[Congressional Record Volume 168, Number 124 (Tuesday, July 26, 2022)]
[House]
[Pages H7120-H7124]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




        MEDICAL MARIJUANA AND CANNABIDIOL RESEARCH EXPANSION ACT

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 8454) to expand research on cannabidiol and marijuana, and 
for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 8454

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. 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) 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);
       (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--
       (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) 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) 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) 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.''.

     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) If the Attorney General grants an application for 
     registration under clause (i),

[[Page H7121]]

     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) 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) 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
       ``(DD) 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) 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) 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) 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 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) 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
       (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

[[Page H7122]]

       (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. ADEQUATE AND UNINTERRUPTED SUPPLY.

       (a) 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) 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 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. 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. 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. 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 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. 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. FEDERAL RESEARCH.

       (a) 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) 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.
       (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).

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Georgia (Mr. Carter) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 8454.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 8454, the Medical Marijuana 
and Cannabidiol Research Expansion Act, legislation that would expand 
comprehensive cannabis research.
  In March, the Senate passed S. 253, the Cannabidiol and Marihuana 
Research Expansion Act. In April, the House considered and passed H.R. 
5657, the Medical Marijuana Research Act, which also passed with strong 
bipartisan support last Congress.
  The bill before us today, H.R. 8454, represents a bipartisan, 
bicameral agreement that resolves the differences between both bills 
and brings us to a historic, overdue moment for Congress.
  The consumption of marijuana and marijuana-derived CBD for medical 
use is approved and regulated in 37 States, the District of Columbia, 
Guam, Puerto Rico, and the U.S. Virgin Islands. This translates to tens 
of millions of Americans consuming marijuana every year. Yet, we still 
do not have a comprehensive body of research on the safety or 
therapeutic effects or benefits of marijuana products.
  Because of its status as a schedule I substance, research on 
marijuana has been regulated in a restrictive, time-consuming way, and 
the existing research is not representative of the products that are 
currently available to many Americans.
  H.R. 8454 streamlines the registration process for conducting 
research on marijuana and manufacturing marijuana products for research 
purposes and drug development. The bill maintains the appropriate 
oversight and control by the Department of Health and Human Services 
and the Drug Enforcement Administration and requires both applicants 
and regulators to adhere to clear protocols and timelines.
  The bill requires HHS and DEA to respond to registration applicants 
in a timely manner and requires a regular assessment to confirm an 
adequate supply of marijuana, including specific

[[Page H7123]]

strains, for medical research. This ensures that the marijuana being 
provided for medical research appropriately reflects the strains and 
THC content in millions of products across the country.
  Mr. Speaker, this bill also clarifies that doctors can discuss with 
patients the potential harms and benefits of marijuana as a medical 
treatment.
  Finally, H.R. 8454 requires HHS to submit a report to Congress on the 
potential therapeutic effects of marijuana and CBD for serious medical 
conditions, effects on the developing human brain and body, and 
existing barriers to research.
  Mr. Speaker, I thank Representatives Blumenauer, Harris, Holmes 
Norton, Dingell, Cohen, Griffith, Lee, and Case for their leadership on 
this issue. I urge my colleagues to support the bill and look forward 
to the Senate acting expeditiously on our agreement to expand 
comprehensive cannabis research while protecting public health and 
safety.
  Mr. Speaker, I reserve the balance of my time.
  Mr. CARTER of Georgia. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise today to speak in favor of H.R. 8454, the Medical 
Marijuana and Cannabidiol Research Expansion Act. This bill is a 
revised version of H.R. 5657, Medical Marijuana Research Act, which was 
led by Representatives Harris and Blumenauer, and overwhelmingly passed 
the House in April.
  The text of H.R. 8454 that we are considering today is largely 
similar to H.R. 5657, but it is consensus language that was agreed to 
through bipartisan negotiations with the Senate. I am pleased we were 
able to get the language to a good place.
  Marijuana is a schedule I controlled substance under the Controlled 
Substances Act. Research on these substances must be conducted in 
accordance with the Controlled Substances Act and requires the Drug 
Enforcement Administration approve research protocol.
  If a researcher desires to make changes to an approved project, the 
researcher must submit a request to do so, which is then reviewed and 
must be approved by both the DEA and the FDA.
  In addition to the extensive regulatory hurdles that researchers 
face, the actual supply of research-grade marijuana is relatively 
limited. The supply is subject to the single convention on narcotic 
drugs, which imposes certain obligations related to governmental 
oversight of its cultivation.
  While the DEA and the National Institute on Drug Abuse have taken 
some steps to increase the number of domestic manufacturers of 
research-grade marijuana, more could be done in this space. The Medical 
Marijuana Research Expansion Act improves the Federal research 
landscape by streamlining both the research and manufacturing 
registration processes.
  This is critical to better understand the potential benefits and 
possible risks associated with marijuana use, as researchers must be 
able to study actual products that are currently used by consumers for 
both medical and recreational use. These data are long overdue, as 
policy decisions have far outpaced the science.
  States that have fully legalized marijuana have done so in a relative 
information vacuum with less understanding of what it is and what it 
does than virtually any nutritional supplement currently on the market, 
and with far less information than they have on legal substances that 
are easily abused, such as alcohol or tobacco.
  Until we make it easier to conduct the research, making fully 
informed policy decisions will remain challenging. Even rescheduling 
the substance administratively will necessitate robust data on 
potential medical use.
  Recent evaluations conducted separately by the FDA and the National 
Academies of Sciences, Engineering, and Medicine have both illustrated 
the challenges of meeting the required standard of evidence for 
demonstrating effective medical use. Both studies concluded that lack 
of research was a significant factor in denying rescheduling petitions 
in the past.
  If Congress does not act, we will continue to have limited ability to 
study these products in clinical trial settings. This commonsense 
solution will better our understanding of marijuana through legal, 
Federally sanctioned and scientifically valid research on this 
substance.
  Mr. Speaker, I thank Representatives Blumenauer and Harris, along 
with Chairman Pallone, for working together on this legislation, and I 
reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I have no additional speakers, and I 
reserve the balance of my time.
  Mr. CARTER of Georgia. Mr. Speaker, I yield such time as he may 
consume to the gentleman from Maryland (Mr. Harris), one of the leaders 
on this important subject.
  Mr. HARRIS. Mr. Speaker, the chairman of the committee got it right, 
this is historic. This bill is overdue, bipartisan, and bicameral, as 
it should be.
  Today, I rise in support of H.R. 8454, the Medical Marijuana and 
Cannabidiol Research Expansion Act.
  Representative Blumenauer and I have jointly cosponsored this bill 
for four Congresses. Talk about overdue. Although we disagree about 
recreational marijuana--he supports it; I oppose it--we both concur 
that in regard to medical marijuana, we need to do the rigorous 
research to answer the questions.
  As a physician, I realize that if we are going to have marijuana 
legal in over three dozen States for medical uses, we really ought to 
be able to do the research on it to see what it can and can't be used 
for. Many claims are made about it--some are legitimate, some will be 
found to be illegitimate--but the American public deserves to know 
whether medical marijuana and cannabidiol work for those claims that 
are being made.
  This bill makes it easier to do the necessary, rigorous medical 
research just like is done for any other drug that has a claim of 
efficacy in this country. The American public deserves to know what 
medical marijuana is useful for, because for anyone with those 
conditions where it is found to be useful, it could be a godsend. But 
for other conditions where the claims won't be found to be valid with 
rigorous research, it would be found to be ineffective, and that would 
help protect American patients as well.
  This would modernize our research methods, bringing medical marijuana 
up to the scientific standards we use for every other type of 
medication that is sold as a drug in this country.
  Mr. Speaker, I urge support of this bill.
  Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
  Mr. CARTER of Georgia. Mr. Speaker, I yield such time as he may 
consume to the gentleman from Virginia (Mr. Griffith).
  Mr. GRIFFITH. Mr. Speaker, I thank my friend, and leader of the 
committee, Frank Pallone.
  H.R. 8454 is an important bill, and it is interesting to hear the 
conversation here on the floor. Mr. Carter was talking about the 
history that you couldn't get marijuana rescheduled because they didn't 
have enough research, and you can't get the research because it is 
scheduled as a schedule I drug, so we have been trapped in this vortex 
where we can't get the information.
  I, too, am against recreational marijuana. But for medical marijuana, 
I think it has a great benefit. For years, we have been in this trap 
where you couldn't do sufficient research, therefore you couldn't 
reschedule it. It is crazy. We are going to fix it here today.
  My belief is that medical marijuana can be beneficial when used in a 
proper setting. Despite the increasing use of cannabis products around 
the country, there have been very few legitimate peer-reviewed studies 
to determine the effect of cannabis on the body.
  We know it does some good anecdotally for patients with juvenile 
seizures. What we don't know is how much THC has to be in the 
cannabidiol to make it effective. This is what we need research for.

                              {time}  1700

  This bill allows us to obtain approval to conduct cannabis research 
and obtain quality product, not just one strain out of Mississippi, but 
multiple products, quality products, monitored by the Government, to 
make sure it is not being misused, to be used in this research.

[[Page H7124]]

  It encourages research by improving and streamlining the registration 
process for marijuana. It also ensures the availability of verified 
cannabis products necessary for legitimate research by allowing 
approved institutions of higher education, practitioners, and 
manufacturers to manufacture and distribute marijuana for the purpose 
of conducting research.
  As someone who has advocated for this legislation for years, I 
appreciate the work that has been done to get us here today.
  Whatever position you may have on marijuana use, you need to know 
that this bill will allow us to come together and support more 
scientific research so that we can make informed decisions as we move 
forward as legislators.
  I have to tell you, being here live as a legislator is also 
important, because the genesis of this bill was several conversations 
that took place on the floor of this House when people who disagree on 
the underlying issue would argue about what research showed. It finally 
became clear to Representative Blumenauer, to Representative Harris, to 
myself, and to others, that we had to have more research in order to 
get the right answers for the American people.
  Mr. Speaker, I urge everyone to support H.R. 8454.
  Mr. CARTER of Georgia. Mr. Speaker, I would encourage my colleagues 
to support this legislation, and I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, again, I think this is a great way of 
dealing with this issue overall and getting the Senate on board.
  Mr. Speaker, I urge my colleagues to support this important 
legislation, and I yield back the balance of my time.
  Ms. ESHOO. Mr. Speaker, I rise in support of H.R. 8454, the Medical 
Marijuana and Cannabidiol Research Expansion Act. I advanced a 
precursor to this bipartisan bill through my Health Subcommittee and 
I'm proud to support it on the Floor today.
  According to the Department of Health and Human Services National 
Survey on Drug Use, over 48 million Americans reported using cannabis 
in the past year. Thirty-seven states now allow the medicinal use of 
cannabis and 19 states and the District of Columbia have legalized 
cannabis for adult use.
  But state laws and federal policy are a thousand miles apart. As more 
states allow cannabis, the federal government still strictly controls 
and prohibits it, even restricting legitimate medical research.
  The Medical Marijuana Research Act addresses these restrictions on 
research and alleviates a burdensome, out-of-date process for 
scientific researchers. First, it creates a new, less cumbersome 
registration process specifically for marijuana, reducing approval wait 
times and costly security measures. Second, this bill makes it easier 
for researchers to obtain the cannabis they need for their studies 
through reforms in production and distribution regulations.
  Under this bill scientists will no longer be forced to wait more than 
a year to become federally-approved to conduct cannabis research. They 
will also not be forced to use the cannabis grown by a government-
authorized farm at the University of Mississippi. This cannabis lacks 
the properties and potency of commercially-available cannabis and leads 
to inadequate research.
  This is a commonsense bill that will update federal policy to advance 
research on cannabis and its compounds. I urge my colleagues to support 
this bill.
  Mr. BLUMENAUER. Mr. Speaker, today I will vote to pass the Medical 
Marijuana and Cannabidiol Research Expansion Act. This legislation 
would remove barriers for research into cannabis and facilitate access 
to an increased supply of cannabis for research purposes.
  The cannabis laws in this country are broken, including our laws that 
govern cannabis research. Because cannabis is a Schedule I substance, 
researchers must jump through hoops and comply with onerous 
requirements just to do basic research on the medical potential of the 
plant.
  The Medical Marijuana and Cannabidiol Research Expansion Act amends 
the Controlled Substances Act to streamline the registration process 
and expands opportunity for our researchers to investigate the 
potential and impacts of cannabis.
  My partners in the House and Senate and I worked closely with experts 
in Congress and the Department of Health and Human Services (HHS) to 
ensure this legislation will expand cannabis research, not restrict it. 
Specifically, the use of ``practitioners'' includes ``NIH-funded 
researchers,'' according to feedback from HHS. This ensures that this 
legislation will not restrict researchers already considered entities 
eligible to conduct research under the Controlled Substances Act. H.R. 
8454 is designed to streamline and broaden access to researching 
marijuana.
  Enacting this legislation will be an important step forward in making 
the federal government a real partner in the path forward on cannabis. 
In addition to this legislation, we must continue to advance banking 
access for cannabis businesses; prioritize expungements, clemencies, 
and resentencing for cannabis convictions; make robust investments in 
cannabis research; develop accurate tests for impairment; ensure our 
veterans can access medical cannabis; and invest in communities 
targeted in the failed war on drugs.
  The Medical Marijuana and Cannabidiol Research Expansion Act 
demonstrates the power of good faith bipartisan engagement on cannabis 
policy and the opportunity of this moment to enact laws our communities 
need.
  I look forward to working with Senators Dianne Feinstein, Brian 
Schatz, and Chuck Grassley and my co-lead Representative Andy Harris to 
enact this legislation and expand our Nation's cannabis research 
capabilities.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 8454, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. CLOUD. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this motion will be postponed.

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