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HealthH.R. 2821Comments

FDA Modernization Act 3.0

Official title: 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.

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Where the Bill Stands

  1. Introduced, done
  2. Committee, done
  3. Floor Vote, done
  4. Outcome, current stage

What This Bill Does

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.

The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.

Sponsors

Related Documents

Bill on Congress.govWeb Page ↗ (opens in a new tab)

Timeline

  1. SenateReceived in the Senate.
  2. House floor actionsMr. Guthrie moved to suspend the rules and pass the bill.
  3. Passed the House
  4. House floor actionsReported by the Committee on Energy and Commerce. H. Rept. 119-706.
  5. House committee actionsCommittee Consideration and Mark-up Session Held
  6. House committee actionsSubcommittee Consideration and Mark-up Session Held
  7. House committee actionsReferred to the Subcommittee on Health.
  8. Library of CongressIntroduced in House
  9. House floor actionsReferred to the House Committee on Energy and Commerce.
  10. Introduced
  11. Committee

Comments

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