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; and 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; [$1,186,072,000] $1,306,178,000 of which not to exceed [$145,434,000] $149,273,000 in prescription drug user fees authorized by 21 U.S.C. 379(h) may be credited to this appropriation and remain available until expended, Provided, [That fees derived from applications received during fiscal year 2000 shall be subject to the fiscal year 2000 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) $269,245,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs; (2) $309,026,000 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 $11,542,000 shall be available for grants and contracts awarded under section 5 of the Orphan Drug Act (21 U.S.C. 360ee); (3) $132,092,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs; (4) $48,821,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs; (5) $154,271,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs, of which $1,000,000 shall be for premarket review, enforcement and oversight activities related to users and manufacturers of all reprocessed medical devices as authorized by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.), and of which no less than $55,500,000 and 522 full-time equivalent positions shall be for premarket application review activities to meet statutory review times; (6) $34,536,000 shall be for the National Center for Toxicological Research; (7) $34,000,000 shall be for the Office of Tobacco; (8) $25,855,000 shall be for Rent and Related activities, other than the amounts paid to the General Services Administration; (9) $100,180,000 shall be for payments to the General Services Administration for rent and related costs; and (10) $78,046,000 shall be for other activities, including the Office of the Commissioner; the Office of Policy; the Office of the Senior Associate Commissioner; the Office of International and Constituent Relations; the Office of Policy, Legislation, 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 Committee on Appropriations of both Houses of Congress.] no more than $104,954,000 shall be for payments to the General services Administration for rent and related costs.
In addition, mammography user fees authorized by 42 U.S.C. 263(b) may be credited to this account, to remain available until expended.
In addition, export certification user fees authorized by 21U.S.C. 381, as amended, may be credited to this account, to remain available until expended.
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, [$11,350,000] to remain available until expended $31,350,000, and to become available on October 1, 2001, $23,000,000, (7 U.S.C.2209b). (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations act, 2000).
The Food and Drug Administration (FDA) administers laws concerning misbranded and adulterated foods, drugs, human biologics, medical devices, cosmetics, and human-made sources of radiation. The Budget provides a $168.2 million (+13 percent) increase over the FY 2000 enacted program level. The Budget includes $1,157.9 million for Salaries and Expenses, which includes funding for the food safety initiative and tobacco regulation, as well as initiatives for the reporting of medical errors and the prevention of illegal sales of prescription drugs over the Internet. Of the Salaries and expenses amount, $99.1 million will be used for payments to the General Services Administration for rent and rent-related costs (an additional $5.9 million will be derived from fees). The Budget reflects the transfer of the Seafood Inspection Division of the National Oceanic and Atmospheric Administration of the Department of Commerce to the FDA, which will be financed with $12.7 million in currently authorized fees. In addition the budget includes $189.9 million for user fees, an increase of $29.7 million in user fees over FY 2000, which will be used to finance FDA activities. Of the $189.9 million in user fees, $19.5 million consists of new user fees related to the review of direct food additive petitions, food export certificates and for the review of medical device applications, which are represented in the legislative proposal schedule. The buildings and facilities appropriation of $31.4 million provides funds for projects related to the repair, construction, alteration, and improvement of all buildings and facilities of FDA, including the new Los Angeles Laboratory.
Contingent upon the enactment of authorizing legislation, up to $19,483,000 derived from fees assessed for activities related to the review of direct food additive petitions, the issuing of food export certificates and the review of medical device applications may be collected and credited to this appropriation, to remain available until expended for those activities.
The Budget includes $189.9 million in user fees, of which $19.5 million are new user fees to finance FDA activities as reflected in the legislative proposal schedule. Additional appropriation language is being proposed contingent upon the enactment of authorizing legislation. The authorizing legislation will be proposed to authorize the collection and spending of the fees subject to the appropriations action.
That effective October 1, 2000, (1) the functions and authorities related to fish or fishery products under the Agricultural Marketing Act of 1946, including inspections and other activities authorized under section 203(h) of that Act, are transferred from the Secretary of Commerce to the Secretary of Health and Human Services ("HHS"); (2) the Secretary of Commerce shall transfer to the Secretary of HHS (A) all personnel of the Seafood Inspection Division of the National Oceanic and Atmospheric Administration of the Department of Commerce and such other employees of the Department of Commerce as may be designated by the Secretary of Commerce, with the concurrence of the Secretary of HHS, all of whom shall become personnel of a voluntary seafood inspection unit within the Food and Drug Administration ("FDA"); and (B) all assets and liabilities of the Department of Commerce or its components pertaining to the activities specified in clause (1), which shall become assets and liabilities of such seafood inspection unit, including facilities, contracts, property, records, accounts payable and receivable, and unexpended and unobligated balances of funds; (3) all rules, regulations, administrative directives, grants, contracts, and other determinations and agreements in effect on such date relating to the activities specified in clause (1) shall remain in effect until modified, by the Secretary of HHS; (4) the Secretary of HHS is authorized to promulgate, without comment, a final rule transferring to title 21, Code of Federal Regulations, regulations of the Secretary of Commerce necessary to carry out the activities specified in clause (1); (5) all activities of such seafood inspection unit shall be funded exclusively from fees charged for, and other amounts specifically appropriated for, such activities, and fees collected and amounts appropriated for such activities shall not be used for any other purpose; (6) for purposes of any reduction in the personnel complement of the Food and Drug Administration or of such unit on or before September 30, 2005, such unit will be deemed a distinct competitive area within the Food and Drug Administration, under 5 CFR 351.402
Explanation:
1/ Removes Senate language which sets forth specific amounts by program and other areas, (Orphan Grants, premarket review and medical device reuse for Medical Devices, Rent and GSA rent amounts), which provides some flexibility for FDA resource reallocation. Reprogramming language as contained in the General Provisions, section 724 would still apply.
2/ FDA is proposing additive user fees for the Foods and Medical Devices Programs. Fees collected under the Foods Program will be for petitions for food additives submitted and Food Export certificates. User fees collected under the Medical Devices Program will be for premarket applications and premarket application supplement reviews.
3/ Administrative Proposal: Legislation has been drafted to establish the Seafood Inspection Program as a Performance Based Organization (PBO) within FDA of the US Department of Health and Human Services. This legislation will, among other things, transfer the employees of the SIP and the authorities of the Agricultural Marketing Act of 1946 to continue the services that are now being provided by the SIP under NMFS/NOAA/USDC.
The budget proposes: 1) for the short-term, a transfer of the Seafood Inspection Division, (SIP) of the National Oceanic and Atmospheric Administration from the Commerce Department to the Department of Health and Human Services, under the purview of the Food and Drug Administration; and 2) more permanently, the development of legislation to make this program into a Performance Based Organization, still under the auspices of FDA, but to run more like a business.
Edited 3/2/2000