81 FR 51918 - National Mammography Quality Assurance Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 151 (August 5, 2016)

Page Range		51918-51919
FR Document		2016-18592

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.

Federal Register, Volume 81 Issue 151 (Friday, August 5, 2016)

[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Pages 51918-51919]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

51918 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices

Agency is not responsible for providing performed. For parking and security Category Cost
access to electrical outlets. information, please refer to http://
FDA welcomes the attendance of the www.fda.gov/AboutFDA/ Industry Representative ........ $50
public at its advisory committee WorkingatFDA/BuildingsandFacilities/ Nonprofit Organization and
meetings and will make every effort to WhiteOakCampusInformation/ Academic Other Than Uni-
accommodate persons with disabilities. ucm241740.htm. versity of Maryland ............ 50
University of Maryland, Col-
If you require accommodations due to a
FOR FURTHER INFORMATION CONTACT: lege Park and Baltimore ... 0
disability, please contact Janie Kim at Federal Government ............. 0
least 7 days in advance of the meeting. Audrey Thomas, Office of Regulatory
FDA is committed to the orderly Science and Innovation, Food and Drug
Administration, 10903 New Hampshire Streaming Webcast of the Public
conduct of its advisory committee Workshop: This public workshop will
meetings. Please visit our Web site at Ave., Bldg. 1, Rm. 4220, Silver Spring,
MD 20993–0002, 301–796–3520, also be Webcast. There is no registration
http://www.fda.gov/Advisory fee for access to the workshop via the
Committees/AboutAdvisoryCommittees/ Audrey.Thomas@fda.hhs.gov.
Webcast, but registration is still
ucm111462.htm for procedures on SUPPLEMENTARY INFORMATION: The required. Information regarding
public conduct during advisory purpose of this public workshop is to registration and access to the Webcast
committee meetings. provide an opportunity for relevant link is available at http://www.fda.gov/
Notice of this meeting is given under stakeholders including: Clinicians and ScienceResearch/SpecialTopics/
the Federal Advisory Committee Act (5 scientists from FDA and other RegulatoryScience/ucm507079.htm. If
U.S.C. app. 2). government Agencies, academia, non- you have never attended a Connect Pro
Dated: August 1, 2016. profit organizations, and industry to event before, test your connection at
Janice M. Soreth, discuss use of pediatric master protocols https://collaboration.fda.gov/common/
for development of medical products for help/en/support/meeting_test.htm. To
Acting Associate Commissioner, Special
Medical Programs. children. Specifically, the workshop get a quick overview of the Connect Pro
will present the current status of program, visit http://www.adobe.com/
[FR Doc. 2016–18560 Filed 8–4–16; 8:45 am]
pediatric protocol development in the go/connectpro_overview. (FDA has
BILLING CODE 4164–01–P
United States, considerations for verified the Web site addresses in this
pediatric protocol development document, but FDA is not responsible
DEPARTMENT OF HEALTH AND internationally, and development of for any subsequent changes to the Web
HUMAN SERVICES international consortia in this area. sites after this document publishes in
Clinical trial design considerations and the Federal Register.)
Food and Drug Administration the preliminary steps needed for Accommodations: Attendees are
development of pediatric master responsible for their own hotel
[Docket No. FDA–2016–N–0001] protocols, including the role of in vitro accommodations. If you need special
Pediatric Master Protocols; Public diagnostic tests, will also be discussed. accommodations while at FDA’s White
Workshop Finally, examples of pediatric master Oak Campus due to a disability, please
protocol development for medical contact Shari Solomon at
AGENCY: Food and Drug Administration, products with no, partial, and full Shari.Solomon@fda.hhs.gov at least 7
HHS. extrapolation of data from adults to days in advance.
ACTION: Notice of public workshop. children will be presented. The
Dated: August 1, 2016.
workshop will include two panel
SUMMARY: The Food and Drug sessions for interaction and discussion Leslie Kux,
Administration (FDA), in collaboration among the speakers and attendees. Associate Commissioner for Policy.
with the University of Maryland Center Agenda: The agenda is available at [FR Doc. 2016–18555 Filed 8–4–16; 8:45 am]
of Excellence in Regulatory Science and http://www.fda.gov/ScienceResearch/ BILLING CODE 4164–01–P
Innovation, is announcing a public SpecialTopics/RegulatoryScience/
workshop titled, ‘‘Pediatric Master ucm507079.htm (FDA has verified the
Protocols’’. The objective of the Web site address, but FDA is not DEPARTMENT OF HEALTH AND
workshop is to discuss regulatory and responsible for subsequent changes to HUMAN SERVICES
scientific concerns related to pediatric the Web site after this document
master protocols and clinical trial Food and Drug Administration
publishes in the Federal Register).
design considerations for these [Docket No. FDA–2016–N–0001]
Registration: There is a registration fee
protocols. In addition, applications of
to attend this public workshop in-
pediatric master protocols to specific National Mammography Quality
person. Seats are limited and
pediatric therapeutic areas will be Assurance Advisory Committee;
registration will be on a first-come, first-
presented. Notice of Meeting
served basis. To register, please
DATES: The public workshop will be complete registration online at http:// AGENCY: Food and Drug Administration,
held on September 23, 2016, from 8:30 www.fda.gov/ScienceResearch/Special HHS.
a.m. to 4:30 p.m. Topics/RegulatoryScience/ ACTION: Notice.
ADDRESSES: The public workshop will ucm507079.htm (FDA has verified the
be held at FDA’s White Oak Campus, Web site address, but FDA is not SUMMARY: The Food and Drug
mstockstill on DSK3G9T082PROD with NOTICES

10903 New Hampshire Ave., Building responsible for subsequent changes to Administration (FDA) announces a
31 Conference Center, the Great Room the Web site after this document forthcoming public advisory committee
(Rm. 1503), Silver Spring, MD 20993– publishes in the Federal Register). meeting of the National Mammography
0002. Entrance for the public meeting There will be no onsite registration. The Quality Assurance Advisory Committee.
participants (non-FDA employees) is costs of registration, to attend in-person, The general function of the committee is
through Building 1 where routine for different categories of attendees are to provide advice and recommendations
security check procedures will be as follows: to the Agency on FDA’s regulatory

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Document Created: 2016-08-05 06:43:35
Document Modified: 2016-08-05 06:43:35

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The meeting will be held Thursday, September 15, 2016, from 8:30 a.m. to 4:30 p.m.
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.
FR Citation		81 FR 51918

81 FR 51918 - National Mammography Quality Assurance Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 151 (August 5, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration