较少使用和稀有物种的新型动物性药材

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较少使用和稀有物种的新型动物性药材

时间: 2008-07-28

GPO公布日期：2018-04-01

CFR法规编号：21 CFR 516

原文标题：New animal drugs for minor use and minor species

最后比对日期：2018-07-11

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
	516.1	Scope.
	516.2	Purpose.
	516.3	Definitions.
	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.
	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.
	516.1215	Florfenicol.

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较少使用和稀有物种的新型动物性药材

时间: 2008-07-28

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