U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 40Chapter IPart 152Subpart E - Subpart E—Satisfaction of Data Requirements and Protection of Data Submitters' Rights
§ 152.80 - General.
§ 152.81 - Applicability.
§ 152.82 - Definitions.
§ 152.83 - Definition of exclusive use study.
§ 152.84 - When materials must be submitted to the Agency.
§ 152.85 - Formulators' exemption.
§ 152.86 - The cite-all method.
§ 152.90 - The selective method.
§ 152.91 - Waiver of a data requirement.
§ 152.92 - Submission of a new valid study.
§ 152.93 - Citation of a previously submitted valid study.
§ 152.94 - Citation of a public literature study or study generated at government expense.
§ 152.95 - Citation of all studies in the Agency's files pertinent to a specific data requirement.
§ 152.96 - Claim of data gap.
§ 152.97 - Rights and obligations regarding the Data Submitters List.
§ 152.98 - Procedures for transfer of exclusive use or compensation rights to another person.
§ 152.99 - Petitions to cancel registration.
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