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Percentage of INAD submissions consisting of protocols without substantial data reviewed and acted on within the month where the sponsor was notified of the Agency's decision on or before day 50

Dictionary: Sponsors may submit data intended to support an application for new animal drug approval during the investigation of the new animal drug to an INAD file. A protocol is a plan for conducting a study that fully describes the objective(s), design, methodology, study endpoints, statistical considerations, and organization of a study. The protocol may include plans for presenting study results in the final study report or submitting study results to FDA in electronic format.

ONADE intends to notify the sponsor within 50 days of receipt of a protocol whether the protocol is acceptable, unacceptable, or requires an end-review amendment. This measure assesses ONADE's timely review and decision making on one aspect of a new animal drug application. Acceptable protocols are critical for the generation of quality data used in the determination of the safety and effectiveness of a new animal drug. (1)

Information is current as of November 30, 2012.

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• FY 2013
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Footnotes

• (1) This metric is also an Animal 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 INAD submissions consisting of protocols without substantial data reviewed and acted on within the month where the sponsor was notified of the agency's decision on or before day 50

Fiscal Year - 2013

Time	Fiscal Year Target	Number
Oct 2012	N/A	7
Nov 2012	N/A	5
Dec 2012	N/A	TBD
Jan 2013	N/A	TBD
Feb 2013	N/A	TBD
Mar 2013	N/A	TBD
Apr 2013	N/A	TBD
May 2013	N/A	TBD
Jun 2013	N/A	TBD
Jul 2013	N/A	TBD
Aug 2013	N/A	TBD
Sep 2013	N/A	TBD

FY 2013 YTD: 12

Number of INAD protocols without substantial data reviewed and acted on within the month

Fiscal Year - 2013

Time	Fiscal Year Target	Number
Oct 2012	N/A	8
Nov 2012	N/A	5
Dec 2012	N/A	TBD
Jan 2013	N/A	TBD
Feb 2013	N/A	TBD
Mar 2013	N/A	TBD
Apr 2013	N/A	TBD
May 2013	N/A	TBD
Jun 2013	N/A	TBD
Jul 2013	N/A	TBD
Aug 2013	N/A	TBD
Sep 2013	N/A	TBD

FY 2013 YTD: 13