I 117th CONGRESS 2d Session H. R. 8540 IN THE HOUSE OF REPRESENTATIVES July 27, 2022 Mr. Peters (for himself and Mr. Joyce of Ohio ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on the Judiciary , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend the Public Health Service Act to provide for the designation of institutions of higher education as Centers of Excellence in Cannabis Research, and for other purposes.

1. Short title This Act may be cited as the Developing and Nationalizing Key Cannabis Research Act of 2022 . 2. Cannabis research at the Department of Health and Human Services (a) National cannabis research agenda Part B of title IV of the Public Health Service Act ( 42 U.S.C. 284 et seq. ) is amended by adding at the end the following: 409K. National cannabis research agenda (a) In general Not later than 1 year after the date of enactment of the Developing and Nationalizing Key Cannabis Research Act of 2022 , the Director of NIH, in collaboration with the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and the Assistant Secretary for Mental Health and Substance Use, shall develop a national cannabis research agenda that addresses key questions and gaps in evidence, including with respect to each of the following: (1) The safety and efficacy of cannabis in providing therapeutic benefits for certain priority diseases or conditions, which may include epilepsy, multiple sclerosis-related spasticity, chemotherapy-induced pain and discomfort, using cannabis as an alternative to opioid analgesics for acute or chronic pain, sleep apnea, Tourette syndrome, anxiety, post-traumatic stress disorder, and any other disease or condition determined to be appropriate and of importance by the Director. (2) The effect of cannabis on at-risk populations, including children, older individuals, and pregnant or breast-feeding women. (3) The nontherapeutic impacts of cannabis use in the short-term and long-term. (4) The long-term effects of cannabis use, including dose-response relationship and the connection between cannabis use and behavioral health. (5) The clinically appropriate dosages and modes of delivery of cannabis. (6) Public safety considerations related to cannabis, including— (A) variation in the potency of cannabis products; (B) youth access to and use of cannabis, including marketing, packaging, edible formulations, and flavor options that target youth; (C) risk factors for cannabis misuse; (D) impaired driving related to cannabis use; (E) accidental ingestion of cannabis; and (F) relative risk of cannabis as compared to alcohol and tobacco. (b) Definition In this section, the term cannabis means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or its resin. . (b) Surveillance activities Part A of title III of the Public Health Service Act ( 42 U.S.C. 241 et seq. ) is amended by adding at the end the following: 310B. Surveillance activities on cannabis use (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in collaboration with the Assistant Secretary for Mental Health and Substance Use, the Administrator of the Centers for Medicare & Medicaid Services, and the Director of the Agency for Healthcare Research and Quality, shall carry out surveillance activities to collect population-wide data on cannabis use. (b) Permissible activities (1) In general In carrying out activities under this section, the Secretary may collect, as appropriate, with respect to cannabis use— (A) data on— (i) health outcomes, including biological data; (ii) health care utilization, which shall include hospitalizations and utilization of emergency departments related to consumption of cannabis, including among youth; (iii) demographic factors associated with cannabis use; (iv) the variety of products and delivery modes used; and (v) other relevant health information to improve the understanding of cannabis use in all age groups and sub-populations; and (B) data through public health surveillance systems, surveys, questionnaires, and databases of health care records, including, as appropriate, the Behavioral Risk Factor Surveillance System, the Youth Risk Behavioral Surveillance System, the Monitoring the Future health survey, the National Survey on Drug Use and Health, or the Healthcare Cost and Utilization Project (or any successor surveys). (2) Privacy Any data collected under paragraph (1) shall be collected in manner that protects personal privacy to the extent, at a minimum, that is required under applicable Federal and State law. (c) Definition In this section, the term cannabis means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or its resin. . 3. Centers of Excellence in Cannabis Research (a) In general Part B of title IV of the Public Health Service Act ( 42 U.S.C. 284 et seq. ), as amended by section 2, is further amended by adding at the end the following: 409L. Centers of Excellence in Cannabis Research (a) Designation (1) In general The Director of NIH shall designate institutions of higher education as Centers of Excellence in Cannabis Research for the purpose of interdisciplinary research related to cannabis and other biomedical, behavioral, and social issues related to cannabis. (2) Application To be designated as a Center of Excellence in Cannabis Research, an institution of higher education shall submit an application to, and receive approval from, the Director of NIH. Such an application shall be submitted in such manner and contain such information as the Director of NIH may reasonably require. The Director of NIH may not approve such an application unless— (A) the application contains or is supported by reasonable assurances that— (i) the applicant has the experience, or capability— (I) to conduct, through biomedical, behavioral, social, and related disciplines, long-term research on cannabis; and (II) to provide coordination of such research among such disciplines; (ii) the applicant has available to it sufficient personnel and facilities (including laboratory, reference, storage, security, and data analysis facilities) to carry out the research plan required under subparagraph (B); (iii) the applicant has the capacity to conduct academic courses and train students and professionals on appropriate research and knowledge of cannabis; and (iv) the applicant will secure State funds for research related to cannabis to complement any Federal funds for such research under this section; and (B) the application contains a detailed 5-year plan for research relating to cannabis. (3) Priority In selecting institutions of higher education for designation as Centers of Excellence in Cannabis Research, the Director of NIH shall give priority to such institutions that have proven track records in medicinal cannabis research. (4) Geographic representation The Director of NIH shall, to the extent practicable, ensure geographic representation across the United States in designating institutions of higher education as Centers of Excellence in Cannabis Research. (5) Term of designation A designation under this section shall be for a period of 5 years, so long as the institution of higher education continues to meet the requirements of paragraph (2). An institution of higher education may reapply in accordance with the requirements of paragraph (2) for a subsequent designation under this section. (b) Cannabis research (1) Grants or cooperative agreements (A) In general The Director of NIH may make grants to, or enter into cooperative agreements with, 10 Centers that have been designated under this section to expand the current and ongoing interdisciplinary research and clinical trials relating to cannabis research. (B) Authorization of appropriations To carry out this paragraph, there is authorized to be appropriated $50,000,000 for each of fiscal years 2024 through 2028. (2) Research results The Director of NIH shall promptly disseminate research results under this subsection to relevant governmental, academic, and research entities. (c) Definitions In this section: (1) The term cannabis means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or its resin. (2) The term institution of higher education has the meaning given the term in section 101(a) of the Higher Education Act of 1965. . (b) Registration requirements Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (l) Registration of practitioners at Centers of Excellence in Cannabis Research (1) In general The Attorney General shall register under subsection (f) practitioners at Centers of Excellence in Cannabis Research designated under section 409L of the Public Health Service Act to conduct research with marijuana. (2) Testing of constituents To the extent a Center of Excellence in Cannabis Research in a State tests marijuana products that are lawfully available for such testing in such State for cannabinoid and noncannabinoid constituents, no sanction under this title shall apply to such testing, including the acquisition of such products for such testing. (3) Use of marijuana products under State law No sanction under this title shall apply to the acquisition or use of marijuana products for a clinical trial or other research to the extent such clinical trial or other research is conducted— (A) to further the goals of the national cannabis research agenda under section 409K; and (B) at a Center of Excellence in Cannabis Research in a State using marijuana products that are lawfully available for such purpose under laws of the State. (4) Definition In this subsection, the term Center of Excellence in Cannabis Research means a Center of Excellence in Cannabis Research for which a designation is in effect under section 409L(a) of the Public Health Service Act. .