National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 48439-48440 [2016-17421]
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Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Notices
Child Health and Human Development, NIH,
6710B Rockledge Drive, Room 2314,
Bethesda, MD 20892, (301) 496–8535,
dhann@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: July 19, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–17423 Filed 7–22–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development in the
U.S. in accordance with 35 U.S.C. 209
and 37 CFR part 404 to achieve
expeditious commercialization of
results of federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD, 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
Drive, Mail Stop 9702, Rockville, MD
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Novel metastatic
serous epithelial ovarian cancer (SEOC)
genetically engineered mouse models,
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
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cell lines, and orthotopic models based
on Rb, p53 and/or Brca 1/2 inactivation
useful for biomarker discovery and
preclinical testing.
Description of Technology: The high
mortality rate from ovarian cancers can
be attributed to late-stage diagnosis and
lack of effective treatment. Despite
enormous effort to develop better
targeted therapies, platinum-based
chemotherapy still remains the standard
of care for ovarian cancer patients, and
resistance occurs at a high rate. One of
the rate limiting factors for translation of
new drug discoveries into clinical
treatments has been the lack of suitable
preclinical cancer models with high
predictive value.
NCI CAPR has developed Tri-allelic
K18–T121 tg/∂ /Brca1 fl/fl /p53 fl/fl SEOC
GEM Model, GEM-derived SEOC
orthotopic mouse model, and biological
materials derived therefrom, with
several key histopathologic,
immunophenotypical, and genetic
features of human SEOC. SEOC GEMs
were utilized to create orthotopic
immunocompetent transplant models,
and to generate synchronized cohorts of
mice suitable for preclinical studies.
NCI CAPR conducted studies that
determine these models are tractable for
use in routine efficacy studies and
demonstrate the utility of these models
in evaluating the potential efficacy of
novel therapeutics for ovarian cancer.
Potential Commercial Applications:
• These models serve as a foundation
for preclinical research and evaluation
of efficacy of novel therapeutics for
ovarian cancer.
• The GEM models described here
can be used to develop cell lines and
allograft models for evaluating drug
potency relative to Brca1 mutation
status.
• These mouse models provide the
opportunity for evaluation of effective
therapeutics, including prediction of
differential responses in Brca1-wild
type and Brca1–deficient tumors and
development of relevant biomarkers.
Value Proposition:
• Novel resource for evaluating
disease etiology and biomarkers,
therapeutic evaluation, and improved
imaging strategies in epithelial ovarian
cancer
• Similarity to human ovarian cancer
based on transcriptional profiling
• Suitable preclinical cancer models
with high predictive value.
Development Stage: Pre-clinical (in
vivo validation).
Inventor(s): Simone Difilippantonio,
Terry Van Dyke, Zoe Weaver Ohler,
Ludmila Szabova, Sujata Bupp, Yurong
Song, Chaoying Yin.
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48439
Intellectual Property: Research use—
no patent protection will be sought.
Publications:
1. Szabova L., Yin C., Bupp S., et al.
Perturbation of Rb, p53 and Brca1
or Brca2 cooperate in inducing
metastatic serous epithelial ovarian
cancer. Cancer research.
2012;72(16):4141–4153.
2. Szabova L., Bupp S., Kamal M., et al.
Pathway-Specific Engineered
Mouse Allograft Models
Functionally Recapitulate Human
Serous Epithelial Ovarian Cancer.
Katoh M., ed. PLoS ONE.
2014;9(4):e95649.
Collaboration Opportunity:
Researchers at the NCI seek licensing
and/or co-development research
collaborations for the commercialization
of agents for the treatment of SEOC.
Contact Information: Requests for
copies of the patent application or
inquiries about licensing, research
collaborations, and co-development
opportunities should be sent to John D.
Hewes, Ph.D., email: john.hewes@
nih.gov.
Dated: July 11, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–17419 Filed 7–22–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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: National Heart, Lung,
and Blood Institute Special Emphasis Panel
Pediatric Heart Network Clinical Research
Centers (UG1).
Date: August 17–18, 2016
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\25JYN1.SGM
25JYN1
48440
Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Notices
Place: The Dupont Circle Hotel, 1500 New
Hampshire Avenue NW., Washington, DC
20036.
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
sunnarborgsw@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)
Dated: July 19, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–17421 Filed 7–22–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 19, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
[FR Doc. 2016–17420 Filed 7–22–16; 8:45 am]
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Heart, Lung, and Blood
Advisory Council.
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: National Heart, Lung,
and Blood Advisory Council.
Date: August 30, 2016.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 9100, Bethesda, MD
20892 (Teleconference).
Contact Person: Valerie L. Prenger, Ph.D.,
MPH, Acting Division Director, Division of
mstockstill on DSK3G9T082PROD with NOTICES
Extramural Research Activities, National
Heart, Lung, and Blood Institute, 6701
Rockledge Drive, Room 7214, Bethesda, MD
20892–7924, 301–435–0270, prengerv@
nhlbi.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/nhlbac/
index.htm, where an agenda and any
additional information for the meeting will
be posted when available.
(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)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Project: Mental Health First Aid
Evaluation-NEW
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Mental Health
Services (CMHS) is requesting approval
from the Office of Management and
Budget (OMB) for new data collection
Number of
respondents
Instrument/Activity
MHFA/YMHFA Pre-Training Survey ....................................
MHFA/YMHFA Post-Training Survey ..................................
MHFA/YMHFA 3-Month Follow-Up Survey .........................
MHFA/YMHFA 6-Month Follow-Up Survey .........................
Qualitative Interviews ...........................................................
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Responses
per
respondent
22,800
22,800
19,380
17,100
23
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activities associated with its Mental
Health First Aid (MHFA) program.
This information is needed to
evaluate implementation of MHFA and
Youth Mental Health First Aid in three
distinct grant programs: Project
Advancing Wellness and Resilience in
Education (AWARE) State Education
Agency (SEA) Cooperative Agreements,
which provide funding to support
MHFA and YMHFA training to state
education agencies; Project AWARE
Local Education Agency (LEA) Grants,
which provide funding to school
districts; and Project AWARE
Community (C), a new funding
opportunity in fiscal year 2015 that is
intended to support MHFA and YMHFA
training through a wide range of
community organizations.
The MHFA/YMHFA evaluation will
address both overarching and programspecific questions related to the
implementation and effectiveness of
widespread dissemination of mental
health literacy programs through these
three distinct funding mechanisms and
increase SAMHSA’s understanding of
training, referral benefits, and issues in
varied milieu (e.g., implementation
climate, leadership). These evaluation
questions are essential to address
because, although MHFA/YMHFA has a
track record and well-articulated theory
of action, it is vital for SAMHSA to be
able to identify factors that are expected
to increase or decrease the extent
MHFA/YMHFA is disseminated and
implemented with quality.
This data collection is covered under
the requirements of Public Law 103–62,
the Government Performance and
Results Act (GPRA) of 1993, Title 38,
section 527, Evaluation and Data
Collection, as well as 38 CFR 1.15,
Standards for Program Evaluation.
SAMHSA is requesting clearance for
four data collection instruments:
(1) MHFA/YMHFA Pre-Training
Survey
(2) MHFA/YMHFA Post-Training
Survey
(3) MHFA/YMHFA 3-Month and 6Month Follow-Up Survey
(4) Qualitative protocol for interviews
with site coordinators
The table below reflects the
annualized hourly burden.
Total
responses
1
1
1
1
1
E:\FR\FM\25JYN1.SGM
22,800
22,800
19,380
17,100
23
25JYN1
Hours per
response
.33
.25
.17
.17
.75
Total burden
hours
7,524
5,700
3,294
2,907
17.25
Agencies
[Federal Register Volume 81, Number 142 (Monday, July 25, 2016)]
[Notices]
[Pages 48439-48440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17421]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; 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: National Heart, Lung, and Blood Institute
Special Emphasis Panel Pediatric Heart Network Clinical Research
Centers (UG1).
Date: August 17-18, 2016
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
[[Page 48440]]
Place: The Dupont Circle Hotel, 1500 New Hampshire Avenue NW.,
Washington, DC 20036.
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 sunnarborgsw@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)
Dated: July 19, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-17421 Filed 7-22-16; 8:45 am]
BILLING CODE 4140-01-P