The Internal Revenue Service (IRS) has issued documents related to the annual fee for manufacturers and importers of brand name pharmaceuticals under section 9008 of the ACA, which is payable beginning in 2011. Specifically, IRS Notice 2010-71 describes a proposed methodology for calculating the fee (including a discussion of covered entities, sales taken into account; an adjustment methodology; information submission requirements; and the fee calculation methodology). It also describes how the IRS will provide each covered entity with a preliminary 2011 fee calculation that will serve as a basis for comments by the covered entity on the proposed methodology. Preliminary 2011 fee calculations will be based on information submitted by manufacturers on Form 8947, Report of Branded Prescription Drug Information, which should be submitted to the IRS by January 20, 2011. The preliminary fee will be calculated and sent to each covered entity by May 2, 2011. If the IRS subsequently promulgates regulations that modify the fee calculation methodology, the modified methodology will be used to determine final fee amounts for 2011 that will be sent to each covered entity by August 15, 2011. The IRS seeks comments on all aspects of its prescription drug fee procedures; comments are due June 2, 2011. A Reed Smith analysis of the guidance is available here.  Separately, the IRS has released a request for public comments on issues to be addressed in future guidance on the new ACA excise tax on medical devices, which applies to sales of taxable medical devices after December 31, 2012. Comments specifically are requested on the excise tax exemption for any medical device “determined by the Secretary to be of a type which is generally purchased by the general public at retail for individual use,” and on issues pertaining to the application of existing Chapter 32 rules (pertaining to Manufacturers Excise Taxes) to this provision. The comment deadline is March 3, 2011. The solicitation notice (Notice 2010-89) will be published in IRB 2010-52, dated December 27, 2010.