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Title 21 - Title 21

Part 516 - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

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Details about Part 516

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ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

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51 sections

§516.1 - Scope.

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§516.11 - Scope of this subpart.

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§516.111 - Scope of this subpart.

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§516.115 - Definitions.

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§516.117 - Submission of correspondence under this subpart.

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§516.119 - Permanent-resident U.S. agent for foreign requestors and holders.

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§516.12 - Purpose.

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§516.121 - Meetings.

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§516.123 - Informal conferences regarding agency administrative actions.

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§516.125 - Investigational use of minor species new animal drugs to support indexing.

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§516.129 - Content and format of a request for determination of eligibility for indexing.

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§516.13 - Definitions.

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§516.131 - Refuse to file a request for determination of eligibility for indexing.

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§516.133 - Denying a request for determination of eligibility for indexing.

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§516.135 - Granting a request for determination of eligibility for indexing.

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§516.137 - Notification of decision regarding eligibility for indexing.

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§516.14 - Submission of requests for designation.

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§516.141 - Qualified expert panels.

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§516.143 - Written report.

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§516.145 - Content and format of a request for addition to the index.

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§516.147 - Refuse to file a request for addition to the index.

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§516.149 - Denying a request for addition to the index.

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§516.151 - Granting a request for addition to the index.

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§516.153 - Notification of decision regarding index listing.

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§516.155 - Labeling of indexed drugs.

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§516.157 - Publication of the index and content of an index listing.

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§516.16 - Eligibility to request designation.

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§516.161 - Modifications to indexed drugs.

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§516.163 - Change in ownership of an index file.

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§516.165 - Records and reports.

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§516.167 - Removal from the index.

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§516.1684 - Paclitaxel.

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§516.171 - Confidentiality of data and information in an index file.

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§516.2 - Purpose.

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§516.20 - Content and format of a request for MUMS-drug designation.

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§516.2065 - Rabacfosadine.

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§516.21 - Documentation of minor use status.

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§516.22 - Permanent-resident U.S. agent for foreign sponsor.

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§516.23 - Timing of requests for MUMS-drug designation.

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§516.24 - Granting MUMS-drug designation.

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§516.25 - Refusal to grant MUMS-drug designation.

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§516.26 - Amendment to MUMS-drug designation.

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§516.27 - Change in sponsorship.

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§516.28 - Publication of MUMS-drug designations.

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§516.29 - Termination of MUMS-drug designation.

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§516.3 - Definitions.

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§516.30 - Annual reports for a MUMS-designated drug.

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§516.31 - Scope of MUMS-drug exclusive marketing rights.

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§516.34 - FDA recognition of exclusive marketing rights.

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§516.36 - Insufficient quantities of MUMS-designated drugs.

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§516.52 - Availability for public disclosure of data and information in requests.

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