81 FR 48439 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 142 (July 25, 2016)

Page Range		48439-48440
FR Document		2016-17421

Federal Register, Volume 81 Issue 142 (Monday, July 25, 2016)

[Federal Register Volume 81, Number 142 (Monday, July 25, 2016)]
[Notices]
[Pages 48439-48440]
From the Federal Register Online  [www.thefederalregister.org]
[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 [email protected]

(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

Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Notices 48439

Child Health and Human Development, NIH, cell lines, and orthotopic models based Intellectual Property: Research use—
6710B Rockledge Drive, Room 2314, on Rb, p53 and/or Brca 1/2 inactivation no patent protection will be sought.
Bethesda, MD 20892, (301) 496–8535, useful for biomarker discovery and Publications:
dhann@mail.nih.gov. preclinical testing. 1. Szabova L., Yin C., Bupp S., et al.
(Catalogue of Federal Domestic Assistance Description of Technology: The high Perturbation of Rb, p53 and Brca1
Program Nos. 93.864, Population Research; mortality rate from ovarian cancers can or Brca2 cooperate in inducing
93.865, Research for Mothers and Children;
be attributed to late-stage diagnosis and metastatic serous epithelial ovarian
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and lack of effective treatment. Despite cancer. Cancer research.
Infertility Loan Repayment Program, National enormous effort to develop better 2012;72(16):4141–4153.
Institutes of Health, HHS) targeted therapies, platinum-based 2. Szabova L., Bupp S., Kamal M., et al.
Dated: July 19, 2016. chemotherapy still remains the standard Pathway-Specific Engineered
Michelle Trout, of care for ovarian cancer patients, and Mouse Allograft Models
resistance occurs at a high rate. One of Functionally Recapitulate Human
Program Analyst, Office of Federal Advisory
Committee Policy. the rate limiting factors for translation of Serous Epithelial Ovarian Cancer.
new drug discoveries into clinical Katoh M., ed. PLoS ONE.
[FR Doc. 2016–17423 Filed 7–22–16; 8:45 am] treatments has been the lack of suitable 2014;9(4):e95649.
BILLING CODE 4140–01–P preclinical cancer models with high Collaboration Opportunity:
predictive value. Researchers at the NCI seek licensing
NCI CAPR has developed Tri-allelic and/or co-development research
DEPARTMENT OF HEALTH AND K18–T121 tg/∂ /Brca1 fl/fl /p53 fl/fl SEOC
HUMAN SERVICES collaborations for the commercialization
GEM Model, GEM-derived SEOC of agents for the treatment of SEOC.
National Institutes of Health orthotopic mouse model, and biological Contact Information: Requests for
materials derived therefrom, with copies of the patent application or
Government-Owned Inventions; several key histopathologic, inquiries about licensing, research
Availability for Licensing immunophenotypical, and genetic collaborations, and co-development
features of human SEOC. SEOC GEMs opportunities should be sent to John D.
AGENCY: National Institutes of Health, were utilized to create orthotopic Hewes, Ph.D., email: john.hewes@
HHS. immunocompetent transplant models, nih.gov.
ACTION: Notice. and to generate synchronized cohorts of Dated: July 11, 2016.
mice suitable for preclinical studies.
SUMMARY: The invention listed below is John D. Hewes,
NCI CAPR conducted studies that
owned by an agency of the U.S. determine these models are tractable for Technology Transfer Specialist, Technology
Government and is available for Transfer Center, National Cancer Institute.
use in routine efficacy studies and
licensing and/or co-development in the demonstrate the utility of these models [FR Doc. 2016–17419 Filed 7–22–16; 8:45 am]
U.S. in accordance with 35 U.S.C. 209 in evaluating the potential efficacy of BILLING CODE 4140–01–P
and 37 CFR part 404 to achieve novel therapeutics for ovarian cancer.
expeditious commercialization of Potential Commercial Applications:
results of federally-funded research and DEPARTMENT OF HEALTH AND
• These models serve as a foundation
development. Foreign patent HUMAN SERVICES
for preclinical research and evaluation
applications are filed on selected of efficacy of novel therapeutics for
inventions to extend market coverage National Institutes of Health
ovarian cancer.
for companies and may also be available • The GEM models described here National Heart, Lung, and Blood
for licensing and/or co-development. can be used to develop cell lines and Institute; Notice of Closed Meeting
ADDRESSES: Invention Development and allograft models for evaluating drug
Marketing Unit, Technology Transfer potency relative to Brca1 mutation Pursuant to section 10(d) of the
Center, National Cancer Institute, 9609 status. Federal Advisory Committee Act, as
Medical Center Drive, Mail Stop 9702, • These mouse models provide the amended (5 U.S.C. App.), notice is
Rockville, MD, 20850–9702. opportunity for evaluation of effective hereby given of the following meeting.
FOR FURTHER INFORMATION CONTACT: therapeutics, including prediction of The meeting will be closed to the
Information on licensing and co- differential responses in Brca1-wild public in accordance with the
development research collaborations, type and Brca1–deficient tumors and provisions set forth in sections
and copies of the U.S. patent development of relevant biomarkers. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
applications listed below may be Value Proposition: as amended. The grant applications and
obtained by contacting: Attn. Invention • Novel resource for evaluating the discussions could disclose
Development and Marketing Unit, disease etiology and biomarkers, confidential trade secrets or commercial
Technology Transfer Center, National therapeutic evaluation, and improved property such as patentable material,
Cancer Institute, 9609 Medical Center imaging strategies in epithelial ovarian and personal information concerning
Drive, Mail Stop 9702, Rockville, MD cancer individuals associated with the grant
20850–9702, Tel. 240–276–5515 or • Similarity to human ovarian cancer applications, the disclosure of which
email ncitechtransfer@mail.nih.gov. A based on transcriptional profiling would constitute a clearly unwarranted
signed Confidential Disclosure • Suitable preclinical cancer models invasion of personal privacy.
mstockstill on DSK3G9T082PROD with NOTICES

Agreement may be required to receive with high predictive value. Name of Committee: National Heart, Lung,
copies of the patent applications. Development Stage: Pre-clinical (in and Blood Institute Special Emphasis Panel
Pediatric Heart Network Clinical Research
SUPPLEMENTARY INFORMATION: vivo validation).
Centers (UG1).
Technology description follows. Inventor(s): Simone Difilippantonio, Date: August 17–18, 2016
Title of invention: Novel metastatic Terry Van Dyke, Zoe Weaver Ohler, Time: 8:30 a.m. to 5:00 p.m.
serous epithelial ovarian cancer (SEOC) Ludmila Szabova, Sujata Bupp, Yurong Agenda: To review and evaluate grant
genetically engineered mouse models, Song, Chaoying Yin. applications.

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48440 Federal Register / Vol. 81, No. 142 / Monday, July 25, 2016 / Notices

Place: The Dupont Circle Hotel, 1500 New Extramural Research Activities, National activities associated with its Mental
Hampshire Avenue NW., Washington, DC Heart, Lung, and Blood Institute, 6701 Health First Aid (MHFA) program.
20036. Rockledge Drive, Room 7214, Bethesda, MD This information is needed to
Contact Person: Susan Wohler Sunnarborg, 20892–7924, 301–435–0270, prengerv@
Ph.D., Scientific Review Officer, Office of nhlbi.nih.gov.
evaluate implementation of MHFA and
Scientific Review/DERA, National, Heart, Youth Mental Health First Aid in three
Any interested person may file written
Lung, and Blood Institute 6701 Rockledge comments with the committee by forwarding
distinct grant programs: Project
Drive, Room 7182, Bethesda, MD 20892 the statement to the Contact Person listed on Advancing Wellness and Resilience in
sunnarborgsw@nhlbi.nih.gov this notice. The statement should include the Education (AWARE) State Education
(Catalogue of Federal Domestic Assistance name, address, telephone number and when Agency (SEA) Cooperative Agreements,
Program Nos. 93.233, National Center for applicable, the business or professional which provide funding to support
Sleep Disorders Research; 93.837, Heart and affiliation of the interested person. MHFA and YMHFA training to state
Vascular Diseases Research; 93.838, Lung Information is also available on the education agencies; Project AWARE
Diseases Research; 93.839, Blood Diseases Institute’s/Center’s home page:
and Resources Research, National Institutes Local Education Agency (LEA) Grants,
www.nhlbi.nih.gov/meetings/nhlbac/ which provide funding to school
of Health, HHS) index.htm, where an agenda and any
additional information for the meeting will
districts; and Project AWARE
Dated: July 19, 2016.
be posted when available. Community (C), a new funding
Michelle Trout,
(Catalogue of Federal Domestic Assistance
opportunity in fiscal year 2015 that is
Program Analyst, Office of Federal Advisory intended to support MHFA and YMHFA
Committee Policy. Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and training through a wide range of
[FR Doc. 2016–17421 Filed 7–22–16; 8:45 am] community organizations.
Vascular Diseases Research; 93.838, Lung
BILLING CODE 4140–01–P Diseases Research; 93.839, Blood Diseases The MHFA/YMHFA evaluation will
and Resources Research, National Institutes address both overarching and program-
of Health, HHS) specific questions related to the
DEPARTMENT OF HEALTH AND
Dated: July 19, 2016. implementation and effectiveness of
HUMAN SERVICES
Michelle Trout, widespread dissemination of mental
National Institutes of Health Program Analyst, Office of Federal Advisory health literacy programs through these
Committee Policy. three distinct funding mechanisms and
National Heart, Lung, and Blood [FR Doc. 2016–17420 Filed 7–22–16; 8:45 am] increase SAMHSA’s understanding of
Institute; Notice of Meeting BILLING CODE 4140–01–P
training, referral benefits, and issues in
varied milieu (e.g., implementation
Pursuant to section 10(d) of the climate, leadership). These evaluation
Federal Advisory Committee Act, as questions are essential to address
DEPARTMENT OF HEALTH AND
amended (5 U.S.C. App.), notice is because, although MHFA/YMHFA has a
HUMAN SERVICES
hereby given of a meeting of the track record and well-articulated theory
National Heart, Lung, and Blood Substance Abuse and Mental Health of action, it is vital for SAMHSA to be
Advisory Council. Services Administration able to identify factors that are expected
The meeting will be closed to the to increase or decrease the extent
public in accordance with the Agency Information Collection MHFA/YMHFA is disseminated and
provisions set forth in sections Activities: Submission for OMB implemented with quality.
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Review; Comment Request This data collection is covered under
as amended. The grant applications and
Periodically, the Substance Abuse and the requirements of Public Law 103–62,
the discussions could disclose
Mental Health Services Administration the Government Performance and
confidential trade secrets or commercial
property such as patentable material, (SAMHSA) will publish a summary of Results Act (GPRA) of 1993, Title 38,
and personal information concerning information collection requests under section 527, Evaluation and Data
individuals associated with the grant OMB review, in compliance with the Collection, as well as 38 CFR 1.15,
applications, the disclosure of which Paperwork Reduction Act (44 U.S.C. Standards for Program Evaluation.
would constitute a clearly unwarranted Chapter 35). To request a copy of these SAMHSA is requesting clearance for
invasion of personal privacy. documents, call the SAMHSA Reports four data collection instruments:
Clearance Officer on (240) 276–1243. (1) MHFA/YMHFA Pre-Training
Name of Committee: National Heart, Lung,
and Blood Advisory Council.
Survey
Project: Mental Health First Aid (2) MHFA/YMHFA Post-Training
Date: August 30, 2016.
Time: 1:00 p.m. to 3:00 p.m. Evaluation-NEW Survey
Agenda: To review and evaluate grant The Substance Abuse and Mental (3) MHFA/YMHFA 3-Month and 6-
applications. Health Services Administration’s Month Follow-Up Survey
Place: National Institutes of Health, 6701
Rockledge Drive, Room 9100, Bethesda, MD (SAMHSA) Center for Mental Health (4) Qualitative protocol for interviews
20892 (Teleconference). Services (CMHS) is requesting approval with site coordinators
Contact Person: Valerie L. Prenger, Ph.D., from the Office of Management and The table below reflects the
MPH, Acting Division Director, Division of Budget (OMB) for new data collection annualized hourly burden.

Responses
Number of Total Hours per Total burden
mstockstill on DSK3G9T082PROD with NOTICES

Instrument/Activity per
respondents responses response hours
respondent

MHFA/YMHFA Pre-Training Survey .................................... 22,800 1 22,800 .33 7,524
MHFA/YMHFA Post-Training Survey .................................. 22,800 1 22,800 .25 5,700
MHFA/YMHFA 3-Month Follow-Up Survey ......................... 19,380 1 19,380 .17 3,294
MHFA/YMHFA 6-Month Follow-Up Survey ......................... 17,100 1 17,100 .17 2,907
Qualitative Interviews ........................................................... 23 1 23 .75 17.25

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Document Created: 2016-07-23 02:00:43
Document Modified: 2016-07-23 02:00:43

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		August 17-18, 2016
FR Citation		81 FR 48439

81 FR 48439 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 142 (July 25, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health