Center for Scientific Review; Notice of Closed Meetings, 76950-76951 [2016-26770]
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Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Notices
metabolite does not inhibit the noncompetitive glutamatergic N-methyl-Daspartate (NMDA) receptor, and it exerts
rapid actions that activate the a-amino
3-hydroxy-5-methyl-4-isoxazole
propionic acid (AMPA) receptors.
Results indicate a non-NMDA receptor
dependent mechanism underlying
ketamine’s antidepressant properties,
which involve bioactivity of a specific
metabolite (2R, 6R-HNK) could be
exploited for drug development.
Additionally, the researchers have
established appropriate salt, crystal and
polymorph forms of the agent and
multiple methods of synthesis. Full
ADME and polypharmacology
assessment is complete as well as preformulations studies.
To expedite the research,
development and commercialization of
2R,6R-hydroxynorketamine (a
metabolite of ketamine), the National
Institutes of Health, UMB and their
collaborators are seeking one or more
CRADA and/or license agreements with
appropriate pharmaceutical or
biotechnology companies in accordance
with the regulations governing the
transfer of Government-developed
technology and its public sector
objectives, as outlined below. The
purpose of a CRADA is to find a partner
to collaborate in the development and
commercialization of a technology that
is in early phases of clinical
development. Under the CRADA, key
activities related to the clinical
development of 2R,6R-HNK as a
therapeutic to treat a variety of mental
health conditions including depressive
disorders will be performed.
Collaborators should have proven
experience in drug development with
specialized expertise within depression
and/or related mental health disorders.
Owing to NIH’s commitment to public
dissemination of data, a key criterion
will be that all outcomes from the
collaborative effort will be published
including the outcomes of all clinical
trials. Further, it is the goal of NIH,
UMB and other collaborators to develop
the technology to the fullest extent (as
therapeutic for multiple clinical
indications including, but not limited
to, anxiety, suicidal ideation,
anhedonia, PTSD, addiction,
neuropathic pain, among others).
How to Apply: Interested potential
CRADA collaborators will receive
detailed information on the current
status of the project after signing a
confidentiality disclosure agreement
(CDA) with NIH, UMB and other
collaborators. Interested candidate
partners must submit a statement of
interest and capability, no more than
five pages long, to the NCATS point of
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contact before January 3, 2017 for
consideration. Guidelines for the
preparation of a full CRADA proposal
will be communicated by the NIH to
respondents that have demonstrated
sufficient mutual interests and
capabilities that indicate the partnering
entity will appropriately and
substantially contribute to the proposed
collaboration. Capability statements
submitted after the due date may be
considered if a suitable CRADA
collaborator has not been identified by
NIH and UMB among the initial pool of
respondents.
Respondents interested in submitting
a CRADA proposal should be aware that
it may be necessary for them to secure
a patent license to the backgroundpatent applications in order to
commercialize products arising from a
CRADA. Licensing of background
technology patent rights related to this
CRADA opportunity and claimed in the
pending patent applications are
available for either exclusive or nonexclusive licensing and licensing by
NIH is subject to 35 U.S.C. 207 and 37
CFR part 404. CRADA partners are
afforded an option to negotiate an
exclusive license from the NIH for
inventions arising from the performance
of the CRADA research plan.
The full CRADA proposal should
include a capability statement with a
detailed description of: (1)
Collaborator’s Expertise with mental
health disorders such as depression, (2)
Collaborators’ expertise in preclinical
development efforts including
toxicology and chemistry,
manufacturing and controls (CMC), (3)
Expertise in regulatory affairs,
particularly at the IND filing and early
stage clinical trials stages, (4)
Collaborator’s ability to support,
directly or through contract
mechanisms, and upon the successful
completion of relevant milestones, the
ongoing pharmacokinetics and
biological studies, long term toxicity
studies, process chemistry and other
pre-clinical development studies
needed to obtain regulatory approval of
a given therapy so as to ensure a high
probability of eventual successful
commercialization and; (5)
Collaborator’s ability to provide
adequate funding to support some preclinical studies of the project as well as
clinical trials.
Publications
Frm 00040
Patent Status
(1) ‘‘Use Of (2R,6R)-HNK, (S)Dehydronorketamine and (R,S)ketamine metabolites in the treatment of
depression and neuropathic pain’’;
Irving W. Wainer, Ruin Moaddel,
Michel Bernier, Carlos A. Zarate, Mary
Tanga, Marc C. Torjman, Michael
Goldberg; Assignees: National Institute
of Aging (NIA), National Institute of
Mental Health (NIMH), SRI
International, University of Medicine
and Dentistry of New Jersey (UMDNJ);
U.S. Provisional Patent Application #
61/547,336; Filed: October 14, 2011;
NIH Reference # E–092–2011.
(2) ‘‘Methods of using (2S,6S)-HNK
and (2R,6R)-HNK to treat various
depressive disorders and anxiety
disorders’’; Craig Thomas, Todd D.
Gould, Irving W. Wainer, Carlos A.
Zarate, Ruin Moaddel, Patrick Morris,
Panos Zanos; Assignees: National
Institute of Aging (NIA), National
Institute of Mental Health (NIMH),
National Center for Advancing
Translational Sciences (NCATS),
University of Maryland at Baltimore
(UMB); U.S. Provisional Patent
Application # 62/313317; Filed: March
25, 2016; NIH Reference #E–036–2016.
(3) ‘‘Crystal forms and methods of
synthesis of (2R, 6R)-HNK and (2S,6S)HNK’’; Craig Thomas, Patrick Morris,
Carlos A. Zarate, Ruin Moaddel, Todd
D. Gould, Panos Zanos; Assignees:
National Center for Advancing
Translational Sciences (NCATS),
National Institute of Mental Health
(NIMH), National Institute of Aging
(NIA), University of Maryland at
Baltimore (UMB); U.S. Provisional
Patent Application #62/313309; Filed:
March 25, 2016; NIH Reference #E–116–
2016.
Dated: October 31, 2016.
Pamela McInnes,
Deputy Director, Office of the Director,
National Center for Advancing Translational
Sciences.
[FR Doc. 2016–26628 Filed 11–3–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Zanos P, Moaddel R, Morris PJ, Georgiou P,
Fischell J, Elmer GI, Manickavasagom A,
Yuan P, Pribut HJ, Singh NS, Dossou
KSS, Fang Y, Huang X–P, Mayo CL,
Wainer IW, Albuquerque EX, Thompson
SM, Thomas CJ, Zarate CA, Gould TD.
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NMDA receptor inhibition-independent
antidepressant actions of a ketamine
metabolite. Nature, May 4, 2016, doi:
10:1038/nature17998.
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Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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Federal Register / Vol. 81, No. 214 / Friday, November 4, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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, chatterm@csr.nih.gov.
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, bennettc3@csr.nih.gov.
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,
macarthurlh@csr.nih.gov.
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).
VerDate Sep<11>2014
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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, tuoj@
nei.nih.gov.
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, rosenzweign@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: 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; The Atherosclerosis Risk in
Communities Study (National Heart
Lung and Blood Institute)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health, National
Heart, Lung, and Blood Institute
(NHLBI) will publish periodic
summaries of propose projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
SUMMARY:
PO 00000
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plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Jacqueline Wright, 6701
Rockledge Drive, MSC 7936, Bethesda,
MD 20892, or call non-toll-free number
(301) 435–0384, or Email your request
to: jacqueline.wright@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: The
Atherosclerosis Risk in Communities
Study, 0925–0281, REVISION, National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH).
Need and Use of Information
Collection: The ARIC study was
initiated in 1985 to examine the major
factors contributing to the occurrence of
and the trends for cardiovascular
diseases among men, women, African
Americans and white persons in four
U.S. communities: Forsyth County,
North Carolina; Jackson, Mississippi;
suburbs of Minneapolis, Minnesota; and
Washington County, Maryland. The
cohort in Jackson is selected to
represent only African American
residents of the city. The primary
objectives of the study are to: (1)
Investigate factors associated with both
atherosclerosis and clinical
cardiovascular diseases and (2) measure
occurrence of and trend in coronary
heart disease (CHD) and relate them to
community levels of risk factors,
medical care, and atherosclerosis. Some
specific activities for this revision of
ARIC are continued telephone follow-up
of the ARIC cohort, with twice yearly
calls to identify new cardiovascular
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]]>Agencies
[Federal Register Volume 81, Number 214 (Friday, November 4, 2016)]
[Notices]
[Pages 76950-76951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26770]
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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
[[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, chatterm@csr.nih.gov.
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, bennettc3@csr.nih.gov.
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, macarthurlh@csr.nih.gov.
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,
tuoj@nei.nih.gov.
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, rosenzweign@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: 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
