Animal Drug User Fee Amendments of 2008

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.

8/14/2008--Public Law. (This measure has not been amended since it was passed by the House on July 30, 2008. The summary of that version is repeated here.) 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.


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Sponsor

• Rep. Frank Pallone [D, NJ-6]
• and 5 Co-Sponsors
  • Rep. Joe Barton [R, TX-6]
  • Rep. Nathan Deal [R, GA-9]
  • Rep. Diana DeGette [D, CO-1]
  • Rep. John Dingell [D, MI-15]
  • Rep. Edolphus Towns [D, NY-10]
  close

Committees

• House Energy and Commerce
• 1 more
  • House Energy and Commerce
  close

Amendments

This bill has no amendments.

Amendments to H.R.6432

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		This Bill Has Become Law
July 08, 2008		July 30, 2008		August 01, 2008		August 14, 2008		August 14, 2008

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• Enacted on Aug 14, 2008. Became Public Law No: 110-316.
• Signed on Aug 14, 2008.
• Aug 06, 2008. Presented to President.
• Aug 01, 2008: Message on Senate action sent to the House.
• Aug 01, 2008. Cleared for White House.
• Passed by Unanimous Consent in the Senate on Aug 01, 2008. Passed Senate without amendment by Unanimous Consent.
• Jul 31, 2008: Received in the Senate, read twice.
• Jul 31, 2008: Received in the Senate.
• Passed by voice vote in the House on Jul 30, 2008. On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
• Jul 30, 2008: The title of the measure was amended. Agreed to without objection.
• Jul 30, 2008: DEBATE - The House proceeded with forty minutes of debate on H.R. 6432.
• Jul 30, 2008: Mr. Pallone moved to suspend the rules and pass the bill, as amended.
• Jul 30, 2008: Considered under suspension of the rules.
• Added to calendar on Jul 30, 2008: Placed on the Union Calendar, Calendar No. 520..
• Jul 30, 2008: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-804.
• Added to calendar on Jul 16, 2008: Ordered to be Reported (Amended) by Voice Vote..
• Jul 16, 2008: Committee Consideration and Mark-up Session Held.
• Jul 09, 2008: Subcommittee Consideration and Mark-up Session Held.
• Jul 09, 2008: Forwarded by Subcommittee to Full Committee by Voice Vote .
• Jul 08, 2008: Referred to the House Committee on Energy and Commerce.
• Jul 08, 2008: Referred to the Subcommittee on Health.
• Introduced on Jul 08, 2008.

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Related Issue Areas:

• Medicine
• Administrative fees
• Administrative remedies
• Agriculture
• 25 more
• Animals
• Antibiotics
• Budgets
• Civil liberties
• Clinical trials
• Congress
• Congressional reporting requirements
• Consumers
• Data banks
• Drug approvals
• Drug resistance in microorganisms
• Drugs
• Food
• Food safety
• Generic drugs
• Government information
• Government publicity
• Law
• Livestock
• Meat
• Medical care
• Right of petition
• Technology
• User charges
• Veterinary medicine

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In the News

August 19, 2008 Animal Generic Drug User Fee Signed into Law

President Bush signed into law the Animal Drug User Fee Amendments of 2008 (HR 6432) on Thursday, which among other things, authorizes a new user fee ...

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Source: CatChannel.com, Ca

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August 15, 2008 GADA Applauds the Presidential Signing of the Animal Generic Drug User Fee Act of 2008

WASHINGTON, Aug. 14 /PRNewswire/ -- The Generic Animal Drug Alliance (GADA) today announced that President Bush signed into law the Animal Generic Drug User Fee Act of 2008 (Title II of H.R.6432). Under the Animal Generic Drug User Fee Act (AGDUFA),

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August 06, 2008 US congress approves animal-drug review laws

The Senate approved HR 6432, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA), by unanimous consent. ...

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Blog Coverage

September 19, 2008 overuse of antibiotics in factory farming

accordingly, during the house energy and commerce committee's recent review of adufa legislation (hr 6432), health subcommittee chairman frank pallone jr. (d-nj) introduced an amendment that would require drug sponsors to report ...

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August 25, 2008 Animal Drug User Fee Programs

HR 6432, the Animal Drug User Fee Amendments of 2008, a bill to reauthorize the program, was introduced on July 8, 2008. Subsequently, the bill was forwarded without amendment to the full committee by the House Energy and Commerce ...

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August 14, 2008 president signs hr 4040, the cpsc bill

president bush signs hr 4040, hr 4137, and hr 6432 into law. hr 4040, the “consumer product safety improvement act of 2008,” which reauthorizes the consumer product safety commission for fys 2010-2014 and expands the commission’s role ...

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