§ 152.93 Citation of a previously submitted valid study.

An applicant may demonstrate compliance for a data requirement by citing a valid study previously submitted to the Agency. The study is not to be submitted to the Agency with the application.

(a) Study originally submitted by the applicant. If the applicant certifies that he is the original data submitter, no documentation other than the citation is necessary.

(b) Study previously submitted by another person. If the applicant is not the original data submitter, the applicant may cite the study only in accordance with paragraphs (b) (1) through (3) of this section.

(1) Citation with authorization of original data submitter. The applicant may cite any valid study for which he has obtained the written authorization of the original data submitter. The applicant must obtain written authorization to cite any study that is an exclusive use study. The applicant must certify that he has obtained from the original data submitter a written authorization that contains at least the following information: