National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 8081-8082 [2016-03121]
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Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
status so that this information can be
integrated into appropriate treatment
decisions that can improve patient
outcomes. POC PT/INR testing is
increasingly being viewed as a testing
modality with performance expectations
similar to that of traditional laboratory
testing. From a regulatory standpoint,
POC PT/INR devices have been
reviewed and cleared for prescription
use under appropriate professional
supervision or prescription home use
(patient self-testing), depending on the
claimed intended use. For this
workshop, both settings will be open for
discussion.
II. Topics for Discussion at the Public
Workshop
This public workshop will consist of
presentations covering the topics listed
in this document. Following the
presentations, there will be a moderated
panel discussion where participants
will be asked to provide their
perspectives. The workshop panel
discussion will focus on identifying
potential solutions to address the
scientific and regulatory challenges
associated with POC PT/INR devices. In
advance of the meeting, FDA plans to
post a discussion paper outlining FDA’s
current thinking on the various topics
mentioned in the following list, and
invite comment on this from the
community.
Topics to be discussed at the public
workshop include, but are not limited
to, the following:
• Current regulatory process involved
with the clearance of POC PT/INR
devices.
• Current benefit/risk balance of POC
PT/INR devices.
• Technological differences amongst
marketed POC PT/INR devices,
advantages and limitations of each
technology, and comparability of test
results obtained using different
technologies.
• Challenges associated with
correlating results from whole blood
POC PT/INR devices to conventional
plasma-based laboratory tests.
• Appropriate study design for
validation and usability studies from the
perspectives of the Agency,
manufacturers and end users to help
improve our understanding of the
accuracy, reliability and safety of POC
PT/INR devices.
• Types of quality control and the test
system elements assessed by the
controls.
• Challenges associated with different
sample matrices (venous, fingerstick,
arterial).
Registration: Registration is free and
available on a first-come, first-served
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basis. Persons interested in attending
this public workshop must register
online by 4 p.m., March 10, 2016. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. If time and
space permits, onsite registration on the
day of the public workshop will be
provided beginning at 7 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan, Center for Devices and
Radiological Health, Office of
Communication and Education, 301–
796–5661, email: Susan.Monahan@
fda.hhs.gov no later than March 4, 2016.
To register for the public workshop,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number. Those without
Internet access should contact Susan
Monahan (contact for special
accommodations) to register. Registrants
will receive confirmation after they have
been accepted. You will be notified if
you are on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. The Webcast link will
be available on the workshop Web page
after March 10, 2016. Please visit FDA’s
Medical Devices News & Events—
Workshops & Conferences calendar at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov. A link to the
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transcripts will also be available
approximately 45 days after the public
workshop on the Internet at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list).
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03153 Filed 2–16–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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 material,
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: National Heart, Lung,
and Blood Institute Special Emphasis Panel
Career Development Program in Emergency
Care Research (K12).
Date: March 10, 2016.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington, DC/Rockville
1750 Rockville Pike, Rockville, MD 20852.
Contact Person: Stephanie J. Webb, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel
Pathophysiology and Treatment of Bicuspid
Aortic Valve Disease.
Date: March 11, 2016.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7188, Bethesda, MD 20892–7924, 301–435–
0287, carolko@mail.nih.gov.
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Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: February 10, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–03121 Filed 2–16–16; 8:45 am]
BILLING CODE 4140–01–P
Dated: February 10, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–03124 Filed 2–16–16; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
National Cancer Institute; Notice of
Closed Meetings
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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 material,
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: National Cancer
Institute Special Emphasis Panel; Omnibus
SEP–12.
Date: March 15, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, Downtown,
7335 Wisconsin Avenue, Bethesda, MD
20814.
Contact Person: Timothy C. Meeker, MD,
Ph.D., Scientific Review Officer, Resources
and Training Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W624, Rockville, MD 20850, 240–
276–6464 meekert@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Planning
Grants for Global Research Infrastructure in
Non-Communicable Disease.
Date: April 27–28, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marriott Courtyard Gaithersburg
Washingtonian Center, 204 Boardwalk Place,
Gaithersburg, MD 20878.
Contact Person: Michael B. Small, Ph.D.,
Chief, Program & Review Extramural Staff
Training Office, Division of Extramural
Activities, National Cancer Institute, NIH,
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9609 Medical Center Drive, Room 7W412,
Bethesda, MD 20892–9750, 240–276–6438
smallm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Development of In Vitro
Diagnostics for the Detection of
Diseases or Pathogenic Agents
National Institute of Diabetes
and Digestive and Kidney Diseases,
National Institutes of Health, Public
Health Service, HHS.
ACTION: Notice.
AGENCY:
This notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), at the
National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant to
Altra Tech, Ltd. (‘‘AltraTech’’), a
company incorporated under the laws of
the Ireland, having an office in
Shannon, Ireland, an exclusive patent
commercialization license to practice
the following inventions embodied in
the following patent applications: US
Provisional Patent Application No.60/
846,354, entitled, ‘‘(S,S)-trans-1,2cyclopentane Diamine-modified and
Gamma-lysine-modified Peptide
Nucleic Acids as Probes for Nucleic
Acid Detection: Synthesis and
Applications,’’ filed 22 Sep 2006 [HHS
Ref No. E–308–2006/0–US–01]; US
Provisional Patent Application No. 60/
896,667, entitled, ‘‘Synthesis of Transtert-butyl-2aminocyclopentylcarbamate,’’ filed 23
Mar 2007 [HHS Ref No. E–308–2006/1–
US–01]; International Application PCT/
US2007/020466, entitled, ‘‘Synthesis of
Trans-tert-butyl-2aminocyclopentylcarbamate,’’ filed 21
Sep 2007 [HHS Ref No. E–308–2006/2–
SUMMARY:
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PCT–01]; US Patent Application No. 12/
441,925, filed 21 Sep 2007, [HHS Ref
No. E–308–2006/2–US–02]; US Patent
Application No. 12/409,159, entitled,
‘‘Cross-Coupled Peptide Nucleic Acids
for Detection of Nucleic Acids of
Pathogens,’’ filed 23 Mar 2009 [HHS Ref
No. E–308–2006/3–US–01]; US Patent
No. 9,156,778, entitled, ‘‘Cross-Coupled
Peptide Nucleic Acids for Detection of
Nucleic Acids of Pathogens,’’ issued 13
Oct 2015 [HHS Ref No. E–308–2006/3–
US–02]; US Provisional Patent
Application No. 61/684,354, entitled,
Cyclopentane-peptide Nucleic Acids for
Qualitative and Quantitative Detection
of Nucleic Acids,’’ filed 17 Aug 2012
[HHS Ref No. E–260–2012/0–US–01];
International Application PCT/US2013/
055252, filed 16 Aug 2013 [HHS Ref No.
E–260–2012/0–PCT–02]; European
Patent Application No. 13753962.3,
filed 11 Feb 2015, [HHS Ref No E–260–
2012/0–EP–03]; Korea Patent
Application No. 10–2015–7006286, filed
11 Mar 2015, [HHS Ref No E–260–2012/
0–KR–04]; US Patent Application No.
14/421,732, filed 13 Feb 2015, [HHS Ref
No E–260–2012/0–US–05]; US
Provisional Patent Application No. 61/
333,442, filed 11 May 2010, [HHS Ref
No E–129–2010/0–US–01]; International
Patent Application No. PCT/US2011/
036090, filed 11 May 2011, [HHS Ref
No. E–129–2010/0–PCT–02]; European
Patent Application No. 11721899.0,
filed 11 May 2011, [HHS Ref No. E–129–
2010/0–EP–03]; and US Patent
Application No. 13/697,123, filed 9 Nov
2012, [HHS Ref No. E–129–2010/0–US–
04].
The patent rights in these inventions
have been assigned to the United States
of America. AltraTech is seeking a
worldwide territory for this license. The
field of use may be limited to exclusive
use of the licensed patent rights limited
to the development and sale of transcyclopentane-modified peptide nucleic
acids (PNA) in a diagnostic test system
incorporating AltraTech’s proprietary
sample preparation and AltraTech’s
proprietary semiconductor sensor
technology for the detection of
infectious diseases or pathogenic agents
including viruses and microorganisms.
DATES: Only written comments or
applications for a license (or both)
which are received by the Technology
Advancement Office, NIDDK, on or
before March 3, 2016 will be
considered.
ADDRESSES: Requests for copies of the
patent application, patents, inquiries,
comments, and other materials relating
to the contemplated exclusive license
should be directed to: Patrick McCue,
Ph.D., Senior Licensing and Patenting
E:\FR\FM\17FEN1.SGM
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Agencies
[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8081-8082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03121]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed
Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings 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 material, 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: National Heart, Lung, and Blood Institute
Special Emphasis Panel Career Development Program in Emergency Care
Research (K12).
Date: March 10, 2016.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington, DC/Rockville 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Stephanie J. Webb, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD
20892, 301-435-0291, stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel Pathophysiology and Treatment of Bicuspid
Aortic Valve Disease.
Date: March 11, 2016.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Garden Inn Bethesda, 7301 Waverly Street,
Bethesda, MD 20814.
Contact Person: Chang Sook Kim, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7188, Bethesda, MD
20892-7924, 301-435-0287, carolko@mail.nih.gov.
[[Page 8082]]
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: February 10, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-03121 Filed 2-16-16; 8:45 am]
BILLING CODE 4140-01-P