45 CFR 160.312 - Secretarial action regarding complaints and compliance reviews.
Code of Federal Regulations - Title 45: Public Welfare (2010)
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Title 45: Public Welfare
SUBTITLE A: DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C: ADMINISTRATIVE DATA STANDARDS AND RELATED REQUIREMENTS
PART 160: GENERAL ADMINISTRATIVE REQUIREMENTS
Subpart C: Compliance and Investigations
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 or a compliance review pursuant to ? 160.308 indicates noncompliance, the Secretary will 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 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 and provide the covered entity an opportunity to submit written evidence of any mitigating factors or affirmative defenses for consideration under ?? 160.408 and 160.410 of this part. The covered entity must submit any such evidence to the Secretary within 30 days (computed in the same manner as prescribed under ? 160.526 of this part) of receipt of such notification; and
(ii) If, following action pursuant to paragraph (a)(3)(i) of this section, the Secretary finds that a civil money penalty should be imposed, inform the covered entity of such finding in a notice of proposed determination in accordance with ? 160.420 of this part.
(b) Resolution when no violation is found. If, after an investigation pursuant to ? 160.306 or a compliance review pursuant to ? 160.308, the Secretary determines that further action is not warranted, the Secretary will so inform the covered entity and, if the matter arose from a complaint, the complainant, in writing.
