U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 516Subpart C - 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.
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