THE BUDGET FOR FISCAL YEAR 2007
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
General and special funds: 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; [$1,838,567,000] $1,916,329,000: Provided, That of the amount provided under this heading, [$305,332,000] $320,600,000 shall be derived from prescription drug user fees authorized by 21 U.S.C. 379h, shall be credited to this account and remain available until expended, and shall not include any fees pursuant to 21 U.S.C. 379h(a)(2) and (a)(3) assessed for fiscal year  2008 but collected in fiscal year  2007; [$40,300,000] $43,726,000 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 [$11,318,000] $11,604,000 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  2007, including any such fees assessed prior to the current fiscal year but credited during the current year, shall be subject to the fiscal year  2007 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) $443,153,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs; (2) $520,564,000 shall be for the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs; (3) $178,714,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs; (4) $99,787,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs; (5) $245,770,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs; (6) $41,152,000 shall be for the National Center for Toxicological Research; (7) $58,515,000 shall be for Rent and Related activities, of which $21,974,000 is for White Oak Consolidation, other than the amounts paid to the General Services Administration for rent; (8) $134,853,000 shall be for payments to the General Services Administration for rent; and (9) $116,059,000 shall be for other activities, including the Office of the Commissioner; the Office of Management; the Office of External 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 Secretary may, contingent upon the enactment of authorizing legislation, charge a fee for conducting reinspections and issuing export certificates for food and animal feed: Provided, That such fees, in an amount not to exceed $25,536,000 shall be credited to this account, to remain available until expended for the purpose of such reinspections and issuance of export certificates for food and animal feed: Provided further, That the amount appropriated from the General Fund for fiscal year 2007 shall be reduced by the amount credited to this account under this paragraph so as to result in a final fiscal year 2007 appropriation from the General Fund estimated at not more than $1,545,349,000.
[For an additional amount for "Food and Drug Administration, Salaries and Expenses'', to prepare for and respond to an influenza pandemic, $20,000,000, to remain available until September 30, 2007: Provided, That of the total amount appropriated $18,000,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs, and $2,000,000 shall be for other activities including the Office of the Commissioner and the Office of Management: Provided further, That the amounts provided under this heading are designated as an emergency requirement pursuant to section 402 of H. Con. Res. 95 (109th Congress), the concurrent resolution on the budget for fiscal year 2006.]
Buildings and Facilities
For plans, construction, repair, improvement, extension, alteration, and purchase of fixed equipment or facilities of or used by the Food and Drug Administration, where not otherwise provided, [$8,000,000] $4,950,000, to remain available until expended.
FDA certifies color additives for use in foods, drugs, and cosmetics. It also lists color additives for use in foods, drugs, medical devices, and cosmetics (21 U.S.C. 346a, 356, 357, 376). These services are financed wholly by fees paid by the industries affected.
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 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 includes funding for counterterrorism 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 funding for pandemic preparedness, food defense, drug safety, tissue safety, the critical path to personalized medicine, medical device and animal drug review, and headquarters consolidation in White Oak, Maryland.
In an attempt to simplify the appropriations language, we are identifying the overall appropriation levels for the agency. To achieve simplification, we have not enumerated appropriations for the individual programs that are funded through the overall appropriation.
The Administration is proposing authorizing legislation that requires establishments to pay the full costs of reinspections and associated follow-up work when FDA reinspects facilities due to failure to meet Good Manufacturing Practices (GMPs) or other important FDA requirements. Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007. FDA currently funds this activity through discretionary appropriations. Imposing a fee would generate $22,000,000 in revenue, an amount sufficient to fully fund reinspections.
The Administration is proposing legislation authorizing FDA to collect user fees for issuing food and animal feed export certificates. Under this proposal, these activities will be classified as mandatory user fees in FY 2007. FDA currently funds this activity through discretionary appropriations. Imposing a fee would generate $3,536,000 million in revenue, an amount sufficient to fully fund the export certification program. Private sector exporters would bear the cost of the program, but would reap its benefits through the Agency's enhanced ability to facilitate exports of their products. The Administration will work with Congress to reclassify these fees as discretionary in 2008.