[Federal Register Volume 69, Number 127 (Friday, July 2, 2004)]
[Notices]
[Pages 40384-40385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15012]


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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: [email protected].

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: 
[email protected].

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]
BILLING CODE 4160-01-S