MainOCTEC provides presentations at public meetings to facilitate drug development on medical countermeasures (MCM) against the effects of chemical, biological, radiological, and nuclear (CBRN) agents. Sponsors of such MCM are often small companies or other federal agencies with limited drug development experience and the need for assistance in navigating the complexities of FDA. From January 2012 to July 2012, CDER was in the process of reorganizing their FDA-TRACK Dashboard to better align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research. Therefore, FY12 will have missing data during that period. Number025

Oct 20091Nov 20092Dec 20091Jan 20101Feb 20100Mar 20102Apr 20101May 20101Jun 20103Jul 20100Aug 20101Sep 20101025

FY 2011 Total: 12

Oct 20101Nov 20104Dec 20101Jan 20110Feb 20110Mar 20110Apr 20110May 20110Jun 20114Jul 20111Aug 20110Sep 20111025

FY 2012 6 month total: 7

Oct 20111Nov 20112Dec 20110Jan 2012-Feb 2012-Mar 2012-Apr 2012-May 2012-Jun 2012-Jul 20120Aug 20120Sep 20124 0

FY 2013 YTD: 3

Oct 2012 2 Nov 2012 1 Dec 2012 0 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 MainOCTEC provides early consultation to sponsors of MCM to assist them as they begin their development process, via teleconferences, meetings, and significant correspondence. OCTEC continues to be involved throughout the drug development process by participating in review divisions' sponsor meetings to provide scientific consultation for special issues related to MCM against CBRN agents, including MCM for the military, products held by the Strategic National Stockpile, and Emergency Use Authorization. From January 2012 to July 2012, CDER was in the process of reorganizing their FDA-TRACK Dashboard to better align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research. Therefore, FY12 will have missing data during that period. Number025

Oct 200915Nov 200914Dec 20098Jan 20106Feb 20101Mar 201011Apr 201013May 201010Jun 20109Jul 20106Aug 20102Sep 20105025

FY 2011 Total: 46

Oct 20104Nov 20103Dec 20102Jan 20113Feb 20113Mar 20114Apr 20113May 20115Jun 20113Jul 20117Aug 20113Sep 20116025

FY 2012 6 month total: 37

Oct 201111Nov 201110Dec 20112Jan 2012-Feb 2012-Mar 2012-Apr 2012-May 2012-Jun 2012-Jul 20127Aug 20126Sep 20121 0

FY 2013 YTD: 13

Oct 2012 1 Nov 2012 10 Dec 2012 2 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 MainOCTEC represents the Center or agency as a liaison to provide input on areas of unmet medical needs related to counter-terrorism drug modalities (e.g., whether drugs are approved and/or labeled for the specific intended use). From January 2012 to July 2012, CDER was in the process of reorganizing their FDA-TRACK Dashboard to better align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research. Therefore, FY12 will have missing data during that period. Number025

Oct 200910Nov 20098Dec 20095Jan 20103Feb 20102Mar 201019Apr 201014May 20108Jun 20108Jul 20107Aug 201015Sep 20104025

FY 2011 Total: 122

Oct 20108Nov 20106Dec 201010Jan 20119Feb 20118Mar 201117Apr 201110May 201113Jun 20117Jul 201114Aug 20116Sep 201114

FY 2012 6 Month Total: 102

Oct 201116Nov 201121Dec 201114Jan 2012-Feb 2012-Mar 2012-Apr 2012-May 2012-Jun 2012-Jul 201211Aug 201227Sep 201213 0

FY 2013 YTD: 22

Oct 2012 5 Nov 2012 9 Dec 2012 8 Jan 2013 Feb 2013 Mar 2013 Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard