[Federal Register: June 28, 2002 (Volume 67, Number 125)]
[Notices]
[Page 43635]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn02-76]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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