National Mammography Quality Assurance Advisory Committee; Notice of Meeting, 51918-51919 [2016-18592]

Download as PDF 51918 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 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 Janie Kim 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 https://www.fda.gov/Advisory Committees/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. 2016–18560 Filed 8–4–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Pediatric Master Protocols; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop titled, ‘‘Pediatric Master Protocols’’. The objective of the workshop is to discuss regulatory and scientific concerns related to pediatric master protocols and clinical trial design considerations for these protocols. In addition, applications of pediatric master protocols to specific pediatric therapeutic areas will be presented. SUMMARY: The public workshop will be held on September 23, 2016, from 8:30 a.m. to 4:30 p.m. ADDRESSES: The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be mstockstill on DSK3G9T082PROD with NOTICES DATES: VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Audrey Thomas, Office of Regulatory Science and Innovation, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993–0002, 301–796–3520, Audrey.Thomas@fda.hhs.gov. The purpose of this public workshop is to provide an opportunity for relevant stakeholders including: Clinicians and scientists from FDA and other government Agencies, academia, nonprofit organizations, and industry to discuss use of pediatric master protocols for development of medical products for children. Specifically, the workshop will present the current status of pediatric protocol development in the United States, considerations for pediatric protocol development internationally, and development of international consortia in this area. Clinical trial design considerations and the preliminary steps needed for development of pediatric master protocols, including the role of in vitro diagnostic tests, will also be discussed. Finally, examples of pediatric master protocol development for medical products with no, partial, and full extrapolation of data from adults to children will be presented. The workshop will include two panel sessions for interaction and discussion among the speakers and attendees. Agenda: The agenda is available at https://www.fda.gov/ScienceResearch/ SpecialTopics/RegulatoryScience/ ucm507079.htm (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). Registration: There is a registration fee to attend this public workshop inperson. Seats are limited and registration will be on a first-come, firstserved basis. To register, please complete registration online at https:// www.fda.gov/ScienceResearch/Special Topics/RegulatoryScience/ ucm507079.htm (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). There will be no onsite registration. The costs of registration, to attend in-person, for different categories of attendees are as follows: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Category Cost Industry Representative ........ Nonprofit Organization and Academic Other Than University of Maryland ............ University of Maryland, College Park and Baltimore ... Federal Government ............. $50 50 0 0 Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. There is no registration fee for access to the workshop via the Webcast, but registration is still required. Information regarding registration and access to the Webcast link is available at https://www.fda.gov/ ScienceResearch/SpecialTopics/ RegulatoryScience/ucm507079.htm. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Accommodations: Attendees are responsible for their own hotel accommodations. If you need special accommodations while at FDA’s White Oak Campus due to a disability, please contact Shari Solomon at Shari.Solomon@fda.hhs.gov at least 7 days in advance. Dated: August 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–18555 Filed 8–4–16; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: E:\FR\FM\05AUN1.SGM 05AUN1 Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices 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: https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. 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 https:// 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. FOR FURTHER INFORMATION CONTACT: mstockstill on DSK3G9T082PROD with NOTICES 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. VerDate Sep<11>2014 17:42 Aug 04, 2016 Jkt 238001 • 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 https://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 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 51919 meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than September 6, 2016. SUMMARY: Submit your comments, including the ICR title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: The Teaching Health Center Graduate Medical Education (THCGME) Program Eligible Resident/Fellow FTE Chart. OMB No. 0915–0367—Revision. Abstract: The Teaching Health Center Graduate Medical Education (THCGME) Program, section 340H of the Public ADDRESSES: E:\FR\FM\05AUN1.SGM 05AUN1

Agencies

[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.

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

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: https://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 https://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 https://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 https://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

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