; or (II) with respect to which the Secretary has authorized under subsection (g) the use of any patent, clinical trial data, or other government-granted exclusivity related to such drug by another sponsor, until the date that is 1 year after the date on which another application for such drug, for which the sponsor relies upon a such authorization under subsection (g), is approved under such section 505 or such section 351. (B) Spike in price If a manufacturer increases the wholesale acquisition cost of a prescription drug by more than the percentage by which the Consumer Price Index for All Urban Consumers for that year exceeds such index for the preceding calendar year, such prescription drug shall be deemed to have a wholesale acquisition cost that is not appropriate unless the Bureau determines, based on the information submitted under paragraphs (2) and (3) of subsection (a) and under subsection (b)(2) and the considerations described in paragraph (1), that the wholesale acquisition cost is appropriate. (3) Opportunity to comment Prior to making a determination on whether the wholesale acquisition cost of a prescription drug is appropriate, the Bureau shall ensure relevant stakeholders, including patients, have an opportunity to comment. (f) Required actions if price is not appropriate (1) Notice and requirement to remit excess If the Bureau determines that the wholesale acquisition cost of a prescription drug is not appropriate, the Bureau shall notify and direct the manufacturer to lower the wholesale acquisition cost to a level that would be deemed appropriate. The Bureau shall also require the manufacturer to remit the excess revenue earned as a result of the prescription drug having a price that is not appropriate. (2) Patient rebate The Director of the Bureau shall establish a process to distribute funds remitted under paragraph (1) to patients who were impacted by the prescription drug having a price that is not appropriate. (g) Enforcement (1) In general If, within 30 days of receiving a notice that