; and (B) may be developed in partnership with the Secretary, infectious disease experts, diagnostic experts, or another entity. (2) Consultation The Secretary shall work with relevant professional societies and the Critical Need Antimicrobial Advisory Group established under section 2(g) to ensure that clinical guidelines issued by the Secretary under paragraph (3), with respect to an antimicrobial drug designated under subsection (a), includes the use of appropriate diagnostic approaches, taking into consideration the diagnostic plan submitted by a sponsor under paragraph (1). (3) Publication of clinical guidelines Not later than 1 year after the Secretary makes the first designation under subsection (a), and not less than every 3 years thereafter, the Secretary shall publish clinical guidelines in collaboration with relevant professional societies with respect to each antimicrobial drug designated under subsection (a) which shall set forth the evidence-based recommendations for prescribing the drug, in accordance with the submissions of the sponsor under paragraph (1) and after consultation under paragraph (2), as appropriate. 4. Subscription contracts (a) Application for a subscription contract (1) Submission of applications After approval under section 505(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c) ) or licensure under section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ), the sponsor of an antimicrobial drug designated as a critical need antimicrobial under section 3 may submit an application for a subscription contract with the Secretary, under a procedure established by the Secretary. (2) Review of applications The Secretary shall, in consultation with the Committee— (A) review all applications for subscription contracts under paragraph (1) and assess all required application components