---
kind: "section"
citation: "21 C.F.R. § 1316.59"
title: "21"
number: "1316.59"
heading: "Submission and receipt of evidence."
url: "https://uscodex.org/cfr/21/1316.59"
---

# §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](/cfr/21/1316.44.md) or otherwise;
  - (3) Any waiver of hearing (together with any statement filed therewith) filed pursuant to [§ 1316.49](/cfr/21/1316.49.md) or otherwise;
  - (4) The prehearing ruling, if any, made pursuant to [§ 1316.55](/cfr/21/1316.55.md);
  - (5) **Any other document necessary to show the basis for the hearing.**

## Notes

### Authority

Authority: 21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.

### Source

Source: 36 FR 7820, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.