
[Federal Register: January 29, 2009 (Volume 74, Number 18)]
[Notices]               
[Page 5166-5167]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ja09-57]                         


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Request for Nominations for Voting 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 members to serve on the Allergenic Products 
Advisory Committee;Blood Products Advisory Committee; Cellular, Tissue, 
and Gene Therapies Advisory Committee; Transmissible Spongiform 
Encephalopathies Advisory Committee; and the Vaccines and Related 
Biological Products Advisory Committee. Nominations will be accepted 
for current vacancies and those that will or may occur through 
September 30, 2009.
    FDA has a special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented on 
advisory committees and, therefore, encourages nominations of qualified 
candidates from these groups.

DATES:  Because scheduled vacancies occur on various dates throughout 
each year, no cutoff date is established for the receipt of 
nominations. However, when possible, nominations should be received at 
least 6 months before the date of scheduled vacancies for each year, as 
indicated in this document.

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), Food and Drug Administration, 
5600 Fishers Lane, rm. 15A-12, Rockville, MD 20857. Information about 
becoming a member on an FDA advisory committee can also be obtained by 
visiting FDA's Web site athttp://www.fda.gov/oc/advisory/default.htm.

FOR FURTHER INFORMATION CONTACT:  Linda Amendt, Center for Biologics 
Evaluation and Research (HFM-71), Food and Drug Administration,1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-1370, e-
mail:Linda.Amendt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Vacancies

    FDA is requesting nominations of voting members with appropriate 
expertise for vacancies listed as follows:

                                Table 1.
------------------------------------------------------------------------
   Committee and Expertise     Current & Upcoming     Approximate Date
           Needed                   Vacancies              Needed
------------------------------------------------------------------------
Allergenics Products                             3           Immediately
 Advisory Committee--
 allergy, immunology,
 pediatrics, internal
 medicine, biochemistry,
 statistics, and related
 specialties
                                                 2       August 31, 2009
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Blood Products Advisory                          2           Immediately
 Committee--clinical and
 administrative medicine,
 hematology, immunology,
 blood banking, tissue
 banking, surgery,
 anesthesia, critical care,
 internal medicine,
 infectious diseases,
 biochemistry, engineering,
 biological and physical
 sciences, biotechnology,
 computer technology,
 statistics, epidemiology,
 sociology/ethics, clinical
 trial design, and other
 related professions
                                                 4    September 30, 2009
------------------------------------------------------------------------
Cellular, Tissue, and Gene                       4           Immediately
 Therapies Advisory
 Committee--cellular
 therapies, tissue
 transplantation, gene
 transfer therapies and
 xenotransplantation
 including biostatistics,
 bioethics, hematology/
 oncology, human tissues and
 transplantation,
 reproductive medicine,
 general medicine and
 various medical specialties
 including surgery and
 oncology, immunology,
 virology, molecular
 biology, cell biology,
 developmental biology,
 tumor biology,
 biochemistry, rDNA
 technology, nuclear
 medicine, gene therapy,
 infectious diseases, and
 cellular kinetics
                                                 3        March 31, 2009
------------------------------------------------------------------------
Transmissible Spongiform                         1           Immediately
 Encephalopathies Advisory
 Committee--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
                                                 4      January 31, 2009
------------------------------------------------------------------------
Vaccines and Related                             4           Immediately
 Biological Products
 Advisory Committee--
 immunology, molecular
 biology, rDNA, virology,
 bacteriology, epidemiology
 or biostatistics, allergy,
 preventive medicine,
 infectious diseases,
 pediatrics, microbiology,
 and biochemistry
                                                 1      January 31, 2009
------------------------------------------------------------------------

II. Functions

A. 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 diseases.

B. Blood Products Advisory Committee

    The 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 use in the 
diagnosis, prevention, of treatment of human diseases.

C. 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

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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.

D. 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.

E. 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.

III. Qualifications

    Persons nominated for membership on the committees shall have 
adequately diversified experience appropriate to the work of the 
committee in such fields as clinical and administrative medicine, 
engineering, biological and physical sciences, statistics, and other 
related professions. The nature of specialized training and experience 
necessary to qualify the nominee as an expert suitable for appointment 
may include experience in medical practice, teaching, and/or research 
relevant to the field of activity of the committee. The particular need 
for vacancies on each committee for the calendar years 2008 and 2009 is 
shown in table 1 of this document. The term of office is up to 4 years 
depending on the appointment date. Committees meet one to five times a 
year. Most meetings are for 2 days.

IV. Nomination Procedures

    Any interested person may nominate one or more qualified persons 
for membership on one or more of the advisory committees. Self-
nominations are also accepted. Nominations shall include the name of 
the committee, a complete curriculum vitae of each nominee, current 
business address and telephone number, and shall state that the nominee 
is aware of the nomination. Potential candidates will be required to 
provide detailed information concerning such matters as financial 
holdings, employment, and research grants and/or contracts to permit 
evaluation of possible sources of conflict of interest.
    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 21, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-1821 Filed 1-28-09; 8:45 am]

BILLING CODE 4160-01-S
