Description - Process map explaining the Sponsor and VDD steps through the submission review and approval process

Pre-submission information may be available from a consultation with the VDD that preceded filing of the submission.  The VDD receives a submission from the sponsor, which initiates processing of the submission.  Following the initial processing, a letter of acknowledgement is issued to the sponsor, or if the submission is so deficient that it cannot proceed, a rejection letter is issued to the sponsor, ending the process.  Upon successful completion of the initial processing, the submission is screened.  Screening may result in the submission being accepted for review, or the issuance of a rejection letter, which ends the process.

Submissions accepted for review are then reviewed.  The conclusion of review comes when all involved review streams have completed their reviews, and the submission is then moved to the final decision step.  From the final decision step, a submission may either be issued a letter of approval, or a letter refusing to approve.  Both letters issued from the final decision step end the process.

During screening, review and the final decision steps, a letter requesting more information may be sent to the sponsor.  Packages sent in response to a letter request for more information trigger new processing and screening, and are incorporated with the initial submission once accepted for review.

At all steps in the process in the VDD Area (i.e.: initial processing, screening, review and final decision), data is entered into the tracking system.