21 CFR Part 516 — New Animal Drugs for Minor Use and Minor Species
Subpart A — General Provisions
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.
Subpart C — Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
- § 516.111— Scope of this subpart.
- § 516.115— Definitions.
- § 516.117— Submission of correspondence under this subpart.
- § 516.119— Permanent-resident U.S. agent for foreign requestors and holders.
- § 516.121— Meetings.
- § 516.123— Informal conferences regarding agency administrative actions.
- § 516.125— Investigational use of minor species new animal drugs to support indexing.
- § 516.129— Content and format of a request for determination of eligibility for indexing.
- § 516.131— Refuse to file a request for determination of eligibility for indexing.
- § 516.133— Denying a request for determination of eligibility for indexing.
- § 516.135— Granting a request for determination of eligibility for indexing.
- § 516.137— Notification of decision regarding eligibility for indexing.
- § 516.141— Qualified expert panels.
- § 516.143— Written report.
- § 516.145— Content and format of a request for addition to the index.
- § 516.147— Refuse to file a request for addition to the index.
- § 516.149— Denying a request for addition to the index.
- § 516.151— Granting a request for addition to the index.
- § 516.153— Notification of decision regarding index listing.
- § 516.155— Labeling of indexed drugs.
- § 516.157— Publication of the index and content of an index listing.
- § 516.161— Modifications to indexed drugs.
- § 516.163— Change in ownership of an index file.
- § 516.165— Records and reports.
- § 516.167— Removal from the index.
- § 516.171— Confidentiality of data and information in an index file.