[Federal Register Volume 89, Number 185 (Tuesday, September 24, 2024)]
[Notices]
[Pages 77870-77872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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#a3f3d1ccc9c6c0d7e0cfc6c2d1c2cdc0c6e1d1c2cdc0cbe3cec2cacf8dcdcacb8dc4ccd5"><span class="__cf_email__" data-cfemail="4e1e3c21242b2d3a0d222b2f3c2f202d2b0c3c2f202d260e232f27226020272660292138">[email 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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
NIH Other Transaction           Other                        239               1              11           2,629
 Application Form.               Transaction
                                 Applicant.
                                                 ---------------------------------------------------------------
    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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