[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8540 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8540

 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.


_______________________________________________________________________


                    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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Developing and Nationalizing Key 
Cannabis Research Act of 2022''.

SEC. 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:

``SEC. 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:

``SEC. 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.''.

SEC. 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:

``SEC. 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.''.
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