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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Issues ADUFA Performance Report for FY 04-05

FDA Veterinarian Newsletter 2006 Volume XXI, No I

The Center for Veterinary Medicine (CVM) confirmed in a recent report about its user fee program that the Center exceeded the performance goals set for Fiscal Year (FY) 2004 and, according to the data available at the end of that fiscal year, is exceeding its FY 2005 goals for those FY 2005 submissions reviewed and acted on as of September 30, 2005. Until all submissions in the FY 2005 receipt cohort (all applications submitted during FY 2005) are completed, only a preliminary performance assessment can be provided for that cohort.

Through the Animal Drug User Fee Act (ADUFA) of 2003, Congress authorized the Food and Drug Administration (FDA) to collect user fees to add resources to CVM’s drug review process. At the same time, FDA agreed to meet certain deadlines for animal drug review. The deadlines require FDA to review and act on submissions within shorter periods of time each new year over the five-year life of the Act.

ADUFA also requires FDA to present Congress with annual performance reports following the close of a fiscal year. (The Federal fiscal year begins October 1 and ends September 30 of the following calendar year.)

All ADUFA review performance statistics are based on a fiscal year receipt cohort. This methodology calculates performance statistics for submissions for the fiscal year, in which FDA received them, regardless of when FDA ultimately acted on the submissions. A result of this approach is that the statistics shown for a particular year may change from one report to the next. As time passes, FDA completes work on more submissions in a receipt cohort. As more submissions are completed, the statistics for that year of receipt must be adjusted to reflect the new completions. Until all submissions in a cohort are completed, FDA can provide only a preliminary performance assessment for that cohort.

CVM’s ADUFA performance goal is review at least 90 percent of a cohort of applications within the specified time frame.

The first ADUFA performance report FDA issued, released about a year ago, reported data available at the close of FY 2004. The more recent report (FDA’s second, released in May 2006) contains complete performance data for FY 2004 cohort, and a preliminary performance report for FY 2005 based on data available on September 30, 2005.

[Table accompanying the article follows.]

Under ADUFA, CVM’s goal is to complete 90 percent of applications within the time frame specified for the type of application.

 Fiscal YearDeadline for review,
number of days
Number of applications
acted on
Number completed
on time
On time
Original New Animal Drug Application (NADA), reactivationsFY 200429577100%
FY 2005*27011100%
Administrative NADAs, reactivationsFY 2004901010100%
FY 2005*8566100%
Non-manufacturing supplemental NADAs, reactivationsFY 20043201414100%
FY 2005*28533100%
Manufacturing supplemental NADAs, reactivationsFY 200422536335999%
FY 2005*190297296100%
Investigational New Animal Drug (INAD) studiesFY 2004320243243100%
FY 2005*285162162100%
INAD study protocolsFY 200412517317299%
FY 2005*10014814799%

(*The FY 2005 figures are as of September 30, 2005.)