Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 11208-11209 [2013-03488]
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11208
Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices
Location: 5630 Fishers Lane, FDA
Conference Room 1066, Rockville, MD
20857. For those unable to attend in
person, the meeting will also be
Webcast. The Web cast will be available
at the following link https://fda.yorkcast.
com/webcast/Viewer/
?peid=63bc1bd2838040b48
eb7db7cbedfc4191d.
Contact Person: Bryan Emery or
Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–1277 or 301–827–1297, 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 14, 2013, the
Committee will meet in open session to
discuss FDA’s draft risk assessment
model for potential exposure to the
variant Creutzfeldt-Jakob disease (vCJD)
agent in Red Blood Cells for transfusion
in the United States.
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 March 7, 2013. On
March 14, 2013, 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
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19:09 Feb 14, 2013
Jkt 229001
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 27, 2013. 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 28, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets. Seating for
this meeting may be limited, so the
public is encouraged to watch the free
Webcast if you are unable to attend. The
link for the Webcast will be available
beginning at 8 a.m. on March 14, 2013
(see Location).
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 Bryan Emery
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 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03577 Filed 2–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–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
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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 March 20, 2013, from 8 a.m. to
6 p.m.
Location: Holiday Inn, Ballroom, Two
Montgomery Village Ave., Gaithersburg,
MD 20879. The hotel’s phone number is
301–948–8900.
Contact Person: Jamie Waterhouse,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 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, 2013, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application for the MitraClip
Delivery System sponsored by Abbott
Vascular. The system consists of three
major components: The delivery
catheter, the steerable sleeve, and the
MitraClip device. The MitraClip device
is a single sized, percutaneously
implanted mechanical clip for the
reduction of mitral regurgitation. The
MitraClip device grasps and coapts the
mitral valve leaflets resulting in fixed
approximation of the mitral leaflets
throughout the cardiac cycle. The
implantable MitraClip device is
fabricated with metal alloys and
polyester fabric (Clip cover) that are
commonly used in cardiovascular
implants. The proposed indication for
use: The MitraClip Delivery System is
indicated for the percutaneous
reduction of significant symptomatic
mitral regurgitation (MR≥3) in patients
who have been determined by a cardiac
surgeon to be too high risk for open
mitral valve surgery and in whom
existing comorbidities would not
E:\FR\FM\15FEN1.SGM
15FEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices
preclude the expected benefit from
correction of the mitral regurgitation.
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 March 13, 2013.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on March 20, 2013.
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 1, 2013. 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 4, 2013.
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 James Clark,
Conference Management Staff, at
James.Clark@fda.hhs.gov or 301–796–
5293, at least 7 days in advance of the
meeting.
VerDate Mar<15>2010
19:09 Feb 14, 2013
Jkt 229001
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 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03488 Filed 2–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment
Request (30-Day FRN):
Drug Accountability Report Form and
Investigator Registration Procedure in
the Conduct of Investigational Trials for
the Treatment of Cancer (NCI)
SUMMARY: In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collected below. This proposed
information collection was previously
published in the Federal Register on
September 20, 2012 (77 FR 58401) and
allowed 60-days for public comment.
No public comments were received. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after March 1, 2011, unless it
displays a valid OMB control number.
Written comments or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response times, should be directed to
the Attention: NIH Desk Officer, Office
of Management and Budget, at
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
11209
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Charles
L. Hall, Jr., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, Division of the
Cancer Treatment and Diagnosis, and
Centers, National Cancer Institute,
Executive Plaza North, Room 7148, 9000
Rockville Pike, Bethesda, MD 20892 or
call non-toll-free number 301–496–5725
or Email your request, including your
address to: Hallch@mail.nih.gov.
Comments regarding this information
collection are best assured of having
their full effect if received within 30
days following the date of this
publication.
Proposed Collection: Drug
Accountability Report Form and
Investigator Registration Procedure in
the Conduct of Investigational Trials for
the Treatment of Cancer (NCI), OMB
No.0925–0613, Expiration Date: 2/28/
2013, Revision, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The U.S. Food and Drug
Administration (FDA) holds the
National Cancer Institute (NCI)
responsible, as a sponsor of
investigational drug trials, for the
collection of information about the
clinical investigators who participate in
these trials and to assure the FDA that
systems for accountability are being
maintained by investigators in its
clinical trials program. The information
collected is used to identify qualified
investigators and to facilitate the
submission and distribution of
important information relative to the
investigational drug and the response of
the patient to that drug. Investigators are
physicians who specialize in the
treatment of patients with cancer. Data
obtained from the Drug Accountability
Record is used to track the dispensing
of investigational anticancer agents from
receipt from the NCI to dispensing or
administration to patients. NCI and/or
its auditors use this information for
compliance purposes.
OMB approval is requested for 3
years. There are no costs to the
respondents other than their time. The
total estimated annualized burden hours
are 14,328.
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11208-11209]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03488]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-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 (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 March 20, 2013, from 8
a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel's phone number is 301-948-8900.
Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 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, 2013, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the MitraClip Delivery System sponsored by
Abbott Vascular. The system consists of three major components: The
delivery catheter, the steerable sleeve, and the MitraClip device. The
MitraClip device is a single sized, percutaneously implanted mechanical
clip for the reduction of mitral regurgitation. The MitraClip device
grasps and coapts the mitral valve leaflets resulting in fixed
approximation of the mitral leaflets throughout the cardiac cycle. The
implantable MitraClip device is fabricated with metal alloys and
polyester fabric (Clip cover) that are commonly used in cardiovascular
implants. The proposed indication for use: The MitraClip Delivery
System is indicated for the percutaneous reduction of significant
symptomatic mitral regurgitation (MR>=3) in patients who have been
determined by a cardiac surgeon to be too high risk for open mitral
valve surgery and in whom existing comorbidities would not
[[Page 11209]]
preclude the expected benefit from correction of the mitral
regurgitation.
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
March 13, 2013. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on March 20, 2013. 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 1, 2013. 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 4, 2013.
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 James Clark,
Conference Management Staff, at James.Clark@fda.hhs.gov or 301-796-
5293, 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 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03488 Filed 2-14-13; 8:45 am]
BILLING CODE 4160-01-P
