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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.
