HHS Seeks Feedback on Proposed Information Collection Rules
Published Date: 12/8/2025
Notice
Summary
The Department of Health and Human Services wants your thoughts on updated forms about research misconduct rules. If you work at or with research institutions, these changes affect how you report issues. You’ve got until January 7, 2026, to share your feedback—no cost, just your voice to help improve the process!
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Annual Research Misconduct Report
If your institution conducts Public Health Service (PHS)-supported research, you must submit the Annual Report on Possible Research Misconduct (form PHS-6349) once per year. The notice estimates 6,619 institutions will respond, each response takes about 10 minutes, and the total annual burden for this form is 1,103 hours.
New Universal Assurance Form
The Office of Research Integrity is discontinuing form PHS-6315 and replacing it with a new Research Integrity Assurance Establishment form (PHS-7091) that lets all institutions subject to 42 CFR part 93 establish an assurance with ORI regardless of sub-awardee status. PHS-7091 is to be submitted once when seeking an ORI assurance for the first time, and may also be submitted on a case-by-case basis at the conclusion of institutional research misconduct proceedings.
New Institutional Record Transmittal Form
ORI created a new Institutional Record Transmittal form (PHS-7092) to capture different types of information collected during institutional research misconduct proceedings. The notice estimates 230 institutions will use this form, with each response taking about 10 minutes and a total annual burden of 38 hours.
Updated Small Institution Statement
ORI will continue to use a Small Institution Statement as an addendum to forms PHS-6349 and PHS-7091 to assist small institutions, and that statement has been updated to reflect new regulatory language in the 2024 Final Rule (42 CFR part 93).
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