S 355
· 119th Congress
· Health
FDA Modernization Act 3.0
Sponsor
Latest action
Held at the desk.
Action timeline
Every recorded action on this bill, newest first. Stage badges color-code the legislative path.
Dec 17, 2025
floor
Message on Senate action sent to the House.
Dec 17, 2025
floor
Received in the House.
Dec 17, 2025
floor
Held at the desk.
Dec 16, 2025
committee
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Health, Education, Labor, and Pensions Committee
Dec 16, 2025
floor
Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
Dec 16, 2025
passed
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Dec 16, 2025
passed
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
Feb 03, 2025
introduced
Introduced in Senate
Feb 03, 2025
introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health, Education, Labor, and Pensions Committee
Text versions
Each stage of the bill — official text published by GPO. Click any format to read on congress.gov / govinfo.
CRS summaries
Plain-English summaries written by the Congressional Research Service — neutral, nonpartisan staff who summarize bills as they advance through stages. The authoritative description of what each version of the bill does.
00
Introduced in Senate
Feb 03, 2025
FDA Modernization Act 3.0
This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug.
The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications, and may make other changes to the regulations as appropriate.
The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
via Congressional Research Service · published through congress.gov
Changelog
ⓘ
How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.
ih / is — Introduced in House / Senate. First filed version.rfh / rfs — Referred to a committee for review.rh / rs — Reported back by the committee to the floor (often with amendments — this is where most language changes happen).pcs / pch — Placed on Calendar for floor consideration.eh / es — Engrossed. Passed by the originating chamber. Text is now what was actually voted on.rdh / rds — Received by the other chamber.eah / eas — Engrossed Amendment. The other chamber passed an amended version.ath / ats — Agreed to. Both chambers settled on the same text.enr — Enrolled. Final reconciled text, sent to the President.pl — Public Law. Signed by the President. It's now law.pp — Public Print. Official printing post-enactment.
Most bills die before eh/es. Going from pcs → enr is the full path through both chambers.
ⓘ
How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.
ih/is— Introduced in House / Senate. First filed version.rfh/rfs— Referred to a committee for review.rh/rs— Reported back by the committee to the floor (often with amendments — this is where most language changes happen).pcs/pch— Placed on Calendar for floor consideration.eh/es— Engrossed. Passed by the originating chamber. Text is now what was actually voted on.rdh/rds— Received by the other chamber.eah/eas— Engrossed Amendment. The other chamber passed an amended version.ath/ats— Agreed to. Both chambers settled on the same text.enr— Enrolled. Final reconciled text, sent to the President.pl— Public Law. Signed by the President. It's now law.pp— Public Print. Official printing post-enactment.
Most bills die before eh/es. Going from pcs → enr is the full path through both chambers.
Line-level diff between text versions of this bill — what actually changed at each legislative stage.
+51
−49
26 unchanged
--- Introduced (Senate)
+++ Engrossed (Senate)
@@ -1,5 +1,5 @@
[From the U.S. Government Publishing Office]
-[S. 355 Introduced in Senate (IS)]
+[S. 355 Engrossed in Senate (ES)]
<DOC>
@@ -7,24 +7,9 @@
1st Session
S. 355
-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.
-
_______________________________________________________________________
-IN THE SENATE OF THE UNITED STATES
-
-February 3, 2025
-
-Mr. Booker (for himself, Mr. Schmitt, Mr. King, Mr. Kennedy, Mr.
-Whitehouse, Mr. Marshall, Mr. Blumenthal, Mr. Paul, and Mr. Lujan)
-introduced the following bill; which was read twice and referred to the
-Committee on Health, Education, Labor, and Pensions
-
-_______________________________________________________________________
-
-A BILL
+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
@@ -40,27 +25,28 @@
SEC. 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:
+(1) In general.--In order 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), 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--
+(A) to amend the sections of title 21, Code of
+Federal Regulations, described in paragraph (2) to
+replace any references to ``animal'' tests, data,
+studies, models, and research with a reference to
+nonclinical tests, data, studies, models, and research;
+and
+(B) to add the definition of ``nonclinical test''
+in section 505(z) of the Federal Food, Drug, and
+Cosmetic Act (21 U.S.C. 355(z)) to sections 312.3,
+314.3, 315.2, and 601.31 of title 21, Code of Federal
+Regulations.
+(2) CFR sections described.--The sections of title 21, Code
+of Federal Regulations, described in this paragraph are the
+following:
(A) Section 312.22(c).
(B) Section 312.23(a)(3)(iv).
(C) Section 312.23(a)(5)(ii).
@@ -88,19 +74,35 @@
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,
+(3) 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) 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).
-<all>
+
+Passed the Senate
+
+Attest:
+
+Secretary.
+119th CONGRESS
+
+1st Session
+
+S. 355
+
+_______________________________________________________________________
+
+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.
Lobbying activity
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4
filings · 2026 Q3
4
filings · 2026 Q3
3
filings · 2025 Q2
2
filings · 2026 Q4
2
filings · 2025 Q3
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Cosponsors (9)
Members who signed on to support this bill.