Title 21

PART 516 SUBPART B

Subpart B - Designation of a Minor Use or Minor Species New Animal Drug

• 21 U.S.C. 360ccc-1, 360ccc-2, 371.
• 72 FR 41017, July 26, 2007, unless otherwise noted.

21:6.0.1.1.10.2.1.1	SECTION 516.11	516.11 Scope of this subpart.
21:6.0.1.1.10.2.1.2	SECTION 516.12	516.12 Purpose.
21:6.0.1.1.10.2.1.3	SECTION 516.13	516.13 Definitions.
21:6.0.1.1.10.2.1.4	SECTION 516.14	516.14 Submission of requests for designation.
21:6.0.1.1.10.2.1.5	SECTION 516.16	516.16 Eligibility to request designation.
21:6.0.1.1.10.2.1.6	SECTION 516.20	516.20 Content and format of a request for MUMS-drug designation.
21:6.0.1.1.10.2.1.7	SECTION 516.21	516.21 Documentation of minor use status.
21:6.0.1.1.10.2.1.8	SECTION 516.22	516.22 Permanent-resident U.S. agent for foreign sponsor.
21:6.0.1.1.10.2.1.9	SECTION 516.23	516.23 Timing of requests for MUMS-drug designation.
21:6.0.1.1.10.2.1.10	SECTION 516.24	516.24 Granting MUMS-drug designation.
21:6.0.1.1.10.2.1.11	SECTION 516.25	516.25 Refusal to grant MUMS-drug designation.
21:6.0.1.1.10.2.1.12	SECTION 516.26	516.26 Amendment to MUMS-drug designation.
21:6.0.1.1.10.2.1.13	SECTION 516.27	516.27 Change in sponsorship.
21:6.0.1.1.10.2.1.14	SECTION 516.28	516.28 Publication of MUMS-drug designations.
21:6.0.1.1.10.2.1.15	SECTION 516.29	516.29 Termination of MUMS-drug designation.
21:6.0.1.1.10.2.1.16	SECTION 516.30	516.30 Annual reports for a MUMS-designated drug.
21:6.0.1.1.10.2.1.17	SECTION 516.31	516.31 Scope of MUMS-drug exclusive marketing rights.
21:6.0.1.1.10.2.1.18	SECTION 516.34	516.34 FDA recognition of exclusive marketing rights.
21:6.0.1.1.10.2.1.19	SECTION 516.36	516.36 Insufficient quantities of MUMS-designated drugs.
21:6.0.1.1.10.2.1.20	SECTION 516.52	516.52 Availability for public disclosure of data and information in requests.

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