Notice2024-11256
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 22, 2024
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
<html>
<head>
<title>Federal Register, Volume 89 Issue 100 (Wednesday, May 22, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45000-45001]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11256]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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#f3a3819c99969087b09f969281929d9096b181929d909bb39e929a9fdd9d9a9bdd949c85"><span class="__cf_email__" data-cfemail="19496b76737c7a6d5a757c786b78777a7c5b6b78777a71597478707537777071377e766f">[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 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
----------------------------------------------------------------------------------------------------------------
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
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
----------------------------------------------------------------------------------------------------------------
RECORDKEEPING
----------------------------------------------------------------------------------------------------------------
SBIR/STTR Life Cycle Certification.............. 1,500 1 15/60 375
---------------------------------------------------------------
Grand Total................................. 236,226 .............. .............. 579,365
----------------------------------------------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 22, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.