2011-23185. Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Tobacco Products ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its Tobacco Products Scientific Advisory Committee, notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancies effective with this notice.

DATES:

Send letters stating interest in participating in the selection process to FDA by October 12, 2011 (see sections I and II of this document for details). Concurrently, nomination material for prospective candidates should be sent to FDA by October 12, 2011.

ADDRESSES:

All letters of interest and nominations should be submitted in writing to [e-mail], or by mail to Caryn Cohen, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT:

Caryn Cohen, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373 (choose Option 4), FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The Agency requests nominations for nonvoting industry representatives on the Tobacco Products Scientific Advisory Committee.

I. Tobacco Products Scientific Advisory Committee

The Tobacco Products Scientific Advisory Committee (the Committee) advises the Commissioner of Food and Drugs (the Commissioner) or designee in discharging responsibilities as they relate to the regulation of tobacco products. The Committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and recommendations to the Commissioner.

The Committee includes three nonvoting members who represent industry interests. These members include one representative of the tobacco manufacturing industry, one representative of the interests of tobacco growers, and one representative of the interests of the small business tobacco manufacturing industry. The representative of the interests of the small business tobacco manufacturing industry may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Committee.

With this notice, nominations are sought for the following positions: (1) One representative of the interests of tobacco growers, and an alternate to this representative; (2) a pool of individuals, with varying areas of expertise, to represent the interests of the small business tobacco manufacturing industry on a rotating, sequential basis; and (3) an individual to serve as alternate to the representative of the tobacco manufacturing industry.

II. Selection Procedure

Any industry organization interested in participating in the selection of appropriate nonvoting member(s) to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT and DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations, and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the letter, to serve as the nonvoting member to represent industry interests on the Committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent the industry interests.

III. Application Procedure

Individuals may self-nominate and/or organizations may nominate one or more individuals to serve as a nonvoting industry representative (for the roles specified in this document). Nominations must include a current resume or curriculum vitae of the nominee including current business address and/or home address, telephone number, e-mail address if available, and the role for which the individual is being nominated. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.)

FDA has a special interest in ensuring that women, minority groups, and individuals with physical disabilities are adequately represented on its advisory committees and, therefore, encourages nominations for appropriately qualified candidates from these groups.

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

Dated: September 7, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.