E8-1815. Request for Notification from Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Blood Products Advisory Committee and Request for Nominations for a Nonvoting Industry ...

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 Blood Products Advisory Committee, Center for Biologics Evaluation and Research (CBER), notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy on September 30, 2008, 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 the interest to FDA by March 3, 2008, for vacancies listed in the notice. Concurrently, nomination material for prospective candidates should be sent to FDA by March 3, 2008.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Donald W. Jehn, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration (HFM-71), 1401 Rockville Pike, Rockville, MD 20892, 301-827-1277, [e-mail].

SUPPLEMENTARY INFORMATION:

The agency requests nominations for a nonvoting industry representative to the Blood Products Advisory Committee.

I. Function

The Blood Products Advisory Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood products derived from blood and serum or biotechnology which are intended for the use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which FDA has regulatory responsibility. The committee also advises the Commissioner of Food and Drugs (the Commissioner) on its findings regarding the safety, effectiveness, and labeling of the products, clinical and laboratory studies involving such products, the affirmation or revocation of biological product licenses, and on the quality and relevance of FDA's research program which provides the scientific support for regulating these agents.

II. Selection Procedure

Any blood products industry, association, or organization interested 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) within 30 days of publication of this document (see 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 primary and alternate candidate, within 60 days after the receipt of the FDA letter, and the primary candidate will serve as the nonvoting member to represent industry interests for the Blood Products Advisory 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. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days (see DATES). 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 advisory committees.

Dated: January 24, 2008.

Randall W. Lutter,

Deputy Commissioner for Policy.