[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: 21CFR17.34]

[Page 180-181]
 
                        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.  17.34  Determining the amount of penalties and assessments.

    (a) When determining an appropriate amount of civil money penalties 
and assessments, the presiding officer and the Commissioner of Food and 
Drugs or

[[Page 181]]

entity designated by the Commissioner to decide the appeal (currently 
the DAB) shall evaluate any circumstances that mitigate or aggravate the 
violation and shall articulate in their opinions the reasons that 
support the penalties and assessments imposed.
    (b) The presiding officer and the entity deciding the appeal shall 
refer to the factors identified in the statute under which the penalty 
is assessed for purposes of determining the amount of penalty.
    (c) Nothing in this section shall be construed to limit the 
presiding officer or the entity deciding the appeal from considering any 
other factors that in any given case may mitigate or aggravate the 
offense for which penalties and assessments are imposed.