Animal Generic Drug User Fee Act of 2008

Summary

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 collect: (1) an application fee from persons who submit an abbreviated application for a generic new animal drug on or after July 1, 2008; (2) an annual product fee from applicants named in an abbreviated application or supplemental abbreviated application for a generic new animal drug product that has been submitted for listing for commercial distribution who have such an application pending before the Secretary after September 1, 2008; and (3) an annual sponsor fee from generic new animal drug sponsors who have such an application or an investigational submission pending after such date. Sets forth the total revenues to be collected from each of such fees in each of FY2009-FY2013. Provides for revenue adjustments based on application review workloads. Requires the Secretary to establish such fees before each fiscal year based on such revenue amounts and adjustments and total review costs. Deems such an application or investigational submission to be incomplete until all such fees have been paid. Authorizes the Secretary to waive or reduce such fees where the drug is intended solely to provide for a minor use or minor species indication. Conditions fee assessment and obligation on appropriation funding levels. Requires the Secretary to report annually on: (1) the Food and Drug Administration's (FDA's) progress in expediting the development process and the review of abbreviated applications and investigational submissions for generic new animal drugs; and (2) implementation of the fee authority and FDA's use of the fees. Sets forth consultation requirements regarding the process for the review of such abbreviated applications for the five years after FY2013.

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Documents

6 official files

• Reported in House (text)

  Reported in House · EN · 30 July 2008

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• Reported in House (PDF)

  Reported in House · EN · 30 July 2008

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• Reported to House with amendment(s)

  summary · EN · 30 July 2008

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• Introduced in House (text)

  Introduced in House · EN · 8 July 2008

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• Introduced in House (PDF)

  Introduced in House · EN · 8 July 2008

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• Introduced in House

  summary · EN · 8 July 2008

  Open at official source

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