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U.S. Department of Health and Human Services

Advisory Committees

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August 15, 2013: Risk Communication Advisory Committee & Tobacco Products Scientific Advisory Committee Joint Meeting

August 15, 2013: Risk Communication Advisory Committee and
Tobacco Products Scientific Advisory Committee Joint Meeting Announcement

Date:   
August 15, 2013

Time: 
The meeting will be open to the public on August 15, 2013 from 9:00 a.m. to 5:00 p.m. 

Location: 
FDA White Oak Conference Center, Building 31, Room 1503
10903 New Hampshire Avenue
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”.

Seating for this meeting may be limited, so the public is encouraged to watch the
free webcast instead of traveling to the meeting.  The link for the webcast is:

https://collaboration.fda.gov/rcactpsac813/ 

or visit the Risk Communication Advisory Committee website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/default.htm

The link will become active shortly before the open session begins at 9:00 a.m.  

Agenda: 
The Federal Food, Drug & Cosmetic Act (the FD&C Act) requires tobacco product manufacturers and importers to report quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products or tobacco smoke by brand and subbrand.  The FD&C Act also requires the Agency to publish a list of HPHCs by brand and by quantity in each brand and subbrand by April of 2013, in a format that is understandable and not misleading to the layperson.
On August 15, 2013, the Committees will meet in joint session to discuss the results of the FDA consumer research “Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents” [OMB Control No. 0910-0736] to assess the impact of HPHC information on consumer perceptions and comprehension, and how to effectively communicate information about the HPHCs of tobacco products to the general public.

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:

Luis G. Bravo
Designated Federal Official
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 3274
Silver Spring, MD 20993

Copies must be received by 4 p.m. August 1, 2013.

• Oral presentations from the public will be scheduled between approximately
1:00 p.m. and 2:00 p.m. on August 15, 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:

Luis G. Bravo
Designated Federal Official
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 3274
Silver Spring, MD 20993
 

Phone:  240-402-5274 

FAX:  301-847-8609

Email: RCAC@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).