81 FR 21882 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 71 (April 13, 2016)

Page Range		21882-21883
FR Document		2016-08530

Federal Register, Volume 81 Issue 71 (Wednesday, April 13, 2016)

[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Notices]
[Pages 21882-21883]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration

[[Page 21883]]

(FDA). The meeting will be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical 
Devices 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 May 24, 2016, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's phone 
number is 301-977-8900.
    Contact Person: Evella Washington, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, 
[email protected], 301-796-6683, 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.
    Agenda: On May 24, 2016, the committee will discuss, make 
recommendations and vote on information related to the premarket 
approval application regarding St. Jude Medical's AMPLATZER Patent 
Foramen Ovale (PFO) Occluder. The AMPLATZER PFO Occluder is a 
percutaneously delivered permanent cardiac implant for PFO closure. The 
device is indicated for preventing recurrent ischemic stroke in 
patients who have had a cryptogenic stroke due to a presumed 
paradoxical embolism.
    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 May 
10, 2016. Oral presentations from the public will be scheduled on May 
24, 2016 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 April 28, 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 May 2, 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 AnnMarie Williams, [email protected], 301-796-5966, 
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: April 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-08530 Filed 4-12-16; 8:45 am]
 BILLING CODE 4164-01-P

21882 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Notices

OMB No.: 0970–0430. families receiving CCDF-funded child These changes will help us better
Description: Thee Child Care and care services. The revised ACF–700 understand Tribal activities as they
Development Fund (CCDF) Tribal report consists of two parts: (1) relate to compliance, quality of child
Annual Report (ACF–700) requests Administrative Data, and (2) Tribal care, use of funds, and technical
annual Tribal aggregate information on Narrative. The content and format of the assistance needs. Information from the
services provided through the CCDF, narrative section have been revised to ACF–700 will be included in the
which is required by CCDF regulations make the form easier to complete, with Secretary’s Report to Congress, as
(45 CFR parts 98 and 99). Tribal Lead new check box formatting. These appropriate, and will be shared with all
Agencies (TLAs) are required to submit proposed revisions will allow the Office TLAs to inform them of CCDF-funded
annual aggregate data appropriate to of Child Care (OCC) to more easily activities in other Tribal programs.
Tribal programs on children and generate and quantify data in the report. Respondents: Tribal Governments.

ANNUAL BURDEN ESTIMATES
Number of Average bur-
Number of Total burden
Instrument responses per den hours
respondents hours
respondent per response

ACF–700 Report .............................................................................................. 260 1 38 9,880

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Community Services, 330 C Street SW.,
Hours: 9,880. HUMAN SERVICES Washington, DC 20201. Telephone:
In compliance with the requirements 202–401–2333; Email: seth.hassett@
Administration for Children and acf.hhs.gov
of Section 506(c)(2)(A) of the Paperwork
Families
Reduction Act of 1995, the SUPPLEMENTARY INFORMATION: The White
Administration for Children and [CFDA Number: 93.569] House Rural Council recently launched
Families is soliciting public comment Rural Impact, a new effort to bring
on the specific aspects of the Announcing the Award of a Single together federal agencies and public and
Source Expansion Supplement to private partners to support a multi-
information collection described above.
Community Action Partnership in generational approach to investing in
Copies of the proposed collection of
Washington, DC rural families and communities. HHS is
information can be obtained and
comments may be forwarded by writing AGENCY: Office of Community Services, a member of the federal interagency
to the Administration for Children and ACF, HHS. team that supports this effort. Within
Families, Office of Planning, Research HHS, the Administration for Children
ACTION: Notice of award of a single-
and Evaluation, 370 L’Enfant and Families, including the Office of
source expansion supplement to
Community Services, has a significant
Promenade SW., Washington, DC 20447, Community Action Partnership in
reach into rural America funding a wide
Attn: ACF Reports Clearance Officer. Washington, DC, to create a new
range of services and projects that help
Email address: infocollection@ learning cluster focused on child
rural families and communities.
acf.hhs.gov. All requests should be poverty in rural communities and
identified by the title of the information expanding access to multi-generational Statutory Authority: This program is
programs. authorized by Sections 674(b)(2)(A) and
collection. 678A of the CSBG Act, as amended (42
The Department specifically requests SUMMARY: The Administration for U.S.C. 9903(b)(2)(A) and 9913).
comments on: (a) Whether the proposed Children and Families (ACF), Office of Christopher Beach,
collection of information is necessary Community Services (OCS), Division of
Senior Grants Policy Specialist, Office of
for the proper performance of the State Assistance announces a single- Administration.
functions of the agency, including source program expansion supplement
[FR Doc. 2016–08506 Filed 4–12–16; 8:45 am]
whether the information shall have in the amount of $50,000 to Community
BILLING CODE 4184–27–P
practical utility; (b) the accuracy of the Action Partnership in Washington, DC
agency’s estimate of the burden of the 20036. The supplement will support the
proposed collection of information; (c) creation of a new learning cluster DEPARTMENT OF HEALTH AND
the quality, utility, and clarity of the focused on addressing child poverty in HUMAN SERVICES
information to be collected; and (d) rural communities and tribal lands and
ways to minimize the burden of the increasing access to multi-generational Food and Drug Administration
collection of information on programs. This effort supports a recent
respondents, including through the use Administration initiative, Rural Impact. [Docket No. FDA–2016–N–0001]
of automated collection techniques or Rural Impact is a new effort, overseen
by the White House Rural Council, to Circulatory System Devices Panel of
other forms of information technology. the Medical Devices Advisory
bring together federal agencies and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Consideration will be given to Committee; Notice of Meeting
public and private partners to support a
comments and suggestions submitted
multi-generational approach to AGENCY: Food and Drug Administration,
within 60 days of this publication. investing in rural families, HHS.
Robert Sargis, communities, and tribal places.
ACTION: Notice.
Reports Clearance Officer. DATES: The period of support is May 15,
[FR Doc. 2016–08481 Filed 4–12–16; 8:45 am] 2015–September 29, 2015. This notice announces a forthcoming
BILLING CODE 4184–01–P FOR FURTHER INFORMATION CONTACT: Seth meeting of a public advisory committee
Hassett, Division Director, Office of of the Food and Drug Administration

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Document Created: 2016-04-13 03:11:21
Document Modified: 2016-04-13 03:11:21

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.
FR Citation		81 FR 21882

81 FR 21882 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 71 (April 13, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration