[Federal Register Volume 70, Number 130 (Friday, July 8, 2005)]
[Notices]
[Pages 39516-39517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13421]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Nonvoting Members Representing 
Industry Interests on Public Advisory Panels or Committees; Medical 
Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for nonvoting industry representatives to serve on certain 
device panels of the Medical Devices Advisory Committee in the Center 
for Devices and Radiological Health.

DATES: Industry organizations interested in participating in the 
selection of a nonvoting member to represent industry for the vacancies 
listed in this document must send a letter to FDA by August 8, 2005, 
stating their interest in one or more panels. Concurrently, nomination 
materials for prospective candidates should be sent to FDA by August 8, 
2005. A nominee may either be self-nominated or nominated by an 
organization to serve as a nonvoting industry representative.

ADDRESSES: All letters of interest and nominations should be sent to 
Kathleen L. Walker (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices 
and Radiological Health (HFZ-17), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0450, ext. 114, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: 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 one nonvoting member to represent the interests of the 
medical device manufacturing industry.
    FDA is requesting nominations for nonvoting members representing 
industry interests for the vacancies listed in table 1 of this 
document.

                Table 1.--Medical Device Panel Vacancies
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                                      Approximate Date Representative is
       Medical Devices  Panels                      Needed
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Anesthesiology and Respiratory        December 1, 2005
 Therapy Devices Panel
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Dental Products Panel                 November 1, 2005
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General Hospital and Personal Use     January 1, 2006
 Devices Panel
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Immunology Devices Panel              Immediate
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Ophthalmic Devices Panel              November 1, 2005
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I. Functions

    The medical device panels perform the following functions: (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 (the 
Commissioner) 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 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.

[[Page 39517]]

II. Selection Procedure

    Any organization in the medical device manufacturing industry 
wishing to participate in the selection of a nonvoting member to 
represent industry on a particular panel should send a letter stating 
that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) 
within 30 days of publication of this document. Persons who nominate 
themselves as industry representatives for the panels will not 
participate in the selection process. It is, therefore, recommended 
that nominations be made by someone within an organization, trade 
association, or firm who is willing to participate in the selection 
process. Within the subsequent 30 days, FDA will send a letter to each 
organization and a list of all nominees along with their resumes. The 
letter will state that the interested organizations are responsible for 
conferring with one another to select a candidate, within 60 days after 
receiving the letter, to serve as the nonvoting industry representative 
on a particular device panel. If no individual is selected within that 
60 days, the Commissioner may select the nonvoting member to represent 
industry interests.

III. Application Procedure

    Individuals may nominate themselves or an organization representing 
the medical device industry may nominate one or more individuals to 
serve as a nonvoting industry representative. A current curriculum 
vitae (which includes the nominee's business address, telephone number, 
and e-mail address) and the name of the panel of interest should be 
sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT). 
FDA will forward all nominations to the organizations that have 
expressed interest in participating in the selection process for that 
panel.
    FDA has a special interest in ensuring that women, minority groups, 
individuals with disabilities, and small businesses are adequately 
represented on its advisory committees. Therefore, the agency 
encourages nominations for appropriately qualified candidates from 
these groups.
    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 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-13421 Filed 7-7-05; 8:45 am]
BILLING CODE 4160-01-S