[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR160.306]

[Page 673]
 
                        TITLE 45--PUBLIC WELFARE
 
                    SUBTITLE A--DEPARTMENT OF HEALTH
                           AND HUMAN SERVICES
 
PART 160--GENERAL ADMINISTRATIVE REQUIREMENTS--Table of Contents
 
                  Subpart C--Compliance and Enforcement
 
Sec. 160.306  Complaints to the Secretary.

    (a) Right to file a complaint. A person who believes a covered 
entity is not complying with the applicable requirements of this part 
160 or the applicable standards, requirements, and implementation 
specifications of subpart E of part 164 of this subchapter may file a 
complaint with the Secretary.
    (b) Requirements for filing complaints. Complaints under this 
section must meet the following requirements:
    (1) A complaint must be filed in writing, either on paper or 
electronically.
    (2) A complaint must name the entity that is the subject of the 
complaint and describe the acts or omissions believed to be in violation 
of the applicable requirements of this part 160 or the applicable 
standards, requirements, and implementation specifications of subpart E 
of part 164 of this subchapter.
    (3) A complaint must be filed within 180 days of when the 
complainant knew or should have known that the act or omission 
complained of occurred, unless this time limit is waived by the 
Secretary for good cause shown.
    (4) The Secretary may prescribe additional procedures for the filing 
of complaints, as well as the place and manner of filing, by notice in 
the Federal Register.
    (c) Investigation. The Secretary may investigate complaints filed 
under this section. Such investigation may include a review of the 
pertinent policies, procedures, or practices of the covered entity and 
of the circumstances regarding any alleged acts or omissions concerning 
compliance.