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Animal Drug and Animal Generic Drug User Fee Amendments of 2023

USA118th CongressS-1844| Senate 
| Updated: 7/26/2023
Tammy Baldwin

Tammy Baldwin

Democratic Senator

Wisconsin

Cosponsors (1)
Markwayne Mullin (Republican)

Health, Education, Labor, and Pensions 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); (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); and (4) provides for the regulation of zootechnical animal food substances as food additives (zootechnical animal food substances are added to the food or drinking water of animals to affect the byproducts of the animal's digestion, reduce foodborne pathogens, or alter the animal's gastrointestinal biome). 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

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Timeline

Bill from Previous Congress

S 115-2434
Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Jun 7, 2023
Introduced in Senate
Jun 7, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 15, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.
Jul 26, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.
Jul 26, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 174.
Sep 20, 2023

Latest Companion Bill Action

HR 118-1418
Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
  • Bill from Previous Congress

    S 115-2434
    Animal Drug and Animal Generic Drug User Fee Amendments of 2018


  • June 7, 2023
    Introduced in Senate


  • June 7, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • June 15, 2023
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.


  • July 26, 2023
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.


  • July 26, 2023
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 174.


  • September 20, 2023

    Latest Companion Bill Action

    HR 118-1418
    Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.

Health

Related Bills

  • HR 118-1418: Animal Drug and Animal Generic Drug User Fee Amendments of 2023
  • S 118-1842: Innovative FEED Act
  • HR 118-6687: Innovative FEED Act of 2023
  • HR 118-5860: Continuing Appropriations Act, 2024 and Other Extensions Act
Research and developmentUser charges and feesVeterinary medicine and animal diseases

Animal Drug and Animal Generic Drug User Fee Amendments of 2023

USA118th CongressS-1844| Senate 
| Updated: 7/26/2023
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); (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); and (4) provides for the regulation of zootechnical animal food substances as food additives (zootechnical animal food substances are added to the food or drinking water of animals to affect the byproducts of the animal's digestion, reduce foodborne pathogens, or alter the animal's gastrointestinal biome). 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
2 versions available

Suggested Questions

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

Timeline

Bill from Previous Congress

S 115-2434
Animal Drug and Animal Generic Drug User Fee Amendments of 2018
Jun 7, 2023
Introduced in Senate
Jun 7, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 15, 2023
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.
Jul 26, 2023
Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.
Jul 26, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 174.
Sep 20, 2023

Latest Companion Bill Action

HR 118-1418
Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
  • Bill from Previous Congress

    S 115-2434
    Animal Drug and Animal Generic Drug User Fee Amendments of 2018


  • June 7, 2023
    Introduced in Senate


  • June 7, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • June 15, 2023
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment favorably.


  • July 26, 2023
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment. Without written report.


  • July 26, 2023
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 174.


  • September 20, 2023

    Latest Companion Bill Action

    HR 118-1418
    Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 210.
Tammy Baldwin

Tammy Baldwin

Democratic Senator

Wisconsin

Cosponsors (1)
Markwayne Mullin (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 118-1418: Animal Drug and Animal Generic Drug User Fee Amendments of 2023
  • S 118-1842: Innovative FEED Act
  • HR 118-6687: Innovative FEED Act of 2023
  • HR 118-5860: Continuing Appropriations Act, 2024 and Other Extensions Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Research and developmentUser charges and feesVeterinary medicine and animal diseases