2024-11251. Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)

AGENCY:

National Institutes of Health.

ACTION:

Notice.

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 [e-mail]. 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 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

Information collection forms	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total annual burden hours
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) Form	561	1	90/60	842
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 Form	2,251	1	10	22,510
PHS Human Subjects and Clinical Trial Information	54,838	1	13	712,894
Biosketch (424 Electronic)	80,946	1	2	161,892
Data Management and Sharing Plan	73,117	1	2	146,234
PHS Fellowship—Electronic
PHS Fellowship Supplemental Form (includes F reference letters)	6,707	1	13	87,191
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
NIH Other Transaction
NIH Other Transaction Application Form	239	1	11	2,629
Total Annual Burden Hours		486,749		2,175,670

Dated: May 13, 2024.

Lawrence A. Tabak,

Principal Deputy Director, National Institutes of Health.