← REGULATORY CHANGES
FEDERAL REGISTER · RULEJanuary 17, 2025IN FORCE

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

What this record is not

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.

STATUSIN FORCE
EFFECTIVEJan 17, 2025
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGNot tagged
Document type
Rule
Agency
Health and Human Services Department
Published
January 17, 2025
Effective
January 17, 2025
Document number
2025-01145
CFR references
21 CFR 16
Docket
FDA-2024-N-3654
RIN
0910-AI97
ABSTRACT

The Food and Drug Administration (FDA or Agency) published in the Federal Register of September 20, 2024, a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency. The comment period closed December 4, 2024. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.

Abstract as published in the Federal Register.

READ THE FULL DOCUMENT

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.

View on federalregister.gov →

That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.

Create a free account