DEFINITION OF OUTSTANDING DATA REQUIREMENT.

SEC. 101. DEFINITION OF OUTSTANDING DATA REQUIREMENT. Section 2 (7 U.S.C. 136) is amended by adding at the end thereof the following new subsection: “(ff) Outstanding Data Requirement.— “(1) In general.— The term ‘outstanding data requirement’ means a requirement for any study, information, or data that is necessary to make a determination under section 3(c)(5) and which study, information, or data— “(A) has not been submitted to the Administrator; or “(B) if submitted to the Administrator, the Administrator has determined must be resubmitted because it is not valid, complete, or adequate to make a determination under section 3(c)(5) and the regulations and guidelines issued under such section. “(2) Factors.— In making a determination under paragraph (1)(B) respecting a study, the Administrator shall examine, at a minimum, relevant protocols, documentation of the conduct and analysis of the study, and the results of the study to determine whether the study and the results of the study fulfill the data requirement for which the study was submitted to the Administrator.”.