1. Short title This Act may be cited as the Promoting Life-Saving New Therapies for Neonates Act of 2017 . 2. Promoting the development of safe and effective therapies for neonates Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360aa et seq.) is amended by inserting after section 529A the following: 530. Exclusivity to encourage development of safe and effective therapies for neonates (a) Definitions In this section: (1) Neonatal drug The term neonatal drug means a drug for the prevention or treatment of a disease or condition of a preterm or full-term neonate. (2) Neonatal drug application The term neonatal drug application means a human drug application, as defined in section 735(1), that— (A) is for a drug or biological product— (i) that is for the prevention or treatment of a disease or condition listed on the Priority List of Critical Needs for Neonates described in subsection (c); and (ii) that contains no active ingredient (including any ester or salt of the active ingredient) that has been previously approved in any other application under section 505(b)(1), 505(b)(2), or 505(j) of this Act or section 351(a) or 351(k) of the Public Health Service Act; (B) is submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act; (C) the Secretary determines to be eligible for a neonatal drug exclusivity voucher, in accordance with subsection (b); (D) relies on clinical data derived from studies examining a neonatal population and dosages of the drug intended for that population