; and (4) the number of such applications that are subject to priority review. II Incentivizing competition 201. Generic priority review voucher Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 506G the following: 506H. Generic priority review voucher (a) Definitions In this section: (1) The term priority review with respect to an application under section 505(j) means review and action by the Secretary on such application by the Secretary not later than 150 calendar days after such application has been submitted for review. (2) The term priority review voucher means a voucher for priority review for an application under section 505(j). Such voucher shall be awarded upon the approval of the application described in 505(j)(11)(A), unless such application contains a certification under subclauses (III) and (IV) of section 505(j)(2)(A)(vii). (b) Generic Priority Review Vouchers, in general The Secretary shall award a priority review voucher to the sponsor of an application described in 505(j)(11)(A) upon approval by the Secretary of such application. (c) Transferability (1) In general The recipient of a priority review voucher under subsection (a) may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used. (2) Notification to the Secretary Each person to whom a voucher is transferred shall notify the Secretary of such change in ownership of such voucher not later than 30 calendar days after such transfer. (d) Notification The sponsor shall notify the Secretary not later than 30 calendar days prior to the submission of a human drug application that is intended to be the subject of a priority review voucher, except in the case of such an application that was pending as of October 1, 2015, in which case the sponsor of such pending application shall notify the Secretary not later than 30 days after the date on which such voucher is