2011-4191. Tobacco Products Scientific Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Tobacco Products Scientific Advisory Committee. This meeting was announced in the Federal Register of January 26, 2011 (76 FR 4705). The amendment is being made to reflect a change in the Date and Time, Agenda, Procedures, and Closed Committee Deliberations portions of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Caryn Cohen, Office of Science, 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.

SUPPLEMENTARY INFORMATION:

In the Federal Register of January 26, 2011, FDA announced that a meeting of the Tobacco Products Scientific Advisory Committee would be held on March 1 and 2, 2011. On page 4075, in the third column, the Date and Time portion of the document is changed to read as follows:

Date and Time: The meeting will be held on March 2, 2011, from 8 a.m. to 5 p.m.

On page 4076, in the first column, the Agenda portion is changed to read as follows:

Agenda: On March 2, 2011, the Committee will continue to: (1) Receive updates from the Menthol Report Subcommittee and (2) receive and discuss presentations regarding the data requested by the Committee at the March 30 and 31, 2010, meeting of the Tobacco Products Advisory Committee.

On page 4076, in the first column, the Procedure portion is changed to read as follows:

Procedure: On March 2, 2011, from 10:30 a.m. to 5 p.m., 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 February 15, 2011. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. on March 2, 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 February 8, 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 February 9, 2011.

On page 4076, in the second column, the Closed Committee Deliberations portion is changed to read as follows:

Closed Committee Deliberations: On March 2, 2011, from 8 a.m. to 10 a.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 confidential data provided by the Federal Trade Commission (FTC) and the tobacco industry.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

Dated: February 18, 2011.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.