[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Proposed Rules]
[Page 277]
From the Federal Register Online via the Government Publishing 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]
BILLING CODE 4160-01-P