(1) A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study;
(2) A person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit; or
(3) A testing facility, if it both initiates and actually conducts the study.
21 CFR § 58.3
As used in this part, the following terms shall have the meanings specified: