FDA Modernization Act 3.0
Summary
What This Bill Does
The FDA Modernization Act 3.0 forces FDA regulations to catch up with the 2023 statutory change allowing nonclinical testing methods. Within one year, HHS, acting through the FDA Commissioner, must publish an interim final rule replacing references to animal tests, animal data, animal studies, animal models, and animal research in specified parts of title 21 with references to nonclinical tests, data, studies, models, and research. The rule must also add the Federal Food, Drug, and Cosmetic Act definition of nonclinical test to FDA regulatory definitions for investigational new drugs, new drug applications, biological products, and related provisions. The interim rule becomes effective immediately without a separate good-cause showing under the Administrative Procedure Act.
Who Benefits and How
Non-animal testing technology developers benefit because FDA regulations must expressly recognize nonclinical tests rather than only animal tests. Drug sponsors benefit from clearer regulatory text for using qualifying nonclinical data in investigational and approval submissions. Biologics manufacturers benefit because the definition is added to biologics-related regulations as well as drug regulations. Animal welfare organizations benefit because the regulatory language reduces reliance on animal-test terminology.
Who Bears the Burden and How
The Food and Drug Administration must revise many CFR sections within one year and issue an immediately effective interim final rule. The HHS Secretary must use rulemaking authority without relying on a separate good-cause justification. Drug application reviewers must apply the updated nonclinical-test terminology across investigational, new drug, generic, over-the-counter, and biologics contexts.
Key Provisions
- Requires HHS and FDA to publish an interim final rule within one year implementing nonclinical-testing amendments to FDCA section 505(i).
- Amends specified FDA regulations to replace animal-test references with nonclinical-test references.
- Adds the statutory definition of nonclinical test to 21 CFR 312.3, 314.3, 315.2, and 601.31.
- Provides immediate effectiveness for the interim final rule without requiring a separate APA good-cause showing.
- Corrects the duplicate subsection designation for clinical trial diversity action plans in FDCA section 505.
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
Requires the Secretary of Health and Human Services, acting through the FDA Commissioner, to issue an immediately effective interim final rule within one year replacing animal-test references across specified FDA drug and biologics regulations with references to nonclinical tests and adding the statutory definition of nonclinical test to 21 CFR 312.3, 314.3, 315.2, and 601.31, while correcting a duplicate subsection designation in section 505 of the Federal Food, Drug, and Cosmetic Act.
Key Policy Areas
Healthcare, Pharmaceuticals, Biotechnology, Animal Welfare
Primary Purpose
Requires the Secretary of Health and Human Services, acting through the FDA Commissioner, to issue an immediately effective interim final rule within one year replacing animal-test references across specified FDA drug and biologics regulations with references to nonclinical tests and adding the statutory definition of nonclinical test to 21 CFR 312.3, 314.3, 315.2, and 601.31, while correcting a duplicate subsection designation in section 505 of the Federal Food, Drug, and Cosmetic Act.
Policy Domains
House resolution provisions
Identified Gains
- Non-animal testing technology developers
- Drug sponsors
- Biologics manufacturers
- Animal welfare organizations
Identified Costs
- Food and Drug Administration
- HHS Secretary
- Drug application reviewers
Sponsors
Legislative Progress
ReportedAdditional sponsors: Mr. Doggett, Mr. Nadler, Mr. Carey, Mr. Fitzpatrick, …
Committed to the Committee of the Whole House on the …
Committee Consideration and Mark-up Session Held
Ordered to be Reported by the Yeas and Nays: 44 …
Forwarded by Subcommittee to Full Committee by Voice Vote.
Subcommittee Consideration and Mark-up Session Held
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Mr. Carter of Georgia (for himself, Ms. Barragán, Mr. Buchanan, …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Biologics manufacturers, Drug sponsors, Non-animal testing technology developers
Drug application reviewers, Food and Drug Administration, HHS Secretary
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "fda"
- → Food and Drug Administration
- "hhs"
- → Department of Health and Human Services
- "fdca"
- → Federal Food, Drug, and Cosmetic Act
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