S 355
FDA Modernization Act 3.0
Take action
Record your position on this measure.
Sign in to record your position, submit testimony, or contact your legislator.
Sign in to take action- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
This bill, the FDA Modernization Act 3.0, directs the Food and Drug Administration (FDA) to update its regulations to align with a provision in the Consolidated Appropriations Act of 2023. Specifically, it requires the FDA to publish an interim final rule that replaces references to animal testing with references to nonclinical testing methods across numerous sections of the Code of Federal Regulations. This change aims to promote the use of alternative testing methods in drug development.
Key provisions
- The FDA must publish an interim final rule within one year of enactment.
- The rule must replace animal testing references with nonclinical testing references.
- The rule applies to specific sections of the Code of Federal Regulations (21 CFR).
- The Secretary of Health and Human Services can make additional changes to regulations as needed.
- The definition of ‘nonclinical test’ is added to several key sections of the Code of Federal Regulations.
- The bill amends the Federal Food, Drug, and Cosmetic Act to designate a specific subsection related to clinical trial diversity action plans.
- The interim final rule will take effect immediately.
Who is affected
- Food and Drug Administration (FDA)
- Pharmaceutical companies
- Researchers developing new drugs
- Healthcare professionals
- Patients
Notable changes
- Shift from animal testing to nonclinical testing methods in FDA regulations.
Sponsors
Official sponsors from legislative records.
Primary sponsor
Cosponsors
Angus S., Jr. King
Arguments in favor
Reasons to support this legislation.
No arguments in favor have been submitted.
Submit yoursArguments opposed
Reasons to oppose this legislation.
No arguments opposed have been submitted.
Submit yoursRead the latest version inline or switch to a previous version.
119th CONGRESS — 1st Session
S. 355
IN THE SENATE OF THE UNITED STATES
A BILL
To require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.
This Act may be cited as the FDA Modernization Act 3.0
.
Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish an interim final rule pursuant to subsections (b) and (c) to ensure implementation of the amendments to section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) made by section 3209(a) of the Consolidated Appropriations Act, 2023 (Public Law 117–328; 136 Stat. 5821).
Notwithstanding subparagraph (B) of section 553(b) of title 5, United States Code, the interim final rule issued by the Secretary of Health and Human Services under paragraph (1) shall become immediately effective as an interim final rule without requiring the Secretary of Health and Human Services to demonstrate good cause therefor.
animaltests, data, studies, models, and research with a reference to nonclinical tests, data, studies, models, and research in the following sections of title 21, Code of Federal Regulations:
Section 312.22(c).
Section 312.23(a)(3)(iv).
Section 312.23(a)(5)(ii).
Section 312.23(a)(5)(iii).
Section 312.23(a)(8).
Section 312.23(a)(8)(i).
Section 312.23(a)(8)(ii).
Section 312.23(a)(10)(i).
Section 312.23(a)(10)(ii).
Section 312.33(b)(6).
Section 312.82(a).
Section 312.88.
Section 314.50(d)(2).
Section 314.50(d)(2)(iv).
Section 314.50(d)(5)(i).
Section 314.50(d)(5)(vi)(a).
Section 314.50(d)(5)(vi)(b).
Section 314.93(e)(2).
Section 315.6(d).
Section 330.10(a)(2).
Section 601.35(d).
Any other section necessary to ensure regulatory consistency with the amendments to section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) made by section 3209(a) of the Consolidated Appropriations Act, 2023 (Public Law 117–328; 136 Stat. 5821).
The definition of nonclinical test in section 505(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z)) shall be added to sections 312.3, 314.3, 315.2, and 601.31 of title 21, Code of Federal Regulations.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by designating the second subsection (z) (relating to clinical trial diversity action plans), as added by section 3601(a) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022 (division FF of Public Law 117–328), as subsection (aa).