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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 516 - New Animal Drugs for Minor Use and Minor Species |
| 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 - XXX |
| Subpart E - Conditionally Approved New Animal Drugs For Minor Use and Minor Species |
| § 516.498 - Crofelemer. |
| § 516.812 - Enrofloxacin. |
| § 516.1012 - Fuzapladib. |
| § 516.1215 - Florfenicol. |
| § 516.1318 - Masitinib. |
| § 516.1449 - Molidustat oral suspension. |
| § 516.1684 - Paclitaxel. |
| § 516.1760 - Phenobarbital. |
| § 516.1780 - Pimobendan. |
| § 516.1858 - Potassium bromide. |
| § 516.2065 - Rabacfosadine. |
| § 516.2475 - Torsemide. |
| § 516.2980 - Verdinexor. |