S. 5046 – FDA Modernization Act 3.0

AI-Generated Summary

Updated January 20, 2026 at 6:49 PM UTC

The FDA Modernization Act 3.0 directs the Department of Health and Human Services, through the FDA commissioner, to issue a rule that updates FDA regulations to replace references to animal testing with the term “nonclinical testing.” The rule must be published within one year of the law’s enactment and take effect immediately. It aligns FDA regulations with recent amendments to the Food, Drug, and Cosmetic Act made by the 2023 Consolidated Appropriations Act. The changes affect a wide range of FDA drug and biologic testing regulations.

Key Provisions

HHS must publish an interim final rule within one year, and the rule becomes effective right away without the usual good‑cause requirement.
The rule replaces references to “animal” tests, data, studies, models, and research with “nonclinical” equivalents in numerous specific sections of the FDA’s Code of Federal Regulations.
The definition of “nonclinical test” is added to several CFR parts to clarify its meaning.
HHS may make additional regulatory changes as needed to fully implement the replacement of animal references.
A technical amendment updates the designation of subsection (z) of Section 505 of the FD&C Act to subsection (aa).

Legislative Activity

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7 earlier actions

HouseFloor Latest Action

Held at the desk.

December 16, 2024 • 2:40 PM

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SenateIntro Referral

Introduced in Senate

September 12, 2024

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

September 12, 2024

SenateCommittee

Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.

Health, Education, Labor, and Pensions Committee

December 12, 2024

SenateFloor

Measure laid before Senate by unanimous consent. (consideration: CR S7044)

December 12, 2024

SenateFloor

Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7044)

December 12, 2024

SenateFloor

Message on Senate action sent to the House.

December 13, 2024

HouseFloor

Received in the House.

December 16, 2024 • 12:11 PM

HouseFloor

Held at the desk.

December 16, 2024 • 2:40 PM

Floor Debate

1 member

What members said about S. 5046 on the floor

1 Democrat

Sen. Charles E. SchumerD-NY · Dec 12, 2024

Mr. President, I ask unanimous consent that the Committee on Health, Education, Labor, and Pensions be discharged from further consideration of S. 5046 and the Senate proceed to its immediate…

Bill Text

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Engrossed in SenateIssued December 12, 2024

118th CONGRESS

2d Session

S. 5046

AN ACT

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.

1.

Short title

This Act may be cited as the FDA Modernization Act 3.0.

2.

Regulations on nonclinical testing methods

(a)

Interim final rule

(1)

In general

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).

(2)

Effectiveness of interim final rule

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.

(b)

Inclusions

(1)

In general

The interim final rule shall replace any references to animal tests, 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:

(A)

Section 312.22(c).

(B)

Section 312.23(a)(3)(iv).

(C)

Section 312.23(a)(5)(ii).

(D)

Section 312.23(a)(5)(iii).

(E)

Section 312.23(a)(8).

(F)

Section 312.23(a)(8)(i).

(G)

Section 312.23(a)(8)(ii).

(H)

Section 312.23(a)(10)(i).

(I)

Section 312.23(a)(10)(ii).

(J)

Section 312.33(b)(6).

(K)

Section 312.82(a).

(L)

Section 312.88.

(M)

Section 314.50(d)(2).

(N)

Section 314.50(d)(2)(iv).

(O)

Section 314.50(d)(5)(i).

(P)

Section 314.50(d)(5)(vi)(a).

(Q)

Section 314.50(d)(5)(vi)(b).

(R)

Section 314.93(e)(2).

(S)

Section 315.6(d).

(T)

Section 330.10(a)(2).

(U)

Section 601.35(d).

(V)

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).

(2)

Additional changes

The Secretary may make such additional changes to the sections of title 21, Code of Federal Regulations, described in subparagraphs (A) through (V) of paragraph (1) as the Secretary determines appropriate to fully implement the replacement required under such paragraph.

(c)

Definition of nonclinical test

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.

(d)

Technical amendment

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).

Passed the Senate December 12, 2024.

Secretary