Document ID: FDA-2008-N-0038-0007
Agency: fda
Document Type: Notice
Title: 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 Representative on the Blood Products Advisory Committee
Posted Date: 2008-02-01T05:00Z

[Federal Register: February 1, 2008 (Volume 73, Number 22)]
[Notices]               
[Page 6186-6187]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01fe08-73]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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 Representative on the Blood 
Products 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 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, donald.jehn@fda.hhs.gov.

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

[[Page 6187]]

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.
[FR Doc. E8-1815 Filed 1-31-08; 8:45 am]

BILLING CODE 4160-01-S