2011-13779. Tobacco Products Scientific Advisory Committee; Notice of 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). At least one portion of the meeting will be closed to the public.

Name of Committee: Tobacco Products Scientific Advisory Committee.

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

Date and Time: The meeting will be held on July 21, 2011, from 9 a.m. to 5 p.m., and on July 22, 2011, from 8 a.m. to 5 p.m.

Location: Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373.

Contact Person: Caryn Cohen, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373 (choose option 4), e-mail: [e-mail], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product 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 Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Agenda: On the morning of July 21, 2011, the committee will discuss changes proposed by committee members to the Tobacco Products Scientific Advisory Committee (TPSAC) Menthol Report submitted to the Agency on March 18, 2011. The committee will consider additional oral and written comments from the public on the Menthol Report and the proposed changes to the report, as submitted according to the instructions in the Procedure portion of this document. The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee. Redacted versions of the document, reflecting the changes to the report proposed by the committee members, will be made available on the FDA Web site at http://www.fda.gov/​AdvisoryCommittees/​CommitteesMeetingMaterials/​TobaccoProductsScientificAdvisoryCommittee/​ucm237359.htm,, no later than June 22, 2011. On the afternoon of July 21, 2011, and on July 22, 2011, the TPSAC will initiate discussions on the issue of the nature and impact of the use of dissolvable tobacco products on the public health. These discussions will begin the process for the TPSAC's required report to the Secretary of Health and Human Services regarding the issue of the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children. The final report should take into consideration the following: (1) The risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

FDA intends to make redacted 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 link.

Procedure: On July 21, 2011, from 9 a.m. to 5 p.m., and on July 22, from 8 a.m. to 12 noon, the meeting is open to the public. 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 July 5, 2011. Oral presentations from the public will be scheduled between approximately 10 a.m. and 11 a.m. on both July 21, 2011, and July 22, 2011. 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 June 27, 2011. 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 June 28, 2011.

Closed Committee Deliberations: On July 22, 2011, from 1 p.m. to 5 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). This portion of the meeting must be closed because the Committee will be discussing trade secret and/or confidential data regarding dissolvable tobacco products provided by the tobacco companies.

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/​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: May 25, 2011.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.