Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Animal Drugs, Feeds, and Related Products
  6. New Animal Drugs for Minor Use and Minor Species
  7. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

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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.