[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.33]
[Page 180]
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.
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