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Data / Federal rules / 2024-21232

Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments

The Food and Drug Administration published this proposed rule in the Federal Register on September 20, 2024. Comments closed on December 4, 2024.

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What the agency says

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the Scope section of our regulation that provides for a regulatory hearing before the Agency to clarify when such hearings are available. We are proposing to revise the list of statutory provisions enumerated in the Scope section of the regulation by removing one statutory reference and adding a different statutory reference.

Key facts

Document number
2024-21232
Type
Proposed rule
Action
Proposed rule
Agency
Health and Human Services Department; Food and Drug Administration
Published
September 20, 2024
Comments due
December 4, 2024
Dates
Either electronic or written comments on the proposed rule or its companion direct final rule must be submitted by December 4, 2024. If FDA receives any timely significant adverse comments on the direct final rule with which this proposed rule is associated, we will publish a document withdrawing the direct final rule within 30 days after the comment period ends, and we will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.
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
4

The document on federalregister.gov PDF

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 2026-10-23. 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.