The FDA is seeking comments on a draft guidance document entitled “User Fees and Refunds for Premarket Approval Applications” (PMAs). The draft document outlines the types of PMAs subject to user fees, as well as those that do not have an associated user fee, and identifies industry and FDA actions on these submissions that may result in a refund of the fee. Comments on the draft guidance will be accepted through April 15, 2009. The FDA also has released “Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files,” which is designed to simplify the preparation and evaluation of submissions in support of new animal drug applications. Comments will be accepted until June 1, 2009.