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<measures><measure><type>Main</type><parent-measure></parent-measure><title>Percentage of after hours Emergency Investigational New Drug (IND) requests that OCTEC addressed within two hours</title><dictionary>Emergency INDs, described in 21 CFR 312.36, allow FDA to authorize use of an investigational drug in an emergency situation that does not allow time for submission of an IND in accordance with 21 CFR 312.23 or 312.34. All requests are urgent, so it is imperative that those received after normal business hours are addressed immediately. OCTEC serves as the CDER coordinator to provide immediate responses to after-hours emergency IND requests.</dictionary><measure-description>Percent</measure-description><chart-type>column</chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>50</chart-min><chart-max>100</chart-max><title>2010</title><target-header></target-header><target-description>Measure was implemented starting December 2010</target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>N/A</value></time><time><frame>Nov 2009</frame><target></target><value>N/A</value></time><time><frame>Dec 2009</frame><target></target><value>N/A</value></time><time><frame>Jan 2010</frame><target></target><value>N/A</value></time><time><frame>Feb 2010</frame><target></target><value>N/A</value></time><time><frame>Mar 2010</frame><target></target><value>N/A</value></time><time><frame>Apr 2010</frame><target></target><value>N/A</value></time><time><frame>May 2010</frame><target></target><value>N/A</value></time><time><frame>Jun 2010</frame><target></target><value>N/A</value></time><time><frame>Jul 2010</frame><target></target><value>N/A</value></time><time><frame>Aug 2010</frame><target></target><value>N/A</value></time><time><frame>Sep 2010</frame><target></target><value>N/A</value></time></fiscal-year><fiscal-year><chart-min>50</chart-min><chart-max>100</chart-max><title>2011</title><target-header></target-header><target-description>Measure was implemented starting December 2010</target-description><summary>FY 2011 Overall: 98%</summary><time><frame>Oct 2010</frame><target></target><value>N/A</value></time><time><frame>Nov 2010</frame><target></target><value>N/A</value></time><time><frame>Dec 2010</frame><target></target><value>100</value></time><time><frame>Jan 2011</frame><target></target><value>100</value></time><time><frame>Feb 2011</frame><target></target><value>100</value></time><time><frame>Mar 2011</frame><target></target><value>100</value></time><time><frame>Apr 2011</frame><target></target><value>100</value></time><time><frame>May 2011</frame><target></target><value>100</value></time><time><frame>Jun 2011</frame><target></target><value>80</value></time><time><frame>Jul 2011</frame><target></target><value>100</value></time><time><frame>Aug 2011</frame><target></target><value>100</value></time><time><frame>Sep 2011</frame><target></target><value>100</value></time></fiscal-year><fiscal-year><chart-min>50</chart-min><chart-max>100</chart-max><title>2012</title><target-header></target-header><target-description></target-description><summary>FY 2012 Average: 100%</summary><time><frame>Oct 2011</frame><target></target><value>100</value></time><time><frame>Nov 2011</frame><target></target><value>100</value></time><time><frame>Dec 2011</frame><target></target><value>100</value></time><time><frame>Jan 2012</frame><target></target><value></value></time><time><frame>Feb 2012</frame><target></target><value></value></time><time><frame>Mar 2012</frame><target></target><value></value></time><time><frame>Apr 2012</frame><target></target><value></value></time><time><frame>May 2012</frame><target></target><value></value></time><time><frame>Jun 2012</frame><target></target><value></value></time><time><frame>Jul 2012</frame><target></target><value></value></time><time><frame>Aug 2012</frame><target></target><value></value></time><time><frame>Sep 2012</frame><target></target><value></value></time></fiscal-year></measure><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm206295.htm</url><text>FDA-TRACK CDER Center Director Offices Dashboard</text></link></related-links><measure><type>Main</type><parent-measure></parent-measure><title>Emergency IND requests addressed by OCTEC for CDER-regulated products after business hours including weekends and holidays</title><dictionary>Emergency INDs, described in 21 CFR 312.36, allow FDA to authorize use of an investigational drug in an emergency situation that does not allow time for submission of an IND in accordance with 21 CFR 312.23 or 312.34. All requests are urgent, so it is imperative that those received after normal business hours are addressed immediately. OCTEC serves as the CDER coordinator to provide immediate responses to after-hours emergency IND requests.</dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>30</chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>22</value></time><time><frame>Nov 2009</frame><target></target><value>24</value></time><time><frame>Dec 2009</frame><target></target><value>7</value></time><time><frame>Jan 2010</frame><target></target><value>9</value></time><time><frame>Feb 2010</frame><target></target><value>9</value></time><time><frame>Mar 2010</frame><target></target><value>5</value></time><time><frame>Apr 2010</frame><target></target><value>5</value></time><time><frame>May 2010</frame><target></target><value>7</value></time><time><frame>Jun 2010</frame><target></target><value>4</value></time><time><frame>Jul 2010</frame><target></target><value>5</value></time><time><frame>Aug 2010</frame><target></target><value>5</value></time><time><frame>Sep 2010</frame><target></target><value>8</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max>30</chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>8</value></time><time><frame>Nov 2010</frame><target></target><value>5</value></time><time><frame>Dec 2010</frame><target></target><value>4</value></time><time><frame>Jan 2011</frame><target></target><value>13</value></time><time><frame>Feb 2011</frame><target></target><value>26</value></time><time><frame>Mar 2011</frame><target></target><value>17</value></time><time><frame>Apr 2011</frame><target></target><value>15</value></time><time><frame>May 2011</frame><target></target><value>11</value></time><time><frame>Jun 2011</frame><target></target><value>5</value></time><time><frame>Jul 2011</frame><target></target><value>5</value></time><time><frame>Aug 2011</frame><target></target><value>2</value></time><time><frame>Sep 2011</frame><target></target><value>3</value></time></fiscal-year><fiscal-year><chart-min></chart-min><chart-max></chart-max><title>2012</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2011</frame><target></target><value>7</value></time><time><frame>Nov 2011</frame><target></target><value>5</value></time><time><frame>Dec 2011</frame><target></target><value>4</value></time><time><frame>Jan 2012</frame><target></target><value></value></time><time><frame>Feb 2012</frame><target></target><value></value></time><time><frame>Mar 2012</frame><target></target><value></value></time><time><frame>Apr 2012</frame><target></target><value></value></time><time><frame>May 2012</frame><target></target><value></value></time><time><frame>Jun 2012</frame><target></target><value></value></time><time><frame>Jul 2012</frame><target></target><value></value></time><time><frame>Aug 2012</frame><target></target><value></value></time><time><frame>Sep 2012</frame><target></target><value></value></time></fiscal-year></measure></measures>
    






