2010-21894. 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.

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: [phone].

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: [e-mail]; 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: [e-mail].

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 [e-mail] 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 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.