21 C.F.R. § 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. (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. (2) Shall state all defenses on which the respondent intends to rely;
3. (3) Shall state all reasons why the respondent contends that the penalties and assessments should be less than the requested amount; and
4. (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) 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) 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) of this section.
(d) The respondent may, on motion, amend its answer to conform with the evidence as justice may require.