Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 22147-22148 [2014-08970]
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Federal Register / Vol. 79, No. 76 / Monday, April 21, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Next-Generation Sequencing
Technology, Data Formats
Standardization and Promotion of
Interoperability Protocols; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ehiers on DSK2VPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), is announcing a public workshop
entitled ‘‘Next-Generation Sequencing
(NGS) Technology, Data Format
Standardization and Promotion of
Interoperability Protocols.’’ The goal of
this public workshop is to facilitate
establishing protocols for ensuring the
safety and quality of next-generation
sequencing (NGS)-related information
without sacrificing scientific merit or
interfering with innovative processes.
The purpose of the workshop is to
engage NGS stakeholders in a forum to
discuss the current use of the
technology and the development of data
standards of NGS-related information.
Date and Time: The public workshop
will be held on September 24 and 25,
2014, from 8:30 a.m. to 4:30 p.m.
Location: The public workshop will
be held at the National Institute of
Health Campus, 9000 Rockville Pike,
Bldg. 35, Rm. 610, Bethesda, MD 20892.
Pre-registered participants will receive
additional information on parking and
public transportation with their email
registration confirmation.
Contact Person: Khaled Bouri, Office
of Regulatory Science and Innovation,
Food and Drug Administration, 10903
New Hampshire Ave., Rm. 4164, Silver
Spring, MD 20903, 301–796–8476,
email: Khaled.Bouri@fda.hhs.gov.
Registration: Please go to https://ngsdata-standardization.eventbrite.com to
register. There is no registration fee for
the public workshop. Early registration
is recommended because seating is
limited. Registration will be confirmed
by email. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 8 a.m.
This workshop will also be accessible
via Webcast by following this link:
https://collaboration.fda.gov/
NGSStandards/.
If you need special accommodations
due to a disability, please contact
Khaled Bouri (see Contact Person) at
least 7 days in advance.
Transcripts and Additional
Information About the Workshop: The
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workshop agenda and additional
background materials will be accessible
at: https://www.fda.gov/
ScienceResearch/SpecialTopics/
RegulatoryScience/ucm227840.htm.
Please be advised that as soon as
possible after the public workshop a
transcript will be available at the same
Web site. Transcripts of the public
workshop may also be requested in
writing from the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Building, Rockville, MD
20857.
Dated: April 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08969 Filed 4–18–14; 8:45 am]
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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 June 17, 2014, from 8 a.m. to 6
p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building. 1.
Contact Person: Abbas Bandukwala,
Center for Devices and Radiological
Health, Food and Drug Administration,
PO 00000
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22147
10903 New Hampshire Ave., Bldg. 66,
Rm. 1535, Silver Spring MD 20993–
0002, 301–796–6386, email:
Abbas.Bandukwala@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
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 June 17, 2014, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
application (PMA) for the Maestro®
Rechargeable System sponsored by
Enteromedics, Inc. The Maestro®
Rechargeable System provides VBLOC
Therapy. The implantable device is a
neuromodulator, which delivers high
frequency (5000 Hertz), controllable
electrical pulses to the intra-abdominal
vagus nerve trunks. The effect of VBLOC
therapy is reported to suppress neural
signals carried by the vagus nerve
trunks, resulting in decreased hunger
pangs, decreased digestive enzyme
secretion and calorie absorption, and
increased satiety. The device consists of
implantable electronic device
components that deliver VBLOC
therapy, and external components that
regulate device performance.
The proposed indication for use for
the Maestro® Rechargeable System, as
stated in the PMA, is as follows:
The Maestro® Rechargeable System is
indicated for use in weight reduction in
adult patients with obesity that have a
Body Mass Index (BMI) of at least 40
kilograms per square meter (kg/m2), or
a BMI of at least 35 kg/m2 with one or
more obesity related comorbid
conditions, and have failed a more
conservative weight reduction
alternative.
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\21APN1.SGM
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ehiers on DSK2VPTVN1PROD with NOTICES
22148
Federal Register / Vol. 79, No. 76 / Monday, April 21, 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 May 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 May 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 May 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 James Clark
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: April 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08970 Filed 4–18–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives; Reopening of
Notification Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA) is reopening the
period for industry organizations
interested in participating in the
selection of nonvoting industry
representatives to represent the interests
of the pharmaceutical manufacturing
industry and the pharmacy
compounding industry on the Pharmacy
Compounding Advisory Committee for
the Center for Drug Evaluation and
Research to notify FDA of such interest.
FDA announced a request for
notification of interest in selection of
industry representatives and for
nominations in the Federal Register on
January 13, 2014. This notice requested
industry organizations that were
interested in participation in the
selection process to notify FDA in
writing by February 12, 2014, and stated
that nominations would be accepted for
the two nonvoting vacancies by the
same date. Industry organizations that
did not notify FDA by the deadline of
their interest in participating in the
selection of nonvoting pharmacy
compounding and pharmaceutical
manufacturing industry representatives
have now expressed interest in
participating. Therefore, FDA is
reopening the notification period for an
additional two weeks so that any
interested industry organizations
wanting to participate can notify the
Agency of their interest.
DATES: Any industry organization
interested in participating in the
selection of appropriate nonvoting
members to represent the interests of the
pharmacy compounding industry and
the pharmaceutical manufacturing
industry on the Pharmacy
Compounding Advisory Committee
should send a letter stating the interest
to FDA by May 5, 2014, for the
vacancies announced in the Federal
Register on January 13, 2014 (79 FR
2177).
SUMMARY:
PO 00000
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All letters of interest should
be submitted electronically to PCAC@
fda.hhs.govmailto:, or in writing by mail
to Jayne E. Peterson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Avenue, Bldg. 31, Rm. 2417,
Silver Spring, MD 20993.
FOR FURTHER INFORMATION CONTACT:
Jayne E. Peterson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993, 301–796–
9001, FAX: 301–847–8533, email:
PCAC@fda.hhs.gov.
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.
ADDRESSES:
Dated: April 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08968 Filed 4–18–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Fogarty International Center; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Fogarty
International Center Advisory Board.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Fogarty International
Center Advisory Board.
Date: May 13, 2014.
Closed: May 13, 2014 8:00 a.m. to 9:45 a.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Notices]
[Pages 22147-22148]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08970]
-----------------------------------------------------------------------
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 June 17, 2014, from 8
a.m. to 6 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building. 1.
Contact Person: Abbas Bandukwala, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1535, Silver Spring MD 20993-0002, 301-796-6386,
email: Abbas.Bandukwala@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 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 June 17, 2014, the committee will discuss, make
recommendations, and vote on information regarding the premarket
application (PMA) for the Maestro[supreg] Rechargeable System sponsored
by Enteromedics, Inc. The Maestro[supreg] Rechargeable System provides
VBLOC Therapy. The implantable device is a neuromodulator, which
delivers high frequency (5000 Hertz), controllable electrical pulses to
the intra-abdominal vagus nerve trunks. The effect of VBLOC therapy is
reported to suppress neural signals carried by the vagus nerve trunks,
resulting in decreased hunger pangs, decreased digestive enzyme
secretion and calorie absorption, and increased satiety. The device
consists of implantable electronic device components that deliver VBLOC
therapy, and external components that regulate device performance.
The proposed indication for use for the Maestro[supreg]
Rechargeable System, as stated in the PMA, is as follows:
The Maestro[supreg] Rechargeable System is indicated for use in
weight reduction in adult patients with obesity that have a Body Mass
Index (BMI) of at least 40 kilograms per square meter (kg/m\2\), or a
BMI of at least 35 kg/m\2\ with one or more obesity related comorbid
conditions, and have failed a more conservative weight reduction
alternative.
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 22148]]
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
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 May 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 May 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 James Clark 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: April 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08970 Filed 4-18-14; 8:45 am]
BILLING CODE 4160-01-P
