Main Licensed manufacturers must submit a prior approval supplement to FDA for any change to a product that has a substantial impact to have an adverse effect on the identity, strength, quality, purity or potency of the product as they may relate to the safety or effectiveness of the product. Examples of such changes include production process, quality controls, equipment, facilities, or responsible personnel. FDA approval must be obtained prior to distribution of the product made with the change. This measure will allow OCBQ to monitor its performance in issuing decisions for manufacturing supplements requiring prior approval within established timeframes. <i>Information is current as of September 30, 2012</i> (1) The monthly percentages are based on a denominator that excludes supplements that were withdrawn by the manufacturers prior to the due date. 0 100

FY 2010 Overall: 100%

Oct 2009 90 100 Nov 2009 90 100 Dec 2009 90 100 Jan 2010 90 100 Feb 2010 90 100 Mar 2010 90 100 Apr 2010 90 100 May 2010 90 100 Jun 2010 90 100 Jul 2010 90 100 Aug 2010 90 100 Sep 2010 90 100 0 100

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 0 100

FY 2012 Overall: 90%

Oct 2011 90 100 Nov 2011 90 100 Dec 2011 90 100 Jan 2012 90 N/A 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 Sub Percentage of manufacturing supplements requiring prior approval with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt (1) Number column

FY 2010 Total: 59

Oct 2009 2 Nov 2009 4 Dec 2009 4 Jan 2010 12 Feb 2010 15 Mar 2010 2 Apr 2010 4 May 2010 1 Jun 2010 6 Jul 2010 2 Aug 2010 5 Sep 2010 2

FY 2011 Total: 113

Oct 2010 3 Nov 2010 4 Dec 2010 1 Jan 2011 11 Feb 2011 4 Mar 2011 4 Apr 2011 33 May 2011 34 Jun 2011 6 Jul 2011 1 Aug 2011 9 Sep 2011 3

FY 2012 Total: 47

Oct 2011 2 Nov 2011 1 Dec 2011 4 Jan 2012 0 Feb 2012 1 Mar 2012 2 Apr 2012 12 May 2012 0 Jun 2012 5 Jul 2012 3 Aug 2012 13 Sep 2012 4 Sub Percentage of manufacturing supplements requiring prior approval with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt (1) Number column

FY 2010 Total: 70

Oct 2009 2 Nov 2009 4 Dec 2009 4 Jan 2010 12 Feb 2010 15 Mar 2010 2 Apr 2010 4 May 2010 1 Jun 2010 17 Jul 2010 2 Aug 2010 5 Sep 2010 2

FY 2011 Total: 119

Oct 2010 3 Nov 2010 7 Dec 2010 1 Jan 2011 11 Feb 2011 4 Mar 2011 4 Apr 2011 35 May 2011 34 Jun 2011 7 Jul 2011 1 Aug 2011 9 Sep 2011 3

FY 2012 Total: 52

Oct 2011 2 Nov 2011 1 Dec 2011 6 Jan 2012 0 Feb 2012 1 Mar 2012 3 Apr 2012 12 May 2012 1 Jun 2012 5 Jul 2012 3 Aug 2012 13 Sep 2012 5 http://www.fda.gov/AboutFDA/Transparency/track/ucm206804.htm FDA-TRACK CBER Dashboard word text word defintion ਍††਍਍਍਍਍਍਍