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 Department of Health and Human Services National Institutes of Health
 AGENCY: National Institutes of Health, Department of Health and Human Services.
 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) Applications and Pre-Award Reporting Requirements, Revision, OMB 0925-0001, 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. This collection also continues to include PHS applications and pre-award reporting requirements: PHS 398 [paper] Public Health Service Grant Application forms and instructions; PHS 398 [electronic] PHS Grant Application component forms and agency specific instructions used in combination with the SF424 (R&R); PHS Fellowship Supplemental Form and agency specific instructions used in combination with the SF424 (R&R) forms/instructions for Fellowships [electronic]; PHS 416-1 Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Application Instructions and Forms used only for a change of sponsoring institution application [paper]; Instructions for a Change of Sponsoring Institution for NRSA Fellowships (F30, F31, F32 and F33) and non-NRSA Fellowships; PHS 416-5 Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice; and PHS 6031 Payback Agreement. The PHS 398 (paper and electronic are currently approved under 0925-0001). All forms expire 2/28/2023. Post-award reporting requirements are simultaneously consolidated under 0925-0002 and include the RPPR. The PHS 398 and SF 424 applications are used by applicants to request Federal assistance funds for traditional investigator-initiated research projects and to request access to databases and other PHS resources. The PHS 416-1 is used only for a change of sponsoring institution application. PHS Fellowship Supplemental Form and agency specific instructions is used in combination with the SF424 (R&R) forms/instructions for Fellowships and is used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The PHS 416-5 is used by individuals to indicate the start of their NRSA awards. The PHS 6031 Payback Agreement is used by individuals at the time of activation to certify agreement to fulfill the payback provisions. 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 will facilitate NIH's development of data systems to facilitate oversight of clinical trials as well as understand where gaps in the research portfolio may exist. In addition, some of the data collected here will ultimately be accessible to investigators to pre-populate certain 
                    ( print page 34892)
                    sections of forms when registering their trials with 
                    *ClinicalTrials.gov*. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,023,454. Estimated Annualized Burden Hours
Information collection forms
Number of 
                             respondents
Number of 
                             responses per respondent
Average 
                             burden per  
                             response  
                             (in hours)
Total annual burden hoursPHS 398—Paper
4,247
1
35
148,645PHS 398/424—ElectronicPHS Assignment Request Form
37,120
1
30/60
18,560PHS 398 Cover Page Supplement
74,239
1
1
74,239PHS 398 Modular Budget
56,693
1
1
56,693PHS 398 Training Budget
1,122
1
2
2,244PHS 398 Training Subaward Budget Attachment(s) Form
561
1
90/60
842PHS 398 Research Plan
70,866
1
10
708,660PHS 398 Research Training Program Plan
1,122
1
10
11,220Data Tables
1,515
1
4
6,060PHS 398 Career Development Award Supplemental Form
2,251
1
10
22,510PHS Human Subjects and Clinical Trial Information
54,838
1
13
712,894Biosketch (424 Electronic)
80,946
1
2
161,892PHS Fellowship—ElectronicPHS Fellowship Supplemental Form (includes F reference letters)
6,707
1
12.5
83,838Biosketch (Fellowship)
6,707
1
2
13,414416-1
29
1
10
290PHS 416-5
6,707
1
5/60
559PHS 6031
6,217
1
5/60
518VCOC Certification
6
1
5/60
1SBIR/STTR Funding Agreement Certification
1,500
1
15/60
375Total Annual Burden Hours

421,777

2,023,454
 Dated: June 1, 2022. Tara A. Schwetz, Acting Principal Deputy Director, National Institutes of Health.


[FR Doc. 2022-12278 Filed 6-7-22; 8:45 am] BILLING CODE 4140-01-P