21 CFR 60.40 - Request for hearing.
(a) Any person may request, not later than 60 days after the publication under § 60.34(a) of FDA's due diligence determination, that FDA conduct an informal hearing on the due diligence determination.
(b) The request for a hearing under this section shall:
(1) Be sent by mail, personal delivery, or any other mode of written communication to the Division of Dockets Management and filed under the relevant product file;
(2) Specify the facts and the action that are the subject of the hearing;
(3) Provide the name and address of the person requesting the hearing; and
(4) Certify that the requesting party has served a true and complete copy of the request upon the petitioner and the applicant by certified or registered mail (return receipt requested) or by personal delivery.