Animal Drug and Animal Generic Drug User Fee Amendments of 2023

Summary

Animal Drug and Animal Generic Drug User Fee Amendments of 2023 This bill reauthorizes the Food and Drug Administration (FDA) to collect fees for brand-name and generic animal drug applications through FY2028. It also makes related updates to fee calculations and FDA reporting requirements. The bill also (1) provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly; (2) authorizes the FDA to remove species from the definition of major species (currently horses, dogs, cats, cattle, pigs, chickens, and turkeys); and (3) provides statutory authority for the FDA to report on its progress supporting antimicrobial stewardship in veterinary settings (i.e., supporting responsible use of antimicrobial drugs for animals to slow the development of drug-resistant bacteria). Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the FDA before they may be offered on the commercial market. The FDA is authorized to collect fees for animal drug applications in order to support its regulatory activities; this authority currently expires at the end of FY2023.

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Timeline

1. 7 June 2023

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 7 June 2023

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 15 June 2023

   Reported

   Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.

   Source: Committee

4. 26 July 2023

   Calendars

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 174.

   Source: Calendars

5. 26 July 2023

   Reported

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.

   Source: Committee

6. 26 July 2023

   Reported

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Reported to Senate · 26 July 2023 · Download file
• Introduced in Senate · 7 June 2023 · Download file

Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 26 July 2023

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• Reported to Senate (PDF)

  Reported to Senate · EN · 26 July 2023

  ViewDownloadOpen at official source

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• Reported to Senate

  summary · EN · 26 July 2023

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  Vertaal document

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• Introduced in Senate (text)

  Introduced in Senate · EN · 7 June 2023

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  Vertaal document

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

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 7 June 2023

  ViewDownloadOpen at official source

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  Vertaal document

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

• Introduced in Senate

  summary · EN · 7 June 2023

  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. Baldwin, Tammy [D-WI] · D · Sponsor
• Sen. Mullin, Markwayne [R-OK] · R · Sponsor
• · sshr00 · Standing

Related records

• related to → Animal Drug and Animal Generic Drug User Fee Amendments of 2023
• related to → Innovative FEED Act
• related to ← Continuing Appropriations Act, 2024 and Other Extensions Act
• related to ← Innovative FEED Act of 2023