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.

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Revision Notes - October 16, 2020

PHS 398 Career Development Award Supplemental Form

  • Under "12. Description of Candidate's Contribution to Program Goals", added hyperlink to Notice of NIH's Interest in Diversity (NOT-OD-20-031).

PHS 398 Research Training Program Plan Form

  • Under section "C. Recruitment Plan to Enhance Diversity" of the "Program Plan", added hyperlinks to the Notice of NIH's Interest in Diversity (NOT-OD-20-031).

PHS Human Subjects and Clinical Trials Information

  • Removed language that indicated to skip the rest of the form if you answered "No" to the "Does the proposed research involve human specimens and/or data?" question.
  • Modified text in instruction to "4.1.d. Study Phase" to match form option "N/A".

Form Screenshots

  • Updated form screenshots

Release Notes - February 25, 2020

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

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

SF 424 (R&R) Form

  • Clarified instructions regarding Agency Routing Identifier.
  • Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT):
    • Added language under section "21. Cover Letter Attachment," sub-section content (Item 9).
  • Updated general and SBIR/STTR instructions for the Type of Applicant question, as "Women Owned" and "Socially and Economically Disadvantaged" information is now collected though SAM.
  • Clarified instruction regarding the content of the "Cover Letter Attachment" to indicate that it must not be used to communicate application assignment preferences.

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

  • Added instructions for Career Development and Fellowship applications for the "Credential, e.g., agency login" field under the PD/PI Credential Field of the "Profile- Project Director/Principal Investigator" section.
  • Made minor text edits.

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

  • Within section F. Other Direct Costs: "8-10: Other"- removed instruction to list inpatient and outpatient care costs specifically on lines 8 and 9.
  • Within section F. Other Direct Costs: "8-10: Other"- removed note regarding requesting an exception to the single IRB (sIRB) policy.
  • Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT):
  • Added special instruction for proposed human fetal tissue research under "Who should use the R&R Budget Form?"
    • Added special instructions under "Additional Instructions for Multi-project".
  • Added special instruction for proposed human fetal tissue research under section "F.8-10. Other."
  • Added special instruction for proposed human fetal tissue research under section "L. Budget Justification."
  • Added special instruction for proposed human fetal tissue research under section "F.1. Materials and Supplies."
  • Made minor text edits.

Forms-F Changes

PHS 398 Cover Page Supplement Form

  • Updated OMB Expiration Date to 2/28/2023
  • Added new "Human Fetal Tissue" Section.
  • Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT).
  • Added new "Does the proposed project involve human fetal tissue obtained from elective abortions?" field.
  • Added new instructions and attachment for "HFT Compliance Assurance."
  • Added new instructions and attachment for "HFT Sample IRB Consent Form."
  • Renumbered form fields.

PHS 398 Modular Budget Form

  • Updated OMB Expiration Date to 2/28/2023.
  • Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT):
    • Added special instruction for proposed human fetal tissue research under "Who should use the PHS 398 Modular Budget Form?"
  • Made minor text edits.

PHS 398 Training Budget Form

  • Updated OMB Expiration Date to 2/28/2023

PHS 398 Training Subaward Budget Attachment(s) Form

  • Updated OMB Expiration Date to 2/28/2023

PHS Additional Indirect Costs Form

  • Updated OMB Expiration date to 2/28/2023

PHS 398 Research Plan Form

Updated OMB Expiration Date to 2/28/2023

Clarified instructions on the content of the "Letters of Support" attachment in the "Other Research Plan Section."

  • Removed previous instructions for applications submitted for due dates on or before January 24, 2019 within section 3, "Research Strategy."
  • Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT):
    • Under the introductory part of section 3, "Research Strategy": Added new section titled Note for Applications Proposing the Use of Human Fetal Tissue.
      • Within section 3 "Research Strategy", subsection 3 "Approach" - added a new bullet point for this information titled 'Special Instructions for Proposed Human Fetal Tissue Research."
  • Made minor text edits.

PHS 398 Career Development Award Supplemental Form

  • Updated OMB Expiration Date to 2/28/2023
  • Added instructions about rigor, experimental design, and quantitative approaches to the "Candidate Information and Goals for Career Development" section.
  • Added new "Description of Candidate's Contribution to Program Goals" attachment.
  • Renumbered form fields.
  • Removed previous instructions for applications submitted for due dates on or before January 24, 2019 within section 4 "Research Strategy."
  • Added instructions for applications proposing the use of human fetal tissue obtained from elective abortions (HFT):
  • Under the introductory part of Section 4 "Research Strategy:: Added a new section titled Note for Applications Proposing the Use of Human Fetal Tissue.
    • Within Section 4 "Research Strategy" - subsection 3 "Approach" - added a new bullet point for this information titled Special Instructions for Proposed Human Fetal Tissue Research.
  • Made minor text edits.

PHS 398 Research Training Program Plan Form

  • Updated OMB Expiration Date to 2/28/2023
  • Removed previous instructions for applications submitted for due dates on or before January 24, 2019 within Section 8 "Letters of Support."
  • Added instructions to the "Proposed Training" section of the "Program Plan" about rigor, experimental design, and quantitative approaches.
  • Added instructions for the "Plan for Instruction in Methods for Enhancing Reproducibility" attachment.
  • Updated instructions for the "Progress Report (for Renewal applications)" attachment.
  • Made minor text edits.

PHS Fellowship Supplemental Form

  • Updated OMB Expiration Date to 2/28/2023
  • Added instructions about rigor, experimental design, and quantitative approaches to the "Training Goals and Objectives" section of the "Applicant's Background and Goals for Fellowship Training" attachment.
  • Added instructions for the "Authentication of Key Biological and/or Chemical Resources" field.
  • Added new "Description of Candidate's Contribution to Program Goals" attachment.
  • Renumbered form fields.
  • Made minor text edits.

PHS Human Subjects and Clinical Trials Information

  • Updated OMB Expiration date to 2/28/2023.
  • Changes were made to the form's organization in the following sections:
  • Who should use the PHS Human Subjects and Clinical Trials Information form
  • Using the PHS Human Subjects and Clinical Trials Information form
  • Use of Human Specimens and/or Data
  • Clarified and updated instructions throughout. Significant changes were made for the following fields:
    • "Provide the ClinicalTrials.gov Identifier"
    • "Section 2 - Study Population Characteristics" instructions now reflect updated exceptions for required questions.
    • Study Timeline
    • Section 3.2: "Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?" - reflect updated instructions.
    • "Data and Safety Monitoring Plan" attachment
  • Updated instructions for delayed onset studies regarding use of single IRB.
  • Added new "Inclusion of Individuals Across the Lifespan" attachment.
  • Updated instructions for the "Inclusion of Women and Minorities" attachment to reflect separate "Inclusion of Individuals Across the Lifespan" attachment.
  • Added new "Inclusion Enrollment Report Title" field.
  • Removed the "Brief Summary" field.

Changed the "Narrative Study" field to "Detailed Description."

  • Updated instructions to Section 3.2 "Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?" and the single IRB plan attachment.
    • Included instructions specific for AHRQ applicants.
  • Included instructions specific for AHRQ applicants to Section 3.3 "Data and Safety Monitoring Plan."
  • Added new "Is this an applicable clinical trial under FDAAA?" field.
  • Renumbered form fields.

PHS Assignment Request Form

  • Updated OMB Expiration Date to 2/28/2023.
  • Updated language in the form to clarify that this form is for suggestions.
  • Removed the "Do Not Assign to Awarding Component" and "Do Not Assign to Study Section" fields and instructions.
  • Added new "Rationale for assignment suggestions" field.