SUBPART B—Designation of a Minor Use or Minor Species New Animal Drug (§516.11 to §516.52)
- 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.