[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18994-18995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07397]


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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 to provide opportunity for public comment on proposed data 
collection projects, the National Institutes of Health (NIH) will 
publish periodic summaries of propose 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 Including Research Performance Progress Report 
(RPPR) 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 because 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 535,579.

                                        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

[[Page 18995]]

 
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
Final Progress Report...........................           2,000               1               1           2,000
SBIR/STTR Phase II Final Progress Report........           1,330               1               1           1,330
                                                 ---------------------------------------------------------------
    Reporting Burden Total......................  ..............  ..............  ..............         535,204
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                                                  RECORDKEEPING
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SBIR/STTR Life Cycle Certification..............           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
    Grand Total.................................         220,983         415,029  ..............         535,579
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    Dated: April 4, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-07397 Filed 4-9-21; 8:45 am]
BILLING CODE 4140-01-P