[Federal Register: March 4, 2004 (Volume 69, Number 43)]
[Page 10237]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

National Mammography Quality Assurance Advisory Committee; Notice 
of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    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 
    (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 
    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 
    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]