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AgVetLink April 2005 

DAS Reports 

We remind applicants again that they should review DAS reports done on their behalf by the ACVM Group’s Data Assessment Service (or any other DAS provider) before requesting the application proceed into the Review and Evaluation (R&E) system. The DAS reports may raise issues or recommend label amendments that the applicant may need to address/clarify before submitting the application into R&E.

While the ACVM Group endeavours to signal to applicants any issues over an application in the DAS assessment service before finalising the DAS reports, it is the responsibility of the applicant to review the DAS reports prior to submitting them with the application into the R&E system.  If the applicant disagrees with any of the recommendations in the final DAS report(s), then he/she should consult first with the DAS provider (which may or may not be the ACVM Group) before proceeding to the R&E system.

Furthermore, once the application is in the R&E system, the ACVM Group will not enter into discussions over issues raised or label amendments suggested in DAS reports, bearing in mind the tight regulatory timeframes operating under the ACVM Act for making a decision on an application.  In such cases, the applicant has the option of either withdrawing the application and resubmitting it with appropriate changes, or proceeding with the application based on the DAS report’s original recommendations.