[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Rules and Regulations]
[Pages 83781-83782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 16

[Docket No. FDA-2024-N-3654]
RIN 0910-AI97


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
correcting a final rule entitled ``Regulatory Hearing Before the Food 
and Drug Administration; General Provisions; Amendments'' that appeared

[[Page 83782]]

in the Federal Register of September 20, 2024. The final rule 
inadvertently omitted the effective date for a provision in the 
regulatory text. This document corrects the error in the DATES portion.

DATES: Effective February 3, 2025.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, 
Legislation, and International Affairs, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-9148.

SUPPLEMENTARY INFORMATION: In FR Doc. 2024-21231, published in the 
Federal Register of Friday, September 20, 2024 (89 FR 77019), on page 
77019, in the third column, the DATES section is corrected to read as 
follows:

DATES: Effective date: This rule is effective February 3, 2025, except 
for amendatory instruction number 3, amending 21 CFR 16.1(b)(2), which 
is effective December 18, 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 days after the comment 
period on this direct final rule ends.

    Dated: October 10, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24100 Filed 10-17-24; 8:45 am]
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