Description: Appendix 6b: Advance Notice of Compliance with Conditions (NOC/c) Consideration Requested for a New Drug Submission (NDS) or Supplement to a New Drug Submission (SNDS)

If the sponsor wishes to have the submission considered under the NOC/c policy at the outset, a pre-NDS or pre-S/NDS meeting must be held. The decision to grant or reject eligibility will be provided within 10 working days of finalization of meeting minutes. If the submission is deemed not eligible, the sponsor may choose to appeal the decision. In the meantime, the sponsor may not file the submission for consideration under the NOC/c policy. If the submission is eligible, the sponsor must file the submission within 60 days. Screening time for eligible submissions is 25 days following 10 days of processing days. Possible outcomes include: a screening deficiency notice, or, if the submission is acceptable, the submission will enter review. Review target is 200 days. Possible outcomes following review are: a NON, NOD, or an NOC/c-QN. If the outcome of the review is an NOC/c- QN, the response to QN must be filed within 30 days (with a review target of 30 days), upon which the NOC with conditions may be granted.