[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34888-34890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12279]


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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.

ACTION: Notice.

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[[Page 34889]]

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 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
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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
iEdison.........................................           5,697               1           15/60           1,424
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

[[Page 34890]]

 
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
                                                 ---------------------------------------------------------------
    Reporting Burden Total......................  ..............  ..............  ..............         531,874
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                                                  RECORDKEEPING
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SBIR/STTR Life Cycle Certification..............           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
    Grand Total.................................  ..............         411,699  ..............         532,249
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    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