Submission for OMB Review; Comment Request: National Institutes of Health Information Collection Forms To Support Genomic Data Sharing for Research Purposes, 6119-6120 [2013-01851]
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Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices
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[FR Doc. 2013–01876 Filed 1–28–13; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request: National Institutes
of Health Information Collection Forms
To Support Genomic Data Sharing for
Research Purposes
PHS, DHHS, National Institutes
of Health (NIH).
ACTION: Request for comments
AGENCY:
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on October 5, 2012 (77 FR
61008), and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. NIH may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
SUMMARY:
October 1, 1995, unless it displays a
currently valid OMB control number.
Proposed Collection: Title: National
Institutes of Health Information
Collection Forms to Support Genomic
Data Sharing for Research Purposes;
Type of Information Collection Request:
New; Need and Use of Information
Collection: The NIH mission is to seek
fundamental knowledge about the
nature and behavior of living systems
and the application of that knowledge to
enhance health, lengthen life, and
reduce the burdens of illness and
disability. The sharing of research data
supports this mission and is essential to
facilitate the translation of research
results into knowledge, products,
practices, and procedures that improve
human health.
By enabling secondary research
questions to be addressed, data sharing
maximizes the public benefit achieved
through research investments. NIH’s
Policy for Sharing of Data Obtained in
NIH Supported or Conducted GenomeWide Association Studies (GWAS) was
established to enable the full value of
GWAS data to be realized. GWAS data
are maintained in a central data
repository, the database of Genotypes
and Phenotypes (dbGaP), which is
administered by the National Center for
Biotechnology Information (NCBI), part
of the National Library of Medicine at
NIH.
As stipulated in the NIH GWAS
Policy, all principal investigators (PIs)
who receive NIH funding to conduct
genomic research are expected to
register studies with genomic data in
dbGaP. The nature of the genomic,
phenotypic, and other associated data
generated through large-scale human
genomic studies requires responsible
stewardship throughout research and
data sharing activities. Since the data
being collected and shared are from
human research participants, the
protection of participant interests is
paramount. PIs submitting data to
dbGaP must describe any limitations on
sharing the data, as defined in the
Study Registration and Data Submission:
PI ..............................................................................................
Senior Official ..................................................................................
srobinson on DSK4SPTVN1PROD with
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondent
informed consent provided by the
participants from whom the data were
originally collected. PIs must also
provide basic study information such as
the type of data that will be submitted
to dbGaP and a description of the study.
Researchers interested in using dbGaP
data for secondary research must submit
a request through dbGaP and be granted
permission from the relevant NIH Data
Access Committees to access the data.
As part of the request process,
researchers must provide information
such as a description of the proposed
research use of the dbGaP datasets, a
data security plan, and a Data Use
Certification, in which the researcher
agrees to the terms and conditions for
use of the data. NIH has developed
online forms, which will be available
through dbGaP, in an effort to reduce
the burden for researchers to complete
the study registration, data submission,
and data access processes.
Frequency of Response: As necessary.
Description of Respondents: PIs and
senior officials from their institutions.
Estimate of Burden: The burden
associated with this information
collection is calculated in two parts: (1)
the burden associated with registering
genomic studies and submitting data to
dbGaP and (2) the burden associated
with applying for genomic data in
dbGaP. The annual reporting burden for
study registration and data submission
is as follows: Estimated Number of
Respondents: 100; Estimated Number of
Responses per Respondent: 1; and
Estimated Total Annual Burden Hours
Requested: 63. The annual cost to
respondents is estimated at $2,506. The
annual reporting burden for applying for
genomic data in dbGaP is as follows:
Estimated Number of Respondents: 1,
266; Estimated Number of Responses
per Respondent: 2; and Estimated Total
Annual Burden Hours Requested: 1,583.
The annual cost to respondents is
estimated at $63,452. There are no
capital, operating, or maintenance costs
to the respondents.
Average
burden per
response
(in hours)
Estimated total
annual burden
hours
50
50
1
1
45/60
30/60
38
25
Total ...................................................................................
Data Access Request:
PI ..............................................................................................
Senior Official ..................................................................................
100
............................
............................
63
633
633
2
2
45/60
30/60
950
633
Total ...................................................................................
1,266
............................
............................
1,583
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6120
Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Notices
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instrument, contact: Sarah
Carr, Acting Director, Office of Clinical
Research and Bioethics Policy, Office of
Science Policy, NIH, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892;
telephone 301–496–9838; fax 301–496–
9839; or email GWAS@od.nih.gov,
Attention: Ms. Carr.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: January 18, 2013.
Sarah Carr,
Acting Director, Office of Clinical Research
and Bioethics Policy, Office of Science Policy,
National Institutes of Health.
[FR Doc. 2013–01851 Filed 1–28–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSK4SPTVN1PROD with
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
VerDate Mar<15>2010
16:47 Jan 28, 2013
Jkt 229001
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. 207 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:
Novel Derivatives of
Docosahexaenoylethanolamide as
Therapeutics for Neuronal Disorders
Description of Technology: This
technology provides derivatives of
Docosahexaenoylethanolamide
(synaptamide or DEA) which have
increased potency and hydrolysis
resistance as compared to DEA
(structures of these derivatives are
available upon request), as well as
methods of using these derivatives to
promote neurogenesis, neurite growth,
and/or synaptogenesis.
Docosahexaenoic acid (DHA), an n-3
polyunsaturated fatty acid that
accumulates in the brain during
development, has been shown to play a
key role in learning and memory
development. Studies have also shown
that DEA, a metabolite derived from
DHA is very potent in accelerating
neuronal growth and development. The
inventors have discovered that the novel
DEA derivatives they have designed are
even more potent than DEA or DHA in
accelerating neuronal growth,
synaptogenesis and development. The
inventors have shown that treatment of
progenitor neural cells with some of
these novel DEA derivatives leads to an
increase in the amount of somatic
neurons produced after differentiation.
These novel compounds can be
developed as therapeutics for conditions
such as trauma, stroke, multiple
sclerosis, Alzheimer’s disease, brain and
spinal cord injuries, and peripheral
nerve injuries for rehabilitation.
Potential Commercial Applications:
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• Agents to promote neurogenesis,
neurite growth, and synaptogenesis.
• Therapeutics for neurological
conditions, such as traumatic brain
injury, spinal cord injury, peripheral
nerve injury, stroke, multiple sclerosis,
autism, Alzheimer’s disease,
Huntington’s disease, Parkinson’s
disease, and amyotrophic lateral
sclerosis.
Competitive Advantages: These
derivatives of DEA provide increased
potency and hydrolysis resistance
compared to DEA.
Development Stage:
• Prototype.
• Early-stage.
• Pre-clinical.
• In vitro data available.
Inventors: Erika Englund (NCATS),
Juan Marugan (NCATS), Samarjit
Patnaik (NCATS), Hee-Yong Kim
(NIAAA)
Publications:
1. Kim HY, et al. NDocosahexaenoylethanolamide
promotes development of hippocampal
neurons. Biochem J. 2011 Apr
15;435(2):327–36. [PMID 21281269].
2. Kim HY, et al. A synaptogenic
amide N-docosahexaenoylethanolamide
promotes hippocampal development.
Prostaglandins Other Lipid Mediat.
2011 Nov;96(1–4):114–20. [PMID
21810478].
3. Cao D, et al. Docosahexaenoic acid
promotes hippocampal neuronal
development and synaptic function. J
Neurochem. 2009 Oct;111(2):510–21.
[PMID 19682204].
Intellectual Property: HHS Reference
No. E–070–2012/0 — U.S. Provisional
Application No. 61/624,741 filed 16 Apr
2012.
Licensing Contact: Suryanarayana
(Sury) Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov.
Collaborative Research Opportunity:
The National Center for Advancing
Translational Sciences is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize this technology. For
collaboration opportunities, please
contact Dr. Juan Marugan at
maruganj@mail.nih.gov or Dr. Krishna
Balakrishnan at balakrik@mail.nih.gov.
High-Affinity Rabbit Monoclonal
Antibodies to Mesothelin for Treatment
of Cancer
Description of Technology:
Mesothelin is a cell surface protein that
is highly expressed in aggressive
cancers, such as malignant
mesothelioma, ovarian cancer and
pancreatic cancer. Because of this
selective expression, mesothelin is an
E:\FR\FM\29JAN1.SGM
29JAN1
]]>Agencies
[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Pages 6119-6120]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01851]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request: National Institutes
of Health Information Collection Forms To Support Genomic Data Sharing
for Research Purposes
AGENCY: PHS, DHHS, National Institutes of Health (NIH).
ACTION: Request for comments
-----------------------------------------------------------------------
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request to
review and approve the information collection listed below. This
proposed information collection was previously published in the Federal
Register on October 5, 2012 (77 FR 61008), and allowed 60 days for
public comment. No public comments were received. The purpose of this
notice is to allow an additional 30 days for public comment. NIH may
not conduct or sponsor, and the respondent is not required to respond
to, an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Proposed Collection: Title: National Institutes of Health
Information Collection Forms to Support Genomic Data Sharing for
Research Purposes; Type of Information Collection Request: New; Need
and Use of Information Collection: The NIH mission is to seek
fundamental knowledge about the nature and behavior of living systems
and the application of that knowledge to enhance health, lengthen life,
and reduce the burdens of illness and disability. The sharing of
research data supports this mission and is essential to facilitate the
translation of research results into knowledge, products, practices,
and procedures that improve human health.
By enabling secondary research questions to be addressed, data
sharing maximizes the public benefit achieved through research
investments. NIH's Policy for Sharing of Data Obtained in NIH Supported
or Conducted Genome-Wide Association Studies (GWAS) was established to
enable the full value of GWAS data to be realized. GWAS data are
maintained in a central data repository, the database of Genotypes and
Phenotypes (dbGaP), which is administered by the National Center for
Biotechnology Information (NCBI), part of the National Library of
Medicine at NIH.
As stipulated in the NIH GWAS Policy, all principal investigators
(PIs) who receive NIH funding to conduct genomic research are expected
to register studies with genomic data in dbGaP. The nature of the
genomic, phenotypic, and other associated data generated through large-
scale human genomic studies requires responsible stewardship throughout
research and data sharing activities. Since the data being collected
and shared are from human research participants, the protection of
participant interests is paramount. PIs submitting data to dbGaP must
describe any limitations on sharing the data, as defined in the
informed consent provided by the participants from whom the data were
originally collected. PIs must also provide basic study information
such as the type of data that will be submitted to dbGaP and a
description of the study.
Researchers interested in using dbGaP data for secondary research
must submit a request through dbGaP and be granted permission from the
relevant NIH Data Access Committees to access the data. As part of the
request process, researchers must provide information such as a
description of the proposed research use of the dbGaP datasets, a data
security plan, and a Data Use Certification, in which the researcher
agrees to the terms and conditions for use of the data. NIH has
developed online forms, which will be available through dbGaP, in an
effort to reduce the burden for researchers to complete the study
registration, data submission, and data access processes.
Frequency of Response: As necessary.
Description of Respondents: PIs and senior officials from their
institutions.
Estimate of Burden: The burden associated with this information
collection is calculated in two parts: (1) the burden associated with
registering genomic studies and submitting data to dbGaP and (2) the
burden associated with applying for genomic data in dbGaP. The annual
reporting burden for study registration and data submission is as
follows: Estimated Number of Respondents: 100; Estimated Number of
Responses per Respondent: 1; and Estimated Total Annual Burden Hours
Requested: 63. The annual cost to respondents is estimated at $2,506.
The annual reporting burden for applying for genomic data in dbGaP is
as follows: Estimated Number of Respondents: 1, 266; Estimated Number
of Responses per Respondent: 2; and Estimated Total Annual Burden Hours
Requested: 1,583. The annual cost to respondents is estimated at
$63,452. There are no capital, operating, or maintenance costs to the
respondents.
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Estimated total
Type of respondent number of responses per per response (in annual burden
respondents respondent hours) hours
----------------------------------------------------------------------------------------------------------------
Study Registration and Data Submission:
PI.................................. 50 1 45/60 38
Senior Official......................... 50 1 30/60 25
-----------------------------------------------------------------------
Total........................... 100 ................ ................ 63
Data Access Request:
PI.................................. 633 2 45/60 950
Senior Official......................... 633 2 30/60 633
-----------------------------------------------------------------------
Total........................... 1,266 ................ ................ 1,583
----------------------------------------------------------------------------------------------------------------
[[Page 6120]]
Request For Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instrument, contact: Sarah Carr, Acting Director, Office of Clinical
Research and Bioethics Policy, Office of Science Policy, NIH, 6705
Rockledge Drive, Suite 750, Bethesda, MD 20892; telephone 301-496-9838;
fax 301-496-9839; or email GWAS@od.nih.gov, Attention: Ms. Carr.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: January 18, 2013.
Sarah Carr,
Acting Director, Office of Clinical Research and Bioethics Policy,
Office of Science Policy, National Institutes of Health.
[FR Doc. 2013-01851 Filed 1-28-13; 8:45 am]
BILLING CODE 4140-01-P
