ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT INNOVATION.

SEC. 3212. ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT INNOVATION.(a) In General.—Section 505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355f) is amended—(1) in subsection (c)—(A) in paragraph (2), by striking “; or” and inserting “;”; (B) in paragraph (3), by striking the period and inserting “; or”; and (C) by adding at the end the following:“(4) an application pursuant to section 351(a) of the Public Health Service Act.” ; (2) in subsection (d)(1), by inserting “of this Act or section 351(a) of the Public Health Service Act” after “section 505(b)”; and (3) by amending subsection (g) to read as follows:“(g) Qualified Infectious Disease Product.—The term ‘qualified infectious disease product’ means a drug (including a biological product), including an antibacterial or antifungal drug, for human use that—“(1) acts on bacteria or fungi or on substances produced by such bacteria or fungi; and “(2) is intended to treat a serious or life-threatening infection, including such an infection caused by—“(A) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or “(B) qualifying pathogens listed by the Secretary under subsection (f).” . (b) Priority Review.—Section 524A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n–1(a)) is amended by inserting “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” before the period.