2024-24100. Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction

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Department of Health and Human Services

Food and Drug Administration

1. 21 CFR Part 16
2. [Docket No. FDA-2024-N-3654]
3. RIN 0910-AI97

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 ( print 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.