Expanding Cannabis Research and Information Act

I 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 pe- riod to be subsequently determined by the Speaker, in each case for con- sideration of such provisions as fall within the jurisdiction of the com- mittee concerned A BILL To promote cannabis research, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Expanding Cannabis 4 Research and Information Act’’. 5 SEC. 2. CANNABIS RESEARCH AT THE DEPARTMENT OF 6 HEALTH AND HUMAN SERVICES. 7 (a) NATIONAL CANNABIS RESEARCH AGENDA.—Part 8 B of title IV of the Public Health Service Act (42 U.S.C. 9 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 2 •HR 4322 IH 284 et seq.) is amended by adding at the end the fol- 1 lowing: 2 ‘‘SEC. 409K. NATIONAL CANNABIS RESEARCH AGENDA. 3 ‘‘Not later than 1 year after the date of enactment 4 of the Expanding Cannabis Research and Information 5 Act, the Director of NIH, in collaboration with the Direc- 6 tor of the Centers for Disease Control and Prevention and 7 the Assistant Secretary for Mental Health and Substance 8 Use, shall develop a national cannabis research agenda 9 that addresses key questions and gaps in evidence, includ- 10 ing with respect to each of the following: 11 ‘‘(1) The efficacy of cannabis in providing 12 therapeutic benefits for certain priority diseases or 13 conditions, which may include epilepsy, multiple scle- 14 rosis-related spasticity, chemotherapy-induced pain 15 and discomfort, using cannabis as an alternative to 16 opioid analgesics for acute or chronic pain, sleep 17 apnea, Tourette syndrome, anxiety, post-traumatic 18 stress disorder, and any other disease or condition 19 determined to be appropriate and of importance by 20 the Director. 21 ‘‘(2) The effect of cannabis on at-risk popu- 22 lations, including children, older individuals, and 23 pregnant or breast-feeding women. 24 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 3 •HR 4322 IH ‘‘(3) The long-term effects of cannabis use, in- 1 cluding dose-response relationship and the connec- 2 tion between cannabis use and behavioral health. 3 ‘‘(4) The clinically appropriate modes of deliv- 4 ery of cannabis. 5 ‘‘(5) Public safety considerations related to can- 6 nabis, including— 7 ‘‘(A) variation in the potency of cannabis 8 products; 9 ‘‘(B) youth access to and use of cannabis, 10 including marketing, packaging, edible formula- 11 tions, and flavor options that target youth; 12 ‘‘(C) risk factors for cannabis misuse; 13 ‘‘(D) impaired driving related to cannabis 14 use; and 15 ‘‘(E) accidental ingestion of cannabis.’’. 16 (b) SURVEILLANCE ACTIVITIES.—Part A of title III 17 of the Public Health Service Act (42 U.S.C. 241 et seq.) 18 is amended by adding at the end the following: 19 ‘‘SEC. 310B. SURVEILLANCE ACTIVITIES ON CANNABIS USE. 20 ‘‘(a) IN GENERAL.—The Secretary, acting through 21 the Director of the Centers for Disease Control and Pre- 22 vention, in collaboration with the Assistant Secretary for 23 Mental Health and Substance Use, the Administrator of 24 the Centers for Medicare & Medicaid Services, and the Di- 25 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 4 •HR 4322 IH rector of the Agency for Healthcare Research and Quality, 1 shall carry out surveillance activities to collect population- 2 wide data on cannabis use. 3 ‘‘(b) PERMISSIBLE ACTIVITIES.— 4 ‘‘(1) IN GENERAL.—In carrying out activities 5 under this section, the Secretary may collect, as ap- 6 propriate, with respect to cannabis use— 7 ‘‘(A) data on— 8 ‘‘(i) health outcomes, including bio- 9 logical data; 10 ‘‘(ii) health care utilization, which 11 shall include hospitalizations and utiliza- 12 tion of emergency departments related to 13 consumption of cannabis, including among 14 youth; 15 ‘‘(iii) demographic factors associated 16 with cannabis use; 17 ‘‘(iv) the variety of products and deliv- 18 ery modes used; and 19 ‘‘(v) other relevant health information 20 to improve the understanding of cannabis 21 use in all age groups and sub-populations; 22 and 23 ‘‘(B) data through public health surveil- 24 lance systems, surveys, questionnaires, and 25 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 5 •HR 4322 IH databases of health care records, including, as 1 appropriate, the Behavioral Risk Factor Sur- 2 veillance System, the Youth Risk Behavioral 3 Surveillance System, the Monitoring the Future 4 health survey, the National Survey on Drug 5 Use and Health, or the Healthcare Cost and 6 Utilization Project (or any successor surveys). 7 ‘‘(2) PRIVACY.—Any data collected under para- 8 graph (1) shall be collected in manner that protects 9 personal privacy to the extent, at a minimum, that 10 is required under applicable Federal and State 11 law.’’. 12 SEC. 3. RESCHEDULING OF MARIHUANA. 13 (a) IN GENERAL.—Subsection (c) of schedule I of 14 section 202(c) of the Controlled Substances Act (21 15 U.S.C. 812(c)) is amended by striking paragraph (10). 16 (b) SCHEDULE III.—Schedule III of section 202(c) 17 of the Controlled Substances Act (21 U.S.C. 812(c)) is 18 amended by adding at the end the following: 19 ‘‘(f) Marihuana.’’. 20 SEC. 4. CENTERS OF EXCELLENCE IN CANNABIS RE- 21 SEARCH. 22 (a) IN GENERAL.—Part B of title IV of the Public 23 Health Service Act (42 U.S.C. 284 et seq.), as amended 24 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 6 •HR 4322 IH by section 2(a), is further amended by adding at the end 1 the following: 2 ‘‘SEC. 409L. CENTERS OF EXCELLENCE IN CANNABIS RE- 3 SEARCH. 4 ‘‘(a) DESIGNATION.— 5 ‘‘(1) IN GENERAL.—The Director of NIH shall 6 designate institutions of higher education as Centers 7 of Excellence in Cannabis Research for the purpose 8 of interdisciplinary research related to cannabis and 9 other biomedical, behavioral, and social issues re- 10 lated to cannabis. No institution of higher education 11 may be designated as a Center unless an application 12 therefor has been submitted to, and approved by, the 13 Director of NIH. Such an application shall be sub- 14 mitted in such manner and contain such information 15 as the Director of NIH may reasonably require. The 16 Director of NIH may not approve such an applica- 17 tion unless— 18 ‘‘(A) the application contains or is sup- 19 ported by reasonable assurances that— 20 ‘‘(i) at least 1 individual employed by 21 the applicant— 22 ‘‘(I) is registered under section 23 303(f) of the Controlled Substances 24 Act to conduct research with con- 25 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 7 •HR 4322 IH trolled substances in schedule III of 1 section 202(c) of that Act; and 2 ‘‘(II) is an active participant in 3 the cannabis research activities of the 4 applicant; 5 ‘‘(ii) the applicant has not had a reg- 6 istration to conduct research with con- 7 trolled substances under section 303 of the 8 Controlled Substances Act denied, revoked, 9 or suspended under section 304 of that 10 Act; 11 ‘‘(iii) the applicant has the experience, 12 or capability, to conduct, through bio- 13 medical, behavioral, social, and related dis- 14 ciplines, long-term research on cannabis 15 and to provide coordination of such re- 16 search among such disciplines; 17 ‘‘(iv) the applicant has available to it 18 sufficient personnel and facilities (includ- 19 ing laboratory, reference, storage, security, 20 and data analysis facilities) to carry out 21 the research plan required under subpara- 22 graph (B); and 23 ‘‘(v) the applicant has the capacity to 24 conduct academic courses and train stu- 25 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 8 •HR 4322 IH dents and professionals on appropriate re- 1 search and knowledge of cannabis; and 2 ‘‘(B) the application contains a detailed 5- 3 year plan for research relating to cannabis. 4 ‘‘(2) GEOGRAPHIC REPRESENTATION.—The Di- 5 rector of NIH shall ensure geographic representation 6 across the United States in designating institutions 7 of higher education as Centers of Excellence in Can- 8 nabis Research. 9 ‘‘(3) TERM OF DESIGNATION.—A designation 10 under this section shall be for a period of 5 years. 11 An institution of higher education may reapply in 12 accordance with the requirements under paragraph 13 (1) for a subsequent designation under this section. 14 ‘‘(b) CANNABIS RESEARCH.— 15 ‘‘(1) GRANTS OR COOPERATIVE AGREE- 16 MENTS.— 17 ‘‘(A) IN GENERAL.—The Director of NIH 18 may make grants to, or enter into cooperative 19 agreements with, Centers that have been des- 20 ignated under this section to expand the cur- 21 rent and ongoing interdisciplinary research and 22 clinical trials relating to cannabis research. 23 ‘‘(B) USE OF FUNDS.—Amounts made 24 available under a grant or cooperative agree- 25 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 9 •HR 4322 IH ment under subparagraph (A) may be used to 1 address key questions and gaps in evidence ad- 2 dressed by the national cannabis research agen- 3 da described in paragraphs (1) through (5) of 4 section 409K. 5 ‘‘(2) RESEARCH RESULTS.—The Director of 6 NIH shall promptly disseminate research results 7 under this subsection to relevant governmental, aca- 8 demic, and research entities. 9 ‘‘(c) DEFINITIONS.—In this section: 10 ‘‘(1) CANNABIS.—The term ‘cannabis’ has the 11 meaning given the term ‘marihuana’ in section 102 12 of the Controlled Substances Act. 13 ‘‘(2) INSTITUTION OF HIGHER EDUCATION.— 14 The term ‘institution of higher education’ has the 15 meaning given the term in section 101(a) of the 16 Higher Education Act of 1965.’’. 17 (b) REGISTRATION REQUIREMENTS.—Section 303(f) 18 of the Controlled Substances Act (21 U.S.C. 823(f)) is 19 amended by adding after the period at the end the fol- 20 lowing: ‘‘The Attorney General shall register under this 21 part practitioners at Centers of Excellence in Cannabis 22 Research designated under section 409L of the Public 23 Health Service Act to conduct research with marihuana. 24 No separate registration shall be required for each indi- 25 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 10 •HR 4322 IH vidual employed by a Center of Excellence in Cannabis Re- 1 search who is conducting research described in subsection 2 (a)(1) of that section and in accordance with applicable 3 State and local laws, nor shall separate registrations be 4 required for distinct research activities, including research 5 activities related to distinct constituent compounds of 6 marihuana or amended protocols. The registration shall 7 expire on the date on which the entity is no longer des- 8 ignated as such a Center of Excellence in Cannabis Re- 9 search under that section. A Center of Excellence in Can- 10 nabis Research registered under this part may cultivate 11 marihuana, including any constituent component of mari- 12 huana, to conduct research under this part if the Attorney 13 General has determined that the research to be conducted 14 is for legitimate scientific research and is consistent with 15 effective controls against diversion. A Center of Excellence 16 in Cannabis Research may contract with such additional 17 manufacturers of marihuana registered under this section 18 to meet the needs of the Center of Excellence in Cannabis 19 Research to the maximum extent permissible under inter- 20 national treaties to which the United States is a signatory 21 and which govern marihuana. Before entering into such 22 contract, the Center of Excellence in Cannabis Research 23 shall submit to the Attorney General a request to enter 24 into the contract that includes information to demonstrate 25 VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS 11 •HR 4322 IH the experience or capability of the contractor to conduct 1 such cultivation and assurances that the contractor will 2 comply with the provisions of this Act. Not later than 60 3 days after the date on which the request is submitted, the 4 request shall be deemed to be approved by the Attorney 5 General, unless the Attorney General determines that the 6 granting of such request is inconsistent with the public 7 interest. A Center of Excellence in Cannabis Research reg- 8 istered under this section may purchase or acquire com- 9 mercially available marihuana for the purpose of research 10 described in section 409L(a)(1) of the Public Health Serv- 11 ice Act in accordance with the law of the State in which 12 the transaction occurs. No Federal funds may be used by 13 the Center of Excellence in Cannabis Research for such 14 purchase or acquisition.’’. 15 Æ VerDate Sep 11 2014 23:16 Sep 13, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\H4322.IH H4322 kjohnson on DSK79L0C42 with BILLS