FDA Fiscal Year 2016 Justification of Estimates for Appropriations

282 Pages·2015·3.95 MB·English

DEPARTMENT
of HEALTH
and HUMAN
SERVICES

Fiscal Year
2016

Food and Drug Administration

Justification of
Estimates for
Appropriations Committees
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LETTER FROM THE COMMISSIONER

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TABLE OF CONTENTS
Letter from the Commissioner ....................................................................................................................... i
Table of Contents ......................................................................................................................................... iii
Organization Chart ........................................................................................................................................ v
EXECUTIVE SUMMARY
Executive Summary ...................................................................................................................................... 1
All Purpose Table ....................................................................................................................................... 12
Major Activities Table ................................................................................................................................ 16
FY 2015 Budget Authority Crosswalk........................................................................................................ 17
FY 2016 Budget Authority Crosswalk........................................................................................................ 18
BUDGET EXHIBITS
Appropriation Language ............................................................................................................................. 19
Appropriation Language Analysis .............................................................................................................. 21
Amounts Available for Obligation .............................................................................................................. 23
Summary of Changes .................................................................................................................................. 24
Budget Authority by Activity ..................................................................................................................... 25
Appropriations History ............................................................................................................................... 26
NARRATIVE BY ACTIVITY
Foods ........................................................................................................................................................... 27
Human Drugs .............................................................................................................................................. 55
Office of Orphan Products Development .................................................................................................... 67
Biologics ..................................................................................................................................................... 73
Animal Drugs and Feeds ............................................................................................................................. 89
Devices and Radiological Health .............................................................................................................. 109
National Center for Toxicological Research ............................................................................................. 129
Office of Regulatory Affairs – Field Activities ........................................................................................ 141
Tobacco Control Act ................................................................................................................................. 167
FDA Headquarters .................................................................................................................................... 177
Infrastructure – GSA Rent, Other Rent, and White Oak........................................................................... 195
Building And Facilities ............................................................................................................................. 203
SUPPLEMENTARY TABLES
Object Classification Tables ..................................................................................................................... 211
Salary and Expenses ................................................................................................................................. 214
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Detail of Full-Time Equivalents ............................................................................................................... 215
Detail of Positions ..................................................................................................................................... 216
Physicians’ Comparability Allowance (PCA) Worksheet ........................................................................ 217
SIGNIFICANT ITEMS
Appropriations Committee Significant Items ........................................................................................... 219
House Appropriations Committees Significant Items............................................................................... 223
Senate Appropriations Committees Significant Items .............................................................................. 245
FDA SPECIFIC ITEMS
Geographical Distribution of FDA Facilities ............................................................................................ 259
HIV/AIDS Functional Table ..................................................................................................................... 260
Crosscuts ................................................................................................................................................... 261
Central Accounts ....................................................................................................................................... 262
HHS Charges and Assessments ................................................................................................................ 263
GLOSSARY
Glossary of Acronyms .............................................................................................................................. 267
Glossary of Tables .................................................................................................................................... 273

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ORGANIZATION CHART

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EXECUTIVE SUMMARY
EXECUTIVE SUMMARY
This Executive Summary describes the fiscal year (FY) 2016 Budget for the U.S. Food and Drug
Administration (FDA). FDA is the agency within the U.S. Department of Health and Human
Services (HHS) responsible for protecting and promoting the public health by ensuring the
safety, effectiveness, and security of human and animal drugs, biological products, and medical
devices; ensuring the safety of food and feed, cosmetics, and radiation-emitting products; and
regulating tobacco products.
RECENT ACCOMPLISHMENTS
FDA delivers significant, quantifiable results that help Americans every day and is a sound
investment. A selection of significant, recent accomplishments is presented below.
Food Safety
FDA published seven major proposed rules and, based on stakeholder feedback, four
supplemental proposals to implement the Food Safety Modernization Act (FSMA). FDA also
completed 8,607 high-risk food establishment inspections in FY 2014, exceeding the target of
6,507 inspections by 32 percent. These actions are key steps toward implementing FSMA’s risk-
based, prevention approach to reducing foodborne illness and strengthening public confidence in
the food supply.
Drug Quality and Security Act (DQSA)
During fiscal year 2014, FDA continued to conduct inspections of compounding facilities,
including outsourcing facilities, issued numerous warning letters, initiated several enforcement
actions, and continued to develop the framework to implement the new law. Since the DQSA
was passed in November 2013, FDA has issued numerous policy documents to implement both
section 503A, as amended by the DQSA to remove uncertainty regarding its validity, as well as
the new section 503B covering outsourcing facilities. FDA continues to work on numerous
additional rules and guidances. In addition, FDA has announced the membership of a Pharmacy
Compounding Advisory Committee which will provide advice on scientific, technical, and
medical issues concerning drug compounding under sections 503A and 503B.
FDA has also published several draft guidances to support implementation of Title II of DQSA,
the Drug Supply Chain Security Act and is continuing to implement the law and further enhance
the safety of the drug supply chain. Ten years after enactment of DQSA, the system will
facilitate the exchange of information at the individual package level about where a drug has
been in the supply chain.
Tobacco Regulation
FDA published the proposed “deeming rule” to extend FDA’s tobacco authority to additional
tobacco products, including e-cigarettes. FDA advanced outreach to 1,500 industry and public
health stakeholder groups, generating media coverage in more than 1,844 online and print media
outlets. FDA has received over 135,000 comments to the proposed rule and is reviewing these
comments in preparation of the final rule. Public health-based regulation of these products can
help reduce the death and disease toll from tobacco use.
Product Safety and Quality
FDA expanded surveillance of medical products under the Sentinel Initiative, which provides
significant public health benefits by developing new approaches and methods to monitor the
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EXECUTIVE SUMMARY
safety of marketed medical products to complement existing FDA surveillance
capabilities. Monitoring the safety of its regulated products is a major part of FDA’s mission to
protect public health. The Sentinel system enables FDA to actively query diverse automated
healthcare data holders – like electronic health record systems, administrative and insurance
claims databases, and registries – to evaluate possible medical product safety issues quickly and
securely.
Ebola Epidemic Response
FDA has used its authorities to the fullest extent possible to protect and promote the public
health, both domestically and abroad, in response to the Ebola epidemic in West Africa. FDA
contributed to national and global policy development, helped expedite the development and
availability of investigational medical products for Ebola – including providing regulatory advice
and guidance to commercial developers and U.S. agencies that support medical product
development – to accelerate development programs, collaborated extensively with the World
Health Organization and several international regulatory counterparts to support international
response efforts, facilitated access to investigational medical products for patients with Ebola
when requested by clinicians, and authorized the use of seven investigational diagnostic tests for
Ebola under FDA's Emergency Use Authorization authority. FDA also monitored for fraudulent
products that claim to prevent or treat Ebola and took action, as warranted, to protect public
health.
Medical Product Application Review
FDA established a new review program for New Molecular Entity (NME) new drug applications
and original Biologics License Applications (BLAs) under the Prescription Drug User Fee Act
(PDUFA). The latest PDUFA reauthorization, PDUFA V, authorizes the program from October
1, 2012, through October 1, 2017. PDUFA V will enhance FDA’s capacity to fulfill its mission
of bringing to market novel drug products for patients. The goals of the program are to increase
the efficiency and effectiveness of the first review cycle and decrease the number of review
cycles necessary for approval. As of September 30, 2014, FDA has received more than 100
applications through this program, which involves a more interactive review with applicants. All
of the FY 2014 program cohort applications that received actions by September 30, 2014, were
reviewed and acted on within the goal date.
The Medical Device User Fee Amendments of 2012 (MDUFA III) was designed to provide
aggressive premarket performance goals and enhance the accountability, predictability, and
transparency of the Devices Program. FDA has met or exceeded all FY 2014 MDUFA III
performance goals for 510(k) submissions and Premarket Approval (PMA) applications. At the
same time, FDA has decreased the overall median time to full Investigational Device Exemption
(IDE) approval by over 50 percent, demonstrating FDA’s commitment to increase the efficiency
with which medical devices are developed and made available to U.S. patients.
FDA also exceeded all performance goals and completed the review and action on 99.8 percent
of original New Animal Drug Applications (NADAs) and other ADUFA sentinel submissions
within timeframes specified by ADUFA for applications reviewed in FY 2013. FDA also
completed the review and action on 100 percent of original Abbreviated New Animal Drugs and
Reactivations and other AGDUFA sentinel submissions as required and within the timeframes in
FY 2013.
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