117 HR 8454 : Medical Marijuana and Cannabidiol Research Expansion Act U.S. House of Representatives 2022-07-27 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS2d SessionH. R. 8454IN THE SENATE OF THE UNITED STATESJuly 27, 2022ReceivedAN ACTTo expand research on cannabidiol and marijuana, and for other purposes.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the Medical Marijuana and Cannabidiol Research Expansion Act.(b)

Table of contents

The table of contents for this Act is as follows: Sec. 1. Short title; table of contents.Sec. 2. Definitions.Sec. 3. Determination of budgetary effects.Title I—Registrations for marijuana researchSec. 101. Marijuana research applications.Sec. 102. Research protocols.Sec. 103. Applications to manufacture marijuana for research.Sec. 104. Adequate and uninterrupted supply.Sec. 105. Security requirements.Sec. 106. Prohibition against reinstating interdisciplinary review process for non-NIH-funded researchers.Title II—Development of FDA-approved drugs using cannabidiol and marijuanaSec. 201. Medical research on cannabidiol.Sec. 202. Registration for the commercial production and distribution of Food and Drug Administration-approved drugs.Title III—Doctor-patient relationshipSec. 301. Doctor-patient relationship.Title IV—Federal researchSec. 401. Federal research.

2.

Definitions

(a)

In general

In this Act—(1)the term appropriately registered means that an individual or entity is registered under the Controlled Substances Act (21 U.S.C. 801 et seq.) to engage in the type of activity that is carried out by the individual or entity with respect to a controlled substance on the schedule that is applicable to cannabidiol or marijuana, as applicable;(2)the term cannabidiol means—(A)the substance, cannabidiol, as derived from marijuana that has a delta-9-tetrahydrocannabinol level that is greater than 0.3 percent; and(B)the synthetic equivalent of the substance described in subparagraph (A);(3)the terms controlled substance, dispense, distribute, manufacture, marijuana, and practitioner have the meanings given such terms in section 102 of the Controlled Substances Act (21 U.S.C. 802), as amended by this Act;(4)the term covered institution of higher education means an institution of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) that—(A)(i)has highest or higher research activity, as defined by the Carnegie Classification of Institutions of Higher Education; or(ii)is an accredited medical school or an accredited school of osteopathic medicine; and(B)is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.);(5)the term drug has the meaning given the term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1));(6)the term medical research for drug development means medical research that is—(A)a preclinical study or clinical investigation conducted in accordance with section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or otherwise permitted by the Department of Health and Human Services to determine the potential medical benefits of marijuana or cannabidiol as a drug; and(B)conducted by a covered institution of higher education, practitioner, or manufacturer that is appropriately registered under the Controlled Substances Act (21 U.S.C. 801 et seq.); and(7)the term State means any State of the United States, the District of Columbia, and any territory of the United States.(b)

Updating term

Section 102(16) of the Controlled Substances Act (21 U.S.C. 802(16)) is amended—(1)in subparagraph (A), by striking the term marihuana means and inserting the terms marihuana and marijuana mean; and(2)in subparagraph (B), by striking The term marihuana does not and inserting The terms marihuana and marijuana do not.

3.

Determination of budgetary effects

The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled Budgetary Effects of PAYGO Legislation for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.

Passed the House of Representatives July 26, 2022.Cheryl L. Johnson,Clerk.