21 CFR Subpart B
Designation of a Minor Use or Minor Species New Animal Drug
June 25, 2020
§
516.14
Submission of requests for designation
§
516.16
Eligibility to request designation
§
516.11
Scope of this subpart
§
516.12
Purpose
§
516.13
Definitions
§
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
Tried the LawStack mobile app?
Join thousands and try LawStack mobile for FREE today.
- Carry the law offline, wherever you go.
- Download CFR, USC, rules, and state law to your mobile device.
