Submission for OMB Review; 30-Day Comment Request Proposed Collection; 60-Day Comment Request; NIH Information Collection Forms To Support Genomic Data Sharing for Research Purposes (Office of Director), 37324-37326 [2019-16289]
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Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
Bureau, HRSA, 5600 Fishers Lane,
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SUPPLEMENTARY INFORMATION: ACBSCT
provides advice and recommendations
to the Secretary of HHS (Secretary) and
the HRSA Administrator on the
activities of the C.W. Bill Young Cell
Transplantation Program and the
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The principal purpose of these programs
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Members of the public will have the
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least three business days before the
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should notify Robert Walsh at the
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as amended. The grant applications and
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Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Resource-Related
Research Projects (R24).
Date: August 20, 2019.
Time: 10:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
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(Telephone Conference Call).
Contact Person: David C. Chang, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 5601
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20852 david.chang3@nih.gov.
Name of Committee: National Institute of
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Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement (U01
Clinical Trial Required).
Date: August 22, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Roberta Binder, Ph.D.
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G21A, National Institutes of Health/
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, (240) 669–5050,
rbinder@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
[FR Doc. 2019–16306 Filed 7–30–19; 8:45 am]
Dated: July 25, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4165–15–P
[FR Doc. 2019–16245 Filed 7–30–19; 8:45 am]
Maria G. Button,
Director, Division of the Executive Secretariat.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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.,
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National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Proposed
Collection; 60-Day Comment Request;
NIH Information Collection Forms To
Support Genomic Data Sharing for
Research Purposes (Office of Director)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
PO 00000
Notice.
Frm 00095
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In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
SUMMARY:
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.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Lyric A. Jorgenson, Acting
Director, Division of Scientific Data
Sharing Policy, Office of Science Policy,
NIH, 6705 Rockledge Dr., Suite 750,
Bethesda, MD 20892, or call non-tollfree
number (301) 496–9838 or email your
request including your address to:
SciencePolicy@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on May 1, 2019, page 18555 (84
FR 18555) 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.
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.
In compliance with 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 for review and
approval of the information collection
listed below.
Proposed Collection: NIH Information
Collection Forms to Support Genomic
Data Sharing for Research Purposes—
0925–0670—Expiration Date 07/31/
2019—Revision—Office of the Director
(OD), National Institutes of Health
(NIH).
ADDRESSES:
E:\FR\FM\31JYN1.SGM
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Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
Need and Use of Information
Collection: Sharing research data
supports the National Institutes of
Health (NIH) mission and is essential to
facilitate the translation of research
results into knowledge, products, and
procedures that improve human health.
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
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 (NIH GDS Policy). Human
genomic data submissions and
controlled access are managed through
a central data repository, the database of
Genotypes and Phenotypes (dbGaP)
access 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
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. 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
5,850.
which is administered by the National
Center for Biotechnology Information
(NCBI), part of the National Library of
Medicine at NIH. Under the NIH 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 NIHdesignated data repository will maintain
the data. As 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 controlled
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Type of respondent
Number of respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hour
Study Registration and Data Submission
dbGaP Registration and Submission.
Investigator Submitting Data
300 ........................................
1
1
300
Institutional Official to Certify
Submission.
300 ........................................
1
30/60
150
1,500 .....................................
2
45/60
2,250
1,500 .....................................
2
30/60
1,500
2
15/60
750
2
18/60
900
12,600
........................
5,850
Requesting Access to Data
Data Access Request ............
Data Access Request ............
Requester Submitting Request.
Institutional Signing Official
to Certify Request.
Project Renewal or Project Close-out
Project Renewal or Project
Close-out form.
Project Renewal or Project
Close-out form.
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Total ...............................
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Requester Submitting Request.
Institutional Signing Official
to Certify Request.
1,500 (same individuals as
above).
1,500 (same individuals as
above).
...............................................
...............................................
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37326
Federal Register / Vol. 84, No. 147 / Wednesday, July 31, 2019 / Notices
Dated: July 24, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–16289 Filed 7–30–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Loan Repayment
Programs (Office of the Director)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice
In compliance with 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.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
SUMMARY:
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
ADDRESSES:
In compliance with 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 for review and
approval of the information collection
listed below.
Proposed Collection: Loan Repayment
Programs (LRP), 0925–0361, expiration
date 08/31/19, EXTENSION, Office of
the Director (OD), National Institutes of
Health.
Need and Use of Information
Collection: The NIH makes available
financial assistance, in the form of
educational loan repayment, to M.D.,
Ph.D., Pharm.D., Psy.D., D.O., D.D.S.,
D.M.D., D.P.M., DC, N.D., O.D., D.V.M,
or equivalent doctoral degree holders
who perform biomedical or behavioral
research in NIH intramural laboratories
or as extramural grantees or scientists
funded by domestic non-profit
organizations for a minimum of two
years (three years for the General
Research subcategory) in research areas
supporting the mission and priorities of
the NIH. The information proposed for
collection will be used by the DLR to
determine an applicant’s eligibility for
the program.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
27,481.
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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Steve Boehlert,
Director of Operations, Division of Loan
Repayment, National Institutes of
Health, 6700B Rockledge Dr., Room
2300 (MSC 6904), Bethesda, Maryland
20892–6904 or email your request,
including your address to BoehlerS@
od.nih.gov or call (301) 451–4465.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on May 21, 2019, page numbers
23060–23061 (84 FR 23060) 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.
The Office of the Director (OD), National
Institutes of Health (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.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Average time
per response
(in hours)
Total annual
burden hours
Initial Extramural Applicants ............................................................................
Renewal Extramural Applicants .......................................................................
Initial Intramural Applicants .............................................................................
Renewal Intramural Applicants ........................................................................
Recommenders ................................................................................................
Institutional Contacts .......................................................................................
NIH LRP Coordinators .....................................................................................
1,650
1,000
40
40
10,760
2,650
80
1
1
1
1
1
1
1
8
8
8
8
30/60
5/60
30/60
13,200
8,000
320
320
5,380
221
40
Total ..........................................................................................................
16,220
16,220
........................
27,481
Dated: July 24, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–16288 Filed 7–30–19; 8:45 am]
BILLING CODE 4140–01–P
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences Amended; Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
General Medical Sciences Council,
September 19, 2019, 9:00 a.m. to
September 20, 2019, 12:00 p.m.,
National Institutes of Health, Natcher
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Building, 45 Center Drive, Conference
Rooms E1 & E2, Bethesda, MD 20892,
which was published in the Federal
Register on February 14, 2019, 84 FR
4089.
The meeting notice is amended to
change the date and time of the meeting
from September 19–20, 2019, 9:00 a.m.–
12:00 p.m. to September 19, 2019, 8:30
a.m.–5:00 p.m. The meeting is partially
closed to the public.
E:\FR\FM\31JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37324-37326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16289]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Proposed
Collection; 60-Day Comment Request; NIH Information Collection Forms To
Support Genomic Data Sharing for Research Purposes (Office of Director)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request for review and approval of the
information collection listed below.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30-days of the date of
this publication.
ADDRESSES: 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,
[email protected] or by fax to 202-395-6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Dr. Lyric A.
Jorgenson, Acting Director, Division of Scientific Data Sharing Policy,
Office of Science Policy, NIH, 6705 Rockledge Dr., Suite 750, Bethesda,
MD 20892, or call non-tollfree number (301) 496-9838 or email your
request including your address to: [email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on May 1, 2019, page 18555
(84 FR 18555) 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.
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.
In compliance with 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 for review and
approval of the information collection listed below.
Proposed Collection: NIH Information Collection Forms to Support
Genomic Data Sharing for Research Purposes--0925-0670--Expiration Date
07/31/2019--Revision--Office of the Director (OD), National Institutes
of Health (NIH).
[[Page 37325]]
Need and Use of Information Collection: Sharing research data
supports the National Institutes of Health (NIH) mission and is
essential to facilitate the translation of research results into
knowledge, products, and procedures that improve human health. 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 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 (NIH 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 NIH. Under the NIH 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
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 controlled access 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 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. 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 5,850.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (in burden hour
respondent hours)
----------------------------------------------------------------------------------------------------------------
Study Registration and Data Submission
----------------------------------------------------------------------------------------------------------------
dbGaP Registration and Investigator 300............ 1 1 300
Submission. Submitting Data.
Institutional 300............ 1 30/60 150
Official to
Certify
Submission.
----------------------------------------------------------------------------------------------------------------
Requesting Access to Data
----------------------------------------------------------------------------------------------------------------
Data Access Request.......... Requester 1,500.......... 2 45/60 2,250
Submitting
Request.
Data Access Request.......... Institutional 1,500.......... 2 30/60 1,500
Signing
Official to
Certify Request.
----------------------------------------------------------------------------------------------------------------
Project Renewal or Project Close-out
----------------------------------------------------------------------------------------------------------------
Project Renewal or Project Requester 1,500 (same 2 15/60 750
Close-out form. Submitting individuals as
Request. above).
Project Renewal or Project Institutional 1,500 (same 2 18/60 900
Close-out form. Signing individuals as
Official to above).
Certify Request.
-----------------------------------------------
Total.................... ................ ............... 12,600 .............. 5,850
----------------------------------------------------------------------------------------------------------------
[[Page 37326]]
Dated: July 24, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-16289 Filed 7-30-19; 8:45 am]
BILLING CODE 4140-01-P
