Rule2025-01145

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

Primary source

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Published
January 17, 2025
Effective
January 17, 2025

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

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.

Full Text

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<title>Federal Register, Volume 90 Issue 11 (Friday, January 17, 2025)</title>
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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Rules and Regulations]
[Page 5590]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-01145]


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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; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; withdrawal.

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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77019, is withdrawn effective January 17, 2025.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, 
<a href="/cdn-cgi/l/email-protection#93d0c7c3c1f6f4e6fff2e7fafcfde0d3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="8bc8dfdbd9eeecfee7eaffe2e4e5f8cbedefeaa5e3e3f8a5ece4fd">[email&#160;protected]</span></a>.

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.
[FR Doc. 2025-01145 Filed 1-16-25; 8:45 am]
BILLING CODE 4164-01-P


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Indexed from Federal Register on January 17, 2025.

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