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U.S. Department of Health and Human Services

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Percentage of after hours Emergency Investigational New Drug (IND) requests that OCTEC addressed within two hours

Measure was implemented starting December 2010

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.

Fiscal Year - 2011

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Measure was implemented starting December 2010

TimeTargetPercent
Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/A100
Jan 2011N/A100
Feb 2011N/A100
Mar 2011N/A100
Apr 2011N/A100
May 2011N/A100
Jun 2011N/A80
Jul 2011N/A100
Aug 2011N/A100
Sep 2011N/A100

FY 2011 Overall: 98%

Emergency IND requests addressed by OCTEC for CDER-regulated products after business hours including weekends and holidays

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.

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A8
Nov 2010N/A5
Dec 2010N/A4
Jan 2011N/A13
Feb 2011N/A26
Mar 2011N/A17
Apr 2011N/A15
May 2011N/A11
Jun 2011N/A5
Jul 2011N/A5
Aug 2011N/A2
Sep 2011N/A3

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.