21 CFR Part 516
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
- PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter E—Animal Drugs, Feeds, and Related Products
- Subpart A—General Provisions
- § 516.1 Scope.
- § 516.2 Purpose.
- § 516.3 Definitions.
- 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.
- Subpart D [Reserved]
- Subpart E—Conditionally Approved New Animal Drugs For Minor Use and Minor Species
- § 516.498 Crofelemer.
- § 516.570 Doramectin.
- § 516.900 Fluralaner.
- § 516.1012 Fuzapladib.
- § 516.1287 Lotilaner, moxidectin, praziquantel, and pyrantel.
- § 516.1449 Molidustat oral suspension.
- § 516.1760 Phenobarbital.
- § 516.1780 Pimobendan.
- § 516.2106 Sirolimus.
- § 516.2475 Torsemide.
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