[Federal Register Volume 70, Number 54 (Tuesday, March 22, 2005)]
[Notices]
[Pages 14472-14473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5551]


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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 Committees

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 the 
National Mammography Quality Assurance Advisory Committee (NMQAAC) in 
the Center for Devices and Radiological Health (CDRH). 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.

DATES: Industry organizations interested in participating in the 
selection of a nonvoting member to represent industry for the vacancies 
listed in this notice must send a letter to FDA by April 21, 2005, 
stating their interest in the

[[Page 14473]]

committee (NMQAAC). Concurrently, nomination materials for prospective 
candidates should be sent to FDA by April 21, 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 
the contact person listed in the FOR FURTHER INFORMATION section of 
this notice.

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.

SUPPLEMENTARY INFORMATION: 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 National Mammography Quality Assurance Advisory 
Committee.

I. Functions of NMQAAC

    The functions of the NMQAAC are to advise FDA 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 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.

II. Selection Procedure

    Any organization representing the mammography device industry 
wishing to participate in the selection of a nonvoting member to 
represent industry should send a letter stating that interest to the 
FDA contact (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 
member representing the a particular committee. If no individual is 
selected within the 60 days, the Commissioner of Food and Drugs (the 
Commissioner) may select the nonvoting member to represent industry 
interests.

III. Qualifications

    Persons nominated for membership on the committee as an industry 
representative 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.

IV. Application Procedure

    Individuals may nominate themselves, or an organization 
representing the mammography device industry may nominate one or more 
individuals to serve as nonvoting industry representatives. A current 
curriculum vitae (which includes the nominee's business address, 
telephone number, and e-mail address) and the name of the committee of 
interest should be sent to the FDA contact person. FDA will forward all 
nominations to the organizations that have expressed interest in 
participating in the selection process for the committee.
    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: March 14, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-5551 Filed 3-21-05; 8:45 am]
BILLING CODE 4160-01-S