Title 21

PART 516

Part 516 - New Animal Drugs For Minor Use And Minor Species

PART 516 - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Authority:21 U.S.C. 360ccc-1, 360ccc-2, 371. Source:72 FR 41017, July 26, 2007, unless otherwise noted.

21:6.0.1.1.10.1SUBPART A
Subpart A - General Provisions
21:6.0.1.1.10.1.1.1SECTION 516.1
   516.1 Scope.
21:6.0.1.1.10.1.1.2SECTION 516.2
   516.2 Purpose.
21:6.0.1.1.10.1.1.3SECTION 516.3
   516.3 Definitions.
21:6.0.1.1.10.2SUBPART B
Subpart B - Designation of a Minor Use or Minor Species New Animal Drug
21:6.0.1.1.10.2.1.1SECTION 516.11
   516.11 Scope of this subpart.
21:6.0.1.1.10.2.1.2SECTION 516.12
   516.12 Purpose.
21:6.0.1.1.10.2.1.3SECTION 516.13
   516.13 Definitions.
21:6.0.1.1.10.2.1.4SECTION 516.14
   516.14 Submission of requests for designation.
21:6.0.1.1.10.2.1.5SECTION 516.16
   516.16 Eligibility to request designation.
21:6.0.1.1.10.2.1.6SECTION 516.20
   516.20 Content and format of a request for MUMS-drug designation.
21:6.0.1.1.10.2.1.7SECTION 516.21
   516.21 Documentation of minor use status.
21:6.0.1.1.10.2.1.8SECTION 516.22
   516.22 Permanent-resident U.S. agent for foreign sponsor.
21:6.0.1.1.10.2.1.9SECTION 516.23
   516.23 Timing of requests for MUMS-drug designation.
21:6.0.1.1.10.2.1.10SECTION 516.24
   516.24 Granting MUMS-drug designation.
21:6.0.1.1.10.2.1.11SECTION 516.25
   516.25 Refusal to grant MUMS-drug designation.
21:6.0.1.1.10.2.1.12SECTION 516.26
   516.26 Amendment to MUMS-drug designation.
21:6.0.1.1.10.2.1.13SECTION 516.27
   516.27 Change in sponsorship.
21:6.0.1.1.10.2.1.14SECTION 516.28
   516.28 Publication of MUMS-drug designations.
21:6.0.1.1.10.2.1.15SECTION 516.29
   516.29 Termination of MUMS-drug designation.
21:6.0.1.1.10.2.1.16SECTION 516.30
   516.30 Annual reports for a MUMS-designated drug.
21:6.0.1.1.10.2.1.17SECTION 516.31
   516.31 Scope of MUMS-drug exclusive marketing rights.
21:6.0.1.1.10.2.1.18SECTION 516.34
   516.34 FDA recognition of exclusive marketing rights.
21:6.0.1.1.10.2.1.19SECTION 516.36
   516.36 Insufficient quantities of MUMS-designated drugs.
21:6.0.1.1.10.2.1.20SECTION 516.52
   516.52 Availability for public disclosure of data and information in requests.
21:6.0.1.1.10.3SUBPART C
Subpart C - Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
21:6.0.1.1.10.3.1.1SECTION 516.111
   516.111 Scope of this subpart.
21:6.0.1.1.10.3.1.2SECTION 516.115
   516.115 Definitions.
21:6.0.1.1.10.3.1.3SECTION 516.117
   516.117 Submission of correspondence under this subpart.
21:6.0.1.1.10.3.1.4SECTION 516.119
   516.119 Permanent-resident U.S. agent for foreign requestors and holders.
21:6.0.1.1.10.3.1.5SECTION 516.121
   516.121 Meetings.
21:6.0.1.1.10.3.1.6SECTION 516.123
   516.123 Informal conferences regarding agency administrative actions.
21:6.0.1.1.10.3.1.7SECTION 516.125
   516.125 Investigational use of minor species new animal drugs to support indexing.
21:6.0.1.1.10.3.1.8SECTION 516.129
   516.129 Content and format of a request for determination of eligibility for indexing.
21:6.0.1.1.10.3.1.9SECTION 516.131
   516.131 Refuse to file a request for determination of eligibility for indexing.
21:6.0.1.1.10.3.1.10SECTION 516.133
   516.133 Denying a request for determination of eligibility for indexing.
21:6.0.1.1.10.3.1.11SECTION 516.135
   516.135 Granting a request for determination of eligibility for indexing.
21:6.0.1.1.10.3.1.12SECTION 516.137
   516.137 Notification of decision regarding eligibility for indexing.
21:6.0.1.1.10.3.1.13SECTION 516.141
   516.141 Qualified expert panels.
21:6.0.1.1.10.3.1.14SECTION 516.143
   516.143 Written report.
21:6.0.1.1.10.3.1.15SECTION 516.145
   516.145 Content and format of a request for addition to the index.
21:6.0.1.1.10.3.1.16SECTION 516.147
   516.147 Refuse to file a request for addition to the index.
21:6.0.1.1.10.3.1.17SECTION 516.149
   516.149 Denying a request for addition to the index.
21:6.0.1.1.10.3.1.18SECTION 516.151
   516.151 Granting a request for addition to the index.
21:6.0.1.1.10.3.1.19SECTION 516.153
   516.153 Notification of decision regarding index listing.
21:6.0.1.1.10.3.1.20SECTION 516.155
   516.155 Labeling of indexed drugs.
21:6.0.1.1.10.3.1.21SECTION 516.157
   516.157 Publication of the index and content of an index listing.
21:6.0.1.1.10.3.1.22SECTION 516.161
   516.161 Modifications to indexed drugs.
21:6.0.1.1.10.3.1.23SECTION 516.163
   516.163 Change in ownership of an index file.
21:6.0.1.1.10.3.1.24SECTION 516.165
   516.165 Records and reports.
21:6.0.1.1.10.3.1.25SECTION 516.167
   516.167 Removal from the index.
21:6.0.1.1.10.3.1.26SECTION 516.171
   516.171 Confidentiality of data and information in an index file.
21:6.0.1.1.10.4SUBPART D
Subpart D [Reserved]
21:6.0.1.1.10.5SUBPART E
Subpart E - Conditionally Approved New Animal Drugs For Minor Use and Minor Species
21:6.0.1.1.10.5.1.1SECTION 516.1684
   516.1684 Paclitaxel.
21:6.0.1.1.10.5.1.2SECTION 516.2065
   516.2065 Rabacfosadine.