Subpart C. Subpart C—Substantial Equivalence Reports

• § 1107.16 - Submission of a substantial equivalence report.
• § 1107.18 - Required content and format of an SE Report.
• § 1107.19 - Comparison information.
• § 1107.20 - Amendments.
• § 1107.22 - Withdrawal by applicant.
• § 1107.24 - Change in ownership of an SE Report.