2011-25120. Request for Notification From Industry Organizations Interested in Participating in the Selection Process and Request for Nominations for a Nonvoting Industry Representative on the Vaccines and Biological Products Advisory Committee

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve the Vaccines and Related Biological Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.

DATES:

Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by October 31, 2011, for the vacancy listed in this document. Concurrently, nomination materials for prospective candidates should be sent to FDA by October 31, 2011.

ADDRESSES:

All letters of interest and nominations should be submitted in writing to Donald Jehn (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT:

Donald Jehn, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, FAX: [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The Agency intends to add a nonvoting industry representative on the CBER Advisory Committee.

I. Vaccines and Related Biological Products Advisory Committee

The Vaccines and Related Biological Products 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 vaccines and related biological products. Members are asked to provide their expert scientific and technical advice to FDA to help make sound decisions on the safety, effectiveness, and appropriate use, of vaccines and related biological products.

II. Selection Procedure

Any industry organization interested in participating in the selection of an appropriate nonvoting member 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 FDA letter, to serve as the nonvoting member to represent industry interests for 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 industry interests.

III. Application Procedure

Individuals may self-nominate and/or an organization 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, email address if available, and the role for which the individual is being 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, individuals with physical disabilities, and small businesses 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 the advisory committees.

Dated: September 23, 2011.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.