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

<DOC>





                                                 Union Calendar No. 508
116th CONGRESS
  2d Session
                                H. R. 3797

                      [Report No. 116-619, Part I]

To amend the Controlled Substances Act to make marijuana accessible for 
 use by qualified marijuana researchers for medical purposes, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 17, 2019

Mr. Blumenauer (for himself, Mr. Harris, Ms. Lofgren, Mr. Griffith, Mr. 
Bishop of Utah, and Mrs. Dingell) 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

                            December 7, 2020

    Additional sponsors: Mr. Gaetz, Mrs. Rodgers of Washington, Mr. 
 Stewart, Ms. Norton, Ms. Titus, Ms. Lee of California, Mr. Grijalva, 
   Mr. Correa, Mrs. Hartzler, Mr. Walden, Mr. Smucker, Mr. Carter of 
Georgia, Ms. Blunt Rochester, Mr. Curtis, Mr. Steil, and Mr. Casten of 
                                Illinois

                            December 7, 2020

  Reported from the Committee on Energy and Commerce with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

                            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
 [For text of introduced bill, see copy of bill as introduced on July 
                               17, 2019]


_______________________________________________________________________

                                 A BILL


 
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 medical 
        research for 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; and
                    (B) offer to qualified marijuana researchers 
                marijuana products available through State authorized 
                marijuana programs that are consistent with the 
                guidance issued under subsection (c); and
            (2) beyond the date specified in paragraph (1), may, at the 
        Secretary's discretion, continue through grants, contracts, or 
        cooperative agreements, to so produce and supply marijuana.
    (b) Requirement to Verify Registration.--Before supplying marijuana 
to any person through the National Institute on Drug Abuse Drug Supply 
Program or from State authorized marijuana programs, 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 (e) of this section; 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).
    (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 
the use of marijuana from State authorized marijuana programs, 
including necessary quality or production standards for marijuana 
intended for use in medical research.
    (d) Compliance With Guidance.--The Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, shall 
ensure that a qualified marijuana researcher is in compliance with 
guidance issued by the Food and Drug Administration related to 
botanical drug development.
    (e) 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 a practitioner to 
conduct research with marijuana if--
            ``(i) the applicant is authorized to dispense, or conduct 
        research with respect to, controlled substances in schedules 
        II, III, IV, and V under the laws of the State in which the 
        applicant practices;
            ``(ii) the applicant's research protocol has been reviewed 
        and approved by the Secretary under section 505(i) of the 
        Federal Food, Drug, and Cosmetic Act; and
            ``(iii) the Secretary has determined the applicant is 
        qualified to conduct bona fide research.
A practitioner so registered shall be referred to in this Act as a 
`qualified marijuana researcher'.
    ``(B)(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.
    ``(C) 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.
    ``(D)(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 practitioners conducting research 
with marijuana pursuant to a registration under this paragraph shall be 
consistent with the security 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 reapplying 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 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 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.
    ``(F) 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 (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 involved in 
        research.''.

SEC. 3. MANUFACTURE AND DISTRIBUTION OF MARIJUANA FOR USE IN 
              LEGITIMATE, MEDICAL 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, Medical Research.--
            ``(1) Registration of manufacturers.--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 manufacture 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), 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--
                    ``(A) maintenance of effective controls against 
                diversion of marijuana and any controlled substance 
                compounded therefrom into other than legitimate 
                medical, scientific, or research channels;
                    ``(B) compliance with applicable State and local 
                laws relating to controlled substance misuse and 
                diversion; and
                    ``(C) prior conviction record of the applicant 
                under Federal or State laws relating to the 
                manufacture, distribution, or dispensing of such 
                substances.
            ``(2) Registration of distributors.--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), 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
                    ``(B) past experience in the distribution of 
                controlled substances, and the existence of effective 
                controls against diversion.
            ``(4) 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).
            ``(5) Requirement to verify use for legitimate, medical 
        research.--As a condition on 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);
                    ``(B) in the case of distribution, to complete, 
                with respect to that distribution, the DEA Controlled 
                substance order form in accordance with section 308 and 
                to upload such forms to the system used by the Drug 
                Enforcement Agency 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 manufactured under this subsection--
                            ``(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 
                        pursuant to an investigational new drug 
                        exemption 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.
            ``(6) 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.
            ``(7) 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)(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 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''.
                                                 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 marijuana 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