Center For Scientific Review; Notice of Closed Meetings, 78372 [2013-30747]
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78372
Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices
contact John D. Hewes, Ph.D. at hewesj@
mail.nih.gov.
Software for Evaluating Drug Induced
Hepatotoxicity
Description of Technology: This
invention pertains to a software tool for
assisting differential medical diagnosis
of drug-induced liver injury
(hepatotoxicity) using clinical trial data.
The software is capable of identifying a
small subset of patients at risk for
hepatotoxicity out of a pool of
thousands of clinical trial participants.
This software tool is the only one of its
kind developed using SAS/IntrNet®.
Potential Commercial Applications:
• Hepatotoxicity detection
• Drug interactions
Competitive Advantages:
• Personalized predictions
• SAS/IntrNet® compatible
Development Stage: Prototype
Inventor: Ted J. Guo (FDA)
Publications:
1. Guo T, et al. A Tool to Help You
Decide [detect potentially serious liver
injury]. Silver Spring, Maryland:
Presentation at the Annual Conference
of the American Association for the
Study of Liver Diseases, 2008.
2. Guo T, et al. How a SAS/IntrNet
tool was created at the FDA for the
detection of potential drug-induced
liver injury using data with CDISC
standard. San Diego, California:
Proceedings of the Western Users of
SAS Software Annual Conference, 2009.
3. Watkins PB, et al. Evaluation of
drug-induced serious hepatotoxicity
(eDISH): application of this data
organization approach to phase III
clinical trials of rivaroxaban after total
hip or knee replacement surgery. Drug
Saf. 2011 Mar 1;34(3):243–52. [PMID
21332248]
Intellectual Property: HHS Reference
No. E–103–2012/0—Software Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Michael
Shmilovich; 301–435–5019; shmilovm@
mail.nih.gov.
emcdonald on DSK67QTVN1PROD with NOTICES
Hexanucleotide Repeat in the C9orf72
Gene for the Diagnosis and Treatment
of Amyotrophic Lateral Sclerosis and
Frontotemporal Dementia
Description of Technology: This
invention relates to the discovery of a
pathogenic GGCCCC hexanucleotide
repeat expansion in the first intron of
the C9orf72 gene on chromosome 9p21
in patients exhibiting amyotrophic
lateral sclerosis (ALS) and/or
frontotemporal dementia (FTD). The
VerDate Mar<15>2010
18:06 Dec 24, 2013
Jkt 232001
inventors have previously identified a
strong association signal in this genomic
region and used this information to
identify the underlying pathogenic
mutation. The pathogenic repeat
expansion accounts for up to 50% of
familial ALS and familial FTD cases and
up to 10% of sporadic ALS and sporadic
FTD cases in European ancestry
populations. The inventors represent
that this finding will be the basis of
diagnostic screening for ALS and/or
FTD patients, as well as an important
target in the development of
therapeutics for ALS and/or FTD.
Potential Commercial Applications:
Diagnosis and treatment of ALS and/or
FTD.
Competitive Advantages: Improved
diagnosis and treatment of ALS and/or
FTD.
Development Stage: In vitro data
available
Inventors: Stuart Pickering-Brown
(The University of Manchester), Bryan
Traynor (NIA), Andrew Singleton (NIA),
Huw Morris (Cardiff University), Peter
Heutink (Vu University Medical Center
Amsterdam), John Hardy (University
College London), Pentti Tienari
(University of Helsinki)
Intellectual Property: HHS Reference
No. E–275–2011/0—
• US Provisional Application No. 61/
529,531 filed 31 August 2011
• PCT Application No. PCT/GB2012/
052140 filed 31 August 2012
Licensing Contact: Jaime M. Greene;
301–435–5559; greenejaime@
mail.nih.gov
Dated: December 19, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–30745 Filed 12–24–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; 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,
PO 00000
Frm 00048
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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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict; Biological Chemistry and
Macromolecular Biophysics.
Date: January 6, 2014.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: John L. Bowers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4170,
MSC 7806, Bethesda, MD 20892, (301) 435–
1725, bowersj@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Myalgic
Encephalomyelitis/Chronic Fatigue
Syndrome.
Date: January 16, 2014.
Time: 2:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Lynn E. Luethke, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5166,
MSC 7844, Bethesda, MD 20892, (301) 806–
3323, luethkel@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project: Research Resources Reverse Site
Visit.
Date: January 21–23, 2014.
Time: 7:00 p.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza Washington, DC—
Rockville Hotel, 3 Research Ct., Rockville,
MD 20850.
Contact Person: Lee Rosen, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5116,
MSC 7854, Bethesda, MD 20892, (301) 435–
1171, rosenl@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 19, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–30747 Filed 12–24–13; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Page 78372]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30747]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; 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: Center for Scientific Review Special Emphasis
Panel; Member Conflict; Biological Chemistry and Macromolecular
Biophysics.
Date: January 6, 2014.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: John L. Bowers, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4170, MSC 7806, Bethesda, MD
20892, (301) 435-1725, bowersj@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
Date: January 16, 2014.
Time: 2:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Lynn E. Luethke, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5166, MSC 7844, Bethesda, MD
20892, (301) 806-3323, luethkel@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Program Project: Research Resources Reverse Site Visit.
Date: January 21-23, 2014.
Time: 7:00 p.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Crowne Plaza Washington, DC--Rockville Hotel, 3 Research
Ct., Rockville, MD 20850.
Contact Person: Lee Rosen, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5116, MSC 7854, Bethesda, MD 20892, (301) 435-
1171, rosenl@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: December 19, 2013.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-30747 Filed 12-24-13; 8:45 am]
BILLING CODE 4140-01-P
