[Federal Register Volume 59, Number 115 (Thursday, June 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14648]


[[Page Unknown]]

[Federal Register: June 16, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Request for Nominations for 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 consumer representatives and an industry representative 
to serve on certain device panels of the Medical Devices Advisory 
Committee and consumer representatives for the Technical Electronic 
Product Radiation Safety Standards Committee in the Center for Devices 
and Radiological Health. Nominations will be accepted for current 
vacancies and for those that will or may occur through February 28, 
1995.
     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, extends 
particular encouragement to nominations for appropriately qualified 
female, minority, and physically disabled candidates, and nominations 
from small businesses that manufacture medical devices subject to the 
regulations.

DATES: Nominations should be received by August 15, 1994 for vacancies 
listed in this notice.

ADDRESSES: All nominations and curricula vitae for consumer 
representatives for the medical device panels should be sent to Susan 
Meadows (address below).
     All nominations and curricula vitae (which includes nominee's 
office address and telephone number) for the industry representative 
for the Obstetrics and Gynecology Devices Panel and the consumer 
representatives for the Technical Electronic Product Radiation Safety 
Standards Committee should be sent to Kay Levin (address below).

FOR FURTHER INFORMATION CONTACT:
     Regarding consumer interests for the medical device panels: Susan 
K. Meadows, Office of Consumer Affairs (HFE-20), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5006.
     Regarding industry interests for the Obstetrics and Gynecology 
Devices Panel and the consumer interests for the Technical Electronic 
Product Radiation Safety Standards Committee: Kay A. Levin, Food and 
Drug Administration, Center for Devices and Radiological Health (HFZ-
10), 12720 Twinbrook Pkwy., Rockville, MD 20857, 301-443-9422.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for members 
representing consumer and industry interests for the vacancies listed 
below: 

------------------------------------------------------------------------
                                      Approximate Date Representative is
                                                    Needed              
        Committee or Panel          ------------------------------------
                                         Consumer           Industry    
------------------------------------------------------------------------
 Circulatory System                  July 1, 1994.....   NV             
 Gastroenterology and Urology        Jan. 1, 1995.....  NV              
 General Hospital and Personal Use   Jan. 1, 1995.....  NV              
 Immunology                          Mar. 1, 1995.....  NV              
 Obstetrics and Gynecology           NV...............  Feb. 1, 1995    
 Technical Electronic Product         IMMED (3).......  NV              
 Radiation Safety Standards                                             
                                     Jan. 1, 1995 (1).  NV              
------------------------------------------------------------------------
NV = No vacancy                                                         
IMMED = Immediate vacancy                                               

 Functions

 Medical Device Panels

     The functions of the medical device panels are to: (1) Review and 
evaluate data on the safety and effectiveness of marketed and 
investigational devices; (2) advise the Commissioner of Food and Drugs 
regarding recommended classification of these devices into one of three 
regulatory categories; (3) recommend the assignment of a priority for 
the application of regulatory requirements for devices classified in 
the standards or premarket approval category; (4) advise on any 
possible risks to health associated with the use of devices; (5) advise 
on formulation of product development protocols and review premarket 
approval applications for those devices classified in the premarket 
approval category; (6) review classification of devices to recommend 
changes in classification as appropriate; (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; and (9) respond to requests from the agency to review and make 
recommendations on specific issues or problems concerning the safety 
and effectiveness of devices.

 Technical Electronic Product Radiation Safety Standards Committee

     The function of the Technical Electronic Product Radiation Safety 
Standards Committee is to provide advice and consultation on technical 
feasibility, reasonableness, and practicability of performance 
standards for electronic products to control the emission of radiation 
from such products. The committee may recommend electronic product 
radiation safety standards for consideration.

Consumer and Industry Representation

Medical Device Panels

     Section 513 of the act, as amended by the Medical Device 
Amendments of 1976 (21 U.S.C. 360c), 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.

Technical Electronic Product Radiation Safety Standards Committee

     Section 534(f) of the act, as amended by the Safe Medical Devices 
Act of 1990 (21 U.S.C. 360kk(f)), provides that the Technical 
Electronic Product Radiation Safety Standards Committee include five 
members from governmental agencies, including State or Federal 
Governments, five members from the affected industries, and five 
members from the general public, of which at least one shall be a 
representative of organized labor.

 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 Representative for the Obstetrics and Gynecology Devices 
Panel

     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 industrial 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 Representative for the Obstetrics and Gynecology Devices 
Panel

     Regarding nominations for members representing the interests of 
industry on the Obstetrics and Gynecology Devices Panel, 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 10, 1994.
 Linda A. Suydam,
 Interim Deputy Commissioner for Operations.
[FR Doc. 94-14648 Filed 6-15-94; 8:45 am]
BILLING CODE 4160-01-F