I 
114TH CONGRESS 
2D SESSION 
H. R. 5549 
To amend the Controlled Substances Act to make marijuana accessible for 
use by qualified medical marijuana researchers, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 21, 2016 
Mr. HARRIS (for himself, Mr. BLUMENAUER, Mr. GRIFFITH, and Mr. FARR) 
introduced the following bill; which was referred to the Committee on En-
ergy 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 amend the Controlled Substances Act to make marijuana 
accessible for use by qualified medical marijuana re-
searchers, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Marijuana Re-
search Act of 2016’’. 
SEC. 2. PRODUCTION AND SUPPLY. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services— 
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(6) by inserting before paragraph (4), as so 
designated, the following: 
‘‘(3)(A) The Attorney General shall register a practi-
tioner to conduct research with marijuana if— 
‘‘(i) the applicant is authorized to dispense, or 
conduct research with respect to, controlled sub-
stances in schedules II, III, IV, and V under the 
laws of the State in which the applicant practices; 
‘‘(ii) the applicant’s research protocol— 
‘‘(I) has been reviewed and allowed by— 
‘‘(aa) the Secretary under section 
505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)); or 
‘‘(bb) the National Institutes of 
Health or another Federal agency that 
funds scientific research; or 
‘‘(II) in the case of nonhuman research 
that is not federally funded, has been volun-
tarily submitted by the applicant to, and ap-
proved by, the National Institutes of Health; 
and 
‘‘(iii) the applicant has demonstrated that there 
are effective procedures in place to adequately safe-
guard against diversion of the marijuana from legiti-
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mate medical or scientific use, in accordance with 
subparagraph (E). 
‘‘(B) The Attorney General shall grant an application 
for registration under this paragraph unless the Attorney 
General determines that the issuance of the registration 
would be inconsistent with the public interest. In deter-
mining the public interest, the following factors shall be 
considered: 
‘‘(i) The applicant’s experience in dispensing, or 
conducting research with respect to, controlled sub-
stances. 
‘‘(ii) The applicant’s conviction record under 
Federal or State laws relating to the manufacture, 
distribution, or dispensing of controlled substances. 
‘‘(iii) Compliance with applicable State, Fed-
eral, or local laws relating to controlled substances. 
‘‘(iv) Such other conduct by the applicant that 
may threaten the public health and safety. 
‘‘(C) Not later than 90 days after the date of enact-
ment of the Medical Marijuana Research Act of 2016, for 
purposes of subparagraph (A)(ii)(II), the National Insti-
tutes of Health shall establish a process that— 
‘‘(i) allows a researcher to voluntarily submit 
the research protocol of the researcher for review 
and approval; and 
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‘‘(ii) provides a researcher described in clause 
(i) with a decision not less than 30 days after the 
date on which the research protocol is submitted. 
‘‘(D)(i) Not later than 60 days after the date on 
which the Attorney General receives a complete applica-
tion for registration under this paragraph, the Attorney 
General shall approve or deny the application. 
‘‘(ii) For purposes of clause (i), an application shall 
be deemed complete when the applicant has submitted 
documentation showing that the requirements under sub-
paragraph (A) are satisfied. 
‘‘(E)(i) A researcher registered under this paragraph 
shall store marijuana to be used in research in a securely 
locked, substantially constructed cabinet. 
‘‘(ii) Except as provided in clause (i), any security 
measures required by the Attorney General for practi-
tioners conducting research with marijuana pursuant to 
a registration under this paragraph shall be consistent 
with the security measures for practitioners conducting re-
search on other controlled substances in schedule II that 
have a similar risk of diversion and abuse. 
‘‘(F)(i) If the Attorney General grants an application 
for registration under this paragraph, the applicant may 
amend or supplement the research protocol without re-
applying if the applicant does not— 
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‘‘(I) change the type of drug, the source of the 
drug, or the conditions under which the drug is 
stored, tracked, or administered; or 
‘‘(II) otherwise increase the risk of diversion. 
‘‘(ii) If an applicant amends or supplements the re-
search protocol or initiates research on a new research 
protocol under clause (i), the applicant shall, in order to 
renew the registration under this paragraph, provide no-
tice to the Attorney General of the amended or supple-
mented research protocol or any new research protocol in 
the applicant’s renewal materials. 
‘‘(iii)(I) If an applicant amends or supplements a re-
search protocol and the amendment or supplement in-
volves a change to the type of drug, the source of the drug, 
or conditions under which the drug is stored, tracked, or 
administered or otherwise increases the risk of diversion, 
the applicant shall provide notice to the Attorney General 
not later than 30 days before proceeding on such amended 
or supplemental research or new research protocol, as the 
case may be. 
‘‘(II) If the Attorney General does not object during 
the 30-day period following a notification under subclause 
(I), the applicant may proceed with the amended or sup-
plemental research or new research protocol. 
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‘‘(iv) The Attorney General may object to an amend-
ed or supplemental protocol or a new research protocol 
under clause (i) or (iii) only if additional security meas-
ures are needed to safeguard against diversion or abuse. 
‘‘(G) If marijuana or a compound of marijuana is 
listed on a schedule other than schedule I, the provisions 
of paragraphs (1), (2), and (4) that apply to research with 
a controlled substance in the applicable schedule shall 
apply to research with marijuana or that compound, as 
applicable, in lieu of the provisions of subparagraphs (A) 
through (G) of this paragraph.’’. 
(b) CONFORMING AMENDMENT.—Section 102(16) of 
the Controlled Substances Act (21 U.S.C. 802(16)) is 
amended by inserting ‘‘or ‘marijuana’ ’’ after ‘‘The term 
‘marihuana’ ’’. 
SEC. 4. MANUFACTURE AND DISTRIBUTION OF MARIJUANA 
FOR 
USE 
IN 
LEGITIMATE, 
MEDICAL 
RE-
SEARCH. 
Section 303 of the Controlled Substances Act (21 
U.S.C. 823), as amended by section 3, is further amended 
by adding at the end the following: 
‘‘(k) REGISTRATION OF PERSONS TO MANUFACTURE 
AND DISTRIBUTE MARIJUANA FOR USE IN LEGITIMATE, 
MEDICAL RESEARCH.— 
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‘‘(1) REGISTRATION OF MANUFACTURERS.—Be-
ginning not later than the day that is 1 year after 
the date of enactment of the Medical Marijuana Re-
search Act of 2016, the Attorney General shall reg-
ister an applicant to manufacture marijuana to the 
extent the marijuana will be used exclusively by 
qualified medical marijuana researchers for research 
pursuant to subsection (f)(3), unless the Attorney 
General determines that the issuance of such reg-
istration is inconsistent with the public interest. In 
determining the public interest, the Attorney Gen-
eral shall— 
‘‘(A) take into consideration— 
‘‘(i) maintenance of effective controls 
against diversion of marijuana and any 
controlled substance compounded there-
from into other than legitimate medical, 
scientific, or research channels; 
‘‘(ii) compliance with applicable State 
and local law; and 
‘‘(iii) prior conviction record of the 
applicant under Federal or State laws re-
lating to the manufacture, distribution, or 
dispensing of such substances; and 
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‘‘(B) not take into consideration any fac-
tors other than the factors listed in subpara-
graph (A). 
‘‘(2) REGISTRATION OF DISTRIBUTORS.—Begin-
ning not later than the day that is 1 year after the 
date of enactment of the Medical Marijuana Re-
search Act of 2016, the Attorney General shall reg-
ister an applicant to distribute marijuana that is in-
tended to be used exclusively by qualified medical 
marijuana researchers for research pursuant to sub-
section (f)(3), unless the Attorney General deter-
mines that the issuance of such registration is incon-
sistent with the public interest. In determining the 
public interest, the Attorney General shall— 
‘‘(A) take into consideration— 
‘‘(i) maintenance of effective controls 
against diversion of marijuana and any 
controlled substance compounded there-
from into other than legitimate medical, 
scientific, or research channels; 
‘‘(ii) compliance with applicable State 
and local law; 
‘‘(iii) prior conviction record of the 
applicant under Federal or State laws re-
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lating to the manufacture, distribution, or 
dispensing of such substances; and 
‘‘(iv) past experience in the distribu-
tion of controlled substances, and the exist-
ence in the establishment of effective con-
trols against diversion; and 
‘‘(B) not take into consideration any fac-
tors other than the factors listed in subpara-
graph (A). 
‘‘(3) NO LIMIT ON NUMBER OF MANUFACTUR-
ERS
AND
DISTRIBUTORS.—Notwithstanding any 
other provision of law, the Attorney General shall 
not impose or implement any limit on the number of 
persons eligible to be registered to manufacture or 
distribute marijuana pursuant to paragraph (1) or 
(2). 
‘‘(4) REQUIREMENT TO VERIFY USE FOR LE-
GITIMATE, MEDICAL RESEARCH.—As a condition on 
registration under this section to manufacture or 
distribute marijuana, the Attorney General shall re-
quire the registrant— 
‘‘(A) to require any person to whom the 
marijuana will be supplied to submit docu-
mentation demonstrating that the marijuana 
will be used exclusively by qualified medical 
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marijuana researchers for research pursuant to 
subsection (f)(3); and 
‘‘(B) not later than 30 days after receipt 
of such documentation, and before supplying 
the marijuana to such person, to review such 
documentation and verify that the marijuana 
will be so used. 
‘‘(5) TIMING.—Not later than 30 days after re-
ceipt of a request for registration under this sub-
section to manufacture or distribute marijuana, the 
Attorney General shall— 
‘‘(A) grant or deny the request; and 
‘‘(B) in the case of a denial, provide a 
written explanation of the basis for the denial. 
‘‘(6) DEFINITION.—For purposes of this sub-
section, the term ‘qualified medical marijuana re-
searcher’ means a researcher who is registered to 
conduct research with marijuana under subsection 
(f)(3).’’. 
SEC. 5. TERMINATION OF INTERDISCIPLINARY REVIEW 
PROCESS FOR NON-NIH-FUNDED RESEARCH-
ERS. 
The Secretary of Health and Human Services may 
not— 
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(1) reinstate the Public Health Service inter-
disciplinary review process described in the guidance 
entitled ‘‘Guidance on Procedures for the Provision 
of Marijuana for Medical Research’’ (issued on May 
21, 1999); or 
(2) create an additional review of scientific pro-
tocols that is only conducted for research on mari-
juana other than the review of research protocols 
performed at the request of a researcher conducting 
nonhuman research that is not federally funded, in 
accordance with section 303(f)(3)(A)(ii)(II) of the 
Controlled 
Substances 
Act 
(21 
U.S.C. 
823(f)(3)(A)(ii)(II)), as amended by section 3. 
SEC. 6. CONSIDERATION OF RESULTS OF RESEARCH. 
Immediately upon the approval by the Food and 
Drug Administration of an application for a marijuana- 
based drug under section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355), and (irrespective of 
whether any such approval is granted) not later than the 
date that is 5 years after the date of enactment of this 
Act, the Secretary of Health and Human Services shall— 
(1) conduct a review of existing medical and 
other research with respect to marijuana; 
(2) submit a report to the Congress on the re-
sults of such review; and 
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(3) include in such report whether, taking into 
consideration the factors listed in section 201(c) of 
the Controlled Substances Act (21 U.S.C. 811(c)), 
as well as any potential for medical benefits, any 
gaps in research, and any impacts of Federal restric-
tions and policy on research, marijuana should be 
transferred to a schedule other than schedule I (if 
marijuana has not been so transferred already). 
SEC. 7. NO PRODUCTION QUOTAS FOR MARIJUANA GROWN 
FOR LEGITIMATE, MEDICAL RESEARCH. 
Section 306 of the Controlled Substances Act (21 
U.S.C. 826) is amended by adding at the end the fol-
lowing: 
‘‘(i) The Attorney General may only establish a quota 
for production of marijuana that is manufactured and dis-
tributed in accordance with the Medical Marijuana Re-
search Act of 2016 that meets the changing medical, sci-
entific, and industrial needs for marijuana.’’. 
SEC. 8. ARTICLE 28 OF THE SINGLE CONVENTION ON NAR-
COTIC DRUGS. 
Article 28 of the Single Convention on Narcotic 
Drugs shall not be construed to prohibit, or impose addi-
tional restrictions upon, research involving marijuana, or 
the manufacture, distribution, or dispensing of marijuana, 
that is conducted in accordance with the Controlled Sub-
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