To amend the Federal Food, Drug, and Cosmetic Act with respect to transparency and reporting regarding over-the-counter drug monograph activities, and for other purposes.
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 with respect to
transparency and reporting regarding over-the-counter drug monograph activities, and for
other purposes., changes federal law or congressional policy affecting importers, exporters, and commercial firms. The main policy domain is Trade, Healthcare, Technology.
Who Benefits and How
importers, exporters, and commercial firms 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, importers, exporters, and commercial firms may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section S1: 1. Short title This Act may be cited as the OTC Monograph Drug User Fee Transparency Act.
- Section H8B16CA9BA9DF49DDA439CB35CBC88377: 2. OTC monograph drug performance reports Section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–73) is amended— in subsection (a)— by...
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
This bill, To amend the Federal Food, Drug, and Cosmetic Act with respect to transparency and reporting regarding over-the-counter drug monograph activities, and for other purposes., changes federal law or congressional policy affecting importers, exporters, and commercial firms.
Key Policy Areas
Trade, Healthcare, Technology
Primary Purpose
This bill, To amend the Federal Food, Drug, and Cosmetic Act with respect to transparency and reporting regarding over-the-counter drug monograph activities, and for other purposes., changes federal law or congressional policy affecting importers, exporters, and commercial firms.
Policy Domains
Whole bill
Identified Gains
- importers, exporters, and commercial firms
Identified Costs
- federal implementing agencies
- importers, exporters, and commercial firms
Sponsors
Legislative Progress
IntroducedMr. Kaine introduced the following bill; which was read twice …
Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_secretary"
- → The Secretary identified in the operative section
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