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 - July 29, 2022

Updated hyperlinks to new NIH Small Business Education and Entrepreneurial Development (SEED) website and relevant web pages throughout the Application Guide.

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

  • Minor text edits to instructions to Additional Instructions for SBIR/STTR for F. Other Direct Costs.

SBIR / STTR Information Form

  • Updated instructions for "8. Commercialization Plan" and "9. Have you received SBIR Phase II awards from the Federal Government?".

Release Notes - February 14, 2022

General Document Updates

  • Updated "Download General Instructions-PDF" link. Updated PDF Header to reflect Forms-G.

R&R Senior / Key Person Profile (Expanded)

  • Minor text edits to instructions for the Biographical Sketch.

Form Screenshots

  • Updated PHS 398 Cover Page Supplement and SBIR/STTR Information form screenshots.

Release Notes - October 25, 2021

Application Process

  • Minor text edits.

Program Overview

  • Updated information about Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR).

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

FORMS-G application packages incorporate the latest versions of the federal-wide forms managed by Grants.gov (OMB Number: 4040-0001 and 4040-0010, Expiration Date: 12/31/2022).

SF 424 (R&R) Form

  • Changed form fields and instructions to reflect the replacement of "DUNS" with the Unique Entity Identifier "UEI".
  • Increased character limits for the "Department" and "Division" fields to 100 characters.
  • Updated the Country and State lists.
  • Updated Additional Instructions for SBIR/STTR for the following fields:

1. Type of submission
4a. Federal Identifier
5. Applicant Information
8. Type of Application
12. Proposed Project
14. Project Director/Principal Investigator Contact Information
15. Estimated Project Funding

R&R Other Project Information Form

  • Clarified instruction for projects involving public health surveillance activities for "1. Are Human Subjects Involved?"
  • Added "Notes on public health surveillance activities" for "1.a. If YES to Human Subjects".
  • Updated Additional Instructions for SBIR/STTR for fields "10. Facilities & Other Resources" and "12. Other Attachments."
  • Added formatting instructions reiterating that the use of hyperlinks and URLS are not allowed unless specified in the funding opportunity announcement for the following fields:

9. Bibliography & References Cited

10. Facilities & Other Resources

11. Equipment

R&R Senior/Key Person Profile (Expanded) Form

  • Increased character limits for the "Department" and "Division" fields to 100 characters.
  • Updated the Country and State lists.
  • Added instructions that the "Credential, e.g., agency login" field is required, and a valid eRA Commons Username must be provided, for all Senior/Key Persons.
  • Updated format and content instructions for the Biographical Sketch to capture the new NIH Biographical Sketch format and reiterate instructions on the use of hyperlinks and URLs.
  • Updated Additional Instructions for Career Development for the "Current & Pending Support" attachment field to capture the new NIH Other Support format.

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

  • Changed form fields and instructions to reflect the replacement of "DUNS" with the Unique Entity Identifier "UEI".
  • Within section F. Other Direct Costs, increased the number of available "Other" direct costs lines from 3 to 10.
  • Updated Additional Instructions for SBIR / STTR.
  • Clarified instructions for the "Budget Justification" attachment regarding quotes.

SBIR / STTR Information Form

  • Changed form fields and instructions to reflect the replacement of "DUNS" with the Unique Entity Identifier "UEI".
  • Added new question "Does the application include a request of SBIR or STTR funds for Technical and Business Assistance (TABA)? If yes, please follow the agency specific instructions to provide the budget request and justification. (Please answer no if you plan to use the agency TABA vendor, which does not require you to include a request for TABA funds in your application.)."
  • Renumbered form fields.
  • Added formatting instructions reiterating that the use of hyperlinks and URLS are not allowed unless specified in the funding opportunity announcement for the attachment fields.

Project / Performance Site Location(s) Form

  • Changed form fields and instructions to reflect the replacement of "DUNS" with the Unique Entity Identifier "UEI".
  • Updated the Country and State lists.
  • Updated Additional Instructions for SBIR/STTR.

Forms-G Changes

PHS 398 Cover Page Supplement Form

  • Updated OMB Expiration Date to 9/30/2024.

PHS 398 Modular Budget Form

  • Updated OMB Expiration Date to 9/30/2024.
  • Clarified instructions for the "Budget Justification" attachments regarding quotes and the use of hyperlinks and URLS.

PHS 398 Training Budget Form

  • Updated OMB Expiration Date to 9/30/2024.
  • Changed form fields and instructions to reflect the replacement of "DUNS" with the Unique Entity Identifier "UEI".
  • Added instructions reiterating that the use of hyperlinks and URLS are not allowed in the "Budget Justification" attachment unless specified in the funding opportunity announcement.

PHS 398 Training Subaward Budget Attachment(s) Form

  • Updated OMB Expiration Date to 9/30/2024.
  • Changed form fields and instructions to reflect the replacement of "DUNS" with the Unique Entity Identifier "UEI".
  • Added instructions reiterating that the use of hyperlinks and URLS are not allowed in the "Budget Justification" attachment unless specified in the funding opportunity announcement.

PHS Additional Indirect Costs Form

  • Updated OMB Expiration date to 9/30/2024.
  • Changed form fields and instructions to reflect the replacement of "DUNS" with the Unique Entity Identifier "UEI".
  • Added instructions reiterating that the use of hyperlinks and URLS are not allowed in the "Budget Justification" attachment unless specified in the funding opportunity announcement.

PHS 398 Research Plan Form

Updated OMB Expiration Date to 9/30/2024.

  • Added instructions reiterting that the use of hyperlinks and URLs are not allowed unless specified in the funding opportunity announcement for the following fields:
    • 1. Introduction to Application
    • 2. Specific Aims
    • 3. Research Strategy
    • 4. Progress Report Publication List
    • 9. Letters of Support
  • Updated Additional Instructions for SBIR/STTR for fields "2. Specific Aims", "3. Research Strategy", and "9. Letters of Support".
  • Made minor text edits.

PHS 398 Career Development Award Supplemental Form

  • Updated OMB Expiration Date to 9/30/2024.
  • Added instructions reiterating that the use of hyperlinks and URLS are not allowed unless specified in the funding opportunity announcement for the "Letters of Support" field.
  • Clarified instruction for "12. Description of Candidate's Contribution to Program Goals" attachment.
  • Made minor text edits.

PHS 398 Research Training Program Plan Form

  • Updated OMB Expiration Date to 9/30/2024.
  • Added instructions reiterating that the use of hyperlinks and URLS are not allowed unless specified in the funding opportunity announcement for the following fields:

8. Letters of Support

12. Consortium/Contractual Arrangements

12. Appendix

PHS Fellowship Supplemental Form

  • Updated OMB Expiration Date to 9/30/2024.
  • Clarified instruction for "12. Description of Candidate's Contribution to Program Goals" attachment.
  • Added instructions reiterating that the use of hyperlinks and URLS are not allowed unless specified in the funding opportunity announcement throughout all attachment fields.
  • Added new "Childcare Costs" section.
  • Renumbered form fields.
  • Made minor text edits.

PHS Human Subjects and Clinical Trials Information

  • Updated OMB Expiration date to 9/30/2024.
  • Updated instructions for Delayed Onset Study(ies).
  • Clarified instructions for providing an explanation for any use of human specimens and/or data not considered to be human subjects research.
  • Added Additional Instructions for SBIR/STTR in the form introduction.
  • Added instructions reiterating that the use of hyperlinks and URLS are not allowed unless specified in the funding opportunity announcement throughout attachment fields.
  • Updated Additional Instructions for Research, Additional Instructions for Career Development, and Additional Instructions for Fellowships related to the mentor or co-mentor statement related to Clinical Trials Research Experience.
  • Changed the "If yes, describe single IRB plan" attachment field to "Single IRB plan attachment."
  • Removed NIH-specific instructions not applicable at time of submission since the single IRB plan attachment is no longer provided with the application submission.
  • Updated PHS Inclusion Enrollment Report to reflect new OMB form number, OMB Number: 0925-0770 , Expiration Date: 9/30/2024 .
  • Updated the Country and State lists.
  • Clarified instruction for unique file names for "5.1 Other Clinical Trial-related Attachments".
  • Made minor text edits.

PHS Assignment Request Form

  • Updated OMB Expiration Date to 9/30/2024.

Form Screenshots

  • Updated form screenshots.

  • New version of the SBIR/STTR Information form.