U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 516Subpart B - Subpart B—Designation of a Minor Use or Minor Species New Animal Drug
§ 516.11 - Scope of this subpart.
§ 516.12 - Purpose.
§ 516.13 - Definitions.
§ 516.14 - Submission of requests for designation.
§ 516.16 - Eligibility to request designation.
§ 516.20 - Content and format of a request for MUMS-drug designation.
§ 516.21 - Documentation of minor use status.
§ 516.22 - Permanent-resident U.S. agent for foreign sponsor.
§ 516.23 - Timing of requests for MUMS-drug designation.
§ 516.24 - Granting MUMS-drug designation.
§ 516.25 - Refusal to grant MUMS-drug designation.
§ 516.26 - Amendment to MUMS-drug designation.
§ 516.27 - Change in sponsorship.
§ 516.28 - Publication of MUMS-drug designations.
§ 516.29 - Termination of MUMS-drug designation.
§ 516.30 - Annual reports for a MUMS-designated drug.
§ 516.31 - Scope of MUMS-drug exclusive marketing rights.
§ 516.34 - FDA recognition of exclusive marketing rights.
§ 516.36 - Insufficient quantities of MUMS-designated drugs.
§ 516.52 - Availability for public disclosure of data and information in requests.
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