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Designation of a Minor Use or Minor Species New Animal Drug
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Animal Drugs, Feeds, and Related Products
New Animal Drugs for Minor Use and Minor Species
Designation of a Minor Use or Minor Species New Animal Drug
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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.