To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill, To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs., changes federal law or congressional policy affecting federal agencies and legislative administrators. The main policy domain is Government Operations, Healthcare, Energy.
Who Benefits and How
federal agencies and legislative administrators may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.
Who Bears the Burden and How
federal implementing agencies may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section HCA9A06A8558C48B4BEBC9D265BD36745: 1. Short title This Act may be cited as the Animal Drug and Animal Generic Drug User Fee Amendments of 2023.
- Section H35B57914FC344603A3D92D897AB578F4: 2. Table of contents The table of contents for this Act is the following:
- Section H73CBC7AD785D4551AF412CD2A877DB47: 101. Short title; finding This title may be cited as the Animal Drug User Fee Amendments of 2023. Congress finds that the fees authorized by the amendments...
- Section H6DA7C91CD9D64478947F1882015BBC01: 102. Definitions Section 739 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11) is amended— in paragraph (3), by striking national drug code and...
- Section H33F204F61C094D8A853A1328A8AECD56: 103. Authority to assess and use animal drug fees Section 740(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(a)(1)(A)(ii)) is...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
This bill, To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs., changes federal law or congressional policy affecting federal agencies and legislative administrators.
Key Policy Areas
Government Operations, Healthcare, Energy
Primary Purpose
This bill, To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs., changes federal law or congressional policy affecting federal agencies and legislative administrators.
Policy Domains
Whole bill
Identified Gains
Contextual inference, no direct clause citation- federal agencies and legislative administrators
Contextual inference, no direct clause citation
Identified Costs
Contextual inference, no direct clause citation- federal implementing agencies
Contextual inference, no direct clause citation
Sponsors
Legislative Progress
ReportedReported by Mr. Sanders, with an amendment
Ms. Baldwin (for herself and Mr. Mullin) introduced the following …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Animal drug fee program, Congress (oversight), Congress (public health oversight)
FDA Center for Veterinary Medicine faces effects in multiple directions
Animal drug applicants with pending applications, Animal drug industry (transparency), Animal drug manufacturers (brand-name)
Positive-direction: Animal drug applicants with pending applications, Animal drug industry (transparency), Generic animal drug applicants with pending applications
Negative-direction: Animal drug manufacturers (brand-name), Generic animal drug manufacturers
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_commission"
- → The commission identified in the operative section
- "secretary_of_health_and_human_services"
- → Secretary of Health and Human Services
Key Definitions
Terms defined in this bill
a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug
a substance that— is added to the food or drinking water of animals
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology