Expanding Cannabis Research and Information Act

II 116TH CONGRESS 1ST SESSION S. 2400 To promote cannabis research, and for other purposes. IN THE SENATE OF THE UNITED STATES JULY 31, 2019 Mr. DURBIN introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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. 9 284 et seq.) is amended by adding at the end the fol- 10 lowing: 11 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 2 •S 2400 IS ‘‘SEC. 409K. NATIONAL CANNABIS RESEARCH AGENDA. 1 ‘‘Not later than 1 year after the date of enactment 2 of the Expanding Cannabis Research and Information 3 Act, the Director of NIH, in collaboration with the Direc- 4 tor of the Centers for Disease Control and Prevention and 5 the Assistant Secretary for Mental Health and Substance 6 Use, shall develop a national cannabis research agenda 7 that addresses key questions and gaps in evidence, includ- 8 ing with respect to each of the following: 9 ‘‘(1) The efficacy of cannabis in providing 10 therapeutic benefits for certain priority diseases or 11 conditions, which may include epilepsy, multiple scle- 12 rosis-related spasticity, chemotherapy-induced pain 13 and discomfort, using cannabis as an alternative to 14 opioid analgesics for acute or chronic pain, sleep 15 apnea, Tourette syndrome, anxiety, post-traumatic 16 stress disorder, and any other disease or condition 17 determined to be appropriate and of importance by 18 the Director. 19 ‘‘(2) The effect of cannabis on at-risk popu- 20 lations, including children, older individuals, and 21 pregnant or breast-feeding women. 22 ‘‘(3) The long-term effects of cannabis use, in- 23 cluding dose-response relationship and the connec- 24 tion between cannabis use and behavioral health. 25 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 3 •S 2400 IS ‘‘(4) The clinically appropriate modes of deliv- 1 ery of cannabis. 2 ‘‘(5) Public safety considerations related to can- 3 nabis, including— 4 ‘‘(A) variation in the potency of cannabis 5 products; 6 ‘‘(B) youth access to and use of cannabis, 7 including marketing, packaging, edible formula- 8 tions, and flavor options that target youth; 9 ‘‘(C) risk factors for cannabis misuse; 10 ‘‘(D) impaired driving related to cannabis 11 use; and 12 ‘‘(E) accidental ingestion of cannabis.’’. 13 (b) SURVEILLANCE ACTIVITIES.—Part A of title III 14 of the Public Health Service Act (42 U.S.C. 241 et seq.) 15 is amended by adding at the end the following: 16 ‘‘SEC. 310B. SURVEILLANCE ACTIVITIES ON CANNABIS USE. 17 ‘‘(a) IN GENERAL.—The Secretary, acting through 18 the Director of the Centers for Disease Control and Pre- 19 vention, in collaboration with the Assistant Secretary for 20 Mental Health and Substance Use, the Administrator of 21 the Centers for Medicare & Medicaid Services, and the Di- 22 rector of the Agency for Healthcare Research and Quality, 23 shall carry out surveillance activities to collect population- 24 wide data on cannabis use. 25 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 4 •S 2400 IS ‘‘(b) PERMISSIBLE ACTIVITIES.— 1 ‘‘(1) IN GENERAL.—In carrying out activities 2 under this section, the Secretary may collect, as ap- 3 propriate, with respect to cannabis use— 4 ‘‘(A) data on— 5 ‘‘(i) health outcomes, including bio- 6 logical data; 7 ‘‘(ii) health care utilization, which 8 shall include hospitalizations and utiliza- 9 tion of emergency departments related to 10 consumption of cannabis, including among 11 youth; 12 ‘‘(iii) demographic factors associated 13 with cannabis use; 14 ‘‘(iv) the variety of products and deliv- 15 ery modes used; and 16 ‘‘(v) other relevant health information 17 to improve the understanding of cannabis 18 use in all age groups and sub-populations; 19 and 20 ‘‘(B) data through public health surveil- 21 lance systems, surveys, questionnaires, and 22 databases of health care records, including, as 23 appropriate, the Behavioral Risk Factor Sur- 24 veillance System, the Youth Risk Behavioral 25 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 5 •S 2400 IS Surveillance System, the Monitoring the Future 1 health survey, the National Survey on Drug 2 Use and Health, or the Healthcare Cost and 3 Utilization Project (or any successor surveys). 4 ‘‘(2) PRIVACY.—Any data collected under para- 5 graph (1) shall be collected in manner that protects 6 personal privacy to the extent, at a minimum, that 7 is required under applicable Federal and State 8 law.’’. 9 SEC. 3. RESCHEDULING OF MARIHUANA. 10 (a) IN GENERAL.—Subsection (c) of schedule I of 11 section 202(c) of the Controlled Substances Act (21 12 U.S.C. 812(c)) is amended by striking paragraph (10). 13 (b) SCHEDULE III.—Schedule III of section 202(c) 14 of the Controlled Substances Act (21 U.S.C. 812(c)) is 15 amended by adding at the end the following: 16 ‘‘(f) Marihuana.’’. 17 SEC. 4. CENTERS OF EXCELLENCE IN CANNABIS RE- 18 SEARCH. 19 (a) IN GENERAL.—Part B of title IV of the Public 20 Health Service Act (42 U.S.C. 284 et seq.), as amended 21 by section 2(a), is further amended by adding at the end 22 the following: 23 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 6 •S 2400 IS ‘‘SEC. 409L. CENTERS OF EXCELLENCE IN CANNABIS RE- 1 SEARCH. 2 ‘‘(a) DESIGNATION.— 3 ‘‘(1) IN GENERAL.—The Director of NIH shall 4 designate institutions of higher education as Centers 5 of Excellence in Cannabis Research for the purpose 6 of interdisciplinary research related to cannabis and 7 other biomedical, behavioral, and social issues re- 8 lated to cannabis. No institution of higher education 9 may be designated as a Center unless an application 10 therefor has been submitted to, and approved by, the 11 Director of NIH. Such an application shall be sub- 12 mitted in such manner and contain such information 13 as the Director of NIH may reasonably require. The 14 Director of NIH may not approve such an applica- 15 tion unless— 16 ‘‘(A) the application contains or is sup- 17 ported by reasonable assurances that— 18 ‘‘(i) at least 1 individual employed by 19 the applicant— 20 ‘‘(I) is registered under section 21 303(f) of the Controlled Substances 22 Act to conduct research with con- 23 trolled substances in schedule III of 24 section 202(c) of that Act; and 25 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 7 •S 2400 IS ‘‘(II) is an active participant in 1 the cannabis research activities of the 2 applicant; 3 ‘‘(ii) the applicant has not had a reg- 4 istration to conduct research with con- 5 trolled substances under section 303 of the 6 Controlled Substances Act denied, revoked, 7 or suspended under section 304 of that 8 Act; 9 ‘‘(iii) the applicant has the experience, 10 or capability, to conduct, through bio- 11 medical, behavioral, social, and related dis- 12 ciplines, long-term research on cannabis 13 and to provide coordination of such re- 14 search among such disciplines; 15 ‘‘(iv) the applicant has available to it 16 sufficient personnel and facilities (includ- 17 ing laboratory, reference, storage, security, 18 and data analysis facilities) to carry out 19 the research plan required under subpara- 20 graph (B); and 21 ‘‘(v) the applicant has the capacity to 22 conduct academic courses and train stu- 23 dents and professionals on appropriate re- 24 search and knowledge of cannabis; and 25 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 8 •S 2400 IS ‘‘(B) the application contains a detailed 5- 1 year plan for research relating to cannabis. 2 ‘‘(2) GEOGRAPHIC REPRESENTATION.—The Di- 3 rector of NIH shall ensure geographic representation 4 across the United States in designating institutions 5 of higher education as Centers of Excellence in Can- 6 nabis Research. 7 ‘‘(3) TERM OF DESIGNATION.—A designation 8 under this section shall be for a period of 5 years. 9 An institution of higher education may reapply in 10 accordance with the requirements under paragraph 11 (1) for a subsequent designation under this section. 12 ‘‘(b) CANNABIS RESEARCH.— 13 ‘‘(1) GRANTS OR COOPERATIVE AGREE- 14 MENTS.— 15 ‘‘(A) IN GENERAL.—The Director of NIH 16 may make grants to, or enter into cooperative 17 agreements with, Centers that have been des- 18 ignated under this section to expand the cur- 19 rent and ongoing interdisciplinary research and 20 clinical trials relating to cannabis research. 21 ‘‘(B) USE OF FUNDS.—Amounts made 22 available under a grant or cooperative agree- 23 ment under subparagraph (A) may be used to 24 address key questions and gaps in evidence ad- 25 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 9 •S 2400 IS dressed by the national cannabis research agen- 1 da described in paragraphs (1) through (5) of 2 section 409K. 3 ‘‘(2) RESEARCH RESULTS.—The Director of 4 NIH shall promptly disseminate research results 5 under this subsection to relevant governmental, aca- 6 demic, and research entities. 7 ‘‘(c) DEFINITIONS.—In this section: 8 ‘‘(1) CANNABIS.—The term ‘cannabis’ has the 9 meaning given the term ‘marihuana’ in section 102 10 of the Controlled Substances Act. 11 ‘‘(2) INSTITUTION OF HIGHER EDUCATION.— 12 The term ‘institution of higher education’ has the 13 meaning given the term in section 101(a) of the 14 Higher Education Act of 1965.’’. 15 (b) REGISTRATION REQUIREMENTS.—Section 303(f) 16 of the Controlled Substances Act (21 U.S.C. 823(f)) is 17 amended by adding after the period at the end the fol- 18 lowing: ‘‘The Attorney General shall register under this 19 part practitioners at Centers of Excellence in Cannabis 20 Research designated under section 409L of the Public 21 Health Service Act to conduct research with marihuana. 22 No separate registration shall be required for each indi- 23 vidual employed by a Center of Excellence in Cannabis Re- 24 search who is conducting research described in subsection 25 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 10 •S 2400 IS (a)(1) of that section and in accordance with applicable 1 State and local laws, nor shall separate registrations be 2 required for distinct research activities, including research 3 activities related to distinct constituent compounds of 4 marihuana or amended protocols. The registration shall 5 expire on the date on which the entity is no longer des- 6 ignated as such a Center of Excellence in Cannabis Re- 7 search under that section. A Center of Excellence in Can- 8 nabis Research registered under this part may cultivate 9 marihuana, including any constituent component of mari- 10 huana, to conduct research under this part if the Attorney 11 General has determined that the research to be conducted 12 is for legitimate scientific research and is consistent with 13 effective controls against diversion. A Center of Excellence 14 in Cannabis Research may contract with such additional 15 manufacturers of marihuana registered under this section 16 to meet the needs of the Center of Excellence in Cannabis 17 Research to the maximum extent permissible under inter- 18 national treaties to which the United States is a signatory 19 and which govern marihuana. Before entering into such 20 contract, the Center of Excellence in Cannabis Research 21 shall submit to the Attorney General a request to enter 22 into the contract that includes information to demonstrate 23 the experience or capability of the contractor to conduct 24 such cultivation and assurances that the contractor will 25 VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS 11 •S 2400 IS comply with the provisions of this Act. Not later than 60 1 days after the date on which the request is submitted, the 2 request shall be deemed to be approved by the Attorney 3 General, unless the Attorney General determines that the 4 granting of such request is inconsistent with the public 5 interest. A Center of Excellence in Cannabis Research reg- 6 istered under this section may purchase or acquire com- 7 mercially available marihuana for the purpose of research 8 described in section 409L(a)(1) of the Public Health Serv- 9 ice Act in accordance with the law of the State in which 10 the transaction occurs. No Federal funds may be used by 11 the Center of Excellence in Cannabis Research for such 12 purchase or acquisition.’’. 13 Æ VerDate Sep 11 2014 04:26 Aug 09, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\S2400.IS S2400 kjohnson on DSK79L0C42 with BILLS