[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     
----------------------------------------------------------------------------------------------------------------
Circulatory System Devices Panel                                        July 1, 1999.......   NV                
Immunology Devices Panel                                                March 1, 1999......   NV                
Obstetrics and Gynecology Devices Panel                                 NV.................  February 1, 1999   
----------------------------------------------------------------------------------------------------------------
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

[[Page 36244]]

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]
BILLING CODE 4160-01-F