Animal Drug and Animal Generic Drug User Fee Amendments of 2023

Summary

Animal 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 provides for a specific fee for requests to establish generic investigational new animal drug files and requires other application fees to be adjusted accordingly. 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 March 2023

   Introduced

   Introduced in House

   Source: IntroReferral

2. 7 March 2023

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

3. 7 March 2023

   Introduced

   Introduced in House

   Source: IntroReferral

4. 17 March 2023

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

5. 17 May 2023

   Vote

   Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 .

   Source: Committee

6. 17 May 2023

   Committee

   Subcommittee Consideration and Mark-up Session Held.

   Source: Committee

7. 24 May 2023

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

8. 24 May 2023

   Vote

   Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0.

   Source: Committee

9. 9 June 2023

   Calendars

   Placed on the Union Calendar, Calendar No. 80.

   Source: Calendars

10. 9 June 2023

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.

    Source: Committee

11. 9 June 2023

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.

    Source: Committee

12. 17 July 2023

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

13. 17 July 2023

    Passed

    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)

    Source: Floor

14. 17 July 2023

    Floor

    Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.

    Source: Floor

15. 17 July 2023

    Passed

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)

    Source: Floor

16. 17 July 2023

    Floor

    DEBATE - The House proceeded with forty minutes of debate on H.R. 1418.

    Source: Floor

17. 17 July 2023

    Floor

    Considered under suspension of the rules. (consideration: CR H3620-3624)

    Source: Floor

18. 18 July 2023

    Introduced

    Received in the Senate.

    Source: IntroReferral

19. 20 September 2023

    Introduced

    Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.

    Source: Calendars

Votes

No vote records are attached yet.

Versions

• Placed on Calendar Senate · 20 September 2023 · Official file
• Engrossed in House · 17 July 2023 · Official file
• Reported in House · 9 June 2023 · Official file
• Introduced in House · 7 March 2023 · Official file

Documents

11 official files

• Placed on Calendar Senate (text)

  Placed on Calendar Senate · EN · 20 September 2023

  ViewDownloadOpen at official source

• Placed on Calendar Senate (PDF)

  Placed on Calendar Senate · EN · 20 September 2023

  ViewDownloadOpen at official source

• Engrossed in House (text)

  Engrossed in House · EN · 17 July 2023

  ViewDownloadOpen at official source

• Engrossed in House (PDF)

  Engrossed in House · EN · 17 July 2023

  ViewDownloadOpen at official source

• Passed House

  summary · EN · 17 July 2023

  Open at official source

• Reported in House (text)

  Reported in House · EN · 9 June 2023

  ViewDownloadOpen at official source

• Reported in House (PDF)

  Reported in House · EN · 9 June 2023

  ViewDownloadOpen at official source

• Reported to House

  summary · EN · 9 June 2023

  Open at official source

• Introduced in House (text)

  Introduced in House · EN · 7 March 2023

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 7 March 2023

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 7 March 2023

  Open at official source

Sponsors

• Greg Pence · R · Sponsor
• Kim Schrier · D · Sponsor
• Rep. Lee, Susie [D-NV-3] · D · Cosponsor
• · hsif00 · Standing

Related records

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