[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Notices]
[Pages 36242-36244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17601]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Nonvoting Representatives of Consumer
and Industry 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 and nonvoting
industry 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 June 30, 1999.
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,
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encourages nominations for appropriately qualified candidates from
these groups, as well as nominations from small businesses that
manufacture medical devices subject to the regulations.
DATES: Nominations should be received by (insert date 30 days after
date of publication in the Federal Register), for vacancies listed in
this notice.
ADDRESSES: All nominations and curricula vitae for consumer
representatives should be submitted in writing to Annette J. Funn
(address below). All nominations and curricula vitae (which includes
nominee's office address and telephone number) for industry
representatives should be submitted in writing to Kathleen L. Walker
(address below).
FOR FURTHER INFORMATION CONTACT:
Regarding consumer representatives: Annette Funn, Office of
Consumer Affairs (HFE-88), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-5006.
Regarding industry representatives: Kathleen L. Walker, Office of
Systems and Management (HFZ-17), CDRH, Food and Drug Administration,
2098 Gaither Rd., Rockville, MD 20850, 301-594-1283, ext. 114.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for nonvoting
members representing consumer and industry interests for the vacancies
listed below:
----------------------------------------------------------------------------------------------------------------
Approximate Date Representative is
Needed
Medical Devices Panels -----------------------------------------
Consumer Industry
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Circulatory System Devices Panel July 1, 1999....... NV
Immunology Devices Panel March 1, 1999...... NV
Obstetrics and Gynecology Devices Panel NV................. February 1, 1999
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NV = No vacancy
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;
(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.
Consumer and Industry Representation
Section 520(f)(3) of the Federal Food, Drug, and Cosmetic Act (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
members one nonvoting representative of consumer interests and one
nonvoting representative of interests of the medical device
manufacturing industry.
Nomination Procedures
Consumer Representatives
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.
Industry Representatives
Any organization in the medical device manufacturing industry
(industry interests) wishing to participate in the selection of an
appropriate member of a particular panel may nominate one or more
qualified persons to represent industry interests. Persons who nominate
themselves as industry representatives for the panels will not
participate in the selection process. It is, therefore, recommended
that all nominations be made by someone with an organization, trade
association, or firm who is willing to participate in the selection
process.
Nominees shall be full-time employees of firms that manufacture
products that would come before the panel, or consulting firms that
represent manufacturers. Nominations shall include a complete
curriculum vitae of each nominee. The term of office is up to 4 years,
depending on the appointment date.
Selection Procedures
Consumer Representatives
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.
Industry Representatives
Regarding nominations for members representing the interests of
industry, a letter will be sent to each person that has made a
nomination, and to those organizations indicating an interest in
participating in the selection process, together with a complete list
of all such organizations and the nominees. This letter will state that
it is the responsibility of each nominator or organization indicating
an interest in
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participating in the selection process to consult with the others in
selecting a single member representing industry interests for the panel
within 60 days after receipt of the letter. If no individual is
selected within 60 days, the agency will select the nonvoting member
representing industry interests.
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 26, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17601 Filed 7-1-98; 8:45 am]
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