Main Sponsors may submit data intended to support an application for generic new animal drug approval during the investigation of the generic new animal drug to a JINAD file. A protocol is a plan for conducting a study that fully describes the objective(s), design, methodology, study endpoints, statistical considerations, and organization of a study. The protocol may include plans for presenting study results in the final study report or submitting study results to FDA in electronic format. Acceptable protocols are critical for the generation of quality data used in the determination of the safety and effectiveness of a generic new animal drug. Note: October 1, 2008 is the effective date of the AGDUFA. <i>Information is current as of February 28, 2013.</i> This metric is also an Animal Generic Drug User Fee Program performance goal. In the yearly performance report to Congress, performance is reported for a defined fiscal year receipt cohort. The methodology for reporting by fiscal year receipt cohort calculates performance statistics for submissions for the fiscal year FDA received them, regardless of when FDA ultimately acted on or approved the submissions. The data reported here is the measurement of the number of applications reviewed in a given month regardless of the cohort year. Percent column Target

FY 2010 Overall: 100

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

FY 2011 Overall: 100

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

FY 2012 Overall: 93

Oct 2011 90 100 Nov 2011 90 100 Dec 2011 90 100 Jan 2012 90 100 Feb 2012 90 100 Mar 2012 90 - Apr 2012 90 - May 2012 90 100 Jun 2012 90 50 Jul 2012 90 100 Aug 2012 90 100 Sep 2012 90 100 Fiscal Year Target

FY 2013 YTD: -

Oct 2012 90 - Nov 2012 90 - Dec 2012 90 - Jan 2013 90 - Feb 2013 90 - Mar 2013 90 Apr 2013 90 May 2013 90 Jun 2013 90 Jul 2013 90 Aug 2013 90 Sep 2013 90 Sub Percentage of JINAD submissions consisting of protocols without substantial data completed on time Number column Target

FY 2010 Total: 7

Oct 2009 N/A N/A Nov 2009 N/A N/A Dec 2009 N/A N/A Jan 2010 N/A N/A Feb 2010 N/A N/A Mar 2010 N/A N/A Apr 2010 N/A N/A May 2010 N/A N/A Jun 2010 N/A N/A Jul 2010 N/A 0 Aug 2010 N/A 0 Sep 2010 N/A 7

FY 2011 Total: 10

Oct 2010 N/A 1 Nov 2010 N/A 3 Dec 2010 N/A 1 Jan 2011 N/A 0 Feb 2011 N/A 0 Mar 2011 N/A 0 Apr 2011 N/A 0 May 2011 N/A 1 Jun 2011 N/A 1 Jul 2011 N/A 2 Aug 2011 N/A 0 Sep 2011 N/A 1

FY 2012 Total: 14

Oct 2011 N/A 2 Nov 2011 N/A 1 Dec 2011 N/A 1 Jan 2012 N/A 2 Feb 2012 N/A 1 Mar 2012 N/A 0 Apr 2012 N/A 0 May 2012 N/A 3 Jun 2012 N/A 1 Jul 2012 N/A 1 Aug 2012 N/A 1 Sep 2012 N/A 1 Fiscal Year Target

FY 2013 YTD: 0

Oct 2012 0 Nov 2012 0 Dec 2012 0 Jan 2013 0 Feb 2013 0 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Percentage of JINAD submissions consisting of protocols without substantial data completed on time Number column Target

FY 2010 Total: 7

Oct 2009 N/A N/A Nov 2009 N/A N/A Dec 2009 N/A N/A Jan 2010 N/A N/A Feb 2010 N/A N/A Mar 2010 N/A N/A Apr 2010 N/A N/A May 2010 N/A N/A Jun 2010 N/A N/A Jul 2010 N/A 0 Aug 2010 N/A 0 Sep 2010 N/A 7

FY 2011 Total: 10

Oct 2010 N/A 1 Nov 2010 N/A 3 Dec 2010 N/A 1 Jan 2011 N/A 0 Feb 2011 N/A 0 Mar 2011 N/A 0 Apr 2011 N/A 0 May 2011 N/A 1 Jun 2011 N/A 1 Jul 2011 N/A 2 Aug 2011 N/A 0 Sep 2011 N/A 1

FY 2012 Total: 15

Oct 2011 N/A 2 Nov 2011 N/A 1 Dec 2011 N/A 1 Jan 2012 N/A 2 Feb 2012 N/A 1 Mar 2012 N/A 0 Apr 2012 N/A 0 May 2012 N/A 3 Jun 2012 N/A 2 Jul 2012 N/A 1 Aug 2012 N/A 1 Sep 2012 N/A 1 Fiscal Year Target

FY 2013 YTD: 0

Oct 2012 0 Nov 2012 0 Dec 2012 0 Jan 2013 0 Feb 2013 0 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/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm Animal Generic Drug User Fee Act (AGDUFA) JINAD Generic Investigational New Animal Drug AGDUFA Animal Generic Drug User Fee Act ਍††਍਍਍਍਍਍਍