[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.33]

[Page 210]
 
                        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. 17.33  The hearing and burden of proof.

    (a) The presiding officer shall conduct a hearing on the record to 
determine whether the respondent is liable for a civil money penalty 
and, if so, the appropriate amount of any such civil money penalty 
considering any aggravating or mitigating factors.
    (b) In order to prevail, the Center must prove respondent's 
liability and the appropriateness of the penalty under the applicable 
statute by a preponderance of the evidence.
    (c) The respondent must prove any affirmative defenses and any 
mitigating factors by a preponderance of the evidence.
    (d) The hearing shall be open to the public unless otherwise ordered 
by the presiding officer, who may order closure only to protect trade 
secrets or confidential commercial information, as defined in Sec. 
20.61 of this chapter, information the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy, or other 
information that would be withheld from public disclosure under part 20 
of this chapter.