40 CFR 160.12: Statement of compliance or non-compliance.

Any person who submits to EPA an application for a research or marketing permit and who, in connection with the application, submits data from a study to which this part applies shall include in the application a true and correct statement, signed by the applicant, the sponsor, and the study director, of one of the following types:

(a) A statement that the study was conducted in accordance with this part; or

(b) A statement describing in detail all differences between the practices used in the study and those required by this part; or

(c) A statement that the person was not a sponsor of the study, did not conduct the study, and does not know whether the study was conducted in accordance with this part.