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  5. Early Planning For Grant Application Submissions
  1. Orphan Products Clinical Trials Grants Program

Early Planning For Grant Application Submissions

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Applicants must have an active Dun and Bradstreet Universal Numbering System (DUNS) number and System for Award Management (SAM) registration to complete the Grants.gov registration.  After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) code to register in SAM.

For more details about required registrations for grant application see the General Instructions of SF424 (R&R) (Current Version E).

A Letter of Intent to the FDA Office of Orphan Products Grant Program Director is required by May 25, 2019.