Document ID: FDA-2010-N-0449-0001
Agency: fda
Document Type: Notice
Title: Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products: Public Workshops; Request for Comments
Posted Date: 2010-09-02T04:00Z

[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Notices]               
[Page 53976-53977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se10-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0449]

 
Risks and Benefits of Long-Term Use of Nicotine Replacement 
Therapy Products; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA), Center for Drug 
Evaluation and Research (CDER) is announcing a scientific workshop to 
solicit feedback on the risks and benefits associated with the long-
term use of nicotine replacement therapy (NRT) products. NRT products 
facilitate smoking cessation by ameliorating the symptoms of nicotine 
withdrawal and are available as approved nonprescription and 
prescription drugs. No currently-approved NRT product is intended for 
use beyond 12 weeks to relieve the acute withdrawal symptoms 
experienced when quitting smoking.
    Date and Time: The public workshop will be held on October 26 and 
27, 2010, from 8:30 a.m. to 5 p.m.
    Location: The workshop will be held at the Radisson Hotel, Reagan 
National Airport, 2020 Jefferson Davis Highway, Arlington, VA 22202, 
703-920-8600, FAX: 703-920-2840.
    Contacts: Mary C. Gross, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 
6178, Silver Spring, MD 20993-0002, 301-796-3519, email: 
mary.gross@fda.hhs.gov; or Dominic Chiapperino, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 3134, Silver Spring, MD 20993-0002, 301-
796-1183, email: dominic.chiapperino@fda.hhs.gov.
    Registration to Attend the Workshop and Requests to Participate in 
Open Public Hearing: If you wish to attend or testify for the open 
public hearing, please email your registration to 
NRTPublicMeeting@fda.hhs.gov by October 5, 2010. Those without email 
access may register by contacting one of the persons listed in the 
Contacts section of the document. Please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email address, and telephone number. Registration is free and 
will be on a first-come, first-served basis. Early registration is 
recommended because seating is limited. FDA may limit the number of 
participants from each organization as well as the total number of 
participants based on space limitations. Registrants will receive 
confirmation once they have been accepted for the workshop. Onsite 
registration on the day of the meeting will be based on space 
availability. If registration reaches maximum capacity, FDA will post a 
notice closing meeting registration for the workshop at: http://
www.fda.gov/Drugs/NewsEvents/ucm221185.htm.
    An open public hearing will be held between 1:30 p.m. to 2:30 p.m. 
on October 27, 2010, during which speaker testimony will be accepted. 
We will try to accommodate all persons who wish to testify, however, 
the duration of each

[[Page 53977]]

speaker's testimony during this open public hearing may be limited by 
time constraints.
    Comments: Submit either electronic or written comments by December 
27, 2010. 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. It is only necessary to send one set of comments. 
It is no longer necessary to send two copies of mailed 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.
    If you need special accommodations due to a disability, contact 
Mary Gross or Dominic Chiapperino (see Contacts) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION:

I. Introduction

    Nicotine is the primary addictive substance in tobacco. NRT 
products are designed to help people stop smoking by supplying 
controlled amounts of purified nicotine to replace the nicotine derived 
from smoking. People who use NRT products instead of cigarettes during 
an attempt to quit smoking obtain nicotine to ease the symptoms 
associated with quitting, but significantly reduce their exposure to 
harmful chemicals present in tobacco products and tobacco smoke. NRT 
products are available over-the-counter (OTC) and by prescription. The 
labeling for all NRT products recommends that they be used for a short 
time only (up to 12 weeks) to relieve the acute withdrawal symptoms 
experienced when quitting smoking. Prescription NRT products are 
marketed under the brand name Nicotrol and are available as a nasal 
spray and oral inhaler. OTC NRT products include skin patches 
(transdermal nicotine patches, various brand names and generics), 
chewing gum (Nicorette and generics) and lozenges (Commit, Nicorette, 
and generics).
    FDA will explore the following topics during this public workshop:
     What is known about the long-term safety of nicotine from 
animal studies?
     What is known about the long-term safety of nicotine from 
human studies?
     What evidence is there that long-term NRT helps people to 
sustain abstinence from smoking?
     What evidence is there that long-term NRT helps people to 
sustain reduced smoking levels?
     What evidence is there that using NRT to maintain reduced 
levels of smoking, rather than complete abstinence, yields clinical 
benefits?
     What is known about dependence/addiction to NRT products?
     Does the route of administration/speed of onset influence 
the addiction potential?
     What factors mitigate against abuse/addiction to NRT 
products and against initiation of NRT products by people who have 
never used tobacco products previously?
    FDA will post the agenda and additional workshop background 
material approximately 5 days before the workshop at: http://
www.fda.gov/Drugs/NewsEvents/ucm221185.htm.

II. Transcripts

    Please be advised that approximately 30 days after the public 
workshop, a transcript will be available. It will be accessible at 
http://www.regulations.gov, and may be viewed at the Division of 
Dockets Management (see Comments). A transcript will also be available 
in either hardcopy or on CD-ROM, after submission of a Freedom of 
Information request. Written requests are to be sent to Division of 
Freedom of Information (HFI-35), Office of Management Programs, Food 
and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 
20857.

    Dated: August 27, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-21894 Filed 9-1-10; 8:45 am]
BILLING CODE 4160-01-S