G.120 - Significant Changes

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.1. Materials and Supplies."
    • 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."
  • 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.