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AGENCY:
National Institutes of Health, HHS.
ACTION:
Notice.
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 ProjectClearanceBranch@mail.nih.gov. 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 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
| Form name | Type of respondent | Number of respondents | Number of responses per respondent | Average burden per response (in hours) | Total annual burden hours |
|---|---|---|---|---|---|
| PHS 398—Paper | Grant Applicant | 4,247 | 1 | 35 | 148,645 |
| 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 Budget Attachment(s) Form | Grant Applicant | 561 | 1 | 90/60 | 842 |
| PHS 398 Research Plan | Grant Applicant | 70,866 | 1 | 10 | 708,660 |
| PHS 398 Research Training Program Plan | Grant Applicant | 1,122 | 1 | 10 | 11,220 |
| Data Tables | Grant Applicant | 1,515 | 1 | 4 | 6,060 |
| PHS 398 Career Development Award Supplemental Form | Grant Applicant | 2,251 | 1 | 10 | 22,510 |
| PHS Human Subjects and Clinical Trial Information | Grant Applicant | 54,838 | 1 | 13 | 712,894 |
| Biosketch (424 Electronic) | Grant Applicant | 80,946 | 1 | 2 | 161,892 |
| Data Management and Sharing Plan | Grant Applicant | 73,117 | 1 | 2 | 146,234 |
| VCOC Certification | Grant Applicant | 6 | 1 | 5/60 | 1 |
| SBIR/STTR Funding Agreement Certification | Grant Applicant | 1,500 | 1 | 15/60 | 375 |
| PHS Fellowship—Electronic | |||||
| PHS Fellowship Supplemental Form (includes F reference letters) | Fellowship Grant Applicant | 6,707 | 1 | 13 | 87,191 |
| Biosketch (Fellowship) | Fellowship Grant Applicant | 6,707 | 1 | 2 | 13,414 |
| 416-1 | Fellowship Grant Applicant | 29 | 1 | 10 | 290 |
| PHS 416-5 | Fellowship Grant Applicant | 6,707 | 1 | 5/60 | 559 |
| PHS 6031 | Fellowship Grant Applicant | 6,217 | 1 | 5/60 | 518 |
| NIH Other Transaction | |||||
| NIH Other Transaction Application Form | Other Transaction Applicant | 239 | 1 | 11 | 2,629 |
| Total | 486,749 | 486,749 | 2,175,670 |