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FDA uses consulting and related services to obtain expertise which is not feasible to maintain on the permanent staff. Because of the broad range of products that FDA regulates and the complexity of skills needed to evaluate them, it is essential for the Agency to call upon a variety of experts in academia and the private sector in order to ensure that Agency decisions are based on the best available scientific advice. In addition, experts from specialized disciplines advise both headquarters and field offices on both health issues and the latest laboratory methodology. Contractual services

also assist in gathering a range of opinion for Agency decision-making, through such means as surveys and economic analyses. It should be noted that these services comprise less than one-half of one percent of FDA's operating budget. To retain on permanent staff the expertise available through consultants would be far more costly.

All of FDA's major programs utilize consulting services in varying degrees on special needs as they arise. Appointive consultants are essential for providing scientific input from a variety of sources into the Agency's regulatory decisions. Other appointive consultants include expert advisors with specialized knowledge, not available within the permanent staff, who assist in maintaining up-to-date laboratory and inspection practices. In addition, standing Advisory Committees, such as the Anti-infective Drugs Advisory Committee, are essential to provide expert opinion on both new drugs and on problems encountered with marketed drugs. Medical Device Advisory Committees, such as the Respiratory and Nervous System Devices Panel, are specifically required by the 1976 Medical Device Amendments. Contract services are used to obtain a range of scientific expertise on key problems in such areas as nutrition and food safety.

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1/ Revised budget estimate, original request was for $332,799,000. 2/ Revised budget estimate, original request was for $352,974,000. 3/ Includes Rental Payments to GSA (Standard Level User Charges) which was established as a separate account for $18,942,000 in 1983; $22,164,000 in 1984; $26,072,000 in 1985; $25,888 in 1986; and $24,627,000 in 1987.

4/ Does not include Buildings and Facilities, which was appropriated as a separate account for $3,450,000 in 1984, $1,450,000 in 1985, $1,441,000 in 1986, and $1,450,000 in 1987. 1986 estimate includes Budget Amendment of $9,778,000 to restore 5% pay cut. 1987 estimate includes Amendments of $5,625 which were included in the appropriations.

5/ Appropriated amount includes $18,073,000 which was subsequently sequestered.

6/ Includes $1,450,000 for Buildings and Facilities, formerly appropriated as a separate account.

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1/ Revised budget estimate; initial request was $15,000,000.

2/ $875,000 appropriated in the Jobs Bill Supplemental Appropriations. 3/ Funding of facilities projects in 1984, 1985, 1986 and 1987 was included in the Program Expenses request but appropriated in this account.

4/ Includes $4,875,000 in the initial 1984 Appropriation and $13,867,000 by a Supplemental Appropriation.

5/ Appropriated amount includes $62,000 which was subsequently sequestered.

6/ Includes $500,000 now proposed for rescission.

Z/ $1,450,000 for Buildings and Facilities projects is included in the Program Expenses request for 1988.

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