[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67466-67467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28223]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Request for Notification From Industry Organizations Interested 
in Participating in the Selection Process for Nonvoting Industry 
Representatives and Request for Nominations for Nonvoting Industry 
Representatives on the National Mammography Quality Assurance Advisory 
Committees

AGENCY: Food and Drug Administration, HHS.

[[Page 67467]]


ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any 
industry organization interested in participating in the selection of 
nonvoting industry representatives to serve on the National Mammography 
Quality Assurance Advisory Committee (NMQAAC) in the Center for Devices 
and Radiological Health notify FDA in writing. A nominee may either be 
self-nominated or nominated by an organization to serve as a nonvoting 
industry representative. Nominations will be accepted for current 
vacancies effective with this notice.

DATES: Any industry organizations interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to FDA by December 
1, 2011, for the vacancies listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
by December 1, 2011.

ADDRESSES: All letters of interest and nominations should be submitted 
in writing to Margaret J. Ames (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT: Margaret J. Ames, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5234, Silver Spring, MD 20993, (301) 796-
5960, email: [email protected].

SUPPLEMENTARY INFORMATION:
    The Mammography Quality Standards Reauthorization Act of 2004 (Pub. 
L. 108-365) requires the addition of at least two industry 
representatives with expertise in mammography equipment to the NMQAAC. 
The Agency is requesting nominations for nonvoting industry 
representatives on the NMQAAC.

I. NMQAAC

    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. Qualifications

    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.

III. Selection Procedure

    Any industry organization interested in participating in the 
selection of appropriate nonvoting members to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations and a list of all nominees 
along with their current resumes. The letter will also state that it is 
the responsibility of the interested organizations to confer with one 
another and to select candidates, within 60 days after the receipt of 
the FDA letter, to serve as nonvoting members to represent industry 
interests for the committee. The interested organizations are not bound 
by the list of nominees in selecting candidates. However, if no 
individual is selected within the 60 days, the Commissioner of Food and 
Drugs will select the nonvoting members to represent industry 
interests.

IV. Application Procedure

    Individuals may self nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Contact information, a current curriculum vitae, and 
the name of the committee of interest should be sent to the FDA contact 
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of 
publication of this document (see DATES). FDA will forward all 
nominations to the organizations expressing interest in participating 
in the selection process for the committee. (Persons who nominate 
themselves as nonvoting industry representatives will not participate 
in the selection process).
    FDA has a special interest in ensuring that women, minority groups, 
individuals with physical disabilities, and small businesses are 
adequately represented on its advisory committees and, therefore, 
encourages nominations for appropriately qualified candidates from 
these groups. Specifically, in this document, nominations for nonvoting 
representatives of industry interests are encouraged from the 
mammography manufacturing industry.
    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: October 26, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-28223 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P