; (B) improving clinical outcomes for patients with multi-drug-resistant infections; (C) being a first-approved antimicrobial drug that has the potential to address, or has the evidence of addressing, unmet medical needs for the treatment of a serious or life-threatening infection, and, to a lesser extent, second and third drugs that treat such infections; (D) route of administration, especially through oral administration; (E) (i) containing no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) that has been approved in any other application under section 505(b) of the Federal Food, Drug, and Cosmetic Act or intending to be the subject of a new biological product license application under section 351(a); (ii) being a member of a new class of drugs with a novel target or novel mode of action that are distinctly different from the target or mode of any antimicrobial drug approved under section 505 of such Act or licensed under section 351, including reduced toxicity; or (iii) not being affected by cross-resistance to any antimicrobial drug approved under such section 505 or licensed under such section 351; (F) addressing a multi-drug resistant infection through a novel chemical scaffold or mechanism of action; (G) having received a transitional subscription contract under subsection (f); and (H) any other characteristic the Committee or the Critical Need Antimicrobial Advisory Group established under subsection (g) determines necessary. (d) Regulations (1) In general Not later than 18 months after the appointment of the initial members of the Committee, the Secretary shall issue proposed regulations which shall include— (A) a process by which the sponsors can apply for an antimicrobial drug to become a critical need antimicrobial drug under section 399OO–1; (B) how subscription contracts under section 399OO–2 shall be established and paid