[Federal Register Volume 90, Number 128 (Tuesday, July 8, 2025)]
[Notices]
[Pages 30073-30075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-12669]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; NIH Information
Collection Web Interface and Forms To Support Genomic Data Sharing for
Research Purposes (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 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: Julia
Slutsman, Ph.D., Director, Data Sharing Policies Implementation, Office
of Extramural Research, NIH, 6705 Rockledge Drive, Suite 800-C,
Bethesda, MD 20892, or call non-toll-
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free number (301) 594-7783; 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 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: Sharing research data is
integral to the mission of the National Institutes of Health (NIH) as
it advances our understanding of factors that influence health and
disease, while also providing opportunities to accelerate research
through the power of combining large, information-rich datasets. 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, NIH established the
Database of Genotypes and Phenotypes (dbGaP) and issued the NIH Genomic
Data Sharing (GDS) Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html). The Database of Genotypes and Phenotypes
(dbGaP) was developed to archive and distribute the data results of
eligible NIH-funded research studies that have investigated the
interaction of genotype (the genetic constitution of an individual
organism) and phenotype (the set of observable characteristics of an
individual resulting from the interaction of its genotype with the
environment) in humans. The 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. Human genomic
data submissions, controlled-access genomic data, and related
phenotypic data are managed through the database of Genotypes and
Phenotypes (dbGaP); dbGaP 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. As part of the study
registration process, investigators must provide basic study
information, such as the types of data that will be submitted to dbGaP
and a description of the study, via a form provided by the funding NIH
institute. While individual NIH institutes currently use different
forms, NIH seeks to harmonize the current forms into a single Study
Registration Information Form. In addition, to keep pace with changes
in genomics research, NIH has developed a Data Agnostic Submission Form
to accept submission of non-genomic data generated with genomic data.
Requesters interested in using controlled-access human data for
secondary research must apply through the dbGaP Authorized Access
System and be granted permission from the relevant NIH Data Access
Committee (DAC). As part of the application process, requesters and
their institutions provide basic information, such as the proposed
research use of the data, and agree to the terms of access delineated
in the Data Use Certification agreement. Beginning on January 25, 2025,
requesters and their institutions are expected to attest that their
systems or, if applicable, their third-party IT system or Cloud Service
Provider secure the data according to standards set for in the NIH
Security Best Practices for Users of Controlled-Access Data (https://sharing.nih.gov/sites/default/files/flmngr/NIH-Security-BPs-for-Users-of-Controlled-Access-Data.pdf). This attestation will be a part of
completing the request in the dbGaP Authorized Access System.
NIH has developed online forms and digital interfaces, available
either as PDF files or through dbGaP, to minimize burden for
researchers and their institutional officials completing the study
registration (i.e., Study Registration Information Form), attesting to
security standards in the data access request, and submitting data.
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 25,950 hours.
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
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Data Agnostic Submission Investigator 9,000 1 30/60 4,500
Certification. Submitting Data.
Data Agnostic Submission Institutional 9,000 1 30/60 4,500
Certification. Signing
Official
Certifying Data
Submission.
Study Registration Information Investigator 400 1 1 400
Form. Submitting Data.
Data Derivative Institutional Investigator 50 1 30/60 25
Certification. Submitting Data.
Data Derivative Institutional Institutional 50 1 30/60 25
Certification. Signing
Official
Certifying Data
Submission.
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Requesting Access to Data
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dbGaP Authorized Access System Investigator 4,000 6 30/60 12,000
Requesting Data.
dbGaP Authorized Access System Institutional 1,500 6 30/60 4,500
Signing
Official
Certifying Data
Request.
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Total..................... ................ 24,000 51,500 .............. 25,950
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Dated: July 1, 2025.
Jon Lorsch,
Acting Deputy Director for Extramural Research, National Institutes of
Health.
[FR Doc. 2025-12669 Filed 7-7-25; 8:45 am]
BILLING CODE 4140-01-P