42 CFR § 3.408 - Factors considered in determining the amount of a civil money penalty.

---
identifier: "/us/cfr/t42/s3.408"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 3.408 - Factors considered in determining the amount of a civil money penalty."
title_number: 42
title_name: "Public Health"
section_number: "3.408"
section_name: "Factors considered in determining the amount of a civil money penalty."
chapter_name: "PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL PROVISIONS"
part_number: "3"
part_name: "PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6."
regulatory_source: "73 FR 70796, Nov. 21, 2008, unless otherwise noted."
cfr_part: "3"
---


# 3.408 Factors considered in determining the amount of a civil money penalty.

In determining the amount of any civil money penalty, the Secretary may consider as aggravating or mitigating factors, as appropriate, any of the following:

(a) The nature of the violation.

(b) The circumstances, including the consequences, of the violation, including:

(1) The time period during which the violation(s) occurred; and

(2) Whether the violation caused physical or financial harm or reputational damage;

(c) The degree of culpability of the respondent, including:

(1) Whether the violation was intentional; and

(2) Whether the violation was beyond the direct control of the respondent.

(d) Any history of prior compliance with the Patient Safety Act, including violations, by the respondent, including:

(1) Whether the current violation is the same or similar to prior violation(s);

(2) Whether and to what extent the respondent has attempted to correct previous violations;

(3) How the respondent has responded to technical assistance from the Secretary provided in the context of a compliance effort; and

(4) How the respondent has responded to prior complaints.

(e) The financial condition of the respondent, including:

(1) Whether the respondent had financial difficulties that affected its ability to comply;

(2) Whether the imposition of a civil money penalty would jeopardize the ability of the respondent to continue to provide health care or patient safety activities; and

(3) The size of the respondent.

(f) Such other matters as justice may require.