Sec. 503. Expedited review
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Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by adding at the end the following: The Secretary shall establish a program to expedite the development and review of applications for drugs containing cannabis that are manufactured by a small business concerned owned and controlled by socially and economically disadvantaged individuals or Native entities that operate in the cannabis industry. A sponsor of a drug containing cannabis that is manufactured by a small business concern owned and controlled by socially and economically disadvantaged individuals or Native entities that operate in the cannabis industry may request that the Secretary designate such drug for expedited review under this section.
A request for designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act. The actions to expedite the development and review of an application designated for expedited review under this section may include, as appropriate— holding meetings with the sponsor and the review team throughout the development of the drug; 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 for approval is as efficient as practicable; and priority review, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.
Not later than 1 year after the date of enactment of the Cannabis Administration and Opportunity Act , and after good faith, meaningful, and timely consultation with Native entities, the Secretary shall issue guidance on the implementation of this section. Such guidance shall— set forth the process by which a person may seek a designation under subsection (b); and identify the criteria the Secretary will use in evaluating a request for designation under this section. In this section:
The term drug containing cannabis means any drug that contains any article made or derived from cannabis. The term Native entity means— an Indian Tribe (as defined in section 3 of the Cannabis Administration and Opportunity Act ); a Native Corporation (as defined in section 3 of the Alaska Native Claims Settlement Act ( 43 U.S.C. 1602 )); and a Native Hawaiian-serving entity. The term Native Hawaiian-serving entity means— a Native Hawaiian organization (as defined in section 6207 of the Elementary and Secondary Education Act of 1965 ( 20 U.S.C. 7517 )); the Department of Hawaiian Home Lands; and the Office of Hawaiian Affairs.
The term small business concern owned and controlled by socially and economically disadvantaged individuals has the meaning given the term in section 8(d)(3)(C) of the Small Business Act. The sponsor of any application under section 505 for a drug containing cannabis shall provide effective controls and procedures to guard against theft and diversion of such drug, which may include, if the Secretary determines necessary, a risk evaluation and mitigation strategy under section 505–1.
The Secretary shall prescribe, by regulation, standards for controls and procedures for drugs described in subsection (a). For purposes of this section, the term drug containing cannabis means any drug that contains any article made or derived from cannabis. .
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