Notice2024-21802
Submission for OMB Review; 30-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director)
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
September 24, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with the requirement 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.
Full Text
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<title>Federal Register, Volume 89 Issue 185 (Tuesday, September 24, 2024)</title>
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[Federal Register Volume 89, Number 185 (Tuesday, September 24, 2024)]
[Notices]
[Pages 77872-77874]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21802]
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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, HHS.
ACTION: Notice.
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SUMMARY: In compliance with the requirement 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.
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 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#cd9dbfa2a7a8aeb98ea1a8acbfaca3aea88fbfaca3aea58da0aca4a1e3a3a4a5e3aaa2bb"><span class="__cf_email__" data-cfemail="a3f3d1ccc9c6c0d7e0cfc6c2d1c2cdc0c6e1d1c2cdc0cbe3cec2cacf8dcdcacb8dc4ccd5">[email protected]</span></a>.
Formal requests for additional plans and
[[Page 77873]]
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on May 22, 2024, pages
45000-45001 (89 FR 45000) and allowed 60 days for comment. One public
comment was received. The purpose of this notice is to allow an
additional 30 days for public comment.
The Office of the Director (OD), Office of Extramural Research
(OER), National Institutes of Health (NIH), 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 Office of
Management and Budget (OMB) control number.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, NIH has submitted to OMB a request for review and approval
of the information collection listed below.
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 Fiscal Year
2025, NIH will require applicable recipients to address progress in
association with their approved Data Management and Sharing (DMS) Plans
within 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 progress report forms will be
updated to align with this requirement. The Training Data Tables will
also be updated to reduce 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 for 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-33. The Common Forms are part of a separate OMB
collection, currently approved under 3145-0279 (Expiration Date 10/31/
2026). As such, elements that will be 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 Biographical Sketch
Supplement to reflect the supplemental information requested. The
application and progress 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, Centers for
Disease Control and Prevention, and Agency for Healthcare Research and
Quality recipients. 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, Department of Health and Human
Services (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 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. The PHS 3734 serves as the official record of recipient
relinquishment of a PHS award when an award is transferred from one
recipient 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 629,463.
Estimated Annualized Burden Hours
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Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hours
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Reporting
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PHS 416-7..................... Recipient....... 12,580 1 30/60 6,290
PHS 6031-1.................... Recipient....... 1,778 1 20/60 593
PHS 568....................... Recipient....... 11,180 1 5/60 932
PHS 2271...................... Recipient....... 22,035 1 15/60 5,509
PHS 2590...................... Recipient....... 243 1 18 4,374
RPPR--Core Data............... Recipient....... 32,098 1 9 288,882
Biosketch (Part of RPPR)...... Recipient....... 2,544 1 2 5,088
Data Tables (Part of RPPR).... Recipient....... 758 1 4 3,032
Trainee Diversity Report (Part Recipient....... 480 1 15/60 120
of RPPR).
PHS Human Subjects and Recipient....... 6,420 1 3 25,680
Clinical Trial Information.
Publication Reporting......... Recipient....... 97,023 3 5/60 24,256
Final RPPR--Core Data......... Recipient....... 18,000 1 11 198,000
Data Tables (Part of Final Recipient....... 758 1 4 3,032
RPPR).
Trainee Diversity Report (Part Recipient....... 480 1 15/60 120
of Final RPPR).
PHS Human Subjects and Recipient....... 3,600 1 4 14,400
Clinical Trial Information
(Part of Final RPPR).
PHS 3734...................... Recipient....... 479 1 30/60 240
Data Management and Sharing Recipient....... 15,649 1 2 31,298
Plan (Part of RPPR).
[[Page 77874]]
Data Management and Sharing Recipient....... 8,621 1 2 17,242
Plan (Part of Final RPPR).
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Reporting Burden Total.... ................ .............. .............. .............. 629,088
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Recording Keeping
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SBIR/STTR Life Cycle Recipient....... 1,500 1 15/60 375
Certification.
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Grand Total............... ................ 236,226 430,272 .............. 629,463
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Dated: September 16, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-21802 Filed 9-23-24; 8:45 am]
BILLING CODE 4140-01-P
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