[Federal Register Volume 65, Number 224 (Monday, November 20, 2000)]
[Notices]
[Pages 69776-69777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29536]
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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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The Food and Drug Administration (FDA) is requesting nominations
for voting members to serve on the Allergenic Products Advisory
Committee, Biological Response Modifiers Advisory Committee, Blood
Products 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, 2002.
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 notice.
ADDRESSES: All nominations and curricula vitae should be sent to the
addresses below.
FOR FURTHER INFORMATION CONTACT: Regarding nominations, except for
consumer representatives: Nancy T. Cherry, Scientific Advisors and
Consultants Staff, Center for Biologics Evaluation and Research (HFM-
71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852-1448, 301-827-0314.
Regarding nominations for consumer representatives: Maureen A.
Hess, Office of Consumer Affairs (HFE-50), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4421.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting
members with appropriate expertise for vacancies listed below.
1. Allergenic Products Advisory Committee: Three vacancies
occurring August 31, 2001; immunology, pediatrics, internal medicine,
biochemistry, statistics, and related scientific fields.
2. Biological Response Modifiers Advisory Committee: Five vacancies
occurring March 31, 2001; biological response modifiers, immunology,
virology, molecular biology, rDNA technology, infectious diseases,
viral oncology, statistics, and cellular kinetics.
3. Blood Products Advisory Committee: Nine vacancies occurring
September 30, 2001; clinical and administrative medicine, hematology,
immunology, blood banking, surgery, internal medicine, biochemistry,
engineering, statistics, biological and physical sciences, and other
related scientific fields.
4. Transmissible Spongiform Encephalopathies Advisory Committee:
Three vacancies occurring January 31, 2002; clinical administrative
medicine, hematology, virology, neurology, infectious diseases,
immunology, blood banking, surgery, internal medicine, biochemistry,
biostatistics, epidemiology, biological and physical sciences,
sociology/ethics, and other related professions.
5. Vaccines and Related Biological Products Advisory Committee:
Three vacancies occurring January 31, 2002; immunology, molecular
biology, rDNA, virology, bacteriology, epidemiology, biostatistics,
allergy, preventive medicine, infectious diseases, pediatrics,
microbiology, and biochemistry.
Functions
Allergenic Products Advisory 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.
Biological Response Modifiers Advisory Committee
Reviews and evaluates available data relating to the safety,
effectiveness, and appropriate use of biological response modifiers
which are intended for use in
[[Page 69777]]
the prevention and treatment of a broad spectrum of human diseases.
Blood Products Advisory 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.
Transmissible Spongiform Encephalopathies Advisory 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.
Vaccines and Related Biological Products Advisory 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.
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
needs at this time for each committee are shown above. The term of
office is up to 4 years, depending on the appointment date.
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.
Consumer Representatives
Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory committees to represent
consumer interests. Self-nominations are also accepted. To be eligible
for selection, the applicant's experience and/or education will be
evaluated against Federal civil service criteria for the position to
which the person will be appointed.
Selection of members representing consumer interests is conducted
through procedures that include use of a consortium of consumer
organizations that has the responsibility for recommending candidates
for the agency's selection. Candidates should possess appropriate
qualifications to understand and contribute to the committee's work.
Nominations shall include a complete curriculum vitae of each
nominee, current address and telephone numbers, and shall state that
the nominee is aware of the nomination, is willing to serve as a
member, 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. The nomination should state whether
the nominee is interested only in a particular advisory committee or in
any advisory committee. The term of office is up to 4 years, depending
on the appointment date.
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 7, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-29536 Filed 11-20-00; 8:45 am]
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