[Federal Register: July 8, 2005 (Volume 70, Number 130)]
[Notices]
[Page 39516-39517]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy05-55]
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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; Medical
Devices Advisory Committee
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.
DATES: Industry organizations interested in participating in the
selection of a nonvoting member to represent industry for the vacancies
listed in this document must send a letter to FDA by August 8, 2005,
stating their interest in one or more panels. Concurrently, nomination
materials for prospective candidates should be sent to FDA by August 8,
2005. 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 (see FOR FURTHER INFORMATION CONTACT).
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, 240-276-0450, ext. 114, e-mail:
klw@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION: 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 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 in table 1 of this
document.
Table 1.--Medical Device Panel Vacancies
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Approximate Date Representative is
Medical Devices Panels Needed
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Anesthesiology and Respiratory December 1, 2005
Therapy Devices Panel
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Dental Products Panel November 1, 2005
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General Hospital and Personal Use January 1, 2006
Devices Panel
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Immunology Devices Panel Immediate
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Ophthalmic Devices Panel November 1, 2005
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I. Functions
The medical device panels perform the following functions: (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 (the
Commissioner) 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.
[[Page 39517]]
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 document. 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 industry representative
on a particular device panel. If no individual is selected within that
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 a nonvoting industry representative. 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 (see FOR FURTHER INFORMATION CONTACT).
FDA will forward all nominations to the organizations that have
expressed interest in participating in the selection process for that
panel.
FDA has a special interest in ensuring that women, minority groups,
individuals with disabilities, and small businesses are adequately
represented on its advisory committees. Therefore, the agency
encourages nominations for appropriately qualified candidates from
these groups.
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 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-13421 Filed 7-7-05; 8:45 am]
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