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Title 42

This content is from the eCFR and is authoritative but unofficial.

Displaying title 42, up to date as of 7/09/2026. Title 42 was last amended 7/01/2026.
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  1. Title 42 —Public Health
  2. Chapter I —Public Health Service, Department of Health and Human Services
  3. Subchapter A —General Provisions
  4. Part 3 —Patient Safety Organizations and Patient Safety Work Product
  5. Subpart D —Enforcement Program
  6. § 3.408
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eCFR Content

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.

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§ 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.

eCFR Content