30-day FRN

30-day 2016-05910.pdf

NIH Information Collection Forms to Support Genomic Data Sharing for Research Purposes (OD)

30-day FRN

OMB: 0925-0670

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Federal Register / Vol. 81, No. 51 / Wednesday, March 16, 2016 / Notices

Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Jose H. Guerrier, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1137, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurogenesis During Development
and in Adulthood.
Date: April 8, 2016.
Time: 11:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Nicholas Gaiano, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5178,
MSC 7844, Bethesda, MD 20892–7844, 301–
435–1033, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Hematology and Vascular Biology.
Date: April 11–12, 2016.
Time: 10:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Anshumali Chaudhari,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4124,
MSC 7802, Bethesda, MD 20892, 301–435–
1210, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA RM13–
007: New Innovator Award.
Date: April 13–14, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Baltimore—Inner
Harbor, 222 St Paul Place, Baltimore, MD
21202.
Contact Person: Rajiv Kumar, Ph.D., Chief,
MOSS IRG, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 4216, MSC 7802, Bethesda, MD
20892, 301–435–1212, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 11, 2016.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05963 Filed 3–15–16; 8:45 am]
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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;
Clinical Research in HIV/HLB Diseases.
Date: Date: April 12, 2016.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Dupont Circle Hotel, 1500 New
Hampshire Ave. NW., Washington, DC
20036.
Contact Person: Stephanie L. Constant,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7189, Bethesda, MD 20892, 301–
443–8784, [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: March 11, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05965 Filed 3–15–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; NIH Information
Collection Forms To Support Genomic
Data Sharing for Research Purposes
(OD)
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

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to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on December 1,
2015, page 75120 and allowed 60 days
for public comment. A public comment
was received. The purpose of this notice
is to allow an additional 30 days for
public comment. The Office of the
Director (OD), National Institutes of
Health, 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.
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: NIH Desk Officer.
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.
For Further Information Contact: To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Dina Paltoo, Office of Science
Policy, 6705 Rockledge Drive or call
non-toll-free number (301) 496–9838 or
Email your request, including your
address to: [email protected]. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Forms to
Support Genomic Data Sharing for
Research Purposes, 0925–0670,
Expiration Date 03/31/2016—
REVISION, Office of the Director, OD,
National Institutes of Health (NIH).
Need and Use of Information
Collection: Sharing research data
supports the NIH mission and is
essential to facilitate the translation of
research results into knowledge,
products, and procedures that improve
human health. The NIH has
longstanding policies to make a broad
range of research data, including
genomic data, publicly available in a
timely manner from the research
activities that it funds. Genomic
research data sharing is an integral
element of the NIH mission as it
facilitates advances in our
understanding of factors that influence
health and disease, while also providing

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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

Study Registration and Data
Submission.
Requesting Access to Data ...
Renewal/project Close-out
Process.

Grand Total ....................

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

2

15/60

317

Signing Official to Certify Request.

633 (same individuals as listed above).
633 (same individuals as listed above).

2

18/60

380

...............................................

1,566 .....................................

5,064

........................

2,505

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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

mstockstill on DSK4VPTVN1PROD with NOTICES

National Institutes of Health

18:11 Mar 15, 2016

Total annual
burden hour

Number of respondents

Dated: March 10, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.

VerDate Sep<11>2014

Average
burden per
response
(in hours)

Number of
responses per
respondent

Type of respondent

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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, [email protected].
(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

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