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/ 2002
/ July
/ Friday, July 12, 2002
[Federal Register: July 12, 2002 (Volume 67, Number 134)]
[Notices]
[Page 46194-46195]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy02-68]
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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, 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 December 31, 2003.
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.
[[Page 46195]]
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
appropriate contact person in the FOR FURTHER INFORMATION CONTACT
section of this document.
FOR FURTHER INFORMATION CONTACT:
Regarding nominations except for consumer representatives: Jane
Brown, 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: Linda Sherman,
Advisory Committee Oversight and Management Staff (HF-4), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1220.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting
members with appropriate expertise for vacancies listed as follows:
1. Allergenic Products Advisory Committee: Three vacancies
occurring August 31, 2003; immunology, pediatrics, internal medicine,
biochemistry, statistics, consumer interest, and related scientific
fields.
2. Blood Products Advisory Committee: One vacancy occurring in
September 30, 2002, and six vacancies occurring on September 30, 2003;
clinical and administrative medicine, hematology, immunology, blood
banking, surgery, internal medicine, biochemistry, engineering,
statistics, biological and physical sciences, and other related
scientific fields.
3. Transmissible Spongiform Encephalopathies Advisory Committee:
Five vacancies occurring January 31, 2003; 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.
4. Vaccines and Related Biological Products Advisory Committee:
Five vacancies occurring in January 31, 2003; immunology, molecular
biology, recombinant deoxyribonucleic acid (rDNA), virology,
bacteriology, epidemiology, biostatistics, allergy, preventive
medicine, infectious diseases, pediatrics, microbiology, biochemistry,
and consumer interest.
Functions
1. 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.
2. 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.
3. 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.
4. 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 in section I of this
document. 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 consumer organizations that have 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 vita 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: July 5, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-17514 Filed 7-11-02; 8:45 am]
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