21 CFR 1316.59 - Submission and receipt of evidence.
(a) The presiding officer shall admit only evidence that is competent, relevant, material and not unduly repetitious.
(b) Opinion testimony shall be admitted when the presiding officer is satisfied that the witness is properly qualified.
(c) The authenticity of all documents submitted in advance shall be deemed admitted unless written objection thereto is filed with the presiding officer, except that a party will be permitted to challenge such authenticity at a later time upon a showing of good cause for failure to have filed such written objection.
(d) Samples, if otherwise admissible into evidence, may be displayed at the hearing and may be described for purposes of the record, or may be admitted in evidence as exhibits.
(e) Where official notice is taken or is to be taken of a material fact not appearing in the evidence of record, any party, on timely request, shall be afforded opportunity to controvert such fact.
(f) The presiding officer shall file as exhibits copies of the following documents:
(1) The order to show cause or notice of hearing;
(2) Any notice of waiver or modification of rules made pursuant to § 1316.44 or otherwise;
(3) Any waiver of hearing (together with any statement filed therewith) filed pursuant to § 1316.49 or otherwise;
(4) The prehearing ruling, if any, made pursuant to § 1316.55;
(5) Any other document necessary to show the basis for the hearing.