[Federal Register Volume 67, Number 125 (Friday, June 28, 2002)]
[Notices]
[Page 43635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


National Mammography Quality Assurance Advisory Committee; Notice 
of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: National Mammography Quality Assurance Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on August 26, 2002, from 9 
a.m. to 6 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Charles Finder, Center for Devices and Radiological 
Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 301-594-3332, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12397. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will receive information on the American 
College of Radiology Imaging Network trial of full field digital 
mammography (FFDM), potential new applications of FFDM such as 
tomosynthesis, facility inspection findings, and the status of current 
inspection followup actions, and changes to the Mammography Quality 
Standards Act (the MQSA) compliance guidance. The committee will also 
receive updates on the status of accreditation and certification of 
FFDM, States as certification agencies under the MQSA, reauthorization 
of the MQSA, and the inspection demonstration project. The MQSA 
compliance guidance documents, which are in a question-and-answer 
format, are available to the public on the Internet at http://www.fda.gov/cdrh/mammography/guidance-docs.html. This guidance is being 
updated continually in response to questions that FDA receives from the 
public.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by August 16, 
2002. Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. and 10:30 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before August 16, 2002, 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Shirley Meeks, 
Conference Management Staff, at 301-594-1283, ext. 105, at least 7 days 
in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 21, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-16352 Filed 6-27-02; 8:45 am]
BILLING CODE 4160-01-S