PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in Senate · Feb 5, 2003
Animal Drug User Fee Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to assess and collect fees for an animal drug or a supplemental animal drug application (if it requires safety or effectiveness data). Requires payment upon submission or the application will be considered incomplete and not accepted. Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.Assesses annual fees on animal drug products, establishments, and sponsors.Establishes a fee schedule for FY 2004 through 2007, including total fee revenues for animal drug products, establishments, and sponsors. Adjusts fees to reflect inflation, review workload, and operating reserves of carryover user fees (in the final year).Directs the Secretary to establish before each fiscal year, based on the fee schedule revenue amounts and the adjustments, the following: (1) animal drug application and supplement fees; (2) animal drug sponsor fees; (3) animal drug establishment fees; and (4) animal drug product fees. Reduces or waives fees: (1) in excess of administrative costs; (2) that present a significant barrier to innovation; (3) if an animal drug application or supplemental animal drug application is intended solely for use of an animal drug in specified types of feed; (4) if an animal drug application or supplemental animal drug application is intended solely to provide for minor uses or use in minor species; or (5) for first applications by a small business.Makes fees available for obligation only to the extent provided in advance in appropriations Acts. Offsets any excess fees against subsequent appropriations.
People & committees
Sen. Ensign, John [R-NV] · R–NV
Legislative record
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Became Public Law No: 108-130.
Became Public Law No: 108-130.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Message on Senate action sent to the House.
Senate agreed to House amendment by Unanimous Consent. (consideration: CR S14279-14282; text as Senate agreed to House amendment: CR S14279-14282)
Resolving differences -- Senate actions: Senate agreed to House amendment by Unanimous Consent.(consideration: CR S14279-14282; text as Senate agreed to House amendment: CR S14279-14282)
Message on House action received in Senate and at desk: House amendment to Senate bill.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H10293-10296)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H10293-10296)
DEBATE - The House proceeded with forty minutes of debate on S. 313.
Considered under suspension of the rules. (consideration: CR H10293-10297)
Mr. Upton moved to suspend the rules and pass the bill, as amended.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Received in the House.
Message on Senate action sent to the House.
Passed Senate with an amendment by Unanimous Consent.
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S7266)
Senate vitiated previous passage.
Passed Senate with amendments by Unanimous Consent. (consideration: CR S7165-7171; text as passed Senate: CR H7168-7171; text of measure as reported in Senate: CR S7165-7168)
Passed/agreed to in Senate: Passed Senate with amendments by Unanimous Consent.(consideration: CR S7165-7171; text as passed Senate: CR H7168-7171; text of measure as reported in Senate: CR S7165-7168)
Placed on Senate Legislative Calendar under General Orders. Calendar No. 104.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with amendments. With written report No. 108-51.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with amendments. With written report No. 108-51.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
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Source last updated: Apr 21, 2025. Consult Congress.gov for the current record.
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Analyze S.313 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
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