Proposed Collection; 60-Day Comment Request; NIH Information Collection Forms To Support Genomic Data Sharing for Research Purposes (OD), 18555-18557 [2019-08855]
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Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Notices
TABLE 7—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS—Continued
PHS guideline section
Description of collection of information activity
21 CFR section
(unless otherwise stated)
3.2.2 ................................................
3.2.3 ................................................
Document collaboration with accredited microbiology labs ..................
Procedures to ensure the humane care of animals ..............................
3.2.4 ................................................
Procedures consistent for accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) and consistent with the National
Research Council’s (NRC) Guide.
Herd health maintenance and surveillance to be documented, available, and in accordance with documented procedures; record
standard veterinary care.
Animal facility SOPs ..............................................................................
Validate assay methods ........................................................................
Procurement and processing of xenografts using documented aseptic
conditions.
Develop, implement, and enforce SOP’s for procurement and screening processes.
Communicate to FDA animal necropsy findings pertinent to health of
recipient.
PHS specimens to be linked to health records; provide to FDA justification for types of tissues, cells, and plasma, and quantities of
plasma and leukocytes collected.
Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program life-long (justify >2 yrs.); investigator
case histories (2 yrs. after investigation is discontinued).
Sponsor to justify amount and type of reserve samples .......................
System for prompt retrieval of PHS specimens and linkage to medical
records (recipient and source animal).
Notify FDA of a clinical episode potentially representing a xenogeneic
infection.
Document collaborations (transfer of obligation) ...................................
Develop educational materials (sponsor provides investigators with
information needed to conduct investigation properly).
Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories.
312.52.
9 CFR parts 1, 2, and 3 and PHS
Policy.1
AAALAC International Rules of Accreditation 2 and NRC Guide.3
3.2.5, 3.4, and 3.4.1 ........................
3.2.6 ................................................
3.3.3 ................................................
3.6.1 ................................................
3.6.2 ................................................
3.6.4 ................................................
3.7.1 ................................................
4.1.1 ................................................
4.1.2 ................................................
4.1.2.2 .............................................
4.1.2.3 .............................................
4.2.2.1 .............................................
4.2.3.1 .............................................
4.3 ...................................................
211.100 and 211.122.
PHS Policy.1
211.160(a).
211.100 and 211.122.
211.84(d) and 211.122(c).
312.32(c).
312.23(a)(6).
312.23(a)(6)(iii)(f) and
312.62(b) and (c).
(g),
and
211.122.
312.57(a).
312.32.
312.52.
312.50.
312.57 and 312.62(b).
1 The ‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (https://www.grants.nih.gov/grants/olaw/references/
phspol.htm).
2 AAALAC International Rules of Accreditation (https://www.aaalac.org/accreditation/rules.cfm).
3 The NRC’s ‘‘Guide for the Care and Use of Laboratory Animals.’’
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: April 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–08845 Filed 4–30–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
National Institutes of Health
FOR FURTHER INFORMATION CONTACT:
DATES:
BILLING CODE 4164–01–P
Proposed Collection; 60-Day Comment
Request; NIH Information Collection
Forms To Support Genomic Data
Sharing for Research Purposes (OD)
jbell on DSK30RV082PROD with NOTICES
for public comment on proposed data
collection projects, the National
Institutes of Health Office of the
Director (OD) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for opportunity
SUMMARY:
VerDate Sep<11>2014
19:24 Apr 30, 2019
Jkt 247001
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 Formal
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
requests for additional plans and
instruments must be requested in
writing.
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address 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
from those who are to respond,
including the use of appropriate
automated, electronic, mechanical, or
other technological collection
SUPPLEMENTARY INFORMATION:
E:\FR\FM\01MYN1.SGM
01MYN1
18556
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Notices
techniques or other forms of information
technology.
Proposed Collection Title: NIH
Information Collection Forms to
Support Genomic Data Sharing for
Research Purposes—0925–0670—
Expiration Date 07/31/2019—
EXTENSION—Office of the Director
(OD), National Institutes of Health
(NIH).
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
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
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.
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
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.
jbell on DSK30RV082PROD with NOTICES
Grand Total ....................
VerDate Sep<11>2014
19:24 Apr 30, 2019
Requester Submitting Request.
Institutional Signing Official
to Certify Request.
1,500 (same individuals as
listed above).
1,500 (same individuals as
listed above).
...............................................
6,600 .....................................
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01MYN1
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Notices
Dated: April 23, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2019–08855 Filed 4–30–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSK30RV082PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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), Tittle 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: Cell Biology
Integrated Review Group; Cellular
Signaling and Regulatory Systems Study
Section.
Date: May 23–24, 2019.
Time: 8:00 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Chevy Chase,
4300 Military Road NW, Washington,
DC 20015.
Contact Person: David Balasundaram,
Ph.D., Scientific Review Officer, Center
for Scientific Review, National Institutes
of Health, 6701 Rockledge Drive, Room
5189, MSC 7840, Bethesda, MD 20892
301–435–1022, balasundaramd@
csr.nih.gov.
Name of Committee: Center for
Scientific Review Special Emphasis
Panel; Fellowships: Behavioral
Neuroscience.
Date: May 29–30, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham Grand Chicago
Riverfront, 71 E Wacker Drive, Chicago,
IL 60601.
Contact Person: Mei Qin, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room
5213, Bethesda, MD 20892, 301–875–
2215, qinmei@csr.nih.gov.
VerDate Sep<11>2014
19:24 Apr 30, 2019
Jkt 247001
Name of Committee: Population
Sciences and Epidemiology Integrated
Review Group; Social Sciences and
Population Studies A Study Section.
Date: May 30–31, 2019.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Mayflower Hotel,
1127 Connecticut Avenue NW,
Washington, DC 20036.
Contact Person: Suzanne Ryan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room
3139, MSC 7770, Bethesda, MD 20892,
(301) 435–1712, ryansj@csr.nih.gov.
(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: April 25, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–08780 Filed 4–30–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney 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.,
as amended. The cooperative agreement
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the cooperative agreement applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–18–014:
Human Islet Research Network—Consortium
on Targeting and Regeneration (HIRN–CTAR)
(U01 Clinical Trial Not Allowed).
Date: June 5, 2019.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
PO 00000
Frm 00084
Fmt 4703
Sfmt 9990
18557
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–18–015:
Human Pancreas Analysis Program (HPAP–
T1D).
Date: June 18, 2019.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–18–016:
Human Pancreas Analysis Program for Type2 Diabetes (HPAP–T2D).
Date: June 19, 2019.
Time: 12:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: April 25, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–08775 Filed 4–30–19; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\01MYN1.SGM
01MYN1
]]>Agencies
[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Notices]
[Pages 18555-18557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08855]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; NIH Information
Collection Forms To Support Genomic Data Sharing for Research Purposes
(OD)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, for opportunity for public comment on proposed data
collection projects, the National Institutes of Health Office of the
Director (OD) will publish periodic summaries of proposed projects to
be submitted to the Office of Management and Budget (OMB) for review
and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
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-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.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address 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 from those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection
[[Page 18556]]
techniques or other forms of information technology.
Proposed Collection Title: NIH Information Collection Forms to
Support Genomic Data Sharing for Research Purposes--0925-0670--
Expiration Date 07/31/2019--EXTENSION--Office of the Director (OD),
National Institutes of Health (NIH).
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
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. listed above).
Project Renewal or Project Institutional 1,500 (same 2 18/60 900
Close-out form. Signing individuals as
Official to listed above).
Certify Request.
----------------------------------------------------------------
Grand Total.............. ................ 6,600.......... 12,600 .............. 5,850
----------------------------------------------------------------------------------------------------------------
[[Page 18557]]
Dated: April 23, 2019.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2019-08855 Filed 4-30-19; 8:45 am]
BILLING CODE 4140-01-P
