Notice2022-12279
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD)
Primary source
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Published
June 8, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 110 (Wednesday, June 8, 2022)</title>
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[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34888-34890]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#9ccceef3f6f9ffe8dff0f9fdeefdf2fff9deeefdf2fff4dcf1fdf5f0b2f2f5f4b2fbf3ea"><span class="__cf_email__" data-cfemail="560624393c333522153a3337243738353314243738353e163b373f3a78383f3e78313920">[email protected]</span></a>.
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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>. 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
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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
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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
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