STLC ISS Submission Guidance

Guidance to Industry Preparing Supporting Summaries for Single Tier Effectiveness Statements

Individual Study Summary (ISS) Submission Guidance

  1. Submit ISSs for previously accepted studies as they are available. See the single tier implementation timeline for current goals for completion.

    • Co-submit an electronic copy of the historical study report if it was originally submitted as paper copy. This will help the CVB expand its collection of digitized key documents.

    • If known, also provide the submission date and CVB mail log number of the original study.

    • Include a copy of the CVB acceptance letter if it is readily available, but latitude is given for letters that would be problematic to locate.

  2. Submit ISSs for new studies concurrently with the study report being submitted for review, all in one submission.

  3. Please submit ISSs electronically, preferably using the NCAH Portal. For non-portal users, provide the submission electronically on a CD, DVD, memory stick or other similar device. As a reminder, the device will remain with the CVB and will not be returned to the firm. Complete APHIS Form 2049 and include the Microsoft Word document of the ISS and additional related reports/letters as applicable. Use the following values on APHIS Form 2049 to clearly identify the submissions:
     
    • Submission Type

      • Use Report for summaries co-submitted with new studies for regulatory review

      • Use Historical Study Summary for previously reviewed studies

    • Product Codes: Enter all current product codes to which the study applies.

    • Attachment type (NCAH Portal users only): Use Draft Individual Summary to upload the ISS. Use Incoming Document (Core) for any other co-submitted documents.

  4. ISSs will be reviewed for acceptable format, clarity, and consistency by the Single-Tier Implementation Team. The Team is a small group of reviewers who have developed expertise in ISSs. (New study reports will continue to be reviewed by the reviewer of record for each firm.) If any major revisions are needed, the CVB will maintain transparency with the submitter to generate an acceptable ISS.

  5. Once the ISS is cleared for publication, the cleared version will be converted by the CVB to PDF, and a copy will be provided to the submitter for the firm’s files. This ISS may then appear in a Product Compilation Summary (PCS) for any applicable product. Firms will be given two weeks to contact the CVB at CVB.Single.Tier@aphis.usda.gov if content errors with the cleared ISS are noted. Effective June 20, 2017, due to limited resources, the CVB will not accept new requests for cosmetic changes to the ISS. Cosmetic updates may be considered when the implementation period for single tier summaries is over (October 31, 2020).

 

Return to STLC Industry Guidance page

 

Questions?

Questions may be directed to CVB.Single.Tier@aphis.usda.gov.

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