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Electronic Code of Federal Regulations

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e-CFR Data is current as of October 23, 2014

Title 21Chapter ISubchapter EPart 516


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

rule

Subpart A—GENERAL PROVISIONS

§516.1
Scope.
§516.2
Purpose.
§516.3
Definitions.
rule

Subpart B—DESIGNATION OF A MINOR USE OR MINOR SPECIES NEW ANIMAL DRUG

§516.11
Scope of this subpart.
§516.12
Purpose.
§516.13
Definitions.
§516.14
Submission of requests for designation.
§516.16
Eligibility to request designation.
§516.20
Content and format of a request for MUMS-drug designation.
§516.21
Documentation of minor use status.
§516.22
Permanent-resident U.S. agent for foreign sponsor.
§516.23
Timing of requests for MUMS-drug designation.
§516.24
Granting MUMS-drug designation.
§516.25
Refusal to grant MUMS-drug designation.
§516.26
Amendment to MUMS-drug designation.
§516.27
Change in sponsorship.
§516.28
Publication of MUMS-drug designations.
§516.29
Termination of MUMS-drug designation.
§516.30
Annual reports for a MUMS-designated drug.
§516.31
Scope of MUMS-drug exclusive marketing rights.
§516.34
FDA recognition of exclusive marketing rights.
§516.36
Insufficient quantities of MUMS-designated drugs.
§516.52
Availability for public disclosure of data and information in requests.
rule

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.
rule

Subpart D—[RESERVED]

rule

Subpart E—CONDITIONALLY APPROVED NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

§516.1318
Masitinib.
§516.1684
Paclitaxel.


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