Meeting+Minutes+Jan-21-09+DL&ER+Workgroup

**1. eGateway Accounts:** eGateway accounts need to be set up sooner rather than later. Although the process is not heavily involved, the volume of requests may increase dramatically closer to the June 1, 2009 date and create a backlog of requests, thereby slowing down the process. It is best to try and have account set up now and identify any potential issues up front.

Close communications with manufacturers needs to be in place to ensure delisting occurs flawlessly. One way to avoid having a gap with delisting and having the labeler list is there may be a gap. To avoid this issue, it may be best to contact spl@fda.hhs.gov to communicate the delisting and to enter all products on one list and the effective time when they should be delisted. Otherwise, delisting may never occur if product is inactive as third party manufacturer may not make an effort to migrate into SPL4. Question to FDA: Is SPL version 4 changing the old system? If an SPL is submitted in r4 to delist a product, but there have been no changes in r4 previously, will the changes update in the FDA's current system?
 * 2. Delisting manufacturers:**