On August 15, 2011, the IRS released temporary regulations that provide guidance to drug manufacturers on the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs, as mandated by the ACA. The temporary regulations provide an overview of the fee requirement (including an explanation of the terms used in implementing the fee), set forth how the fee is calculated (and subsequently adjusted), discuss information manufacturers must submit to the IRS, describe the dispute resolution process to allow covered entities to submit error reports relating to the preliminary fee calculation, and provide for a notice of the final fee calculation. The temporary regulations also explain how manufacturers pay the fee, how the fee is treated for tax purposes, and how to make refund claims. While these temporary regulations generally are consistent with the approach proposed in previous IRS guidance, certain modifications and additions were made in response to public comments. The temporary regulations are scheduled to be published on August 18, 2011 and are effective upon publication. The IRS also issued proposed regulations on this issue. The text of the temporary regulations serves as the text of the proposed regulations, which are also to be published August 18. Comments regarding the proposed regulations will be accepted if received by 90 days after publication.