[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45000-45001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11256]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Post-Award Reporting 
Requirements Including Research Performance Progress Report Collection 
(OD)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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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 [email protected]. 
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 01/31/
2026, Office of the Director (OD), National Institutes of Health (NIH).
    Need and Use of Information Collection: Starting in 2025, NIH will 
require applicable recipients to address progress in association with 
their approved Data Management and Sharing Plans within the Research 
Performance Progress Report (RPPR) in accordance with the final NIH 
Policy for Data Management and Sharing 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 
the 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 
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 
(NSPM)-33. The Common Forms are part of a separate OMB collection, 
currently approved under 3145-0279. As such, elements 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 Biosketch 
Supplement to reflect the supplemental information requested. The 
application and progress

[[Page 45001]]

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 (FDA), 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. 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, 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 are 
used by NRSA recipients to activate, terminate, and provide for payback 
of an NRSA. Closeout of an award requires a Final Invention Statement 
(HHS 568) and a Final Progress Report. 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.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 579,365.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
          Information collection forms               Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
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                                                    REPORTING
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PHS 416-7.......................................          12,580               1           30/60           6,290
PHS 6031-1......................................           1,778               1           20/60             593
PHS 568.........................................          11,180               1            5/60             932
PHS 2271........................................          22,035               1           15/60           5,509
PHS 2590........................................             243               1              18           4,374
RPPR-Core Data..................................          32,098               1               8         256,784
Biosketch (Part of RPPR)........................           2,544               1               2           5,088
Data Tables (Part of RPPR)......................             758               1               4           3,032
Trainee Diversity Report (Part of RPPR).........             480               1           15/60             120
PHS Human Subjects and Clinical Trial                      6,420               1               3          25,680
 Information....................................
Publication Reporting...........................          97,023               3            5/60          24,256
Final RPPR--Core Data...........................          18,000               1              10         180,000
Data Tables (Part of Final RPPR)................             758               1               4           3,032
Trainee Diversity Report (Part of Final RPPR)...             480               1           15/60             120
PHS Human Subjects and Clinical Trial                      3,600               1               4          14,400
 Information (Part of Final RPPR)...............
PHS 3734........................................             479               1           30/60             240
Data Management and Sharing Plan (Part of RPPR).          15,649               1               2          31,298
Data Management and Sharing Plan (Part of Final            8,621               1               2          17,242
 RPPR)..........................................
                                                 ---------------------------------------------------------------
    Reporting Burden Total......................  ..............  ..............  ..............         578,990
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                                                  RECORDKEEPING
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SBIR/STTR Life Cycle Certification..............           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
    Grand Total.................................         236,226  ..............  ..............         579,365
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    Dated: May 9, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-11256 Filed 5-21-24; 8:45 am]
BILLING CODE 4140-01-P