Subpart B - DESIGNATION OF A MINOR USE OR MINOR SPECIES NEW ANIMAL DRUG
- Section 516.11 - Scope of this subpart
- Section 516.12 - Purpose
- Section 516.13 - Definitions
- Section 516.14 - Submission of requests for designation
- Section 516.16 - Eligibility to request designation
- Section 516.20 - Content and format of a request for MUMS-drug designation
- Section 516.21 - Documentation of minor use status
- Section 516.22 - Permanent-resident U.S. agent for foreign sponsor
- Section 516.23 - Timing of requests for MUMS-drug designation
- Section 516.24 - Granting MUMS-drug designation
- Section 516.25 - Refusal to grant MUMS-drug designation
- Section 516.26 - Amendment to MUMS-drug designation
- Section 516.27 - Change in sponsorship
- Section 516.28 - Publication of MUMS-drug designations
- Section 516.29 - Termination of MUMS-drug designation
- Section 516.30 - Annual reports for a MUMS-designated drug
- Section 516.31 - Scope of MUMS-drug exclusive marketing rights
- Section 516.34 - FDA recognition of exclusive marketing rights
- Section 516.36 - Insufficient quantities of MUMS-designated drugs
- Section 516.52 - Availability for public disclosure of data and information in requests