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S 5046 118th Congress Senate Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Medical research Research administration and funding

FDA Modernization Act 3.0

Introduced: September 12, 2024 Introduced by: Booker, Cory A. Democratic · New Jersey See on congress.gov
This bill died when the 118th Congress ended
It never became law before the 118th Congress (2023–2024) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 9 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 16, 2024
Held at the desk.
Dec 16, 2024
Received in the House.
Dec 13, 2024
Message on Senate action sent to the House.
Dec 12, 2024
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7044)
Dec 12, 2024
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Dec 12, 2024
Measure laid before Senate by unanimous consent. (consideration: CR S7044)
Dec 12, 2024
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Sep 12, 2024
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 12, 2024
Introduced in Senate
 Amendments to this bill 1

Amendments propose changes to this bill. Members vote on amendments separately before the final bill vote. An agreed amendment becomes part of the bill; a failed amendment does not.

1 agreed to

AmendmentSponsorPurposeStatusLatest action
SAMDT 3,328 Booker, Cory A. In the nature of a substitute. Agreed to Dec 12, 2024
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 Plain-English summary Congressional Research Service

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. 

What's happening now December 16, 2024

Held at the desk.

 Related & companion bills 1
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
Cite this page click to expand
APA
U.S. Congress. (2026). S. 5046: FDA Modernization Act 3.0. 118th Congress. Open America. https://openamerica.io/bill/118-S-5046/
MLA
"S. 5046: FDA Modernization Act 3.0." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-S-5046/.
Bluebook (legal)
S. 5046, 118th Cong. (2026), https://openamerica.io/bill/118-S-5046/.
Markdown link
[S. 5046: FDA Modernization Act 3.0](https://openamerica.io/bill/118-S-5046/)
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