2012-22866. Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on the Transmissible Spongiform Encephalopathies Advisory Committee, and Request for ...

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 Transmissible Spongiform Encephalopathies 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 on the Transmissible Spongiform Encephalopathies 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 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 FDA by October 18, 2012, for the vacancy listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA by October 18, 2012.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Bryan Emery, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852-1448, 301-827-1277, FAX: [phone], [e-mail].

SUPPLEMENTARY INFORMATION:

The Agency intends to add a nonvoting industry representative to the following advisory committee:

I. CBER Advisory Committee

Transmissible Spongiform Encephalopathies Advisory Committee

Members are selected by the Commissioner of Food and Drugs (the Commissioner) or designee from among authorities knowledgeable in the fields of clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, and other related professions.

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) 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 résumés. 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. Contact information, 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 of publication of this document (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 seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the blood, epidemiology, and neurovirology manufacturing industry.

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 12, 2012.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.