Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 21882-21883 [2016-08530]

Download as PDF 21882 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Notices OMB No.: 0970–0430. Description: Thee Child Care and Development Fund (CCDF) Tribal Annual Report (ACF–700) requests annual Tribal aggregate information on services provided through the CCDF, which is required by CCDF regulations (45 CFR parts 98 and 99). Tribal Lead Agencies (TLAs) are required to submit annual aggregate data appropriate to Tribal programs on children and families receiving CCDF-funded child care services. The revised ACF–700 report consists of two parts: (1) Administrative Data, and (2) Tribal Narrative. The content and format of the narrative section have been revised to make the form easier to complete, with new check box formatting. These proposed revisions will allow the Office of Child Care (OCC) to more easily generate and quantify data in the report. These changes will help us better understand Tribal activities as they relate to compliance, quality of child care, use of funds, and technical assistance needs. Information from the ACF–700 will be included in the Secretary’s Report to Congress, as appropriate, and will be shared with all TLAs to inform them of CCDF-funded activities in other Tribal programs. Respondents: Tribal Governments. ANNUAL BURDEN ESTIMATES Number of respondents Instrument asabaliauskas on DSK3SPTVN1PROD with NOTICES ACF–700 Report .............................................................................................. Estimated Total Annual Burden Hours: 9,880. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: infocollection@ acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016–08481 Filed 4–12–16; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 17:41 Apr 12, 2016 Jkt 238001 260 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA Number: 93.569] Announcing the Award of a Single Source Expansion Supplement to Community Action Partnership in Washington, DC Office of Community Services, ACF, HHS. ACTION: Notice of award of a singlesource expansion supplement to Community Action Partnership in Washington, DC, to create a new learning cluster focused on child poverty in rural communities and expanding access to multi-generational programs. AGENCY: The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of State Assistance announces a singlesource program expansion supplement in the amount of $50,000 to Community Action Partnership in Washington, DC 20036. The supplement will support the creation of a new learning cluster focused on addressing child poverty in rural communities and tribal lands and increasing access to multi-generational programs. This effort supports a recent Administration initiative, Rural Impact. Rural Impact is a new effort, overseen by the White House Rural Council, to bring together federal agencies and public and private partners to support a multi-generational approach to investing in rural families, communities, and tribal places. DATES: The period of support is May 15, 2015–September 29, 2015. FOR FURTHER INFORMATION CONTACT: Seth Hassett, Division Director, Office of SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden hours per response 1 Total burden hours 38 9,880 Community Services, 330 C Street SW., Washington, DC 20201. Telephone: 202–401–2333; Email: seth.hassett@ acf.hhs.gov The White House Rural Council recently launched Rural Impact, a new effort to bring together federal agencies and public and private partners to support a multigenerational approach to investing in rural families and communities. HHS is a member of the federal interagency team that supports this effort. Within HHS, the Administration for Children and Families, including the Office of Community Services, has a significant reach into rural America funding a wide range of services and projects that help rural families and communities. SUPPLEMENTARY INFORMATION: Statutory Authority: This program is authorized by Sections 674(b)(2)(A) and 678A of the CSBG Act, as amended (42 U.S.C. 9903(b)(2)(A) and 9913). Christopher Beach, Senior Grants Policy Specialist, Office of Administration. [FR Doc. 2016–08506 Filed 4–12–16; 8:45 am] BILLING CODE 4184–27–P 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. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration E:\FR\FM\13APN1.SGM 13APN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Notices (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, Evella.Washington@fda.hhs.gov, 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 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. 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 https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the VerDate Sep<11>2014 17:41 Apr 12, 2016 Jkt 238001 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, AnnMarie.Williams@ fda.hhs.gov, 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 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: 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 21883 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Meeting of the Presidential Commission for the Study of Bioethical Issues Office of the Secretary, Office of the Assistant Secretary for Health, Presidential Commission for the Study of Bioethical Issues, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty fifth meeting on May 3, 2016. At this meeting, the Commission will reflect on the past, present, and future impact of national bioethics advisory bodies. Topics will include the history of national bioethics advisory bodies and their contributions to health policy, perspectives about similar bodies elsewhere, and discussion about what the future holds for groups like the Commission. SUMMARY: The meeting will take place May 3, 2016, from 9 a.m. to approximately 5 p.m. ADDRESSES: Grand Hyatt Washington Hotel, 1000 H St. NW., Washington, DC 20001 FOR FURTHER INFORMATION CONTACT: Lisa M. Lee, Executive Director, Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue NW., Suite C–100, Washington, DC 20005. Telephone: 202–233–3960. Email: Lisa.Lee@bioethics.gov. Additional information may be obtained at www.bioethics.gov. DATES: Pursuant to the Federal Advisory Committee Act of 1972, Public Law 92–463, 5 U.S.C. app. 2, notice is hereby given of the twenty fifth meeting of the Commission. The meeting will be open to the public with attendance limited to space available. The meeting will also be webcast at www.bioethics.gov. Under authority of Executive Order 13521, dated November 24, 2009, the President established the Commission. The Commission is an expert panel of not more than 13 members who are drawn from the fields of bioethics, science, medicine, technology, engineering, law, philosophy, theology, or other areas of the humanities or social sciences. The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, SUPPLEMENTARY INFORMATION: E:\FR\FM\13APN1.SGM 13APN1

Agencies

[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Notices]
[Pages 21882-21883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

    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, 
Evella.Washington@fda.hhs.gov, 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 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.
    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 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 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, AnnMarie.Williams@fda.hhs.gov, 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 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: 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

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