rity measures for practitioners conducting research on other 
controlled substances in schedule II that have a similar risk 
of diversion and abuse. 
‘‘(E)(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 change the type of mari-
juana, the source of the marijuana, or the conditions under 
which the marijuana is stored, tracked, or administered. 
‘‘(ii) If an applicant amends or supplements the re-
search protocol or initiates research on a new research pro-
tocol under clause (i), the applicant shall, in order to renew 
the registration under this paragraph, provide notice to the 
Attorney General of the amended or supplemented research 
protocol or any new research protocol in the applicant’s re-
newal materials. 
‘‘(iii)(I) If an applicant amends or supplements a re-
search protocol and the amendment or supplement involves 
a change to the type of marijuana, the source of the mari-
juana, or conditions under which the marijuana 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. 
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‘‘(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 supple-
mental research or new research protocol. 
‘‘(iv) The Attorney General may object to an amended 
or supplemental protocol or a new research protocol under 
clause (i) or (iii) only if additional security measures are 
needed to safeguard against diversion or abuse. 
‘‘(F) If marijuana or a compound of marijuana is list-
ed 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 applica-
ble, in lieu of the provisions of subparagraphs (A) through 
(E) of this paragraph. 
‘‘(G) Nothing in this paragraph shall be construed as 
limiting the authority of the Secretary under section 505(i) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(i)) or over requirements related to research protocols, 
including changes in— 
‘‘(i) the method of administration of marijuana; 
‘‘(ii) the dosing of marijuana; and 
‘‘(iii) the number of individuals or patients in-
volved in research.’’. 
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SEC. 3. 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 2, is further amended 
by adding at the end the following: 
‘‘(l) REGISTRATION OF PERSONS TO MANUFACTURE 
AND DISTRIBUTE MARIJUANA FOR USE IN LEGITIMATE, 
MEDICAL RESEARCH.— 
‘‘(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, the Attorney General shall register an ap-
plicant to manufacture marijuana (including any de-
rivative, extract, preparation, and compound thereof) 
that is intended for the ultimate and exclusive use by 
qualified marijuana researchers for research pursuant 
to subsection (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 take into 
consideration— 
‘‘(A) maintenance of effective controls 
against diversion of marijuana and any con-
trolled substance compounded therefrom into 
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other than legitimate medical, scientific, or re-
search channels; 
‘‘(B) compliance with applicable State and 
local laws relating to controlled substance misuse 
and diversion; and 
‘‘(C) prior conviction record of the appli-
cant under Federal or State laws relating to the 
manufacture, distribution, or dispensing of such 
substances. 
‘‘(2) REGISTRATION OF DISTRIBUTORS.—Begin-
ning not later than the day that is 1 year after the 
date of enactment of the Medical Marijuana Research 
Act, the Attorney General shall register an applicant 
to distribute marijuana (including any derivative, ex-
tract, preparation, and compound thereof) that is in-
tended for the ultimate and exclusive use by qualified 
marijuana researchers for research pursuant to sub-
section (f)(3), unless the Attorney General determines 
that the issuance of such registration is inconsistent 
with the public interest. 
‘‘(3) PUBLIC
INTEREST.—In determining the 
public interest under paragraph (2), the Attorney 
General shall take into consideration— 
‘‘(A) the factors specified in subparagraphs 
(A), (B), and (C) of such paragraph; and 
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‘‘(B) past experience in the distribution of 
controlled substances, and the existence of effec-
tive controls against diversion. 
‘‘(4) NO LIMIT ON NUMBER OF MANUFACTURERS 
AND DISTRIBUTORS.—Notwithstanding any other pro-
vision of law, the Attorney General shall not impose 
or implement any limit on the number of persons eli-
gible to be registered to manufacture or distribute 
marijuana pursuant to paragraph (1) or (2). 
‘‘(5) REQUIREMENT TO VERIFY USE FOR LEGITI-
MATE, MEDICAL RESEARCH.—As a condition on reg-
istration under this section to manufacture or dis-
tribute marijuana, the Attorney General shall require 
the registrant— 
‘‘(A) to require any person to whom the 
marijuana will be supplied to submit docu-
mentation demonstrating that the marijuana 
(including any derivative, extract, preparation, 
and compound thereof) will be ultimately used 
exclusively by qualified marijuana researchers 
for research pursuant to subsection (f)(3); 
‘‘(B) in the case of distribution, to complete, 
with respect to that distribution, the DEA Con-
trolled substance order form in accordance with 
section 308 and to upload such forms to the sys-
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tem used by the Drug Enforcement Agency for 
such distribution; 
‘‘(C) to include in the labeling of any mari-
juana so manufactured or distributed— 
‘‘(i) the following statement: ‘This ma-
terial is for biomedical and scientific re-
search purposes only.’; and 
‘‘(ii) the name of the requestor of the 
marijuana; 
‘‘(D) to limit the transfer and sale of any 
marijuana 
manufactured 
under 
this 
sub-
section— 
‘‘(i) to researchers who are registered 
under this Act to conduct research with 
marijuana; and 
‘‘(ii) for purposes of use in preclinical 
research or in a clinical investigation pur-
suant to an investigational new drug ex-
emption under 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)); 
and 
‘‘(E) to transfer or sell any marijuana 
manufactured under this subsection only with 
prior, written consent for the transfer or sale by 
the Attorney General. 
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‘‘(6) TIMING.—Not later than 60 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 writ-
ten explanation of the basis for the denial. 
‘‘(7) DEEMED APPROVAL.—If the Attorney Gen-
eral fails to grant or deny a request for registration 
under this subsection to manufacture or distribute 
marijuana within the 60-day period referred to in 
paragraph (5), such request is deemed approved.’’. 
SEC. 4. TERMINATION OF INTERDISCIPLINARY REVIEW 
PROCESS FOR NON-NIH-FUNDED QUALIFIED 
MARIJUANA RESEARCHERS. 
The Secretary of Health and Human Services may 
not— 
(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 per-
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formed at the request of a qualified marijuana re-
searcher conducting nonhuman research that is not 
federally 
funded, 
in 
accordance 
with 
section 
303(f)(3)(A)(iii)(II) of the Controlled Substances Act, 
as added by section 2 of this Act. 
SEC. 5. CONSIDERATION OF RESULTS OF RESEARCH. 
Immediately upon the approval by the Food and Drug 
Administration of an application for a drug that contains 
marijuana 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 results 
of such review; and 
(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 re-
search, and any impacts of Federal restrictions and 
policy on research, marijuana should be transferred to 
a schedule other than schedule I (if marijuana has 
not been so transferred already). 
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SEC. 6. PRODUCTION QUOTAS FOR MARIJUANA GROWN FOR 
LEGITIMATE, SCIENTIFIC RESEARCH. 
Section 306 of the Controlled Substances Act (21 
U.S.C. 826) is amended by adding at the end the following: 
‘‘(j) 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 that meets the changing medical, scientific, and 
industrial needs for marijuana.’’. 
SEC. 7. 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 additional re-
strictions upon, research involving marijuana, or the man-
ufacture, distribution, or dispensing of marijuana, that is 
conducted in accordance with the Controlled Substances Act 
(21 U.S.C. 801 et seq.), this Act, and the amendments made 
by this Act. 
SEC. 8. DEFINITIONS. 
(a) QUALIFIED MARIJUANA RESEARCHER.—In this 
Act, the term ‘‘qualified marijuana researcher’’ has the 
meaning given the term in section 303(f)(3) of the Con-
trolled Substances Act, as added by section 2(d) of this Act. 
(b) UPDATING TERM.—Section 102(16) of the Con-
trolled Substances Act (21 U.S.C. 802(16)) is amended— 
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(1) in subparagraph (A), by striking ‘‘the term 
‘marihuana’ means’’ and inserting ‘‘the terms ‘mari-
huana’ and ‘marijuana’ mean’’; and 
(2) in subparagraph (B), by striking ‘‘The term 
‘marihuana’ does not’’ and inserting ‘‘The terms 
‘marihuana’ and ‘marijuana’ do not’’. 
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Union Calendar No. 508 
116TH CONGRESS 
2D SESSION 
H. R. 3797 
[Report No. 116–619, Part I] 
A BILL 
To amend the Controlled Substances Act to make 
marijuana accessible for use by qualified mari-
juana researchers for medical purposes, and for 
other purposes. 
DECEMBER 7, 2020 
Reported from the Committee on Energy and Commerce 
with an amendment 
DECEMBER 7, 2020 
Committee on the Judiciary discharged; committed to the 
Committee of the Whole House on the State of the 
Union and ordered to be printed 
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