; and (D) is for a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under section 505(b)(1) or section 351(a) of the Public Health Service Act. (3) Human drug application The term human drug application has the meaning given such term in section 735(1). (4) Priority review The term priority review , with respect to a human drug application, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures in the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act. (5) Priority review voucher The term priority review voucher means a voucher issued by the Secretary to the sponsor of an endemic orphan fungal disease drug application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 505(b)(1) or section 351(a) of the Public Health Service Act after the date of approval of the endemic orphan fungal disease drug application. (b) Priority Review Voucher (1) In general The Secretary shall award a priority review voucher to the sponsor of an endemic orphan fungal disease drug application upon approval by the Secretary of such endemic orphan fungal disease drug application. (2) Transferability The sponsor of a endemic orphan fungal disease drug application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 505(b)(1) or section 351(a) of the Public Health Service Act will be submitted after the date of the approval of the endemic orphan fungal disease drug application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used. (3) Notification (A) In