21 CFR Part 516 - 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.