G.120 - Significant Changes

The Application Instructions are updated and released 2-3 times per year as needed. Additionally, minor revisions may be made outside of these releases.

This section details all significant changes and revisions made to the instructions since the last major release.

Indicates Changes Within the instructions, new instructions will be marked with this symbol.

In the web version, use your mouse to hover over the icon to read an explanation of the change.

In a PDF version, this symbol will be visible but will not display hover text. For more information, see the explanation in the Significant Changes section below.

Release Notes - August 5, 2023

Program Overview - Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)

Added new "Disclosure Requirements Regarding Ties to Foreign Countries" and "Denial of Awards" subsections outlining requirements related to the implementation of NIH SBIR and STTR Foreign Disclosure Pre-award Requirements and the HHS Due Diligence Program, applicable for competing applications submitted for due dates on or after September 5, 2023.

R&R Other Project Information Form

Updated Additional Instructions for SBIR/STTR for the content of 10. Facilities & Other Resources for applications submitted for due dates on or after September 5, 2023.

R&R Budget and associated R&R Subaward Budget Attachment(s) Form

Updated special instructions for applicants submitting a Data Management and Sharing (DMS) Plan within the following sections for applications submitted for due dates on or after October 5, 2023:

Under "Who should use the R&R Budget Form?" "Additional instructions for Multi-Project"

B. Other Personnel. Other Direct Costs "8-17 Other"

L. Budget Justification

PHS 398 Modular Budget Form

Updated instructions for the "Additional Narrative Justification" Budget Justification attachment content and special instructions for applicants submitting Data Management and Sharing (DMS) Plans.

Release Notes - October 25, 2022

How to Use the Application Instructions

  • Added reminder to not include personal identifiable information (PII) or protected health information (PHI) in the application.

SF-424 Research and Related (R&R) Form Changes

R&R Budget and associated R&R Subaward Budget Attachment(s) Form

  • Added special instructions for applicants submitting a Data Management and Sharing (DMS) Plan within the following sections:
  • Under "Who should use the R&R Budget Form?" "Additional instructions for Multi-Project"
  • B. Other Personnel. Other Direct Costs "8-17 Other"
  • L. Budget Justification

Forms-H Changes

FORMS-H application packages incorporate the latest versions of the PHS forms managed by NIH (OMB Number: 0925-0001 and 0925-0770, Expiration Date: 01/31/2026).

PHS 398 Modular Budget Form

  • Added special instructions for applicants submitting Data Management and Sharing (DMS) Plans.

PHS 398 Research Plan Form

  • Added new item 11. Other Plan(s) and added instructions for applicants submitting Data Management and Sharing (DMS) Plans.
  • Renumbered form fields.
  • Updated instructions for section 10, Resource Sharing Plan(s) to remove instructions for the Data Sharing Plan and Genomic Data Sharing (GDS). The DMS Plan will now be attached in the new item 11, Other Plan(s).
  • Clarified instructions for renewal or resubmission applications involving changes between single PD/PI to or from multiple PD/PIs.

PHS 398 Career Development Award Supplemental Form

  • Added new item 17. Other Plan(s) and added instructions for applicants submitting Data Management and Sharing (DMS) Plans.
  • Renumbered form fields.
  • Updated instructions for 16. Resource Sharing Plan(s) to remove instructions for the Data Sharing Plan and Genomic Data Sharing (GDS). The DMS Plan will now be attached in the new item 17. Other Plan(s).

PHS 398 Research Training Program Plan Form

  • Added new item 13. Other Plan(s) for potential future use with other plans.
  • Renumbered form fields.
  • Clarified instructions for renewal or resubmission applications involving changes between single PD/PI to or from multiple PD/PIs.

PHS Fellowship Supplemental Form

  • Added new item 17. Other Plan(s) for potential future use with other plans.
  • Renumbered form fields.
  • Updated instructions for 16. Resource Sharing Plan(s) to remove instructions for the Data Sharing Plan and Genomic Data Sharing (GDS).

Form Screenshots

  • Updated form screenshots.