Notice Number: NOT-FD-20-006
Key Dates
Release Date: December 3, 2019
Issued by
FOOD AND DRUG ADMINISTRATION (FDA)
Purpose
FDA will require 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.
Below are the prior approval request types that will be available in eRA Commons for FDA grantees:
Carryover
A carryover request will be available in Prior Approval when the following conditions are met:
As part of the process, several key pieces of information will be required to complete the request:
Change of PD/PI
A Change of PD/PI will be available in Prior Approval when the following conditions are met:
As part of the process, several key pieces of information will be required to complete the request:
Following files will need to be uploaded as an attached to the request:
No Cost Extensions
A No Cost Extension will be available in Prior Approval when the following conditions are met:
As part of the process, several key pieces of information will be required to complete the request:
Other
An "Other" Prior Approval request type will be available in Prior Approval when the following condition is met:
As part of the process, several key pieces of information will be required to complete the request:
Please review the Notice of Award for Other Prior Approval requirements. Any requests involving budgetary issues/changes must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to the submission of the request and expenditure of funds for additional guidance and clarification.
Resources
Additional resources concerning the Prior Approval Module including tutorials and User Guide can be found at:
Tutorials:
User guide: eRA Commons User Guide (Prior Approval)
Inquiries
Please direct all inquiries to:
Questions concerning prior approval submission requirements for a specific award should be directed to the Grants Management Specialist listed in the Notice of Award or assigned to the award in eRA Commons.
General questions concerning the eRA Commons should be directed to the eRA Commons Helpdesk at:
eRA Commons Helpdesk
Web: https://inside.era.nih.gov/era-service-desk.htm
Toll-free: 1-866-504-9552
Phone: 301-402-7469
TTY: 301-451-5939
Hours: Mon-Fri, 7a.m. to 8 p.m.. Eastern Time
Questions concerning this Notice may be directed to:
Food and Drug Administration (FDA)
Office of Acquisitions and Grants Services (OAGS)
Grants Management Branch
Email: OAGSGrantsPolicy@fda.hhs.gov