Main Designation provides drug companies with incentives. Upon approval or conditional approval of a product, designation provides sponsors with seven years of exclusive marketing rights and an opportunity to apply for grants. A drug company submits a request to OMUMS for a drug to be designated for a specific use. After the designation request is granted, no other identical designation may be granted. However, more than one designation can be granted for the same drug, as long as the designations are for different dosage forms or different intended uses. Designation requires that the drug company actively work toward approval and provide annual reports to OMUMS to show due diligence. Once a drug company receives a drug designation, the company or other organizations or individuals working with the company are eligible for grants through the federal government. This grant money is used to reduce the cost of conducting safety and effectiveness studies. <i>Information is current as of February 28, 2013.</i> Percent column Fiscal Year Target

FY 2010 Overall: 92

Oct 2009 N/A Nov 2009 N/A Dec 2009 N/A Jan 2010 90 100 Feb 2010 90 - Mar 2010 90 89 Apr 2010 90 100 May 2010 90 83 Jun 2010 90 100 Jul 2010 90 100 Aug 2010 90 100 Sep 2010 90 100 Fiscal Year Target

FY 2011 Overall: 98

Oct 2010 90 - Nov 2010 90 100 Dec 2010 90 100 Jan 2011 90 100 Feb 2011 90 100 Mar 2011 90 100 Apr 2011 90 100 May 2011 90 86 Jun 2011 90 100 Jul 2011 90 100 Aug 2011 90 100 Sep 2011 90 100 Fiscal Year Target

FY 2012 Overall: 100%

Oct 2011 90 100 Nov 2011 90 100 Dec 2011 90 100 Jan 2012 90 100 Feb 2012 90 100 Mar 2012 90 100 Apr 2012 90 100 May 2012 90 100 Jun 2012 90 100 Jul 2012 90 100 Aug 2012 90 100 Sep 2012 90 100 Fiscal Year Target

FY 2013 YTD: 100%

Oct 2012 90 100 Nov 2012 90 100 Dec 2012 90 100 Jan 2013 90 100 Feb 2013 90 100 Mar 2013 90 Apr 2013 90 May 2013 90 Jun 2013 90 Jul 2013 90 Aug 2013 90 Sep 2013 90 Sub Percentage of designation submissions reviewed and acted on within 100 days Number column Target

FY 2010 Total: 44

Oct 2009 N/A Nov 2009 N/A Dec 2009 N/A Jan 2010 N/A 5 Feb 2010 N/A 0 Mar 2010 N/A 8 Apr 2010 N/A 3 May 2010 N/A 15 Jun 2010 N/A 6 Jul 2010 N/A 2 Aug 2010 N/A 3 Sep 2010 N/A 2 Target

FY 2011 Total: 57

Oct 2010 N/A 0 Nov 2010 N/A 2 Dec 2010 N/A 2 Jan 2011 N/A 4 Feb 2011 N/A 5 Mar 2011 N/A 7 Apr 2011 N/A 2 May 2011 N/A 6 Jun 2011 N/A 5 Jul 2011 N/A 7 Aug 2011 N/A 8 Sep 2011 N/A 9

FY 2012 Total: 66

Oct 2011 N/A 11 Nov 2011 N/A 2 Dec 2011 N/A 8 Jan 2012 N/A 2 Feb 2012 N/A 7 Mar 2012 N/A 3 Apr 2012 N/A 3 May 2012 N/A 3 Jun 2012 N/A 10 Jul 2012 N/A 4 Aug 2012 N/A 5 Sep 2012 N/A 8 Fiscal Year Target

FY 2013 YTD: 22

Oct 2012 3 Nov 2012 3 Dec 2012 5 Jan 2013 1 Feb 2013 10 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Percentage of designation submissions reviewed and acted on within 100 days Number column Target

FY 2010 Total: 48

Oct 2009 N/A Nov 2009 N/A Dec 2009 N/A Jan 2010 N/A 5 Feb 2010 N/A 0 Mar 2010 N/A 9 Apr 2010 N/A 3 May 2010 N/A 18 Jun 2010 N/A 6 Jul 2010 N/A 2 Aug 2010 N/A 3 Sep 2010 N/A 2 Target

FY 2011 Total: 58

Oct 2010 N/A 0 Nov 2010 N/A 2 Dec 2010 N/A 2 Jan 2011 N/A 4 Feb 2011 N/A 5 Mar 2011 N/A 7 Apr 2011 N/A 2 May 2011 N/A 7 Jun 2011 N/A 5 Jul 2011 N/A 7 Aug 2011 N/A 8 Sep 2011 N/A 9

FY 2012 Total: 66

Oct 2011 N/A 11 Nov 2011 N/A 2 Dec 2011 N/A 8 Jan 2012 N/A 2 Feb 2012 N/A 7 Mar 2012 N/A 3 Apr 2012 N/A 3 May 2012 N/A 3 Jun 2012 N/A 10 Jul 2012 N/A 4 Aug 2012 N/A 5 Sep 2012 N/A 8 Fiscal Year Target

FY 2013 YTD: 22

Oct 2012 3 Nov 2012 3 Dec 2012 5 Jan 2013 1 Feb 2013 10 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 http://www.fda.gov/AboutFDA/Transparency/track/ucm203425.htm FDA-TRACK CVM Dashboard http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm064838.htm CVM Drug Designation word text word defintion ਍††਍਍਍਍਍਍਍