99–791 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
2 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
3 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
4 

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 

enacted 

FY 2017 

estimate 

Committee 

provision 

Office of the Secretary ........................................................................................................ $5,051 $10,178 $5,051 

Office of Tribal Relations ................................................................................................... 502 755 502 

Office of Homeland Security and Emergency Coordination ............................................... 1,496 1,592 1,496 

Office of Advocacy and Outreach ....................................................................................... 1,209 11,220 1,209 

Office of the Assistant Secretary for Administration ......................................................... 804 807 804 

Departmental Administration .............................................................................................. 25,124 27,420 24,124 

Office of the Assistant Secretary for Congressional Relations ......................................... 3,869 3,919 3,869 


SSpencer on DSK4SPTVN1PROD with REPORTS
5 

OFFICE OF THE SECRETARY—Continued 

[Dollars in Thousands] 

FY 2016 

enacted 

FY 2017 

estimate 

Committee 

provision 

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 emVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00005 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
6 

ployee, 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 CommitVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
7 

tees 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 subVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00007 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
8 

mitted 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] 

Year GSA Rent and 

DHS Costs Change 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
9 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
10 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
11 

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 pro- vides 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, welldocumented 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
12 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
13 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
14 

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 transiVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00014 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
15 

tion, 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
16 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
17 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
18 

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 inVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00018 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
19 

creasingly 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 toVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00019 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
20 

ward 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
21 

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 mandaVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00021 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
22 

tory 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] 

Program/Activity Authorization 2016 

enacted 

2017 

estimate 

Committee 

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 Program).7 U.S.C. 3222 ........................... 54,185 58,000 54,185 

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 Institutions .. 7 U.S.C. 3241 ........................... 9,219 9,219 9,219 

Education Grants for Alaska Native and Native Hawaiian-Serving Institutions.7 U.S.C. 3156 ........................... 3,194 3,194 3,194 

Research Grants for 1994 Institutions ...................... 7 U.S.C. 301 note ..................... 1,801 3,914 1,801 

Capacity Building for Non Land-Grant Colleges of 

Agriculture.

7 U.S.C. 3319i .......................... 5,000 – – – – – – 


SSpencer on DSK4SPTVN1PROD with REPORTS
23 

NATIONAL INSTITUTE OF FOOD AND AGRICULTURE—RESEARCH AND EDUCATION ACTIVITIES— 

Continued 

[Dollars in Thousands] 

Program/Activity Authorization 2016 

enacted 

2017 

estimate 

Committee 

provision 

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 Military 

Veterans.

................................................... – – – 2,500 – – – 

Continuing Animal Health and Disease Research 

Program.

7 U.S.C. 3195 ........................... 4,000 – – – 4,000 

Supplemental and Alternative Crops ......................... 7 U.S.C. 3319d ......................... 825 – – – – – – 

Multicultural Scholars, Graduate Fellowship and Institution Challenge Grants.7 U.S.C. 3152(b) ...................... 9,000 – – – 9,000 

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 Education ..... 7 U.S.C. 5811, 5812, 5831, 

and 5832.

24,667 29,967 24,667 

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 Expenses.................................................... 6,549 7,527 6,549 

Total, Necessary Expenses ........................ ................................................... 20,339 23,277 20,339 

Total, Research and Education Activities.................................................... $819,685 $836,915 $832,860 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
24 

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] 

Program/Activity Authorization FY 2016 

enacted 

FY 2017 

estimate 

Committee 

provision 

Smith-Lever Act, Section 3(b) and (c) programs and 

Cooperative Extension.

7 U.S.C. 343(b) and (c) and 

208(c) of P.L. 93–471.

$300,000 $300,000 $300,000 

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 Program 7 U.S.C. 7642 ........................... 1,250 – – – 1,250 

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 Education 

Programs.

................................................... 4,610 4,610 4,610 

New Technologies for Agricultural Extension .... ................................................... 1,550 – – – 1,550 

Children, Youth, and Families at Risk .............. ................................................... 8,395 8,395 8,395 

Federally Recognized Tribes Extension Program ................................................... 3,039 5,839 3,039 

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 Expenses for Extension Activities.................................................... 7,805 8,144 7,805 

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 appropria- tion of $30,900,000. 


SSpencer on DSK4SPTVN1PROD with REPORTS
25 

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] 

Program/Activity Authorization FY 2016 

enacted 

FY 2017 

estimate 

Committee 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
26 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
27 

[Dollars in Thousands] 

Committee provision 

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 Assistance ................................................................. 37,213 

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 StatisVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00027 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
28 

tical 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
29 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
30 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
31 

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 shortterm 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
32 

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 APHISfunded 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
33 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
34 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
35 

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 Receipts) ................................................................. $10,316,645 $10,929,841

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 Available, Start of Year ....................................................... 223,344 125,000 

Unavailable for Obligations (recoveries & offsetting collections) .............................. 0 0 

Transfer of Prior Year Funds to FNS (F&V) ................................................................. ¥122,000 ¥125,000 

Budget Authority: ................................................................................................ 1,303,000 1,322,000 

Rescission of Current Year Funds ............................................................................... ¥215,636 ¥231,443 

Appropriations Temporarily Reduced—Sequestration ................................................. ¥77,384 ¥79,557 

Unavailable for Obligations (F&V Transfer to FNS) .................................................... ¥125,000 ¥125,000 

Available for Obligation: ..................................................................................... 884,980 886,000 

Less Obligations: 

Child Nutrition Programs (Entitlement Commodities) ....................................... 465,000 465,000 

State Option Contract ......................................................................................... 5,000 5,000 

Removal of Defective Commodities .................................................................... 2,500 2,500 

Emergency Surplus Removal .............................................................................. 118,500 0 

Small Business Support ..................................................................................... 0 0 

Disaster Relief .................................................................................................... 5,000 5,000 

Additional Fruits, Vegetables, and Nuts Purchases .......................................... 107,500 206,000 

Fresh Fruit and Vegetable Program ................................................................... 40,000 44,000 

Estimated Future Needs ..................................................................................... 87,192 102,571 

Total, Commodity Procurement .................................................................. 830,692 830,071 

Administrative Funds: 

Commodity Purchase Support ................................................................... 33,799 35,440 

Marketing Agreements and Orders ............................................................ 20,489 20,489 


SSpencer on DSK4SPTVN1PROD with REPORTS
36 

ESTIMATED TOTAL FUNDS AVAILABLE AND BALANCE CARRIED FORWARD FISCAL YEARS 2016– 

2017—Continued 

[Dollars in Thousands] 

FY 2016 enacted FY 2017 estimate 

Total, Administrative Funds ............................................................. 54,288 55,929 

Total Obligations ................................................................................................ 884,980 886,000 

Unobligated Balance, End of Year .............................................................................. 0 0 

Unavailable for Obligations (F&V Transfer to FNS) .................................................... 125,000 125,000 

Balances, Collections, and Recoveries Not Available ................................................. 0 0 

Total, End of Year Balances ..................................................................... $125,000 $125,000 

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 Administra- tion, 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
37 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
38 

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 handwashing 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)

Appropriation Transfer from 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
39 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
40 

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 ......................................................................... 1500,000 

Provided in the bill ............................................................................. 1500,000 

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). 


SSpencer on DSK4SPTVN1PROD with REPORTS
41 

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] 

FY 2016 

enacted 

FY 2017 

estimate 

Committee 

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 

subsidy 

Guaranteed 

loan subsidy Grants Administrative 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 

enacted 

FY 2017 

estimate 

Committee 

provision 

Farm Loan Subsidies: 

Farm Operating: 

Direct ............................................................................................... $53,961 $62,198 $62,198 


SSpencer on DSK4SPTVN1PROD with REPORTS
42 

AGRICULTURE CREDIT PROGRAMS—SUBSIDIES AND GRANTS—Continued 

[Dollars in Thousands] 

FY 2016 

enacted 

FY 2017 

estimate 

Committee 

provision 

Unsubsidized Guaranteed ............................................................... 14,352 15,327 15,327 

Emergency Loans ..................................................................................... 1,262 1,262 1,938 

Indian Highly Fractionated Land ............................................................. – – – 2,550 2,550 

Individual Development Accounts ............................................................ – – – 1,500 – – – 

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 1Does 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$7,857,970,000 

2017 budget estimate ......................................................................... 18,839,089,000 

Provided in the bill ............................................................................. 18,839,089,000 

Comparison: 

2016 appropriation ...................................................................... +981,119,000 

2017 budget estimate .................................................................. – – – 1 Current indefinite appropriation. 


SSpencer on DSK4SPTVN1PROD with REPORTS
43 

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 $6,871,132,000 

2017 budget estimate ......................................................................... 113,476,854,000 

Provided in the bill ............................................................................. 113,476,854,000 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
44 

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 appro- priation 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
45 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
46 

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 pro- vides 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 ProVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00046 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
47 

gram, 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)

FY 2016 

enacted 

FY 2017 

estimate 

Committee 

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 Program Account .............................................................. 34,707,000 36,451,000 33,414,000 

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] 

Loan level Subsidy level Administrative 

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 nonprofit 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
48 

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 2016 

enacted 

FY 2017 

estimate 

Committee 

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 

enacted 

FY 2017 

estimate 

Committee 

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. 524) ................................................................... – – – 111 111 

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 Expenses ................................................................. $417,854 $426,821 $410,086 

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 .................................................................. – – – 


SSpencer on DSK4SPTVN1PROD with REPORTS
49 

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 commuVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00049 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
50 

nities 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] 

FY 2016 

enacted 

FY 2017 

estimate 

Committee 

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 

Subsidy and Grants ...................................... $42,278 $37,000 $47,100 

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 

enacted 

FY 2017 

estimated 

Committee 

provision 

Loan Level: 

Business and Industry Guaranteed Loans ..................................... ($919,768) ($892,244) ($919,768) 

Subsidy and Grants: 

Business and Industry Guaranteed Loans ..................................... 35,687 35,779 36,883 

Rural Business Development Grants .............................................. 24,000 55,000 35,000 

Delta Regional Authority/Appalachian Regional Commission ........ 3,000 – – – 5,000 

Total, Rural Business Program Subsidy and Grants ... $62,687 $90,779 $76,883 

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 consoliVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00050 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
51 

dated 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] 

Loan level Subsidy level Administrative 

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)

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
52 

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 pro- vides 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 efVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00052 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
53 

forts 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] 

FY 2016 enacted FY 2017 estimate Committee 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
54 

[Dollars in Thousands] 

FY 2016 enacted FY 2017 estimate Committee provision 

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] 

Loan level Subsidy level Administrative 

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 

enacted 

FY 2017 

estimate 

Committee 

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 Authorizations .............................................................. $6,940,000 $7,190,056 $6,940,000 

DISTANCE LEARNING, TELEMEDICINE, AND BROADBAND PROGRAM

[Dollars in Thousands] 

FY 2016 

enacted 

FY 2017 

estimate 

Committee 

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: 


SSpencer on DSK4SPTVN1PROD with REPORTS
55 

[Dollars in Thousands] 

FY 2016 

enacted 

FY 2017 

estimate 

Committee 

provision 

Grants ...................................................................................................... 22,000 34,950 25,000 

Total, Loan Subsidy and Grants ..................................................... $36,872 $74,442 $62,560 

COMMITTEE PROVISIONS

For the Distance Learning, Telemedicine, and Broadband Pro- gram, 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 activiVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00055 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
56 

ties 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 reVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00056 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
57 

quirement 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
58 

[Dollars in Thousands] 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
59 

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 Com- mittee 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
60 

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 Program .................................................................. 414,000 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
61 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
62 

TITLE V 

FOREIGN ASSISTANCE AND RELATED PROGRAMS 

FOREIGN AGRICULTURAL SERVICE

SALARIES AND EXPENSES

(INCLUDING TRANSFERS OF FUNDS)

Appropriation Transfer from export 

loan account Total 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
63 

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 deter- mined 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
64 

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 .................................................................. – – – 


SSpencer on DSK4SPTVN1PROD with REPORTS
65 

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] 

Appropriation User Fees Total, FDA 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
66 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
67 

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 ApplicaVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00067 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
68 

tions 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
69 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
70 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
71 

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 indiVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00071 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
72 

vidual’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 


SSpencer on DSK4SPTVN1PROD with REPORTS
73 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
74 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
75 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
76 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
77 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
78 

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 furVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00078 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
79 

ther 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
80 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
81 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
82 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
83 

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: 


SSpencer on DSK4SPTVN1PROD with REPORTS
84 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 016 here HR531.001
85 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 017 here HR531.002
86 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 018 here HR531.003
87 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 019 here HR531.004
88 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 020 here HR531.005
89 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 021 here HR531.006
90 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 022 here HR531.007
91 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 023 here HR531.008
92 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 024 here HR531.009
93 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 025 here HR531.010
94 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 026 here HR531.011
95 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
96 

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): 


SSpencer on DSK4SPTVN1PROD with REPORTS
97 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
98 

through 2004, and $250,000 for each of fiscal years ø2010 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 

øSection 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 SecVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00098 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
99 

retary 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
100 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
101 

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 apVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00101 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
102 

proved 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; 


SSpencer on DSK4SPTVN1PROD with REPORTS
103 

(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 noninfringeVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00103 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
104 

ment, 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.— 


SSpencer on DSK4SPTVN1PROD with REPORTS
105 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
106 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
107 

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. øThe 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
108 

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 reasonVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00108 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
109 

able 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
110 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
111 

(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), inforVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00111 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
112 

mation 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.— 


SSpencer on DSK4SPTVN1PROD with REPORTS
113 

(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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
114 

(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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
115 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
116 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
117 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
118 

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 AC- TION.— 

(I) IN GENERAL.—No action may be brought under 

section 2201 of title 28, United States Code, by an apVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00118 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
119 

plicant 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 APPLICA- TION.—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 


SSpencer on DSK4SPTVN1PROD with REPORTS
120 

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 exVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00120 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
121 

clusivity 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
122 

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 peVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00122 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
123 

riod 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— 


SSpencer on DSK4SPTVN1PROD with REPORTS
124 

(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 simiVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00124 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
125 

lar 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
126 

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 deVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00126 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
127 

velopment of effective research methods for the study 

of drug safety questions. 

(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTI- FICATION 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
128 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
129 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
130 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
131 

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, 


SSpencer on DSK4SPTVN1PROD with REPORTS
132 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
133 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
134 

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: 


SSpencer on DSK4SPTVN1PROD with REPORTS
135 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
136 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
137 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
138 

(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 CER- TAIN 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
139 

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: llllllllll. 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: 

lllllllllllll. 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 intenVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00139 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
140 

tionally 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 llllllllll. 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: lllll. 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; 


SSpencer on DSK4SPTVN1PROD with REPORTS
141 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
142 

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 informaVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00142 Fmt 6659 Sfmt 6602 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
143 

tion 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.— 


SSpencer on DSK4SPTVN1PROD with REPORTS
144 

(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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
145 

(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). 


SSpencer on DSK4SPTVN1PROD with REPORTS
146 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
147 

(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— 


SSpencer on DSK4SPTVN1PROD with REPORTS
148 

(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— 


SSpencer on DSK4SPTVN1PROD with REPORTS
149 

(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— 


SSpencer on DSK4SPTVN1PROD with REPORTS
150 

(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— 


SSpencer on DSK4SPTVN1PROD with REPORTS
151 

(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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
152 

(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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
153 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
154 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
155 

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). 


SSpencer on DSK4SPTVN1PROD with REPORTS
156 

(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. 

ø(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— 

ø(A) representing breakthrough technologies, 

ø(B) for which no approved alternatives exist, 

ø(C) which offer significant advantages over existing approved alternatives, or 

ø(D) the availability of which is in the best interest of the 

patients.¿ 

ø(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
157 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
158 

(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, 


SSpencer on DSK4SPTVN1PROD with REPORTS
159 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
160 

(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, 


SSpencer on DSK4SPTVN1PROD with REPORTS
161 

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 adviVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00161 Fmt 6659 Sfmt 6601 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
162 

sory 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). 


SSpencer on DSK4SPTVN1PROD with REPORTS
163 

(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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
164 

(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 


SSpencer on DSK4SPTVN1PROD with REPORTS
165 

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. 

* * * * * * * 


SSpencer on DSK4SPTVN1PROD with REPORTS
166 

SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT 

DECISIONS REGARDING DEVICES. 

(a) DOCUMENTATION OF RATIONALE FOR SIGNIFICANT DECI- SIONS.— 

(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 DECI- SION.—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 inperson 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
167 

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 


SSpencer on DSK4SPTVN1PROD with REPORTS
168 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
169 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
170 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
171 

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: 

Agency/Program Last year of 

authorization Authorization level Appropriation in last year of authorization 

Appropriations in this bill 

CFTC ............................................... 2013 Such sums 205,000,000 250,000,000 

Food and Nutrition Service: 

Farmers’ Market Nutrition 

Program: ........................... 2015 Such sums 16,548,000 18,548,000 

State Administrative Expenses .............................. 2015 Such sums 263,686,000 279,058,000 

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 

Authority Outlays Budget 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 

Authority Outlays Budget 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
172 

[In millions of dollars] 

302(b) Allocation This Bill 

Budget 

Authority Outlays Budget Authority Outlays 

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 

Authority Outlays Budget 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
173 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0106 here 98528.001
174 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0107 here 98528.002
175 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0108 here 98528.003
176 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0109 here 98528.004
177 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0110 here 98528.005
178 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0111 here 98528.006
179 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0112 here 98528.007
180 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0113 here 98528.008
181 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0114 here 98528.009
182 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0115 here 98528.010
183 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0116 here 98528.011
184 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0117 here 98528.012
185 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0118 here 98528.013
186 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0119 here 98528.014
187 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0120 here 98528.015
188 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0121 here 98528.016
189 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0122 here 98528.017
190 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0123 here 98528.018
191 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0124 here 98528.019
192 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0125 here 98528.020
193 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0126 here 98528.021
194 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0127 here 98528.022
195 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0128 here 98528.023
196 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0129 here 98528.024
197 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0130 here 98528.025
198 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0131 here 98528.026
199 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0132 here 98528.027
200 


SSpencer on DSK4SPTVN1PROD with REPORTSInsert offset folio 0133 here 98528.028
(201) 

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 ecigarettes 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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
202 

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 McGovernDole 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 Sum- mer 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
203 

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. 


SSpencer on DSK4SPTVN1PROD with REPORTS
(204) 

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 proviVerDate Sep 11 2014 07:36 Apr 27, 2016 Jkt 099791 PO 00000 Frm 00204 Fmt 6604 Sfmt 6604 E:\HR\OC\HR531.XXX HR531

SSpencer on DSK4SPTVN1PROD with REPORTS
205 

sions 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 


SSpencer on DSK4SPTVN1PROD with REPORTS
206 

failing to adequately address nutrition and farm worker protections. I urge all my colleagues to oppose this bill. 

ROSA DELAURO. 

Æ 


SSpencer on DSK4SPTVN1PROD with REPORTS