Medical Marijuana and Cannabidiol Research Expansion Act
Bill: H.R.8454 | Sponsor: Rep. Blumenauer, Earl (D-OR)
Policy area: Crime and Law Enforcement

Summary:
Medical Marijuana and Cannabidiol Research Expansion Act
This act establishes a new, separate registration process to facilitate research on marijuana.
Specifically, the act directs the Drug Enforcement Administration (DEA) to follow procedures specified in the act to register (1) practitioners to conduct marijuana research, and (2) manufacturers to supply marijuana for the research.
The act allows certain registered entities (including institutions of higher education, practitioners, and manufacturers) to manufacture, distribute, dispense, or possess marijuana or cannabidiol (CBD) for the purposes of medical research. Additionally, the act directs the DEA to register manufacturers and distributors of CBD or marijuana for the purpose of commercial production of an approved drug that contains marijuana or its derivative.
Finally, the act includes various other provisions, including provisions that

[117th Congress Public Law 215]
[From the U.S. Government Publishing Office]



[[Page 136 STAT. 2257]]

Public Law 117-215
117th Congress

                                 An Act


 
     To expand research on cannabidiol and marijuana, and for other 
            purposes. <<NOTE: Dec. 2, 2022 -  [H.R. 8454]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Medical 
Marijuana and Cannabidiol Research Expansion Act.>> 
SECTION 1. <<NOTE: 21 USC 801 note.>>  SHORT TITLE; TABLE OF 
                              CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Medical Marijuana 
and Cannabidiol Research Expansion Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Determination of budgetary effects.

              TITLE I--REGISTRATIONS FOR MARIJUANA RESEARCH

Sec. 101. Marijuana research applications.
Sec. 102. Research protocols.
Sec. 103. Applications to manufacture marijuana for research.
Sec. 104. Adequate and uninterrupted supply.
Sec. 105. Security requirements.
Sec. 106. Prohibition against reinstating interdisciplinary review 
           process for non-NIH-funded researchers.

   TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND 
                                MARIJUANA

Sec. 201. Medical research on cannabidiol.
Sec. 202. Registration for the commercial production and distribution of 
           Food and Drug Administration-approved drugs.

                 TITLE III--DOCTOR-PATIENT RELATIONSHIP

Sec. 301. Doctor-patient relationship.

                       TITLE IV--FEDERAL RESEARCH

Sec. 401. Federal research.

SEC. 2. DEFINITIONS.

    (a) <<NOTE: 21 USC 801 note.>>  In General.--In this Act--
            (1) the term ``appropriately registered'' means that an 
        individual or entity is registered under the Controlled 
        Substances Act (21 U.S.C. 801 et seq.) to engage in the type of 
        activity that is carried out by the individual or entity with 
        respect to a controlled substance on the schedule that is 
        applicable to cannabidiol or marijuana, as applicable;
            (2) the term ``cannabidiol'' means--
                    (A) the substance, cannabidiol, as derived from 
                marijuana that has a delta-9-tetrahydrocannabinol level 
                that is greater than 0.3 percent; and
                    (B) the synthetic equivalent of the substance 
                described in subparagraph (A);

[[Page 136 STAT. 2258]]

            (3) the terms ``controlled substance'', ``dispense'', 
        ``distribute'', ``manufacture'', ``marijuana'', and 
        ``practitioner'' have the meanings given such terms in section 
        102 of the Controlled Substances Act (21 U.S.C. 802), as amended 
        by this Act;
            (4) the term ``covered institution of higher education'' 
        means an institution of higher education (as defined in section 
        101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) that--
                    (A)(i) has highest or higher research activity, as 
                defined by the Carnegie Classification of Institutions 
                of Higher Education; or
                    (ii) is an accredited medical school or an 
                accredited school of osteopathic medicine; and
                    (B) is appropriately registered under the Controlled 
                Substances Act (21 U.S.C. 801 et seq.);
            (5) the term ``drug'' has the meaning given the term in 
        section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321(g)(1));
            (6) the term ``medical research for drug development'' means 
        medical research that is--
                    (A) a preclinical study or clinical investigation 
                conducted in accordance with section 505(i) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) 
                or otherwise permitted by the Department of Health and 
                Human Services to determine the potential medical 
                benefits of marijuana or cannabidiol as a drug; and
                    (B) conducted by a covered institution of higher 
                education, practitioner, or manufacturer that is 
                appropriately registered under the Controlled Substances 
                Act (21 U.S.C. 801 et seq.); and
            (7) the term ``State'' means any State of the United States, 
        the District of Columbia, and any territory of the United 
        States.

    (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. 3. 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.

              TITLE I--REGISTRATIONS FOR MARIJUANA RESEARCH

SEC. 101. MARIJUANA RESEARCH APPLICATIONS.

    Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) 
is amended--

[[Page 136 STAT. 2259]]

            (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)(A) Registration applications'';
            (4) by striking ``Article 7'' and inserting the following:

    ``(3) Article 7''; and
            (5) by inserting after paragraph (2)(A), as so designated, 
        the following:

    ``(B)(i) The Attorney General shall register a practitioner to 
conduct research with marijuana (including any derivative, extract, 
preparation, and compound thereof) if--
            ``(I) the applicant's research protocol has been reviewed 
        and allowed--
                    ``(aa) by the Secretary of Health and Human Services 
                under section 505(i) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(i));
                    ``(bb) by the National Institutes of Health or 
                another Federal agency that funds scientific research; 
                or
                    ``(cc) pursuant to sections 1301.18 and 1301.32 of 
                title 21, Code of Federal Regulations, or any successors 
                thereto; and
            ``(II) the applicant has demonstrated to the Attorney 
        General that there are effective procedures in place to 
        adequately safeguard against diversion of the controlled 
        substance for legitimate medical or scientific use pursuant to 
        section 105 of the Medical Marijuana and Cannabidiol Research 
        Expansion Act, including demonstrating that the security 
        measures are adequate for storing the quantity of marijuana the 
        applicant would be authorized to possess.

    ``(ii) <<NOTE: Determination.>>  The Attorney General may deny an 
application for registration under this subparagraph only if the 
Attorney General determines that the issuance of the registration would 
be inconsistent with the public interest. In determining the public 
interest, the Attorney General shall consider the factors listed in--
            ``(I) subparagraphs (B) through (E) of paragraph (1); and
            ``(II) subparagraph (A) of paragraph (1), if the applicable 
        State requires practitioners conducting research to register 
        with a board or authority described in such subparagraph (A).

    ``(iii)(I) <<NOTE: Deadline.>>  Not later than 60 days after the 
date on which the Attorney General receives a complete application for 
registration under this subparagraph, the Attorney General shall--
            ``(aa) approve the application; or
            ``(bb) request supplemental information.

    ``(II) For purposes of subclause (I), an application shall be deemed 
complete when the applicant has submitted documentation showing that the 
requirements under clause (i) are satisfied.
    ``(iv) <<NOTE: Deadline.>>  Not later than 30 days after the date on 
which the Attorney General receives supplemental information as 
described in clause (iii)(I)(bb) in connection with an application 
described in this subparagraph, the Attorney General shall approve or 
deny the application.

    ``(v) If an application described in this subparagraph is denied, 
the Attorney General shall provide a written explanation of the basis of 
denial to the applicant.''.

[[Page 136 STAT. 2260]]

SEC. 102. RESEARCH PROTOCOLS.

    (a) In General.--Paragraph (2)(B) of section 303(f) of the 
Controlled Substances Act (21 U.S.C. 823(f)), as added by section 101 of 
this Act, is further amended by adding at the end the following:
    ``(vi)(I) <<NOTE: Notifications. Deadlines.>>  If the Attorney 
General grants an application for registration under clause (i), the 
registrant may amend or supplement the research protocol without 
notification to, or review by, the Drug Enforcement Administration if 
the registrant does not change--
            ``(aa) the quantity or type of marijuana or cannabidiol 
        (including any derivative, extract, preparation, and compound 
        thereof);
            ``(bb) the source of such marijuana or cannabidiol; or
            ``(cc) the conditions under which such marijuana or 
        cannabidiol is stored, tracked, or administered.

    ``(II)(aa) If a registrant under clause (i) seeks to change the type 
of marijuana or cannabidiol (including any derivative, extract, 
preparation, and compound thereof), the source of such marijuana or 
cannabidiol, or the conditions under which such marijuana or cannabidiol 
is stored, tracked, or administered, the registrant shall notify the 
Attorney General via registered mail, or an electronic means permitted 
by the Attorney General, not later than 30 days before implementing an 
amended or supplemental research protocol.
    ``(bb) <<NOTE: Effective date.>>  A registrant may proceed with an 
amended or supplemental research protocol described in item (aa) if the 
Attorney General does not explicitly object during the 30-day period 
beginning on the date on which the Attorney General receives the notice 
under item (aa).

    ``(cc) The Attorney General may only object to an amended or 
supplemental research protocol under this subclause if additional 
security measures are needed to safeguard against diversion or abuse.
    ``(dd) If a registrant under clause (i) seeks to address additional 
security measures identified by the Attorney General under item (cc), 
the registrant shall notify the Attorney General via registered mail, or 
an electronic means permitted by the Attorney General, not later than 30 
days before implementing an amended or supplemental research protocol.
    ``(ee) <<NOTE: Effective date.>>  A registrant may proceed with an 
amended or supplemental research protocol described in item (dd) if the 
Attorney General does not explicitly object during the 30-day period 
beginning on the date on which the Attorney General receives the notice 
under item (dd).

    ``(III)(aa) If a registrant under clause (i) seeks to change the 
quantity of marijuana needed for research and the change in quantity 
does not impact the factors described in item (bb) or (cc) of subclause 
(I) of this clause, the registrant shall notify the Attorney General via 
registered mail or using an electronic means permitted by the Attorney 
General.
    ``(bb) A notification under item (aa) shall include--
            ``(AA) the Drug Enforcement Administration registration 
        number of the registrant;
            ``(BB) the quantity of marijuana or cannabidiol already 
        obtained;
            ``(CC) the quantity of additional marijuana or cannabidiol 
        needed to complete the research; and

[[Page 136 STAT. 2261]]

            ``(DD) <<NOTE: Attestation.>>  an attestation that the 
        change in quantity does not impact the source of the marijuana 
        or cannabidiol or the conditions under which the marijuana or 
        cannabidiol is stored, tracked, or administered.

    ``(cc) The Attorney General shall ensure that--
            ``(AA) any registered mail return receipt with respect to a 
        notification under item (aa) is submitted for delivery to the 
        registrant providing the notification not later than 3 days 
        after receipt of the notification by the Attorney General; and
            ``(BB) notice of receipt of a notification using an 
        electronic means permitted under item (aa) is provided to the 
        registrant providing the notification not later than 3 days 
        after receipt of the notification by the Attorney General.

    ``(dd)(AA) <<NOTE: Effective date.>>  On and after the date 
described in subitem (BB), a registrant that submits a notification in 
accordance with item (aa) may proceed with the research as if the change 
in quantity has been approved on such date, unless the Attorney General 
notifies the registrant of an objection described in item (ee).

    ``(BB) The date described in this subitem is the date on which a 
registrant submitting a notification under item (aa) receives the 
registered mail return receipt with respect to the notification or the 
date on which the registrant receives notice that the notification using 
an electronic means permitted under item (aa) was received by the 
Attorney General, as the case may be.
    ``(ee) A notification submitted under item (aa) shall be deemed to 
be approved unless the Attorney General, not later than 10 days after 
receiving the notification, explicitly objects based on a finding that 
the change in quantity--
            ``(AA) does impact the source of the marijuana or 
        cannabidiol or the conditions under which the marijuana or 
        cannabidiol is stored, tracked, or administered; or
            ``(BB) necessitates that the registrant implement additional 
        security measures to safeguard against diversion or abuse.

    ``(IV) Nothing in this clause shall limit the authority of the 
Secretary of Health and Human Services over requirements related to 
research protocols, including changes in--
            ``(aa) the method of administration of marijuana or 
        cannabidiol;
            ``(bb) the dosing of marijuana or cannabidiol; and
            ``(cc) the number of individuals or patients involved in 
        research.''.

    (b) <<NOTE: 21 USC 823 note.>>  Regulations.--Not later than 1 year 
after the date of enactment of this Act, the Attorney General shall 
promulgate regulations to carry out the amendment made by this section.
SEC. 103. APPLICATIONS TO MANUFACTURE MARIJUANA FOR RESEARCH.

    (a) In General.--Section 303 of the Controlled Substances Act (21 
U.S.C. 823), as amended by sections 101 and 102 of this Act, is further 
amended--
            (1) by redesignating subsections (c) through (k) as 
        subsections (d) through (l), respectively;
            (2) by inserting after subsection (b) the following:

    ``(c)(1)(A) <<NOTE: Notice. Federal 
Register, publication. Deadline.>>  As it relates to applications to 
manufacture marijuana for research purposes, when the Attorney General 
places a notice in the Federal Register to increase the number of 
entities registered under this Act to manufacture marijuana to supply 
appropriately

[[Page 136 STAT. 2262]]

registered researchers in the United States, the Attorney General shall, 
not later than 60 days after the date on which the Attorney General 
receives a completed application--
            ``(i) approve the application; or
            ``(ii) request supplemental information.

    ``(B) For purposes of subparagraph (A), an application shall be 
deemed complete when the applicant has submitted documentation showing 
each of the following:
            ``(i) The requirements designated in the notice in the 
        Federal Register are satisfied.
            ``(ii) The requirements under this Act are satisfied.
            ``(iii) The applicant will 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 controlled substances in 
                schedule I; 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)).
            ``(iv) The applicant will transfer or sell any marijuana 
        manufactured under this subsection only with prior, written 
        consent for the transfer or sale by the Attorney General.
            ``(v) The applicant has completed the application and review 
        process under subsection (a) for the bulk manufacture of 
        controlled substances in schedule I.
            ``(vi) The applicant has established and begun operation of 
        a process for storage and handling of controlled substances in 
        schedule I, including for inventory control and monitoring 
        security in accordance with section 105 of the Medical Marijuana 
        and Cannabidiol Research Expansion Act.
            ``(vii) The applicant is licensed by each State in which the 
        applicant will conduct operations under this subsection, to 
        manufacture marijuana, if that State requires such a license.

    ``(C) <<NOTE: Deadline.>>  Not later than 30 days after the date on 
which the Attorney General receives supplemental information requested 
under subparagraph (A)(ii) with respect to an application, the Attorney 
General shall approve or deny the application.

    ``(2) If an application described in this subsection is denied, the 
Attorney General shall provide a written explanation of the basis of 
denial to the applicant.'';
            (3) in subsection (h)(2), as so redesignated, by striking 
        ``subsection (f)'' each place it appears and inserting 
        ``subsection (g)'';
            (4) in subsection (j)(1), as so redesignated, by striking 
        ``subsection (d)'' and inserting ``subsection (e)''; and
            (5) in subsection (k), as so redesignated, by striking 
        ``subsection (f)'' each place it appears and inserting 
        ``subsection (g)''.

    (b) Technical and Conforming Amendments.--
            (1) The Controlled Substances Act (21 U.S.C. 801 et seq.) is 
        amended--
                    (A) in section 102 (21 U.S.C. 802)--
                          (i) in paragraph (52)(B)--
                                    (I) by striking ``303(f)'' each 
                                place it appears and inserting 
                                ``303(g)''; and

[[Page 136 STAT. 2263]]

                                    (II) in clause (i), by striking 
                                ``(d), or (e)'' and inserting ``(e), or 
                                (f)''; and
                          (ii) in paragraph (54), by striking ``303(f)'' 
                      each place it appears and inserting ``303(g)'';
                    (B) in section 302(g)(5)(A)(iii)(I)(bb) (21 U.S.C. 
                822(g)(5)(A)(iii)(I)(bb)), by striking ``303(f)'' and 
                inserting ``303(g)'';
                    (C) in section 304 (21 U.S.C. 824), by striking 
                ``303(g)(1)'' each place it appears and inserting 
                ``303(h)(1)'';
                    (D) in section 307(d)(2) (21 U.S.C. 827(d)(2)), by 
                striking ``303(f)'' and inserting ``303(g)'';
                    (E) in section 309A(a)(2) (21 U.S.C. 829a(a)(2)), in 
                the matter preceding subparagraph (A), by striking 
                ``303(g)(2)'' and inserting ``303(h)(2)'';
                    (F) in section 311(h) (21 U.S.C. 831(h)), by 
                striking ``303(f)'' each place it appears and inserting 
                ``303(g)'';
                    (G) in section 401(h)(2) (21 U.S.C. 841(h)(2)), by 
                striking ``303(f)'' each place it appears and inserting 
                ``303(g)'';
                    (H) in section 403(c)(2)(B) (21 U.S.C. 
                843(c)(2)(B)), by striking ``303(f)'' and inserting 
                ``303(g)''; and
                    (I) in section 512(c)(1) (21 U.S.C. 882(c)(1)) by 
                striking ``303(f)'' and inserting ``303(g)''.
            (2) Section 1008(c) of the Controlled Substances Import and 
        Export Act (21 U.S.C. 958(c)) is amended--
                    (A) in paragraph (1), by striking ``303(d)'' and 
                inserting ``303(e)''; and
                    (B) in paragraph (2)(B), by striking ``303(h)'' and 
                inserting ``303(i)''.
            (3) Title V of the Public Health Service Act (42 U.S.C. 
        290aa et seq.) is amended--
                    (A) in section 520E-4(c) (42 U.S.C. 290bb-36d(c)), 
                by striking ``303(g)(2)(B)'' and inserting 
                ``303(h)(2)(B)''; and
                    (B) in section 544(a)(3) (42 U.S.C. 290dd-3(a)(3)), 
                by striking ``303(g)'' and inserting ``303(h)''.
            (4) Title XVIII of the Social Security Act (42 U.S.C. 1395 
        et seq.) is amended--
                    (A) in section 1833(bb)(3)(B) (42 U.S.C. 
                1395l(bb)(3)(B)), by striking ``303(g)'' and inserting 
                ``303(h)'';
                    (B) in section 1834(o)(3)(C)(ii) (42 U.S.C. 
                1395m(o)(3)(C)(ii)), by striking ``303(g)'' and 
                inserting ``303(h)''; and
                    (C) in section 1866F(c)(3)(C) (42 U.S.C. 1395cc-
                6(c)(3)(C)), by striking ``303(g)'' and inserting 
                ``303(h)''.
            (5) Section 1903(aa)(2)(C)(ii) of the Social Security Act 
        (42 U.S.C. 1396b(aa)(2)(C)(ii)) is amended by striking 
        ``303(g)'' each place it appears and inserting ``303(h)''.
SEC. 104. <<NOTE: 21 USC 823 note.>>  ADEQUATE AND UNINTERRUPTED 
                        SUPPLY.

    (a) <<NOTE: Deadline. Assessment.>>  In General.--On an annual 
basis, the Attorney General, in consultation with the Secretary of 
Health and Human Services, shall assess whether there is an adequate and 
uninterrupted supply of marijuana, including of specific strains, for 
research purposes.

    (b) <<NOTE: Determination.>>  Report to Congress.--If the Attorney 
General, in consultation with the Secretary of Health and Human 
Services, determines there is an inadequate or interrupted supply of 
marijuana, including of specific strains for research purposes, the 
Attorney General shall

[[Page 136 STAT. 2264]]

report to Congress within 60 days of the determination on at least--
            (1) the factors contributing to the inadequate or 
        interrupted supply of marijuana;
            (2) expected impacts of the inadequate or interrupted supply 
        on ongoing research protocols; and
            (3) specific steps the Attorney General will take to restore 
        an adequate and uninterrupted supply of marijuana, including of 
        specific strains, for research purposes.
SEC. 105. <<NOTE: 21 USC 823 note.>>  SECURITY REQUIREMENTS.

    (a) In General.--An individual or entity engaged in researching 
marijuana or its components shall store it in a securely locked, 
substantially constructed cabinet.
    (b) Requirements for Other Measures.--Any other security measures 
required by the Attorney General to safeguard against diversion shall be 
consistent with those required for practitioners conducting research on 
other controlled substances in schedules I and II in section 202(c) of 
the Controlled Substances Act (21 U.S.C. 812(c)) that have a similar 
risk of diversion and abuse.
SEC. 106. <<NOTE: 42 USC 241 note.>>  PROHIBITION AGAINST 
                        REINSTATING 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) require another review of scientific protocols that is 
        applicable only to research on marijuana or its components.

   TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND 
                                MARIJUANA

SEC. 201. <<NOTE: 21 USC 823 note.>>  MEDICAL RESEARCH ON 
                        CANNABIDIOL.

    Notwithstanding any provision of the Controlled Substances Act (21 
U.S.C. 801 et seq.), the Safe and Drug-Free Schools and Communities Act 
(20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code, or 
any other Federal law, an appropriately registered covered institution 
of higher education, practitioner, or manufacturer may manufacture, 
distribute, dispense, or possess marijuana or cannabidiol if the 
marijuana or cannabidiol is manufactured, distributed, dispensed, or 
possessed, respectively, for purposes of medical research for drug 
development or subsequent commercial production in accordance with 
section 202.
SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUCTION AND 
                        DISTRIBUTION OF FOOD AND DRUG 
                        ADMINISTRATION-APPROVED DRUGS.

    The Attorney General shall register an applicant to manufacture or 
distribute cannabidiol or marijuana for the purpose of commercial 
production of a drug containing or derived from marijuana that is 
approved by the Secretary of Health and Human Services under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in 
accordance with the applicable requirements

[[Page 136 STAT. 2265]]

under subsection (a) or (b) of section 303 of the Controlled Substances 
Act (21 U.S.C. 823).

                 TITLE III--DOCTOR-PATIENT RELATIONSHIP

SEC. 301. <<NOTE: 21 USC 801 note.>>  DOCTOR-PATIENT RELATIONSHIP.

    It shall not be a violation of the Controlled Substances Act (21 
U.S.C. 801 et seq.) for a State-licensed physician to discuss--
            (1) the currently known potential harms and benefits of 
        marijuana derivatives, including cannabidiol, as a treatment 
        with the legal guardian of the patient of the physician if the 
        patient is a child; or
            (2) the currently known potential harms and benefits of 
        marijuana and marijuana derivatives, including cannabidiol, as a 
        treatment with the patient or the legal guardian of the patient 
        of the physician if the patient is a legal adult.

                       TITLE IV--FEDERAL RESEARCH

SEC. 401. <<NOTE: 42 USC 284 note.>>  FEDERAL RESEARCH.

    (a) <<NOTE: Reports.>>  In General.--Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and Human 
Services, in coordination with the Director of the National Institutes 
of Health and the heads of other relevant Federal agencies, shall submit 
to the Caucus on International Narcotics Control, the Committee on the 
Judiciary, and the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce and the Committee 
on the Judiciary of the House of Representatives a report on--
            (1) the potential therapeutic effects of cannabidiol or 
        marijuana on serious medical conditions, including intractable 
        epilepsy;
            (2) the potential effects of marijuana, including--
                    (A) the effect of increasing delta-9-
                tetrahydrocannabinol levels on the human body and 
                developing adolescent brains; and
                    (B) the effect of various delta-9-
                tetrahydrocannabinol levels on cognitive abilities, such 
                as those that are required to operate motor vehicles or 
                other heavy equipment; and
            (3) <<NOTE: Recommenda- tions.>>  the barriers associated 
        with researching marijuana or cannabidiol in States that have 
        legalized the use of such substances, which shall include--
                    (A) recommendations as to how such barriers might be 
                overcome, including whether public-private partnerships 
                or Federal-State research partnerships may or should be 
                implemented to provide researchers with access to 
                additional strains of marijuana and cannabidiol; and
                    (B) recommendations as to what safeguards must be in 
                place to verify--
                          (i) the levels of tetrahydrocannabinol, 
                      cannabidiol, or other cannabinoids contained in 
                      products obtained from such States is accurate; 
                      and
                          (ii) that such products do not contain harmful 
                      or toxic components.

[[Page 136 STAT. 2266]]

    (b) Activities.--To the extent practicable, the Secretary of Health 
and Human Services, either directly or through awarding grants, 
contacts, or cooperative agreements, shall expand and coordinate the 
activities of the National Institutes of Health and other relevant 
Federal agencies to better determine the effects of cannabidiol and 
marijuana, as outlined in the report submitted under paragraphs (1) and 
(2) of subsection (a).

    Approved December 2, 2022.

LEGISLATIVE HISTORY--H.R. 8454:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 168 (2022):
            July 26, considered and passed House.
            Nov. 16, considered and passed Senate.

                                  <all>