[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.9]

[Page 175]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 17_CIVIL MONEY PENALTIES HEARINGS--Table of Contents
 
Sec.  17.9  Answer.

    (a) The respondent may request a hearing by filing an answer with 
the Division of Dockets Management (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) 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.