Animal Generic Drug User Fee Act of 2008

To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.

7/30/2008--Reported to House amended. Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services 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.
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.
Terminates the authority to assess and use generic new animal drug fees on October 1, 2013. Terminates reporting requirements on January 31, 2014.

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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.6433

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
July 08, 2008

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All Bill Actions

• Added to calendar on Jul 30, 2008: Placed on the Union Calendar, Calendar No. 521..
• Jul 30, 2008: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-805.
• 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: Forwarded by Subcommittee to Full Committee by Voice Vote .
• Jul 09, 2008: Subcommittee Consideration and Mark-up Session Held.
• Jul 08, 2008: Referred to the Subcommittee on Health.
• Jul 08, 2008: Referred to the House Committee on Energy and Commerce.
• Introduced on Jul 08, 2008.

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Related Issue Areas:

• Veterinary medicine
• Telecommunication
• Technology
• Sunset legislation
• 24 more
• Science policy
• Pharmaceutical research
• Medicine
• Medical care
• Law
• Government publicity
• Government information
• Generic drugs
• Food and Drug Administration (FDA)
• Executive departments
• Electronic government information
• Drug industry
• Drug approvals
• Department of Health and Human Services
• Congressional reporting requirements
• Congress
• Business
• Budgets
• Authorization
• Appropriations
• Animals
• Administrative procedure
• Administrative fees
• Health policy

Data from the Congressional Research Service

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Blog Coverage

August 28, 2008 Weber 6433 Saucing System

Fees authorized by HR 6433 could be collected and made available ... www.cbo.gov/doc.cfm?index=9625 Find Corpus Christi apartments and homes for rent in the GREATER ... Visit The Veranda to search and view our rental properties . ...

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July 07, 2008 HR 6433, To amend the Federal Food, Drug, and Cosmetic Act to ...

HR 6433 would amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs.... Vote on This Bill: For | Against.

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July 07, 2008 Bill Action: Introduced: HR 6433: To amend the Federal Food, Drug ...

Rep. Frank Pallone [D-NJ] introduced HR 6433: To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs. [This event matched these trackers: Active Legislation ]

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