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