[Federal Register: July 11, 2002 (Volume 67, Number 133)]
[Notices]
[Page 45981-45982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy02-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Members on Public Advisory
Committees; Drug Safety and Risk Management Advisory Committee
(Formally Drug Abuse Advisory Committee)
AGENCY: Food and Drug Administration.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for four members to serve on the Drug Safety and Risk
Management Advisory Committee in the Center for Drug Evaluation and
Research.
FDA has a special interest in ensuring that women, minority groups,
and the physically challenged are adequately represented on advisory
committees and, therefore, extends particular encouragement to
nominations for appropriately qualified female, minority, or physically
challenged candidates. Final selection from each vacancy will be
determined by the expertise required to meet specific agency needs and
in a manner to ensure appropriate balance on membership.
DATES: Nominations should be received before September 1, 2002.
ADDRESSES: All nominations for membership should be sent to Kimberly
Topper, and all nominations for consumer-nominated members should be
sent to Linda Sherman (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Kimberly Topper, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7001, e-mail:
topperk@cder.fda.gov; or
Linda Sherman, Advisory Committee Oversight and Management Staff
(HF-4), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-1220, e-mail: lsherman@oc.fda.gov.
SUPPLEMENTARY INFORMATION: On June 1, 2002, the Drug Safety and Risk
Management Advisory Committee (formerly Drug Abuse Advisory Committee)
was rechartered with 9 of the proposed 13 members. Accordingly, FDA is
requesting nominations for members to serve on the Drug Safety and Risk
Management Advisory Committee (formerly Drug Abuse Advisory Committee).
Function: The committee advises the Commissioner of Food and Drugs
regarding the scientific and medical evaluation of all information
gathered
[[Page 45982]]
by the Department of Health and Human Services (DHHS) and the
Department of Justice with regard to safety, abuse potential, risk
management, risk communication, and quantitative evaluation of
spontaneous reports, and recommends actions to be taken by DHHS with
regard to marketing, investigation, and control of such drugs or other
substances.
Criteria for Members
Persons nominated for membership on the committees described
previously in this document must have adequately diversified research
and/or clinical experience appropriate to the work of the committee in
such fields as anesthesiology, surgery, internal medicine, infectious
disease, asthma, rheumatology, microbiology, pediatrics, ophthalmology,
cardiology, clinical/medical oncology, hematology, radiology, nuclear
medicine, biostatistics, epidemiology, dermatopathology/
immunodermatology, dermatology, psychopharmacology, neurochemistry,
neuropharmacology, endocrinology, obstetrics and gynecology,
reproductive endocrinology, gastroenterology, pharmacology, clinical
pharmacology, hepatology, virology, pharmaceutical manufacturing,
bioavailability and bioequivalence research, pharmacokinetics,
neurology, psychiatry, psychology, neuropharmacology, neuropathology,
pulmonary disease, allergy, immunology, clinical immunology, safety,
abuse potential, risk management, risk communication and quantitative
evaluation of spontaneous reports or other appropriate areas of
expertise.
The specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment is subject to review, but
may include experience in medical practice, teaching, research, and/or
public service relevant to the field of activity of the committee. The
term of office is up to 4 years.
Criteria for Consumer-Nominated Members
FDA currently attempts to place on each of the committees described
previously in this document one voting member who is nominated by
consumer organizations. These members are recommended by consumer
organizations which have the responsibility for screening,
interviewing, and recommending candidates with appropriate scientific
credentials. Candidates are sought who are aware of the consumer impact
of committee issues, but who also possess enough technical background
to understand and contribute to the committee's work. This would
involve, for example, an understanding of research design, benefit/risk
and the legal requirements for safety and efficacy of the products
under review, and considerations regarding individual products. The
agency notes, however, that for some advisory committees, it may
require such nominees to meet the same technical qualifications and
specialized training required of other expert members of the committee.
The term of office for these members is up to 4 years. Nominations for
all committees listed previously in this document are invited for
consideration for membership as openings become available.
Nomination Procedure
Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory committees. Nominations
shall specify the committee for which the nominee is recommended.
Nominations shall state that the nominee is aware of the nomination, is
willing to serve as a member of the advisory committee, and appears to
have no conflict on interest that would preclude committee membership.
Potential candidates will be asked by FDA to provide detailed
information concerning such matters as financial holdings,
consultancies, and research grants or contracts in order 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: July 5, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-17477 Filed 7-10-02; 8:45 am]
BILLING CODE 4160-01-S