Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 2870-2871 [2016-00824]
Download as PDF
<![CDATA[
2870
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Request for Nominations on the
Technical Electronic Product Radiation
Safety Standards Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting any
industry organizations interested in
participating in the selection of voting
industry representatives to serve on the
Technical Electronic Product Radiation
Safety Standards Committee for the
Center for Devices and Radiological
Health to notify FDA in writing. FDA is
also requesting nominations for voting
industry representatives to serve on the
Technical Electronic Product Radiation
Safety Standards Committee. A nominee
may either be self-nominated or
nominated by an organization to serve
as a voting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
SUMMARY:
Any industry organization
interested in participating in the
selection of an appropriate voting
member to represent industry interests
must send a letter stating that interest to
FDA by February 18, 2016, (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by February 18,
2016.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of voting industry representative
nomination should be sent to Margaret
Ames (see FOR FURTHER INFORMATION
CONTACT). All nominations for voting
industry representatives may be
submitted electronically by accessing
the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:50 Jan 15, 2016
Jkt 238001
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5234, Silver Spring,
MD 20993, 301–796–5960, FAX: 301–
847–8505, margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency requests nominations for voting
industry representatives to the following
advisory committee:
I. Technical Electronic Product
Radiation Safety Standards Committee
This Committee provides advice and
consultation to the Commissioner of
Food and Drugs on the technical
feasibility, reasonableness, and
practicability of performance standards
for electronic products, to control the
emission of radiation from such
products, and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate voting member to represent
industry interests should send a letter
stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT)
within 30 days of publication of this
document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations,
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
voting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the voting
member to represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a voting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
the selection process for the committee.
Persons who nominate themselves as
voting industry representatives will not
participate in the selection process.
FDA seeks to include the views of
women, men, members of all racial and
ethnic groups, and individuals with and
without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–00825 Filed 1–15–16; 8:45 am]
BILLING CODE 4164–01–P
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.
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 15 and 16, 2016, from 8
a.m. to 6 p.m.
Location: Holiday Inn Gaithersburg,
Ballroom, Two Montgomery Village
Ave., Gaithersburg, MD 20879. The
hotel telephone number is 301–948–
8900.
Contact Person: Dimitrus Culbreath,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 3610, Silver Spring, MD 20993–
0002, 301–796–6872,
Dimitrus.Culbreath@fda.hhs.gov, 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
E:\FR\FM\19JAN1.SGM
19JAN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
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 15, 2016, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application for the Absorb GT1
Bioresorbable Vascular Scaffold (BVS)
System sponsored by Abbott Vascular.
The Absorb GT1 BVS System is a
temporary scaffold that will fully resorb
over time and is indicated for improving
coronary luminal diameter in patients
with ischemic heart disease due to de
novo native coronary artery lesions
(length ≤ 24 millimeters (mm)) with a
reference vessel diameter of ≥ 2.5 mm
and ≤ 3.75 mm.
On March 16, 2016, the committee
will discuss, make recommendations,
and vote on information related to the
premarket approval application for the
AngelMed Guardian System sponsored
by Angel Medical Systems, Inc. The
AngelMed Guardian System is an
implantable cardiac monitor intended to
alert patients to ST segment shifts
indicating coronary ischemia. The
AngelMed Guardian System is intended
for use in patients with prior acute
coronary syndrome events, and at risk
for recurrent events, to ST segment
changes indicating cardiac ischemia.
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 1, 2016. Oral
presentations from the public will be
scheduled on March 15 and 16, 2016,
between approximately 1 p.m. and 2
p.m. Those individuals interested in
VerDate Sep<11>2014
17:50 Jan 15, 2016
Jkt 238001
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 22, 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 24, 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 artair.mallett@fda.hhs.gov, 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
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: January 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–00824 Filed 1–15–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0073]
Request for Information on
Psychosocial Predictors of Uptake of
Tobacco and Other Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for information.
The Food and Drug
Administration (FDA), Center for
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
2871
Tobacco Products (CTP), is opening a
docket to obtain data and information
related to psychosocial predictors of
uptake and continued use of tobacco
products, including specific categories
of tobacco products and specific
individual tobacco products, as well as
other products from which predictors
may be adapted for or extrapolated to
tobacco products. FDA is seeking data
and information in the form of reports
and manuscripts that are unpublished
or not available through indexed
bibliographic databases. The purpose of
this request for information (RFI) is to
gather additional information that could
help identify and evaluate predictors of
consumer initiation, uptake, and use of
tobacco products. FDA has already
searched the publicly available
scientific literature and is now seeking
to supplement that with information
that is not included in the published
scientific literature.
DATES: Submit either electronic or
written comments or information by
March 4, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2870-2871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00824]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 15 and 16, 2016,
from 8 a.m. to 6 p.m.
Location: Holiday Inn Gaithersburg, Ballroom, Two Montgomery
Village Ave., Gaithersburg, MD 20879. The hotel telephone number is
301-948-8900.
Contact Person: Dimitrus Culbreath, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 3610, Silver Spring, MD 20993-0002, 301-796-6872,
Dimitrus.Culbreath@fda.hhs.gov, 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
[[Page 2871]]
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 15, 2016, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the Absorb GT1 Bioresorbable Vascular Scaffold
(BVS) System sponsored by Abbott Vascular. The Absorb GT1 BVS System is
a temporary scaffold that will fully resorb over time and is indicated
for improving coronary luminal diameter in patients with ischemic heart
disease due to de novo native coronary artery lesions (length <= 24
millimeters (mm)) with a reference vessel diameter of >= 2.5 mm and <=
3.75 mm.
On March 16, 2016, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the AngelMed Guardian System sponsored by
Angel Medical Systems, Inc. The AngelMed Guardian System is an
implantable cardiac monitor intended to alert patients to ST segment
shifts indicating coronary ischemia. The AngelMed Guardian System is
intended for use in patients with prior acute coronary syndrome events,
and at risk for recurrent events, to ST segment changes indicating
cardiac ischemia.
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 1, 2016. Oral presentations from the public will be scheduled on
March 15 and 16, 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
February 22, 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 24,
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 artair.mallett@fda.hhs.gov, 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 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: January 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-00824 Filed 1-15-16; 8:45 am]
BILLING CODE 4164-01-P
