Notice2022-12278
Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (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
June 8, 2022
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
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<title>Federal Register, Volume 87 Issue 110 (Wednesday, June 8, 2022)</title>
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[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34891-34892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>.
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
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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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