As noted in CASAA’s Action plan, this is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are attacking this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness, and extending beyond comments to the FDA docket. On May 11, 2014, CASAA released the first of several Calls to Action anticipated in CASAA’s Action Plan. On May 21st, 2014, CASAA released the second Call to Action. On June 13, 2014, CASAA released the third Call to Action. On July 17, 2014, CASAA released the first Call to Prepare. On July 23, 2014, CASAA released the second Call to Prepare.This is the Fourth Call to Action in CASAA’s Action Plan.