; (B) improving clinical outcomes for patients with multi-drug resistant infections; (C) being a first-approved drug that treats certain multi-drug resistant infections, and, to a lesser extent, second and third drugs that treat such infections; (D) addressing an infection located in an organ or other location that is challenging to treat; (E) addressing a multi-drug resistant infection through a novel chemical scaffold or mechanism of action, especially through oral administration; (F) having received a transitional subscription contract under subsection (f); and (G) any other characteristic the Secretary, in collaboration with the Committee, determines necessary. (d) Regulations (1) In general Not later than 1 year 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 3; (B) how subscription contracts under such section shall be established and paid; (C) the favored characteristics under subsection (c)(2), how such characteristics will be weighed, and the minimum number and kind of favored characteristics needed for an antimicrobial drug to be designated a critical need antimicrobial drug