Data / Federal rules / 2024-21231
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
The Food and Drug Administration published this final rule in the Federal Register on September 20, 2024. It took effect on February 3, 2025. Comments closed on December 4, 2024.
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What the agency says
The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency in order to clarify when such hearings are available. We are revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.
Key facts
- Document number
- 2024-21231
- Type
- Final rule
- Action
- Direct final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 20, 2024
- Takes effect
- February 3, 2025
- Comments due
- December 4, 2024
- Dates
- This rule is effective February 3, 2025. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by December 4, 2024. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule within 30
- Docket
- Docket No. FDA-2024-N-3654
- Regulation ID (RIN)
- 0910-AI97
- Code of Federal Regulations
- 21 CFR 16
- Topics
- Administrative practice and procedure
- Pages
- 5
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Published in September 2024
Read from the Federal Register API, last updated 2026-10-24. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.