Main Manufacturing supplemental ANADAs are applications in which the sponsor proposes to make a change in the abbreviated new animal drug manufacturing process. Approval of any changes in the manufacturing of a new animal drug is critical to continued assurance of the quality, safety, and effectiveness of the new animal drug. This measure assesses ONADE's timely review and decision making on one aspect of a new animal drug application. 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 90 100 Aug 2010 90 100 Sep 2010 90 - Target

FY 2011 Overall: 100

Oct 2010 90 100 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 90 100 Jun 2011 90 100 Jul 2011 90 100 Aug 2011 90 100 Sep 2011 90 100

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 manufacturing supplemental ANADAs and reactivations of such supplemental applications completed on time Number column Target

FY 2010 Total: 30

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 15 Aug 2010 90 15 Sep 2010 N/A 0

FY 2011 Total: 185

Oct 2010 N/A 13 Nov 2010 N/A 14 Dec 2010 N/A 14 Jan 2011 N/A 16 Feb 2011 N/A 16 Mar 2011 N/A 12 Apr 2011 N/A 9 May 2011 N/A 16 Jun 2011 N/A 6 Jul 2011 N/A 19 Aug 2011 N/A 18 Sep 2011 N/A 32

FY 2012 Total: 176

Oct 2011 N/A 11 Nov 2011 N/A 10 Dec 2011 N/A 14 Jan 2012 N/A 14 Feb 2012 N/A 24 Mar 2012 N/A 14 Apr 2012 N/A 6 May 2012 N/A 14 Jun 2012 N/A 11 Jul 2012 N/A 14 Aug 2012 N/A 23 Sep 2012 N/A 21 Fiscal Year Target

FY 2013 YTD: 41

Oct 2012 6 Nov 2012 11 Dec 2012 6 Jan 2013 13 Feb 2013 5 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Sub Percentage of manufacturing supplemental ANADAs and reactivations of such supplemental applications completed on time Number column Target

FY 2010 Total: 30

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 15 Aug 2010 90 15 Sep 2010 90 0

FY 2011 Total: 185

Oct 2010 N/A 13 Nov 2010 N/A 14 Dec 2010 N/A 14 Jan 2011 N/A 16 Feb 2011 N/A 16 Mar 2011 N/A 12 Apr 2011 N/A 9 May 2011 N/A 16 Jun 2011 N/A 6 Jul 2011 N/A 19 Aug 2011 N/A 18 Sep 2011 N/A 32

FY 2012 Total: 176

Oct 2011 N/A 11 Nov 2011 N/A 10 Dec 2011 N/A 14 Jan 2012 N/A 14 Feb 2012 N/A 24 Mar 2012 N/A 14 Apr 2012 N/A 6 May 2012 N/A 14 Jun 2012 N/A 11 Jul 2012 N/A 14 Aug 2012 N/A 23 Sep 2012 N/A 21 Fiscal Year Target

FY 2013 YTD: 41

Oct 2012 6 Nov 2012 11 Dec 2012 6 Jan 2013 13 Feb 2013 5 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) ANADAs Abbreviated New Animal Drug Applications AGDUFA Animal Generic Drug User Fee Act ਍††਍਍਍਍਍਍਍