[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3797 Engrossed in House (EH)]

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116th CONGRESS
  2d Session
                                H. R. 3797

_______________________________________________________________________

                                 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:

                                                                 Clerk.
116th CONGRESS

  2d Session

                               H. R. 3797

_______________________________________________________________________

                                 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.