; and (bb) the Secretary determines is a covered part D drug with respect to which there is limited ability for PDP sponsors and MA organizations to negotiate manufacturer rebates, such that the Secretary determines that the failure to apply this paragraph will have a significant fiscal impact on the program under this title. (iii) Part D price defined For purposes of this paragraph, the term part D price means, with respect to a covered part D drug, the price (including discounts, rebates, and other price concessions) that may be charged to PDP sponsors and MA organizations for such drug for part D eligible individuals who are enrolled under a prescription drug plan or under an MA–PD plan. (iv) Regulations for identification of specified drugs The Secretary, not later than one year after the date of the enactment of this paragraph, shall promulgate regulations regarding the identification of single source drugs and biologicals as specified drugs. (v) Process to petition that drug is no longer a specified drug The Secretary shall establish a process under which a manufacturer for a specified drug may petition the Secretary for the rescinding of a previous identification of a drug as a specified drug under clause (ii) based upon the drug involved no longer being a specified drug. (B) Price determination process For purposes of subparagraph (A), the process described in this subparagraph, with respect to the part D price for a specified drug for a plan year, is the following: (i) Limited period for negotiation for first plan year (I) In general The Secretary shall negotiate such price with the drug manufacturer involved for a period of not more than 90 days beginning on the date of identification of the drug as a specified drug for such plan year by the Secretary. (II) Successful negotiations In the case that such negotiation with respect to such 90-day period results in a price that is agreed to by both the Secretary and manufacturer, such price shall be the maximum part D price for such specified drug through the