Notice2022-25840
Submission for OMB Review; 30-Day Comment Request;
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 28, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 227 (Monday, November 28, 2022)</title>
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[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73009-73010]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25840]
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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 (Office of Director)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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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 recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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: Julia Slutsman, Ph.D. Director, Genomic Data
Sharing Policy Implementation, OER, OD, NIH, Natcher Building, Room
3AN-44D, 6705 Rockledge Dr., Suite 750, Bethesda, MD 20892, or call
non-toll-free number (301) 594-7783 or email your request, including
your address to: <a href="/cdn-cgi/l/email-protection#6a19061f1e19070b002a070b030644040302440d051c"><span class="__cf_email__" data-cfemail="42312e3736312f2328022f232b2e6c2c2b2a6c252d34">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on September 21, 2022,
pages 57705-57707 (87 FR 57705) 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 November 30, 2022, 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--REVISION--expiration
date 11/30/2022, 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
[[Page 73010]]
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 158,776.
Estimated Annualized Burden Hours
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Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hour
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dbGaP Registration and Investigator 1,050 1 1 1050
Submission. Submitting Data.
Institutional Certification... Investigator 1,050 1 45/60 788
filling out
Institutional
Certification.
Institutional Certification... Institutional 1,050 1 45/60 788
Official to
Certify
Submission.
Provisional Institutional Investigator 100 1 45/60 75
Certification. filling out
Provisional
Institutional
Certification.
Provisional Institutional Institutional 100 1 45/60 75
Certification. Official to
Certify
Provisional
Submission.
Data Access Request........... Requester 3,900 10 1 39,000
Submitting
Request.
Data Access Request........... Institutional 3,900 10 1 39,000
Signing
Official to
Certify Request.
Project Renewal or Project Requester 3,900 10 1 39,000
Close-out form. Submitting
Request.
Project Renewal or Project Institutional 3,900 10 1 39,000
Close-out form. Signing
Official to
Certify Request.
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Total..................... ................ 18,950 159,350 .............. 158,776
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Dated: November 21, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-25840 Filed 11-25-22; 8:45 am]
BILLING CODE 4140-01-P
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