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Designation of a Minor Use or Minor Species New Animal Drug | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter E
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.