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Executive Summary

FDA FY 1987 FUNDING OF $410 MIL. PASSED BY HOUSE APPROPRIATIONS CMTE. July 16 is $39 mil. less than the Administration's budget request. In February, the Administration requested $449 mil, of which $423 mil. was earmarked for appropriations and $26 mil. for user charge revenues. The committee report on the Agriculture Appropriations Bill states that $11.4 mil. of the $26 mil. for user fees would have been used to offset routine operating costs, according to the Administration's budget proposal. The report explains that the Appropriations Committee "added to the adjusted fiscal year 1986 base the $11.4 mil. shortfall in funds the FDA would have if user fee legislation is not enacted." The House Appropriations Committee specifically barred FDA from adopting NDA and ANDA user fees in its previous bill for FDA's fiscal 1986 budget. In its current report, the committee states: "Although FDA has taken a different tack in proposing user fees be authorized through separate specific legislation, the committee is concerned that FDA's role in approving new drug applications is of direct public benefit and, as such, the process should not be burdened with user fees." The agency published a proposed rule for user charges last August. The House committee stated that it has provided a general increase of $14.4 mil. which "is to go toward decreasing the time for new product approval for drugs and medical devices and radiological products; and to the food safety and food economics programs." The committee said the increase "should be divided among the programs proportional to the budget request of each program." The House 1987 appropriation bill also includes $6.6 mil. "that remains available to FDA in fiscal year 1986 subject to a budget request," the committee report states. The report adds that "the committee understands that FDA is in critical need of these funds, but the Office of Management and Budget refuses to request the funds previously made available by Congress." The 1987 appropriations for FDA are $32.9 mil. over fiscal year 1986 appropriations, excluding the $6.6 mil. subject to a budget request. The bill authorizes that $5.2 mil. be available for orphan product work, "of which not less than $3.5 mil. shall be available only for the orphan product grants and contracts." The committee said it also agrees with the budget request of $10 mil. for AIDS work. The committee requested that FDA not close any laboratories in fiscal year 1987 and asked the agency to submit with its fiscal 1988 budget request "a detailed estimate of costs versus savings for each of the laboratories." FDA's Office of Regulatory Affairs recommended in May that five field labs be closed as their leases expire over the next two years because of underutilization ("The Pink Sheet" June 2, In Brief). The appropriations report notes: "The committee is aware of the fact that it initially costs a considerable amount of money to close a facility due to contract and lease termination costs and the relocation of many employees. The fiscal year 1987 budget request includes no funds for these costs."

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