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STLC Approved ISS Guidance

Updating Product Codes Associated With Approved ISSs

Licensees and permittees may need to update the list of product codes associated with a cleared (approved) ISS. When this occurs, use the following process:

    • Do NOT resubmit the ISS.

    • Make a formal submission with the following parameters:

      • Submission type = Historical Study Summary

      • Brief Description = ”Request to update product codes associated with previously cleared ISS”

      • Related Submissions = ML of submission where ISS was processed

    • Attach a justification for each code addition.

The CVB will evaluate the request. If eligible, a new ISS with only the newly requested product code(s) will be generated by the CVB based on the previously cleared (approved) ISS, and then returned under the new submission. The previously cleared (approved) ISS will not be changed. If the codes are not eligible to be added to a previously cleared (approved) ISS, the request will be denied.

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