[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4322 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 4322

         To promote cannabis research, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 12, 2019

    Ms. Shalala (for herself, Mr. Gaetz, and Ms. Lee of California) 
 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 promote 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 ``Expanding Cannabis Research and 
Information Act''.

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.

    ``Not later than 1 year after the date of enactment of the 
Expanding Cannabis Research and Information Act, the Director of NIH, 
in collaboration with the Director of the Centers for Disease Control 
and Prevention 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 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 long-term effects of cannabis use, including 
        dose-response relationship and the connection between cannabis 
        use and behavioral health.
            ``(4) The clinically appropriate modes of delivery of 
        cannabis.
            ``(5) 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; and
                    ``(E) accidental ingestion of cannabis.''.
    (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.''.

SEC. 3. RESCHEDULING OF MARIHUANA.

    (a) In General.--Subsection (c) of schedule I of section 202(c) of 
the Controlled Substances Act (21 U.S.C. 812(c)) is amended by striking 
paragraph (10).
    (b) Schedule III.--Schedule III of section 202(c) of the Controlled 
Substances Act (21 U.S.C. 812(c)) is amended by adding at the end the 
following:
    ``(f) Marihuana.''.

SEC. 4. 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(a), 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. No institution of higher 
        education may be designated as a Center unless an application 
        therefor has been submitted to, and approved by, 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) at least 1 individual employed by the 
                        applicant--
                                    ``(I) is registered under section 
                                303(f) of the Controlled Substances Act 
                                to conduct research with controlled 
                                substances in schedule III of section 
                                202(c) of that Act; and
                                    ``(II) is an active participant in 
                                the cannabis research activities of the 
                                applicant;
                            ``(ii) the applicant has not had a 
                        registration to conduct research with 
                        controlled substances under section 303 of the 
                        Controlled Substances Act denied, revoked, or 
                        suspended under section 304 of that Act;
                            ``(iii) the applicant has the experience, 
                        or capability, to conduct, through biomedical, 
                        behavioral, social, and related disciplines, 
                        long-term research on cannabis and to provide 
                        coordination of such research among such 
                        disciplines;
                            ``(iv) 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); 
                        and
                            ``(v) the applicant has the capacity to 
                        conduct academic courses and train students and 
                        professionals on appropriate research and 
                        knowledge of cannabis; and
                    ``(B) the application contains a detailed 5-year 
                plan for research relating to cannabis.
            ``(2) Geographic representation.--The Director of NIH shall 
        ensure geographic representation across the United States in 
        designating institutions of higher education as Centers of 
        Excellence in Cannabis Research.
            ``(3) Term of designation.--A designation under this 
        section shall be for a period of 5 years. An institution of 
        higher education may reapply in accordance with the 
        requirements under paragraph (1) 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, 
                Centers that have been designated under this section to 
                expand the current and ongoing interdisciplinary 
                research and clinical trials relating to cannabis 
                research.
                    ``(B) Use of funds.--Amounts made available under a 
                grant or cooperative agreement under subparagraph (A) 
                may be used to address key questions and gaps in 
                evidence addressed by the national cannabis research 
                agenda described in paragraphs (1) through (5) of 
                section 409K.
            ``(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) Cannabis.--The term `cannabis' has the meaning given 
        the term `marihuana' in section 102 of the Controlled 
        Substances Act.
            ``(2) Institution of higher education.--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(f) of the Controlled 
Substances Act (21 U.S.C. 823(f)) is amended by adding after the period 
at the end the following: ``The Attorney General shall register under 
this part practitioners at Centers of Excellence in Cannabis Research 
designated under section 409L of the Public Health Service Act to 
conduct research with marihuana. No separate registration shall be 
required for each individual employed by a Center of Excellence in 
Cannabis Research who is conducting research described in subsection 
(a)(1) of that section and in accordance with applicable State and 
local laws, nor shall separate registrations be required for distinct 
research activities, including research activities related to distinct 
constituent compounds of marihuana or amended protocols. The 
registration shall expire on the date on which the entity is no longer 
designated as such a Center of Excellence in Cannabis Research under 
that section. A Center of Excellence in Cannabis Research registered 
under this part may cultivate marihuana, including any constituent 
component of marihuana, to conduct research under this part if the 
Attorney General has determined that the research to be conducted is 
for legitimate scientific research and is consistent with effective 
controls against diversion. A Center of Excellence in Cannabis Research 
may contract with such additional manufacturers of marihuana registered 
under this section to meet the needs of the Center of Excellence in 
Cannabis Research to the maximum extent permissible under international 
treaties to which the United States is a signatory and which govern 
marihuana. Before entering into such contract, the Center of Excellence 
in Cannabis Research shall submit to the Attorney General a request to 
enter into the contract that includes information to demonstrate the 
experience or capability of the contractor to conduct such cultivation 
and assurances that the contractor will comply with the provisions of 
this Act. Not later than 60 days after the date on which the request is 
submitted, the request shall be deemed to be approved by the Attorney 
General, unless the Attorney General determines that the granting of 
such request is inconsistent with the public interest. A Center of 
Excellence in Cannabis Research registered under this section may 
purchase or acquire commercially available marihuana for the purpose of 
research described in section 409L(a)(1) of the Public Health Service 
Act in accordance with the law of the State in which the transaction 
occurs. No Federal funds may be used by the Center of Excellence in 
Cannabis Research for such purchase or acquisition.''.
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