[Federal Register: March 4, 2004 (Volume 69, Number 43)]
[Notices]
[Page 10237]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr04-62]
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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 April 19, 2004, 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 3014512397. Please call the Information
Line for up-to-date information on this meeting.
Agenda: The committee will discuss the following issues:
(1) Mechanisms to reduce the regulatory and inspection burden on
facilities;
(2) Whether mammographic images obtained from reconstructed
compressed digital data (lossless or lossy data compression) can be
used for primary interpretation or storage;
(3) Whether images obtained from digitized film-screen
mammograms can be used for primary interpretation or storage; and
(4) Revisions to Mammography Quality Standards Act (MQSA)
compliance guidance.
The committee will also receive updates on recently approved
alternative standards, full field digital mammography accreditation
and certification, the inspection demonstration program, the status
of MQSA reauthorization, and the new post inspection enforcement
strategy.
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. This guidance is 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 April 5,
2004. Oral presentations from the public will be scheduled between
approximately 9:30 a.m. and 10:30 a.m. on April 19, 2004. Time
allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person
before April 5, 2004, 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: February 25, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-4786 Filed 3-3-04; 8:45 am]
BILLING CODE 4160-01-S