Title 21, Part 516 — New Animal Drugs for Minor Use and Minor Species
59 sections
Section 516.1
Scope.
Section 516.2
Purpose.
Section 516.3
Definitions.
Section 516.11
Scope of this subpart.
Section 516.12
Purpose.
Section 516.13
Definitions.
Section 516.14
Submission of requests for designation.
Section 516.16
Eligibility to request designation.
Section 516.20
Content and format of a request for MUMS-drug designation.
Section 516.21
Documentation of minor use status.
Section 516.22
Permanent-resident U.S. agent for foreign sponsor.
Section 516.23
Timing of requests for MUMS-drug designation.
Section 516.24
Granting MUMS-drug designation.
Section 516.25
Refusal to grant MUMS-drug designation.
Section 516.26
Amendment to MUMS-drug designation.
Section 516.27
Change in sponsorship.
Section 516.28
Publication of MUMS-drug designations.
Section 516.29
Termination of MUMS-drug designation.
Section 516.30
Annual reports for a MUMS-designated drug.
Section 516.31
Scope of MUMS-drug exclusive marketing rights.
Section 516.34
FDA recognition of exclusive marketing rights.
Section 516.36
Insufficient quantities of MUMS-designated drugs.
Section 516.52
Availability for public disclosure of data and information in requests.
Section 516.111
Scope of this subpart.
Section 516.115
Definitions.
Section 516.117
Submission of correspondence under this subpart.
Section 516.119
Permanent-resident U.S. agent for foreign requestors and holders.
Section 516.121
Meetings.
Section 516.123
Informal conferences regarding agency administrative actions.
Section 516.125
Investigational use of minor species new animal drugs to support indexing.
Section 516.129
Content and format of a request for determination of eligibility for indexing.
Section 516.131
Refuse to file a request for determination of eligibility for indexing.
Section 516.133
Denying a request for determination of eligibility for indexing.
Section 516.135
Granting a request for determination of eligibility for indexing.
Section 516.137
Notification of decision regarding eligibility for indexing.
Section 516.141
Qualified expert panels.
Section 516.143
Written report.
Section 516.145
Content and format of a request for addition to the index.
Section 516.147
Refuse to file a request for addition to the index.
Section 516.149
Denying a request for addition to the index.
Section 516.151
Granting a request for addition to the index.
Section 516.153
Notification of decision regarding index listing.
Section 516.155
Labeling of indexed drugs.
Section 516.157
Publication of the index and content of an index listing.
Section 516.161
Modifications to indexed drugs.
Section 516.163
Change in ownership of an index file.
Section 516.165
Records and reports.
Section 516.167
Removal from the index.
Section 516.171
Confidentiality of data and information in an index file.
Section 516.498
Crofelemer.
Section 516.570
Doramectin.
Section 516.1012
Fuzapladib.
Section 516.1449
Molidustat oral suspension.
Section 516.1760
Phenobarbital.
Section 516.1780
Pimobendan.
Section 516.1858
Potassium bromide.
Section 516.2106
Sirolimus.
Section 516.2475
Torsemide.
Section 516.2980
Verdinexor.