DRAFT Appendix N Pilot Program

Appendix N Modification Committee Chair Status Report on 2015 NCIMS Proposal 211 Pilot Program

The effective date for the implementation of the 2015 NCIMS Proposal 211 Pilot Program has not been finalized. It is dependent on FDA CVM evaluation of test methods for acceptance in the Pilot, and the completion of the “Tetracycline Pilot Program” laboratory forms based on FDA CVM acceptance of submitted methods. The Appendix N Committee’s best estimate of the effective date pending the completion of the tasks mentioned will probably be in the second quarter of 2017.

The deliverables are:

  1. Finalize evaluation of test methods for acceptance in the Pilot – FDA CVM
    a. Charm SL review completion and summary from CVM is expected to be submitted to the Appendix N Committee in December
    b. IDEXX is planning to submit documents week of November 14th, 2016.
  2. Finalize Laboratory Forms for “Tetracycline Pilot Program”.
    a. NCIMS Lab Committee currently has these documents under review.
  3. Exemption – LPET; “Appendix N Modification LEO Responsibilities Appendix N Committee DRAFT”. Completed

The committee has completed the following documents (file names and titles) for posting on the NCIMS website as an update to NCIMS stakeholders:

  1. DRAFT 2015 NCIMS Proposal 211 Pilot Program Accepted Tetracycline Test Kit Using Both Undiluted and Diluted Steps
  2. DRAFT Appendix N Pilot Program Question and Answer Version 3
  3. DRAFT PowerPoint 2015 NCIMS Proposal 211 Raw Milk Testing Pilot for Non-Beta Lactam Drugs Version 3
  4. DRAFT Appendix N Modification LEO Responsibilities For New Tetracycline Test Kits

 

Roger Hooi
NCIMS Appendix N Modification Committee Chair
November 14, 2016