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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 40Chapter IPart 158Subpart A - Subpart A—General Provisions
§ 158.1 - Purpose and scope.
§ 158.3 - Definitions.
§ 158.5 - Applicability.
§ 158.30 - Flexibility.
§ 158.32 - Format of data submissions.
§ 158.33 - Confidential data.
§ 158.34 - Flagging of studies for potential adverse effects.
§ 158.45 - Waivers.
§ 158.60 - Minor use data policies.
§ 158.70 - Satisfying data requirements.
§ 158.75 - Requirements for additional data.
§ 158.80 - Use of other data.
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