Center For Scientific Review; Notice of Closed Meetings, 78372 [2013-30747]

Download as PDF 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 Fmt 4703 Sfmt 9990 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 E:\FR\FM\26DEN1.SGM 26DEN1

Agencies

[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