Department of Health and Human Services.

Department of Health and Human Services. food and drug administration salaries and expenses For necessary expenses of the Food and Drug Administration, including hire and purchase of passenger motor vehicles; for payment of space rental and related costs pursuant to Public Law 92-313 for programs and activities of the Food and Drug Administration which are included in this Act; for rental of special purpose space in the District of Columbia or elsewhere; in addition to amounts appropriated to the FDA Innovation Account, for carrying out the activities described in section 1002(b)(4) of the 21st Century Cures Act (Public Law 114-255); for miscellaneous and emergency expenses of enforcement activities, authorized and approved by the Secretary and to be accounted for solely on the Secretary’s certificate, not to exceed $25,000; and notwithstanding section 521 of Public Law 107-188; $5,138,041,000: Provided, That of the amount provided under this heading, $911,346,000 shall be derived from prescription drug user fees authorized by 21 U.S.C. 379h, and shall be credited to this account and remain available until expended; $193,291,000 shall be derived from medical device user fees authorized by 21 U.S.C. 379j, and shall be credited to this account and remain available until expended; $493,600,000 shall be derived from human generic drug user fees authorized by 21 U.S.C. 379j-42, and shall be credited to this account and remain available until expended; $40,214,000 shall be derived from biosimilar biological product user fees authorized by 21 U.S.C. 379j-52, and shall be credited to this account and remain available until expended; $18,093,000 shall be derived from animal drug user fees authorized by 21 U.S.C. 379j-12, and shall be credited to this account and remain available until expended; $9,419,000 shall be derived from generic new animal drug user fees authorized by 21 U.S.C. 379j-21, and shall be credited to this account and remain available until expended; $672,000,000 shall be derived from tobacco product user fees authorized by 21 U.S.C. 387s, and shall be credited to this account and remain available until expended: Provided further, That in addition to and notwithstanding any other provision under this heading, amounts collected for prescription drug user fees, medical device user fees, human generic drug user fees, biosimilar biological product user fees, animal drug user fees, and generic new animal drug user fees that exceed the respective fiscal year 2018 limitations are appropriated and shall be credited to this account and remain available until expended: Provided further, That fees derived from prescription drug, medical device, human generic drug, biosimilar biological product, animal drug, and generic new animal drug assessments for fiscal year 2018, including any such fees collected prior to fiscal year 2018 but credited for fiscal year 2018, shall be subject to the fiscal year 2018 limitations: Provided further, That the Secretary may accept payment during fiscal year 2018 of user fees specified under this heading and authorized for fiscal year 2019, prior to the due date for such fees, and that amounts of such fees assessed for fiscal year 2019 for which the Secretary accepts payment in fiscal year 2018 shall not be included in amounts under this heading: Provided further, That none of these funds shall be used to develop, establish, or operate any program of user fees authorized by 31 U.S.C. 9701: Provided further, That of the total amount appropriated: (1) $1,041,615,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs; (2) $1,617,881,000 shall be for the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs; (3) $359,614,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs; (4) $197,252,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs; (5) $487,197,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs; (6) $63,331,000 shall be for the National Center for Toxicological Research; (7) $625,646,000 shall be for the Center for Tobacco Products and for related field activities in the Office of Regulatory Affairs; (8) not to exceed $172,003,000 shall be for Rent and Related activities, of which $50,559,000 is for White Oak Consolidation, other than the amounts paid to the General Services Administration for rent; (9) not to exceed $237,671,000 shall be for payments to the General Services Administration for rent; and (10) $335,831,000 shall be for other activities, including the Office of the Commissioner of Food and Drugs, the Office of Foods and Veterinary Medicine, the Office of Medical and Tobacco Products, the Office of Global and Regulatory Policy, the Office of Operations, the Office of the Chief Scientist, and central services for these offices: Provided further, That not to exceed $25,000 of this amount shall be for official reception and representation expenses, not otherwise provided for, as determined by the Commissioner: Provided further, That any transfer of funds pursuant to section 770(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(n)) shall only be from amounts made available under this heading for other activities: Provided further, That of the amounts that are made available under this heading for “other activities”, and that are not derived from user fees, $1,500,000 shall be transferred to and merged with the appropriation for “Department of Health and Human Services—Office of Inspector General” for oversight of the programs and operations of the Food and Drug Administration and shall be in addition to funds otherwise made available for oversight of the Food and Drug Administration: Provided further, That of the total amount made available under this heading, $1,500,000 shall be used by the Commissioner of Food and Drugs, in coordination with the Secretary of Agriculture, for consumer outreach and education regarding agricultural biotechnology and biotechnology-derived food products and animal feed, including through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian impacts of such biotechnology, food products, and feed: Provided further, That funds may be transferred from one specified activity to another with the prior approval of the Committees on Appropriations of both Houses of Congress. In addition, mammography user fees authorized by 42 U.S.C. 263b, export certification user fees authorized by 21 U.S.C. 381, priority review user fees authorized by 21 U.S.C. 360n and 360ff, food and feed recall fees, food reinspection fees, and voluntary qualified importer program fees authorized by 21 U.S.C. 379j-31, outsourcing facility fees authorized by 21 U.S.C. 379j-62, prescription drug wholesale distributor licensing and inspection fees authorized by 21 U.S.C. 353(e)(3), third-party logistics provider licensing and inspection fees authorized by 21 U.S.C. 360eee-3(c)(1), third-party auditor fees authorized by 21 U.S.C. 384d(c)(8), and medical countermeasure priority review voucher user fees authorized by 21 U.S.C. 360bbb-4a, shall be credited to this account, to remain available until expended. buildings and facilities For plans, construction, repair, improvement, extension, alteration, demolition, and purchase of fixed equipment or facilities of or used by the Food and Drug Administration, where not otherwise provided, $11,788,000, to remain available until expended. fda innovation account, cures act For necessary expenses to carry out the purposes described under section 1002(b)(4) of the 21st Century Cures Act, in addition to amounts available for such purposes under the heading “Salaries and Expenses”, $60,000,000, to remain available until expended: Provided, That amounts appropriated in this paragraph are appropriated pursuant to section 1002(b)(3) of the 21st Century Cures Act, are to be derived from amounts transferred under section 1002(b)(2)(A) of such Act, and may be transferred by the Commissioner of Food and Drugs to the appropriation for “Department of Health and Human Services—Food and Drug Administration—Salaries and Expenses” solely for the purposes provided in such Act: Provided further, That upon a determination by the Commissioner that funds transferred pursuant to the previous proviso are not necessary for the purposes provided, such amounts may be transferred back to the account: Provided further, That such transfer authority is in addition to any other transfer authority provided by law.