[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Proposed Rules]
[Page 277]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2012-N-1148]


Food and Drug Administration Actions Related to Nicotine 
Replacement Therapies and Smoking-Cessation Products; Report to 
Congress on Innovative Products and Treatments for Tobacco Dependence; 
Public Hearing; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; Extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice of public hearing that appeared in the 
Federal Register of November 28, 2012 (77 FR 70955). In the public 
hearing notice, FDA requested comments on FDA consideration of 
applicable approval mechanisms and additional indications for nicotine 
replacement therapies (NRTs), and input on a report to Congress 
examining the regulation and development of innovative products and 
treatments for tobacco dependence. The Agency is taking this action to 
allow interested persons additional time to submit comments.

DATES: Submit either electronic or written comments by January 16, 
2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ayanna Augustus, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 22, Rm. 3219, Silver Spring, MD 20993, 301-796-
3980, FAX: 301-796-2310, email: Section918PublicMeeting@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of November 28, 2012, FDA published a 
document announcing a public meeting on December 17, 2012, and the 
opening of a public docket to receive comments related to the 
implementation of section 918 of the FD&C Act (21 U.S.C. 387r), as 
amended by the Tobacco Control Act (Pub. L. 111-31). Under Section 
918(a), the Secretary of the Department of Health and Human Services 
(the Secretary of HHS) is required to consider certain new approval 
mechanisms and additional indications for NRTs. Several NRTs, including 
nicotine-containing gums, patches, and lozenges, are already marketed 
for smoking cessation. Section 918(b) requires that the Secretary of 
HHS, after consultation with recognized scientific, medical, and public 
health experts, submit a report to Congress examining how best to 
regulate, promote, and encourage the development of ``innovative 
products and treatments (including nicotine-based and non-nicotine-
based products and treatments)'' to better achieve the following three 
goals: (1) Total abstinence from tobacco use, (2) reductions in 
consumption of tobacco, and (3) reductions in the harm associated with 
continued tobacco use. FDA will consider the information it obtains 
from the public hearing and related docket submissions in its 
implementation of the requirements of section 918, including in 
drafting the report to Congress required by section 918(b).

II. Submission of Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: December 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31578 Filed 1-2-13; 8:45 am]
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