[Federal Register: March 22, 2007 (Volume 72, Number 55)]
[Notices]
[Page 13500-13501]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr07-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 in the Center for Biologics
Evaluation and Research (CBER). Nominations will be accepted for
vacancies that will or may occur through January 31, 2008.
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 6
months before the date of scheduled vacancies for each year, as
indicated in this notice.
ADDRESSES: All nominations and curricula vitae should be sent to the
contact person listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
FOR FURTHER INFORMATION CONTACT: Donald Jehn, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research
(HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448, 301-827-0314, e-mail: donald.jehn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting
members with appropriate expertise for vacancies listed below:
Table 1.
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Advisory Committee and Expertise No. of Approximate Date
Needed to Fill Vacancies Vacancies Members are Needed
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Allergenic Products Advisory 2 As soon as possible
Committee--allergy, immunology,
pediatrics, internal medicine,
biochemistry, statistics, and
related scientific fields
2 August 31, 2007
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Blood Products Advisory Committee-- 2 September 30, 2007
clinical and administrative
medicine, hematology, immunology,
blood banking, surgery, internal
medicine, biochemistry, engineering,
statistics, biological and physical
sciences, biotechnology, computer
technology, epidemiology, consumer
advocacy, sociology/ethics, clinical
trials, behavioral science, risk
communication and other related
professions
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[[Page 13501]]
Cellular, Tissue, and Gene Therapies 1 March 31, 2007
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
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Transmissible Spongiform 4 As soon as possible
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,
consumer advocacy, sociology/ethics,
and other related professions
3 January 31, 2008
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Vaccines and Related Biological 3 As soon as possible
Products Advisory Committee--
immunology, molecular biology, rDNA,
virology, bacteriology,
epidemiology, biostatistics,
allergy, preventive medicine,
infectious diseases, pediatrics,
microbiology, biochemistry, and
other related scientific fields
5 January 31, 2008
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I. 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 and products
derived from blood and serum or biotechnology which are intended for
use in the diagnosis, prevention, or 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 intended for transplantation, implantation, infusion and transfer
in the prevention and treatment of a broad spectrum of human diseases
and in 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.
II. 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 through January 31, 2008, is shown in
Table 1 of this document. The term of office is up to 4 years,
depending on the appointment date.
III. 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, is willing to serve as a member (name of
committee(s) must be specified), and appears to have no conflict of
interest that would preclude membership. 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 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: March 14, 2007.
Randall W. Lutter,
Associate Commissioner for Policy.
[FR Doc. E7-5193 Filed 3-21-07; 8:45 am]
BILLING CODE 4160-01-S