[Federal Register Volume 71, Number 193 (Thursday, October 5, 2006)]
[Notices]
[Pages 58866-58868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16438]


-----------------------------------------------------------------------

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for nonvoting industry representatives to serve on the 
National Mammography Quality Assurance Advisory Committee (NMQAAC) and 
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 November 6, 2006, 
stating their interest in the NMQAAC or one or more panels. 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by November 6, 2006. A nominee

[[Page 58867]]

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, 7520 
Standish Pl. (MPN1), Rockville, MD 20855, 301-827-7293, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

A. NMQAAC

    The Mammography Quality Standards Reauthorization Act of 2004 
(Public Law 108-365) requires the addition of at least two industry 
representatives with expertise in mammography equipment to the NMQAAC.

B. Medical Devices Advisory Committee

    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 following vacancies listed in table 1 of 
this document:

                                Table 1.
------------------------------------------------------------------------
                                                  Approximate Date
              Committee/Panel                 Representative is Needed
------------------------------------------------------------------------
NMQAAC                                      February 1, 2007
------------------------------------------------------------------------
Certain Panels of the Medical Devices Advisory Committee
------------------------------------------------------------------------
General and Plastic Surgery Devices Panel   Immediate
------------------------------------------------------------------------
Hematology and Pathology Devices Panel      Immediate
------------------------------------------------------------------------

II. Functions

A. NMQAAC

    The functions of the NMQAAC are to advise FDA on the following 
topics: (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 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.

B. Medical Devices Advisory Committee

    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.

II. Selection Procedure

    Any organization representing the mammography device industry or 
the medical device manufacturing industry wishing to participate in the 
selection of a nonvoting member to represent industry should send a 
letter stating that interest to the contact person (see FOR FURTHER 
INFORMATION CONTACT) within 30 days of publication of this notice. 
Persons who nominate themselves as industry representatives 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 committee or device panel. If no individual is selected 
within that 60 days, the Commissioner may select the nonvoting member 
to represent industry interests.

IV. Qualifications

A. NMQAAC

    Persons nominated for membership as an industry representative on 
the NMQAAC must meet the following criteria: (1) Demonstrate expertise 
in mammography equipment and (2) be able to discuss equipment 
specifications and quality control procedures affecting mammography 
equipment. The industry representative must be able to represent the 
industry perspective on issues and actions before the advisory 
committee, serve as liaison between the committee and interested 
industry parties, and facilitate dialogue with the advisory committee 
on mammography equipment issues.

B. Medical Devices Advisory Committee

    Persons nominated for the device panels should be full time 
employees of firms that manufacture products that would come before the 
panel, or

[[Page 58868]]

consulting firms that represent manufacturers, or have similar 
appropriate ties to industry.

V. Application Procedure

    Individuals may nominate themselves, or an organization 
representing the mammography device industry or 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 committee or panel of interest should be sent to the 
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 committee or 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: September 28, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16438 Filed 10-4-06; 8:45 am]
BILLING CODE 4160-01-S