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<bill bill-stage="Introduced-in-House" bill-type="olc" dms-id="H39FED8E13AE341F68EE729850393F889" key="H" public-private="public"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>116 HR 4322 IH: Expanding Cannabis Research and Information Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2019-09-12</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>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.</dc:rights>
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<distribution-code display="yes">I</distribution-code><congress display="yes">116th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 4322</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20190912">September 12, 2019</action-date><action-desc><sponsor name-id="S001206">Ms. Shalala</sponsor> (for herself, <cosponsor name-id="G000578">Mr. Gaetz</cosponsor>, and <cosponsor name-id="L000551">Ms. Lee of California</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name>, and in addition to the Committee on <committee-name committee-id="HJU00">the Judiciary</committee-name>, 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</action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To promote cannabis research, and for other purposes.</official-title></form>
	<legis-body id="H5DB1251D97F44151AFBE0A299F55F9AF" style="OLC">
 <section id="H85588EAF0C364FE39D5AA6FE2D989C9A" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Expanding Cannabis Research and Information Act</short-title></quote>.</text> </section><section id="H9C23B54C923844498BCBBB989DB95964"><enum>2.</enum><header>Cannabis research at the Department of Health and Human Services</header> <subsection id="H23D94DB7982549EC9698C1316B003DE2"><enum>(a)</enum><header>National cannabis research agenda</header><text>Part B of title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284">42 U.S.C. 284</external-xref> et seq.) is amended by adding at the end the following:</text>
				<quoted-block display-inline="no-display-inline" id="HD6256D397B824DC29D2F3FF25D2DB746" style="OLC">
 <section id="H7333C221B460430295B8FCD48951F243"><enum>409K.</enum><header>National cannabis research agenda</header><text display-inline="no-display-inline">Not later than 1 year after the date of enactment of the <short-title>Expanding Cannabis Research and Information Act</short-title>, 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:</text>
 <paragraph id="H8D72AA538F564708AED860449BDBB227"><enum>(1)</enum><text>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.</text>
 </paragraph><paragraph id="HFE03AFE57D1C480591248EF051399657"><enum>(2)</enum><text>The effect of cannabis on at-risk populations, including children, older individuals, and pregnant or breast-feeding women.</text>
 </paragraph><paragraph id="H7496CA54E4874CD0B2014A42A3A49807"><enum>(3)</enum><text>The long-term effects of cannabis use, including dose-response relationship and the connection between cannabis use and behavioral health.</text>
 </paragraph><paragraph id="HE97E2494062C430D8CC7F5041C53FAF8"><enum>(4)</enum><text>The clinically appropriate modes of delivery of cannabis.</text> </paragraph><paragraph id="H58B14EF5590D4350959CAD44AC6A1342"><enum>(5)</enum><text>Public safety considerations related to cannabis, including—</text>
 <subparagraph id="HB3E82D6242064F7AA533D2D7EB1C39DF"><enum>(A)</enum><text>variation in the potency of cannabis products;</text> </subparagraph><subparagraph id="HD89F9E7B83EE48659F8C3B67508CA1A2"><enum>(B)</enum><text>youth access to and use of cannabis, including marketing, packaging, edible formulations, and flavor options that target youth;</text>
 </subparagraph><subparagraph id="H65D2CE104CE54C339334D6F38B5EE21E"><enum>(C)</enum><text>risk factors for cannabis misuse;</text> </subparagraph><subparagraph id="HF74C9D44D3FD4B129B9E15EDA659EDCE"><enum>(D)</enum><text>impaired driving related to cannabis use; and</text>
 </subparagraph><subparagraph id="H78C6EA1C8390495EBC4ECA6A86ABA29D"><enum>(E)</enum><text>accidental ingestion of cannabis.</text></subparagraph></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="HA19C8151325046719BE66AB7B62AAE02"><enum>(b)</enum><header>Surveillance activities</header><text>Part A of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/241">42 U.S.C. 241</external-xref> et seq.) is amended by adding at the end the following:</text>
				<quoted-block display-inline="no-display-inline" id="HEB9A434F3A064521956D4AC63A96D03B" style="OLC">
					<section id="HB7D4A9E53127403594EC6F2533D39CC5"><enum>310B.</enum><header>Surveillance activities on cannabis use</header>
 <subsection id="H2932D5E341A74EB2BE1EA69103DCDCD3"><enum>(a)</enum><header>In general</header><text>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 &amp; 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.</text>
						</subsection><subsection id="H662D4F6209FB49508A77216AF3B1241F"><enum>(b)</enum><header>Permissible activities</header>
 <paragraph id="H3BAEA12722744EB89CA66D1D8F53ED3D"><enum>(1)</enum><header>In general</header><text>In carrying out activities under this section, the Secretary may collect, as appropriate, with respect to cannabis use—</text>
 <subparagraph id="H1600AA264C3244D0A4914350E263AF0F"><enum>(A)</enum><text>data on—</text> <clause id="H039EB48429424F1EA999886DF7807EC5"><enum>(i)</enum><text>health outcomes, including biological data;</text>
 </clause><clause id="H1B6F0985C3774116A745D187DF03DBBF"><enum>(ii)</enum><text>health care utilization, which shall include hospitalizations and utilization of emergency departments related to consumption of cannabis, including among youth;</text>
 </clause><clause id="H51FFCD58F0F54B308348561847B87437"><enum>(iii)</enum><text>demographic factors associated with cannabis use;</text> </clause><clause id="HA6E68DFC40EF44579B48938B47C50B53"><enum>(iv)</enum><text>the variety of products and delivery modes used; and</text>
 </clause><clause id="H207B6DB1FF7A4BC7A6F1C8964AD44B81"><enum>(v)</enum><text>other relevant health information to improve the understanding of cannabis use in all age groups and sub-populations; and</text>
 </clause></subparagraph><subparagraph id="H1BD9F0B9FE9F46E59388324C01A17B16"><enum>(B)</enum><text>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).</text>
 </subparagraph></paragraph><paragraph id="H80B3325C7D224D3A8FB6C18CEFF83162"><enum>(2)</enum><header>Privacy</header><text>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.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
			</subsection></section><section id="HC5D368A9F17B448483A100AA291F4AEE"><enum>3.</enum><header>Rescheduling of marihuana</header>
 <subsection id="H5DE5B92B3D8641528CAFB5C440F21BE0"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subsection (c) of schedule I of section 202(c) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/812">21 U.S.C. 812(c)</external-xref>) is amended by striking paragraph (10).</text>
 </subsection><subsection id="H6687930DB166413E9FBC6266D810E36C"><enum>(b)</enum><header>Schedule III</header><text>Schedule III of section 202(c) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/812">21 U.S.C. 812(c)</external-xref>) is amended by adding at the end the following:</text>
				<quoted-block display-inline="no-display-inline" id="HA0E5EEB93FC840B98DF968599025FB79" style="OLC">
 <subsection commented="no" display-inline="no-display-inline" id="H0F182754EB5B443F826C7D8332D5C931"><enum>(f)</enum><text>Marihuana.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection></section><section id="HFD446F4F665C4005AEBF2F9FBD5B49FC"><enum>4.</enum><header>Centers of excellence in cannabis research</header> <subsection id="HF934A7BD56E04AADBD9A8F155ED9888B"><enum>(a)</enum><header>In general</header><text>Part B of title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284">42 U.S.C. 284</external-xref> et seq.), as amended by section 2(a), is further amended by adding at the end the following:</text>
				<quoted-block display-inline="no-display-inline" id="H82502032618F4969A3F1E8ADA77C71DE" style="OLC">
					<section id="HC907E356E7194EA49F37D5A1FC28ABFB"><enum>409L.</enum><header>Centers of excellence in cannabis research</header>
						<subsection id="HAAE9939F9BE54322A12695FD9FE40E7B"><enum>(a)</enum><header>Designation</header>
 <paragraph id="H76EA523F33AE44E9966F3D6B8222725D"><enum>(1)</enum><header>In general</header><text>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—</text>
 <subparagraph id="HBDD1037CBA3845D885D05C2860AAB6A2"><enum>(A)</enum><text>the application contains or is supported by reasonable assurances that—</text> <clause commented="no" id="HC99BF0DBAC554D6C81401547E805CEE7"><enum>(i)</enum><text>at least 1 individual employed by the applicant—</text>
 <subclause commented="no" id="H96D1F0D68A1D41E4B2447A8D69935D18"><enum>(I)</enum><text>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</text>
 </subclause><subclause commented="no" id="HC9217A5EDFF74C8C96A12B76F188E010"><enum>(II)</enum><text>is an active participant in the cannabis research activities of the applicant;</text> </subclause></clause><clause commented="no" id="HEB23F8D207C4416A82EA99A62175C3DA"><enum>(ii)</enum><text>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;</text>
 </clause><clause id="HD57FD9EB0F384BCEBAA48563026808BD"><enum>(iii)</enum><text>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;</text>
 </clause><clause id="HB5901DE634EF410CA875AE550E9610B0"><enum>(iv)</enum><text>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</text>
 </clause><clause id="H0309419BDA824A2B80B66F95E17C5109"><enum>(v)</enum><text>the applicant has the capacity to conduct academic courses and train students and professionals on appropriate research and knowledge of cannabis; and</text>
 </clause></subparagraph><subparagraph id="H8BE6812031014E1F90BF6BAB6BD8999A"><enum>(B)</enum><text>the application contains a detailed 5-year plan for research relating to cannabis.</text> </subparagraph></paragraph><paragraph id="H6D408C879BC04169B0595575D79AC4E0"><enum>(2)</enum><header>Geographic representation</header><text>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.</text>
 </paragraph><paragraph id="HE7433E830B704A8E9427A668B10767E7"><enum>(3)</enum><header>Term of designation</header><text>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.</text>
							</paragraph></subsection><subsection id="H6B3EC8D108BF4128ADDD629E70462D9D"><enum>(b)</enum><header>Cannabis research</header>
							<paragraph id="H93782167691341C18FC5827CD3FFD53A"><enum>(1)</enum><header>Grants or cooperative agreements</header>
 <subparagraph id="H2C5828A125B34E56AD9CB8DCB94BF711"><enum>(A)</enum><header>In general</header><text>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.</text>
 </subparagraph><subparagraph id="H3FC4B58CBAA94DBD9FF265EDA5C873AF"><enum>(B)</enum><header>Use of funds</header><text>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.</text>
 </subparagraph></paragraph><paragraph id="HEFB3278E6A36461D983BB9BABA4F2FD4"><enum>(2)</enum><header>Research results</header><text>The Director of NIH shall promptly disseminate research results under this subsection to relevant governmental, academic, and research entities.</text>
 </paragraph></subsection><subsection id="H64C6A3620BD54B1FA36AA869E4BA696F"><enum>(c)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HE113D49317D34B4E87A448BEDA2C50FB"><enum>(1)</enum><header>Cannabis</header><text>The term <term>cannabis</term> has the meaning given the term <quote>marihuana</quote> in section 102 of the Controlled Substances Act.</text>
 </paragraph><paragraph id="H4F7B145D0D004D09BCC9D269E0F5EBD5"><enum>(2)</enum><header>Institution of higher education</header><text>The term <term>institution of higher education</term> has the meaning given the term in section 101(a) of the Higher Education Act of 1965.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection commented="no" display-inline="no-display-inline" id="H3C3A9F3B0A8847FE992EF5E45135D006"><enum>(b)</enum><header display-inline="yes-display-inline">Registration requirements</header><text display-inline="yes-display-inline">Section 303(f) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(f)</external-xref>) is amended by adding after the period at the end the following: <quote>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.</quote>.</text>
			</subsection></section></legis-body></bill>


