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 Department of Health and Human Services National Institutes of Health
 AGENCY: National Institutes of Health.
 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 (NIH) 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 within 60 days of the date of this publication.
 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: 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 on 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 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 9/30/2024, Office of the Director (OD), National Institutes of Health (NIH). *Need and Use of Information Collection:*
                     Starting in January 2023, NIH will require applicants and recipients to submit and address Data Management and Sharing Plans within the SF424 Research and Related (R&R) application and 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 application and progress report forms will be updated to align with this requirement. NIH will also be updating the PHS 2271 Statement of Appointment form so that trainees appointed to institutional Ruth L. Kirschstein National Service Research Awards (NSRA) can document when they receive support for childcare costs. 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 (AHRQ) grantees. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. The phased transition to the RPPR required the maintenance of dual reporting processes for a period of time. Continued use of the PHS Non-competing Continuation Progress Report (PHS 2590), exists for a small group of grantees. This collection also includes other PHS post-award reporting requirements: PHS 416-7 NRSA Termination Notice, PHS 2271 Statement of Appointment, 6031-1 NRSA Annual Payback Activities Certification, HHS 568 Final Invention Statement and Certification, iEdison, and PHS 3734 Statement Relinquishing Interests and Rights in a PHS Research Grant. The PHS 416-7, 2271, and 6031-1 is used by NSRA recipients to activate, terminate, and provide for payback of a NSRA. Closeout of an award requires a Final Invention Statement (HHS 568) and Final Progress Report. iEdison allows grantees and Federal agencies to meet statutory requirements for reporting inventions and patents. The PHS 3734 serves as the official record of grantee relinquishment of a PHS award when an award is transferred from one grantee institution to another. Pre-award reporting requirements are simultaneously consolidated under 0925-0001 and the changes to the collection here are related. Clinical trials are complex and challenging research activities. Oversight systems and tools are critical for NIH to ensure participant safety, data integrity, and accountability of the use of public funds. NIH has been engaged in a multi-year effort to examine how clinical trials are supported and the level of oversight needed. The collection of more structured information in the PHS applications and pre-award reporting requirements as well as continued monitoring and update during the post-award reporting requirements will facilitate NIH's oversight of clinical trials. In addition, some of the data reported in the RPPR will ultimately be accessible to investigators to update certain sections of forms when registering or reporting their trials with 
                    *ClinicalTrials.gov. Frequency of response:*
                     Applicants may submit applications for published receipt dates. For NSRA awards, fellowships are activated, and trainees appointed. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 532,249. 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**REPORTING**PHS 416-7
12,580
1
30/60
6,290PHS 6031-1
1,778
1
20/60
593PHS 568
11,180
1
5/60
932iEdison
5,697
1
15/60
1,424PHS 2271
22,035
1
15/60
5,509PHS 2590
243
1
18
4,374RPPR—Core Data
32,098
1
8
256,784Biosketch (Part of RPPR)
2,544
1
2
5,088( print page 34890)Data Tables (Part of RPPR)
758
1
4
3,032Trainee Diversity Report (Part of RPPR)
480
1
15/60
120PHS Human Subjects and Clinical Trial Information
6,420
1
3
25,680Publication Reporting
97,023
3
5/60
24,256Final RPPR—Core Data
18,000
1
10
180,000Data Tables (Part of Final RPPR)
758
1
4
3,032Trainee Diversity Report (Part of Final RPPR)
480
1
15/60
120PHS Human Subjects and Clinical Trial Information (Part of Final RPPR)
3,600
1
4
14,400PHS 3734
479
1
30/60
240Reporting Burden Total



531,874**RECORDKEEPING**SBIR/STTR Life Cycle Certification
1,500
1
15/60
375Grand Total

411,699

532,249
 Dated: June 1, 2022. Tara A. Schwetz, Acting Principal Deputy Director, National Institutes of Health.


[FR Doc. 2022-12279 Filed 6-7-22; 8:45 am] BILLING CODE 4140-01-P