Subpart E—Satisfaction of Data Requirements and Protection of Data Submitters' Rights
Sections
Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.
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152.80
§ 152.80 General. -
152.81
§ 152.81 Applicability. -
152.82
§ 152.82 Definitions. -
152.83
§ 152.83 Definition of exclusive use study. -
152.84
§ 152.84 When materials must be submitted to the Agency. -
152.85
§ 152.85 Formulators' exemption. -
152.86
§ 152.86 The cite-all method. -
152.90
§ 152.90 The selective method. -
152.91
§ 152.91 Waiver of a data requirement. -
152.92
§ 152.92 Submission of a new valid study. -
152.93
§ 152.93 Citation of a previously submitted valid study. -
152.94
§ 152.94 Citation of a public literature study or study generated at government expense. -
152.95
§ 152.95 Citation of all studies in the Agency's files pertinent to a specific data requirement. -
152.96
§ 152.96 Claim of data gap. -
152.97
§ 152.97 Rights and obligations regarding the Data Submitters List. -
152.98
§ 152.98 Procedures for transfer of exclusive use or compensation rights to another person. -
152.99
§ 152.99 Petitions to cancel registration.