Omnibus Appropriations Act, 2009/Division A/Title VI

TITLE VI — Related Agency 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; $2,622,267,000, of which $7,641,000 shall be for the purposes, and in the amounts, specified in the final paragraph under ``Food and Drug Administration, Salaries and Expenses´´ in the explanatory statement described in section 4 (in the matter preceding division A of this consolidated Act):

Provided, That of the amount provided under this heading, $510,665,000 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 2010 but collected in fiscal year 2009; $52,547,000 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; $15,260,000 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; and $4,831,000 shall be derived from animal generic drug user fees authorized by 21 U.S.C. 379f, and shall be credited to this account and shall remain available until expended:

Provided further, That fees derived from prescription drug, medical device, animal drug, and animal generic drug assessments for fiscal year 2009 received during fiscal year 2009, including any such fees assessed prior to fiscal year 2009 but credited for fiscal year 2009, shall be subject to the fiscal year 2009 limitations:

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) $648,722,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs;

(2) $777,437,000 shall be for the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs, of which no less than $41,358,000 shall be available for the Office of Generic Drugs;

(3) $271,490,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs;

(4) $134,344,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs;

(5) $310,547,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs;

(6) $52,511,000 shall be for the National Center for Toxicological Research;

(7) not to exceed $111,758,000 shall be for Rent and Related activities, of which $41,281,000 is for White Oak Consolidation, other than the amounts paid to the General Services Administration for rent;

(8) not to exceed $155,425,000 shall be for payments to the General Services Administration for rent; and

(9) $160,033,000 shall be for other activities, including the Office of the Commissioner; the Office of Scientific and Medical Programs; the Office of Policy, Planning and Preparedness; the Office of International and Special Programs; the Office of Operations; and central services for these offices:

Provided further, That none of the funds made available under this heading shall be used to transfer funds under section 770(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd):

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, and priority review user fees authorized by 21 U.S.C. 360n may be credited to this account, to remain available until expended.

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, $12,433,000, to remain available until expended.

Independent Agency

Farm Credit Administration

limitation on administrative expenses

Not to exceed $49,000,000 (from assessments collected from farm credit institutions, including the Federal Agricultural Mortgage Corporation) shall be obligated during the current fiscal year for administrative expenses as authorized under 12 U.S.C. 2249:

Provided, That this limitation shall not apply to expenses associated with receiverships.