2013-14947. Joint Meeting of the Risk Communication Advisory Committee and Tobacco Products Scientific Advisory Committee; Notice of Joint Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Risk Communication Advisory Committee and Tobacco Products Scientific Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

DATES:

Date and Time: The meeting will be held on August 15, 2013 from 9 a.m. to 5 p.m.

ADDRESSES:

Food and Drug Administration, White Oak Campus.

Location: FDA White Oak Conference Center, Bldg. 31, Rm. 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.

Contact Person: Luis G. Bravo, Designated Federal Official, 10903 New Hampshire Ave., Bldg. 32, Rm. 3274, Silver Spring, MD 20993, 1-877-287-1373 (choose option 5), email: [e-mail], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. 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 Web site at http://www.fda.gov/​AdvisoryCommittees/​default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

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.

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. Background material is available at http://www.fda.gov/​AdvisoryCommittees/​Calendar/​default.htm. Scroll down to the appropriate advisory committee meeting link.

Procedure: 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. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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. Interested persons can also log on to https://collaboration.fda.gov/​rcac/​ to hear and see the proceedings.

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 Luis G. Bravo 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/​AdvisoryCommittees/​AboutAdvisoryCommittees/​ucm111462.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).

Dated: June 18, 2013.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.