[Federal Register: June 12, 2002 (Volume 67, Number 113)]
[&thnsp;Notices]
[Page 40316]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn02-89]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Nonvoting Representatives of Consumer
Interests on Public Advisory Panels or Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for nonvoting consumer representatives to serve on certain
device panels of the Medical Devices Advisory Committee in the Center
for Devices and Radiological Health (CDRH). Nominations will be
accepted for current vacancies and for those that will or may occur
through July 31, 2003. FDA has a special interest in ensuring that
women, minority groups, individuals with disabilities, and small
businesses are adequately represented on advisory committees and,
therefore, encourages nominations for appropriately qualified
candidates from these groups.
DATES: Nominations for vacancies listed in this notice should be
received by July 12, 2002.
ADDRESSES: All nominations and curricula vitae (which include nominee's
office address, telephone number, and e-mail address) should be
submitted in writing to Linda Ann Sherman, Advisory Committee and
Oversight Management Staff (HF–4), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, e-mail: LSHERMAN@OC.FDA.GOV.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for nonvoting
members representing consumer interests for the vacancies listed as
follows:
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Approximate Date Consumer
Medical Devices Panels Representative Is Needed
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Anesthesiology and Respiratory Immediately
Therapy
Circulatory System July 1, 2002
Gastroenterology and Urology Jan. 1, 2003
General Hospital and Personal Use Jan. 1, 2003
Immunology Mar. 1, 2003
Microbiology Mar. 1, 2003
Molecular and Clinical Genetics June 1, 2003
Radiological Feb. 1, 2003
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I. Function
The functions of the medical device panels are to: (1) Review and
evaluate data on the safety and effectiveness of marketed and
investigational devices and make recommendations for their regulation;
(2) advise the Commissioner of Food and Drugs regarding recommended
classification or reclassification of these devices into one of three
regulatory categories; (3) advise on any possible risks to health
associated with the use of devices; (4) advise on formulation of
product development protocols; (5) review premarket approval
applications for medical devices; (6) review guidelines and guidance
documents; (7) recommend exemption to certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act
(the act)); (8) advise on the necessity to ban a device; (9) respond to
requests from the agency to review and make recommendations on specific
issues or problems concerning the safety and effectiveness of devices;
and (10) make recommendations on the quality in the design of clinical
studies regarding the safety and effectiveness of marketed and
investigational devices.
II. Consumer Representation
Section 520(f)(3) of the act (21 U.S.C. 360j(f)(3)), as amended by
the Medical Device Amendments of 1976, provides that each medical
device panel include as a member one nonvoting representative of
consumer interests.
III. Nomination Procedure
Any interested person may nominate one or more qualified persons as
a member of a particular advisory committee or panel to represent
consumer interests as identified in this notice. 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.
Nominations shall include a complete curriculum vitae of each
nominee 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 panel or in any advisory committee or
panel. The term of office is up to 4 years, depending on the
appointment date.
IV. Selection Procedure
Selection of members representing consumer interests is conducted
through procedures which include use of a consortium of consumer
organizations which 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.
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: June 5, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02–14838 Filed 6–11–02; 8:45 am]
BILLING CODE 4160–01–S