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Animal Drug and Animal Generic Drug User Fee Amendments of 2023

USA118th CongressHR-1418| House 
| Updated: 9/20/2023
Greg Pence

Greg Pence

Republican Representative

Indiana

Cosponsors (2)
Kim Schrier (Democratic)Susie Lee (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.

Bill Text Versions

View Text
4 versions available

Suggested Questions

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Timeline

Bill from Previous Congress

HR 115-5554
Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Mar 7, 2023
Introduced in House
Mar 7, 2023
Referred to the House Committee on Energy and Commerce.
Mar 17, 2023
Referred to the Subcommittee on Health.
May 17, 2023
Subcommittee Consideration and Mark-up Session Held.
May 17, 2023
Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 .
May 24, 2023
Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0.
May 24, 2023
Committee Consideration and Mark-up Session Held.
Jun 9, 2023
Placed on the Union Calendar, Calendar No. 80.
Jun 9, 2023
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.
Jul 17, 2023
Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
Jul 17, 2023
Considered under suspension of the rules. (consideration: CR H3620-3624)
Jul 17, 2023
DEBATE - The House proceeded with forty minutes of debate on H.R. 1418.
Jul 17, 2023
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)
Jul 17, 2023
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)
Jul 17, 2023
Motion to reconsider laid on the table Agreed to without objection.
Jul 18, 2023
Received in the Senate.
Jul 26, 2023

Latest Companion Bill Action

S 118-1844
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.
Sep 20, 2023
Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
  • Bill from Previous Congress

    HR 115-5554
    Animal Drug and Animal Generic Drug User Fee Amendments of 2018


  • March 7, 2023
    Introduced in House


  • March 7, 2023
    Referred to the House Committee on Energy and Commerce.


  • March 17, 2023
    Referred to the Subcommittee on Health.


  • May 17, 2023
    Subcommittee Consideration and Mark-up Session Held.


  • May 17, 2023
    Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 .


  • May 24, 2023
    Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0.


  • May 24, 2023
    Committee Consideration and Mark-up Session Held.


  • June 9, 2023
    Placed on the Union Calendar, Calendar No. 80.


  • June 9, 2023
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.


  • July 17, 2023
    Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.


  • July 17, 2023
    Considered under suspension of the rules. (consideration: CR H3620-3624)


  • July 17, 2023
    DEBATE - The House proceeded with forty minutes of debate on H.R. 1418.


  • July 17, 2023
    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)


  • July 17, 2023
    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)


  • July 17, 2023
    Motion to reconsider laid on the table Agreed to without objection.


  • July 18, 2023
    Received in the Senate.


  • July 26, 2023

    Latest Companion Bill Action

    S 118-1844
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.


  • September 20, 2023
    Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.

Health

Related Bills

  • HR 118-5860: Continuing Appropriations Act, 2024 and Other Extensions Act
  • S 118-1844: Animal Drug and Animal Generic Drug User Fee Amendments of 2023
Research and developmentUser charges and feesVeterinary medicine and animal diseases

Animal Drug and Animal Generic Drug User Fee Amendments of 2023

USA118th CongressHR-1418| House 
| Updated: 9/20/2023
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.

Bill Text Versions

View Text
4 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 115-5554
Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Mar 7, 2023
Introduced in House
Mar 7, 2023
Referred to the House Committee on Energy and Commerce.
Mar 17, 2023
Referred to the Subcommittee on Health.
May 17, 2023
Subcommittee Consideration and Mark-up Session Held.
May 17, 2023
Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 .
May 24, 2023
Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0.
May 24, 2023
Committee Consideration and Mark-up Session Held.
Jun 9, 2023
Placed on the Union Calendar, Calendar No. 80.
Jun 9, 2023
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.
Jul 17, 2023
Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.
Jul 17, 2023
Considered under suspension of the rules. (consideration: CR H3620-3624)
Jul 17, 2023
DEBATE - The House proceeded with forty minutes of debate on H.R. 1418.
Jul 17, 2023
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)
Jul 17, 2023
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)
Jul 17, 2023
Motion to reconsider laid on the table Agreed to without objection.
Jul 18, 2023
Received in the Senate.
Jul 26, 2023

Latest Companion Bill Action

S 118-1844
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.
Sep 20, 2023
Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
  • Bill from Previous Congress

    HR 115-5554
    Animal Drug and Animal Generic Drug User Fee Amendments of 2018


  • March 7, 2023
    Introduced in House


  • March 7, 2023
    Referred to the House Committee on Energy and Commerce.


  • March 17, 2023
    Referred to the Subcommittee on Health.


  • May 17, 2023
    Subcommittee Consideration and Mark-up Session Held.


  • May 17, 2023
    Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by the Yeas and Nays: 29 - 0 .


  • May 24, 2023
    Ordered to be Reported (Amended) by the Yeas and Nays: 49 - 0.


  • May 24, 2023
    Committee Consideration and Mark-up Session Held.


  • June 9, 2023
    Placed on the Union Calendar, Calendar No. 80.


  • June 9, 2023
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-104.


  • July 17, 2023
    Mr. Bilirakis moved to suspend the rules and pass the bill, as amended.


  • July 17, 2023
    Considered under suspension of the rules. (consideration: CR H3620-3624)


  • July 17, 2023
    DEBATE - The House proceeded with forty minutes of debate on H.R. 1418.


  • July 17, 2023
    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)


  • July 17, 2023
    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3620-3623)


  • July 17, 2023
    Motion to reconsider laid on the table Agreed to without objection.


  • July 18, 2023
    Received in the Senate.


  • July 26, 2023

    Latest Companion Bill Action

    S 118-1844
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.


  • September 20, 2023
    Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
Greg Pence

Greg Pence

Republican Representative

Indiana

Cosponsors (2)
Kim Schrier (Democratic)Susie Lee (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 118-5860: Continuing Appropriations Act, 2024 and Other Extensions Act
  • S 118-1844: Animal Drug and Animal Generic Drug User Fee Amendments of 2023
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Research and developmentUser charges and feesVeterinary medicine and animal diseases