers, 
the Committee directs the FDA to seek ways to continually 
enhance engagement with Chinese regulators on cosmetic 
technical and regulatory issues. The Committee directs the FDA 
to promote international regulatory harmonization and trade in 
cosmetic products by supporting international trade 
negotiations on cosmetics in the Transatlantic Trade and 
Investment Partnership, the International Cooperation on 
Cosmetics Regulation (ICCR), and other bilateral and 
multilateral trade agreements.
    Olive Oil.--The Committee is concerned with reports that 
consistently describe the prevalence of adulterated and 
fraudulently labeled olive oil imported into the United States 
and sold to American consumers. In addition, some products 
labeled as olive oil may contain seed oil, which poses a 
serious health risk to consumers who are allergic to seed oil. 
The Committee directs the FDA to take a sampling of imported 
olive oil to determine if it is adulterated or misbranded, 
pursuant to Section 342 or Section 343 of the FDCA, 
respectively, and report to Congress within 270 days on its 
findings and what actions the FDA will take to ensure consumer 
safety and proper labeling of imported olive oil.
    Opioid Abuse.--The abuse, misuse and diversion of opioid 
painkillers has precipitated an epidemic in the United States. 
The CDC indicates that one American loses his or her battle 
with addiction every twenty minutes. For years, the Committee 
has encouraged the FDA to utilize the full breadth of its 
regulatory authority to address this challenge. The Committee 
is pleased that, with the Opioids Action Plan, the FDA has 
acknowledged that the agency shoulders some responsibility for 
turning the tide of abuse. The FDA's recent regulatory changes 
related to scheduling and labeling of opioids are positive 
developments, as are efforts to encourage the development of 
abuse-deterrent formulations (ADF) and new evidence-based 
medication-assisted therapies (MAT).
    The use of opioids as first-line therapies for any form of 
pain has led to over-prescribing, and the CDC has made clear 
that clinicians should consider opioid therapy only if expected 
benefits for both pain and function are anticipated to outweigh 
the risks to the patient. With respect to prescribing patterns, 
the Committee supports efforts to incentivize ADF use by 
clinicians and to increase the number of prescribers who 
receive training on pain management and safe prescribing of 
opioid drugs in order to decrease inappropriate opioid 
prescribing. The Committee notes that 38,370 Extended Release/
Long-Acting (ER/LA) opioid analgesic prescribers have been 
trained through the FDA's Risk Evaluation and Mitigation 
Strategy (REMS), but is disappointed that this constitutes less 
than half of the 80,000 prescriber training goal that was 
established in 2012. Even if the FDA was on track to meet its 
lofty goal of having 60 percent of ER/LA prescribed take a REMS 
class by 2017, there will still be some 128,000 prescribers 
without additional, opioid-specific training. The Committee 
understands that FDA intends to share these lackluster results 
with an advisory committee to assess its impact on preventing 
the misuse and abuse of opioids, and to determine what changes, 
if any, need to be made to the program.
    The Committee notes that treatment is not a ``one size, 
fits all'' enterprise and that every patient's treatment 
regimen should be tailored by his or her doctor to his or her 
unique needs. The federal government, therefore, ought to be 
promoting the full suite of available treatment options--
including abstinence-based models and non-opioid medications--
rather than picking winners and losers. The Committee supports 
efforts at the FDA and elsewhere to develop MATs that improve 
efficacy of daily administration, are resistant to diversion 
and misuse, and/or help patients on a path to abstinence. 
Finally, the Committee has been supportive of naloxone 
distribution and training licensed healthcare professionals and 
emergency responders on its use. When considering the 
appropriateness of providing naloxone over the counter, the 
Committee asks the FDA to ensure that the administration of 
naloxone serves as a point of intervention to spur an honest 
conversation between the patient and his doctor about addiction 
and treatment.
    Over-the-Counter (OTC) Monograph Resources.--The Committee 
understands that, over the past few years, funding allocated to 
OTC monograph issues has declined, in part due to stagnation in 
rulemaking and timely responses to Citizen Petitions related to 
OTC Monograph ingredients. The FDA is directed to provide an 
exhibit within the fiscal year 2018 budget justification with 
the total obligations and staffing levels associated with OTC 
Monograph issues for the past 11 years (fiscal years 2006-
2016). In addition, the FDA is directed to develop detailed 
justifications and supporting documentation if the agency 
proposes to increase funding or staffing levels with regard to 
reforms of the OTC process in future budget submissions.
    Packaged Ice.--The Committee recognizes that packaged ice 
is produced in the U.S., traded internationally, and consumed 
as both a packaged food and a food ingredient. The FDA has had 
a citizen petition regarding a proposed standard of identity 
for packaged ice for a significant and unacceptable length of 
time and is directed to provide quarterly status reports to the 
Committee on this effort until a response has been provided. 
Further, the Conference for Food Protection recently reviewed 
issues related to commercial ice machines in the retail 
environment and found that research is needed to identify the 
type of microbial growth and locations of concern within these 
machines. Therefore, the FDA is directed to research the issue 
more carefully and establish a cleaning and sanitizing 
frequency standard for commercial ice machines.
    Pediatric Devices.--The Committee applauds the FDA's 
support of development of pediatric medical devices through the 
Pediatric Device Consortia and notes the significant investment 
of more than $65,000,000 in non-FDA funding that consortia 
members have raised to advance pediatric device projects. The 
program funds consortia to assist innovators in developing 
medical and surgical devices designed for the unique needs of 
children that often go unmet by devices currently available on 
the market. The Committee provides an increase of $2,500,000 in 
fiscal year 2017 for the consortium to better leverage federal 
investments and move more devices to the market. The Committee 
directs that the agency spend no less than $6,000,000 in order 
to attract additional funds for these vital projects.
    Pet Food Imports.--As of September 2014, the FDA has 
received more than 5,800 complaints of illness related to 
consumption of chicken, duck, or sweet potato jerky treats, 
nearly all of which are imported from China. The reports 
involve more than 5,800 dogs, 25 cats, three humans and include 
more than 1,000 pet deaths. These incidents date back to 2007. 
The Committee requests that the FDA provide it with a timeline 
of all activities associated with the investigation into the 
pet illnesses associated these products, including any import 
alerts and import refusals, within 60 days of the enactment of 
this Act. In addition, the Committee requests that the agency 
provide it with semi-annual reports on the status of the 
investigation into these illnesses beginning in April 2016 and 
continuing until the issue has been resolved.
    Pharmacy Compounding.--The Committee remains concerned with 
the draft MOU that the FDA proposed under Section 503A of the 
FDCA. Section 503A distinguishes between ``distribution'' and 
``dispensing'' for the purposes of the MOU. In the DQSA, 
Congress only allowed the FDA to regulate ``distribution''. The 
MOU appears to exceed the authority granted in the statute by 
redefining ``distribution'' in a manner that includes 
dispensing. Congress did not intend to include dispensing of 
compounded drugs over state lines within the scope of the MOU. 
The MOU should not address dispensing of compounded drugs to a 
patient over state lines if all other requirements of 503A are 
met.
    Premium Cigars.--The Committee includes statutory language 
exempting premium and traditional large cigars, in keeping with 
FDA's intent under Option 2 of its proposed rule ``Deeming 
Tobacco Products To Be Subject to the Federal Food, Drug, and 
Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act (TCA); Regulations on the Sale and 
Distribution of Tobacco Products and Required Warning 
Statements for Tobacco Products'' (Docket No. FDA-2014-N-0189). 
The Committee notes that premium cigars are shown to be 
distinct from other tobacco products in their effects on youth 
initiation, the frequency of their use by youth and young 
adults, and other such behavioral and economic factors. Lastly, 
a large number of participants in this unique business are 
small and very small operations that might not be able to 
maintain jobs and a physical presence in the United States due 
to the financial impact of this pending regulatory burden. 
Given that there is very little mention of cigars throughout 
the TCA, it is clear Congress did not intend to focus on the 
unique subset of premium cigars.
    Prescription Drug Labeling Inserts.--The Committee is aware 
of FDA proposals that would subvert repeatedly expressed 
Congressional intent by permitting the distribution of 
prescription drugs without printed prescribing information on 
or within the packages from which such drugs are to be 
dispensed. The FDA intends to replace such printed labeling 
with an electronic labeling system for the majority of 
prescription drugs. On several occasions Congress has directly 
declined to provide the FDA the necessary statutory authority 
to implement this change. As recently as 2012, Congress 
commissioned a GAO report (GAO-13-592) discussing this issue. 
The GAO report concluded that such a change could adversely 
impact public health. Thus, the Committee is very concerned 
that the FDA is moving to promulgate a regulation that would 
generally eliminate printed prescribing information inserts for 
prescription drugs. Therefore, the Committee has included a 
provision prohibiting the FDA from utilizing any funds to 
propose or otherwise promulgate any rule that requires or 
permits any prescription drug or biologic products to be 
distributed without printed prescribing information on or 
within the packaging from which such products are to be 
dispensed, unless such actions are expressly provided by an 
amendment to the FDCA.
    President's Budget Submission to Congress.--The 
Administration has submitted the President's budget request the 
past two years with a false level of base funding for the 
agency. Congress provided funds for the Department of Health 
and Human Services OIG in the FDA's Salaries and Expenses 
Appropriation in fiscal years 2015 and 2016. While those funds 
were transferred to the OIG following an apportionment by the 
Office of Management and Budget, such a transfer did not alter 
the Congressional appropriation level for the FDA. The 
Subcommittee directs the FDA to incorporate the actual funding 
level approved by Congress when displaying the previous year 
funding level in the fiscal year 2018 President's budget.
    Private Accredited Laboratories.--As the FDA begins to 
implement the regulations associated with FSMA and increase 
sampling of food products, the agency is encouraged to use and 
contract with, when appropriate, ISO/IEC 17025 certified, and 
other certified laboratories to advance the goals of FSMA and 
for other data collection purposes.
    Protecting Proprietary Information.--The Committee is 
concerned about the FDA's ability to protect trade secrets and 
confidential information the agency obtains from its regulated 
industries. FDA's access to such information has been expanded 
under FSMA and other regulatory actions. Recent cybersecurity 
breaches at the FDA underscore the importance of the FDA's 
ability to safeguard sensitive information. The agency has a 
legal obligation under the FDCA to protect confidential 
information. The Committee directs the FDA to provide a 
detailed plan on how this information will be protected no 
later than 60 days after enactment.
    Public Disclosure.--The FDA's current rules and policies 
governing what drug and device developers may say about their 
own products were designed decades ago. Since then, the way 
that medicine is practiced and delivered and the way that 
information is communicated have fundamentally changed. The 
Committee urges the FDA to convene a working group with 
stakeholders, including representatives from government, 
industry, health professionals, and patient advocacy groups, in 
order to solicit information to inform the FDA's evaluation of 
its rules and policies regarding the appropriate scope of 
scientific and medical information that can be shared with 
physicians, insurers, and researchers, with appropriate 
safeguards, in order to optimize patient care.
    Ready-to-Eat Foods.--The Committee is aware that the FDA is 
in the process of finalizing guidance documents regarding 
Listeria monocytogenes in ready-to-eat (RTE) foods, which may 
include frozen vegetables that are not currently considered as 
RTE foods. Reducing incidents of listeriosis is an important 
health goal, and the Committee supports the issuance of 
scientifically based guidance. However, including foods that 
are not considered RTE should be justified based upon a 
quantitative risk assessment. The Committee urges the FDA to 
conduct such an assessment prior to taking any action that 
would formally consider frozen vegetables or other foods 
currently not considered RTE as RTE foods.
    Scientific Integrity.--Pursuant to the President's 2009 
memorandum and as directed by the Office of Science and 
Technology Policy, the FDA adopted a scientific integrity 
policy in 2012. It appears to conform to the President's 
directive by maintaining a firm commitment to science-based, 
data-driven decision making, facilitating the free flow of 
scientific and technical information, and requiring a fair and 
transparent approach to resolving scientific disputes. The 
Committee directs the Commissioner to ensure all FDA centers 
agencies are complying with the policy and using it to guide 
their policy and regulatory decisions.
    Sodium Guidance.--The Committee is aware that the FDA is 
considering issuing guidance to food manufacturers in order to 
reduce sodium in various food categories. It is imperative that 
any guidance be issued using the latest sound science. The 
Centers for Disease Control and Prevention and the IOM are 
working together to update the Dietary Reference Intake (DRI) 
report on sodium. The FDA is encouraged to issue any voluntary 
or mandatory guidance based upon an updated DRI report.
    Spent Grains.--The Committee recognizes that the FDA took 
into consideration public comments and revised some of its 
proposed regulations on spent grains used for animal food. 
Processors already complying with FDA human food safety 
requirements would not need to implement additional preventive 
controls when supplying a by-product like wet spent grains for 
animal food. However, further processing a by-product for use 
as animal food such as drying spent grains, would require 
additional compliance under the proposed rule. The FDA has said 
that potential hazards associated with spent grains are minimal 
and steps to prevent contamination are likely already in place. 
The Committee includes bill language to ensure dry and wet 
spent grains used for animal food are regulated equally.
    State Inspections.--The Committee is aware of the December 
2011 OIG report that outlined vulnerabilities in the agency's 
oversight of non-FDA food inspections and the agency's 
intention to further rely on state inspections. The Committee 
understands that both the federal government and states share 
authority and responsibility for domestic food facilities and 
that the FDA will continue to contract with the states to 
conduct inspections on its behalf, which is critical to 
performing its mission in an efficient and effective manner. 
The agency must assure it has strong federal inspection 
standards that are met by both federal investigators and state 
inspectors. The FDA must continue its progress in improving 
federal oversight and monitoring of state inspection programs, 
reviewing and strengthening internal directives and processes, 
and identifying new methods to improve oversight capabilities.
    The FDA should continue working with states to: (1) build 
the capacity and effectiveness of their inspection programs 
through implementation of national program standards, such as 
the Manufactured Food Regulatory Program Standards and the 
Animal Feed Regulatory Program Standards; (2) utilize state or 
private laboratory services with ISO/IEC 17025 laboratory 
accreditation; and (3) improve federal-state collaboration 
during investigations and responses to food borne illness 
outbreaks by supporting the implementation of Rapid Response 
Teams.
    The Committee is aware of the FDA's continuing progress to 
modernize existing IT systems and infrastructure, allowing for 
the secure and efficient exchange of data between the FDA and 
the states, in addition to efforts to add capabilities 
supporting mobile inspection applications. The FDA should 
continue work with state partners toward promoting data 
standards and developing shared database schemas to facilitate 
secure electronic information sharing.
    Staffing at Land Ports of Entry.--The Committee is 
concerned that USDA, FDA, and Customs and Border Protection are 
relying on historical data in determining their staffing models 
at Land Ports of Entry. Recent reports on agriculture imports 
show steep increases in the future, especially along the 
Southwest border and South Texas in particular. It is the sense 
of the Committee that these agencies should be utilizing 
forward looking data for their staffing models to ensure we 
have an appropriate workforce available in the future to 
inspect and certify this growth in agriculture imports as 
efficiently, safely and expeditiously as possible.
    Sunscreen Ingredients.--The Committee is significantly 
concerned that despite the increase in incidence of skin cancer 
in the United States, the Surgeon General's 2014 Call to Action 
to Prevent Skin Cancer, unanimous passage of the Sunscreen 
Innovation Act (SIA) in Congress and President Obama's January 
2016 Presidential Memorandum creating the White House Cancer 
Moonshot Task Force to prevent and cure cancer, the FDA has 
still not approved a new OTC sunscreen ingredient through the 
process created by the SIA. For several years, the House and 
Senate Appropriations Committees have directed the FDA to clear 
the sunscreen backlog and ensure that Americans have access to 
the latest skin cancer prevention technology (H. Rept. 113-116, 
H. Rept. 113-468, H. Rept. 114-205, S. Rept. 114-82). The 
agency has failed to do so. The Committee directs the FDA to 
work with stakeholders to develop a benefit-risk testing 
regimen that appropriately balances the benefit of additional 
skin cancer prevention tools versus the risk of skin cancer to 
the 5 million Americans that will be diagnosed with the 
condition this year. The agency is directed to reach agreement 
with stakeholders on this testing regimen by June 20, 2016 and 
publish the summary of the meetings and results of the specific 
testing requirements on its website. The Committee reminds the 
FDA that section 4(c) of the SIA requires the FDA to report to 
the Senate Health, Education, Labor and Pensions Committee and 
House Energy & Commerce Committee on the implementation of the 
Act on or before May 26, 2016. The FDA shall include in this 
report a detailed analysis of how the FDA is balancing the 
Surgeon General's Call to Action, the President's Moonshot 
effort to remove administrative hurdles to cancer prevention, 
the known public health benefits that regular sunscreen use 
provides to prevent skin cancer and melanoma, and the long 
history of safe and effective use of sunscreens currently 
backlogged at the FDA in comparable countries versus the 
hypothetical risk sunscreens theoretically may pose to human 
health in FDA's GRAS standard. The funding level for the FDA 
maintains the $700,000 increase in fiscal year 2016 to help 
address the critical public health threat resulting from no new 
sunscreen ingredients being available to the public.
    Surrogate Endpoints.--The Committee urges the FDA to issue 
guidance on the use of surrogate and intermediate endpoints for 
accelerated approval of regenerative medicine products under 
section 506(c) of the FDCA (21 U.S.C. 356(c)). In the process 
of issuing guidance, the FDA shall consult with appropriate 
stakeholders in the development of this guidance.
    User Fee Collections/Obligations.--The Committee continues 
to be concerned about the financial management of the FDA's 
user fee programs. The Committee directs that not later than 30 
days after enactment of this Act, and each month thereafter 
through the months covered by this Act, the Commissioner to 
submit to the Committees on Appropriations of the House and 
Senate a report on user fees collected for each user fee 
program included in the Act. The report shall also include 
monthly obligations incurred against such fee collections. The 
report shall include a distinct categorization of the user fee 
balances that are being carried forward into fiscal year 2018 
for each user fee account as well as a detailed explanation of 
what accounts for the balance and what the balance will be used 
for.

                        BUILDINGS AND FACILITIES

 
 
 
2016 appropriation....................................        $8,788,000
2017 budget estimate..................................        11,788,000
Provided in the bill..................................        11,788,000
Comparison:
    2016 appropriation................................        +3,000,000
    2017 budget estimate..............................             - - -
 

                          COMMITTEE PROVISIONS

    For Buildings and Facilities of the Food and Drug 
Administration, the Committee provides $11,788,000.

                          INDEPENDENT AGENCIES


                  Commodity Futures Trading Commission


 
 
 
2016 appropriation....................................      $250,000,000
2017 budget estimate..................................       330,000,000
Provided in the bill..................................       250,000,000
Comparison:
    2016 appropriation................................             - - -
    2017 budget estimate..............................       -80,000,000
 

                          COMMITTEE PROVISIONS

    For the Commodity Futures Trading Commission, the Committee 
provides an appropriation of $250,000,000, of which $50,000,000 
is for the purchase of IT and $3,000,000 is for the Inspector 
General. The bill includes language to permit the Commission to 
sublease its excess space for cost savings and allow the 
Commission to correct leasing payments and potential violations 
of the Anti-Deficiency Act.
    GAO Review of Leasing Costs.--The Committee requested a 
review of GAO's leasing costs following the CFTC's IG review, 
which found approximately $74,000,000 in savings over the life 
of the Commission's leases. GAO's review found that: (1) if 
CFTC had received its full budget request in recent years, it 
could have staffed 1,015 Full Time Equivalents (FTEs) versus a 
capacity of 1,289 FTEs; (2) CFTC's actual occupancy rate of FTE 
ranges from 38 percent to 78 percent; and (3) 26 percent of 
CFTC's claimed occupancy rate is fulfilled by on-site 
contractors that have increased by 324 percent from fiscal year 
2008 to fiscal year 2015. The Committee's inclusion of 
authority to sublease space will allow the agency to find cost-
savings through increasing occupancy rates of leased space. The 
Committee also encourages the Commission to have its on-site 
contractors bear the cost of office space through renegotiation 
of current contracts.
    Collective Bargaining Agreement Reductions.--The Committee 
notes that the Commission's level of FTEs has been reduced from 
a projection of 746 in fiscal year 2015 to an actual level of 
690. These reductions are the result of a self-imposed 
collective bargaining agreement that has limited the 
Commission's ability to increase staffing levels.

                       Farm Credit Administration


                 LIMITATION ON ADMINISTRATIVE EXPENSES

 
 
 
2016 limitation.......................................     ($65,600,000)
2017 budget estimate..................................      (69,800,000)
Provided in the bill..................................      (65,600,000)
Comparison:
    2016 limitation...................................             - - -
    2017 budget estimate..............................        -4,200,000
 

                          COMMITTEE PROVISIONS

    For a limitation on the expenses of the Farm Credit 
Administration (FCA), the Committee provides $65,600,000.

                               TITLE VII


                           GENERAL PROVISIONS


             (INCLUDING RESCISSIONS AND TRANSFERS OF FUNDS)

    The General Provisions contained in the accompanying bill 
for fiscal year 2017 are fundamentally the same as those 
included in last year's appropriations bill.
    The following general provisions are included in the bill:
    Section 701: Limitation on the purchase of passenger motor 
vehicles.
    Section 702: Transfer authority regarding the Working 
Capital Fund.
    Section 703: Limitation on certain obligations.
    Section 704: Indirect cost rates for cooperative agreements 
with nonprofit institutions.
    Section 705: Disbursement of rural development loans.
    Section 706: Authority of the Chief Information Officer 
relating to new IT systems.
    Section 707: Availability of mandatory conservation program 
funding.
    Section 708: Rural Utility Service borrower eligibility.
    Section 709: Rescission of certain unobligated balances.
    Section 710: Prohibition on first-class airline travel.
    Section 711: Use of funds authorized by the Commodity 
Credit Corporation Charter Act.
    Section 712: Funding for advisory committees.
    Section 713: Indirect costs for competitive agricultural 
research grants.
    Section 714: Limitation on certain funds.
    Section 715: Limitation on certain funds.
    Section 716: Language on user fee proposals without 
offsets.
    Section 717: Language on reprogramming.
    Section 718: Language on fees for the business and industry 
guaranteed loan program.
    Section 719: Language on questions for the record.
    Section 720: Language regarding prepackaged news stories.
    Section 721: Language on prohibition on paid details in 
excess of 60 days.
    Section 722: Language regarding rulemaking.
    Section 723: Language regarding spending plans.
    Section 724: Language on controls over humanitarian food 
assistance.
    Section 725: Language regarding Single Family Housing 
Direct Loan Program.
    Section 726: Language regarding USDA loan programs.
    Section 727: Transfer authority regarding the Working 
Capital Fund.
    Section 728: Language regarding purchases made through 
Child Nutrition Programs.
    Section 729: Language regarding potable water supplies.
    Section 730: Language regarding research programs.
    Section 731: Language regarding child nutrition programs.
    Section 732: Language regarding nutrition research.
    Section 733: Language regarding housing loan programs.
    Section 734: Language regarding consumer information.
    Section 735: Language regarding menu labeling.
    Section 736: Language regarding tissue regulation.
    Section 737: Language regarding animal feed.
    Section 738: Language regarding APHIS regulation.
    Section 739: Language regarding animal research.
    Section 740: Language regarding FDA regulation.
    Section 741: Language regarding rural housing lender fees.
    Section 742: Language regarding IT systems.
    Section 743: Language regarding APHIS Buildings & 
Facilities.
    Section 744: Language regarding nutrition programs.
    Section 745: Language regarding certain unobligated 
balances.
    Section 746: Language regarding domestic preference.
    Section 747: Language regarding FDA regulations.
    Section 748: Language regarding emergency food assistance.
    Section 749: Language regarding FDA regulation.
    Section 750: Language regarding persistent poverty.
    Section 751: Language regarding community eligibility.
    Section 752: Language regarding Ebola virus funding.
    Section 753: Language regarding watershed programs.
    Section 754: Language regarding lobbying.
    Section 755: Language regarding 21st Century Cures.
    Section 756: Language regarding FDA regulation.
    Section 757: Language regarding citrus greening.
    Section 758: Language regarding certain unobligated 
balances.
    Section 759: Language regarding certain unobligated 
balances.
    Section 760: Language regarding APHIS regulation.
    Section 761: Language regarding FDA regulation.
    Section 762: Language regarding the use of funds for 
certain horse inspection activities.
    Section 763: Language regarding the SNAP program.
    Section 764: Language regarding FDA guidance.
    Section 765: Language regarding CFTC regulation.
    Section 766: Language regarding food retailer financing.
    Section 767: Language regarding livestock marketing 
arrangements.

                               TITLE VIII


                           GENERAL PROVISIONS


                     (INCLUDING TRANSFERS OF FUNDS)

    The following general provisions are included in the bill:
    Section 801: Language regarding the use of certain 
unobligated balances.
    Section 802: Language regarding the Spending Reduction 
Account.

              HOUSE OF REPRESENTATIVES REPORT REQUIREMENTS


                          Full Committee Votes

    Pursuant to the provisions of clause 3(b) of rule XIII of 
the House of Representatives, the results of each roll call 
vote on an amendment or on the motion to report, together with 
the names of those voting for and those against, are printed 
below:


         STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

    Pursuant to clause 3(c)(4) of rule XIII of the Rules of the 
House of Representatives, the following is a statement of 
general performance goals and objectives for which this measure 
authorizes funding:
    The Committee on Appropriations considers program 
performance, including a program's success in developing and 
attaining outcome-related goals and objectives, in developing 
funding recommendations.

                              RESCISSIONS

    Pursuant to clause 3(f)(2) of rule XIII of the Rules of the 
House of Representatives, the following lists the rescissions 
of unexpended balances included in the accompanying bill:

------------------------------------------------------------------------
                 Program or Activity                         Amount
------------------------------------------------------------------------
USDA Cushion of Credit...............................       $151,487,000
USDA NRCS............................................        $98,000,000
USDA AMS (prior year balances).......................       $231,000,000
USDA RD (prior year balances)........................         $4,221,000
USDA FNS (prior year balances).......................       $100,000,000
------------------------------------------------------------------------

                           TRANSFERS OF FUNDS

    Pursuant to clause 3(f)(2) of rule XIII of the Rules of the 
House of Representatives, the following list includes the 
transfers of unexpended balances included in the accompanying 
bill:
    1. Departmental Administration.--The bill requires 
reimbursement for expenses related to certain hearings.
    2. Office of the Assistant Secretary for Congressional 
Relations.--The bill allows a portion of the funds appropriated 
to the Office of the Assistant Secretary to be transferred to 
agencies.
    3. Agriculture Buildings and Facilities.--The bill allows 
funds appropriated in prior years for rental payments to be 
transferred to meet shortfalls in prior or current year rent.
    4. Hazardous Materials Management.--The bill allows the 
funds appropriated to the Department for hazardous materials 
management to be transferred to agencies of the Department as 
required.
    5. Animal and Plant Health Inspection Service.--Authority 
is included to enable the Secretary of Agriculture to transfer 
from other appropriations or funds of the Department such sums 
as may be necessary to combat emergency outbreaks of certain 
diseases of animals, plants, and poultry.
    6. Funds for Strengthening Markets, Income, and Supply.--
The bill limits the transfer of section 32 funds to purposes 
specified in the bill.
    7. Farm Service Agency Salaries and Expenses.--The bill 
provides that funds provided to other accounts in the agency 
may be merged with the salaries and expenses account of the 
Farm Service Agency.
    8. Dairy Indemnity Program.--The bill authorizes the 
transfer of funds to the Commodity Credit Corporation, by 
reference.
    9. Agricultural Credit Insurance Fund Program Account.--The 
bill provides funds to be transferred to the Farm Service 
Agency.
    10. Commodity Credit Corporation.--The bill includes 
language allowing certain funds to be transferred to the 
Foreign Agricultural Service for information resource 
management activities.
    11. Rural Development Salaries and Expenses.--The bill 
provides that prior year balances from certain accounts shall 
be transferred to and merged with this account.
    12. Rural Housing Insurance Fund Program Account, 
Intermediary Relending Program Fund Account, and Rural 
Electrification and Telecommunications Program Account.--The 
bill provides that funds in this account shall be transferred 
to the salaries and expenses of Rural Development.
    13. Rural Community Facilities Program Account, Rural 
Business Program Account, and Rural Water and Waste Disposal 
Program Account.--The bill provides that balances from these 
accounts may be transferred to and merged with other accounts.
    14. Child Nutrition Programs.--The bill includes authority 
to transfer section 32 funds to these programs.
    15. Foreign Agricultural Service, Salaries and Expenses.--
The bill allows for the transfer of funds from the Commodity 
Credit Corporation Export Loan Program Account.
    16. Food for Peace Title I Direct Credit and Food for 
Progress Program Account.--The bill allows funds to be 
transferred to the Farm Service Agency, Salaries and Expenses 
account. The bill also provides that funds made available for 
the cost of title I agreements and for title I ocean freight 
differential may be used interchangeably.
    17. Commodity Credit Corporation Export Loans Program.--The 
bill provides for transfer of funds to the Foreign Agricultural 
Service and to the Farm Service Agency for overhead expenses 
associated with credit reform.
    18. Food and Drug Administration, Salaries and Expenses.--
The bill allows funds to be transferred among activities.
    19. General Provisions.--The bill allows unobligated 
balances of discretionary funds to be transferred to the 
Working Capital Fund.

   DISCLOSURE OF EARMARKS AND CONGRESSIONALLY DIRECTED SPENDING ITEMS

    Neither the bill nor this report contain any congressional 
earmarks, limited tax benefits, or limited tariff benefits as 
defined in clause 9 of rule XXI of the Rules of the House of 
Representatives.

          COMPLIANCE WITH RULE XIII, CL. 3(E) (RAMSEYER RULE)

    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 italics, existing law in which no change 
is proposed is shown in roman:

          Compliance With Rule XIII, Cl. 3(e) (Ramseyer Rule)

  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 italics, existing law in which no change 
is proposed is shown in roman):

              RICHARD B. RUSSELL NATIONAL SCHOOL LUNCH ACT




           *       *       *       *       *       *       *
SEC. 26. INFORMATION CLEARINGHOUSE.

  (a) In General.--The Secretary shall enter into a contract 
with a nongovernmental organization described in subsection (b) 
to establish and maintain a clearinghouse to provide 
information to nongovernmental groups located throughout the 
United States that assist low-income individuals or communities 
regarding food assistance, self-help activities to aid 
individuals in becoming self-reliant, and other activities that 
empower low-income individuals or communities to improve the 
lives of low-income individuals and reduce reliance on Federal, 
State, or local governmental agencies for food or other 
assistance.
  (b) Nongovernmental Organization.--The nongovernmental 
organization referred to in subsection (a) shall be selected on 
a competitive basis and shall--
          (1) be experienced in the gathering of first-hand 
        information in all the States through onsite visits to 
        grassroots organizations in each State that fight 
        hunger and poverty or that assist individuals in 
        becoming self-reliant;
          (2) be experienced in the establishment of a 
        clearinghouse similar to the clearinghouse described in 
        subsection (a);
          (3) agree to contribute in-kind resources towards the 
        establishment and maintenance of the clearinghouse and 
        agree to provide clearinghouse information, free of 
        charge, to the Secretary, States, counties, cities, 
        antihunger groups, and grassroots organizations that 
        assist individuals in becoming self-sufficient and 
        self-reliant;
          (4) be sponsored by an organization, or be an 
        organization, that--
                  (A) has helped combat hunger for at least 10 
                years;
                  (B) is committed to reinvesting in the United 
                States; and
                  (C) is knowledgeable regarding Federal 
                nutrition programs;
          (5) be experienced in communicating the purpose of 
        the clearinghouse through the media, including the 
        radio and print media, and be able to provide access to 
        the clearinghouse information through computer or 
        telecommunications technology, as well as through the 
        mails; and
          (6) be able to provide examples, advice, and guidance 
        to States, counties, cities, communities, antihunger 
        groups, and local organizations regarding means of 
        assisting individuals and communities to reduce 
        reliance on government programs, reduce hunger, improve 
        nutrition, and otherwise assist low-income individuals 
        and communities become more self-sufficient.
  (c) Audits.--The Secretary shall establish fair and 
reasonable auditing procedures regarding the expenditures of 
funds to carry out this section.
  (d) Funding.--Out of any moneys in the Treasury not otherwise 
appropriated, the Secretary of the Treasury shall pay to the 
Secretary to provide to the organization selected under this 
section, to establish and maintain the information 
clearinghouse, $200,000 for each of fiscal years 1995 and 1996, 
$150,000 for fiscal year 1997, $100,000 for fiscal year 1998, 
$166,000 for each of fiscal years 1999 through 2004, and 
$250,000 for each of fiscal years [2010 through 2016] 2010 
through 2017. The Secretary shall be entitled to receive the 
funds and shall accept the funds, without further 
appropriation.

           *       *       *       *       *       *       *

                              ----------                              


                  FEDERAL FOOD, DRUG, AND COSMETIC ACT


[Section 755 of H.R. (insert #) provides as follows: ``The 
provisions of subtitles A, D, and L of title II of H.R. 6, One 
Hundred Fourteenth Congress (the `21st Century Cures Act'), as 
passed by the House of Representatives on July 10, 2015, are 
hereby enacted into law ''. The following reflects the 
provisions of the Federal Food, Drug, and Cosmetic Act, as 
proposed to be amended by such subtitles of title II of H.R. 6 
(as passed by the House of Representatives on July 10, 2015).]

           *       *       *       *       *       *       *


                      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 issue a scientific and medical 
        evaluation and 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.
  (x) Structured Risk-Benefit Assessment Framework.--
          (1) In general.--The Secretary shall implement a 
        structured risk-benefit assessment framework in the new 
        drug approval process--
                  (A) to facilitate the balanced consideration 
                of benefits and risks; and
                  (B) to develop and implement a consistent and 
                systematic approach to the discussion of, 
                regulatory decisionmaking with respect to, and 
                the communication of, the benefits and risks of 
                new drugs.
          (2) Rule of construction.--Nothing in paragraph (1) 
        shall alter the criteria for evaluating an application 
        for premarket approval of a drug.
  (y) Development and Use of Patient Experience Data To Enhance 
Structured Risk-Benefit Assessment Framework.--
          (1) In general.--Not later than 2 years after the 
        date of the enactment of this subsection, the Secretary 
        shall establish and implement processes under which--
                  (A) an entity seeking to develop patient 
                experience data may submit to the Secretary--
                          (i) initial research concepts for 
                        feedback from the Secretary; and
                          (ii) with respect to patient 
                        experience data collected by the 
                        entity, draft guidance documents, 
                        completed data, and summaries and 
                        analyses of such data;
                  (B) the Secretary may request such an entity 
                to submit such documents, data, and summaries 
                and analyses; and
                  (C) patient experience data may be developed 
                and used to enhance the structured risk-benefit 
                assessment framework under subsection (x).
          (2) Patient experience data.--In this subsection, the 
        term ``patient experience data'' means data collected 
        by patients, parents, caregivers, patient advocacy 
        organizations, disease research foundations, medical 
        researchers, research sponsors, or other parties 
        determined appropriate by the Secretary that is 
        intended to facilitate or enhance the Secretary's risk-
        benefit assessments, including information about the 
        impact of a disease or a therapy on patients' lives.

           *       *       *       *       *       *       *


SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.

  (a) In General.--The Secretary shall establish a program to 
evaluate the potential use of evidence from clinical 
experience--
          (1) to help to support the approval of a new 
        indication for a drug approved under section 505(b); 
        and
          (2) to help to support or satisfy postapproval study 
        requirements.
  (b) Evidence From Clinical Experience Defined.--In this 
section, the term ``evidence from clinical experience'' means 
data regarding the usage, or the potential benefits or risks, 
of a drug derived from sources other than randomized clinical 
trials, including from observational studies, registries, and 
therapeutic use.
  (c) Program Framework.--
          (1) In general.--Not later than 18 months after the 
        date of enactment of this section, the Secretary shall 
        establish a draft framework for implementation of the 
        program under this section.
          (2) Contents of framework.--The framework shall 
        include information describing--
                  (A) the current sources of data developed 
                through clinical experience, including ongoing 
                safety surveillance, registry, claims, and 
                patient-centered outcomes research activities;
                  (B) the gaps in current data collection 
                activities;
                  (C) the current standards and methodologies 
                for collection and analysis of data generated 
                through clinical experience; and
                  (D) the priority areas, remaining challenges, 
                and potential pilot opportunities that the 
                program established under this section will 
                address.
          (3) Consultation.--
                  (A) In general.--In developing the program 
                framework under this subsection, the Secretary 
                shall consult with regulated industry, 
                academia, medical professional organizations, 
                representatives of patient advocacy 
                organizations, disease research foundations, 
                and other interested parties.
                  (B) Process.--The consultation under 
                subparagraph (A) may be carried out through 
                approaches such as--
                          (i) a public-private partnership with 
                        the entities described in such 
                        subparagraph in which the Secretary may 
                        participate; or
                          (ii) a contract, grant, or other 
                        arrangement, as determined appropriate 
                        by the Secretary with such a 
                        partnership or an independent research 
                        organization.
  (d) Program Implementation.--The Secretary shall, not later 
than 24 months after the date of enactment of this section and 
in accordance with the framework established under subsection 
(c), implement the program to evaluate the potential use of 
evidence from clinical experience.
  (e) Guidance for Industry.--The Secretary shall--
          (1) utilize the program established under subsection 
        (a), its activities, and any subsequent pilots or 
        written reports, to inform a guidance for industry on--
                  (A) the circumstances under which sponsors of 
                drugs and the Secretary may rely on evidence 
                from clinical experience for the purposes 
                described in subsection (a)(1) or (a)(2); and
                  (B) the appropriate standards and 
                methodologies for collection and analysis of 
                evidence from clinical experience submitted for 
                such purposes;
          (2) not later than 36 months after the date of 
        enactment of this section, issue draft guidance for 
        industry as described in paragraph (1); and
          (3) not later than 48 months after the date of 
        enactment of this section, after providing an 
        opportunity for public comment on the draft guidance, 
        issue final guidance.
  (f) Rule of Construction.--
          (1) Subject to paragraph (2), nothing in this section 
        prohibits the Secretary from using evidence from 
        clinical experience for purposes not specified in this 
        section, provided the Secretary determines that 
        sufficient basis exists for any such nonspecified use.
          (2) This section shall not be construed to alter--
                  (A) the standards of evidence under--
                          (i) subsection (c) or (d) of section 
                        505, including the substantial evidence 
                        standard in such subsection (d); or
                          (ii) section 351(a) of the Public 
                        Health Service Act; or
                  (B) the Secretary's authority to require 
                postapproval studies or clinical trials, or the 
                standards of evidence under which studies or 
                trials are evaluated.

SEC. 505G. COLLECTING EVIDENCE FROM CLINICAL EXPERIENCE THROUGH 
                    TARGETED EXTENSIONS OF THE SENTINEL SYSTEM.

  (a) In General.--The Secretary shall, in parallel to 
implementing the program established under section 505F and in 
order to build capacity for utilizing the evidence from 
clinical experience described in that section, identify and 
execute pilot demonstrations to extend existing use of the 
Sentinel System surveillance infrastructure authorized under 
section 505(k).
  (b) Pilot Demonstrations.--
          (1) In general.--The Secretary--
                  (A) shall design and implement pilot 
                demonstrations to utilize data captured through 
                the Sentinel System surveillance infrastructure 
                authorized under section 505(k) for purposes 
                of, as appropriate--
                          (i) generating evidence from clinical 
                        experience to improve characterization 
                        or assessment of risks or benefits of a 
                        drug approved under section 505(c);
                          (ii) protecting the public health; or
                          (iii) advancing patient-centered 
                        care; and
                  (B) may make strategic linkages with sources 
                of complementary public health data and 
                infrastructure the Secretary determines 
                appropriate and necessary.
          (2) Consultation.--In developing the pilot 
        demonstrations under this subsection, the Secretary 
        shall--
                  (A) consult with regulated industry, 
                academia, medical professional organizations, 
                representatives of patient advocacy 
                organizations, disease research foundations, 
                and other interested parties through a public 
                process; and
                  (B) develop a framework to promote 
                appropriate transparency and dialogue about 
                research conducted under these pilot 
                demonstrations, including by--
                          (i) providing adequate notice to a 
                        sponsor of a drug approved under 
                        section 505 or section 351 of the 
                        Public Health Service Act of the 
                        Secretary's intent to conduct analyses 
                        of such sponsor's drug or drugs under 
                        these pilot demonstrations;
                          (ii) providing adequate notice of the 
                        findings related to analyses described 
                        in clause (i) and an opportunity for 
                        the sponsor of such drug or drugs to 
                        comment on such findings; and
                          (iii) ensuring the protection from 
                        public disclosure of any information 
                        that is a trade secret or confidential 
                        information subject to section 
                        552(b)(4) of title 5, United States 
                        Code, or section 1905 of title 18, 
                        United States Code.
          (3) HIPAA privacy rule; human subject research 
        regulation.--The Secretary may deem such pilot 
        demonstrations--
                  (A) public health activities, for purposes of 
                which a use or disclosure of protected health 
                information would be permitted as described in 
                section 164.512(b)(1) of title 45, Code of 
                Federal Regulations (or any successor 
                regulation); and
                  (B) outside the scope of ``research'' as 
                defined in section 46.102(d) of title 45, Code 
                of Federal Regulations (or any successor 
                regulation).
  (c) Authorization of Appropriations.--There are authorized to 
be appropriated to carry out this section $3,000,000 for each 
of fiscal years 2016 through 2020.

SEC. 505H. STREAMLINED DATA REVIEW PROGRAM.

  (a) In General.--The Secretary shall establish a streamlined 
data review program under which a holder of an approved 
application submitted under section 505(b)(1) or under section 
351(a) of the Public Health Service Act may, to support the 
approval or licensure (as applicable) of the use of the drug 
that is the subject of such approved application for a new 
qualified indication, submit qualified data summaries.
  (b) Eligibility.--In carrying out the streamlined data review 
program under subsection (a), the Secretary may authorize the 
holder of the approved application to include one or more 
qualified data summaries described in subsection (a) in a 
supplemental application if--
          (1) the drug has been approved under section 505(c) 
        of this Act or licensed under section 351(a) of the 
        Public Health Service Act for one or more indications, 
        and such approval or licensure remains in effect;
          (2) the supplemental application is for approval or 
        licensure (as applicable) under such section 505(c) or 
        351(a) of the use of the drug for a new qualified 
        indication under such section 505(c) or 351(a);
          (3) there is an existing database acceptable to the 
        Secretary regarding the safety of the drug developed 
        for one or more indications of the drug approved under 
        such section 505(c) or licensed under such section 
        351(a);
          (4) the supplemental application incorporates or 
        supplements the data submitted in the application for 
        approval or licensure referred to in paragraph (1); and
          (5) the full data sets used to develop the qualified 
        data summaries are submitted, unless the Secretary 
        determines that the full data sets are not required.
  (c) Public Availability of Information on Program.--The 
Secretary shall post on the public website of the Food and Drug 
Administration and update annually--
          (1) the number of applications reviewed under the 
        streamlined data review program;
          (2) the average time for completion of review under 
        the streamlined data review program versus other review 
        of applications for new indications; and
          (3) the number of applications reviewed under the 
        streamlined data review program for which the Food and 
        Drug Administration made use of full data sets in 
        addition to the qualified data summary.
  (d) Definitions.--In this section:
          (1) The term ``qualified indication'' means--
                  (A) an indication for the treatment of 
                cancer, as determined appropriate by the 
                Secretary; or
                  (B) such other types of indications as the 
                Secretary determines to be subject to the 
                streamlined data review program under this 
                section.
          (2) The term ``qualified data summary'' means a 
        summary of clinical data intended to demonstrate safety 
        and effectiveness with respect to a qualified 
        indication for use of a drug.

           *       *       *       *       *       *       *


                           premarket approval

                          General Requirement

  Sec. 515. (a) A class III device--
          (1) which is subject to a an order issued under 
        subsection (b) (or a regulation promulgated under such 
        subsection prior to the date of enactment of the Food 
        and Drug Administration Safety and Innovation Act); or
          (2) which is a class III device because of section 
        513(f),
is required to have, unless exempt under section 520(g), an 
approval under this section of an application for premarket 
approval or, as applicable, an approval under subsection (c)(2) 
of a report seeking premarket approval.

                  Order To Require Premarket Approval

  (b)(1) In the case of a class III device which--
          (A) was introduced or delivered for introduction into 
        interstate commerce for commercial distribution before 
        the date of enactment of this section; or
          (B) is (i) of a type so introduced or delivered, and 
        (ii) is substantially equivalent to another device 
        within that type;
the Secretary shall by administrative order following 
publication of a proposed order in the Federal Register, a 
meeting of a device classification panel described in section 
513(b), and consideration of comments from all affected 
stakeholders, including patients, payors, and providers, 
notwithstanding subchapter II of chapter 5 of title 5, United 
States Code, require that such device have an approval under 
this section of an application for premarket approval. 
Authority to issue such administrative order shall not be 
delegated below the Director of the Center for Devices and 
Radiological Health, acting in consultation with the 
Commissioner.
  (2) A proposed order required under paragraph (1) shall 
contain--
          (A) the proposed order;
          (B) proposed findings with respect to the degree of 
        risk of illness or injury designed to be eliminated or 
        reduced by requiring the device to have an approved 
        application for premarket approval and the benefit to 
        the public from use of the device;
          (C) opportunity for the submission of comments on the 
        proposed order and the proposed findings; and
          (D) opportunity to request a change in the 
        classification of the device based on new information 
        relevant to the classification of the device.
  (3) After the expiration of the period for comment on a 
proposed order and proposed findings published under paragraph 
(2), consideration of comments submitted on such proposed order 
and findings, and a meeting of a device classification panel 
described in section 513(b), the Secretary shall (A) issue an 
administrative order under paragraph (1) and publish in the 
Federal Register findings on the matters referred to in 
paragraph (2)(B), or (B) publish a notice terminating the 
proceeding for the issuance of the administrative order 
together with the reasons for such termination. If a notice of 
termination is published, the Secretary shall (unless such 
notice is issued because the device is a banned device under 
section 516) initiate a proceeding under section 513(e) to 
reclassify the device subject to the proceeding terminated by 
such notice.

                   Application for Premarket Approval

  (c)(1) Any person may file with the Secretary an application 
for premarket approval for a class III device. Such an 
application for a device shall contain--
          (A) full reports of all information, published or 
        known to or which should reasonably be known to the 
        applicant, concerning investigations which have been 
        made to show whether or not such device is safe and 
        effective;
          (B) a full statement of the components, ingredients, 
        and properties and of the principle or principles of 
        operation, of such device;
          (C) a full description of the methods used in, and 
        the facilities and controls used for, the manufacture, 
        processing, and, when relevant, packing and 
        installation of, such device;
          (D) an identifying reference to any performance 
        standard under section 514 which would be applicable to 
        any aspect of such device if it were a class II device, 
        and either adequate information to show that such 
        aspect of such device fully meets such performance 
        standard or adequate information to justify any 
        deviation from such standard;
          (E) such samples of such device and of components 
        thereof as the Secretary may reasonably require, except 
        that where the submission of such samples is 
        impracticable or unduly burdensome, the requirement of 
        this subparagraph may be met by the submission of 
        complete information concerning the location of one or 
        more such devices readily available for examination and 
        testing;
          (F) specimens of the labeling proposed to be used for 
        such device;
                  (G) the certification required under section 
                402(j)(5)(B) of the Public Health Service Act 
                (which shall not be considered an element of 
                such application); and
          (H) such other information relevant to the subject 
        matter of the application as the Secretary, with the 
        concurrence of the appropriate panel under section 513, 
        may require.
  (2)(A) Any person may file with the Secretary a report 
seeking premarket approval for a class III device referred to 
in subsection (a) that is a reprocessed single-use device. Such 
a report shall contain the following:
          (i) The device name, including both the trade or 
        proprietary name and the common or usual name.
          (ii) The establishment registration number of the 
        owner or operator submitting the report.
          (iii) Actions taken to comply with performance 
        standards under section 514.
          (iv) Proposed labels, labeling, and advertising 
        sufficient to describe the device, its intended use, 
        and directions for use.
          (v) Full reports of all information, published or 
        known to or which should be reasonably known to the 
        applicant, concerning investigations which have been 
        made to show whether or not the device is safe or 
        effective.
          (vi) A description of the device's components, 
        ingredients, and properties.
          (vii) A full description of the methods used in, and 
        the facilities and controls used for, the reprocessing 
        and packing of the device.
          (viii) Such samples of the device that the Secretary 
        may reasonably require.
          (ix) A financial certification or disclosure 
        statement or both, as required by part 54 of title 21, 
        Code of Federal Regulations.
          (x) A statement that the applicant believes to the 
        best of the applicant's knowledge that all data and 
        information submitted to the Secretary are truthful and 
        accurate and that no material fact has been omitted in 
        the report.
          (xi) Any additional data and information, including 
        information of the type required in paragraph (1) for 
        an application under such paragraph, that the Secretary 
        determines is necessary to determine whether there is 
        reasonable assurance of safety and effectiveness for 
        the reprocessed device.
          (xii) Validation data described in section 
        510(o)(1)(A) that demonstrates that the reasonable 
        assurance of the safety or effectiveness of the device 
        will remain after the maximum number of times the 
        device is reprocessed as intended by the person 
        submitting such report.
  (B) In the case of a class III device referred to in 
subsection (a) that is a reprocessed single-use device:
          (i) Subparagraph (A) of this paragraph applies in 
        lieu of paragraph (1).
          (ii) Subject to clause (i), the provisions of this 
        section apply to a report under subparagraph (A) to the 
        same extent and in the same manner as such provisions 
        apply to an application under paragraph (1).
          (iii) Each reference in other sections of this Act to 
        an application under this section, other than such a 
        reference in section 737 or 738, shall be considered to 
        be a reference to a report under subparagraph (A).
          (iv) Each reference in other sections of this Act to 
        a device for which an application under this section 
        has been approved, or has been denied, suspended, or 
        withdrawn, other than such a reference in section 737 
        or 738, shall be considered to be a reference to a 
        device for which a report under subparagraph (A) has 
        been approved, or has been denied, suspended, or 
        withdrawn, respectively.
  (3) Upon receipt of an application meeting the requirements 
set forth in paragraph (1), the Secretary--
          (A) may on the Secretary's own initiative, or
          (B) shall, upon the request of an applicant unless 
        the Secretary finds that the information in the 
        application which would be reviewed by a panel 
        substantially duplicates information which has 
        previously been reviewed by a panel appointed under 
        section 513,
refer such application to the appropriate panel under section 
513 for study and for submission (within such period as he may 
establish) of a report and recommendation respecting approval 
of the application, together with all underlying data and the 
reasons or basis for the recommendation. Where appropriate, the 
Secretary shall ensure that such panel includes, or consults 
with, one or more pediatric experts.
  (4)(A) Prior to the submission of an application under this 
subsection, the Secretary shall accept and review any portion 
of the application that the applicant and the Secretary agree 
is complete, ready, and appropriate for review, except that 
such requirement does not apply, and the Secretary has 
discretion whether to accept and review such portion, during 
any period in which, under section 738(h), the Secretary does 
not have the authority to collect fees under section 738(a).
  (B) Each portion of a submission reviewed under subparagraph 
(A) and found acceptable by the Secretary shall not be further 
reviewed after receipt of an application that satisfies the 
requirements of paragraph (1), unless a significant issue of 
safety or effectiveness provides the Secretary reason to review 
such accepted portion.
  (C) Whenever the Secretary determines that a portion of a 
submission under subparagraph (A) is unacceptable, the 
Secretary shall, in writing, provide to the applicant a 
description of any deficiencies in such portion and identify 
the information that is required to correct these deficiencies, 
unless the applicant is no longer pursuing the application.

            Action on an Application for Premarket Approval

  (d)(1)(A) As promptly as possible, but in no event later than 
one hundred and eighty days after the receipt of an application 
under subsection (c) (except as provided in section 
520(l)(3)(D)(ii) or unless, in accordance with subparagraph 
(B)(i), an additional period as agreed upon by the Secretary 
and the applicant), the Secretary, after considering the report 
and recommendation submitted under paragraph (2) of such 
subsection, shall--
          (i) issue an order approving the application if he 
        finds that none of the grounds for denying approval 
        specified in paragraph (2) of this subsection applies; 
        or
          (ii) deny approval of the application if he finds 
        (and sets forth the basis for such finding as part of 
        or accompanying such denial) that one or more grounds 
        for denial specified in paragraph (2) of this 
        subsection apply.
In making the determination whether to approve or deny the 
application, the Secretary shall rely on the conditions of use 
included in the proposed labeling as the basis for determining 
whether or not there is a reasonable assurance of safety and 
effectiveness, if the proposed labeling is neither false nor 
misleading. In determining whether or not such labeling is 
false or misleading, the Secretary shall fairly evaluate all 
material facts pertinent to the proposed labeling.
  (B)(i) The Secretary may not enter into an agreement to 
extend the period in which to take action with respect to an 
application submitted for a device subject to a regulation 
promulgated under subsection (b) unless he finds that the 
continued availability of the device is necessary for the 
public health.
  (ii) An order approving an application for a device may 
require as a condition to such approval that the sale and 
distribution of the device be restricted but only to the extent 
that the sale and distribution of a device may be restricted 
under a regulation under section 520(e).
  (iii) The Secretary shall accept and review statistically 
valid and reliable data and any other information from 
investigations conducted under the authority of regulations 
required by section 520(g) to make a determination of whether 
there is a reasonable assurance of safety and effectiveness of 
a device subject to a pending application under this section 
if--
          (I) the data or information is derived from 
        investigations of an earlier version of the device, the 
        device has been modified during or after the 
        investigations (but prior to submission of an 
        application under subsection (c)) and such a 
        modification of the device does not constitute a 
        significant change in the design or in the basic 
        principles of operation of the device that would 
        invalidate the data or information; or
          (II) the data or information relates to a device 
        approved under this section, is available for use under 
        this Act, and is relevant to the design and intended 
        use of the device for which the application is pending.
  (2) The Secretary shall deny approval of an application for a 
device if, upon the basis of the information submitted to the 
Secretary as part of the application and any other information 
before him with respect to such device, the Secretary finds 
that--
          (A) there is a lack of a showing of reasonable 
        assurance that such device is safe under the conditions 
        of use prescribed, recommended, or suggested in the 
        proposed labeling thereof;
          (B) there is a lack of a showing of reasonable 
        assurance that the device is effective under the 
        conditions of use prescribed, recommended, or suggested 
        in the proposed labeling thereof;
          (C) the methods used in, or the facilities or 
        controls used for, the manufacture, processing, 
        packing, or installation of such device do not conform 
        to the requirements of section 520(f);
          (D) based on a fair evaluation of all material facts, 
        the proposed labeling is false or misleading in any 
        particular; or
          (E) such device is not shown to conform in all 
        respects to a performance standard in effect under 
        section 514 compliance with which is a condition to 
        approval of the application and there is a lack of 
        adequate information to justify the deviation from such 
        standard.
Any denial of an application shall, insofar as the Secretary 
determines to be practicable, be accompanied by a statement 
informing the applicant of the measures required to place such 
application in approvable form (which measures may include 
further research by the applicant in accordance with one or 
more protocols prescribed by the Secretary).
  (3)(A)(i) The Secretary shall, upon the written request of an 
applicant, meet with the applicant, not later than 100 days 
after the receipt of an application that has been filed as 
complete under subsection (c), to discuss the review status of 
the application.
  (ii) The Secretary shall, in writing and prior to the 
meeting, provide to the applicant a description of any 
deficiencies in the application that, at that point, have been 
identified by the Secretary based on an interim review of the 
entire application and identify the information that is 
required to correct those deficiencies.
  (iii) The Secretary shall notify the applicant promptly of--
          (I) any additional deficiency identified in the 
        application, or
          (II) any additional information required to achieve 
        completion of the review and final action on the 
        application,
that was not described as a deficiency in the written 
description provided by the Secretary under clause (ii).
  (B) The Secretary and the applicant may, by mutual consent, 
establish a different schedule for a meeting required under 
this paragraph.
  (4) An applicant whose application has been denied approval 
may, by petition filed on or before the thirtieth day after the 
date upon which he receives notice of such denial, obtain 
review thereof in accordance with either paragraph (1) or (2) 
of subsection (g), and any interested person may obtain review, 
in accordance with paragraph (1) or (2) of subsection (g), of 
an order of the Secretary approving an application.
  [(5) In order to provide for more effective treatment or 
diagnosis of life-threatening or irreversibly debilitating 
human diseases or conditions, the Secretary shall provide 
review priority for devices--
          [(A) representing breakthrough technologies,
          [(B) for which no approved alternatives exist,
          [(C) which offer significant advantages over existing 
        approved alternatives, or
          [(D) the availability of which is in the best 
        interest of the patients.]
  [(6)] (5)(A)(i) A supplemental application shall be required 
for any change to a device subject to an approved application 
under this subsection that affects safety or effectiveness, 
unless such change is a modification in a manufacturing 
procedure or method of manufacturing and the holder of the 
approved application submits a written notice to the Secretary 
that describes in detail the change, summarizes the data or 
information supporting the change, and informs the Secretary 
that the change has been made under the requirements of section 
520(f).
  (ii) The holder of an approved application who submits a 
notice under clause (i) with respect to a manufacturing change 
of a device may distribute the device 30 days after the date on 
which the Secretary receives the notice, unless the Secretary 
within such 30-day period notifies the holder that the notice 
is not adequate and describes such further information or 
action that is required for acceptance of such change. If the 
Secretary notifies the holder that a supplemental application 
is required, the Secretary shall review the supplement within 
135 days after the receipt of the supplement. The time used by 
the Secretary to review the notice of the manufacturing change 
shall be deducted from the 135-day review period if the notice 
meets appropriate content requirements for premarket approval 
supplements.
  (B)(i) Subject to clause (ii), in reviewing a supplement to 
an approved application, for an incremental change to the 
design of a device that affects safety or effectiveness, the 
Secretary shall approve such supplement if--
          (I) nonclinical data demonstrate that the design 
        modification creates the intended additional capacity, 
        function, or performance of the device; and
          (II) clinical data from the approved application and 
        any supplement to the approved application provide a 
        reasonable assurance of safety and effectiveness for 
        the changed device.
  (ii) The Secretary may require, when necessary, additional 
clinical data to evaluate the design modification of the device 
to provide a reasonable assurance of safety and effectiveness.

     Withdrawal and Temporary Suspension of Approval of Application

  (e)(1) The Secretary shall, upon obtaining, where 
appropriate, advice on scientific matters from a panel or 
panels under section 513, and after due notice and opportunity 
for informal hearing to the holder of an approved application 
for a device, issue an order withdrawing approval of the 
application if the Secretary finds--
          (A) that such device is unsafe or ineffective under 
        the conditions of use prescribed, recommended, or 
        suggested in the labeling thereof;
          (B) on the basis of new information before him with 
        respect to such device, evaluated together with the 
        evidence available to him when the application was 
        approved, that there is a lack of a showing of 
        reasonable assurance that the device is safe or 
        effective under the conditions of use prescribed, 
        recommended, or suggested in the labeling thereof;
          (C) that the application contained or was accompanied 
        by an untrue statement of a material fact;
          (D) that the applicant (i) has failed to establish a 
        system for maintaining records, or has repeatedly or 
        deliberately failed to maintain records or to make 
        reports, required by an applicable regulation under 
        section 519(a), (ii) has refused to permit access to, 
        or copying or verification of, such records as required 
        by section 704, or (iii) has not complied with the 
        requirements of section 510;
          (E) on the basis of new information before him with 
        respect to such device, evaluated together with the 
        evidence before him when the application was approved, 
        that the methods used in, or the facilities and 
        controls used for, the manufacture, processing, 
        packing, or installation of such device do not conform 
        with the requirements of section 520(f) and were not 
        brought into conformity with such requirements within a 
        reasonable time after receipt of written notice from 
        the Secretary of nonconformity;
          (F) on the basis of new information before him, 
        evaluated together with the evidence before him when 
        the application was approved, that the labeling of such 
        device, 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 of such fact; or
          (G) on the basis of new information before him, 
        evaluated together with the evidence before him when 
        the application was approved, that such device is not 
        shown to conform in all respects to a performance 
        standard which is in effect under section 514 
        compliance with which was a condition to approval of 
        the application and that there is a lack of adequate 
        information to justify the deviation from such 
        standard.
  (2) The holder of an application subject to an order issued 
under paragraph (1) withdrawing approval of the application 
may, by petition filed on or before the thirtieth day after the 
date upon which he receives notice of such withdrawal, obtain 
review thereof in accordance with either paragraph (1) or (2) 
of subsection (g).
  (3) If, after providing an opportunity for an informal 
hearing, the Secretary determines there is reasonable 
probability that the continuation of distribution of a device 
under an approved application would cause serious, adverse 
health consequences or death, the Secretary shall by order 
temporarily suspend the approval of the application approved 
under this section. If the Secretary issues such an order, the 
Secretary shall proceed expeditiously under paragraph (1) to 
withdraw such application.

                      Product Development Protocol

  (f)(1) In the case of a class III device which is required to 
have an approval of an application submitted under subsection 
(c), such device shall be considered as having such an approval 
if a notice of completion of testing conducted in accordance 
with a product development protocol approved under paragraph 
(4) has been declared completed under paragraph (6).
  (2) Any person may submit to the Secretary a proposed product 
development protocol with respect to a device. Such a protocol 
shall be accompanied by data supporting it. If, within thirty 
days of the receipt of such a protocol, the Secretary 
determines that it appears to be appropriate to apply the 
requirements of this subsection to the device with respect to 
which the protocol is submitted, the Secretary--
          (A) may, at the initiative of the Secretary, refer 
        the proposed protocol to the appropriate panel under 
        section 513 for its recommendation respecting approval 
        of the protocol; or
          (B) shall so refer such protocol upon the request of 
        the submitter, unless the Secretary finds that the 
        proposed protocol and accompanying data which would be 
        reviewed by such panel substantially duplicate a 
        product development protocol and accompanying data 
        which have previously been reviewed by such a panel.
  (3) A proposed product development protocol for a device may 
be approved only if--
          (A) the Secretary determines that it is appropriate 
        to apply the requirements of this subsection to the 
        device in lieu of the requirement of approval of an 
        application submitted under subsection (c); and
          (B) the Secretary determines that the proposed 
        protocol provides--
                  (i) a description of the device and the 
                changes which may be made in the device,
                  (ii) a description of the preclinical trials 
                (if any) of the device and a specification of 
                (I) the results from such trials to be required 
                before the commencement of clinical trials of 
                the device, and (II) any permissible variations 
                in preclinical trials and the results 
                therefrom,
                  (iii) a description of the clinical trials 
                (if any) of the device and a specification of 
                (I) the results from such trials to be required 
                before the filing of a notice of completion of 
                the requirements of the protocol, and (II) any 
                permissible variations in such trials and the 
                results therefrom,
                  (iv) a description of the methods to be used 
                in, and the facilities and controls to be used 
                for, the manufacture, processing, and when 
                relevant, packing and installation of the 
                device,
                  (v) an identifying reference to any 
                performance standard under section 514 to be 
                applicable to any aspect of such device,
                  (vi) if appropriate, specimens of the 
                labeling proposed to be used for such device,
                  (vii) such other information relevant to the 
                subject matter of the protocol as the 
                Secretary, with the concurrence of the 
                appropriate panel or panels under section 513, 
                may require, and
                  (viii) a requirement for submission of 
                progress reports and, when completed, records 
                of the trials conducted under the protocol 
                which records are adequate to show compliance 
                with the protocol.
  (4) The Secretary shall approve or disapprove a proposed 
product development protocol submitted under paragraph (2) 
within one hundred and twenty days of its receipt unless an 
additional period is agreed upon by the Secretary and the 
person who submitted the protocol. Approval of a protocol or 
denial of approval of a protocol is final agency action subject 
to judicial review under chapter 7 of title 5, United States 
Code.
  (5) At any time after a product development protocol for a 
device has been approved pursuant to paragraph (4), the person 
for whom the protocol was approved may submit a notice of 
completion--
          (A) stating (i) his determination that the 
        requirements of the protocol have been fulfilled and 
        that, to the best of his knowledge, there is no reason 
        bearing on safety or effectiveness why the notice of 
        completion should not become effective, and (ii) the 
        data and other information upon which such 
        determination was made, and
          (B) setting forth the results of the trials required 
        by the protocol and all the information required by 
        subsection (c)(1).
  (6)(A) The Secretary may, after providing the person who has 
an approved protocol an opportunity for an informal hearing and 
at any time prior to receipt of notice of completion of such 
protocol, issue a final order to revoke such protocol if he 
finds that--
          (i) such person has failed substantially to comply 
        with the requirements of the protocol,
          (ii) the results of the trials obtained under the 
        protocol differ so substantially from the results 
        required by the protocol that further trials cannot be 
        justified, or
          (iii) the results of the trials conducted under the 
        protocol or available new information do not 
        demonstrate that the device tested under the protocol 
        does not present an unreasonable risk to health and 
        safety.
  (B) After the receipt of a notice of completion of an 
approved protocol the Secretary shall, within the ninety-day 
period beginning on the date such notice is received, by order 
either declare the protocol completed or declare it not 
completed. An order declaring a protocol not completed may take 
effect only after the Secretary has provided the person who has 
the protocol opportunity for an informal hearing on the order. 
Such an order may be issued only if the Secretary finds--
          (i) such person has failed substantially to comply 
        with the requirements of the protocol,
          (ii) the results of the trials obtained under the 
        protocol differ substantially from the results required 
        by the protocol, or
          (iii) there is a lack of a showing of reasonable 
        assurance of the safety and effectiveness of the device 
        under the conditions of use prescribed, recommended, or 
        suggested in the proposed labeling thereof.
  (C) A final order issued under subparagraph (A) or (B) shall 
be in writing and shall contain the reasons to support the 
conclusions thereof.
  (7) At any time after a notice of completion has become 
effective, the Secretary may issue an order (after due notice 
and opportunity for an informal hearing to the person for whom 
the notice is effective) revoking the approval of a device 
provided by a notice of completion which has become effective 
as provided in subparagraph (B) if he finds that any of the 
grounds listed in subparagraphs (A) through (G) of subsection 
(e)(1) of this section apply. Each reference in such 
subparagraphs to an application shall be considered for 
purposes of this paragraph as a reference to a protocol and the 
notice of completion of such protocol, and each reference to 
the time when an application was approved shall be considered 
for purposes of this paragraph as a reference to the time when 
a notice of completion took effect.
  (8) A person who has an approved protocol subject to an order 
issued under paragraph (6)(A) revoking such protocol, a person 
who has an approved protocol with respect to which an order 
under paragraph (6)(B) was issued declaring that the protocol 
had not been completed, or a person subject to an order issued 
under paragraph (7) revoking the approval of a device may, by 
petition filed on or before the thirtieth day after the date 
upon which he receives notice of such order, obtain review 
thereof in accordance with either paragraph (1) or (2) of 
subsection (g).

                                 Review

  (g)(1) Upon petition for review of--
          (A) an order under subsection (d) approving or 
        denying approval of an application or an order under 
        subsection (e) withdrawing approval of an application, 
        or
          (B) an order under subsection (f)(6)(A) revoking an 
        approved protocol, under subsection (f)(6)(B) declaring 
        that an approved protocol has not been completed, or 
        under subsection (f)(7) revoking the approval of a 
        device,
the Secretary shall, unless he finds the petition to be without 
good cause or unless a petition for review of such order has 
been submitted under paragraph (2), hold a hearing, in 
accordance with section 554 of title 5 of the United States 
Code, on the order. The panel or panels which considered the 
application, protocol, or device subject to such order shall 
designate a member to appear and testify at any such hearing 
upon request of the Secretary, the petitioner, or the officer 
conducting the hearing, but this requirement does not preclude 
any other member of the panel or panels from appearing and 
testifying at any such hearing. Upon completion of such hearing 
and after considering the record established in such hearing, 
the Secretary shall issue an order either affirming the order 
subject to the hearing or reversing such order and, as 
appropriate, approving or denying approval of the application, 
reinstating the application's approval, approving the protocol, 
or placing in effect a notice of completion.
  (2)(A) Upon petition for review of--
          (i) an order under subsection (d) approving or 
        denying approval of an application or an order under 
        subsection (e) withdrawing approval of an application, 
        or
          (ii) an order under subsection (f)(6)(A) revoking an 
        approved protocol, under subsection (f)(6)(B) declaring 
        that an approved protocol has not been completed, or 
        under subsection (f)(7) revoking the approval of a 
        device,
the Secretary shall refer the application or protocol subject 
to the order and the basis for the order to an advisory 
committee of experts established pursuant to subparagraph (B) 
for a report and recommendation with respect to the order. The 
advisory committee shall, after independent study of the data 
and information furnished to it by the Secretary and other data 
and information before it, submit to the Secretary a report and 
recommendation, together with all underlying data and 
information and a statement of the reasons or basis for the 
recommendation. A copy of such report shall be promptly 
supplied by the Secretary to any person who petitioned for such 
referral to the advisory committee.
  (B) The Secretary shall establish advisory committees (which 
may not be panels under section 513) to receive referrals under 
subparagraph (A). The Secretary shall appoint as members of any 
such advisory committee persons qualified in the subject matter 
to be referred to the committee and of appropriately 
diversified professional backgrounds, except that the Secretary 
may not appoint to such a committee any individual who is in 
the regular full-time employ of the United States and engaged 
in the administration of this Act. Members of an advisory 
committee (other than officers or employees of the United 
States), while attending conferences or meetings of their 
committee or otherwise serving at the request of the Secretary, 
shall be entitled to receive compensation at rates to be fixed 
by the Secretary which rates may not exceed the daily 
equivalent for grade GS-18 of the General Schedule for each day 
(including traveltime) they are so engaged; and while so 
serving away from their homes or regular places of business 
each member may be allowed travel expenses, including per diem 
in lieu of subsistence, as authorized by section 5703 of title 
5 of the United States Code for persons in the Government 
service employed intermittently. The Secretary shall designate 
the chairman of an advisory committee from its members. The 
Secretary shall furnish each advisory committee with clerical 
and other assistance, and shall by regulation prescribe the 
procedures to be followed by each such committee in acting on 
referrals made under subparagraph (A).
  (C) The Secretary shall make public the report and 
recommendation made by an advisory committee with respect to an 
application and shall by order, stating the reasons therefor, 
either affirm the order referred to the advisory committee or 
reverse such order and, if appropriate, approve or deny 
approval of the application, reinstate the application's 
approval, approve the protocol, or place in effect a notice of 
completion.

                           Service of Orders

  (h) Orders of the Secretary 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 certified mail addressed to the 
applicant at his last known address in the records of the 
Secretary.

                                Revision

  (i)(1) Before December 1, 1995, the Secretary shall by order 
require manufacturers of devices, which were introduced or 
delivered for introduction into interstate commerce for 
commercial distribution before May 28, 1976, and which are 
subject to revision of classification under paragraph (2), to 
submit to the Secretary a summary of and citation to any 
information known or otherwise available to the manufacturer 
respecting such devices, including adverse safety or 
effectiveness information which has not been submitted under 
section 519. The Secretary may require the manufacturer to 
submit the adverse safety or effectiveness data for which a 
summary and citation were submitted, if such data are available 
to the manufacturer.
  (2) After the issuance of an order under paragraph (1) but 
before the date that is 2 years after the date of enactment of 
the Food and Drug Administration Safety and Innovation Act, the 
Secretary shall issue an administrative order following 
publication of a proposed order in the Federal Register, a 
meeting of a device classification panel described in section 
513(b), and consideration of comments from all affected 
stakeholders, including patients, payors, and providers, 
notwithstanding subchapter II of chapter 5 of title 5, United 
States Code, for each device--
          (A) which the Secretary has classified as a class III 
        device, and
          (B) for which no administrative order has been issued 
        under subsection (b) (or no regulation has been 
        promulgated under such subsection prior to the date of 
        enactment of the Food and Drug Administration Safety 
        and Innovation Act),
revising the classification of the device so that the device is 
classified into class I or class II, unless the administrative 
order issued under this paragraph requires the device to remain 
in class III. In determining whether to revise the 
classification of a device or to require a device to remain in 
class III, the Secretary shall apply the criteria set forth in 
section 513(a).
  (3) The Secretary shall, as promptly as is reasonably 
achievable, but not later than 12 months after the effective 
date of the order requiring a device to remain in class III, 
establish a schedule for the issuance of an administrative 
order under subsection (b) for each device which is subject to 
the order requiring the device to remain in class III.

           *       *       *       *       *       *       *


SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.

  (a) In General.--In order to provide for more effective 
treatment or diagnosis of life-threatening or irreversibly 
debilitating human diseases or conditions, the Secretary shall 
establish a program to provide priority review for devices--
          (1) representing breakthrough technologies;
          (2) for which no approved alternatives exist;
          (3) offering significant advantages over existing 
        approved or cleared alternatives, including the 
        potential to, compared to existing approved or cleared 
        alternatives, reduce or eliminate the need for 
        hospitalization, improve patient quality of life, 
        facilitate patients' ability to manage their own care 
        (such as through self-directed personal assistance), or 
        establish long-term clinical efficiencies; or
          (4) the availability of which is in the best interest 
        of patients.
  (b) Request for Designation.--A sponsor of a device may 
request that the Secretary designate the device for priority 
review under this section. Any such request for designation may 
be made at any time prior to the submission of an application 
under section 515(c), a petition for classification under 
section 513(f)(2), or a notification under section 510(k).
  (c) Designation Process.--
          (1) In general.--Not later than 60 calendar days 
        after the receipt of a request under subsection (b), 
        the Secretary shall determine whether the device that 
        is the subject of the request meets the criteria 
        described in subsection (a). If the Secretary 
        determines that the device meets the criteria, the 
        Secretary shall designate the device for priority 
        review.
          (2) Review.--Review of a request under subsection (b) 
        shall be undertaken by a team that is composed of 
        experienced staff and managers of the Food and Drug 
        Administration and is chaired by a senior manager. 
          (3) Designation determination.--A determination 
        approving or denying a request under subsection (b) 
        shall be considered a significant decision under 
        section 517A and the Secretary shall provide a written, 
        substantive summary of the basis for the determination 
        in accordance with section 517A(a).
          (4) Reconsideration.--
                  (A) Request for reconsideration.--Any person 
                whose request under subsection (b) is denied 
                may, within 30 days of the denial, request 
                reconsideration of the denial in accordance 
                with section 517A(b)--
                          (i) based upon the submission of 
                        documents by such person; or
                          (ii) based upon such documents and a 
                        meeting or teleconference.
                  (B) Response.--Reconsideration of a 
                designation determination under this paragraph 
                shall be conducted in accordance with section 
                517A(b).
          (5) Withdrawal.--If the Secretary approves a priority 
        review designation for a device under this section, the 
        Secretary may not withdraw the designation based on the 
        fact that the criteria specified in subsection (a) are 
        no longer met because of the subsequent clearance or 
        approval of another device that was designated under--
                  (A) this section; or
                  (B) section 515(d)(5) (as in effect 
                immediately prior to the enactment of the 21st 
                Century Cures Act).
  (d) Priority Review.--
          (1) Actions.--For purposes of expediting the 
        development and review of devices designated under 
        subsection (c), the Secretary shall--
                  (A) assign a team of staff, including a team 
                leader with appropriate subject matter 
                expertise and experience, for each device for 
                which a request is submitted under subsection 
                (b);
                  (B) provide for oversight of the team by 
                senior agency personnel to facilitate the 
                efficient development of the device and the 
                efficient review of any submission described in 
                subsection (b) for the device;
                  (C) adopt an efficient process for timely 
                dispute resolution;
                  (D) provide for interactive communication 
                with the sponsor of the device during the 
                review process;
                  (E) expedite the Secretary's review of 
                manufacturing and quality systems compliance, 
                as applicable;
                  (F) disclose to the sponsor in advance the 
                topics of any consultation concerning the 
                sponsor's device that the Secretary intends to 
                undertake with external experts or an advisory 
                committee and provide the sponsor an 
                opportunity to recommend such external experts;
                  (G) for applications submitted under section 
                515(c), provide for advisory committee input, 
                as the Secretary determines appropriate 
                (including in response to the request of the 
                sponsor); and
                  (H) assign staff to be available within a 
                reasonable time to address questions posed by 
                institutional review committees concerning the 
                conditions and clinical testing requirements 
                applicable to the investigational use of the 
                device pursuant to an exemption under section 
                520(g).
          (2) Additional actions.--In addition to the actions 
        described in paragraph (1), for purposes of expediting 
        the development and review of devices designated under 
        subsection (c), the Secretary, in collaboration with 
        the device sponsor, may, as appropriate--
                  (A) coordinate with the sponsor regarding 
                early agreement on a data development plan;
                  (B) take steps to ensure that the design of 
                clinical trials is as efficient as practicable, 
                such as through adoption of shorter or smaller 
                clinical trials, application of surrogate 
                endpoints, and use of adaptive trial designs 
                and Bayesian statistics, to the extent 
                scientifically appropriate;
                  (C) facilitate, to the extent scientifically 
                appropriate, expedited and efficient 
                development and review of the device through 
                utilization of timely postmarket data 
                collection, with regard to applications for 
                approval under section 515(c); and
                  (D) agree to clinical protocols that the 
                Secretary will consider binding on the 
                Secretary and the sponsor, subject to--
                          (i) changes agreed to by the sponsor 
                        and the Secretary;
                          (ii) changes that the Secretary 
                        determines are required to prevent an 
                        unreasonable risk to the public health; 
                        or
                          (iii) the identification of a 
                        substantial scientific issue determined 
                        by the Secretary to be essential to the 
                        safety or effectiveness of the device 
                        involved.
  (e) Priority Review Guidance.--
          (1) Content.--The Secretary shall issue guidance on 
        the implementation of this section. Such guidance shall 
        include the following:
                  (A) The process for a person to seek a 
                priority review designation.
                  (B) A template for requests under subsection 
                (b).
                  (C) The criteria the Secretary will use in 
                evaluating a request for priority review.
                  (D) The standards the Secretary will use in 
                assigning a team of staff, including team 
                leaders, to review devices designated for 
                priority review, including any training 
                required for such personnel on effective and 
                efficient review.
          (2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall propose such 
        guidance for public comment.
  (f) Construction.--
          (1) Purpose.--This section is intended to encourage 
        the Secretary and provide the Secretary sufficient 
        authorities to apply efficient and flexible approaches 
        to expedite the development of, and prioritize the 
        agency's review of, devices that represent breakthrough 
        technologies.
          (2) Construction.--Nothing in this section shall be 
        construed to alter the criteria and standards for 
        evaluating an application pursuant to section 515(c), a 
        report and request for classification under section 
        513(f)(2), or a report under section 510(k), including 
        the recognition of valid scientific evidence as 
        described in section 513(a)(3)(B), and consideration of 
        the least burdensome means of evaluating device 
        effectiveness or demonstrating substantial equivalence 
        between devices with differing technological 
        characteristics, as applicable. Nothing in this section 
        alters the authority of the Secretary to act on an 
        application pursuant to section 515(d) before 
        completion of an establishment inspection, as the 
        Secretary deems appropriate.

           *       *       *       *       *       *       *


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

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

           *       *       *       *       *       *       *


               CHANGES IN THE APPLICATION OF EXISTING LAW

    Pursuant to clause 3(f)(1)(A) of rule XIII of the Rules of 
the House of Representatives, the following statements are 
submitted describing the effect of provisions in the 
accompanying bill that directly or indirectly change the 
application of existing law.
    The bill includes a number of provisions which place 
limitations on the use of funds in the bill or change existing 
limitations and which might, under some circumstances, be 
construed as changing the application of existing law:
    1. Office of the Secretary.--Language is included to limit 
the amount of funds for official reception and representation 
expenses, as determined by the Secretary.
    2. Departmental Administration.--Language is included to 
reimburse the agency for travel expenses incident to the 
holding of hearings.
    3. Agricultural Research Service.--Language is included 
that allows the Agricultural Research Service to grant 
easements at the Beltsville, MD, agricultural research center 
and to grant easements at any facility for the construction of 
a research facility for use by the agency.
    4. Animal and Plant Health Inspection Service.--A provision 
carried in the bill since fiscal year 1973 regarding state 
matching funds has been continued to assure more effective 
operation of the brucellosis control program through state cost 
sharing, with resulting savings to the Federal budget.
    Language is included to allow APHIS to recoup expenses 
incurred from providing technical assistance goods, or services 
to non-APHIS personnel, and to allow transfers of funds for 
agricultural emergencies.
    Language is included to limit the amount of funds for 
representational allowances.
    5. Agricultural Marketing Service, Limitation on 
Administrative Expenses.--The bill includes language to allow 
AMS to exceed the limitation on administrative expenses by 10 
percent with notification to the Appropriations Committees. 
This allows flexibility in case crop size is understated and/or 
other uncontrollable events occur.
    6. Grain Inspection, Packers and Stockyards Administration, 
Inspection and Weighing Services.--The bill includes authority 
to exceed the limitation on inspection and weighing services by 
10 percent with notification to the Appropriations Committees. 
This allows for flexibility if export activities require 
additional supervision and oversight, or other uncontrollable 
factors occur.
    7. Dairy Indemnity Program.--Language is included by 
reference that allows the Secretary to utilize the services of 
the Commodity Credit Corporation for the purpose of making 
dairy indemnity payments.
    8. Agricultural Credit Insurance Fund Program Account.--
Language is included that deems the pink bollworm a boll weevil 
for the purposes of administering the boll weevil loan program.
    9. Risk Management Agency.--Language is included to limit 
the amount of funds for official reception and representation 
expenses.
    10. Commodity Credit Corporation Fund.--Language is 
included to provide for the reimbursement appropriation. 
Language is also included to allow certain funds transferred 
from the Commodity Credit Corporation to be used for 
information resource management. In addition, language is 
included which limits the amount of funds that can be spent on 
operation and maintenance costs of CCC hazardous waste sites.
    11. Natural Resources Conservation Service.--Conservation 
Operations.--Language which has been included in the bill since 
1938 prohibits construction of buildings on land not owned by 
the government, although construction on land owned by states 
and counties is permitted as authorized by law.
    12. Rural Development Salaries and Expenses.--Language is 
included to allow funds to be used for advertising and 
promotional activities and to limit the amount of funds to 
provide modest nonmonetary awards to non-USDA employees.
    13. Rental Assistance Program.--Language is included which 
provides that agreements entered into during the current fiscal 
year be funded for a one-year period. Language also is included 
to renew contracts once during any 12-month period.
    14. Special Supplemental Nutrition Program for Women, 
Infants, and Children (WIC).--Language is included to purchase 
infant formula except in accordance with law and pay for 
activities that are not fully reimbursed by other departments 
or agencies unless authorized by law.
    15. Supplemental Nutrition Assistance Program.--Language is 
included to enter into contracts and employ staff to conduct 
studies, evaluations, or to conduct activities related to 
program integrity.
    16. Foreign Agricultural Service.--Language carried since 
1979 enables this agency to use funds received by an advance or 
by reimbursement to carry out its activities involving 
international development and technical cooperation. Language 
is included to limit the amount of funds for official reception 
and representation expenses.
    17. Commodity Futures Trading Commission.--Language is 
included to limit the amount of funds for official reception 
and representation expenses.
    18. Farm Credit Administration.--The bill includes 
authority to exceed the limitation on assessments by 10 percent 
with notification to the Appropriations Committees.
    19. General Provisions.--
    Section 704: This provision provides that none of the funds 
in this Act may be made available to pay indirect costs charged 
against competitive agricultural research, education, or 
extension grants awarded by the National Institute of Food and 
Agriculture in excess of 10 percent of total direct costs.
    Section 705: This provision allows funds made available in 
the current fiscal year for the Rural Development Loan Fund 
program account; the Rural Electrification and 
Telecommunications Loans program account; and the Rural Housing 
Insurance Fund program account to remain available until 
expended to disburse obligations.
    Section 706: Language is included that requires approval of 
the Chief Information Officer and the concurrence of the 
Executive Information Technology Investment Review Board for 
acquisition of new information technology systems or 
significant upgrades, and that prohibits the transfer of funds 
to the Office of the Chief Information Officer without the 
notification of the Committees on Appropriations of both Houses 
of Congress.
    Section 707: Language is included regarding the 
availability of funds for certain conservation programs.
    Section 708: Language is included regarding certain Rural 
Utilities Service Programs.
    Section 709: Language is included that allows unobligated 
balances of the Farm Service Agency and Rural Development 
mission areas to be used for information technology purposes.
    Section 710: Language is included regarding the prohibition 
of first-class travel by the employees of agencies funded in 
this Act.
    Section 711: Language is included regarding the funds of 
the Commodity Credit Corporation.
    Section 712 Language is included that limits the amount of 
spending for USDA Advisory Committees.
    Section 713: Language is included regarding indirect costs 
for grants.
    Section 714: Language regarding certain limitations of 
mandatory programs.
    Section 715: Language regarding certain limitations of 
mandatory programs.
    Section 716: Language is included that prohibits funds from 
being used to prepare a budget submission to Congress that 
assumes reductions from the previous year's budget due to user 
fee proposals unless the submission also identifies spending 
reductions which should occur if the user fees are not enacted.
    Section 717: Language is included that requires certain 
reprogramming procedures of funds provided in Appropriations 
Acts.
    Section 718: Language is included regarding fees for the 
business and industry guaranteed loan program.
    Section 719: This provision prohibits the Department of 
Agriculture or the Food and Drug Administration from 
transmitting or making available to any non-Department of 
Agriculture or non-Department of Health and Human Services 
employee questions or responses to questions that are a result 
of information requested for the appropriations hearing 
process.
    Section 720: Language regarding prepackaged news stories.
    Section 721: This provision prohibits any employee of the 
Department of Agriculture from being detailed or assigned to 
any other agency or office of the Department for more than 60 
days unless the individual's employing agency or office is 
fully reimbursed by the receiving agency or office for the 
salary and expenses of the employee for the period of 
assignment.
    Section 722: Language is included regarding rulemaking.
    Section 723: Language is included requiring spending plans 
for each agency funded by the Act.
    Section 724: Language is included regarding the use funds 
for humanitarian food assistance programs.
    Section 725: Language is included regarding the Single 
Family Housing Direct Loan Program.
    Section 726: Language is included on certain USDA loan 
programs.
    Section 727: Language is included regarding the Working 
Capital Fund.
    Section 728: Language is included regarding purchases made 
through child nutrition programs.
    Section 729: Language is included regarding farm disaster 
programs.
    Section 730: Language is included regarding the Agriculture 
and Food Research Institute.
    Section 731: Language is included regarding school meal 
programs.
    Section 732: Language is included regarding interagency 
coordination of nutrition research.
    Section 733: Language is included regarding rural loan 
programs.
    Section 734: Language is included regarding disclosure of 
information for pharmaceuticals.
    Section 735: Language is included regarding menu labeling.
    Section 736: Language is included regarding research 
exemptions.
    Section 737: Language is included regarding spent grains 
for animal feed.
    Section 738: Language is included regarding APHIS.
    Section 739: Language is included regarding the Animal 
Welfare Act.
    Section 740: Language is included regarding partially 
hydrogenated oils.
    Section 741: Language is included regarding the Rural 
Housing Service.
    Section 742: Language is included regarding federal IT 
regulations.
    Section 743: Language is included regarding funding for 
APHIS Buildings and Facilities.
    Section 744: Language is included regarding SNAP household 
reporting requirements.
    Section 745: Language is included regarding a rescission of 
unobligated balances.
    Section 746: Language is included regarding RUS programs.
    Section 747: Language is included regarding FDA labeling.
    Section 748: Language is included regarding the emergency 
food assistance program.
    Section 749: Language is included regarding FDA.
    Section 750: Language is included regarding rural poverty 
programs.
    Section 751: Language is included regarding Rural 
Development programs.
    Section 752: Language is included regarding Ebola funding.
    Section 753: Language is included regarding the Emergency 
Watershed Program.
    Section 754: Language is included regarding lobbying by 
federal employees.
    Section 755: Language is included regarding 21st Century 
Cures.
    Section 756: Language is included regarding FDA regulation.
    Section 757: Language is included regarding citrus greening 
disease.
    Section 758: Language is included regarding a rescission of 
certain unobligated balances.
    Section 759: Language is included regarding a rescission of 
certain unobligated balances.
    Section 760: Language is included regarding APHIS 
regulation.
    Section 761: Language is included regarding FDA regulation.
    Section 762: Language is included regarding the use of 
funds for certain horse inspection activities.
    Section 763: Language is included regarding the SNAP 
program.
    Section 764: Language is included regarding FDA guidance.
    Section 765: Language is included regarding CFTC 
regulation.
    Section 766: Language is included regarding food retailer 
financing.
    Section 767: Language is included regarding livestock 
marketing arrangements.
    Section 801: Language is included regarding the use of 
certain unobligated balances.
    Section 802: Language is included regarding the Spending 
Reduction Account.

                  APPROPRIATIONS NOT AUTHORIZED BY LAW

    Pursuant to clause 3(f)(1)(B) of rule XIII of the Rules of 
the House of Representatives, the following table lists the 
appropriations in the accompanying bill which are not 
authorized by law for the period concerned:

----------------------------------------------------------------------------------------------------------------
                                                                           Appropriation in
         Agency/Program              Last year of        Authorization       last year of      Appropriations in
                                     authorization           level           authorization         this bill
----------------------------------------------------------------------------------------------------------------
CFTC............................                2013           Such sums         205,000,000         250,000,000
    Food and Nutrition Service:
    Farmers' Market Nutrition                   2015           Such sums          16,548,000          18,548,000
     Program:...................
    State Administrative                        2015           Such sums         263,686,000         279,058,000
     Expenses...................
    Summer Food Service Program.                2015           Such sums         495,521,000         628,484,000
    WIC.........................                2015           Such sums       6,623,000,000       6,350,000,000
----------------------------------------------------------------------------------------------------------------

                 COMPARISON WITH THE BUDGET RESOLUTION

    Pursuant to clause 3(c)(2) of rule XIII of the Rules of the 
House of Representatives and section 308(a)(1)(A) of the 
Congressional Budget Act of 1974, the following table compares 
the levels of new budget authority provided in the bill with 
the appropriate allocation under section 302(b) of the Budget 
Act:

                                            [In millions of dollars]
----------------------------------------------------------------------------------------------------------------
                                                                  302(b) Allocation             This Bill
                                                             ---------------------------------------------------
                                                                 Budget                    Budget
                                                               Authority     Outlays     Authority     Outlays
----------------------------------------------------------------------------------------------------------------
Comparison of amounts in the bill with Committee allocations
 to its subcommittees: Subcommittee on Agriculture, Rural
 Development, Food and Drug Administration, and Related
 Agencies:
    Mandatory...............................................      115,512      104,156      115,512   \1\104,156
    Discretionary...........................................       21,229       22,192       21,299       22,191
----------------------------------------------------------------------------------------------------------------
\1\Includes outlays from prior-year budget authority.

                      FIVE-YEAR OUTLAY PROJECTIONS

    Pursuant to clause 3(c)(2) of rule XIII and section 
308(a)(1)(B) of the Congressional Budget Act of 1974, the 
following table contains five-year projections associated with 
the budget authority provided in the accompanying bill as 
provided to the Committee by the Congressional Budget Office:

                                            [In millions of dollars]
----------------------------------------------------------------------------------------------------------------
                                                                  302(b) Allocation             This Bill
                                                             ---------------------------------------------------
                                                                 Budget                    Budget
                                                               Authority     Outlays     Authority     Outlays
----------------------------------------------------------------------------------------------------------------
Projection of outlays associated with the recommendation:
    2017....................................................          n.a          n.a          n.a   \1\111,433
    2018....................................................          n.a          n.a          n.a        5,017
    2019....................................................          n.a          n.a          n.a        1,024
    2020....................................................          n.a          n.a          n.a          375
    2021 and future years...................................          n.a          n.a          n.a           77
----------------------------------------------------------------------------------------------------------------
\1\Excludes outlays from prior-year budget authority.

               ASSISTANCE TO STATE AND LOCAL GOVERNMENTS

    Pursuant to clause 3(c)(2) of rule XIII and section 
308(a)(1)(C) of the Congressional Budget Act of 1974, the 
Congressional Budget Office has provided the following 
estimates of the amounts of financial assistance to State and 
local governments is as follows:

                                            [In millions of dollars]
----------------------------------------------------------------------------------------------------------------
                                                                  302(b) Allocation             This Bill
                                                             ---------------------------------------------------
                                                                 Budget                    Budget
                                                               Authority     Outlays     Authority     Outlays
----------------------------------------------------------------------------------------------------------------
Financial assistance to State and local governments for 2017          n.a          n.a       40,690    \1\32,915
----------------------------------------------------------------------------------------------------------------
\1\Excludes outlays from prior-year budget authority.

                          PROGRAM DUPLICATION

    No provision of this bill 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 GAO 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.

                          DIRECTED RULE MAKING

    Pursuant to secton 3(i)(1) of H. Res. 5 (114th Congress), 
the Committee estimates that the bill directs one rulemaking in 
section 756 and two rulemakings in section 761.



     DISSENTING VIEWS OF THE HON. NITA LOWEY AND THE HON. SAM FARR

    The FY2017 Agriculture, Rural Development, Food and Drug 
Administration and Related Agencies Appropriations Act provides 
acceptable, though not ideal, funding levels for many important 
investments. We are grateful that the Committee made some 
improvements to the bill by voting to restore the ban on 
inspection of horses for slaughter for human food and, for the 
first time in this bill, to provide funding for the Healthy 
Foods Financing Initiative.
    However, given our deep concerns about a number of aspects 
of the bill and the remaining amendments adopted in full 
Committee, we do not support this bill in its current form.
    The bill is $451 million below last year's enacted level 
and $281 million below the President's request. Yet despite a 
host of increases for a variety of programs and activities in 
the bill, the majority has once again funded CFTC at $250 
million, equal to the enacted level in 2015 and 2016 and $80 
million below the President's request. There is no question 
that the agency needs more funding than Congress has provided 
in order to implement the laws that Congress enacted. Unlike 
previous years, we hope this year the subcommittee will resolve 
CFTC's funding at a level that allows the agency to fulfill its 
obligations.
    We are disappointed that the Committee adopted bill 
language locking in the swap dealer de minimis level at $8 
billion. This is the fourth consecutive year in which the 
Committee has interjected itself into this matter. We believe 
CFTC has approached this issue responsibly and that an 
appropriations bill is not the appropriate place to deal with 
this issue.
    We strongly oppose the Committee's adoption of an amendment 
that would allow unregulated tobacco products, including e-
cigarettes, to stay on the market without pre-market review by 
the Food and Drug Administration (FDA). There are hundreds of 
brands of e-cigarettes and more than 7,000 e-cigarette flavors, 
including Kool-Aid, gummy bears and cotton candy, intended to 
appeal to young people. And that appeal has worked. CDC found 
that in 2014, e-cigarettes were the most commonly used tobacco 
product among both middle school (3.9%) and high school (13.4%) 
students. CDC also found that the rate of use by high school 
students of e-cigarettes skyrocketed from 1.5% in 2011 to 13.4% 
in 2014. Between just 2013 and 2014, the number of high school 
students using e-cigarette use tripled from 660,000 to 
2,000,000.
    There is no scientific consensus as to whether e-cigarettes 
may be less harmful than regular cigarettes. The American 
people trust FDA to evaluate the data and make unbiased 
decisions about product safety. Congress certainly lacks the 
expertise to make such an assessment.
    We also regret the adoption of bill language that hinders 
USDA's efforts to protect the rights of small livestock 
producers and is strongly opposed by both the American Farm 
Bureau Federation and the National Farmers Union. By preventing 
retaliation against small producers for their ``lawful 
expression, spoken or written or association,'' the proposed 
rule is intended to protect one of our nation's most important 
values--freedom of speech. If a small livestock producer writes 
a letter to a newspaper or participates in a meeting to express 
his or her views, this bill places the producer at risk of 
retaliation by packers, contractors or live poultry dealers.
    In international food programs, we appreciate the increase 
over the budget request for both Food for Peace (FFP) and the 
McGovern-Dole programs. However, we strongly oppose the 
inclusion of bill language that would block use of certain 
other USAID funds for non-emergency food aid in FFP, a practice 
that GAO found to be lawful.
    We are again deeply disappointed that the bill does not 
include the President's requests for flexibility in the FFP and 
McGovern-Dole programs, while it does include inaccurate report 
language about the use of cash and local purchase in food aid. 
We also regret that the bill does not fund the Local and 
Regional Food Aid Procurement Program.
    Moving forward, we will work to increase funding for the 
Summer EBT Demonstration program, which is funded at $5 million 
below the request, and to increase funding for USDA's animal 
welfare activities. Both the Ranking Member of the full 
committee and subcommittee requested these increases.

                       Addressing the Zika Crisis

    On February 22, 2016, the Administration requested nearly 
$1.9 billion to combat the spread of the Zika virus. Two months 
later, the Republican majority has not taken up the 
Administration's request, even as the summer months approach 
and the threat of Zika-infected mosquitoes continues to grow in 
the United States.
    Committee Democrats attempted to address the threat of the 
Zika virus by offering an amendment to fund the 
Administration's request of nearly $1.9 billion. The amendment 
offered by full Committee Ranking Member Nita Lowey would have 
funded prevention, detection, and response to the Zika virus as 
well as additional research, development, and procurement of 
vaccines, therapeutics, and diagnostics. The Republican 
majority, rather than allow a vote on Ranking Member Lowey's 
amendment, introduced a perfecting amendment that denied 
additional emergency funds for a Zika response and reneged on 
America's commitment to continue to fight Ebola, even as new 
cases have surfaced in Africa.
    After the Committee adopted the Republican majority's 
amendment, Labor-HHS-Education subcommittee Ranking Member Rosa 
DeLauro offered an amendment to fund a modified version of the 
emergency request for Zika, as revised by the Administration. 
Ranking Member DeLauro's amendment proposed to allocate 
additional funds for research and advanced development of 
vaccines and diagnostics through the National Institutes of 
Health (NIH) and the Biomedical Advanced Research and 
Development Authority (BARDA), while removing funds requested 
for CDC facilities and a contingency fund. The majority blocked 
the amendment on a largely party-line vote of 20-29.
    The result of the Republican majority's amendment is to 
promote an inadequate response to both Zika and Ebola by 
syphoning resources from the Ebola response to partially fund a 
Zika response. We must confront Zika immediately with dedicated 
resources for CDC, NIH, BARDA, and the U.S. Agency for 
International Development. U.S. efforts to keep Ebola at bay in 
Africa must not be weakened as we increase response to the Zika 
virus in the Americas. We must be prepared to respond to both 
public health crises.
    Moreover, Democrats will find it difficult to support 
individual FY 2017 appropriations bills until it is clear that 
Congress will provide needed resources in FY 2016 to respond to 
the Zika virus.
    As the legislative process continues, we will do our best 
to address the problems we have described here; however, we do 
not support the bill in its current form.

                                   Nita M. Lowey.
                                   Sam Farr.

           ADDITIONAL VIEWS OF THE HONORABLE ROSA L. DELAURO

    The Agricultural Appropriations bill contains some of the 
nation's most important investments in food and medical product 
safety, animal and plant health programs, and vital nutrition 
programs. Unfortunately, the 2017 bill contains a number of 
partisan ideological provisions that completely undermine our 
regulatory agencies' abilities to do their jobs, and puts the 
lives of children, seniors, and families at risk.
    The Food and Drug Administration is one of our most 
critical lines of defense in ensuring the health and wellbeing 
of Americans. This bill includes language that restricts the 
FDA's ability to finalize guidance on laboratory developed 
tests, which are currently unregulated. These tests are the 
precipice for people receiving treatment from life-threatening 
diseases, and having FDA oversight of LDTs is crucial to 
ensuring they have been properly validated and is essential to 
patient safety. This viewpoint has the support of 36 patient 
groups who wrote to the Committee in support of FDA's oversight 
of Laboratory Developed Tests.
    Additionally, I am concerned that this bill includes report 
language to prevent the FDA from finalizing their rule on 
generic drug labeling. Generic drugs should be able update 
their labels with new safety information, just like name brand 
drugs have been able to for almost 30 years.
    This bill also delays the FDA from finalizing menu labeling 
requirements. Americans eat nearly half their meals and snacks 
outside of their homes, and research shows that many of these 
foods have more calories and poorer nutritional quality than 
those prepared at home. Calorie and nutrition transparency is 
crucial for empowering consumers to make healthy choices and is 
a key to address our public health crises of obesity and 
diabetes. A recent Harvard study found restaurant menu calorie 
labeling could save over $4.6 billion in healthcare costs over 
ten years. Consumers have the right to know the nutritional 
content of their food and we should not continue to kick the 
can down the road when it comes to menu labeling.
    Further, the bill includes provisions of the 21st Century 
Cures Act that would expedite the approval process of medical 
devices and weaken the statistical standards for clinical 
trials--such substantial authorizing language has no place in 
an appropriations bill. This is not how Congress is meant to 
work.
    In 2012, after 753 people were sickened, and 63 died, from 
contaminated compounded drugs, Congress passed the Drug Quality 
and Security Act. I was concerned that this law was weak to 
begin with--in that it set up a voluntary regulatory regime for 
compounding pharmacies and failed to require a prescription for 
all compounded drugs. However, this bill contains numerous 
provisions that further weaken the law by lowering the 
standards for compounding facility inspections and ``office 
use'' compounding. Given that the meningitis outbreak caused by 
poorly compounded medicines was less than 4 years ago, now is 
not the time to lower the standards we hold compounding 
pharmacies to.
    In addition, the committee adopted an amendment that will 
exempt already marketed e-cigarettes, nicotine vapor, and other 
tobacco products from FDA's tobacco deeming rule. We must 
protect the nation's youth from the dangers of tobacco use. It 
is now almost seven years since Congress passed the Family 
Smoking Prevention and Tobacco Control Act. Yet there are still 
many kinds of tobacco products that remain unregulated, and 
youth are using those products at disturbing rates. The Centers 
for Disease Control and Prevention recently released data 
showing an alarming increase in use of electronic cigarettes 
among youth continues--almost a tenfold increase in use over 
the past 4 years. The report also found that approximately 4.7 
million children and teenagers who use tobacco, and that 
tobacco use and addiction mostly began during youth and young 
adulthood. More must be done to drive these rates down, and 
sadly this new rider will do just the opposite.
    The issues with the bill are not just limited to provisions 
regarding the FDA. The bill includes a study to explore 
allowing the purchase of vitamins by WIC recipients. Vitamins 
are an unregulated industry with no guarantee of safety or 
effectiveness. Additionally, this committee adopted an 
amendment to block USDA rules to protect farmers from unfair 
and abusive practices that are all too common.
    The Committee adopted the Rogers amendment that redirected 
the funding Congress provided to respond to Ebola public health 
emergency to the emerging threat posed by the Zika virus. This 
is shortsighted, and irresponsible for us to shift these funds 
to another crisis. Instead Congress should immediately pass an 
emergency supplemental appropriations bill to support our 
response to the Zika virus. The Administration requested an 
emergency appropriation of $1.9 billion to face the Zika 
threat. Unfortunately, the Administration has already been 
forced to rob nearly $600 million from Ebola to respond to 
Zika. This is dumbfounding. The Ebola crisis is not over. These 
funds are being directed away from other critical and 
threatening global health risks and are being repurposed only 
as a last resort--not because it is the right thing to do from 
a policy perspective.
    During markup in the full committee, I offered a series of 
amendments would have stripped harmful provisions that exempt 
cigars from the tobacco deeming regulation and weaken 
compounding pharmacy regulations. I am disappointed that 
special interests prevailed and my amendments were rejected on 
voice vote.
    The bill has too many provisions that would harm the health 
and safety of Americans by underfunding our food safety 
regulators and failing to adequately address nutrition and farm 
worker protections. I urge all my colleagues to oppose this 
bill.

                                      Rosa DeLauro.