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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Expanding Cannabis 

5 Research and Information Act’’. 

6 SEC. 2. CANNABIS RESEARCH AT THE DEPARTMENT OF 

7 HEALTH AND HUMAN SERVICES. 

8 (a) NATIONAL CANNABIS RESEARCH AGENDA.—Part 

9 B of title IV of the Public Health Service Act (42 U.S.C. 


kjohnson on DSK79L0C42 with BILLS
2 

•HR 4322 IH

1 284 et seq.) is amended by adding at the end the fol2 lowing: 

3 ‘‘SEC. 409K. NATIONAL CANNABIS RESEARCH AGENDA. 

4 ‘‘Not later than 1 year after the date of enactment 

5 of the Expanding Cannabis Research and Information 

6 Act, the Director of NIH, in collaboration with the Direc7 tor of the Centers for Disease Control and Prevention and 

8 the Assistant Secretary for Mental Health and Substance 

9 Use, shall develop a national cannabis research agenda 

10 that addresses key questions and gaps in evidence, includ11 ing with respect to each of the following: 

12 ‘‘(1) The efficacy of cannabis in providing 

13 therapeutic benefits for certain priority diseases or 

14 conditions, which may include epilepsy, multiple scle15 rosis-related spasticity, chemotherapy-induced pain 

16 and discomfort, using cannabis as an alternative to 

17 opioid analgesics for acute or chronic pain, sleep 

18 apnea, Tourette syndrome, anxiety, post-traumatic 

19 stress disorder, and any other disease or condition 

20 determined to be appropriate and of importance by 

21 the Director. 

22 ‘‘(2) The effect of cannabis on at-risk popu23 lations, including children, older individuals, and 

24 pregnant or breast-feeding women. 


kjohnson on DSK79L0C42 with BILLS
3 

•HR 4322 IH

1 ‘‘(3) The long-term effects of cannabis use, in2 cluding dose-response relationship and the connec3 tion between cannabis use and behavioral health. 

4 ‘‘(4) The clinically appropriate modes of deliv5 ery of cannabis. 

6 ‘‘(5) Public safety considerations related to can7 nabis, including— 

8 ‘‘(A) variation in the potency of cannabis 

9 products; 

10 ‘‘(B) youth access to and use of cannabis, 

11 including marketing, packaging, edible formula12 tions, and flavor options that target youth; 

13 ‘‘(C) risk factors for cannabis misuse; 

14 ‘‘(D) impaired driving related to cannabis 

15 use; and 

16 ‘‘(E) accidental ingestion of cannabis.’’. 

17 (b) SURVEILLANCE ACTIVITIES.—Part A of title III 

18 of the Public Health Service Act (42 U.S.C. 241 et seq.) 

19 is amended by adding at the end the following: 

20 ‘‘SEC. 310B. SURVEILLANCE ACTIVITIES ON CANNABIS USE. 

21 ‘‘(a) IN GENERAL.—The Secretary, acting through 

22 the Director of the Centers for Disease Control and Pre23 vention, in collaboration with the Assistant Secretary for 

24 Mental Health and Substance Use, the Administrator of 

25 the Centers for Medicare & Medicaid Services, and the DiVerDate 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

1 rector of the Agency for Healthcare Research and Quality, 

2 shall carry out surveillance activities to collect population3 wide data on cannabis use. 

4 ‘‘(b) PERMISSIBLE ACTIVITIES.— 

5 ‘‘(1) IN GENERAL.—In carrying out activities 

6 under this section, the Secretary may collect, as ap7 propriate, with respect to cannabis use— 

8 ‘‘(A) data on— 

9 ‘‘(i) health outcomes, including bio10 logical data; 

11 ‘‘(ii) health care utilization, which 

12 shall include hospitalizations and utiliza13 tion of emergency departments related to 

14 consumption of cannabis, including among 

15 youth; 

16 ‘‘(iii) demographic factors associated 

17 with cannabis use; 

18 ‘‘(iv) the variety of products and deliv19 ery modes used; and 

20 ‘‘(v) other relevant health information 

21 to improve the understanding of cannabis 

22 use in all age groups and sub-populations; 

23 and 

24 ‘‘(B) data through public health surveil25 lance systems, surveys, questionnaires, and 


kjohnson on DSK79L0C42 with BILLS
5 

•HR 4322 IH

1 databases of health care records, including, as 

2 appropriate, the Behavioral Risk Factor Sur3 veillance System, the Youth Risk Behavioral 

4 Surveillance System, the Monitoring the Future 

5 health survey, the National Survey on Drug 

6 Use and Health, or the Healthcare Cost and 

7 Utilization Project (or any successor surveys). 

8 ‘‘(2) PRIVACY.—Any data collected under para9 graph (1) shall be collected in manner that protects 

10 personal privacy to the extent, at a minimum, that 

11 is required under applicable Federal and State 

12 law.’’. 

13 SEC. 3. RESCHEDULING OF MARIHUANA. 

14 (a) IN GENERAL.—Subsection (c) of schedule I of 

15 section 202(c) of the Controlled Substances Act (21 

16 U.S.C. 812(c)) is amended by striking paragraph (10). 

17 (b) SCHEDULE III.—Schedule III of section 202(c) 

18 of the Controlled Substances Act (21 U.S.C. 812(c)) is 

19 amended by adding at the end the following: 

20 ‘‘(f) Marihuana.’’. 

21 SEC. 4. CENTERS OF EXCELLENCE IN CANNABIS RE22 SEARCH. 

23 (a) IN GENERAL.—Part B of title IV of the Public 

24 Health Service Act (42 U.S.C. 284 et seq.), as amended 


kjohnson on DSK79L0C42 with BILLS
6 

•HR 4322 IH

1 by section 2(a), is further amended by adding at the end 

2 the following: 

3 ‘‘SEC. 409L. CENTERS OF EXCELLENCE IN CANNABIS RE4 SEARCH. 

5 ‘‘(a) DESIGNATION.— 

6 ‘‘(1) IN GENERAL.—The Director of NIH shall 

7 designate institutions of higher education as Centers 

8 of Excellence in Cannabis Research for the purpose 

9 of interdisciplinary research related to cannabis and 

10 other biomedical, behavioral, and social issues re11 lated to cannabis. No institution of higher education 

12 may be designated as a Center unless an application 

13 therefor has been submitted to, and approved by, the 

14 Director of NIH. Such an application shall be sub15 mitted in such manner and contain such information 

16 as the Director of NIH may reasonably require. The 

17 Director of NIH may not approve such an applica18 tion unless— 

19 ‘‘(A) the application contains or is sup20 ported by reasonable assurances that— 

21 ‘‘(i) at least 1 individual employed by 

22 the applicant— 

23 ‘‘(I) is registered under section 

24 303(f) of the Controlled Substances 

25 Act to conduct research with conVerDate 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

1 trolled substances in schedule III of 

2 section 202(c) of that Act; and 

3 ‘‘(II) is an active participant in 

4 the cannabis research activities of the 

5 applicant; 

6 ‘‘(ii) the applicant has not had a reg7 istration to conduct research with con8 trolled substances under section 303 of the 

9 Controlled Substances Act denied, revoked, 

10 or suspended under section 304 of that 

11 Act; 

12 ‘‘(iii) the applicant has the experience, 

13 or capability, to conduct, through bio14 medical, behavioral, social, and related dis15 ciplines, long-term research on cannabis 

16 and to provide coordination of such re17 search among such disciplines; 

18 ‘‘(iv) the applicant has available to it 

19 sufficient personnel and facilities (includ20 ing laboratory, reference, storage, security, 

21 and data analysis facilities) to carry out 

22 the research plan required under subpara23 graph (B); and 

24 ‘‘(v) the applicant has the capacity to 

25 conduct academic courses and train stuVerDate 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

1 dents and professionals on appropriate re2 search and knowledge of cannabis; and 

3 ‘‘(B) the application contains a detailed 5- 

4 year plan for research relating to cannabis. 

5 ‘‘(2) GEOGRAPHIC REPRESENTATION.—The Di6 rector of NIH shall ensure geographic representation 

7 across the United States in designating institutions 

8 of higher education as Centers of Excellence in Can9 nabis Research. 

10 ‘‘(3) TERM OF DESIGNATION.—A designation 

11 under this section shall be for a period of 5 years. 

12 An institution of higher education may reapply in 

13 accordance with the requirements under paragraph 

14 (1) for a subsequent designation under this section. 

15 ‘‘(b) CANNABIS RESEARCH.— 

16 ‘‘(1) GRANTS OR COOPERATIVE AGREE17 MENTS.— 

18 ‘‘(A) IN GENERAL.—The Director of NIH 

19 may make grants to, or enter into cooperative 

20 agreements with, Centers that have been des21 ignated under this section to expand the cur22 rent and ongoing interdisciplinary research and 

23 clinical trials relating to cannabis research. 

24 ‘‘(B) USE OF FUNDS.—Amounts made 

25 available under a grant or cooperative agreeVerDate 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

1 ment under subparagraph (A) may be used to 

2 address key questions and gaps in evidence ad3 dressed by the national cannabis research agen4 da described in paragraphs (1) through (5) of 

5 section 409K. 

6 ‘‘(2) RESEARCH RESULTS.—The Director of 

7 NIH shall promptly disseminate research results 

8 under this subsection to relevant governmental, aca9 demic, and research entities. 

10 ‘‘(c) DEFINITIONS.—In this section: 

11 ‘‘(1) CANNABIS.—The term ‘cannabis’ has the 

12 meaning given the term ‘marihuana’ in section 102 

13 of the Controlled Substances Act. 

14 ‘‘(2) INSTITUTION OF HIGHER EDUCATION.— 

15 The term ‘institution of higher education’ has the 

16 meaning given the term in section 101(a) of the 

17 Higher Education Act of 1965.’’. 

18 (b) REGISTRATION REQUIREMENTS.—Section 303(f) 

19 of the Controlled Substances Act (21 U.S.C. 823(f)) is 

20 amended by adding after the period at the end the fol21 lowing: ‘‘The Attorney General shall register under this 

22 part practitioners at Centers of Excellence in Cannabis 

23 Research designated under section 409L of the Public 

24 Health Service Act to conduct research with marihuana. 

25 No separate registration shall be required for each indiVerDate 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

1 vidual employed by a Center of Excellence in Cannabis Re2 search who is conducting research described in subsection 

3 (a)(1) of that section and in accordance with applicable 

4 State and local laws, nor shall separate registrations be 

5 required for distinct research activities, including research 

6 activities related to distinct constituent compounds of 

7 marihuana or amended protocols. The registration shall 

8 expire on the date on which the entity is no longer des9 ignated as such a Center of Excellence in Cannabis Re10 search under that section. A Center of Excellence in Can11 nabis Research registered under this part may cultivate 

12 marihuana, including any constituent component of mari13 huana, to conduct research under this part if the Attorney 

14 General has determined that the research to be conducted 

15 is for legitimate scientific research and is consistent with 

16 effective controls against diversion. A Center of Excellence 

17 in Cannabis Research may contract with such additional 

18 manufacturers of marihuana registered under this section 

19 to meet the needs of the Center of Excellence in Cannabis 

20 Research to the maximum extent permissible under inter21 national treaties to which the United States is a signatory 

22 and which govern marihuana. Before entering into such 

23 contract, the Center of Excellence in Cannabis Research 

24 shall submit to the Attorney General a request to enter 

25 into the contract that includes information to demonstrate 


kjohnson on DSK79L0C42 with BILLS
11 

•HR 4322 IH

1 the experience or capability of the contractor to conduct 

2 such cultivation and assurances that the contractor will 

3 comply with the provisions of this Act. Not later than 60 

4 days after the date on which the request is submitted, the 

5 request shall be deemed to be approved by the Attorney 

6 General, unless the Attorney General determines that the 

7 granting of such request is inconsistent with the public 

8 interest. A Center of Excellence in Cannabis Research reg9 istered under this section may purchase or acquire com10 mercially available marihuana for the purpose of research 

11 described in section 409L(a)(1) of the Public Health Serv12 ice Act in accordance with the law of the State in which 

13 the transaction occurs. No Federal funds may be used by 

14 the Center of Excellence in Cannabis Research for such 

15 purchase or acquisition.’’. 

Æ 


kjohnson on DSK79L0C42 with BILLS