[Federal Register Volume 66, Number 114 (Wednesday, June 13, 2001)]
[Notices]
[Pages 31935-31936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14814]


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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 July 31, 2002.
    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, 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 July 13, 2001, for vacancies 
listed in this notice.

ADDRESSES: All nominations and curricula vitae (which includes 
nominee's office address, telephone number, and e-mail address) for 
consumer representatives should be submitted in writing to Maureen A. 
Hess (address below). All nominations and curricula vitae (which 
includes nominee's office address, telephone number, and e-mail 
address) for industry representatives should be submitted in writing to 
Kathleen L. Walker (address below).

FOR FURTHER INFORMATION CONTACT:
    Regarding consumer representatives: Maureen A. Hess, Office of 
Consumer Affairs (HFE-50), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-5006, e-mail: <a href="/cdn-cgi/l/email-protection#24696c415757646b670a6260650a636b72"><span class="__cf_email__" data-cfemail="da9792bfa9a99a9599f49c9e9bf49d958c">[email protected]</span></a>.
    Regarding industry representatives: Kathleen L. Walker, Office of 
Systems and Management (HFZ-17), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1283, ext. 114, e-mail: 
<a href="/cdn-cgi/l/email-protection#1952554e595a5d4b51375f5d58375e564f"><span class="__cf_email__" data-cfemail="246f6873646760766c0a6260650a636b72">[email protected]</span></a>.

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
----------------------------------------------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy Devices Panel                     Dec. 1, 2001              Dec. 1, 2001
Circulatory System Devices Panel                                         July 1, 2002                     NV\1\
Clinical Chemistry and Clinical Toxicology Devices Panel                 Mar. 1, 2002                     NV\1\
Dental Products Panel                                                           NV\1\              Nov. 1, 2001
General Hospital and Personal Use Devices Panel                                 NV\1\              Jan. 1, 2002
Ophthalmic Devices Panel                                                 Nov. 1, 2001              Nov. 1, 2001
----------------------------------------------------------------------------------------------------------------
\1\NV = No vacancy

I. 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

[[Page 31936]]

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 (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. Consumer and Industry Representation

    Section 520(f)(3) of 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.

III. Nomination Procedures

A. 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 haveno 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.

B. 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 vita of each nominee. The term of office is up to 4 years, 
depending on the appointment date.

IV. Selection Procedures

A. 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.

B. 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 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 7, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-14814 Filed 6-13-01; 8:45 am]
BILLING CODE 4160-01-S


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