

[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[
Notices]               
[Page 4582-4583]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja08-82]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Request for Nominations for Voting Consumer Representative 
Members 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 
nominations for voting consumer representatives to serve on the 
Cellular, Tissue, and Gene Therapies Advisory Committee and the 
Allergenic Products Advisory Committee in the Center for Biologics 
Evaluation and Research (CBER). Nominations will be accepted for 
vacancies that will occur through August 31, 2008.

DATES: Nominations will be accepted for those voting consumer 
representative vacancies that will occur on or before August 31, 2008. 
Nominations submitted on or before April 1, 2008, will be given first 
consideration for membership on the Cellular, Tissue, and Gene 
Therapies Advisory Committee and the Allergenic Products Advisory 
Committee. Nominations received after April 1, 2008, will be considered 
for nomination to the committee should nominees still be needed.

ADDRESSES: All nominations for membership should be sent electronically 
to CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight and 
Management Staff (HF-4), 5600 Fisher Lane, rm. 15A-12, Rockville, MD 
20857.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
membership, the primary contact is Gail Dapolito, Center for Biologics 
Evaluation and Research, 301-827-0314, FAX: 301-827-0294, e-mail: 

Gail.Dapolito@fda.hhs.gov. Information about becoming a member on an 

FDA advisory committee can also be obtained by visiting FDA's Web site 
at http://www.fda.gov/oc/advisory/default.htm.


SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting 
consumer representative members on the following CBER committees:

I. Functions

A. 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 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. Allergenic Products Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety, effectiveness, and adequacy of labeling of marketed and 
investigational allergenic biological products or materials that are 
administered to humans for the diagnosis, prevention, or treatment of 
allergies and allergic disease. The committee also makes appropriate 
recommendations to the Commissioner on its findings regarding the 
affirmation or revocation of biological product licenses, the safety, 
effectiveness, and labeling of the products, clinical and laboratory 
studies of such products, amendments or revisions to regulations 
governing the manufacture, testing, and licensing of allergenic 
biological products, and on the quality and relevance of FDA's research 
programs which provide the scientific support for regulating these 
agents.

II. Criteria for Members

    Persons who are nominated for membership as consumer 
representatives on the committees must meet the following criteria: (1) 
Demonstrate ties to consumer and community-based organizations, (2) be 
able to analyze technical data, (3) understand research design, (4) 
discuss benefits and risks, and (5) evaluate the safety and efficacy of 
products under review. The consumer representative must be able to 
represent the consumer perspective on issues and actions before the 
advisory committee; serve as a liaison between the committee and 
interested consumers, associations, coalitions, and consumer 
organizations; and facilitate dialogue with the advisory committee on 
scientific issues that affect consumers.

III. Selection Procedures

    The selection of members representing consumer interests is 
conducted through procedures that include the use of organizations 
representing the public interest and consumer advocacy groups. The 
organizations have the responsibility of recommending candidates of the 
agency's selection.

IV. Nomination Procedures

    All nominations must include a cover letter, a curriculum vitae or 
resume (that includes the nominee's office address, telephone number, 
and e-mail address), and a list of consumer or community-based 
organizations for which the candidate can demonstrate active 
participation. Any interested person or organization may nominate one 
or more qualified persons for membership to represent consumer 
interests on one or more of the advisory committees. Self-nominations 
are also accepted. FDA will ask the potential candidates to provide 
detailed information concerning such matters as financial holdings, 
employment, and research grants and/or contracts to permit evaluation 
of possible sources of a conflict of interest. The nomination should 
specify the committee(s) of interest. The term of office is up to 4 
years, depending on the appointment date.
    FDA has a special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented on its 
advisory committees and, therefore, encourages nominations of qualified 
candidates from these groups.

[[Page 4583]]

    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 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-1297 Filed 1-24-08; 8:45 am]

BILLING CODE 4160-01-S
