Rules and Regulations. Notice

Agency: National Institutes of Health, HHS
Action: Notice
Citation: FR Doc. 2022-21550

Summary

In compliance with 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.

Supplementary Information

This proposed information collection was previously published in the Federal Register on June 8, 2022, pages 34891/34892 (87 FR 34891) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of the Director, 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 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: Public Health Service (PHS) Applications and Pre-Award Related Reporting—0925-0001—09/30/2024, REVISION, Office of the Director, National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health (NIH) and other Public Health Service (PHS) agencies currently use the Research and Research Training Grant Applications and Related Forms and Ruth L. Kirschstein National Research Service Award Applications and Related Forms (0925-0001 Expiration Date: September 30, 2024). This collection is being revised to update competing application forms for the implementation of 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. Starting in January 2023, NIH will require applicants and recipients to submit and address Data Management and Sharing (DMS) Plans within the SF424 Research and Related (R&R) application and the Research Performance Progress Report (RPPR) in accordance with the DMS Policy. The application and progress report forms will be updated to align with this requirement. NIH is also introducing a new, optional DMS Plan format page that applicants may use to develop their DMS Plan. This collection is also being updated to include the application form for NIH Other Transaction awards. Post-award reporting requirements, including the RPPR, are similarly consolidated and concurrently submitted under 0925-0002 (expiration September 30, 2024). OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,175,670. Estimated Annualized Burden Hours Information collection forms Number of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hours PHS 398—Paper 4,247 1 35 148,645 PHS 398/424—Electronic PHS Assignment Request Form 37,120 1 30/60 18,560 PHS 398 Cover Page Supplement 74,239 1 1 74,239 PHS 398 Modular Budget 56,693 1 1 56,693 PHS 398 Training Budget 1,122 1 2 2,244 PHS 398 Training Subaward Budget Attachment(s) Form 561 1 90/60 842 PHS 398 Research Plan 70,866 1 10 708,660 PHS 398 Research Training Program Plan 1,122 1 10 11,220 Data Tables 1,515 1 4 6,060 PHS 398 Career Development Award Supplemental Form 2,251 1 10 22,510 PHS Human Subjects and Clinical Trial Information 54,838 1 13 712,894 Biosketch (424 Electronic) 80,946 1 2 161,892 Data Management and Sharing Plan 73,117 1 2 146,234 PHS Fellowship—Electronic PHS Fellowship Supplemental Form (includes F reference letters) 6,707 1 13 87,191 Biosketch (Fellowship) 6,707 1 2 13,414 416-1 29 1 10 290 PHS 416-5 6,707 1 5/60 559 PHS 6031 6,217 1 5/60 518 VCOC Certification 6 1 5/60 1 SBIR/STTR Funding Agreement Certification 1,500 1 15/60 375 NIH Other Transaction NIH Other Transaction Application Form 239 1 11 2,629 Total Annual Burden Hours 486,749 2,175,670 Dated: September 27, 2022. Tara A. Schwetz, Acting Principal Deputy Director, National Institutes of Health. [FR Doc. 2022-21550 Filed 10-3-22; 8:45 am]