[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR160.312]



[Page 713]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           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.