Notice Number: NOT-FD-15-001
Release Date: August 20, 2015
U.S. Food and Drug Administration (FDA)
FDA will require all Federal Financial Reports (FFRs) (annual and final) due on or after October 31, 2015 to be submitted using the electronic FFR system in the eRA Commons. This includes all initial FFRs being prepared for submission and any revisions being submitted or re-submitted to FDA. The eRA Commons web-based FFR system allows recipients to view information on currently due and late FFRs and to submit FFRs electronically to the FDA.
FDA's implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 1/31/2016, the annual FFR is due 6/30/2016 (90 days after the end of the calendar quarter of 3/31/2016).
Any award in its FINAL year of the project with a project period end date on/or prior to October 31, 2015 must submit all final FFRs with all applicable closeout documents via email to: OAGSGrantsPolicy@fda.hhs.gov. For all other awards, all FFRs must be submitted using the electronic FFR system in the eRA Commons starting November 1, 2015.
Due dates of final reports will remain unchanged. The due date for final FFRs will continue to be 90 days after the project period end date. Reminder, grantees must submit closeout reports in a timely manner. Unless the Chief Grants Management Officer approves an extension, grantees must submit a final FFR, final progress report, and Final Invention Statement and Certification within 90 days of the end of the grant project period. Failure to submit timely and accurate final reports may affect future funding to the organization or awards under the direction of the same PD/PI.
All institutions/organizations must register in the eRA Commons, to allow faculty and staff to take advantage of the electronic submission and retrieval of grant information. Only an individual with signatory authority for the institution or organization in grant-related matters can register an institution. This individual is known as a Signing Official (SO). To register in the eRA Commons, open the eRA Commons homepage and click on the Grantee Organization Registration link. Follow the step-by-step instructions.
Once an institution/organization is registered, the SO can log into eRA Commons, create individual user accounts and designate the roles associated with each account. Roles provide the authority within eRA Commons to perform specific tasks. The FFR role allows institutional or organizational staff to process FFRs for submission to FDA electronically through the eRA Commons. An account for an individual can include multiple roles, including the FFR role; however, an account with only the FFR role assigned can only perform FFR tasks.
Additional resources concerning the FFR system including a User Guide can be found on the eRA home page: http://era.nih.gov/ and https://era.nih.gov/services_for_applicants/reports_and_closeout/financial_status_report.cfm
User guide: http://era.nih.gov/files/ffr_user_guide.pdf.
General questions concerning using the eRA Commons should be directed to the eRA Commons Helpdesk at:
eRA Commons Help Desk
Web: http://ithelpdesk.nih.gov/eRA/ (Preferred method of contact)
Hours: Mon-Fri, 7a.m. to 8 p.m. Eastern Standard Time
Questions concerning specific financial matters in the eRA Commons electronic FFR system and general inquires about this change may be directed to:
Food and Drug Administration (FDA)
Office of Acquisitions and Grants Services
Grants Management Branch
5630 Fishers Lane
Rockville, MD 20857