Code of Federal Regulations Title 45. Public Welfare § 45.1174.7 Contents of a complaint

(1) The allegations of liability against the defendant and the statutory basis for liability, identification of the claims or statements involved, and the reasons liability allegedly arises from such claims or statements;

(2) The maximum amount of penalties and assessments for which the defendant may be held liable;

(3) A statement that the defendant may request a hearing by filing an answer and may be represented by a representative;

(4) Instructions for filing such an answer;  and

(5) A warning that failure to file an answer within thirty days of service of the complaint will result in an imposition of the maximum amount of penalties and assessments.