[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR160.312]

[Page 705]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 160_GENERAL ADMINISTRATIVE REQUIREMENTS--Table of Contents
 
                 Subpart C_Compliance and Investigations
 
Sec. 160.312  Secretarial action regarding complaints and compliance reviews.

    (a) Resolution when noncompliance is indicated. (1) If an 
investigation of a complaint pursuant to Sec. 160.306 or a compliance 
review pursuant to Sec. 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 Sec. Sec. 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 Sec. 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 Sec. 160.420 of this part.
    (b) Resolution when no violation is found. If, after an 
investigation pursuant to Sec. 160.306 or a compliance review pursuant 
to Sec. 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.