Description - Process map explaining the steps through the NDS, ABNDS, SNDS, SABNDS and Administrative Submissions process

The Veterinary Drugs Directorate receives a submission package from the sponsor (either a NDS, ABNDS, SNDS, SABNDS or Administrative submission), which initiates a 45 day screening target (14 days for Administrative submissions).  If deficiencies are found, a Screening Deficiency Notice is issued to the sponsor, and the Veterinary Drugs Directorate's clock stops.  The sponsor has 45 days to respond to the Screening Deficiency Notice.  Significant deficiencies at the first screening, or no response to the Screening Deficiency Notice will result in issuance of a Screening Rejection Notice.  The response to the Screening Deficiency Notice initiates a new 14 day screening target.  If the submission is still deficient after the second screen, then a Screening Rejection Notice is issued.

If the submission is acceptable after either first or second screen, the submission is forwarded to review.  Original NDS and ABNDSs have a 300 day review target, original SNDS and ABNDSs have a 240 day review target, and Administrative submissions have a 90 day review target.  Responses to Notices of Deficiency have a review target half that of the original review target for their respective submission types.  After first review, a submission may either conclude with issuance of a Notice of Compliance or a Notice of Deficiency.  A Notice of Compliance ends the process.  A Notice of Deficiency would be sent to the sponsor, who would have 90 days to reply.  The response to a Notice of Deficiency beings the loop again at the 1st screen, with a 45 day screening target.  All previously described outcomes from screening are possible with a response to a Notice of Deficiency.  Once a Notice of Deficiency response has been accepted for review, only two results are possible, both of which end the process:  an inadequate response or no response to a Notice of Deficiency would result in issuance of a Notice of Non-Compliance; and a submission in compliance would result in issuance of a Notice of Compliance.

Minor Information Requests may be issued by the VDD anytime during review, and do not affect the clock.  Sponsors have 15 days to respond to an MIR, and responses not screened, but sent directly to review.