PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.

SEC. 524A. [21 U.S.C. 360n–1] PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS. (a) In General.—If the Secretary designates a drug under section 505E(d) as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under section 505(b) of this Act, or section 351(a) of the Public Health Service Act, that requires clinical data (other than bioavailability studies) to demonstrate safety or effectiveness. (b) Construction.—Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 505(b) that otherwise meets the criteria for the Secretary to grant priority review.