2025-01145. Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Withdrawal

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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; withdrawal.

SUMMARY:

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.

DATES:

The direct final rule published at September 20, 2024, 89 FR 77019, is withdrawn effective January 17, 2025.

FOR FURTHER INFORMATION CONTACT:

Robert Schwartz, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, [e-mail].

SUPPLEMENTARY INFORMATION:

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the direct final rule published on September 20, 2024, 89 FR 77019 is withdrawn.

Dated: January 13, 2025.

P. Ritu Nalubola,

Associate Commissioner for Policy.