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FEDERAL · 21 CFR

Part 516 — New Animal Drugs for Minor Use and Minor Species

59 sections · Title 21: Food and Drugs

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