21 CFR 60.40 - Request for hearing.
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(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.
(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;
(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.
(c) The request shall state whether the requesting party seeks a hearing within 30 days or 60 days of FDA's receipt of the request.
[53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002]
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.