Animal Drug User Fee Act of 2003
Latest action · Oct 2, 2003 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 13, 2003
- Passed HouseOct 1, 2003
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)
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 Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.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.
Cosponsors 20
Members who signed on, in the order they did. Signatures ran from Mar 13, 2003 to Sep 30, 2003, with 5 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-LA | Christopher John | Original | Mar 13, 2003 |
| D-CO | Diana DeGette | Original | Mar 13, 2003 |
| D-NY | Edolphus Towns | Original | Mar 13, 2003 |
| R-PA | James C. Greenwood | Original | Mar 13, 2003 |
| R-FL | Michael Bilirakis | Original | Mar 13, 2003 |
| R-ID | C. L. (Butch) Otter | Mar 20, 2003 | |
| R-MS | Charles W. "Chip" Pickering | Mar 26, 2003 | |
| R-KY | Ed Whitfield | Apr 10, 2003 | |
| D-IA | Leonard L. Boswell | Apr 10, 2003 | |
| R-MD | Wayne T. Gilchrest | Apr 10, 2003 | |
| R-FL | Adam H. Putnam | May 6, 2003 | |
| R-MI | Mike Rogers | May 6, 2003 | |
| R-IN | Mark E. Souder | May 15, 2003 | |
| D-GA | Nathan Deal | May 15, 2003 | |
| R-NE | Lee Terry | May 19, 2003 | |
| D-VA | Rick Boucher | May 19, 2003 | |
| R-KS | Jerry Moran | Jun 2, 2003 | |
| R-TX | Mac Thornberry | Jun 26, 2003 | |
| R-IN | Chris Chocola | Sep 4, 2003 | |
| R-VA | Bob Goodlatte | Sep 30, 2003 |
Actions 15
Everything that happened, newest first.
- Oct 2, 2003Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Oct 1, 2003Considered under suspension of the rules. (consideration: CR H9054-9059)
- Oct 1, 2003DEBATE - The House proceeded with forty minutes of debate on H.R. 1260.
- Oct 1, 2003Motion to reconsider laid on the table Agreed to without objection.
- Oct 1, 2003Mr. Upton moved to suspend the rules and pass the bill.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 313 | Animal Drug User Fee Act of 2003 | Related bill | Nov 18, 2003 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative fees
- Administrative procedure
- Agriculture and Food
- Animals
- Appropriations
- Collection of accounts
- Commerce
- Congress
- Congressional reporting requirements
- Department of Health and Human Services
- Drug approvals
- Drug industry
- Economics and Public Finance
- Feeds
- Government Operations and Politics
- Government paperwork
- Health
- Indexing (Economic policy)
- Law
- Performance measurement
- Pharmaceutical research
- Science, Technology, Communications
- Small business
- User charges
- Veterinary medicine
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.