Animal Generic Drug User Fee Amendments of 2013

Summary

Animal Generic Drug User Fee Amendments of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees. Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved. Revises the due date for annual generic animal drug user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year. Establishes the total amount of revenue each type of generic user fee shall generate. Authorizes the Secretary of Health and Human Services (HHS) to accept payment of user fees prior to their due date. Extends requirements for the FDA to report to Congress on achieving goals related to the generic animal drug development and review process and the implementation of the authority to collect generic animal drug fees. Terminates the authority to collect generic animal drug user fees October 1, 2018.

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Timeline

1. 9 April 2013

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 9 April 2013

   Introduced

   Introduced in House

   Source: IntroReferral

3. 9 April 2013

   Introduced

   Introduced in House

   Source: IntroReferral

4. 12 April 2013

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 9 April 2013 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 9 April 2013

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 9 April 2013

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 9 April 2013

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Gardner, Cory [R-CO] · R · Sponsor
• Rep. Shimkus, John [R-IL-15] · R · Sponsor
• Rep. Upton, Fred [R-MI-6] · R · Sponsor
• Rep. Pitts, Joseph R. [R-PA-16] · R · Sponsor
• Rep. Waxman, Henry A. [D-CA-33] · D · Sponsor
• Rep. Pallone, Frank [D-NJ-6] · D · Sponsor
• Rep. Burgess, Michael C. [R-TX-26] · R · Sponsor
• Rep. Guthrie, Brett [R-KY-2] · R · Sponsor
• Rep. Kinzinger, Adam [R-IL-16] · R · Sponsor
• · hsif00 · Standing

Related records

• related to ← Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013