81 FR 8081 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 31 (February 17, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 31 (February 17, 2016)
| Page Range | 8081-8082 | |
| FR Document | 2016-03121 |
[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)] [Notices] [Pages 8081-8082] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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, [email protected]. [[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
![Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 8081
status so that this information can be basis. Persons interested in attending transcripts will also be available
integrated into appropriate treatment this public workshop must register approximately 45 days after the public
decisions that can improve patient online by 4 p.m., March 10, 2016. Early workshop on the Internet at http://
outcomes. POC PT/INR testing is registration is recommended because www.fda.gov/MedicalDevices/
increasingly being viewed as a testing facilities are limited and, therefore, FDA NewsEvents/WorkshopsConferences/
modality with performance expectations may limit the number of participants default.htm. (Select this public
similar to that of traditional laboratory from each organization. If time and workshop from the posted events list).
testing. From a regulatory standpoint, space permits, onsite registration on the Dated: February 9, 2016.
POC PT/INR devices have been day of the public workshop will be
Leslie Kux,
reviewed and cleared for prescription provided beginning at 7 a.m.
If you need special accommodations Associate Commissioner for Policy.
use under appropriate professional
due to a disability, please contact Susan [FR Doc. 2016–03153 Filed 2–16–16; 8:45 am]
supervision or prescription home use
(patient self-testing), depending on the Monahan, Center for Devices and BILLING CODE 4164–01–P
claimed intended use. For this Radiological Health, Office of
workshop, both settings will be open for Communication and Education, 301–
796–5661, email: Susan.Monahan@ DEPARTMENT OF HEALTH AND
discussion.
fda.hhs.gov no later than March 4, 2016. HUMAN SERVICES
II. Topics for Discussion at the Public To register for the public workshop,
Workshop please visit FDA’s Medical Devices National Institutes of Health
This public workshop will consist of News & Events—Workshops &
National Heart, Lung, and Blood
presentations covering the topics listed Conferences calendar at http://
Institute; Notice of Closed Meetings
in this document. Following the www.fda.gov/MedicalDevices/
presentations, there will be a moderated NewsEvents/WorkshopsConferences/ Pursuant to section 10(d) of the
panel discussion where participants default.htm. (Select this public Federal Advisory Committee Act, as
will be asked to provide their workshop from the posted events list.) amended (5 U.S.C. App.), notice is
perspectives. The workshop panel Please provide complete contact hereby given of the following meetings.
discussion will focus on identifying information for each attendee, including The meetings will be closed to the
potential solutions to address the name, title, affiliation, address, email, public in accordance with the
scientific and regulatory challenges and telephone number. Those without provisions set forth in sections
associated with POC PT/INR devices. In Internet access should contact Susan 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
advance of the meeting, FDA plans to Monahan (contact for special as amended. The grant applications and
post a discussion paper outlining FDA’s accommodations) to register. Registrants the discussions could disclose
current thinking on the various topics will receive confirmation after they have confidential trade secrets or commercial
mentioned in the following list, and been accepted. You will be notified if property such as patentable material,
invite comment on this from the you are on a waiting list. and personal information concerning
community. Streaming Webcast of the Public individuals associated with the grant
Topics to be discussed at the public Workshop: This public workshop will applications, the disclosure of which
workshop include, but are not limited also be Webcast. The Webcast link will would constitute a clearly unwarranted
to, the following: be available on the workshop Web page invasion of personal privacy.
• Current regulatory process involved after March 10, 2016. Please visit FDA’s
Medical Devices News & Events— Name of Committee: National Heart, Lung,
with the clearance of POC PT/INR and Blood Institute Special Emphasis Panel
devices. Workshops & Conferences calendar at
Career Development Program in Emergency
• Current benefit/risk balance of POC http://www.fda.gov/MedicalDevices/ Care Research (K12).
PT/INR devices. NewsEvents/WorkshopsConferences/ Date: March 10, 2016.
• Technological differences amongst default.htm. (Select this public Time: 9:00 a.m. to 5:00 p.m.
marketed POC PT/INR devices, workshop from the posted events list.) Agenda: To review and evaluate grant
advantages and limitations of each If you have never attended a Connect applications.
technology, and comparability of test Pro event before, test your connection at Place: Hilton Washington, DC/Rockville
results obtained using different https://collaboration.fda.gov/common/ 1750 Rockville Pike, Rockville, MD 20852.
help/en/support/meeting_test.htm. To Contact Person: Stephanie J. Webb, Ph.D.,
technologies.
Scientific Review Officer, Office of Scientific
• Challenges associated with get a quick overview of the Connect Pro
Review/DERA National Heart, Lung, and
correlating results from whole blood program, visit http://www.adobe.com/
Blood Institute, 6701 Rockledge Drive, Room
POC PT/INR devices to conventional go/connectpro_overview. FDA has 7196, Bethesda, MD 20892, 301–435–0291,
plasma-based laboratory tests. verified the Web site addresses, as of the stephanie.webb@nih.gov.
• Appropriate study design for date this document publishes in the Name of Committee: National Heart, Lung,
validation and usability studies from the Federal Register, but Web sites are and Blood Institute Special Emphasis Panel
perspectives of the Agency, subject to change over time. Pathophysiology and Treatment of Bicuspid
manufacturers and end users to help Transcripts: Please be advised that as Aortic Valve Disease.
improve our understanding of the soon as a transcript is available, it will Date: March 11, 2016.
accuracy, reliability and safety of POC be accessible at http:// Time: 9:00 a.m. to 1:00 p.m.
www.regulations.gov. It may be viewed Agenda: To review and evaluate grant
asabaliauskas on DSK5VPTVN1PROD with NOTICES
PT/INR devices.
• Types of quality control and the test at the Division of Dockets Management applications.
(see ADDRESSES). A transcript will also Place: Hilton Garden Inn Bethesda, 7301
system elements assessed by the
be available in either hardcopy or on Waverly Street, Bethesda, MD 20814.
controls. Contact Person: Chang Sook Kim, Ph.D.,
• Challenges associated with different CD–ROM, after submission of a Scientific Review Officer, Office of Scientific
sample matrices (venous, fingerstick, Freedom of Information request. The Review/DERA National Heart, Lung, and
arterial). Freedom of Information office address is Blood Institute, 6701 Rockledge Drive, Room
Registration: Registration is free and available on the Agency’s Web site at 7188, Bethesda, MD 20892–7924, 301–435–
available on a first-come, first-served http://www.fda.gov. A link to the 0287, carolko@mail.nih.gov.
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![8082 Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices
(Catalogue of Federal Domestic Assistance 9609 Medical Center Drive, Room 7W412, PCT–01]; US Patent Application No. 12/
Program Nos. 93.233, National Center for Bethesda, MD 20892–9750, 240–276–6438 441,925, filed 21 Sep 2007, [HHS Ref
Sleep Disorders Research; 93.837, Heart and smallm@mail.nih.gov. No. E–308–2006/2–US–02]; US Patent
Vascular Diseases Research; 93.838, Lung (Catalogue of Federal Domestic Assistance Application No. 12/409,159, entitled,
Diseases Research; 93.839, Blood Diseases Program Nos. 93.392, Cancer Construction;
and Resources Research, National Institutes
‘‘Cross-Coupled Peptide Nucleic Acids
93.393, Cancer Cause and Prevention for Detection of Nucleic Acids of
of Health, HHS) Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Pathogens,’’ filed 23 Mar 2009 [HHS Ref
Dated: February 10, 2016. No. E–308–2006/3–US–01]; US Patent
Treatment Research; 93.396, Cancer Biology
Michelle Trout, No. 9,156,778, entitled, ‘‘Cross-Coupled
Research; 93.397, Cancer Centers Support;
Program Analyst, Office of Federal Advisory 93.398, Cancer Research Manpower; 93.399, Peptide Nucleic Acids for Detection of
Committee Policy. Cancer Control, National Institutes of Health, Nucleic Acids of Pathogens,’’ issued 13
[FR Doc. 2016–03121 Filed 2–16–16; 8:45 am] HHS) Oct 2015 [HHS Ref No. E–308–2006/3–
BILLING CODE 4140–01–P Dated: February 10, 2016. US–02]; US Provisional Patent
Melanie J. Gray,
Application No. 61/684,354, entitled,
Cyclopentane-peptide Nucleic Acids for
DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory
Committee Policy.
Qualitative and Quantitative Detection
HUMAN SERVICES of Nucleic Acids,’’ filed 17 Aug 2012
[FR Doc. 2016–03124 Filed 2–16–16; 8:45 am]
[HHS Ref No. E–260–2012/0–US–01];
National Institutes of Health BILLING CODE 4140–01–P
International Application PCT/US2013/
055252, filed 16 Aug 2013 [HHS Ref No.
National Cancer Institute; Notice of
E–260–2012/0–PCT–02]; European
Closed Meetings DEPARTMENT OF HEALTH AND
Patent Application No. 13753962.3,
HUMAN SERVICES
Pursuant to section 10(d) of the filed 11 Feb 2015, [HHS Ref No E–260–
Federal Advisory Committee Act, as National Institutes of Health 2012/0–EP–03]; Korea Patent
amended (5 U.S.C. App.), notice is Application No. 10–2015–7006286, filed
hereby given of the following meetings. Prospective Grant of Exclusive 11 Mar 2015, [HHS Ref No E–260–2012/
The meetings will be closed to the License: Development of In Vitro 0–KR–04]; US Patent Application No.
public in accordance with the Diagnostics for the Detection of 14/421,732, filed 13 Feb 2015, [HHS Ref
provisions set forth in sections Diseases or Pathogenic Agents No E–260–2012/0–US–05]; US
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Provisional Patent Application No. 61/
as amended. The grant applications and AGENCY: National Institute of Diabetes 333,442, filed 11 May 2010, [HHS Ref
the discussions could disclose and Digestive and Kidney Diseases, No E–129–2010/0–US–01]; International
confidential trade secrets or commercial National Institutes of Health, Public Patent Application No. PCT/US2011/
property such as patentable material, Health Service, HHS. 036090, filed 11 May 2011, [HHS Ref
and personal information concerning ACTION: Notice. No. E–129–2010/0–PCT–02]; European
individuals associated with the grant SUMMARY: This notice, in accordance Patent Application No. 11721899.0,
applications, the disclosure of which with 35 U.S.C. 209(c)(1) and 37 CFR filed 11 May 2011, [HHS Ref No. E–129–
would constitute a clearly unwarranted part 404.7(a)(1)(i), that the National 2010/0–EP–03]; and US Patent
invasion of personal privacy. Institute of Diabetes and Digestive and Application No. 13/697,123, filed 9 Nov
Name of Committee: National Cancer Kidney Diseases (NIDDK), at the 2012, [HHS Ref No. E–129–2010/0–US–
Institute Special Emphasis Panel; Omnibus National Institutes of Health, 04].
SEP–12. Department of Health and Human The patent rights in these inventions
Date: March 15, 2016. Services, is contemplating the grant to have been assigned to the United States
Time: 8:00 a.m. to 5:00 p.m.
Altra Tech, Ltd. (‘‘AltraTech’’), a of America. AltraTech is seeking a
Agenda: To review and evaluate grant worldwide territory for this license. The
applications. company incorporated under the laws of
the Ireland, having an office in field of use may be limited to exclusive
Place: Residence Inn Bethesda, Downtown, use of the licensed patent rights limited
7335 Wisconsin Avenue, Bethesda, MD Shannon, Ireland, an exclusive patent
20814. commercialization license to practice to the development and sale of trans-
Contact Person: Timothy C. Meeker, MD, the following inventions embodied in cyclopentane-modified peptide nucleic
Ph.D., Scientific Review Officer, Resources the following patent applications: US acids (PNA) in a diagnostic test system
and Training Review Branch, Division of Provisional Patent Application No.60/ incorporating AltraTech’s proprietary
Extramural Activities, National Cancer 846,354, entitled, ‘‘(S,S)-trans-1,2- sample preparation and AltraTech’s
Institute, NIH, 9609 Medical Center Drive,
cyclopentane Diamine-modified and proprietary semiconductor sensor
Room 7W624, Rockville, MD 20850, 240– technology for the detection of
276–6464 meekert@mail.nih.gov. Gamma-lysine-modified Peptide
Nucleic Acids as Probes for Nucleic infectious diseases or pathogenic agents
Name of Committee: National Cancer including viruses and microorganisms.
Institute Special Emphasis Panel; Planning Acid Detection: Synthesis and
Applications,’’ filed 22 Sep 2006 [HHS DATES: Only written comments or
Grants for Global Research Infrastructure in
Non-Communicable Disease. Ref No. E–308–2006/0–US–01]; US applications for a license (or both)
Date: April 27–28, 2016. Provisional Patent Application No. 60/ which are received by the Technology
Time: 8:00 a.m. to 5:00 p.m. 896,667, entitled, ‘‘Synthesis of Trans- Advancement Office, NIDDK, on or
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Agenda: To review and evaluate grant tert-butyl-2- before March 3, 2016 will be
applications. aminocyclopentylcarbamate,’’ filed 23 considered.
Place: Marriott Courtyard Gaithersburg Mar 2007 [HHS Ref No. E–308–2006/1– ADDRESSES: Requests for copies of the
Washingtonian Center, 204 Boardwalk Place,
Gaithersburg, MD 20878.
US–01]; International Application PCT/ patent application, patents, inquiries,
Contact Person: Michael B. Small, Ph.D., US2007/020466, entitled, ‘‘Synthesis of comments, and other materials relating
Chief, Program & Review Extramural Staff Trans-tert-butyl-2- to the contemplated exclusive license
Training Office, Division of Extramural aminocyclopentylcarbamate,’’ filed 21 should be directed to: Patrick McCue,
Activities, National Cancer Institute, NIH, Sep 2007 [HHS Ref No. E–308–2006/2– Ph.D., Senior Licensing and Patenting
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Document Created: 2016-02-17 01:17:08
Document Modified: 2016-02-17 01:17:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | March 10, 2016. | |
| FR Citation | 81 FR 8081 |
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