FDA REQUIRES USE OF THE PRIOR APPROVAL MODULE IN THE eRA COMMONS

NOT-FD-20-006 announces the Food And Drug Administration (FDA) requirement that all prior approval requests be submitted in eRA Common's Prior Approval Module effective January 1, 2020.  All prior approval requests must be initiated and submitted by a Signing Official (SO) for the grantee organization.

Prior approval request types that will be available in eRA Commons for FDA grantees are:

  • Carryover
  • Change of PD/PI
  • No Cost Extensions
  • Other

Common types of Other prior approval requests may include:

  • Significant Re-budgeting/Budget Revisions
  • Change in Scope or Objectives
  • Change in Key Personnel
  • Deviation from Terms and Conditions of award
  • Publications
  • Change in Grantee Organization
  • Conferences and Conference Travel

For details on specific request criteria, please see NOT-FD-20-006.