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.

2/4/2025, 11:56 AM

Summary of Bill S 355

Bill 119 s 355, also known as the Nonclinical Testing Methods Act, is a proposed piece of legislation that aims to require the Secretary of Health and Human Services, specifically through the Commissioner of Food and Drugs, to publish a final rule regarding nonclinical testing methods.

Nonclinical testing methods are used to assess the safety and efficacy of drugs, medical devices, and other products before they are approved for use in humans. This bill seeks to establish clear guidelines and standards for these testing methods in order to ensure the safety and effectiveness of products being brought to market.

The final rule that would be published as a result of this bill would provide specific requirements and procedures for nonclinical testing methods, including the use of animals in testing, the validation of testing methods, and the reporting of test results. This rule would help to streamline the testing process, improve the accuracy and reliability of test results, and ultimately protect the health and well-being of consumers. Overall, Bill 119 s 355 aims to enhance the regulation of nonclinical testing methods in order to promote public health and safety. It is an important piece of legislation that seeks to ensure that products being brought to market have undergone rigorous testing and meet high standards of safety and efficacy.

Congressional Summary of S 355

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.

Current Status of Bill S 355

Bill S 355 is currently in the status of Bill Introduced since February 3, 2025. Bill S 355 was introduced during Congress 119 and was introduced to the Senate on February 3, 2025. Bill S 355's most recent activity was Read twice and referred to the Committee on Health, Education, Labor, and Pensions. as of February 3, 2025

Bipartisan Support of Bill S 355

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Policy Area and Potential Impact of Bill S 355

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Alternate Title(s) of Bill S 355

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.