§60.40. Request for hearing. — Inbound Citations

(b) Unless the applicant is the person requesting the revision, the applicant shall respond to the request within 15 days. In responding to the request, the applicant may submit information which is relevant to the events during the regulatory review period but which was not included in the original patent term restoration application. A request for a revision is not equivalent to a due diligence petition under § 60.30 or a request for a hearing under § 60.40. If no response is submitted, FDA will decide the matter on the basis of the information in the patent term restoration application, request for revision, and FDA records.

(4) A request for a hearing filed under § 60.40.