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FORMS-F application changes coming soon

May 8, 2020, 17:41 PM by Melodi Moore

Did You Know_2

In March, NIH sent out Notice Number: NOT-OD-20-077, reminding all in the NIH and AHRQ applicants and recipient community that for NIH due dates on or after May 25, 2020, the new FORMS-F application packet must be used. All new Parent Announcements now include links to the new forms.

How will the FORMS-F differ from the current forms? The Significant Change Document released by NIH explains the modifications.  While most of the changes are mechanism specific, some changes will resonate across all NIH funding mechanisms.  These include:

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

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).
  • 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 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.

Mechanism related changes and more can be found on the Significant Changes page at NIH.