Document ID: FDA-2008-N-0581-0001
Agency: fda
Document Type: Notice
Title: Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representative on Public Advisory Committees
Posted Date: 2008-11-13T05:00Z

[Federal Register: November 13, 2008 (Volume 73, Number 220)]
[Notices]               
[Page 67188-67189]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no08-50]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0581]

 
Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for Nonvoting Industry 
Representative on Public Advisory Committees and Request for 
Nominations for Nonvoting Industry Representative on Public Advisory 
Committees

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 
nonvoting industry representatives to serve on its public advisory 
committees for the Center for Biologics Evaluation and Research (CBER) 
notify FDA in writing. FDA is also requesting nominations for nonvoting 
industry representatives to serve on CBER's public advisory committees. 
A nominee may either be self-nominated or nominated by an organization 
to serve as a nonvoting industry representative. Nominations will be 
accepted for upcoming 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 the interest to FDA by December 
15, 2008, for vacancies listed in the notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by December 
15, 2008.

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

FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Division of Scientific 
Advisors and Consultants, Center for Biologics Evaluation and Research 
(HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20892, 301-827-1289, gail.dapolito@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The agency requests nominations for 
nonvoting industry representatives to the following advisory 
committees.

I. CBER Advisory Committees

A. The Cellular, Tissue and Gene Therapies Advisory Committee

    The Committee reviews and evaluates available data relating to the 
safety, effectiveness, and appropriate use of human cells, human 
tissues, gene transfer therapies and xenotransplantation products which 
are intended for transplantation, implantation, infusion and transfer 
in the prevention and treatment of a broad spectrum of human diseases 
and in the reconstruction, repair or replacement of tissues for various 
conditions. The Committee also considers the quality and relevance of 
FDA's research program which provides scientific support for the 
regulation of these products, and makes appropriate recommendations to 
the Commissioner of Food and Drugs (the Commissioner).

B. Vaccines and Related Biological Products Advisory Committee

    The Committee reviews and evaluates data concerning the safety, 
effectiveness, and appropriate use of vaccines and related biological 
products which are intended for use in the prevention, treatment, or 
diagnosis of human diseases, and, as required, any other product for 
which FDA has regulatory responsibility. The Committee as considers the 
quality and relevance of FDA's research program which provides 
scientific support for the regulation of these products and makes 
appropriate recommendations to the Commissioner.

C. Transmissible Spongiform Encephalopathies Advisory Committee

    The Committee reviews and evaluates available scientific data 
concerning the safety of products which may be at risk for transmission 
of spongiform encephalopathies having an impact on the public health as 
determined by the Commissioner. The Committee will make recommendations 
to the Commissioner regarding the regulation of such 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) 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

[[Page 67189]]

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 a particular 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 the 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: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26963 Filed 11-12-08; 8:45 am]

BILLING CODE 4160-01-S