[Federal Register: June 12, 2002 (Volume 67, Number 113)]
[Page 40316]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Request for Nominations for Nonvoting Representatives of Consumer 
Interests on Public Advisory Panels or Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for nonvoting consumer 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, 2003. 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.

DATES: Nominations for vacancies listed in this notice should be 
received by July 12, 2002.

ADDRESSES: All nominations and curricula vitae (which include nominee's 
office address, telephone number, and e-mail address) should be 
submitted in writing to Linda Ann Sherman, Advisory Committee and 
Oversight Management Staff (HF–4), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, e-mail: LSHERMAN@OC.FDA.GOV.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for nonvoting 
members representing consumer interests for the vacancies listed as 

                                          Approximate Date Consumer
       Medical Devices Panels              Representative Is Needed
Anesthesiology and Respiratory       Immediately
Circulatory System                   July 1, 2002
Gastroenterology and Urology         Jan. 1, 2003
General Hospital and Personal Use    Jan. 1, 2003
Immunology                           Mar. 1, 2003
Microbiology                         Mar. 1, 2003
Molecular and Clinical Genetics      June 1, 2003
Radiological                         Feb. 1, 2003

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 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 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 a member one nonvoting representative of 
consumer interests.

III. Nomination Procedure

    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.

IV. Selection Procedure

    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.
    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 5, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 0214838 Filed 6–11–02; 8:45 am]