---
kind: "section"
citation: "21 C.F.R. § 17.9"
title: "21"
number: "17.9"
heading: "Answer."
url: "https://uscodex.org/cfr/21/17.9"
---

# §17.9. Answer.

- (a) The respondent may request a hearing by filing an answer with the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, within 30 days of service of the complaint. Unless stated otherwise, an answer shall be deemed to be a request for hearing.
- (b) **In the answer, the respondent—**
  - (1) Shall admit or deny each of the allegations of liability made in the complaint; allegations not specifically denied in an answer are deemed admitted;
  - (2) Shall state all defenses on which the respondent intends to rely;
  - (3) Shall state all reasons why the respondent contends that the penalties and assessments should be less than the requested amount; and
  - (4) **Shall state the name, address, and telephone number of the respondent's counsel, if any.**
- (c) If the respondent is unable to file an answer meeting the requirements of [paragraph (b)](#b) of this section within the time provided, the respondent shall, before the expiration of 30 days from service of the complaint, file a request for an extension of time within which to file an answer that meets the requirements of [paragraph (b)](#b) of this section. The presiding officer may, for good cause shown, grant the respondent up to 30 additional days within which to file an answer that meets the requirements of [paragraph (b)](#b) of this section.
- (d) The respondent may, on motion, amend its answer to conform with the evidence as justice may require.

## Notes

### Authority

Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

### Source

Source: 60 FR 38626, July 27, 1995, unless otherwise noted.