Center for Scientific Review; Notice of Closed Meeting, 25294-25295 [2017-11349]
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Federal Register / Vol. 82, No. 104 / Thursday, June 1, 2017 / Notices
Separation allows for support group
services to be categorized as a nonregistered service for which consumer
demographic details are no longer
reported. Additional information
regarding the types of respite services
provided under the OAA is sought. The
proposal separates assistance services
into two types: (1) Case management,
and (2) information and assistance. Case
management assistance services are
categorized as registered, meaning
caregiver demographic data are reported
while information and assistance
services do not include reporting of
demographic data. Supplemental
services are reported in the same
manner as ‘‘other service’’ under Title
III–B, Home and Community-based
Services (HCBS) program. Across the
OAA services, greater detail regarding
expenditure data is proposed. Under
Title III–B, HCBS program, the proposed
data collection expands data regarding
legal assistance services. The ACL also
seeks data on the OAA identified
priority legal issues for closed cases.
Taken as a whole, the proposed
reductions far exceed the proposed
increases in data burden.
The proposed reporting requirements
may be found on the ACL Web site
under State Program Performance
Report (SPR) Proposed Revisions for
Comment, available at: https://
agid.acl.gov/Default.aspx.
The estimated hour burden per
respondent for the SPR in FY 2019 (year
of first report) will change from the 50
hours estimate in FY 2016 to 33.5 hours,
a decrease due to a 70% reduction in
the number of data elements reported.
The number of hours is multiplied by 56
state units on aging, resulting in a total
estimated hour aggregate burden of
1,876 hours (see table below).
TABLE—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
States ................................................
State Performance Report ...............
Dated: May 25, 2017.
Daniel P. Berger,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2017–11286 Filed 5–31–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
mstockstill on DSK30JT082PROD with NOTICES
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: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
PrecISE Asthma Network Data, Modeling,
and Coordination Center.
Date: June 27, 2017.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Suite 7182, Bethesda, MD
20892 (Telephone Conference Call).
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Contact Person: Susan Wohler Sunnarborg,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7182, Bethesda, MD 20892,
susan.sunnarborg@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Clinical Trial Pilot Studies (R34).
Date: June 29, 2017.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: YingYing Li-Smerin, MD,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7184, Bethesda, MD 20892–
7924, 301–827–7942, lismerin@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
CLTR Member Conflicts.
Date: June 29, 2017.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: YingYing Li-Smerin, MD,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7184, Bethesda, MD 20892–
7924, 301–827–7942, lismerin@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
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Number of
responses per
respondent
Average
burden per
response
(in hours)
1
Total burden
hours
33.5
1,876
Dated: May 26, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–11351 Filed 5–31–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
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 meeting.
The meeting 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; HIV and
Drug Abuse: Small Grant Applications.
Date: June 12–13, 2017.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
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Federal Register / Vol. 82, No. 104 / Thursday, June 1, 2017 / Notices
Contact Person: Shalanda A. Bynum, MPH,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
Bethesda, MD 20892, 301–755–4355,
bynumsa@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.
(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: May 26, 2017.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–11349 Filed 5–31–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dehydrogenase 1 (mIDH1) inhibitors for
the Treatment of Human Cancers.
Category: Routine.
Action Needed By: There is no
specific date that this needs to be
approved by, but the sooner the
document is approved, the sooner NIH
can make a potential therapeutic
available to the public.
Summary: Administration of an
inhibitor of mIDH1 can potentially treat
cancers resulting from or characterized
by the presence of mIDH1. Industrial
partners are being sought for licensing
and to help further develop this
technology for use in humans. There are
currently few effective therapeutics to
treat resulting from aberrant activity of
mIDH1, such as acute myeloid
leukemia.
Justification: Although there is no
specific date requirement, rapid
approval is requested in order to make
a potential therapeutic available to the
public quickly.
SUPPLEMENTARY INFORMATION:
National Institutes of Health
Intellectual Property
Prospective Grant of Exclusive Patent
License: Mutant IDH1 Inhibitors Useful
for Treating Cancer
1. International Application No. PCT/US15/
067406 filed on 12/22/2015 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ (HHS Ref. No: E–
243–2014/0–PCT–02), and
2. U.S. Provisional Application No. 62/
353298 filed on 06/22/2016 which is
entitled ‘‘Mutant IDH1 Inhibitors Useful
for Treating Cancer’’ (HHS Ref. No. E–
189–2016/0–US–01)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
National Center for
Advancing Translational Sciences, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an exclusive patent license to
practice the inventions embodied in the
Patent Applications listed in the
Summary Information section of this
notice to GeneXion Oncology, Inc.,
located in New York, NY.
DATES: Only written comments and/or
applications for a license which are
received by the National Center for
Advancing Translational Sciences on or
before July 3, 2017 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
exclusive license should be directed to:
Sury Vepa, Ph.D., J.D., Senior Licensing
and Patenting Manager, National Center
for Advancing Translational Sciences,
NIH, 9800 Medical Center Drive,
Rockville, MD 20850, Phone: 301–217–
9197, Fax: 301–217–5736, or email
sury.vepa@nih.gov. A signed
Confidential Disclosure Agreement may
be required to receive copies of the
patent applications.
Licensing Availability: The
Development of mutant Isocitrate
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SUMMARY:
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The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America and the
University of North Carolina at Chapel
Hill.
The prospective exclusive license
territory may be worldwide and the field
of use may be limited to the use of
Licensed Patent Rights for the following:
‘‘Therapeutics for cancers in humans
which result from or characterized by
the presence of mutant IDH1.’’
The inventions relate to a series of
novel compounds that potently and
selectively inhibit mIDH1. These
compounds reduce 2–HG levels in cell
lines in vitro as well as in human cancer
cells grown in mouse xenografts in vivo.
These compounds show greater than
250-fold selectivity for the mutant
enzyme over the wild-type, show
favorable in vitro stability (in mouse,
rat, dog and human hepatocyte exposure
studies), are AMES negative, and exhibit
no significant metabolic CYP liabilities.
These compounds possess very
favorable in vivo rodent
pharmacokinetics and bioavailability
and are well tolerated in rodents, even
when dosed at high levels.
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Thus, the compounds of the subject
inventions can be used individually or
in combination to develop new
therapies to treat diseases which result
from mutant IDH1 activity. The diseases
caused by mutant IDH1 activity include
cancer (e.g., acute myeloid leukemia,
glioma, cholangiocarcinoma and
potentially other solid tumors) and
selected rare diseases, such as Ollier
Disease.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within thirty (30) days from the date of
this published notice, the National
Center for Advancing Translational
Sciences receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.
Complete applications for a license in
the prospective field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Exclusive Patent License
Agreement. Comments and objections
submitted to this notice will not be
made available for public inspection
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: May 25, 2017.
Pamela McInnes,
Deputy Director, Office of the Director,
National Center for Advancing Translational
Sciences.
[FR Doc. 2017–11241 Filed 5–31–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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.
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Agencies
[Federal Register Volume 82, Number 104 (Thursday, June 1, 2017)]
[Notices]
[Pages 25294-25295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11349]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
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
meeting.
The meeting 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; HIV and Drug Abuse: Small Grant Applications.
Date: June 12-13, 2017.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
[[Page 25295]]
Contact Person: Shalanda A. Bynum, MPH, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206, Bethesda, MD 20892, 301-
755-4355, bynumsa@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.
(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: May 26, 2017.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-11349 Filed 5-31-17; 8:45 am]
BILLING CODE 4140-01-P