[Federal Register: July 2, 2004 (Volume 69, Number 127)]
[Notices]
[Page 40384-40385]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jy04-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Request for Nominations for Nonvoting Members Representing
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 industry representatives to serve on certain
device panels of the Medical Devices Advisory Committee in the Center
for Devices and Radiological Health.
FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees. Therefore, the
agency encourages nominations for appropriately qualified candidates
from these groups.
DATES: Industry organizations interested in participating in the
selection of a nonvoting member to represent industry for vacancies
listed in this notice must send a letter to FDA by August 2, 2004,
stating their interest in one or more panels. Concurrently, nomination
materials for prospective candidates should be sent to FDA by August 2,
2004. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
ADDRESSES: All letters of interest and nominations should be sent to
Kathleen L. Walker, Center for Devices and Radiological Health (HFZ-
17), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD
20850, 301-594-1283, ext. 114, e-mail: KLW@CDRH.FDA.GOV.
FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for
Devices and Radiological Health (HFZ-17), Food and Drug Administration,
2098 Gaither Rd., Rockville, MD 20850, 301-594-1283, ext. 114, e-mail:
KLW@CDRH.FDA.GOV.
SUPPLEMENTARY INFORMATION: Section 520(f)(3) of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 360j(f)(3)), as amended by the Medical
Device Amendments of 1976, provides that each medical device panel
include one nonvoting member to represent the interests of the medical
device manufacturing industry.
FDA is requesting nominations for nonvoting members representing
industry interests for the vacancies listed below:
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Medical Device Panels of the Approximate Date Representative is
Medical Device Advisory Committee Needed
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Circulatory System Devices Panel July 1, 2005
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Ear, Nose, and Throat Devices Panel Nov. 1, 2004
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Immunology Devices Panel Mar. 1, 2005
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Medical Devices Dispute Resolution Oct. 1, 2004
Panel
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Neurological Devices Panel Dec. 1, 2004
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Obstetrics and Gynecology Devices Feb 1, 2005
Panel
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Orthopaedic and Rehabilitation Sept. 1, 2004
Devices Panel
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I. Functions
The functions of the medical device panels are listed as follows:
(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
[[Page 40385]]
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 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. Selection Procedure
Any organization in the medical device manufacturing industry
wishing to participate in the selection of a nonvoting member to
represent industry on a particular panel should send a letter stating
that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT)
within 30 days of publication of this notice. Persons who nominate
themselves as industry representatives for the panels will not
participate in the selection process. It is, therefore, recommended
that nominations be made by someone within an organization, trade
association, or firm who is willing to participate in the selection
process. Within the subsequent 30 days, FDA will send a letter to each
organization and a list of all nominees along with their resumes. The
letter will state that the interested organizations are responsible for
conferring with one another to select a candidate, within 60 days after
receiving the letter, to serve as the nonvoting member representing on
a particular device panel. If no individual is selected within the 60
days, the Commissioner may select the nonvoting member to represent
industry interests.
III. Application Procedure
Individuals may nominate themselves or an organization representing
the medical device industry may nominate one or more individuals to
serve as nonvoting industry representatives. A current curriculum vitae
(which includes the nominee's business address, telephone number, and
e-mail address) and the name of the panel of interest should be sent to
the FDA contact person. FDA will forward all nominations to the
organizations that have expressed interest in participating in the
selection process for that panel.
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 24, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-15012 Filed 7-1-04; 8:45 am]
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