; or (bb) if no amount for such drug is determined under section 1847A, an amount to be determined by the Secretary in a manner similar to the manner in which payment amounts are determined under section 1847A based on information submitted by the manufacturer or sponsor of such drug (as required under clause (v)). (II) In determining the amount payable under section 1847A for purposes of items (aa) and (bb) of subclause (I), subparagraphs (A) and (B) of subsection (b)(1) of such section shall be applied by substituting 100 percent for 106 percent each place it appears and paragraph (8)(B) of such section shall be applied by substituting 0 percent for 6 percent . (ii) For purposes of this subparagraph, a DISARM antimicrobial drug is— (I) a drug— (aa) that— (AA) is approved by the Food and Drug Administration; (BB) is designated by the Food and Drug Administration as a qualified infectious disease product under subsection (d) of section 505E of the Federal Food, Drug, and Cosmetic Act; 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)