Any person may request a revision of the regulatory review period determination within 60 days after its initial publication in the Federal Register. The request shall be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The request shall specify the following:
The type of action requested;
The identity of the product;
The identity of the applicant;
The FDA docket number; and
The basis for the request for revision, including any documentary evidence.
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.
FDA shall apply the provisions of § 60.22 in considering the request for a revision of the regulatory review period determination. lf FDA revises its prior determination, FDA will notify PTO of the revision, send a copy of this notification to the applicant, and publish the revision in the Federal Register, including a statement giving the reasons for the revision.
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