FDA Requires Mandatory Use of the Prior Approval Module in eRA Commons beginning January 1, 2020

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Notice Number: NOT-FD-20-006

Key Dates
Release Date: December 3, 2019

Related Announcements
None

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
• Change of PD/PI
• No Cost Extensions
• Other - Common types of "Other" Prior Approval requests may include the following:

1. Significant Re-budgeting/Budget Revisions
2. Change in Scope or Objectives
3. Change in Key Personnel
4. Deviation from Terms and Conditions of award
5. Publications
6. Change in Grantee Organization
7. Conferences and Conference Travel

Carryover

A carryover request will be available in Prior Approval when the following conditions are met:

1. Prior year’s FFR (Federal Financial Report) has been submitted in eRA Commons.
2. The grant is active, meaning the project period has not ended and the grant has not been closed.

As part of the process, several key pieces of information will be required to complete the request:

1. Unobligated funds to be carried over
2. Explanation of unobligated funds
3. Budget Justification
4. Scientific Justification

Change of PD/PI

A Change of PD/PI will be available in Prior Approval when the following conditions are met:

1. The grant is awarded, and the Project Period End Date has not passed.

As part of the process, several key pieces of information will be required to complete the request:

1. Who is being replaced, removed or added to the grant?
2. What will their level of effort be?
3. What is the effective start date for the requested changes?

Following files will need to be uploaded as an attached to the request:

1. Biosketch for any new PD/PI
2. Other Support for any new PD/PI
3. Justification Document

No Cost Extensions

A No Cost Extension will be available in Prior Approval when the following conditions are met:

1. Grant is within 90 days of the project end date or;
2. The Project Period End Date has expired and has not been closed or has not entered unilateral closeout, whichever comes first.

As part of the process, several key pieces of information will be required to complete the request:

1. Request Detail - the number of months you wish to extend the project end date; the amount of unobligated money still available, and other pertinent information.
2. Three PDF upload fields: Progress Report, Budget Document, Justification Document

Other

An "Other" Prior Approval request type will be available in Prior Approval when the following condition is met:

1. The grant is active, meaning the project period has not ended and the grant has not been closed.

As part of the process, several key pieces of information will be required to complete the request:

1. Description of request
2. Effective Date
3. Budget (as applicable)
4. Supporting Documentation (as applicable)

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:

Carryover

Change of PD/PI

No Cost Extensions

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

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Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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