“(a) In general.—

“(1) DESIGNATION.—The Secretary may, at the request of the sponsor of a nonprescription drug, designate as a priority nonprescription drug under this section a drug intended for nonprescription use that is subject to an application submitted (or to be submitted) under section 505(b), if the Secretary determines that the drug meets the criteria specified in subsection (d).

“(2) NONPRESCRIPTION DEFINED.—In this section, the term ‘nonprescription’ means, with respect to a drug, that such drug is not subject to section 503(b)(1).

“(b) Request for designation.—The sponsor of a drug subject to a pending application under section 505(b) for nonprescription use may request that the Secretary designate the drug as a priority nonprescription drug.

“(c) Designation.—Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether a drug meets the criteria for designation as a priority nonprescription drug under this section, and if so, make such designation.

“(d) Criteria.—

“(1) ELIGIBILITY.—Except as provided in paragraph (2), a drug described in subsection (a) is eligible for designation as a priority nonprescription drug if—

“(A) the drug is intended for a novel nonprescription indication that could provide a meaningful public health benefit;

“(B) the drug is a new molecular entity; or

“(C) the drug contains an active ingredient that has never been available in a nonprescription drug.

“(2) EXCLUSION.—A drug is not eligible for designation as a priority nonprescription drug if the drug is subject to a risk evaluation and mitigation strategy under section 505–1 or if the drug is a controlled substance (as defined in section 102 of the Controlled Substances Act).

“(e) Actions.—If the Secretary designates a drug as a priority nonprescription drug, the Secretary shall take such actions as are appropriate to facilitate the development of, and expedite the review of, an application or supplement to an application for such drug, which may include—

“(1) holding meetings with the sponsor and the review team throughout the development of the drug;

“(2) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary to demonstrate the inapplicability of the criteria described in section 503(b)(1) is as efficient as practicable;

“(3) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

“(4) assigning a cross-disciplinary project lead for the Food and Drug Administration team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; and

“(5) taking steps to ensure that the design of any necessary nonclinical or clinical trials is as efficient as practicable, when scientifically appropriate, including reliance on real world evidence.

“(f) List of conditions.—

“(1) ESTABLISHMENT.—Not later than 18 months after the date of enactment of this section, the Secretary shall publish in the Federal Register a list of conditions for which a nonprescription drug, if developed for the condition, could provide meaningful public health benefit.

“(2) PUBLIC COMMENT.—The Secretary shall provide a period of not less than 30 days for public comment on—

“(A) the list under paragraph (1); and

“(B) any updates to such list.”.

“(a) In general.—

“(1) DESIGNATION.—The Secretary may, at the request of the sponsor of a nonprescription drug, designate as a priority nonprescription drug under this section a drug intended for nonprescription use that is subject to an application submitted (or to be submitted) under section 505(b), if the Secretary determines that the drug meets the criteria specified in subsection (d).

“(2) NONPRESCRIPTION DEFINED.—In this section, the term ‘nonprescription’ means, with respect to a drug, that such drug is not subject to section 503(b)(1).

“(b) Request for designation.—The sponsor of a drug subject to a pending application under section 505(b) for nonprescription use may request that the Secretary designate the drug as a priority nonprescription drug.

“(c) Designation.—Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether a drug meets the criteria for designation as a priority nonprescription drug under this section, and if so, make such designation.

“(d) Criteria.—

“(1) ELIGIBILITY.—Except as provided in paragraph (2), a drug described in subsection (a) is eligible for designation as a priority nonprescription drug if—

“(A) the drug is intended for a novel nonprescription indication that could provide a meaningful public health benefit;

“(B) the drug is a new molecular entity; or

“(C) the drug contains an active ingredient that has never been available in a nonprescription drug.

“(2) EXCLUSION.—A drug is not eligible for designation as a priority nonprescription drug if the drug is subject to a risk evaluation and mitigation strategy under section 505–1 or if the drug is a controlled substance (as defined in section 102 of the Controlled Substances Act).

“(e) Actions.—If the Secretary designates a drug as a priority nonprescription drug, the Secretary shall take such actions as are appropriate to facilitate the development of, and expedite the review of, an application or supplement to an application for such drug, which may include—

“(1) holding meetings with the sponsor and the review team throughout the development of the drug;

“(2) providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary to demonstrate the inapplicability of the criteria described in section 503(b)(1) is as efficient as practicable;

“(3) involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review;

“(4) assigning a cross-disciplinary project lead for the Food and Drug Administration team to facilitate an efficient review of the development program and to serve as a scientific liaison between the review team and the sponsor; and

“(5) taking steps to ensure that the design of any necessary nonclinical or clinical trials is as efficient as practicable, when scientifically appropriate, including reliance on real world evidence.

“(f) List of conditions.—

“(1) ESTABLISHMENT.—Not later than 18 months after the date of enactment of this section, the Secretary shall publish in the Federal Register a list of conditions for which a nonprescription drug, if developed for the condition, could provide meaningful public health benefit.

“(2) PUBLIC COMMENT.—The Secretary shall provide a period of not less than 30 days for public comment on—

“(A) the list under paragraph (1); and

“(B) any updates to such list.”.