21 CFR 17.34
§ 17.34 Determining the amount of penalties and assessments.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 17.34, § 17.34 Determining the amount of penalties and assessments, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83272
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.