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Percentage of JINAD study submissions completed on time

Dictionary: Sponsors may submit data intended to support an application for a generic new animal drug approval during the investigation of the generic new animal drug to a JINAD file. A study submission is a submission containing both the data and conclusions of a study to be considered in support of the approval of a generic new animal drug.

Note: October 1, 2008 is the effective date of the AGDUFA.

Information is current as of November 30, 2012.

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

Footnotes

• 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.

Number of JINAD study submissions completed on time

Fiscal Year - 2010

Time	Target	Number
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	0
Aug 2010	90	0
Sep 2010	90	0

FY 2010 Total: 0

Number of JINAD study submissions completed within the month

Fiscal Year - 2010

Time	Target	Number
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	0
Aug 2010	90	0
Sep 2010	90	0

FY 2010 Total: 0