[Federal Register Volume 61, Number 164 (Thursday, August 22, 1996)]
[Notices]
[Pages 43366-43368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


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 industry representatives 
to serve on certain device panels of the Medical Devices Advisory 
Committee and on the National Mammography Quality Assurance Advisory 
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 June 30, 1997.
    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 October 21, 1996, for 
vacancies listed in this notice.

ADDRESSES: All nominations and curricula vitae for consumer 
representatives should be submitted in writing to Annette Funn (address 
below). All nominations and curricula vitae (which includes nominee's 
office address and telephone number) for the 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, 301-443-5006.
    Regarding industry representatives: Kathleen L. Walker, Food and 
Drug Administration, Center for Devices and Radiological Health (HFZ-
17), 2098 Gaither Rd., Rockville, MD 20850, 301-594-1283, ext. 114.

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

[[Page 43367]]



                                                                        
------------------------------------------------------------------------
                                      Approximate Date Representative is
                                                    Needed              
         Committee or Panel         ------------------------------------
                                          Consumer          Industry    
------------------------------------------------------------------------
Circulatory System Devices Panel     NV...............  July 1, 1997-   
Dental Products Panel:                 ...............                  
  Devices                            November 1, 1996.  NV              
  Cosmetics                          NV...............  November 1, 1996
Ear, Nose, and Throat Devices Panel  NV...............  November 1, 1996
Immunology Devices Panel             NV...............  March 1, 1997   
Neurological Devices Panel           December 1, 1996.  December 1, 1996
Obstetrics and Gynecology Devices    February 1, 1997.  NV              
 Panel                                                                  
Orthopedic and Rehabilitation        NV...............  IMMED           
 Devices Panel                                                          
Radiological Devices Panel           NV...............  February 1, 1997
National Mammography Quality         February 1, 1997.  NA              
 Assurance Advisory Committee                                           
------------------------------------------------------------------------
NV = No vacancy                                                         
NA = Not applicable                                                     
IMMED = Immediate vacancy                                               

Functions

Medical Device Panels

    The functions of the 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.
    The Dental Products Panel also functions at times as a dental drug 
advisory panel. The functions of the drug panel are to: (1) Evaluate 
and recommend whether various prescription drug products should be 
changed to over-the-counter status; (2) evaluate data and make 
recommendations concerning the approval of new dental drug products for 
human use; (3) evaluate data and make recommendations concerning drug 
products that may also be cosmetics; and (4) using the Plaque 
Subcommittee, review and evaluate data concerning the safety and 
effectiveness of active ingredients, and combinations thereof, of 
various currently marketed dental drug products for human use, and the 
adequacy of their labeling. The subcommittee will advise on the 
promulgation of monographs establishing conditions under which these 
drugs are generally recognized as safe and effective and not 
misbranded.




[[Page 43368]]



National Mammography Quality Assurance Advisory Committee

    The functions of the committee are to advise the Food and Drug 
Administration on: (1) Developing appropriate quality standards and 
regulations for mammography facilities; (2) developing appropriate 
standards and regulations for bodies accrediting mammography facilities 
under this program; (3) developing regulations with respect to 
sanctions; (4) developing procedures for monitoring compliance with 
standards; (5) establishing a mechanism to investigate consumer 
complaints; (6) reporting new developments concerning breast imaging 
which should be considered in the oversight of mammography facilities; 
(7) determining whether there exists a shortage of mammography 
facilities in rural and health professional shortage areas and 
determining the effects of personnel or other requirements on access to 
the services of such facilities in such areas; (8) determining whether 
there will exist a sufficient number of medical physicists after 
October 1, 1999; and (9) determining the costs and benefits of 
compliance with these requirements.

Consumer and Industry Representation

Medical Device Panels

    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.

National Mammography Quality Assurance Advisory Committee

    Section 354n of the Public Health Service Act (42 U.S.C 263b), as 
amended by the Mammography Quality Standards Act of 1992, provides that 
at least four of the individuals nominated for membership should be 
from among national breast cancer or consumer health organizations with 
expertise in mammography. The committee may include one technically 
qualified member who is identified with consumer interests.

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 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: August 13, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-21356 Filed 8-21-96; 8:45 am]
BILLING CODE 4160-01-F