81 FR 76950 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 214 (November 4, 2016)

Page Range		76950-76951
FR Document		2016-26770

Federal Register, Volume 81 Issue 214 (Friday, November 4, 2016)

[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Notices]
[Pages 76950-76951]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26770]


-----------------------------------------------------------------------

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

[[Page 76951]]

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; SBIR: Development of Cancer Therapeutics.
    Date: December 5-6, 2016.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Sheraton Reston, 11810 Sunrise Valley Drive, Reston, VA 
20191.
    Contact Person: Malaya Chatterjee, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 6192, MSC 7804, Bethesda, MD 
20892, (301) 806-2515, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.
    Date: December 6, 2016.
    Time: 2:00 p.m. to 4:00 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: M. Catherine Bennett, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5182, MSC 7846, Bethesda, MD 
20892, 301-435-1766, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Mechanisms of Neurogenesis, Cell Fate and 
Maturation, and Degeneration.
    Date: December 7, 2016.
    Time: 10:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Linda MacArthur, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4187, Bethesda, MD 20892, 301-
537-9986, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; HIV/AIDS Innovative Research Applications.
    Date: December 7-8, 2016.
    Time: 10:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 5207, Bethesda, MD 20892, 301-451-8754, 
[email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; The Biomedical Technology Research Resource for 
Macromolecular Modeling and Bioinformatics.
    Date: December 7-9, 2016.
    Time: 4:00 p.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Wyndham Garden Urbana Champaign Hotel, 1001 W Killarney 
Street, Urbana, IL 61801.
    Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD 
20892, (301) 404-7419, [email protected].

(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: November 1, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-26770 Filed 11-3-16; 8:45 am]
BILLING CODE 4140-01-P

76950 Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Notices

metabolite does not inhibit the non- contact before January 3, 2017 for NMDA receptor inhibition-independent
competitive glutamatergic N-methyl-D- consideration. Guidelines for the antidepressant actions of a ketamine
aspartate (NMDA) receptor, and it exerts preparation of a full CRADA proposal metabolite. Nature, May 4, 2016, doi:
rapid actions that activate the a-amino will be communicated by the NIH to 10:1038/nature17998.
3-hydroxy-5-methyl-4-isoxazole respondents that have demonstrated Patent Status
propionic acid (AMPA) receptors. sufficient mutual interests and
Results indicate a non-NMDA receptor capabilities that indicate the partnering (1) ‘‘Use Of (2R,6R)-HNK, (S)-
dependent mechanism underlying entity will appropriately and Dehydronorketamine and (R,S)-
ketamine’s antidepressant properties, substantially contribute to the proposed ketamine metabolites in the treatment of
which involve bioactivity of a specific collaboration. Capability statements depression and neuropathic pain’’;
metabolite (2R, 6R-HNK) could be submitted after the due date may be Irving W. Wainer, Ruin Moaddel,
exploited for drug development. considered if a suitable CRADA Michel Bernier, Carlos A. Zarate, Mary
Additionally, the researchers have collaborator has not been identified by Tanga, Marc C. Torjman, Michael
established appropriate salt, crystal and NIH and UMB among the initial pool of Goldberg; Assignees: National Institute
polymorph forms of the agent and respondents. of Aging (NIA), National Institute of
multiple methods of synthesis. Full Respondents interested in submitting Mental Health (NIMH), SRI
ADME and polypharmacology a CRADA proposal should be aware that International, University of Medicine
assessment is complete as well as pre- it may be necessary for them to secure and Dentistry of New Jersey (UMDNJ);
formulations studies. a patent license to the background- U.S. Provisional Patent Application #
To expedite the research, patent applications in order to 61/547,336; Filed: October 14, 2011;
development and commercialization of commercialize products arising from a NIH Reference # E–092–2011.
2R,6R-hydroxynorketamine (a CRADA. Licensing of background (2) ‘‘Methods of using (2S,6S)-HNK
metabolite of ketamine), the National technology patent rights related to this and (2R,6R)-HNK to treat various
Institutes of Health, UMB and their CRADA opportunity and claimed in the depressive disorders and anxiety
collaborators are seeking one or more pending patent applications are disorders’’; Craig Thomas, Todd D.
CRADA and/or license agreements with available for either exclusive or non- Gould, Irving W. Wainer, Carlos A.
appropriate pharmaceutical or exclusive licensing and licensing by Zarate, Ruin Moaddel, Patrick Morris,
biotechnology companies in accordance NIH is subject to 35 U.S.C. 207 and 37 Panos Zanos; Assignees: National
with the regulations governing the CFR part 404. CRADA partners are Institute of Aging (NIA), National
transfer of Government-developed afforded an option to negotiate an Institute of Mental Health (NIMH),
technology and its public sector exclusive license from the NIH for National Center for Advancing
objectives, as outlined below. The inventions arising from the performance Translational Sciences (NCATS),
purpose of a CRADA is to find a partner of the CRADA research plan. University of Maryland at Baltimore
to collaborate in the development and The full CRADA proposal should (UMB); U.S. Provisional Patent
commercialization of a technology that include a capability statement with a Application # 62/313317; Filed: March
is in early phases of clinical detailed description of: (1) 25, 2016; NIH Reference #E–036–2016.
development. Under the CRADA, key Collaborator’s Expertise with mental (3) ‘‘Crystal forms and methods of
activities related to the clinical health disorders such as depression, (2) synthesis of (2R, 6R)-HNK and (2S,6S)-
development of 2R,6R-HNK as a Collaborators’ expertise in preclinical HNK’’; Craig Thomas, Patrick Morris,
therapeutic to treat a variety of mental development efforts including Carlos A. Zarate, Ruin Moaddel, Todd
health conditions including depressive toxicology and chemistry, D. Gould, Panos Zanos; Assignees:
disorders will be performed. manufacturing and controls (CMC), (3) National Center for Advancing
Collaborators should have proven Expertise in regulatory affairs, Translational Sciences (NCATS),
experience in drug development with particularly at the IND filing and early National Institute of Mental Health
specialized expertise within depression stage clinical trials stages, (4) (NIMH), National Institute of Aging
and/or related mental health disorders. Collaborator’s ability to support, (NIA), University of Maryland at
Owing to NIH’s commitment to public directly or through contract Baltimore (UMB); U.S. Provisional
dissemination of data, a key criterion mechanisms, and upon the successful Patent Application #62/313309; Filed:
will be that all outcomes from the completion of relevant milestones, the March 25, 2016; NIH Reference #E–116–
collaborative effort will be published ongoing pharmacokinetics and 2016.
including the outcomes of all clinical biological studies, long term toxicity Dated: October 31, 2016.
trials. Further, it is the goal of NIH, studies, process chemistry and other
UMB and other collaborators to develop Pamela McInnes,
pre-clinical development studies Deputy Director, Office of the Director,
the technology to the fullest extent (as needed to obtain regulatory approval of
therapeutic for multiple clinical National Center for Advancing Translational
a given therapy so as to ensure a high Sciences.
indications including, but not limited
probability of eventual successful [FR Doc. 2016–26628 Filed 11–3–16; 8:45 am]
to, anxiety, suicidal ideation,
commercialization and; (5)
anhedonia, PTSD, addiction, BILLING CODE 4140–01–P
Collaborator’s ability to provide
neuropathic pain, among others).
How to Apply: Interested potential adequate funding to support some pre-
CRADA collaborators will receive clinical studies of the project as well as DEPARTMENT OF HEALTH AND
asabaliauskas on DSK3SPTVN1PROD with NOTICES

detailed information on the current clinical trials. HUMAN SERVICES
status of the project after signing a Publications National Institutes of Health
confidentiality disclosure agreement
Zanos P, Moaddel R, Morris PJ, Georgiou P,
(CDA) with NIH, UMB and other Fischell J, Elmer GI, Manickavasagom A, Center for Scientific Review; Notice of
collaborators. Interested candidate Yuan P, Pribut HJ, Singh NS, Dossou Closed Meetings
partners must submit a statement of KSS, Fang Y, Huang X–P, Mayo CL,
interest and capability, no more than Wainer IW, Albuquerque EX, Thompson Pursuant to section 10(d) of the
five pages long, to the NCATS point of SM, Thomas CJ, Zarate CA, Gould TD. Federal Advisory Committee Act, as

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Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Notices 76951

amended (5 U.S.C. App.), notice is Contact Person: Jingsheng Tuo, Ph.D., plans and instruments, submit
hereby given of the following meetings. Scientific Review Officer, Center for comments in writing, or request more
The meetings will be closed to the Scientific Review, National Institutes of information on the proposed project,
public in accordance with the Health, 6701 Rockledge Drive, Room 5207,
Bethesda, MD 20892, 301–451–8754, tuoj@
contact: Dr. Jacqueline Wright, 6701
provisions set forth in sections nei.nih.gov. Rockledge Drive, MSC 7936, Bethesda,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MD 20892, or call non-toll-free number
Name of Committee: Center for Scientific
as amended. The grant applications and Review Special Emphasis Panel; The (301) 435–0384, or Email your request
the discussions could disclose Biomedical Technology Research Resource to: jacqueline.wright@nih.gov. Formal
confidential trade secrets or commercial for Macromolecular Modeling and requests for additional plans and
property such as patentable material, Bioinformatics. instruments must be requested in
and personal information concerning Date: December 7–9, 2016. writing.
individuals associated with the grant Time: 4:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant SUPPLEMENTARY INFORMATION: Section
applications, the disclosure of which 3506(c)(2)(A) of the Paperwork
would constitute a clearly unwarranted applications.
Place: Wyndham Garden Urbana Reduction Act of 1995 requires: Written
invasion of personal privacy. Champaign Hotel, 1001 W Killarney Street, comments and/or suggestions from the
Name of Committee: Center for Scientific Urbana, IL 61801. public and affected agencies are invited
Review Special Emphasis Panel; SBIR: Contact Person: Nitsa Rosenzweig, Ph.D., to address one or more of the following
Development of Cancer Therapeutics. Scientific Review Officer, Center for points: (1) Whether the proposed
Date: December 5–6, 2016. Scientific Review, National Institutes of
Time: 8:00 a.m. to 6:00 p.m. collection of information is necessary
Health, 6701 Rockledge Drive, Room 4152,
Agenda: To review and evaluate grant MSC 7760, Bethesda, MD 20892, (301) 404– for the proper performance of the
applications. 7419, rosenzweign@csr.nih.gov. function of the agency, including
Place: Sheraton Reston, 11810 Sunrise (Catalogue of Federal Domestic Assistance whether the information will have
Valley Drive, Reston, VA 20191. Program Nos. 93.306, Comparative Medicine; practical utility; (2) The accuracy of the
Contact Person: Malaya Chatterjee, Ph.D., 93.333, Clinical Research, 93.306, 93.333, agency’s estimate of the burden of the
Scientific Review Officer, Center for proposed collection of information,
93.337, 93.393–93.396, 93.837–93.844,
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
93.846–93.878, 93.892, 93.893, National including the validity of the
Institutes of Health, HHS) methodology and assumptions used; (3)
MSC 7804, Bethesda, MD 20892, (301) 806–
2515, chatterm@csr.nih.gov. Dated: November 1, 2016. Ways to enhance the quality, utility, and
Name of Committee: Center for Scientific Natasha M. Copeland, clarity of the information to be
Review Special Emphasis Panel; Myalgic Program Analyst, Office of Federal Advisory collected; and (4) Ways to minimize the
Encephalomyelitis/Chronic Fatigue Committee Policy. burden of the collection of information
Syndrome. on those who are to respond, including
[FR Doc. 2016–26770 Filed 11–3–16; 8:45 am]
Date: December 6, 2016. the use of appropriate automated,
Time: 2:00 p.m. to 4:00 p.m. BILLING CODE 4140–01–P
electronic, mechanical, or other
Agenda: To review and evaluate grant
applications.
technological collection techniques or
Place: National Institutes of Health, 6701 DEPARTMENT OF HEALTH AND other forms of information technology.
Rockledge Drive, Bethesda, MD 20892 HUMAN SERVICES Proposed Collection Title: The
(Telephone Conference Call). Atherosclerosis Risk in Communities
Contact Person: M. Catherine Bennett, National Institutes of Health Study, 0925–0281, REVISION, National
Ph.D., Scientific Review Officer, Center for Heart, Lung, and Blood Institute
Scientific Review, National Institutes of Proposed Collection; 60-Day Comment (NHLBI), the National Institutes of
Health, 6701 Rockledge Drive, Room 5182, Request; The Atherosclerosis Risk in Health (NIH).
MSC 7846, Bethesda, MD 20892, 301–435– Communities Study (National Heart Need and Use of Information
1766, bennettc3@csr.nih.gov.
Lung and Blood Institute) Collection: The ARIC study was
Name of Committee: Center for Scientific initiated in 1985 to examine the major
Review Special Emphasis Panel; Member AGENCY: National Institutes of Health, factors contributing to the occurrence of
Conflict: Mechanisms of Neurogenesis, Cell HHS.
Fate and Maturation, and Degeneration. and the trends for cardiovascular
ACTION: Notice. diseases among men, women, African
Date: December 7, 2016.
Time: 10:00 a.m. to 6:00 p.m. SUMMARY: In compliance with the Americans and white persons in four
Agenda: To review and evaluate grant requirement of the Paperwork U.S. communities: Forsyth County,
applications. North Carolina; Jackson, Mississippi;
Place: National Institutes of Health, 6701
Reduction Act of 1995 to provide
opportunity for public comment on suburbs of Minneapolis, Minnesota; and
Rockledge Drive, Bethesda, MD 20892 Washington County, Maryland. The
(Virtual Meeting). proposed data collection projects, the
Contact Person: Linda MacArthur, Ph.D., National Institutes of Health, National cohort in Jackson is selected to
Scientific Review Officer, Center for Heart, Lung, and Blood Institute represent only African American
Scientific Review, National Institutes of (NHLBI) will publish periodic residents of the city. The primary
Health, 6701 Rockledge Drive, Room 4187, summaries of propose projects to be objectives of the study are to: (1)
Bethesda, MD 20892, 301–537–9986, submitted to the Office of Management Investigate factors associated with both
macarthurlh@csr.nih.gov. atherosclerosis and clinical
and Budget (OMB) for review and
Name of Committee: Center for Scientific cardiovascular diseases and (2) measure
asabaliauskas on DSK3SPTVN1PROD with NOTICES

approval.
Review Special Emphasis Panel; HIV/AIDS occurrence of and trend in coronary
Innovative Research Applications. DATES: Comments regarding this heart disease (CHD) and relate them to
Date: December 7–8, 2016. information collection are best assured community levels of risk factors,
Time: 10:00 a.m. to 5:00 p.m. of having their full effect if received
Agenda: To review and evaluate grant
medical care, and atherosclerosis. Some
within 60 days of the date of this specific activities for this revision of
applications. publication.
Place: National Institutes of Health, 6701 ARIC are continued telephone follow-up
Rockledge Drive, Bethesda, MD 20892 FOR FURTHER INFORMATION CONTACT: To of the ARIC cohort, with twice yearly
(Virtual Meeting). obtain a copy of the data collection calls to identify new cardiovascular

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Document Created: 2018-02-14 08:26:35
Document Modified: 2018-02-14 08:26:35

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		December 5-6, 2016.
FR Citation		81 FR 76950

81 FR 76950 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 214 (November 4, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health