[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.3]

[Page 183]
 
                        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. 17.3  Definitions.

    The following definitions are applicable in this part:
    (a) For specific acts giving rise to civil money penalty actions 
brought under 21 U.S.C. 333(g)(1):
    (1) Significant departure, for the purpose of interpreting 21 U.S.C. 
333(g)(1)(B)(i), means a departure from requirements that is either a 
single major incident or a series of incidents that collectively are 
consequential.
    (2) Knowing departure, for the purposes of interpreting 21 U.S.C. 
333(g)(1)(B)(i), means a departure from a requirement taken: (a) With 
actual knowledge that the action is such a departure, or (b) in 
deliberate ignorance of a requirement, or (c) in reckless disregard of a 
requirement.
    (3) Minor violations, for the purposes of interpreting 21 U.S.C. 
333(g)(1)(B)(ii), means departures from requirements that do not rise to 
a level of a single major incident or a series of incidents that are 
collectively consequential.
    (4) Defective, for the purposes of interpreting 21 U.S.C. 
333(g)(1)(B)(iii), includes any defect in performance, manufacture, 
construction, components, materials, specifications, design, 
installation, maintenance, or service of a device, or any defect in 
mechanical, physical, or chemical properties of a device.
    (b) Person or respondent includes an individual, partnership, 
corporation, association, scientific or academic establishment, 
government agency or organizational unit thereof, or other legal entity, 
or as may be defined in the act or regulation pertinent to the civil 
penalty action being brought.
    (c) Presiding officer means an administrative law judge qualified 
under 5 U.S.C. 3105.
    (d) Any term that is defined in the act has the same definition for 
civil money penalty actions that may be brought under that act.
    (e) Any term that is defined in Title 21 of the Code of Federal 
Regulations has the same definition for civil money penalty actions that 
may arise from the application of the regulation(s).
    (f) Any term that is defined in the PHS Act has the same definition 
for civil money penalty actions that may be brought under that act.
    (g) Departmental Appeals Board (DAB) means the Departmental Appeals 
Board of the Department of Health and Human Services.