RELATED AGENCIES AND FOOD AND DRUG ADMINISTRATION
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; 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; $1,820,849,000: Provided, That of the amount provided under this heading, $284,394,000 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, Provided, That this amount shall not include any fees pursuant to 21 U.S.C.
379h(a)(2) and (a)(3) assessed for fiscal year 2006 but collected in fiscal year 2005; $33,938,000 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; and $8,000,000 shall be derived from animal drug user fees authorized by 21 U.S.C. 379j, and shall be credited to this account and remain available until expended: Provided further, That fees derived from prescription drug, medical device, and animal drug assessments received during fiscal year 2005, including any such fees assessed prior to the current fiscal year but credited during the current year, shall be subject to the fiscal year 2005 limitation: 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) 470,405,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs; (2) $499,487,000 shall be for the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs; (3) $172,868,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs; (4) $99,299,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs; (5) $235,078,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs; (6) $40,530,000 shall be for the National Center for Toxicological Research; (7) $62,722,000 shall be for Rent and Related activities, other than the amounts paid to the General Services Administration for rent; (8) $123,015,000 shall be for payments to the General Services Administration for rent; and (9) $117,445,000 shall be for other activities, including the Office of the Commissioner; the Office of Management; the Office of Senior Associate Commissioner; the Office of External Relations; the Office Internal and Constituent Relations; the Office of Policy and Planning; and central services for these offices: 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 may be credited to this account, to remain available until expended.
In addition, export certification user fees authorized by 21 U.S.C. 381 may be credited to this account, to remain available until expended.
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
The budget provides a $108.78 million increase in budget authority over the FY 2004 Omnibus Appropriation Act. In addition, the Budget includes an increase of $39.85 million in current law user fees over FY 2004, which will be used to cover inflationary increases as well as increases in workload for the PDUFA, MDUFMA, and ADUFA programs. In total, the budget includes $1.821 billion for Salaries and Expenses at the program level, which includes funding for counter terrorism activities that specifically relate to the protection of products or therapies regulated by the FDA (such as drugs, vaccines, foods, and animal feed), and the availability of medical products for public health preparedness in the event of an attack. Specifically, the budget requests increased funding for food defense, medical counter measures related to terrorism or other related threats to pubic health, medical device reviews, protecting the safety of the U.S. food and feed supply from Bovine Spongiform Encephalopathy (BSE), inflationary pay increases, and moving expenses for a new Human Drugs facility in White Oak, Maryland.
Salaries and Expenses - Explanatory Notes
1/ Language is retained which provides FDA with the authority to credit to this account fees that may have been collected in excess of amounts appropriated in a previous year, if any such excess collections occurred. This is the intent of section 736(g)(4) of the Food Drug and Cosmetic Act, and it exempts FDA from making small individual refunds of unanticipated excess collections. Excess fees from previous years, if any, would be used to reduce the amount of fees FDA would collect in a subsequent year--in effect lowering the fees that FDA would otherwise assess and collect. This is intended to make appropriation language consistent with authorizing language.
2/ Language is added that enables FDA to collect user fees for drug establishments and products, as set forth in the Prescription Drug User Fee Act (PDUFA), but that such fees collected during fiscal year 2005 year and assessed for fiscal year 2006, not count against the FY 2005 collection ceiling established in the FY 2005 appropriation law.