[Federal Register Volume 86, Number 149 (Friday, August 6, 2021)]
[Notices]
[Pages 43258-43260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16849]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Post-Award 
Reporting Requirements Including Research Performance Progress Report 
Collection (Office of the Director)

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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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.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, 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 
<a href="/cdn-cgi/l/email-protection#6232100d08070116210e070310030c01072010030c010a220f030b0e4c0c0b0a4c050d14"><span class="__cf_email__" data-cfemail="0353716c69666077406f666271626d60664171626d606b436e626a6f2d6d6a6b2d646c75">[email protected]</span></a>. Formal requests for additional 
plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on April 12, 2021, pages 
18994-18995 (86 FR 18994) 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 
(OD) Office of Policy and Extramural Research Administration (OPERA), 
National Institutes of Health, 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, 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.
    Proposed Collection: Public Health Service (PHS) Post-award 
Reporting Requirements Including Research Performance Progress Report 
Collection, Revision, OMB 0925-0002, Expiration Date 2/28/2023, Office 
of the Director (OD), National Institutes of Health (NIH).
    Need and Use of Information Collection: This collection is being 
revised to omit the Inclusion Enrollment

[[Page 43259]]

Report form, which is being converted to a Common form to include the 
Department of Defense (DoD). The Inclusion Enrollment Report is used 
for all applications involving NIH-defined clinical research. This form 
is used to report both planned and cumulative (or actual) enrollment, 
and describes the sex/gender, race, and ethnicity of the study 
participants. Starting in January 2022, NIH will require will 
applicants and recipients to provide their Unique Entity Identifier 
(UEI) instead of the Data Universal Number System (DUNS) number. Also, 
the application forms will be updated to align with the Grants.gov 
updated Country and State lists. NIH also anticipates adding an 
optional field to the end of our forms and applications to get a more 
accurate assessment of the time it takes our applicants to complete the 
various forms and applications. 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 NRSA 
recipients to activate, terminate, and provide for payback of a NRSA. 
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 NRSA 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
----------------------------------------------------------------------------------------------------------------
                                                    Reporting
----------------------------------------------------------------------------------------------------------------
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
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               4          25,680
 Information (Part of RPPR, includes inclusion
 enrollment report).............................
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 RPPR, includes inclusion
 enrollment report))............................
PHS 374.........................................             479               1           30/60             240
                                                 ---------------------------------------------------------------
    Reporting Burden Total......................  ..............  ..............  ..............         531,874
----------------------------------------------------------------------------------------------------------------
                                                  Recordkeeping
----------------------------------------------------------------------------------------------------------------
SBIR/STTR Life Cycle Certification..............           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
    Grand Total.................................         217,653         411,699  ..............         532,249
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[[Page 43260]]

    Dated: July 30, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-16849 Filed 8-5-21; 8:45 am]
BILLING CODE 4140-01-P


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