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 Excepts from payment applications which were previously filed but withdrawn or not approved without a waiver or refund.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; 5 are original cosponsors, there from 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 | |
| R-GA | Nathan Deal | May 15, 2003 | |
| R-NE | Lee Terry | May 19, 2003 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 13, 2003Markup Sep 10, 2003Reported Sep 30, 2003 |
| Health Subcommittee | Referred Mar 24, 2003 | |
| Senate | Health, Education, Labor, and Pensions Committee | Referred Oct 2, 2003 |
Actions 14
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, 2003Mr. Upton moved to suspend the rules and pass the bill.
- 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, 2003Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H9054-9057)
- Oct 1, 2003Motion to reconsider laid on the table Agreed to without objection.
- Sep 30, 2003Reported by the Committee on Energy and Commerce. H. Rept. 108-287.
- Sep 30, 2003Placed on the Union Calendar, Calendar No. 167.
- Sep 10, 2003Committee Consideration and Mark-up Session Held.
- Sep 10, 2003Ordered to be Reported by Voice Vote.
- Mar 24, 2003Referred to the Subcommittee on Health.
- Mar 13, 2003Introduced in House
- Mar 13, 2003Sponsor introductory remarks on measure. (CR E462)
- Mar 13, 2003Referred to the House Committee on Energy and Commerce.
In the Congressional Record 2
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Debate and remarks H9054–H9059Text printed H9054–H9057 | Bob Goodlatte R-VA, Cliff Stearns R-FL, Diana DeGette D-CO, Fred Upton R-MI, Sherrod Brown D-OH | Oct 1, 2003 |
| Extensions | Debate and remarks E462 | Fred Upton R-MI | Mar 13, 2003 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Congressional Budget Office cost estimates 2
- Sep 16, 2003H.R. 1260, Animal Drug User Fee Act of 2003<p>Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on September 10, 2003</p>
- Sep 16, 2003H.R. 1260, Animal Drug User Fee Act of 2003Cost estimate for the bill as ordered reported by the House Committee on Energy and Commerce on September 10, 2003
Printed hearings 2
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| S. Hrg. 108-155 | AGRICULTURE, RURAL DEVELOPMENT, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2004143 pages | Appropriations Committee | May 22, 2003 |
| S. Hrg. 108-155 | AGRICULTURE, RURAL DEVELOPMENT, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2004579 pages | Appropriations Committee | May 8, 2003–May 22, 2003 |
CRS reports 1
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 1
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| RL34459 | Animal Drug User Fee Programs Archived | Report | Aug 4, 2008 |
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 |
Titles 4
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to animal drugs.
- Short Titles as Introduced
- Animal Drug User Fee Act of 2003
- Short Titles as Reported to House
- Animal Drug User Fee Act of 2003
- Short Titles as Passed House
- Animal Drug User Fee Act of 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
Text 4
Each version as it was printed, newest first.
- Oct 2, 2003Referred in Senate
- Oct 1, 2003Engrossed in House
- Sep 30, 2003Reported in House
- Mar 13, 2003Introduced in House
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; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.