[Federal Register Volume 69, Number 233 (Monday, December 6, 2004)]
[Notices]
[Pages 70458-70459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26673]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for a Nonvoting Member Representing 
Industry Interests on a Public Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) requests nominations 
for a nonvoting industry representative to serve on the Cellular Tissue 
and Gene Therapies Advisory Committee (formerly the Biological Response 
Modifiers Advisory Committee) under the purview of the Center for 
Biologics Evaluation and Research (CBER).

DATES: Industry organizations interested in participating in the 
selection of a nonvoting member to represent industry for the vacancy 
listed in this notice must send a letter to FDA by January 5, 2005.
    Concurrently, nomination materials for prospective candidates 
should be sent to FDA by January 5, 2005. A nominee may either be self-
nominated or nominated by an organization to serve as a nonvoting 
industry representative.

ADDRESSES: All letters of interest and nominations should be sent to 
the contact person listed in the FOR FURTHER INFORMATION CONTACT 
section of this document.

FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Division of Scientific 
Advisors and Consultants (HFM-71), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20857-1448, 301-827-0314, e-mail: 
[email protected].

[[Page 70459]]


SUPPLEMENTARY INFORMATION: 
    The agency requests nominations for a no-voting industry 
representative to the advisory committee identified below.

I. Function

    The Cellular, Tissue and Gene Therapies Advisory Committee 
(formerly the Biological Response Modifiers Advisory 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.

II. Selection Procedure

    Any organization in the biologics manufacturing industry wishing to 
participate in the selection of a nonvoting member to represent 
industry on the Cellular, Tissue and Gene Therapies Advisory Committee 
(formerly the Biological Response Modifiers Advisory Committee) should 
send a letter stating that interest to FDA contact identified above 
within 30 days of publication of this notice. Persons who nominate 
themselves as an industry representative for the advisory committee 
will not participate in the selection process. It is, therefore, 
recommended that nominations be made by someone within an organization, 
trade association, or firm who is willing to participate in the 
selection process. Within the subsequent 30 days, FDA will send a 
letter to each organization and a list of all nominees along with their 
resumes. The letter will state that the interested organizations are 
responsible for conferring with one another to select a candidate, 
within 60 days after receiving the letter, to serve as the nonvoting 
member representing industry interests on the advisory committee. If no 
individual is selected within the 60 days, the Commissioner of Food and 
Drugs may select the nonvoting member to represent industry interests.

III. Application Procedure

    Individuals may nominate themselves or an organization representing 
the biologics manufacturing industry may nominate one or more 
individuals to serve as nonvoting industry representatives. A current 
curriculum vitae (which includes the nominee's business address, 
telephone number, and e-mail address) and the name of the committee of 
interest should be sent to FDA contact person. FDA will forward all 
nominations to the organizations that have expressed interest in 
participating in the selection process for that committee.
    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. Therefore, the 
agency 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 29, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-26673 Filed 12-3-04; 8:45 am]
BILLING CODE 4160-01-S