[Federal Register: June 5, 2003 (Volume 68, Number 108)]
[Page 33719-33720]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Request for Nominations for Nonvoting Representatives of Industry 
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 industry

[[Page 33720]]

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, 2004.
    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 for vacancies listed in this notice should be 
received by July 7, 2003.

ADDRESSES: 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, Office of Systems and Management (HFZ-17), CDRH, Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1283, 
ext. 114, e-mail: klw@cdrh.fda.gov.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for nonvoting 
members representing industry interests for the vacancies listed as 

                                     Approximate Date  Representative Is
      Medical Devices  Panels                       Needed
Clinical Chemistry and Clinical      Mar. 1, 2004
Gastroenterology and Urology         Jan. 1, 2004
General and Plastic Surgery          Sept. 1, 2003
Hematology and Pathology             Mar. 1, 2004
Microbiology                         Mar. 1, 2004
Molecular and Clinical Genetics      June 1, 2004
Radiological                         Feb. 1, 2004

I. Functions

    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. 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 
interests of the medical device manufacturing industry.

III. Nomination Procedure

    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 
    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 Procedure

    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: May 29, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-14213 Filed 6-4-03; 8:45 am]