Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 8722-8723 [2014-03139]

Download as PDF 8722 Federal Register / Vol. 79, No. 30 / Thursday, February 13, 2014 / Notices will be collected during a single site visit to each selected organization to conduct on-site observations and indepth interviews (IDI) with each organization’s key informants, such as Principal Investigators, Program Managers, Program Staff, and Program Partners. IDIs will last 1–2 hours each. Case study findings will help CDC to identify areas in which CDC can build upon existing and emerging efforts to provide support services and educational resources to YBCS, highlight barriers and facilitating factors to implementing interventions targeting YBCS, determine the added value of providing the DP11–1111 cooperative agreement (e.g., funding, technical assistance) to various entities, identify lessons learned that can be applied to future implementation of YBCS interventions, and better understand the sustainability of YBCS interventions following/in the absence of CDC funding. Case study selection is based on a purposeful selection of CDC-funded and non-CDC funded organizations that support YBCS populations through educational or service programs. Potential organizations for this project may be funded through state, local, or Tribal government, or the private sector. Information will be collected approximately two years after initiation of CDC’s cooperative agreement. OMB approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 168. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name Private Sector Organizations ............................ Number of responses per respondent Average burden per response (in hr) 7 7 7 1 1 1 1 2 2 7 35 21 5 1 1 1 1 1 1 1 1 5 5 1 1 2 2 5 25 15 1 1 1 1 1 1 Worksheet for Identifying Site Visit Interviews ..... Worksheet for Scheduling Site Visit Interviews ... IDI Guide for Program Directors/Principal Investigators. IDI Guide for Program Managers ......................... IDI Guide for Program Staff Members ................. IDI Guide for Program Partners ........................... Worksheet for Identifying Site Visit Interviews. .... State, Local, and Tribal Government Organizations. Worksheet for Scheduling Site Visit Interviews ... IDI Guide for Program Directors/Principal Investigators. IDI Guide for Program Managers ......................... IDI Guide for Program Staff Members ................. IDI Guide for Program Partners ........................... Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2014–03176 Filed 2–12–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. emcdonald on DSK67QTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. VerDate Mar<15>2010 18:44 Feb 12, 2014 Jkt 232001 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 March 20, 2014, from 8 a.m. to 5 p.m. Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD 20879. The hotel’s telephone number is 301–948–8900. Contact Person: Avena Russell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993–0002, Avena.Russell@fda.hhs.gov, 301–796– 3805, 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/Advisory Committees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 learn about possible modifications before coming to the meeting. Agenda: On March 20, 2014, the committee will discuss, make recommendations, and vote on information regarding the humanitarian device exemption (HDE) application for the XVIVO Perfusion System (XPSTM) sponsored by XVIVO Perfusion, Inc. The proposed Indication for Use for the XVIVO Perfusion System, as stated in the HDE, is as follows: The XPSTM is intended to be used with STEEN Solution for flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation. 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/ E:\FR\FM\13FEN1.SGM 13FEN1 8723 Federal Register / Vol. 79, No. 30 / Thursday, February 13, 2014 / Notices 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 March 13, 2014. 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 March 5, 2014. 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 March 6, 2014. 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams at Annmarie.Williams@ fda.hhs.gov or 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/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: February 7, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–03139 Filed 2–12–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) National Institutes of Health Proposed Collection; Comment Request; NIH Neurobiobank Tissue Access Request In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, SUMMARY: electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301–443–4335 or Email your request, including your address to: nimhprapubliccomments@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments received within 60 days of the date of this publication will receive fullest consideration. Proposed Collection: National Institute of Health Neurobiobank Tissue Access Request–0925–New. National Institute of Mental Health (NIMH), National Institute of Health (NIH). Need and Use of Information Collection: The NIH Neurobiobank Tissue Access Request form is necessary for ‘‘Recipient’’ Principal Investigators and their organization or corporations with approved assurance from the DHHS Office of Human Research Protections to access tissue or biospecimens from the National Neurobiobank for research purposes. The primary use of this information is to document, track, monitor, and evaluate the appropriate use of the Neurobiobank tissue and biospecimen resources, as well as to notify interested recipients of updates, corrections or other changes to the system. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 63. ESTIMATES ANNUAL BURDEN HOURS Number of respondents emcdonald on DSK67QTVN1PROD with NOTICES Form Neurobiobank Tissue Access Request ............................................................ Pre-Mortem Consent and Medical History ...................................................... Frequency of response 50 50 1 1 Total .......................................................................................................... VerDate Mar<15>2010 18:44 Feb 12, 2014 Jkt 232001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Average time per response (in hours) 15/60 1 Annual hour burden 13 50 63 E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 79, Number 30 (Thursday, February 13, 2014)]
[Notices]
[Pages 8722-8723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03139]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Gastroenterology and Urology 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 (FDA). The meeting will 
be open to the public.
    Name of Committee: Gastroenterology and Urology 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 March 20, 2014, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., 
Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900.
    Contact Person: Avena Russell, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1535, Silver Spring, MD 20993-0002, Avena.Russell@fda.hhs.gov, 
301-796-3805, 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 March 20, 2014, the committee will discuss, make 
recommendations, and vote on information regarding the humanitarian 
device exemption (HDE) application for the XVIVO Perfusion System 
(XPS\TM\) sponsored by XVIVO Perfusion, Inc. The proposed Indication 
for Use for the XVIVO Perfusion System, as stated in the HDE, is as 
follows:
    The XPS\TM\ is intended to be used with STEEN Solution for flushing 
and temporary continuous normothermic machine perfusion of initially 
unacceptable excised donor lungs during which time the function of the 
lungs can be reassessed for transplantation.
    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/

[[Page 8723]]

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 
March 13, 2014. 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 March 5, 2014. 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 March 6, 2014.
    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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams at 
Annmarie.Williams@fda.hhs.gov or 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: February 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-03139 Filed 2-12-14; 8:45 am]
BILLING CODE 4160-01-P

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