Title 21

PART 516 SUBPART C

Subpart C - Index of Legally Marketed Unapproved New Animal Drugs for Minor Species Source:72 FR 69121, Dec. 6, 2007, unless otherwise noted.

• 21 U.S.C. 360ccc-1, 360ccc-2, 371.
• Source: 72 FR 41017, July 26, 2007, unless otherwise noted.

21:6.0.1.1.10.3.1.1	SECTION 516.111	516.111 Scope of this subpart.
21:6.0.1.1.10.3.1.2	SECTION 516.115	516.115 Definitions.
21:6.0.1.1.10.3.1.3	SECTION 516.117	516.117 Submission of correspondence under this subpart.
21:6.0.1.1.10.3.1.4	SECTION 516.119	516.119 Permanent-resident U.S. agent for foreign requestors and holders.
21:6.0.1.1.10.3.1.5	SECTION 516.121	516.121 Meetings.
21:6.0.1.1.10.3.1.6	SECTION 516.123	516.123 Informal conferences regarding agency administrative actions.
21:6.0.1.1.10.3.1.7	SECTION 516.125	516.125 Investigational use of minor species new animal drugs to support indexing.
21:6.0.1.1.10.3.1.8	SECTION 516.129	516.129 Content and format of a request for determination of eligibility for indexing.
21:6.0.1.1.10.3.1.9	SECTION 516.131	516.131 Refuse to file a request for determination of eligibility for indexing.
21:6.0.1.1.10.3.1.10	SECTION 516.133	516.133 Denying a request for determination of eligibility for indexing.
21:6.0.1.1.10.3.1.11	SECTION 516.135	516.135 Granting a request for determination of eligibility for indexing.
21:6.0.1.1.10.3.1.12	SECTION 516.137	516.137 Notification of decision regarding eligibility for indexing.
21:6.0.1.1.10.3.1.13	SECTION 516.141	516.141 Qualified expert panels.
21:6.0.1.1.10.3.1.14	SECTION 516.143	516.143 Written report.
21:6.0.1.1.10.3.1.15	SECTION 516.145	516.145 Content and format of a request for addition to the index.
21:6.0.1.1.10.3.1.16	SECTION 516.147	516.147 Refuse to file a request for addition to the index.
21:6.0.1.1.10.3.1.17	SECTION 516.149	516.149 Denying a request for addition to the index.
21:6.0.1.1.10.3.1.18	SECTION 516.151	516.151 Granting a request for addition to the index.
21:6.0.1.1.10.3.1.19	SECTION 516.153	516.153 Notification of decision regarding index listing.
21:6.0.1.1.10.3.1.20	SECTION 516.155	516.155 Labeling of indexed drugs.
21:6.0.1.1.10.3.1.21	SECTION 516.157	516.157 Publication of the index and content of an index listing.
21:6.0.1.1.10.3.1.22	SECTION 516.161	516.161 Modifications to indexed drugs.
21:6.0.1.1.10.3.1.23	SECTION 516.163	516.163 Change in ownership of an index file.
21:6.0.1.1.10.3.1.24	SECTION 516.165	516.165 Records and reports.
21:6.0.1.1.10.3.1.25	SECTION 516.167	516.167 Removal from the index.
21:6.0.1.1.10.3.1.26	SECTION 516.171	516.171 Confidentiality of data and information in an index file.

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