80_FR_77594 80 FR 77355 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

80 FR 77355 - 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 80, Issue 239 (December 14, 2015)

Page Range77355-77355
FR Document2015-31372

Federal Register, Volume 80 Issue 239 (Monday, December 14, 2015) 
[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)]
[Notices]
[Page 77355]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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 (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 Thursday, February 18, 
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 telephone 
number is 301-977-8900.
    Contact Person: Dimitrus Culbreath, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1535, Silver Spring, MD, 20993, 
[email protected], 301-796-6872, 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: The Committee will discuss and make recommendations on 
clinical trial, postapproval study design, and physician training 
requirements for leadless cardiac pacemaker device technology. 
Specifically, the Committee will be asked to make recommendations on 
the acceptability of adverse event rates in acute and chronic 
timeframes as well as indications for use for this device type, given 
availability of other technologies with different adverse event 
profiles; required training and acceptability of observed learning 
curves for the new device type and necessary elements for postapproval 
study collection.
    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 
February 11, 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 February 3, 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 February 4, 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: December 8, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-31372 Filed 12-11-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Notices 77355 if OMB receives it within 30 days of down to the appropriate advisory Agency is not responsible for providing publication. Written comments and committee meeting link, or call the access to electrical outlets. recommendations for the proposed advisory committee information line to FDA welcomes the attendance of the information collection should be sent learn about possible modifications public at its advisory committee directly to the following: Office of before coming to the meeting. meetings and will make every effort to Management and Budget, Paperwork Agenda: The Committee will discuss accommodate persons with disabilities. Reduction Project, Email: OIRA_ and make recommendations on clinical If you require accommodations due to a SUBMISSION@OMB.EOP.GOV, Attn: trial, postapproval study design, and disability, please contact Artair Mallett Desk Officer for the Administration for physician training requirements for at 301–796–9638, at least 7 days in Children and Families. leadless cardiac pacemaker device advance of the meeting. technology. Specifically, the Committee FDA is committed to the orderly Robert Sargis, will be asked to make recommendations conduct of its advisory committee Reports Clearance Officer. on the acceptability of adverse event meetings. Please visit our Web site at [FR Doc. 2015–31314 Filed 12–11–15; 8:45 am] rates in acute and chronic timeframes as http://www.fda.gov/Advisory BILLING CODE 4184–01–P well as indications for use for this Committees/AboutAdvisoryCommittees/ device type, given availability of other ucm111462.htm for procedures on technologies with different adverse public conduct during advisory DEPARTMENT OF HEALTH AND event profiles; required training and committee meetings. HUMAN SERVICES acceptability of observed learning Notice of this meeting is given under curves for the new device type and the Federal Advisory Committee Act (5 Food and Drug Administration necessary elements for postapproval U.S.C. app. 2). [Docket No. FDA–2015–N–0001] study collection. Dated: December 8, 2015. FDA intends to make background Circulatory System Devices Panel of material available to the public no later Jill Hartzler Warner, the Medical Devices Advisory than 2 business days before the meeting. Associate Commissioner for Special Medical Committee; Notice of Meeting If FDA is unable to post the background Programs. material on its Web site prior to the [FR Doc. 2015–31372 Filed 12–11–15; 8:45 am] AGENCY: Food and Drug Administration, meeting, the background material will BILLING CODE 4164–01–P HHS. be made publicly available at the ACTION: Notice. location of the advisory committee meeting, and the background material DEPARTMENT OF HEALTH AND This notice announces a forthcoming will be posted on FDA’s Web site after HUMAN SERVICES meeting of a public advisory committee the meeting. Background material is of the Food and Drug Administration available at http://www.fda.gov/ Office of the Secretary (FDA). The meeting will be open to the AdvisoryCommittees/Calendar/ [Document Identifier: HHS–OS–0990–New– public. default.htm. Scroll down to the 30D] Name of Committee: Circulatory appropriate advisory committee meeting System Devices Panel of the Medical link. Agency Information Collection Devices Advisory Committee. Procedure: Interested persons may Activities; Submission to OMB for General Function of the Committee: present data, information, or views, Review and Approval; Public Comment To provide advice and orally or in writing, on issues pending Request recommendations to the Agency on before the committee. Written FDA’s regulatory issues. AGENCY: Office of the Secretary, HHS. submissions may be made to the contact Date and Time: The meeting will be person on or before February 11, 2016. ACTION: Notice. held on Thursday, February 18, 2016, Oral presentations from the public will SUMMARY: In compliance with section from 8 a.m. to 6 p.m. be scheduled between approximately 1 3507(a)(1)(D) of the Paperwork Location: Hilton Washington DC p.m. and 2 p.m. Those individuals Reduction Act of 1995, the Office of the North/Gaithersburg, Salons A, B, C, and interested in making formal oral Secretary (OS), Department of Health D, 620 Perry Pkwy., Gaithersburg, MD presentations should notify the contact and Human Services, has submitted an 20877. The hotel telephone number is person and submit a brief statement of Information Collection Request (ICR), 301–977–8900. the general nature of the evidence or described below, to the Office of Contact Person: Dimitrus Culbreath, arguments they wish to present, the Management and Budget (OMB) for Center for Devices and Radiological names and addresses of proposed review and approval. The ICR is for a Health, Food and Drug Administration, participants, and an indication of the new collection. Comments submitted 10903 New Hampshire Ave., Bldg. 66, approximate time requested to make during the first public review of this ICR Rm. 1535, Silver Spring, MD, 20993, their presentation on or before February will be provided to OMB. OMB will Dimitrus.Culbreath@fda.hhs.gov, 301– 3, 2016. Time allotted for each accept further comments from the 796–6872, or FDA Advisory Committee presentation may be limited. If the public on this ICR during the review Information Line, 1–800–741–8138 number of registrants requesting to and approval period. (301–443–0572 in the Washington, DC speak is greater than can be reasonably area). A notice in the Federal Register DATES: Comments on the ICR must be accommodated during the scheduled received on or before January 13, 2016. mstockstill on DSK4VPTVN1PROD with NOTICES about last minute modifications that open public hearing session, FDA may impact a previously announced conduct a lottery to determine the ADDRESSES: Submit your comments to advisory committee meeting cannot speakers for the scheduled open public OIRA_submission@omb.eop.gov or via always be published quickly enough to hearing session. The contact person will facsimile to (202) 395–5806. provide timely notice. Therefore, you notify interested persons regarding their FOR FURTHER INFORMATION CONTACT: should always check the Agency’s Web request to speak by February 4, 2016. Information Collection Clearance staff, site at http://www.fda.gov/Advisory Persons attending FDA’s advisory Information.CollectionClearance@ Committees/default.htm and scroll committee meetings are advised that the hhs.gov or (202) 690–6162. VerDate Sep<11>2014 17:36 Dec 11, 2015 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\14DEN1.SGM 14DEN1


Document Created: 2015-12-14 13:47:41
Document Modified: 2015-12-14 13:47:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation80 FR 77355 
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