Document ID: FDA-2012-N-0001-0114
Agency: fda
Document Type: Notice
Title: Requests for Nonvoting Industry Representatives: Transmissible Spongiform Encephalopathies Advisory Committee
Posted Date: 2012-09-18T04:00Z

[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Notices]
[Page 57570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22866]

[[Page 57570]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

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 Nominations for Nonvoting Industry 
Representatives on the Transmissible Spongiform Encephalopathies 
Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: 301-827-
0294, bryan.emery@fda.hhs.gov.

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 r[eacute]sum[eacute]s. 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.
[FR Doc. 2012-22866 Filed 9-17-12; 8:45 am]
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