[Federal Register Volume 89, Number 185 (Tuesday, September 24, 2024)]
[Notices]
[Pages 77872-77874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
                                                    Reporting
----------------------------------------------------------------------------------------------------------------
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).
                                                 ---------------------------------------------------------------
    Reporting Burden Total....  ................  ..............  ..............  ..............         629,088
----------------------------------------------------------------------------------------------------------------
                                                Recording Keeping
----------------------------------------------------------------------------------------------------------------
SBIR/STTR Life Cycle            Recipient.......           1,500               1           15/60             375
 Certification.
                               ---------------------------------------------------------------------------------
    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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