[Federal Register Volume 91, Number 48 (Thursday, March 12, 2026)]
[Notices]
[Pages 12201-12203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-04788]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 30-Day Comment Request; NIH Information
Collection Web Interface and Forms To Support Genomic Data Sharing and
NIH Controlled-Access Data Repository Requirements (OD)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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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 by April 13, 2026.
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: Jon Lorsch,
Ph.D., Deputy Director for Extramural Research, Office of Extramural
Research, NIH, 6705 Rockledge Drive, Suite 800-C, Bethesda, MD 20892,
non-toll-free number (301)-594-7783; [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 minimizes 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 techniques or other forms
of information technology.
Proposed Collection Title: NIH Information Collection Web
Interfaces and Forms to Support Genomic Data Sharing for Research
Purposes--0925-0670--Expiration Date 03/31/2026--REVISION--Office of
the Director (OD), National Institutes of Health (NIH).
Need and Use of Information Collection: To promote robust sharing
of human and non-human genomic data from a wide range of large-scale
genomic research, and to provide appropriate protections for research
involving human data, the NIH issued the Genomic Data Sharing (GDS)
Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html). The
[[Page 12202]]
NIH GDS Policy applies to NIH-funded research that generates large-
scale human or non-human genomic data as well as the use of these data
for subsequent research.
The NIH GDS Policy expects large-scale human genomic and associated
data generated using NIH funds to be submitted to an NIH-designated
repository, which is an NIH Controlled-Access Data Repository (https://grants.nih.gov/policy-and-compliance/policy-topics/sharing-policies/accessing-data/requirements). As a part of that submission, the
submitting institution certifies to NIH that the data are appropriate
to share through the completion and submission of a data submission
form. The data are then made available for secondary research use to
qualified Principal Investigators and their institutions after
submission of a Data Access Request (DAR) to the NIH Data Access
Committee (DAC) for review and approval.
The database of Genotypes and Phenotypes (dbGaP), administered by
the National Library of Medicine (NLM), the National Center for
Biotechnology Information (NCBI), provides an online system to support
data registration and submission as a NIH-designated repository, as
well as for providing an online system for access to these data through
the Authorized Access System. As the NIH controlled-access data
landscape has grown to include not just human genomic and associated
data, and in order to meet the security and operational standards
described in the NIH Guide Notice, ``Required Security and Operational
Standards for NIH Controlled-Access Data Repositories,'' (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-159.html), some non-
genomic NIH CADRs have leveraged the compliant dbGaP registration and
submission system and then subsequently, the Authorized Access System
to grant access to controlled-access data in accordance with the NIH
CADR standards.
The dbGaP legacy data registration and submission system has been
updated to accommodate the newly developed NIH Submission Registration
Information Form and the legacy Authorized Access System collects
information about data security standards. This collection also
introduces modernized online interfaces of the dbGaP data registration
and submission system and Authorized Access system to comply with
national security directives, NIH CADR requirements, and reduce
administrative burden while providing enhanced oversight.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours for all respondents across all forms is 9784 hours.
A.12-1--Estimated Annualized Burden Hours
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Number of Average burden
Form name Type of Number of responses per per response Total annual
respondents respondents respondent (in hours) burden hours
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Study Registration and Data Submission--Legacy System
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Study Registration Information Submitting 283 1 1 283
Form (Attachment 1) and Data Investigator.
Submission (Attachment 4).
Institutional Certification Institutional 272 1 30/60 136
(Attachment 3). Signing
Official.
Data Submission Certification Institutional 11 1 30/60 6
(Attachment 2). Signing
Official.
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Study Registration and Data Submission--New System
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Study Registration Information Submitting 849 1 1 849
Form (Online) and Data Investigator.
Submission (Attachment 6).
Institutional Certification Institutional 816 1 30/60 408
(Attachment 3). Signing
Official.
Data Submission Certification Institutional 33 1 30/60 17
(Attachment 2). Signing
Official.
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Initial DAR Application--Legacy Authorized Access System
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dbGaP Authorized Access System Principal 281 4 45/60 843
(Attachment 5). Investigator.
dbGaP Authorized Access System Institutional 281 4 30/60 562
(Attachment 5). Signing
Official.
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Initial DAR Application--New Authorized Access System
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dbGaP Authorized Access System Principal 842 4 45/60 2526
(Attachment 7). Investigator.
dbGaP Authorized Access System Institutional 842 4 30/60 1684
(Attachment 7). Signing
Official.
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Renewal or Close-out--Legacy Authorized Access System
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Renewal or Close-out Principal 281 4 15/60 281
(Attachment 5). Investigator.
Renewal or Close-out Institutional 281 4 18/60 337
(Attachment 5). Signing
Official.
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[[Page 12203]]
Renewal or Close-out--New Authorized Access System
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Project Renewal or Project Principal 842 4 15/60 842
Close-out form (Attachment 7). Investigator.
Project Renewal or Project Institutional 842 4 18/60 1010
Close-out form (Attachment 7). Signing
Official.
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Total..................... ................ .............. 20,232 .............. 9784
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Dated: March 6, 2026.
Jon Lorsch,
Acting Deputy Director for Extramural Research, National Institutes of
Health.
[FR Doc. 2026-04788 Filed 3-11-26; 8:45 am]
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