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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MIN...
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
§ 516.1 - Scope.
§ 516.2 - Purpose.
§ 516.3 - Definitions.
§ 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.
§ 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.
§ 516.1684 - Paclitaxel.
§ 516.2065 - Rabacfosadine.