Document headings vary by document type but may contain the following:
See the Document Drafting Handbook for more details.
AGENCY:
National Institutes of Health, HHS.
ACTION:
Notice.
SUMMARY:
In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
DATES:
Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
ADDRESSES:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
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: Ms. Mikia P. Currie, Program Analyst, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-toll-free number 301-435-0941 or email your request, including your address to ProjectClearanceBranch@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION:
This proposed information collection was previously published in the Federal Register on May 22, 2024, pages 45000-45001 (89 FR 45000) and allowed 60 days for comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
The Office of the Director (OD), Office of Extramural Research (OER), National Institutes of Health (NIH), may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid Office of Management and Budget (OMB) control number.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, NIH has submitted to OMB a request for review and approval of the information collection listed below.
Proposed Collection Title: Public Health Service (PHS) Post-award Reporting Requirements Revision, OMB 0925-0002, Expiration Date 01/31/2026, Office of the Director (OD), National Institutes of Health (NIH).
Need and Use of Information Collection: Starting in Fiscal Year 2025, NIH will require applicable recipients to address progress in association with their approved Data Management and Sharing (DMS) Plans within the Research Performance Progress Report (RPPR) in accordance with the final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. The progress report forms will be updated to align with this requirement. The Training Data Tables will also be updated to reduce burden and promote consistent information collection, including limiting the scope of information collection to data only relevant to the training stage(s) of the proposed program in table 1 and removing instructions in table 8 that are reported within the RPPR. Effective for May 2025, NIH will be adopting the Common Forms for Biographical Sketch and Current and Pending (Other) Support as part of the directive from Guidance for Implementing National Security Presidential Memorandum-33. The Common Forms are part of a separate OMB collection, currently approved under 3145-0279 (Expiration Date 10/31/2026). As such, elements that will be collected within the Common Forms will be removed from NIH's current NIH Biosketch and Other Support formats. NIH will continue to collect additional information not captured on the Common Forms to adhere to the agency's implementation of the NIH Peer Review Regulations at 42 CFR part 52 as part of the NIH Biosketch form, which will be renamed the NIH Biographical Sketch Supplement to reflect the supplemental information requested. The application and progress report forms and associated instructions will be updated to align with these new requirements. The RPPR is required to be used by all NIH, Food and Drug Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality recipients. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. This collection also includes other PHS post-award reporting requirements: PHS 416-7 National Research Service Award (NRSA) Termination Notice, PHS 2271 Statement of Appointment, 6031-1 NRSA Annual Payback Activities Certification, Department of Health and Human Services (HHS) 568 Final Invention Statement and Certification, and PHS 3734 Statement Relinquishing Interests and Rights in a PHS Research Grant. The PHS 416-7, 2271, and 6031-1 is used by NRSA recipients to activate, terminate, and provide for payback of a NRSA. Closeout of an award requires a Final Invention Statement (HHS 568) and Final Progress Report. The PHS 3734 serves as the official record of recipient relinquishment of a PHS award when an award is transferred from one recipient institution to another. 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 629,463.
Estimated Annualized Burden Hours
| Form name | Type of respondent | Number of respondents | Number of responses per respondent | Average burden per response (in hours) | Total annual burden hours |
|---|---|---|---|---|---|
| Reporting | |||||
| PHS 416-7 | Recipient | 12,580 | 1 | 30/60 | 6,290 |
| PHS 6031-1 | Recipient | 1,778 | 1 | 20/60 | 593 |
| PHS 568 | Recipient | 11,180 | 1 | 5/60 | 932 |
| PHS 2271 | Recipient | 22,035 | 1 | 15/60 | 5,509 |
| PHS 2590 | Recipient | 243 | 1 | 18 | 4,374 |
| RPPR—Core Data | Recipient | 32,098 | 1 | 9 | 288,882 |
| Biosketch (Part of RPPR) | Recipient | 2,544 | 1 | 2 | 5,088 |
| Data Tables (Part of RPPR) | Recipient | 758 | 1 | 4 | 3,032 |
| Trainee Diversity Report (Part of RPPR) | Recipient | 480 | 1 | 15/60 | 120 |
| PHS Human Subjects and Clinical Trial Information | Recipient | 6,420 | 1 | 3 | 25,680 |
| Publication Reporting | Recipient | 97,023 | 3 | 5/60 | 24,256 |
| Final RPPR—Core Data | Recipient | 18,000 | 1 | 11 | 198,000 |
| Data Tables (Part of Final RPPR) | Recipient | 758 | 1 | 4 | 3,032 |
| Trainee Diversity Report (Part of Final RPPR) | Recipient | 480 | 1 | 15/60 | 120 |
| PHS Human Subjects and Clinical Trial Information (Part of Final RPPR) | Recipient | 3,600 | 1 | 4 | 14,400 |
| PHS 3734 | Recipient | 479 | 1 | 30/60 | 240 |
| Data Management and Sharing Plan (Part of RPPR) | Recipient | 15,649 | 1 | 2 | 31,298 |
| Data Management and Sharing Plan (Part of Final RPPR) | Recipient | 8,621 | 1 | 2 | 17,242 |
| Reporting Burden Total | 629,088 | ||||
| Recording Keeping | |||||
| SBIR/STTR Life Cycle Certification | Recipient | 1,500 | 1 | 15/60 | 375 |
| Grand Total | 236,226 | 430,272 | 629,463 |