---
kind: "section"
citation: "45 C.F.R. § 158.603"
title: "45"
number: "158.603"
heading: "Notice to responsible entities."
url: "https://uscodex.org/cfr/45/158.603"
---

# §158.603. Notice to responsible entities.


If HHS learns of a potential violation described in [§ 158.602](/cfr/45/158.602.md) of this subpart or if a State informs HHS of a potential violation prior to imposing any civil monetary penalty HHS must provide written notice to the issuer, to include the following:

- (a) **Describe the potential violation.**
- (b) Provide 30 days from the date of the notice for the responsible entity to respond and to provide additional information to refute an alleged violation.
- (c) State that a civil monetary penalty may be assessed if the allegations are not, as determined by HHS, refuted.

## Notes

### Authority

Authority: 42 U.S.C. 300gg-18.

### Source

Source: 75 FR 74921, Dec. 1, 2010, unless otherwise noted.