To amend the Federal Food, Drug, and Cosmetic Act to establish a process for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for a biological product or other drug, 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 to establish a process for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for a biological product or other drug, and for other purposes., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Government Operations, Education.
Who Benefits and How
health care providers and patients 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, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.
Key Provisions
- Section H1E39D5AAF461413D887C1037EAEA0A27: 1. Short title This Act may be cited as the FDA Modernization Act 3.0.
- Section H6D6B623BC266473EA3AFE5E6DF8A5AF0: 2. Nonclinical testing methods qualification process at the Food and Drug Administration Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act...
- Section H09D283CBCA3949A7AF97C817F174A326: 507A. Nonclinical testing methods qualification process The Secretary shall establish a process for the qualification of a nonclinical testing method, with...
- Section H420B9A80F61F4FC9B0F9C23D88A5F631: 3. Regulations on nonclinical testing methods Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services,...
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 to establish a process for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for a biological product or other drug, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Key Policy Areas
Healthcare, Government Operations, Education
Primary Purpose
This bill, To amend the Federal Food, Drug, and Cosmetic Act to establish a process for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for a biological product or other drug, and for other purposes., changes federal law or congressional policy affecting health care providers and patients.
Policy Domains
Whole bill
Identified Gains
- health care providers and patients
Identified Costs
- federal implementing agencies
- health care providers and patients
Sponsors
Legislative Progress
IntroducedMr. Carter of Georgia (for himself, Ms. Barragán, Mrs. Harshbarger, …
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_commission"
- → The commission identified in the operative section
- "secretary_of_health_and_human_services"
- → Secretary of Health and Human Services
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