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Section 516.1
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Purpose |
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Section 516.2
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Definitions |
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Section 516.3
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Scope of this subpart |
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Section 516.11
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Purpose |
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Section 516.12
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Definitions |
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Section 516.13
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Submission of requests for designation |
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Section 516.14
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Eligibility to request designation |
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Section 516.16
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Content and format of a request for MUMS-drug designation |
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Section 516.20
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Documentation of minor use status |
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Section 516.21
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Permanent-resident U |
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Section 516.22
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Timing of requests for MUMS-drug designation |
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Section 516.23
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Granting MUMS-drug designation |
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Section 516.24
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Refusal to grant MUMS-drug designation |
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Section 516.25
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Amendment to MUMS-drug designation |
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Section 516.26
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Change in sponsorship |
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Section 516.27
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Publication of MUMS-drug designations |
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Section 516.28
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Termination of MUMS-drug designation |
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Section 516.29
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Annual reports for a MUMS-designated drug |
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Section 516.30
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Scope of MUMS-drug exclusive marketing rights |
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Section 516.31
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FDA recognition of exclusive marketing rights |
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Section 516.34
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Insufficient quantities of MUMS-designated drugs |
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Section 516.36
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Availability for public disclosure of data and information in requests |
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Section 516.52
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Scope of this subpart |
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Section 516.111
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Definitions |
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Section 516.115
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Submission of correspondence under this subpart |
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Section 516.117
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Permanent-resident U |
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Section 516.119
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Meetings |
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Section 516.121
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Informal conferences regarding agency administrative actions |
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Section 516.123
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Investigational use of minor species new animal drugs to support indexing |
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Section 516.125
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Content and format of a request for determination of eligibility for indexing |
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Section 516.129
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Refuse to file a request for determination of eligibility for indexing |
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Section 516.131
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Denying a request for determination of eligibility for indexing |
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Section 516.133
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Granting a request for determination of eligibility for indexing |
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Section 516.135
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Notification of decision regarding eligibility for indexing |
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Section 516.137
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Qualified expert panels |
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Section 516.141
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Written report |
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Section 516.143
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Content and format of a request for addition to the index |
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Section 516.145
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Refuse to file a request for addition to the index |
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Section 516.147
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Denying a request for addition to the index |
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Section 516.149
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Granting a request for addition to the index |
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Section 516.151
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Notification of decision regarding index listing |
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Section 516.153
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Labeling of indexed drugs |
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Section 516.155
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Publication of the index and content of an index listing |
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Section 516.157
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Modifications to indexed drugs |
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Section 516.161
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Change in ownership of an index file |
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Section 516.163
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Records and reports |
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Section 516.165
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Removal from the index |
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Section 516.167
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Confidentiality of data and information in an index file |
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Section 516.171
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Masitinib |
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Section 516.1318
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Paclitaxel |
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Section 516.1684
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Acepromazine |