E6-12569. 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 September 28, 2006, from 10 a.m. to 6 p.m., and on September 29, 2006, from 8 a.m. to 1 p.m.

Location: Atrium Court Hotel, Remington 1 and 2, Three Research Ct., Rockville, MD.

Contact Person: Nancy Wynne, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3284, 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: (1) Amendments to the current regulations, and (2) all guidance documents issued since the last meeting. The committee will also receive updates on recently approved alternative standards and the radiological health program. MQSA regulations and guidance documents are available to the public on the Internet at http://www.fda.gov/​cdrh/​mammography.

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 on or before August 29, 2006. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. on September 28, 2006, and between approximately 8:30 a.m. and 9:30 a.m. on September 29, 2006. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person 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 on or before August 29, 2006.

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 301-827-7292, 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: July 27, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.