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U.S. Department of Health and Human Services

Advisory Committees

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April 16-18, 2014 Tobacco Products Scientific Advisory Committee Meeting


Tobacco Products Scientific Advisory Committee
April 16-18, 2014
The meeting will be held on April 16 and 17, 2014 from 8:30 a.m. to 5 p.m. and on April 18, 2014 from 8:30 a.m. to 3 p.m.

 

Location: 

Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard, Room 020B
Rockville, MD  20850

 

Webcast:

The archived webcast for this meeting is available at:

April 16, 2014

https://collaboration.fda.gov/p3bgi8uvfc6/  Due to technical difficulties in the morning on the first day of the meeting, portions of the audio are of somewhat poor quality.

https://collaboration.fda.gov/p1il97fud42/

https://collaboration.fda.gov/p3aqzgincpj/

https://collaboration.fda.gov/p3m3c20jgmv/

https://collaboration.fda.gov/p8k1bo7ft38/

April 17, 2014

https://collaboration.fda.gov/p4o0r6gwlua/

https://collaboration.fda.gov/p2lkyif1xzw/

https://collaboration.fda.gov/p7cshne9zxt/

https://collaboration.fda.gov/p15tv1enaqb/

April 18, 2014

https://collaboration.fda.gov/p5x1e6eas7i/

https://collaboration.fda.gov/p5u7b10x4sr/

https://collaboration.fda.gov/p210tol34of/
 

Agenda: 
  • On April 16, 2014, the Committee will consider scientific issues pertaining to dependence and addiction, including the development of addiction, measurement of dependence and addiction and concepts concerning the assessment of addiction in the review of product submissions. 
  • On April 17, 2014, the Committee will receive information on population modeling in the assessment of tobacco product applications, and discuss the ways modeling can inform decisions critical to population health. 
  • On April 18, 2014, 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 health of individual tobacco users and to the population as a whole.

 

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 April 2, 2014.  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 April 2, 2014.

Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 1:30 p.m. on April 16, between approximately 1:00 p.m. and 1:30 p.m. on April 17, and between approximately 11:30 p.m. and noon on April 18.  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 March 26, 2014

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 March 28, 2014.


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).