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

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 516
8. ›
9. Subpart B

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 516.11
  § 516.11 Scope of this subpart.
• 516.12
  § 516.12 Purpose.
• 516.13
  § 516.13 Definitions.
• 516.14
  § 516.14 Submission of requests for designation.
• 516.16
  § 516.16 Eligibility to request designation.
• 516.20
  § 516.20 Content and format of a request for MUMS-drug designation.
• 516.21
  § 516.21 Documentation of minor use status.
• 516.22
  § 516.22 Permanent-resident U.S. agent for foreign sponsor.
• 516.23
  § 516.23 Timing of requests for MUMS-drug designation.
• 516.24
  § 516.24 Granting MUMS-drug designation.
• 516.25
  § 516.25 Refusal to grant MUMS-drug designation.
• 516.26
  § 516.26 Amendment to MUMS-drug designation.
• 516.27
  § 516.27 Change in sponsorship.
• 516.28
  § 516.28 Publication of MUMS-drug designations.
• 516.29
  § 516.29 Termination of MUMS-drug designation.
• 516.30
  § 516.30 Annual reports for a MUMS-designated drug.
• 516.31
  § 516.31 Scope of MUMS-drug exclusive marketing rights.
• 516.34
  § 516.34 FDA recognition of exclusive marketing rights.
• 516.36
  § 516.36 Insufficient quantities of MUMS-designated drugs.
• 516.52
  § 516.52 Availability for public disclosure of data and information in requests.