[Federal Register Volume 87, Number 191 (Tuesday, October 4, 2022)]
[Notices]
[Pages 60180-60181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21550]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; PHS 
Applications and Pre-Award Related Reporting (Office of the Director)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with 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 request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Ms. Mikia P. Currie, Program Analyst, Office of 
Policy for Extramural Research Administration, 6705 Rockledge Drive, 
Suite 803-B, Bethesda, Maryland 20892, or call non-toll-free number 
(301) 435-0941 or email your request, including your address to: 
[email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on June 8, 2022, pages 
34891/34892 (87 FR 34891) and allowed 60 days for public comment. No 
public comments were received. The purpose of this notice is to allow 
an additional 30 days for public comment.
    The Office of the Director, 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 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: Public Health Service (PHS) Applications and 
Pre-Award Related Reporting--0925-0001--09/30/2024, REVISION, Office of 
the Director, National Institutes of Health (NIH).
    Need and Use of Information Collection: The National Institutes of 
Health (NIH) and other Public Health Service (PHS) agencies currently 
use the Research and Research Training Grant Applications and Related 
Forms and Ruth L. Kirschstein National Research Service Award 
Applications and Related Forms (0925-0001 Expiration Date: September 
30, 2024). This collection is being revised to update competing 
application forms for the implementation of 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. Starting in January 2023, NIH will require applicants and 
recipients to submit and address Data Management and Sharing (DMS) 
Plans within the SF424 Research and Related (R&R) application and the 
Research Performance Progress Report (RPPR) in accordance with the DMS 
Policy. The application and progress report forms will be updated to 
align with this requirement. NIH is also introducing a new, optional 
DMS Plan format page that applicants may use to develop their DMS Plan. 
This collection is also being updated to include the application form 
for NIH Other Transaction awards. Post-award reporting requirements, 
including the RPPR, are similarly consolidated and concurrently 
submitted under 0925-0002 (expiration September 30, 2024).
    OMB approval is requested for three years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2,175,670.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total annual
          Information collection forms              respondents    responses per   response (in    burden hours
                                                                    respondent        hours)
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PHS 398--Paper..................................           4,247               1              35         148,645
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[[Page 60181]]

 
                                             PHS 398/424--Electronic
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PHS Assignment Request Form.....................          37,120               1           30/60          18,560
PHS 398 Cover Page Supplement...................          74,239               1               1          74,239
PHS 398 Modular Budget..........................          56,693               1               1          56,693
PHS 398 Training Budget.........................           1,122               1               2           2,244
PHS 398 Training Subaward Budget Attachment(s)               561               1           90/60             842
 Form...........................................
PHS 398 Research Plan...........................          70,866               1              10         708,660
PHS 398 Research Training Program Plan..........           1,122               1              10          11,220
Data Tables.....................................           1,515               1               4           6,060
PHS 398 Career Development Award Supplemental              2,251               1              10          22,510
 Form...........................................
PHS Human Subjects and Clinical Trial                     54,838               1              13         712,894
 Information....................................
Biosketch (424 Electronic)......................          80,946               1               2         161,892
Data Management and Sharing Plan................          73,117               1               2         146,234
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                                           PHS Fellowship--Electronic
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PHS Fellowship Supplemental Form (includes F               6,707               1              13          87,191
 reference letters).............................
Biosketch (Fellowship)..........................           6,707               1               2          13,414
416-1...........................................              29               1              10             290
PHS 416-5.......................................           6,707               1            5/60             559
PHS 6031........................................           6,217               1            5/60             518
VCOC Certification..............................               6               1            5/60               1
SBIR/STTR Funding Agreement Certification.......           1,500               1           15/60             375
NIH Other Transaction...........................  ..............  ..............  ..............  ..............
NIH Other Transaction Application Form..........             239               1              11           2,629
                                                 ---------------------------------------------------------------
    Total Annual Burden Hours...................  ..............         486,749  ..............       2,175,670
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    Dated: September 27, 2022.

Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-21550 Filed 10-3-22; 8:45 am]
BILLING CODE 4140-01-P