# 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.
**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 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.
| Form name | Type of respondents | Number of | Number of | Average | Total annual burden hours |
| --- | --- | --- | --- | --- | --- |
| | | | | | |
| Study Registration Information Form (Attachment 1) and Data Submission (Attachment 4) | Submitting Investigator | 283 | 1 | 1 | 283 |
| Institutional Certification (Attachment 3) | Institutional Signing Official | 272 | 1 | 30/60 | 136 |
| Data Submission Certification (Attachment 2) | Institutional Signing Official | 11 | 1 | 30/60 | 6 |
| | | | | | |
| Study Registration Information Form (Online) and Data Submission (Attachment 6) | Submitting Investigator | 849 | 1 | 1 | 849 |
| Institutional Certification (Attachment 3) | Institutional Signing Official | 816 | 1 | 30/60 | 408 |
| Data Submission Certification (Attachment 2) | Institutional Signing Official | 33 | 1 | 30/60 | 17 |
| | | | | | |
| dbGaP Authorized Access System (Attachment 5) | Principal Investigator | 281 | 4 | 45/60 | 843 |
| dbGaP Authorized Access System (Attachment 5) | Institutional Signing Official | 281 | 4 | 30/60 | 562 |
| | | | | | |
| dbGaP Authorized Access System (Attachment 7) | Principal Investigator | 842 | 4 | 45/60 | 2526 |
| dbGaP Authorized Access System (Attachment 7) | Institutional Signing Official | 842 | 4 | 30/60 | 1684 |
| | | | | | |
| Renewal or Close-out (Attachment 5) | Principal Investigator | 281 | 4 | 15/60 | 281 |
| Renewal or Close-out (Attachment 5) | Institutional Signing Official | 281 | 4 | 18/60 | 337 |
| | | | | | |
| Project Renewal or Project Close-out form (Attachment 7) | Principal Investigator | 842 | 4 | 15/60 | 842 |
| Project Renewal or Project Close-out form (Attachment 7) | Institutional Signing Official | 842 | 4 | 18/60 | 1010 |
| Total | | | 20,232 | | 9784 |
Dated: March 6, 2026.
Jon Lorsch,
Acting Deputy Director for Extramural Research, National Institutes of Health.