; and (B) not fewer than 5 patient advocates. (3) Chair The Secretary shall appoint as Chair of the Advisory Group a non-voting, independent member who may not be a member represented under paragraph (2). (4) Conflicts of interest In appointing members under paragraph (2) and a Chair under paragraph (3), the Secretary shall ensure that no member receives compensation in any manner from a commercial or for-profit entity that develops antimicrobials or that might benefit from antimicrobial development. (5) Applicability of FACA Except as otherwise provided in this subsection, the Federal Advisory Committee Act shall apply to the Advisory Group. 399OO–1. Designation of antimicrobial drug as critical need antimicrobial drug (a) In general (1) Submission of request The sponsor of an application under section 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351(a) for an antimicrobial drug may request that the Secretary designate the drug as a critical need antimicrobial. A request for such designation may be submitted after the Secretary grants for such drug an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or section 351(a)(3), and shall be submitted not later than 5 years after the date of approval under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensure under section 351(a). (2) Content of request A request under paragraph (1) shall include information, such as clinical, preclinical, and postmarketing data, a list of the favorable characteristics described in section 399OO(c)(2), and any other material that the Secretary in consultation with the Committee requires. (3) Review by secretary The Secretary shall promptly review all requests for designation submitted under this subsection, assess all required application components, and determine if the antimicrobial drug is likely to meet the favorable characteristics identified in the application upon the completion of clinical development. After review, the Secretary shall approve