
[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Rules and Regulations]
[Page 80567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1105

[Docket No. FDA-2016-N-1555]


Refuse To Accept Procedures for Premarket Tobacco Product 
Submissions; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) published in the 
Federal Register of August 8, 2016, a direct final rule regarding 
procedures for refusing to accept premarket tobacco product 
submissions. The comment period closed October 24, 2016. FDA is 
withdrawing the direct final rule because the Agency received 
significant adverse comment. FDA will consider the comments we received 
on the direct final rule to be comments on the companion proposed rule 
published at 81 FR 52371 (August 8, 2016).

DATES: The direct final rule published at 81 FR 52329 (August 8, 2016), 
is withdrawn effective November 16, 2016.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler or Paul Hart, Office 
of Regulations, Center for Tobacco Products, Food and Drug 
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, 
CTPRegulations@fda.hhs.gov.

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 August 8, 2016, (81 FR 
52329) is withdrawn.

    Dated: November 9, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-27456 Filed 11-15-16; 8:45 am]
 BILLING CODE 4164-01-P


