← REGULATORY CHANGES
FEDERAL REGISTER · PROPOSED RULESeptember 20, 2024PROPOSED — NOT IN FORCE

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

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSPROPOSED — NOT IN FORCE
PROPOSED EFFECTIVE—
COMMENTS CLOSEDec 4, 2024 · closed
APPLIES TO · SPEQ TAGNot tagged
Document type
Proposed Rule
Agency
Health and Human Services Department
Published
September 20, 2024
Comments close
December 4, 2024
Document number
2024-21232
CFR references
21 CFR 16
Docket
FDA-2024-N-3654
RIN
0910-AI97
ABSTRACT

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.

Abstract as published in the Federal Register.

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