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U.S. Department of Health and Human Services

Advisory Committees

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August 16, 2013: Tobacco Products Scientific Advisory Committee Meeting

Tobacco Products Scientific Advisory Committee

Date:   August 16, 2013

Time: The meeting will be held on August 16, 2013, from 8:30 a.m. to 3:00 p.m.

NEW Location

FDA White Oak Conference Center
Building 31, Room 1503
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
 

Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading "Resources for You," click on "Public Meetings at the FDA White Oak Campus."  Please note that visitors to the White Oak Campus must enter through Building 1.

Webcast:

Archived recordings of the TPSAC meeting webcasts are available below.


https://collaboration.fda.gov/p70du7o7xmf/
https://collaboration.fda.gov/p6sl3jwkp44/
https://collaboration.fda.gov/p1bi0og6xo4/
 

 

The link will become active shortly before the meeting begins at 8:30 a.m.

Agenda:  On August 16, 2013, the Committee will discuss possible approaches for evaluating information on the risks and potential benefits of a proposed modified risk tobacco product (MRTP) to the population as a whole.  MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.  Before an MRTP can be introduced or delivered for introduction into interstate commerce, an order from FDA under section 911(g) (21 U.S.C. 387k(g)) of the Federal Food, Drug, and Cosmetic Act must be in effect with respect to the tobacco product.  21 U.S.C. 387k(a).
 
In reviewing MRTP applications, among other things, FDA must evaluate the effects of a proposed product on the health of individual tobacco users and the population as a whole, taking into account: (1) The relative health risks to individuals of the MRTP; (2) the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the MRTP; (3) the increased or decreased likelihood that persons who do not use tobacco products will start using the MRTP; (4) the risks and benefits to persons from the use of the MRTP compared to the use of smoking cessation drug or device products approved by FDA to treat nicotine dependence; and (5) comments, data, and information submitted to FDA by interested persons.  21 U.S.C. 387k(g)(4).

Meeting Materials:
Links to meeting materials will be added as they become available.  FDA intends to make complete background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and will be posted on FDA’s website after the meeting.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

• Written submissions may be made to the contact person on or before August 1, 2013.  Please send 20 paper copies, and one electronic copy,  of your submission to:


Caryn Cohen, M.S.
Office of Science
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850

Copies must be received by 4 p.m. (Eastern) on August 1, 2013.

• Oral presentations from the public will be scheduled between approximately
11 a.m. and 12 noon on August 16, 2013.  Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 25, 2013.

Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by July 26, 2013.

Contact Information

• Caryn Cohen, M.S.
  Center for Tobacco Products
  Food and Drug Administration
  9200 Corporate Boulevard
  Rockville, MD 20850

  Phone:  1-877-287-1373 (choose Option 5) 
  FAX:  240-276-3655 
  Email: TPSAC@fda.hhs.gov 

• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington DC area)
  Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

FDA intends to make background material available to the public no later than 2 business days
before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.  FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs.  If you require special accommodations due to a disability, please contact Caryn Cohen at least 7 days in advance of the meeting.  FDA is committed to the orderly conduct of its advisory committee meetings. 

Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).