[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34891-34892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12278]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; PHS Applications and 
Pre-Award Reporting Requirements (OD)

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice.

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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#f9a98b96939c9a8dba959c988b98979a9cbb8b98979a91b994989095d7979091d79e968f"><span class="__cf_email__" data-cfemail="6a3a1805000f091e29060f0b180b04090f28180b0409022a070b030644040302440d051c">[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) Applications 
and Pre-Award Reporting Requirements, Revision, OMB 0925-0001, 
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. 
This collection also continues to include PHS applications and pre-
award reporting requirements: PHS 398 [paper] Public Health Service 
Grant Application forms and instructions; PHS 398 [electronic] PHS 
Grant Application component forms and agency specific instructions used 
in combination with the SF424 (R&R); PHS Fellowship Supplemental Form 
and agency specific instructions used in combination with the SF424 
(R&R) forms/instructions for Fellowships [electronic]; PHS 416-1 Ruth 
L. Kirschstein National Research Service Award (NRSA) Individual 
Fellowship Application Instructions and Forms used only for a change of 
sponsoring institution application [paper]; Instructions for a Change 
of Sponsoring Institution for NRSA Fellowships (F30, F31, F32 and F33) 
and non-NRSA Fellowships; PHS 416-5 Ruth L. Kirschstein National 
Research Service Award Individual Fellowship Activation Notice; and PHS 
6031 Payback Agreement. The PHS 398 (paper and electronic are currently 
approved under 0925-0001). All forms expire 2/28/2023. Post-award 
reporting requirements are simultaneously consolidated under 0925-0002 
and include the RPPR. The PHS 398 and SF 424 applications are used by 
applicants to request Federal assistance funds for traditional 
investigator-initiated research projects and to request access to 
databases and other PHS resources. The PHS 416-1 is used only for a 
change of sponsoring institution application. PHS Fellowship 
Supplemental Form and agency specific instructions is used in 
combination with the SF424 (R&R) forms/instructions for Fellowships and 
is used by individuals to apply for direct research training support. 
Awards are made to individual applicants for specified training 
proposals in biomedical and behavioral research, selected as a result 
of a national competition. The PHS 416-5 is used by individuals to 
indicate the start of their NRSA awards. The PHS 6031 Payback Agreement 
is used by individuals at the time of activation to certify agreement 
to fulfill the payback provisions. 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 will facilitate NIH's development of data systems to 
facilitate oversight of clinical trials as well as understand where 
gaps in the research portfolio may exist. In addition, some of the data 
collected here will ultimately be accessible to investigators to pre-
populate certain

[[Page 34892]]

sections of forms when registering their trials with 
ClinicalTrials.gov.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2,023,454.

                                        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
PHS 398/424--Electronic.........................  ..............  ..............  ..............  ..............
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
PHS Fellowship--Electronic......................  ..............  ..............  ..............  ..............
PHS Fellowship Supplemental Form (includes F               6,707               1            12.5          83,838
 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
                                                 ---------------------------------------------------------------
    Total Annual Burden Hours...................  ..............         421,777  ..............       2,023,454
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    Dated: June 1, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-12278 Filed 6-7-22; 8:45 am]
BILLING CODE 4140-01-P


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