81 FR 85981 - National Center for Advancing Translational Sciences; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 229 (November 29, 2016)

Page Range		85981-85982
FR Document		2016-28625

Federal Register, Volume 81 Issue 229 (Tuesday, November 29, 2016)

[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85981-85982]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28625]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Center for Advancing Translational Sciences; Notice of 
Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of meetings of the 
National Center for Advancing Translational Sciences.
    The meetings will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should

[[Page 85982]]

notify the Contact Person listed below in advance of the meeting.
    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/or contract proposals 
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 and/or contract proposals, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Cures Acceleration Network Review Board.
    Date: January 12, 2017.
    Time: 8:30 a.m. to 2:30 p.m.
    Agenda: Report from the Institute Director.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive 
Secretary, National Center for Advancing Translational Sciences, 1 
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809, 
[email protected].

    Name of Committee: National Center for Advancing Translational 
Sciences Advisory Council.
    Date: January 12, 2017.
    Open: 8:30 a.m. to 2:30 p.m.
    Agenda: Report from the Institute Director and other staff.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Closed: 3:00 p.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Building 31, Conference 
Room 10, 31 Center Drive, Bethesda, MD 20892.
    Contact Person: Anna L. Ramsey-Ewing, Ph.D., Executive 
Secretary, National Center for Advancing Translational Sciences, 1 
Democracy Plaza, Room 1072, Bethesda, MD 20892, 301-435-0809, 
[email protected].

    In the interest of security, NIH has instituted stringent 
procedures for entrance onto the NIH campus. All visitor vehicles, 
including taxicabs, hotel, and airport shuttles will be inspected 
before being allowed on campus. Visitors will be asked to show one 
form of identification (for example, a government-issued photo ID, 
driver's license, or passport) and to state the purpose of their 
visit.

(Catalogue of Federal Domestic Assistance Program Nos. 93.859, 
Pharmacology, Physiology, and Biological Chemistry Research; 93.350, 
B--Cooperative Agreements; 93.859, Biomedical Research and Research 
Training, National Institutes of Health, HHS)

    Dated: November 22, 2016.
David Clary,
 Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-28625 Filed 11-28-16; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 85981

typically mice or rats that are selected • Exhibits progression patterns Time: 4:00 p.m. to 5:00 p.m.
for demonstrating hallmarks of a given relevant to human disease. Agenda: To review and evaluate grant
disease. For cancer research, while Development Stage: Basic (Target ID). applications.
Inventor(s): Chi-Ping Day, Glenn T. Place: National Institutes of Health, 6701
many mouse models exist to simulate Rockledge Drive, Bethesda, MD 20892
the response of the cancer to a particular Merlino, Zoe Weaver Ohler, Rajaa El
(Telephone Conference Call).
drug, all of the current models have Meskini, Terry A. Van Dyke (all of NCI), Contact Person: Mark P. Rubert, Ph.D.,
some limitations in their ability to fully and Thomas Tüting (University Hospital Scientific Review Officer, Center for
predict the concomitant physiological or Bonn). Scientific Review, National Institutes of
immunological response that might Intellectual Property: HHS Reference Health, 6701 Rockledge Drive, Room 5218,
result when the drug progresses to Number E–291–2015/0. This is a MSC 7852, Bethesda, MD 20892, 301–435–
Research Tool. Following the policy of 1775, rubertm@csr.nih.gov.
clinical trials. This is problematic both
in models in which the cancer the National Institutes of Health, patent This notice is being published less than 15
protection will not be sought. days prior to the meeting due to the timing
spontaneously develops in the animal as limitations imposed by the review and
well as models in which cancerous cells Publications:
funding cycle.
or tumors, i.e., allografts (derived from 1. Day CP, et al. ‘‘Glowing head’’ mice:
Name of Committee: Center for Scientific
cells of the same organism) or xenografts A genetic tool enabling reliable
Review Special Emphasis Panel; PAR Panel:
(derived from cells of different preclinical image-based evaluation Novel Strategies for Targeting HIV–CNS
organism, usually humans), are of cancers in immunocompetent Reservoirs without Reactivation.
transplanted into an otherwise cancer- allografts. PLoS One 2014; Date: December 13, 2016.
free animal. 9(11):e109956. [PMID 25369133] Time: 9:00 a.m. to 6:00 p.m.
To address these issues, researchers at 2. Day CP, et al. Preclinical mouse Agenda: To review and evaluate grant
cancer models: A maze of applications.
NCI developed a means of more closely Place: Renaissance Mayflower Hotel, 1127
simulating in mouse models both opportunities and challenges. Cell.
Connecticut Avenue NW., Washington, DC
melanoma cancer itself and the resulting 2015;163(1):39–53. [PMID
20036.
physiological and immunological 26406370] Contact Person: Dimitrios Nikolaos
response by creating a genetically Contact Information: Inquiries about Vatakis, Ph.D., Scientific Review Officer,
engineered mice (GEM)-derived allograft licensing, research collaborations, and Center for Scientific Review, National
(GDA). This allograft both resembles co-development opportunities should be Institutes of Health, 6701 Rockledge Drive,
Room 3190, Bethesda, MD 20892, 301–827–
human-like melanoma and has features sent to John D. Hewes, Ph.D., email:
7480.
that will stimulate a normal john.hewes@nih.gov.
This notice is being published less than 15
immunological response in the mouse. Dated: November 22, 2016. days prior to the meeting due to the timing
Thus, when transplanted into a host, the John D. Hewes, limitations imposed by the review and
resulting tumor-containing mouse may funding cycle.
Technology Transfer and Patenting
be used to test conventional cancer Specialist, Technology Transfer Center, (Catalogue of Federal Domestic Assistance
therapies (e.g., chemotherapy and National Cancer Institute. Program Nos. 93.306, Comparative Medicine;
radiotherapy), targeted drugs (e.g., [FR Doc. 2016–28624 Filed 11–28–16; 8:45 am] 93.333, Clinical Research, 93.306, 93.333,
kinase inhibitors), and 93.337, 93.393–93.396, 93.837–93.844,
BILLING CODE 4140–01–P
immunotherapies with an expectation 93.846–93.878, 93.892, 93.893, National
that the response in the mouse will Institutes of Health, HHS)
more closely mimic the types of DEPARTMENT OF HEALTH AND Dated: November 22, 2016.
responses expected in humans if the HUMAN SERVICES Natasha M. Copeland,
therapy progresses to clinical trials. Program Analyst, Office of Federal Advisory
Further this melanoma-based GDA National Institutes of Health Committee Policy.
approach may represent a new standard [FR Doc. 2016–28623 Filed 11–28–16; 8:45 am]
for building or improving preclinical Center for Scientific Review Notice of
BILLING CODE 4140–01–P
models of other types of cancer. Closed Meetings
Potential Commercial Applications: Pursuant to section 10(d) of the
• This is a novel mouse allograft Federal Advisory Committee Act, as DEPARTMENT OF HEALTH AND
model that provides a preclinical model amended (5 U.S.C. App.), notice is HUMAN SERVICES
of human-like advanced-stage hereby given of the following meetings.
melanoma. The meetings will be closed to the National Institutes of Health
• This allograft model may be useful public in accordance with the
for preclinical testing of conventional National Center for Advancing
provisions set forth in sections Translational Sciences; Notice of
therapies, targeted therapies, and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
immunotherapies. Meetings
as amended. The grant applications and
Value Proposition: the discussions could disclose Pursuant to section 10(d) of the
• Hgf-tg;Cdk4R24C C57BL/6 mouse- confidential trade secrets or commercial Federal Advisory Committee Act, as
derived melanoma allograft with property such as patentable material, amended (5 U.S.C. App.), notice is
humanized pathogenetics allows and personal information concerning hereby given of meetings of the National
adoption of clinically relevant Center for Advancing Translational
asabaliauskas on DSK3SPTVN1PROD with NOTICES

individuals associated with the grant
procedures and endpoints, facilitating applications, the disclosure of which Sciences.
clinical translation. would constitute a clearly unwarranted The meetings will be open to the
• Features a constitutively activated invasion of personal privacy. public as indicated below, with
MET/MAPK pathway and disrupted attendance limited to space available.
Name of Committee: Center for Scientific
CDKN2A pathway. Review Special Emphasis Panel; PA–16–194: Individuals who plan to attend and
• Expresses typical diagnostic Mentored Quantitative Research need special assistance, such as sign
markers of human melanoma such as Development Award. language interpretation or other
DCT and TRP1. Date: December 12, 2016. reasonable accommodations, should

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85982 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices

notify the Contact Person listed below Dated: November 22, 2016. DATES: Only written comments and/or
in advance of the meeting. David Clary, applications for a license which are
The meetings will be closed to the Program Analyst, Office of Federal Advisory received by the NCI Technology
public in accordance with the Committee Policy. Transfer Center on or before December
provisions set forth in sections [FR Doc. 2016–28625 Filed 11–28–16; 8:45 am] 14, 2016 will be considered.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P ADDRESSES: Requests for copies of the
as amended. The grant applications patent applications, inquiries, and
and/or contract proposals and the comments relating to the contemplated
discussions could disclose confidential DEPARTMENT OF HEALTH AND Exclusive Patent License should be
trade secrets or commercial property HUMAN SERVICES directed to: Martha Lubet, Ph.D.,
such as patentable material, and National Institutes of Health Licensing and Patenting Manager, NCI
personal information concerning Technology Transfer Center, 9609
individuals associated with the grant National Institute of Allergy and Medical Center Drive, RM 1E530 MSC
applications and/or contract proposals, Infectious Diseases; Amended Notice 9702, Bethesda, MD 20892–9702 (for
the disclosure of which would of Meeting business mail), Rockville, MD 20850–
constitute a clearly unwarranted 9702 Telephone: (240)–276–5530;
invasion of personal privacy. Notice is hereby given of a change in Facsimile: (240)–276–5504; Email:
the meeting of the National Institute of lubetm@mail.nih.gov.
Name of Committee: Cures Acceleration Allergy and Infectious Diseases Special
Network Review Board.
Emphasis Panel, December 14, 2016, SUPPLEMENTARY INFORMATION: United
Date: January 12, 2017. States Provisional Patent Application
8:00 a.m. to December 15, 2016, 6:00
Time: 8:30 a.m. to 2:30 p.m. No. 62/307600, filed March 14, 2016,
Agenda: Report from the Institute Director.
p.m., Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120 entitled ‘‘Dopamine D3 Receptor
Place: National Institutes of Health, Selective Antagonists/Partial Agonists;
Building 31, Conference Room 10, 31 Center Wisconsin Avenue, Bethesda, MD 20814
which was published in the Federal Methods of Making and Use Thereof’’
Drive, Bethesda, MD 20892. [HHS Reference No. E–053–2016]; and
Contact Person: Anna L. Ramsey-Ewing, Register on November 21, 2016, 81 FR
83253. U.S. 8,748,608, Australian 2007354861,
Ph.D., Executive Secretary, National Center
for Advancing Translational Sciences, 1 This meeting notice is amended to and Canadian 2690789 (which claim
Democracy Plaza, Room 1072, Bethesda, MD change the start date of the meeting priority to PCT/US2007/71412 filed
20892, 301–435–0809, anna.ramseyewing@ from December 14, 2016 to December 9, June 15, 2007) entitled ‘‘4-
nih.gov. 2016. The meeting is closed to the phenylpiperazine derivatives with
Name of Committee: National Center for public. functionalized linkers as dopamine D3
Advancing Translational Sciences Advisory selective ligands and methods of use’’
Dated: November 22, 2016.
Council. [HHS Reference No. E–128–2006] (and
Natasha M. Copeland, U.S. and foreign patent applications or
Date: January 12, 2017.
Program Analyst, Office of Federal Advisory patents claiming priority to the
Open: 8:30 a.m. to 2:30 p.m.
Committee Policy. aforementioned applications).
Agenda: Report from the Institute Director
and other staff. [FR Doc. 2016–28643 Filed 11–28–16; 8:45 am]
With respect to persons who have an
Place: National Institutes of Health, BILLING CODE 4140–01–P obligation to assign their right, title and
Building 31, Conference Room 10, 31 Center interest to the Government of the United
Drive, Bethesda, MD 20892. States of America, the patent rights in
Closed: 3:00 p.m. to 4:30 p.m. DEPARTMENT OF HEALTH AND
these inventions have been assigned to
Agenda: To review and evaluate grant HUMAN SERVICES
the Government of the United States of
applications.
National Institutes of Health America.
Place: National Institutes of Health,
Building 31, Conference Room 10, 31 Center The prospective Exclusive Patent
Drive, Bethesda, MD 20892. Prospective Grant of Exclusive Patent License territory may be worldwide for
Contact Person: Anna L. Ramsey-Ewing, License: Development and the treatment opioid use disorder
Ph.D., Executive Secretary, National Center Commercialization of Dopamine D3 schizophrenia, bipolar disorder and
for Advancing Translational Sciences, 1 Receptor Selective Antagonists/Partial tetrahydrocannabinol dependence, as
Democracy Plaza, Room 1072, Bethesda, MD Agonists for the Treatment of Opioid set forth in the Licensed Patent Rights.
20892, 301–435–0809, anna.ramseyewing@ Use Disorder, Schizophrenia Bipolar The present invention describes
nih.gov. Disorder and Tetrahydrocannabinol Dopamine D3 receptor ligands and
In the interest of security, NIH has Dependence methods of using the ligands to treat
instituted stringent procedures for entrance substance use disorders, schizophrenia,
onto the NIH campus. All visitor vehicles, AGENCY: National Institutes of Health,
HHS. bipolar disorder and other mental
including taxicabs, hotel, and airport shuttles disorders.
will be inspected before being allowed on ACTION: Notice.
This notice is made in accordance
campus. Visitors will be asked to show one
form of identification (for example, a SUMMARY: The National Institute on with 35 U.S.C. 209 and 37 CFR part 404.
government-issued photo ID, driver’s license, Drug Abuse, National Institutes of The prospective Exclusive Patent
Health, Department of Health and License will be royalty bearing and may
asabaliauskas on DSK3SPTVN1PROD with NOTICES

or passport) and to state the purpose of their
visit. Human Services, is contemplating the be granted unless within fifteen (15)
(Catalogue of Federal Domestic Assistance grant of an Exclusive Patent License to days from the date of this published
Program Nos. 93.859, Pharmacology, Braeburn Pharmaceuticals, Inc. notice, the National Institute on Drug
Physiology, and Biological Chemistry (‘‘Braeburn’’) located in Princeton, New Abuse receives written evidence and
Research; 93.350, B—Cooperative Jersey to practice the inventions argument that establishes that the grant
Agreements; 93.859, Biomedical Research embodied in the patent applications of the license would not be consistent
and Research Training, National Institutes of listed in the SUPPLEMENTARY with the requirements of 35 U.S.C. 209
Health, HHS) INFORMATION section of this notice. and 37 CFR part 404.

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Document Created: 2016-11-29 00:33:02
Document Modified: 2016-11-29 00:33:02

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		January 12, 2017.
FR Citation		81 FR 85981

81 FR 85981 - National Center for Advancing Translational Sciences; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 229 (November 29, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health