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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5549 Introduced in House (IH)]

<DOC>

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 
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

_______________________________________________________________________

                                 A BILL

 
To amend the Controlled Substances Act to make marijuana accessible for 
use by qualified medical marijuana researchers, 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 of 
2016''.

SEC. 2. PRODUCTION AND SUPPLY.

    (a) In General.--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 for 
        qualified medical marijuana researchers, shall--
                    (A) continue to produce marijuana through the 
                National Institute on Drug Abuse (NIDA) Drug Supply 
                Program; and
                    (B) offer for sale immature marijuana plants and 
                the seeds of marijuana--
                            (i) to all qualified medical marijuana 
                        researchers who submit a request for such 
                        plants or seeds to engage in research pursuant 
                        to the section 303(f)(3) of the Controlled 
                        Substances Act, as amended by section 3; and
                            (ii) in quantities sufficient to produce an 
                        adequate supply of marijuana for such research; 
                        and
            (2) beyond the date specified in paragraph (1), may, at the 
        Secretary's discretion, continue 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, the Secretary of Health and Human Services shall--
            (1) require the person to submit documentation 
        demonstrating that the person is a qualified medical marijuana 
        researcher seeking to conduct research pursuant to the section 
        303(f)(3) of the Controlled Substances Act, as amended by 
        section 3; and
            (2) not later than 30 days after receipt of such 
        documentation, review such documentation and verify that the 
        marijuana will be used for such research.
    (c) Guidelines on Production.--The Commissioner of Food and Drugs, 
in consultation with the Director of the National Institute on Drug 
Abuse, shall--
            (1) not later than 180 days after the date of enactment of 
        this Act, issue guidelines on the production of marijuana by 
        qualified medical marijuana researchers pursuant to subsection 
        (a)(1)(B); and
            (2) encourage researchers and manufacturers that are 
        authorized to produce or manufacture marijuana pursuant to 
        section 303 of the Controlled Substances Act (21 U.S.C. 823), 
        as amended by this Act, to comply with such guidelines to the 
        extent applicable.
    (d) Definition.--In this section:
            (1) The term ``immature marijuana plant'' means a marijuana 
        plant with no observable flowers or buds.
            (2) The term ``qualified medical marijuana researcher'' 
        means a researcher who is registered to conduct research with 
        marijuana under section 303(f)(3) of the Controlled Substances 
        Act, as amended by section 3.

SEC. 3. FACILITATING MARIJUANA RESEARCH.

    (a) In General.--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--
                    ``(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 voluntarily submitted by the 
                applicant to, and approved by, the National Institutes 
                of Health; and
            ``(iii) the applicant has demonstrated that there are 
        effective procedures in place to adequately safeguard against 
        diversion of the marijuana from legitimate 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 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, Federal, 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 enactment of the 
Medical Marijuana Research Act of 2016, for purposes of subparagraph 
(A)(ii)(II), the National Institutes 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
            ``(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 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.
    ``(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 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.
    ``(F)(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--
            ``(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 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 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 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 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 RESEARCH.

    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.--
            ``(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 of 2016, the Attorney General 
        shall register 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 registration is inconsistent 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 therefrom 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 relating 
                        to the manufacture, distribution, or dispensing 
                        of such substances; and
                    ``(B) not take into consideration any factors other 
                than the factors listed in subparagraph (A).
            ``(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 of 2016, the Attorney General 
        shall register an applicant to distribute marijuana that is 
        intended to 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 
        registration is inconsistent 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 therefrom 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 relating 
                        to the manufacture, distribution, or dispensing 
                        of such substances; and
                            ``(iv) past experience in the distribution 
                        of controlled substances, and the existence in 
                        the establishment of effective controls against 
                        diversion; and
                    ``(B) not take into consideration any factors other 
                than the factors listed in subparagraph (A).
            ``(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, 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 will be used exclusively by 
                qualified medical 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 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) Definition.--For purposes of this subsection, the 
        term `qualified medical marijuana researcher' 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 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 
        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 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. 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 following:
    ``(i) 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 of 2016 that meets 
the changing medical, scientific, and industrial needs for 
marijuana.''.

SEC. 8. 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. 9. NO INTERFERENCE BY DEPARTMENT OF JUSTICE.

    The Attorney General of the United States, and any officer or 
employee of the Department of Justice, shall not interfere with the 
production, distribution, and sale of marijuana in accordance with this 
Act and the amendments made by this Act.

SEC. 10. DEFINITION.

    In this Act, the term ``marijuana'' has the meaning given to that 
term in section 102 of the Controlled Substances Act (21 U.S.C. 802).
                                 <all>
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