[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3797 Referred in Senate (RFS)]
<DOC>
116th CONGRESS
2d Session
H. R. 3797
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 10, 2020
Received
December 18, 2020
Read twice and referred to the Committee on the Judiciary
_______________________________________________________________________
AN ACT
To amend the Controlled Substances Act to make marijuana accessible for
use by qualified marijuana researchers for medical purposes, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medical Marijuana Research Act''.
SEC. 2. FACILITATING MARIJUANA RESEARCH.
(a) Production and Supply.--The Secretary of Health and Human
Services--
(1) until the date on which the Secretary determines that
manufacturers and distributors (other than the Federal
Government) can ensure a sufficient supply of marijuana (as
defined in section 102 of the Controlled Substances Act (21
U.S.C. 802), as amended by section 8) intended for research by
qualified marijuana researchers registered pursuant to
paragraph (3) of section 303(f) of the Controlled Substances
Act (21 U.S.C. 823(f)), as added by section 3, shall--
(A) continue, through grants, contracts, or
cooperative agreements, to produce marijuana through
the National Institute on Drug Abuse Drug Supply
Program;
(B) not later than one year after the date of
enactment of this Act, act jointly with the Attorney
General of the United States to establish and implement
a specialized process for manufacturers and
distributors, notwithstanding the registration
requirements of section 303 of such Act (21 U.S.C.
823), to supply qualified marijuana researchers with
marijuana products--
(i) available through State-authorized
marijuana programs; and
(ii) consistent with the guidance issued
under subsection (c); and
(C) not later than 60 days after the date of
enactment of this Act, jointly convene with the
Attorney General a meeting to initiate the development
of the specialized process described in subparagraph
(B); and
(2) beyond the date specified in paragraph (1), may, at the
Secretary's discretion, continue--
(A) through grants, contracts, or cooperative
agreements, to so produce marijuana; and
(B) to implement such specialized process.
(b) Requirement to Verify Registration.--Before supplying marijuana
to any person through the National Institute on Drug Abuse Drug Supply
Program or through implementation of the specialized process
established under subsection (a)(1)(B), the Secretary of Health and
Human Services shall--
(1) require the person to submit documentation
demonstrating that the person is a qualified marijuana
researcher seeking to conduct research pursuant to section
303(f)(3) of the Controlled Substances Act, as added by
subsection (d) of this section, or a manufacturer duly
registered under section 303(l) of the Controlled Substances
Act, as added by section 3 of this Act; and
(2) not later than 60 days after receipt of such
documentation, review such documentation and verify that the
marijuana will be used for such research (and for no other
purpose authorized pursuant to this Act or the amendments made
by this Act).
(c) Guidance on Use of State-authorized Marijuana Programs.--Not
later than 180 days after the date of the enactment of this Act, the
Secretary of Health and Human Services shall issue guidance related to
marijuana from State-authorized marijuana programs for research.
(d) Research.--Section 303(f) of the Controlled Substances Act (21
U.S.C. 823(f)) is amended--
(1) by redesignating paragraphs (1) through (5) as
subparagraphs (A) through (E), respectively;
(2) by striking ``(f) The Attorney General'' and inserting
``(f)(1) The Attorney General'';
(3) by striking ``Registration applications'' and inserting
the following:
``(2) Registration applications'';
(4) in paragraph (2), as so designated, by striking
``schedule I'' each place that term appears and inserting
``schedule I, except marijuana,'';
(5) by striking ``Article 7'' and inserting the following:
``(4) Article 7''; and
(6) by inserting before paragraph (4), as so designated,
the following:
``(3)(A) The Attorney General shall register the applicant to
conduct research with marijuana if--
``(i) the applicant is authorized to dispense, or conduct
research with respect to, controlled substances in schedule I,
II, III, IV, or V;
``(ii) the applicant is compliant with, and authorized to
conduct the activities described in clause (i) under, the laws
of the State in which the applicant practices; and
``(iii) in the case of an applicant pursuing clinical
research, the applicant's clinical research protocol has been
reviewed and authorized to proceed by the Secretary under
section 505(i) of the Federal Food, Drug, and Cosmetic Act.
``(B) An applicant registered under subparagraph (A) shall be
referred to in this section as a `qualified marijuana researcher'.
``(C)(i) Not later than 60 days after the date on which the
Attorney General receives a complete application 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 subparagraph (A) are satisfied.
``(iii) In the case of a denial under clause (i), the Attorney
General shall provide a written explanation of the basis for the
denial.
``(D) 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 determining the public interest, the
following factors shall be considered:
``(i) The applicant's experience in dispensing, or
conducting research with respect to, controlled substances.
``(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 or local laws
relating to controlled substance misuse or diversion.
``(iv) Such other conduct which may threaten the public
health and safety.
``(E)(i) A qualified marijuana researcher 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 applicants conducting research
with marijuana pursuant to a registration under this paragraph shall be
consistent with the security measures for applicants conducting
research 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 and proceed with the research under
such amended or supplemented protocol, without additional review or
approval by the Attorney General or the Secretary of Health and Human
Services if the applicant does not change the type of marijuana, 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 research 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 notice to the Attorney General of the amended or
supplemented research protocol or any new research protocol in the
applicant's renewal materials.
``(iii)(I) If an applicant amends or supplements a research
protocol and the amendment or supplement involves a change to the type
of marijuana, the source of the marijuana, or conditions under which
the marijuana is stored, tracked, or administered, 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 supplemental 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.
``(G) If 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 (F) of this paragraph.
``(H) 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 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 involved in
research.''.
SEC. 3. MANUFACTURE AND DISTRIBUTION OF MARIJUANA FOR USE IN LEGITIMATE
RESEARCH.
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 Research.--
``(1) Registration of manufacturers.--
``(A) In general.--Beginning not later than the day
that is 1 year after the date of enactment of the
Medical Marijuana Research Act, the Attorney General,
pursuant to subsection (f)(3) and subject to
subparagraph (B) of this paragraph, shall register an
applicant to manufacture marijuana (including any
derivative, extract, preparation, and compound thereof)
that is intended for--
``(i) the ultimate and exclusive use by
qualified marijuana researchers for research
pursuant to subsection (f)(3); or
``(ii) subsequent downstream manufacture by
a duly registered manufacturer for the ultimate
and exclusive use by qualified marijuana
researchers for research pursuant to subsection
(f)(3).
``(B) Public interest.--The Attorney General shall
register an applicant under subparagraph (A) unless the
Attorney General determines that the issuance of such
registration is inconsistent with the public interest.
In determining the public interest, the Attorney
General shall take into consideration--
``(i) maintenance of effective controls
against diversion of marijuana and any
controlled substance compounded therefrom into
other than legitimate medical, scientific, or
research channels;
``(ii) compliance with applicable State and
local laws relating to controlled substance
misuse and diversion;
``(iii) prior conviction record of the
applicant under Federal or State laws relating
to the manufacture, distribution, or dispensing
of such substances; and
``(iv) such other conduct which may
threaten the public health and safety.
``(2) Registration of distributors.--
``(A) In general.--Beginning 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, 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) or intended for
subsequent downstream manufacture by a duly registered
manufacturer for use by qualified marijuana researchers
for research pursuant to such subsection, unless the
Attorney General determines that the issuance of such
registration is inconsistent with the public interest.
``(B) Public interest.--In determining the public
interest under subparagraph (A), the Attorney General
shall take into consideration--
``(i) the factors specified in clauses (i),
(ii), (iii), and (iv) of paragraph (1)(B); and
``(ii) past experience in the distribution
of controlled substances, and the existence of
effective controls against diversion.
``(3) No limit on number of manufacturers 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 legitimate research.--
As a condition of registration under this section to
manufacture or distribute marijuana, the Attorney General shall
require the registrant--
``(A) to require any person to whom the marijuana
will be supplied to submit documentation 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) or for
subsequent downstream manufacture by a duly registered
manufacturer for use by qualified marijuana researchers
for research pursuant to such subsection;
``(B) in the case of distribution, to complete,
with respect to that distribution, the appropriate
order form in accordance with section 308 and to upload
such forms to the system used by the Drug Enforcement
Administration for such distribution;
``(C) to include in the labeling of any marijuana
so manufactured or distributed--
``(i) the following statement: `This
material is for biomedical and scientific
research purposes only.'; and
``(ii) the name of the requestor of the
marijuana;
``(D) to limit the transfer and sale of any
marijuana under this subsection--
``(i) to researchers who are registered
under this Act to conduct research with
marijuana or to manufacturers duly registered
under this subsection; and
``(ii) for purposes of use in preclinical
research or in a clinical investigation
pursuant to an investigational new drug
exemption under 505(i) of the Federal Food,
Drug, and Cosmetic Act or for the purposes of
further manufacturing of marijuana; 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.
``(5) Timing.--Not later than 60 days after receipt of a
request for registration under this subsection 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) Deemed approval.--If the Attorney General 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 interdisciplinary
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 protocols
that is only conducted for research on marijuana other than the
review of research protocols performed at the request of a
qualified marijuana researcher conducting nonhuman research
that is not federally funded, in accordance with section
303(f)(3)(A) 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 (as defined in
section 102 of the Controlled Substances Act (21 U.S.C. 802), as
amended by section 8 of this Act) 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 research, 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).
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 distributed in
accordance with the Medical Marijuana Research Act that meets the
changing medical, scientific, and industrial needs for marijuana.''.
SEC. 7. ARTICLE 28 OF THE SINGLE CONVENTION ON NARCOTIC DRUGS.
Article 28 of the Single Convention on Narcotic Drugs shall not be
construed to prohibit, or impose additional restrictions upon, research
involving marijuana, or the manufacture, 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 Controlled Substances Act, as added by section
2(d) of this Act.
(b) Updating Term.--Section 102(16) of the Controlled Substances
Act (21 U.S.C. 802(16)) is amended--
(1) in subparagraph (A), by striking ``the term `marihuana'
means'' and inserting ``the terms `marihuana' and `marijuana'
mean''; and
(2) in subparagraph (B), by striking ``The term `marihuana'
does not'' and inserting ``The terms `marihuana' and
`marijuana' do not''.
SEC. 9. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of complying
with the Statutory Pay-As-You-Go Act of 2010, shall be determined by
reference to the latest statement titled ``Budgetary Effects of PAYGO
Legislation'' for this Act, submitted for printing in the Congressional
Record by the Chairman of the House Budget Committee, provided that
such statement has been submitted prior to the vote on passage.
Passed the House of Representatives December 9, 2020.
Attest:
CHERYL L. JOHNSON,
Clerk.
Medical Marijuana Research Act
#3797 | HR Congress #116
Policy Area: Health
Subjects: Administrative law and regulatory proceduresAlternative treatmentsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyDrug trafficking and controlled substancesFood and Drug Administration (FDA)Health personnelLicensing and registrationsMedical researchResearch administration and funding
Last Action: Read twice and referred to the Committee on the Judiciary. (12/18/2020)
Bill Text Source: Congress.gov
Summary and Impacts
Original Text