S 355 119th Congress
FDA Modernization Act 3.0
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.
Official Title as Introduced Congress.gov
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Bill journey
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Introduction Congress.gov
Introduced
Introduced in the Senate.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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Introduced in Senate
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Introduced in Senate
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Official action Congress.gov
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794)
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Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
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Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794)
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Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
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Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
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SAMDT 4057
Amendment SA 4057 agreed to in Senate by Unanimous Consent.
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Message on Senate action sent to the House.
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Engrossed in Senate
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Received in the House.
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Held at the desk.
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View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Health, Education, Labor, and Pensions. | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov | |
| Official actionPassed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794) | No additional detail supplied.Floor · Senate | Congress.gov | |
| Official actionPassed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent. | No additional detail supplied.Floor · Library of Congress · Code 17000 | Congress.gov | |
| Official actionMeasure laid before Senate by unanimous consent. (consideration: CR S8793-8794) | No additional detail supplied.Floor · Senate | Congress.gov | |
| Official actionSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. | No additional detail supplied.Discharge · Senate | Congress.gov | |
| Official actionSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. | No additional detail supplied.Committee · Library of Congress · Code 14500 | Congress.gov | |
| AmendmentSAMDT 4057 | Amendment SA 4057 agreed to in Senate by Unanimous Consent. | Congress.gov | |
| Official actionMessage on Senate action sent to the House. | No additional detail supplied.Floor · Senate | Congress.gov | |
| Text versionEngrossed in Senate | A dated text-version record is available. | Congress.gov | |
| Official actionReceived in the House. | No additional detail supplied.Floor · House floor actions · Code H14000 | Congress.gov | |
| Official actionHeld at the desk. | No additional detail supplied.Floor · House floor actions · Code H15000 | Congress.gov |
House roll calls join only on matching Congress, legislation type, and number. Senate roll calls join only on matching source-supplied document type and number, not question text. Committee and related-measure relationships have no date in their relationship records and therefore are counted above but never placed on the chronology.
Congressional Research Service
CRS summary
FDA Modernization Act 3.0This 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.
Official documents
Text versions
- Engrossed in SenateDec 17, 2025
- Introduced in SenateFeb 3, 2025