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 s the burden of the collection of information on 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: Public Health Service (PHS) Post-award Reporting Requirements Revision, OMB 0925-0002, Expiration Date 11/30/2027, Revision, Office of the Director, National Institutes of Health (NIH).

Need and Use of Information Collection: In Fiscal Year 2025, OMB approved through information collections 0925-0001 and 0925-0002, NIH's request to address progress on data management and sharing of NIH-funded research using the Research Performance and Progress Report (RPPR). The DMS Plan format contains six (6) Elements for applicants and recipients to submit free-text narratives explaining how scientific data will be managed and shared for NIH-funded research. Current public reporting burden for the DMS Plan as part of the RPPR information collection is an estimated 2 hours per response, including the time for reviewing instructions, gathering and maintaining the data, and reviewing the collection of information. After several years of implementation experience, NIH is updating the DMS Plan Elements to provide a structured, simplified format to reduce burden and promote consistent information collection. Effective Fiscal Year 2026, NIH will require applicable recipients to use the updated DMS Plan format when reporting on data management and sharing progress. The updated plan format consists of “Yes, No, or Not Applicable” questions. Narrative text is required only for “No” and “Not Applicable” responses and the narrative response is limited to 300 words. This updated format continues building on trans-NIH initiatives to reduce the public reporting burden and promote consistency across all NIH. The RPPR is required to be used by all NIH, Food and Drug Administration (FDA), Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ) recipients. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. Closeout of an award requires a Final Invention Statement (HHS 568) and Final Progress Report. Pre-award reporting requirements are simultaneously consolidated under 0925-0001 and the changes to the collection here are related.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 24,270.

The Deputy Director for Extramural Research, Jon Lorsch, having reviewed and approved this document, authorizes Alycia Booth, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

91 FR 59149