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Advisory Committee Meeting | In Person

Event Title
September 15, 2016: National Mammography Quality Assurance Advisory Committee Meeting Announcement
September 15, 2016

Date:
September 15, 2016

What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

Center Date Time Location
CDRH September 15, 2016 8:30 a.m. - 4:30 p.m. Gaithersburg Holiday Inn– Grand Ballroom
2 Montgomery Village Avenue
Gaithersburg, MD 20879
301–948–8900

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

National Mammography Quality Assurance Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the National Mammography Quality Assurance Advisory Committee.  The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues.  The meeting will be open to the public.

DATES:  The meeting will be held Thursday, September 15, 2016, from 8:30 a.m. to 4:30 p.m.

ADDRESSES:  Gaithersburg Holiday Inn– Grand Ballroom, 2 Montgomery Village Avenue, Gaithersburg, MD  20879.  The hotel's telephone number is 301-948-8900.  Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT:  S.J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1643, Silver Spring, MD, 20993, Sara.Anderson@fda.hhs.gov, 301-796-7047, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).  A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:

Agenda:  The Committee will discuss and make recommendations on:

•    Compliance Analysis.  This presentation will be focused on Mammography Quality Standards Act (MQSA) current compliance trends, such as how most compliance cases originate.  Input from the committee on any trends seen in the analysis, why the trends may be occurring, and possible actions will be sought.
•    Inspection Enhancement Project.  This presentation will describe a proposal to use the inspection program to enhance image quality.  FDA is seeking committee input on anticipated facility questions related to the proposal.
•    The approved alternative standard American College of Radiology Full Field Digital Mammography Quality Control Manual.  The manual will be presented so that committee members have knowledge of this alternative QC manual that facilities can choose to use.
•    Issues related to breast density.  A presentation of current issues followed by a committee discussion on how these issues might effect a possible MQSA requirement for reporting breast density.
•    Future challenges for MQSA, such as the role of synthesized 2D images.  FDA is seeking committee input on this challenge as well as what future challenges MQSA might encounter.

FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.  Background material is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm.  Scroll down to the appropriate advisory committee meeting link.

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 September 7, 2016.  Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m.  Those individuals interested in making 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 30, 2016.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by August 31, 2016.

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 disabilities.  If you require accommodations due to a disability, please contact Artair Mallett at 301 796-9638 at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated:  August 1, 2016.

Janice M. Soreth,

Acting Associate Commissioner,

Special Medical Programs.
 

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

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 disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

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