(a) In general. Annually, each covered entity may submit a completed Form 8947, “Report of Branded Prescription Drug Information,” in accordance with the instructions for the form. Generally, the form solicits information from covered entities on NDCs, orphan drugs, designated entities, rebates, and other information specified by the form or its instructions.

(b) Due date. Form 8947 must be filed by the date prescribed in guidance in the Internal Revenue Bulletin.