To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes.
Public Law 110-316 · H.R. 6432 · 110th Congress · began in the House
Signed by George W. Bush (R) on Aug 14, 2008 · Health
Sponsor: Rep. Frank Pallone (D-NJ-6)
Cosponsors (5): Rep. John Dingell, Rep. Joe Barton,
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.
Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2008 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act to revise definitions, including defining the "process for the review of animal drug applications" to include the review of advertising and labeling prior to an approval of an animal drug application or supplemental animal application after the animal drug has been approved.
(Sec. 103) Requires the Secretary of Health and Human Services to assess 50% of the standard fee for a new animal drug application for a drug that combines active ingredients that have been approved separately.
Sets forth the amount of revenue that animal drug application fees, supplemental and other animal drug application fees, product fees, establishment fees, and sponsor fees are to generate for FY2009-FY2013.
(Sec. 104) Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the animal drug development process and the review of animal drug applications; and (2) implementation of the authority for and use of animal drug fees.
Sets forth a process for the Secretary to develop recommendations for the process of review of animal drug applications after FY2013.
(Sec. 105) Requires the sponsor of any new animal drug that contains an antimicrobial active ingredient to annually report to the Secretary on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Authorizes the Secretary to share such information with the Antimicrobial Resistance Task Force.
(Sec. 108) Terminates the authority to collect and assess animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.
Title II: Animal Generic Drug User Fee - Animal Generic Drug User Fee Act of 2008 - (Sec. 202) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.
Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.
Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.
Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.
Authorizes appropriations for FY2009-FY2013.
(Sec. 203) Requires the Secretary to report to Congress and make publicly available information on: (1) progress toward the goal of expediting the generic new animal drug development process and the review of abbreviated applications for such drugs; and (2) the implementation of the authority for and use of generic new animal drug fees.
Sets forth the process for developing recommendations to present to Congress for the review of abbreviated applications for generic new animal drugs after FY2013.
(Sec. 204) Terminates the authority to assess and use generic new animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.
Title III: Technical Corrections to FDAAA - (Sec. 301) Amends the Federal Food, Drug, and Cosmetic Act to require that consideration of a citizen petition or a petition for a stay of agency action on a new drug application be separate and apart from review and approval of any such application.
(Sec. 302) Amends the Public Health Service Act to make technical corrections to provisions related to the clinical trials data bank.
Committees
The committees the bill was sent to, and what each did with it.
Energy and Commerce Committee · House · markup by, referred to, reported bySubcommittee: Health Subcommittee
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
The record lists no related bills.
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. 22 actions.
- Aug 14, 2008Became lawBecame law · Became Public Law No: 110-316.
- Became lawBecame law · Signed by President.
- Aug 6, 2008FloorFloor · Presented to President.
- Aug 1, 2008FloorFloor · Message on Senate action sent to the House.
- FloorFloor · Passed Senate without amendment by Unanimous Consent.
- OtherOther · Cleared for White House.
- Jul 31, 2008CommitteeCommittee · Received in the Senate, read twice.
- Jul 30, 2008FloorFloor · The title of the measure was amended. Agreed to without objection.
- FloorFloor · 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 H.R. 6432.
- FloorFloor · Considered under suspension of the rules.
- FloorFloor · Mr. Pallone moved to suspend the rules and pass the bill, as amended.
- CalendarCalendar · Placed on the Union Calendar, Calendar No. 520.
- CommitteeCommittee · Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-804.
- Jul 16, 2008CommitteeCommittee · Ordered to be Reported (Amended) by Voice Vote.
- CommitteeCommittee · Committee Consideration and Mark-up Session Held.
- Jul 9, 2008CommitteeCommittee · Forwarded by Subcommittee to Full Committee by Voice Vote .
- CommitteeCommittee · Subcommittee Consideration and Mark-up Session Held.
- Jul 8, 2008CommitteeCommittee · Referred to the Subcommittee on Health.
- CommitteeCommittee · Referred to the House Committee on Energy and Commerce.
- IntroducedIntroduced · Introduced in House
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
No amendments to this bill are on record.
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.