[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Notices]
[Pages 45001-45003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11251]


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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.

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 [email protected]. 
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

[[Page 45002]]

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 01/31/2026, Office of the Director, 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 the 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 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 Biosketch 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 
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 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 are used in combination with the SF424 (R&R) 
forms/instructions for Fellowships and are 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 the 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
          Information collection forms               Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
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PHS 398--Paper..................................           4,247               1              35         148,645
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                                             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

[[Page 45003]]

 
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
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                                              NIH Other Transaction
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NIH Other Transaction Application Form..........             239               1              11           2,629
    Total Annual Burden Hours...................  ..............         486,749  ..............       2,175,670
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    Dated: May 13, 2024.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2024-11251 Filed 5-21-24; 8:45 am]
BILLING CODE 4140-01-P