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CFR › Title 21 › Chapter I › Subchapter A › Part 17 › Section 17.34

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

§ 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 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
USC : Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

§ 554 - Adjudications

§ 555 - Ancillary matters

§ 556 - Hearings; presiding employees; powers and duties; burden of proof; evidence; record as basis of decision

§ 557 - Initial decisions; conclusiveness; review by agency; submissions by parties; contents of decisions; record

USC : Title 21 - FOOD AND DRUGS

§ 331 - Prohibited acts

§ 333 - Penalties

§ 337 - Proceedings in name of United States; provision as to subpoenas

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 360 - Registration of producers of drugs or devices

§ 360c - Classification of devices intended for human use

§ 360f - Banned devices

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 371 - Regulations and hearings

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 262 - Regulation of biological products

§ 263b - Certification of mammography facilities

42 USC § 300aa–28 - Manufacturer recordkeeping and reporting