(a) The Agency normally will review data submitted with an application that have not previously been submitted to the Agency.
(b) The Agency normally will review other data submitted or cited by an applicant only:
(1) As part of the process of reregistering currently registered products;
(2) When acting on an application for registration of a product containing a new active ingredient;
(3) If such data have been flagged in accordance with § 158.34 or 161.34 of this chapter; or
(4) When the Agency determines that it would otherwise serve the public interest.
(c) If the Agency finds that it needs additional data in order to determine whether the product may be registered, it will notify the applicant as early as possible in the review process.
[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007]