; and (CC) has received an extension of its exclusivity period pursuant to subsection (a) of such section; and (bb) that has been designated by the Secretary pursuant to the process established under clause (iv)(I)(bb); or (II) an antibacterial or antifungal biological product— (aa) that is licensed for use, or an antibacterial or antifungal biological product for which an indication is first licensed for use, by the Food and Drug Administration on or after June 5, 2014, under section 351(a) of the Public Health Service Act for human use to treat serious or life-threatening infections, as determined by the Food and Drug Administration, including those caused by, or likely to be caused by— (AA) an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or (BB) a qualifying pathogen (as defined under section 505E(f) of the Federal Food, Drug, and Cosmetic Act); and (bb) has been designated by the Secretary pursuant to the process established under clause (iv)(I)(bb). (iii) The mechanism established pursuant to clause (i) shall provide that the additional payment under clause (i) shall— (I) with respect to a discharge, only be made to a subsection (d) hospital that, as determined by the Secretary, is participating in the National Healthcare Safety Network Antimicrobial Use and Resistance Module of the Centers for Disease Control and Prevention or a similar reporting program, as specified by the Secretary, relating to antimicrobial drugs; and (II) apply to discharges occurring on or after October 1 of the year in which the drug or biological product is designated by the Secretary as a DISARM antimicrobial drug. (iv) (I) The mechanism established pursuant to clause (i) shall provide for a process for— (aa) a manufacturer or sponsor of a drug or biological product to request the Secretary to designate the drug or biological product as a DISARM antimicrobial drug