The eRulemaking Program
10/18/2024 | Press release | Distributed by Public on 10/18/2024 06:26
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Correction
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.
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 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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