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

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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.

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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 77870-77872]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21801]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; 30-Day Comment Request; Public Health
Service (PHS) Applications and Pre-Award Reporting Requirements (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#a3f3d1ccc9c6c0d7e0cfc6c2d1c2cdc0c6e1d1c2cdc0cbe3cec2cacf8dcdcacb8dc4ccd5"><span class="__cf_email__" data-cfemail="4e1e3c21242b2d3a0d222b2f3c2f202d2b0c3c2f202d260e232f27226020272660292138">[email&#160;protected]</span></a>.
Formal requests for additional plans and instruments must be requested
in writing.

SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on May 22, 2024, pages
45001-45003 (89 FR 45001) 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 (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) Applications
and

[[Page 77871]]

Pre-Award Reporting Requirements, Revision, OMB 0925-0001, Expiration
Date 01/31/2026, Office of the Director (OD), National Institutes of
Health (NIH).
Need and Use of Information Collection: Effective for due dates on
or after January 25, 2025, NIH will be implementing several trans-NIH
initiatives to simplify the grants process for applicants and
recipients as well as for peer review. NIH will be updating fellowship
applications to improve fellowship peer review to facilitate the
mission of these programs to identify the most promising candidates and
individualized training opportunities that will assist them along their
paths to support the advancement of the biomedical research enterprise.
NIH will be reducing the number of required attachments and updating
instructions for the PHS Fellowship Supplemental Form to align with the
revised scored review criteria. NIH will also be updating institutional
training grant applications, including adding a new attachment field to
the PHS 398 Research Training Program Plan form for the transparent
collection of the Recruitment Plan to Enhance Diversity while also
providing additional space for applicants within the Program Plan page
limit where this information was previously collected. 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 Research Performance Progress Report
(RPPR). Effective for due dates on or after May 25, 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 (NSPM)-33. The
Common Forms are part of a separate OMB collection, currently approved
under 3145-0279. 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. This
collection also continues to includes 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 Research & Related (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
Individual Fellowship Application Instructions and Forms used only for
a change of sponsoring institution application [paper]; Instructions
for a Change of Sponsoring Institution for National Research Service
Award (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 01/31/2026. Post-award reporting
requirements are simultaneously consolidated under 0925-0002 and
include the RPPR. The PHS 398 and SF424 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.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 2,175,670.

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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PHS 398--Paper................ Grant Applicant. 4,247 1 35 148,645
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PHS 398/424--Electronic
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PHS Assignment Request Form... Grant Applicant. 37,120 1 30/60 18,560
PHS 398 Cover Page Supplement. Grant Applicant. 74,239 1 1 74,239
PHS 398 Modular Budget........ Grant Applicant. 56,693 1 1 56,693
PHS 398 Training Budget....... Grant Applicant. 1,122 1 2 2,244
PHS 398 Training Subaward Grant Applicant. 561 1 90/60 842
Budget Attachment(s) Form.
PHS 398 Research Plan......... Grant Applicant. 70,866 1 10 708,660
PHS 398 Research Training Grant Applicant. 1,122 1 10 11,220
Program Plan.
Data Tables................... Grant Applicant. 1,515 1 4 6,060
PHS 398 Career Development Grant Applicant. 2,251 1 10 22,510
Award Supplemental Form.
PHS Human Subjects and Grant Applicant. 54,838 1 13 712,894
Clinical Trial Information.
Biosketch (424 Electronic).... Grant Applicant. 80,946 1 2 161,892

[[Page 77872]]

Data Management and Sharing Grant Applicant. 73,117 1 2 146,234
Plan.
VCOC Certification............ Grant Applicant. 6 1 5/60 1
SBIR/STTR Funding Agreement Grant Applicant. 1,500 1 15/60 375
Certification.
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PHS Fellowship--Electronic
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PHS Fellowship Supplemental Fellowship Grant 6,707 1 13 87,191
Form (includes F reference Applicant.
letters).
Biosketch (Fellowship)........ Fellowship Grant 6,707 1 2 13,414
Applicant.
416-1......................... Fellowship Grant 29 1 10 290
Applicant.
PHS 416-5..................... Fellowship Grant 6,707 1 5/60 559
Applicant.
PHS 6031...................... Fellowship Grant 6,217 1 5/60 518
Applicant.
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NIH Other Transaction
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NIH Other Transaction Other 239 1 11 2,629
Application Form. Transaction
Applicant.
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Total..................... ................ 486,749 486,749 .............. 2,175,670
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Dated: September 16, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-21801 Filed 9-23-24; 8:45 am]
BILLING CODE 4140-01-P

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