[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Pages 51918-51919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18592]


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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.

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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

[[Page 51919]]

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: Hilton Washington, DC North/Gaithersburg, Salons A, B, C and 
D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
number is 301-977-8900. 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, 
[email protected], 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's contents will be explained and FDA will ask the committee's 
advice on facility roll-out strategies.
     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/Calendar/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.
[FR Doc. 2016-18592 Filed 8-4-16; 8:45 am]
 BILLING CODE 4164-01-P