Next-Generation Sequencing Technology, Data Formats Standardization and Promotion of Interoperability Protocols; Public Workshop, 22147 [2014-08969]
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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
VerDate Mar<15>2010
15:19 Apr 18, 2014
Jkt 232001
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]
BILLING CODE 4160–01–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.
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
Frm 00068
Fmt 4703
Sfmt 4703
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
21APN1
]]>Agencies
[Federal Register Volume 79, Number 76 (Monday, April 21, 2014)]
[Notices]
[Page 22147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08969]
[[Page 22147]]
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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.
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://ngs-data-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
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]
BILLING CODE 4160-01-P
