Proposed Collection; Comment Request; NIH Neurobiobank Tissue Access Request, 8723-8724 [2014-03204]
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Federal Register / Vol. 79, No. 30 / Thursday, February 13, 2014 / Notices
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Dated: February 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–03139 Filed 2–12–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (DHHS)
National Institutes of Health
Proposed Collection; Comment
Request; NIH Neurobiobank Tissue
Access Request
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH), will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on 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,
SUMMARY:
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Keisha Shropshire,
NIMH Project Clearance Liaison,
Science Policy and Evaluation Branch,
OSPPC, NIMH, NIH, Neuroscience
Center, 6001 Executive Boulevard, MSC
9667, Rockville Pike, Bethesda, MD
20892, or call 301–443–4335 or Email
your request, including your address to:
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
received within 60 days of the date of
this publication will receive fullest
consideration.
Proposed Collection: National
Institute of Health Neurobiobank Tissue
Access Request–0925–New. National
Institute of Mental Health (NIMH),
National Institute of Health (NIH).
Need and Use of Information
Collection: The NIH Neurobiobank
Tissue Access Request form is necessary
for ‘‘Recipient’’ Principal Investigators
and their organization or corporations
with approved assurance from the
DHHS Office of Human Research
Protections to access tissue or
biospecimens from the National
Neurobiobank for research purposes.
The primary use of this information is
to document, track, monitor, and
evaluate the appropriate use of the
Neurobiobank tissue and biospecimen
resources, as well as to notify interested
recipients of updates, corrections or
other changes to the system.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
63.
ESTIMATES ANNUAL BURDEN HOURS
Number of
respondents
emcdonald on DSK67QTVN1PROD with NOTICES
Form
Neurobiobank Tissue Access Request ............................................................
Pre-Mortem Consent and Medical History ......................................................
Frequency of
response
50
50
1
1
Total ..........................................................................................................
VerDate Mar<15>2010
18:44 Feb 12, 2014
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Sfmt 4703
Average
time per
response
(in hours)
15/60
1
Annual
hour
burden
13
50
63
E:\FR\FM\13FEN1.SGM
13FEN1
8724
Federal Register / Vol. 79, No. 30 / Thursday, February 13, 2014 / Notices
Dated: January 29, 2014.
Keisha Shropshire,
Project Clearance Officer, NIMH, NIH.
[FR Doc. 2014–03204 Filed 2–12–14; 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 inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing 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.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
emcdonald on DSK67QTVN1PROD with NOTICES
Tumor Infiltrating Lymphocytes From
Human Papillomavirus-Positive
Tumors for the Treatment of Cancer
Description of Technology: Human
papillomaviruses (HPV) cause
anogenital and oropharyngeal cancers,
and these malignancies express viral
oncoproteins that can be recognized by
T cells. When HPV-associated cancers
spread they are incurable and difficult
to palliate with existing treatments.
Tumor infiltrating lymphocytes (TIL)
have been used successfully to treat
advanced stage malignant melanoma,
however their use has been primarily
limited to this disease. This technology
describes a novel TIL therapy for
treating HPV-associated cancers. The
NIH inventors have found TIL can be
grown from HPV positive tumors at
grade and scale suitable for clinical use
and that they can recognize the HPV
oncoproteins that drive transformation
and survival of cancer cells. The
VerDate Mar<15>2010
18:44 Feb 12, 2014
Jkt 232001
inventors have initiated a clinical trial
for the treatment of advanced HPV
positive cancers that are refractory to
standard chemotherapy using HPV–TIL.
Early results of the clinical trial suggest
that HPV–TIL has activity in
chemotherapy-refractory advanced
disease for which no standard treatment
options are available.
Potential Commercial Applications:
HPV–TIL therapy is a novel treatment
approach that may mediate long-lasting
tumor regression from a single dose of
cells.
Competitive Advantages: Early
clinical results suggest that HPV–TIL
has activity in chemotherapy-refractory
advanced disease for which no standard
treatment options are available.
Development Stage: In vitro data
available (human)
Inventors: Christian Hinrichs and
Steven A. Rosenberg (NCI)
Publications:
1. Piersma SJ, et al. Human papilloma
virus specific T cells infiltrating cervical
cancer and draining lymph nodes show
remarkably frequent use of HLA–DQ
and –DP as a restriction element. Int J
Cancer 2008 Feb 1;122(3):486–94.
[PMID 17955486]
2. de Vos van Steenwijk PJ, et al. An
unexpectedly large polyclonal repertoire
of HPV-specific T cells is poised for
action in patients with cervical cancer.
Cancer Res. 2010 Apr 1;70(7):2707–17.
[PMID 20233872]
Intellectual Property: HHS Reference
No. E–494–2013/0—US Provisional
Application No. 61/846,161 filed 15 July
2013
Related Technology: HHS Reference
No. E–495–2013/0—US Provisional
Application No. 61/846,167 filed 15 July
2013
Licensing Contact: Whitney A.
Hastings; 301–451–7337;
hastingw@mail.nih.gov
Improved Culture Medium for Stem
Cell Maintenance and Differentiation
Description of Technology: A novel
low protein culture medium with
defined chemical components that
allows pluripotent stem cell
maintenance and differentiation is
disclosed. The present technology also
provides for production of high quality
cardiac cells from human embryonic
and induced pluripotent stem cells in
chemically defined medium conditions.
Human pluripotent stem cells,
including human embryonic stem cells
and human induced pluripotent stem
cells, can be propagated indefinitely
while still retaining the capacity to
differentiate into all somatic cell types,
and are a potentially inexhaustible
supply of human cells. The capacity to
PO 00000
Frm 00047
Fmt 4703
Sfmt 9990
sustain survival at high density is
critical for maintaining consistent stem
cell cultures and avoiding the
development of abnormal stem cells,
and for proper stem cell differentiation.
Also, it is essential to have high quality
stem cells for all personalized cellular
therapies. NIH investigators developed a
low protein medium that supports the
proliferation and differentiation of stem
cells comprising one or more of a
volume expander, a lipid mix and a
growth factor modulator. Also, the
investigators have used the new
medium to produce high quality cardiac
cells from human embryonic and
induced pluripotent stem cells.
Potential Commercial Applications:
• Improved defined medium to grow,
maintain and differentiate stem cells.
• This medium can be used to
develop culture systems that could be
used to generate specific cell types for
potential clinical applications.
Competitive Advantages: This new
medium could significantly improve
progenitor cell derivation from
embryonic stem cells and induced
pluripotent stem cells and could have
great usage in future translational
applications.
Development Stage:
• Early-stage
• In vitro data available
• In vivo data available (animal)
Inventors: Guokai Chen and
Yongshun Lin (NHLBI)
Intellectual Property: HHS Reference
No. E–089–2013/0—US Provisional
Application No. 61/879,840 filed 19
September 2013
Licensing Contact: Sury Vepa, Ph.D.,
J.D.; 301–435–5020; vepas@mail.nih.gov
Collaborative Research Opportunity:
The National Heart, Lung, and Blood
Institute is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize Stem Cell Culture
Medium. For collaboration
opportunities, please contact Peg
Koelble at koelblep@nhlbi.nih.gov.
Dated: February 10, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–03083 Filed 2–12–14; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 79, Number 30 (Thursday, February 13, 2014)]
[Notices]
[Pages 8723-8724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03204]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS)
National Institutes of Health
Proposed Collection; Comment Request; NIH Neurobiobank Tissue
Access Request
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Mental
Health (NIMH), National Institutes of Health (NIH), will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on 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.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Keisha
Shropshire, NIMH Project Clearance Liaison, Science Policy and
Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001
Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or
call 301-443-4335 or Email your request, including your address to:
nimhprapubliccomments@mail.nih.gov. Formal requests for additional
plans and instruments must be requested in writing.
Comment Due Date: Comments received within 60 days of the date of
this publication will receive fullest consideration.
Proposed Collection: National Institute of Health Neurobiobank
Tissue Access Request-0925-New. National Institute of Mental Health
(NIMH), National Institute of Health (NIH).
Need and Use of Information Collection: The NIH Neurobiobank Tissue
Access Request form is necessary for ``Recipient'' Principal
Investigators and their organization or corporations with approved
assurance from the DHHS Office of Human Research Protections to access
tissue or biospecimens from the National Neurobiobank for research
purposes. The primary use of this information is to document, track,
monitor, and evaluate the appropriate use of the Neurobiobank tissue
and biospecimen resources, as well as to notify interested recipients
of updates, corrections or other changes to the system.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 63.
Estimates Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Form Number of Frequency of per response Annual hour
respondents response (in hours) burden
----------------------------------------------------------------------------------------------------------------
Neurobiobank Tissue Access Request.............. 50 1 15/60 13
Pre-Mortem Consent and Medical History.......... 50 1 1 50
---------------------------------------------------------------
Total....................................... 63
----------------------------------------------------------------------------------------------------------------
[[Page 8724]]
Dated: January 29, 2014.
Keisha Shropshire,
Project Clearance Officer, NIMH, NIH.
[FR Doc. 2014-03204 Filed 2-12-14; 8:45 am]
BILLING CODE 4140-01-P
