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This article was originally published in The Tan Sheet

Executive Summary

FDA USER FEE COLLECTION AUTHORITY FOR 1993 WOULD BE WITHHELD BY SENATE Appropriations Committee under a fiscal 1993 supplemental appropriations bill approved by the committee on June 8. The bill did not include a provision authorizing FDA to collect user fees this year. The version passed by the House on May 26 would allow FDA to collect the full $ 36 mil. authorized in the user fee act for 1993. The Senate committee is "concerned by testimony that no additional full-time equivalents [staff positions] have been approved to accompany this requested increase and the committee believes that the purposes for which these user fees are authorized cannot be fulfilled by the FDA without such a staff increase," the committee explained in a report accompanying the FY 1993 funding bill. If such "an increase is approved by the Office of Management & Budget, the committee will be more disposed to concur with the House." HHS recently submitted to OMB a request to waive the administration's federal personnel freeze so that FDA can proceed with user fee-related hirings. FDA also is looking for ways to accelerate its ongoing recruitment process to reach its goals for expanding its drug review staff (see preceding story). Objections that the Clinton Administration has not met with requirements of the user fee law to augment both appropriations and staff in the product review area were raised by the Pharmaceutical Manufacturers Association in a recent letter to the Senate Appropriations/agriculture subcommittee ("The Tan Sheet" June 7, p. 12). Permission for user fees was excluded from the "chairman's mark," the legislative proposal developed by subcommittee Chairman Dale Bumpers (D-Ark.), full committee Chairman Robert Byrd (D- W.Va.) and staff and used to begin the markup. The issue could be revisited either on the Senate floor (floor debate has not been yet scheduled) or in conference with the House on the supplemental funding bill. The next step for user fees would depend on both the congressional schedule and timing of HHS actions. A House Appropriations/agriculture subcommittee markup of FY 1994 appropriations for FDA and other agencies under subcommittee jurisdiction was postponed from June 9 to June 14.

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