To amend the Federal Food, Drug, and Cosmetic Act to authorize prescription drug application, establishment, and product fees, and for other purposes.
Prescription Drug User Fee Act of 1992 - Amends the Federal Food, Drug, and Cosmetic Act to provide authority for the Secretary of Health and Human Services to assess and collect fees from manufacturers of prescription drugs beginning in FY 1993. Establishes a schedule for human drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees. Provides for the annual adjustment of such fees to reflect increases in the Consumer Price Index for urban consumers or increases in Federal pay. Authorizes the Secretary to waive or reduce fees.
Prohibits the assessment of fees for a fiscal year after FY 1993 unless appropriations for salaries and expenses of the Food and Drug Administration (FDA) are equal or greater than such appropriations for FY 1992. Credits such fees to the appropriation account for salaries and expenses of the FDA. Authorizes appropriations for FY 1993 through 1997.
Provides a mechanism for collecting unpaid fees.
Requires the FDA to make annual reports to the Congress on this Act.
Requires the Secretary to conduct a study to evaluate whether to impose user fees to supplement appropriated funds to improve the process of reviewing applications for new animal drugs. Requires a report to specified congressional committees on the results of such study.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Ordered to be Reported (Amended) by Voice Vote.
Committee Consideration and Mark-up Session Held.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 102-895.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 102-895.
Placed on the Union Calendar, Calendar No. 512.
Mr. Waxman moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules.
DEBATE - The House proceeded with forty minutes of debate.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
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On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 702. Pursuant to the order of September 22, 1992.