Food and Drug Administration, HHS.
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).Start Signature
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]
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