Animal Drug User Fee Act of 2003
Public Law 108-130 · S. 313 · 108th Congress · began in the Senate
Signed by George W. Bush (R) on Nov 18, 2003 · Health
Sponsor: Sen. John Ensign (R-NV)
Cosponsors (4): Sen. Tom Harkin, Sen. Judd Gregg,
Passage votes
- HouseVoice vote
- SenateUnanimous consent
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
Animal Drug User Fee Act of 2003 - (Sec. 3) 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 application, defined as a request for approval of a new animal drug (not including generic drugs). Directs the Secretary to also assess fees for a supplemental animal drug application, defined as a request for a change in an approved animal drug application or in an approved generic 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 Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.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. Declares that only one such fee per category must be paid each year.
Establishes a fee schedule for FY 2004 through 2008, 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 fees and supplemental animal drug application fees (for applications in which safety or effectiveness data are required); (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.
Authorizes appropriations. Offsets any excess fees against subsequent appropriations.
(Sec. 4) Establishes public accountability and reporting requirements.
(Sec. 5) Establishes a sunset date of October 1, 2008, for the provisions of this Act not pertaining to public accountability and reports and a sunset date of 120 days after such date for such accountability and reporting provisions.
Committees
The committees the bill was sent to, and what each did with it.
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Related bills
1 bill the Library of Congress relates to this one.
H.R. 1260Related bill
Animal Drug User Fee Act of 2003
Data notes
Related bills are identified by the Congressional Research Service, the House and the Senate: companion and identical bills, bills with similar text, bills that were folded into this law, and rules that brought it to the floor. A bill that is itself a public law in this site’s data links here; the others link to Congress.gov.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 25 actions.
- Nov 18, 2003Became lawBecame law · Became Public Law No: 108-130.
- Became lawBecame law · Signed by President.
- Nov 12, 2003FloorFloor · Presented to President.
- Nov 10, 2003FloorFloor · Message on Senate action sent to the House.
- Nov 7, 2003Resolving differencesResolving differences · Senate agreed to House amendment by Unanimous Consent.
- OtherOther · Resolving differences -- Senate actions: Senate agreed to House amendment by Unanimous Consent.
- Nov 5, 2003FloorFloor · Message on House action received in Senate and at desk: House amendment to Senate bill.
- Nov 4, 2003FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
- FloorFloor · DEBATE - The House proceeded with forty minutes of debate on S. 313.
- FloorFloor · Considered under suspension of the rules.
- FloorFloor · Mr. Upton moved to suspend the rules and pass the bill, as amended.
- Jun 11, 2003CommitteeCommittee · Referred to the Subcommittee on Health.
- Jun 4, 2003FloorFloor · Received in the House.
- FloorFloor · Message on Senate action sent to the House.
- CommitteeCommittee · Referred to the House Committee on Energy and Commerce.
- Jun 3, 2003FloorFloor · Passed Senate with an amendment by Unanimous Consent.
- FloorFloor · Measure laid before Senate by unanimous consent.
- FloorFloor · Senate vitiated previous passage.
- May 23, 2003FloorFloor · Passed Senate with amendments by Unanimous Consent.
- May 21, 2003CalendarCalendar · Placed on Senate Legislative Calendar under General Orders. Calendar No. 104.
- CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Reported by Senator Gregg with amendments. With written report No. 108-51.
- Feb 12, 2003CommitteeCommittee · Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- Feb 5, 2003CommitteeCommittee · Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- IntroducedIntroduced · Introduced in Senate
Data notes
Every action the Library of Congress lists for the bill, from introduction to signing, plus the dated committee hearings. The source lists many steps twice (the chamber’s own entry and the Library of Congress copy, or a presidential and a became-law entry with the same words); those are shown once. Amendments are listed in their own section.
Amendments
1 amendment offered to the bill, with the last recorded step of each.
- Agreed to
S.Amdt. 846SenateSen. Judd GreggR-NH· offered Jun 3, 2003Agreed to
To provide a complete substitute.
Jun 3, 2003: Amendment SA 846 agreed to in Senate by Unanimous Consent.
Data notes
Amendments offered to this bill in either chamber, as the Library of Congress records them: each with a status read from its last recorded step: agreed to, rejected, withdrawn, ruled out of order, fell with another amendment, or offered with no vote recorded (most Senate amendments are only ever offered). The wording of each amendment is the source’s. Amendments to amendments and amendments to other bills are not listed.
Official record
The bill’s full text is on Congress.gov. Data through Oct 7, 2026.