21 CFR Part 516 - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
- SUBPART A — General Provisions (§§ 516.1 - 516.3)
- SUBPART B — Designation of a Minor Use or Minor Species New Animal Drug (§§ 516.11 - 516.52)
- SUBPART C — Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (§§ 516.111 - 516.171)
- SUBPART D — [Reserved]
- SUBPART E — Conditionally Approved New Animal Drugs For Minor Use and Minor Species (§§ 516.1215 - 516.1318)
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 41 to 50 - Repealed.
§ 50 - Repealed.
21 USC § 360ccc–1 - Index of legally marketed unapproved new animal drugs for minor species
21 USC § 360ccc–2 - Designated new animal drugs for minor use or minor species
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 516 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-14635 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 15, 2012. 21 CFR Part 516 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a conditionally approved supplemental application for conditional approval of a new animal drug (CNADA) intended for a minor use filed by AB Science. The supplemental CNADA provides for a revised indication for masitinib mesylate tablets in dogs.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13095 RIN Docket No. FDA-2012-N-0002 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 31, 2012. 21 CFR Parts 510, 516, 520, 522, and 558 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.