Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2); Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)." The draft guidance provides information to the industry in complying with the Reportable Food Registry requirements prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA). Further, the draft guidance addresses inquiries that the agency has received through its Reportable Food Registry help desk and/or by other means since the implementation of the Reportable Food Registry on September 8, 2009, and provides information on the new Safety Reporting Portal. The agency is also seeking comments from industry on the Reportable Food Registry requirements, and specifically on the issue of "transfer" as discussed in the current Edition 1, and draft Edition 2 guidance.