National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting, 14119 [2016-05967]
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Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices
opportunities to accelerate research
through the power of combining large
and information-rich datasets. To
promote robust sharing of human and
non-human data from a wide range of
large-scale genomic research and
provide appropriate protections for
research involving human data, the NIH
issued the NIH Genomic Data Sharing
Policy (GDS Policy). Human genomic
data submissions and controlled-access
are managed through 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
the NIH.
Under the GDS Policy, all
investigators who receive NIH funding
to conduct large-scale genomic research
are expected to register studies with
human genomic data in dbGaP, no
matter which NIH-designated data
repository will maintain the data. As
a Data Use Certification agreement.
Requests to renew data access and
reports to close out data use are similar
to the initial data access request,
requiring sign-off by both the requestor
and the institution, but also ask for
information about how the data have
been used, and about publications,
presentations, or intellectual property
based on the research conducted with
the accessed data as well as any data
security issues or other data
management incidents.
The NIH has developed online forms,
available through dbGaP, in an effort to
reduce the burden for researchers and
their institutional officials to complete
the study registration, data submission,
data access, and renewal and closeout
processes.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2,505.
part of the registration process,
investigators must provide basic study
information such as the type of data that
will be submitted to dbGaP, a
description of the study, and an
institutional assurance (i.e. Institutional
Certification) of the data submission
which delineates any limitations on the
secondary use of the data (e.g., data
cannot be shared with for-profit
companies, data can be used only for
research of particular diseases).
Investigators interested in using
controlled-access data for secondary
research must apply through dbGaP and
be granted permission from the relevant
NIH Data Access Committee(s). As part
of the application process, investigators
and their institutions must provide
information such as a description of the
proposed research use of controlledaccess datasets that conforms to any
data use limitations, agree to the
Genomic Data User Code of Conduct,
and agree to the terms of access through
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total annual
burden hour
Requesting Access to Data ...
Renewal/project Close-out
Process.
Grand Total ....................
Number of respondents
Investigator Submitting Data
150 ........................................
1
1
150
Institutional Official to Certify
Submission.
Investigator Requesting Data
Signing Official to Certify Request.
Investigator Requesting Data
150 ........................................
1
30/60
75
633 ........................................
633 ........................................
2
2
45/60
30/60
950
633
633 (same individuals as listed above).
633 (same individuals as listed above).
2
15/60
317
Signing Official to Certify Request.
Study Registration and Data
Submission.
Type of respondent
2
18/60
380
...............................................
1,566 .....................................
5,064
........................
2,505
Dated: March 10, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Neurological
Disorders and Stroke, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
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 Board
of Scientific Counselors, National
Institute of Neurological Disorders and
Stroke.
Name of Committee: Board of Scientific
Counselors; National Institute of
Neurological Disorders and Stroke.
Date: April 24–26, 2016.
Time: 6:00 p.m. to 11:30 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
[FR Doc. 2016–05910 Filed 3–15–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Institutes of Health
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Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Alan P. Koretsky, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institute of Neurological
Disorders and Stroke, NIH, 35 Convent Drive,
Room 6A 908, Bethesda, MD 20892, (301)
435–2232, koretskya@ninds.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS).
Dated: March 11, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05967 Filed 3–15–16; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 81, Number 51 (Wednesday, March 16, 2016)]
[Notices]
[Page 14119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05967]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Neurological Disorders and Stroke; 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 a meeting of the
Board of Scientific Counselors, National Institute of Neurological
Disorders and Stroke.
The meeting will be closed to the public as indicated below in
accordance with the provisions set forth in sections 552b(c)(6), Title
5 U.S.C., as amended for the review, discussion, and evaluation of
individual intramural programs and projects conducted by the National
Institute of Neurological Disorders and Stroke, including consideration
of personnel qualifications and performance, and the competence of
individual investigators, the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy.
Name of Committee: Board of Scientific Counselors; National
Institute of Neurological Disorders and Stroke.
Date: April 24-26, 2016.
Time: 6:00 p.m. to 11:30 a.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Alan P. Koretsky, Ph.D., Scientific Director,
Division of Intramural Research, National Institute of Neurological
Disorders and Stroke, NIH, 35 Convent Drive, Room 6A 908, Bethesda,
MD 20892, (301) 435-2232, koretskya@ninds.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.853,
Clinical Research Related to Neurological Disorders; 93.854,
Biological Basis Research in the Neurosciences, National Institutes
of Health, HHS).
Dated: March 11, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-05967 Filed 3-15-16; 8:45 am]
BILLING CODE 4140-01-P
