21 CFR 17.34 - Determining the amount of penalties and assessments.

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There is 1 rule appearing in the Federal Register for 21 CFR 17. View below or at eCFR (GPOAccess)
§ 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 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.

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-02-03; vol. 79 # 22 - Monday, February 3, 2014
    1. 79 FR 6088 - Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule.
      This rule is effective June 18, 2014, without further notice, unless FDA receives significant adverse comment by April 21, 2014. If we receive no timely significant adverse comments, we will publish a document in the Federal Register before May 19, 2014, confirming the effective date of the direct final rule. If we receive any timely significant adverse comments, we will publish a document in the Federal Register withdrawing this direct final rule before June 18, 2014.
      21 CFR Part 17

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 17 after this date.

  • 2014-02-03; vol. 79 # 22 - Monday, February 3, 2014
    1. 79 FR 6088 - Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Direct final rule.
      This rule is effective June 18, 2014, without further notice, unless FDA receives significant adverse comment by April 21, 2014. If we receive no timely significant adverse comments, we will publish a document in the Federal Register before May 19, 2014, confirming the effective date of the direct final rule. If we receive any timely significant adverse comments, we will publish a document in the Federal Register withdrawing this direct final rule before June 18, 2014.
      21 CFR Part 17