---
kind: "section"
citation: "45 C.F.R. § 160.312"
title: "45"
number: "160.312"
heading: "Secretarial action regarding complaints and compliance reviews."
url: "https://uscodex.org/cfr/45/160.312"
---

# §160.312. Secretarial action regarding complaints and compliance reviews.

- (a) **Resolution when noncompliance is indicated.**
  - (1) If an investigation of a complaint pursuant to [§ 160.306](/cfr/45/160.306.md) or a compliance review pursuant to [§ 160.308](/cfr/45/160.308.md) indicates noncompliance, the Secretary may attempt to reach a resolution of the matter satisfactory to the Secretary by informal means. Informal means may include demonstrated compliance or a completed corrective action plan or other agreement.
  - (2) If the matter is resolved by informal means, the Secretary will so inform the covered entity or business associate and, if the matter arose from a complaint, the complainant, in writing.
  - (3) If the matter is not resolved by informal means, the Secretary will—
    - (i) So inform the covered entity or business associate and provide the covered entity or business associate an opportunity to submit written evidence of any mitigating factors or affirmative defenses for consideration under §§ [160.408](/cfr/45/160.408.md) and [160.410](/cfr/45/160.410.md) of this part. The covered entity or business associate must submit any such evidence to the Secretary within 30 days (computed in the same manner as prescribed under [§ 160.526](/cfr/45/160.526.md) of this part) of receipt of such notification; and
    - (ii) If, following action pursuant to [paragraph (a)(3)(i)](#a-3-i) of this section, the Secretary finds that a civil money penalty should be imposed, inform the covered entity or business associate of such finding in a notice of proposed determination in accordance with [§ 160.420](/cfr/45/160.420.md) of this part.
- (b) **Resolution when no violation is found.** If, after an investigation pursuant to [§ 160.306](/cfr/45/160.306.md) or a compliance review pursuant to [§ 160.308](/cfr/45/160.308.md), the Secretary determines that further action is not warranted, the Secretary will so inform the covered entity or business associate and, if the matter arose from a complaint, the complainant, in writing.

## Notes

### Amendments

[78 FR 5690, Jan. 25, 2013]

### Source

Source: 71 FR 8424, Feb. 16, 2006, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 1302(a); 42 U.S.C. 1320d-1320d-9; sec. 264, Pub. L. 104-191, 110 Stat. 2033-2034 (42 U.S.C. 1320d-2 (note)); 5 U.S.C. 552; secs. 13400-13424, Pub. L. 111-5, 123 Stat. 258-279; and sec. 1104 of Pub. L. 111-148, 124 Stat. 146-154.

### Source

Source: 65 FR 82798, Dec. 28, 2000, unless otherwise noted.

### Amendments

[78 FR 5690, Jan. 25, 2013]