Table of Contents

Minor Uses and Minor Species (MUMS)
CVM Updates/FDA News
Federal Register Notices

The Legally-marketed Unapproved New Animal Drug Index (the Index) is a list of legally marketed unapproved new animal drugs to be used in minor species.  In many cases, minor species drug products are intended for uses that cannot reasonably go through the standard drug approval process. They are often intended for use in species too rare or varied to be used in traditional safety and effectiveness studies. The Index will be especially helpful to individuals treating animals or classes of animals representing markets too small to support the costs of the drug approval process, even with the incentives of the Minor Uses and Minor Species (MUMS) Act.

The Center for Veterinary Medicine (CVM) is following the final rule for indexing to administer this provision. The rule lays out how the agency makes determinations regarding the following:  (1) the eligibility of a new animal drug for addition to the Index, (2) the selection of a qualified expert panel to review certain information regarding the drug, and (3) whether the agency agrees with the recommendation of a qualified expert panel that a drug be added to the Index.  Also included in the final rule are the content and format requirements for various submissions of information to the agency.

CVM Updates/FDA News

• CVM Update - FDA Issues Final Regulations on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species,  December 6, 2007

• CVM Update - FDA Issues Proposed Regulations for MUMS Indexing, August 22, 2006

Federal Register Notices

• Final Rule - Docket No. 2006N-0067, CVM 200710.  Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.  Pages  69108-69131 [FR Doc. E7-23580] December 6, 2007 [TXT] [PDF] [PRE-PUB] Effective date February 19, 2008

• Docket No. 2006N-0067, CVM 200678. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension of Comment Period. Pages 57892-57893 [FR Doc. E6-16208] October 2, 2006 | htm | | pdf | | Pre-Pub | Comments due December 20, 2006 

•  Docket No. 2006N-0067, CVM 200537. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Pages 48840-48864 [FR Doc. 06-07070] August 22, 2006 | htm | | pdf | | Pre-Pub | Agency Information Collection Comments Due September 21, 2006 Comments due November 20, 2006
  

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