[Federal Register Volume 59, Number 115 (Thursday, June 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14648]
[[Page Unknown]]
[Federal Register: June 16, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Nominations for 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 consumer representatives and an industry representative
to serve on certain device panels of the Medical Devices Advisory
Committee and consumer representatives for the Technical Electronic
Product Radiation Safety Standards Committee in the Center for Devices
and Radiological Health. Nominations will be accepted for current
vacancies and for those that will or may occur through February 28,
1995.
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, extends
particular encouragement to nominations for appropriately qualified
female, minority, and physically disabled candidates, and nominations
from small businesses that manufacture medical devices subject to the
regulations.
DATES: Nominations should be received by August 15, 1994 for vacancies
listed in this notice.
ADDRESSES: All nominations and curricula vitae for consumer
representatives for the medical device panels should be sent to Susan
Meadows (address below).
All nominations and curricula vitae (which includes nominee's
office address and telephone number) for the industry representative
for the Obstetrics and Gynecology Devices Panel and the consumer
representatives for the Technical Electronic Product Radiation Safety
Standards Committee should be sent to Kay Levin (address below).
FOR FURTHER INFORMATION CONTACT:
Regarding consumer interests for the medical device panels: Susan
K. Meadows, Office of Consumer Affairs (HFE-20), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5006.
Regarding industry interests for the Obstetrics and Gynecology
Devices Panel and the consumer interests for the Technical Electronic
Product Radiation Safety Standards Committee: Kay A. Levin, Food and
Drug Administration, Center for Devices and Radiological Health (HFZ-
10), 12720 Twinbrook Pkwy., Rockville, MD 20857, 301-443-9422.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for members
representing consumer and industry interests for the vacancies listed
below:
------------------------------------------------------------------------
Approximate Date Representative is
Needed
Committee or Panel ------------------------------------
Consumer Industry
------------------------------------------------------------------------
Circulatory System July 1, 1994..... NV
Gastroenterology and Urology Jan. 1, 1995..... NV
General Hospital and Personal Use Jan. 1, 1995..... NV
Immunology Mar. 1, 1995..... NV
Obstetrics and Gynecology NV............... Feb. 1, 1995
Technical Electronic Product IMMED (3)....... NV
Radiation Safety Standards
Jan. 1, 1995 (1). NV
------------------------------------------------------------------------
NV = No vacancy
IMMED = Immediate vacancy
Functions
Medical Device Panels
The functions of the medical device panels are to: (1) Review and
evaluate data on the safety and effectiveness of marketed and
investigational devices; (2) advise the Commissioner of Food and Drugs
regarding recommended classification of these devices into one of three
regulatory categories; (3) recommend the assignment of a priority for
the application of regulatory requirements for devices classified in
the standards or premarket approval category; (4) advise on any
possible risks to health associated with the use of devices; (5) advise
on formulation of product development protocols and review premarket
approval applications for those devices classified in the premarket
approval category; (6) review classification of devices to recommend
changes in classification as appropriate; (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; and (9) respond to requests from the agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices.
Technical Electronic Product Radiation Safety Standards Committee
The function of the Technical Electronic Product Radiation Safety
Standards Committee is to provide advice and consultation on technical
feasibility, reasonableness, and practicability of performance
standards for electronic products to control the emission of radiation
from such products. The committee may recommend electronic product
radiation safety standards for consideration.
Consumer and Industry Representation
Medical Device Panels
Section 513 of the act, as amended by the Medical Device
Amendments of 1976 (21 U.S.C. 360c), 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.
Technical Electronic Product Radiation Safety Standards Committee
Section 534(f) of the act, as amended by the Safe Medical Devices
Act of 1990 (21 U.S.C. 360kk(f)), provides that the Technical
Electronic Product Radiation Safety Standards Committee include five
members from governmental agencies, including State or Federal
Governments, five members from the affected industries, and five
members from the general public, of which at least one shall be a
representative of organized labor.
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 Representative for the Obstetrics and Gynecology Devices
Panel
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 industrial 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 Representative for the Obstetrics and Gynecology Devices
Panel
Regarding nominations for members representing the interests of
industry on the Obstetrics and Gynecology Devices Panel, 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 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 10, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-14648 Filed 6-15-94; 8:45 am]
BILLING CODE 4160-01-F
