[Congressional Record Volume 166, Number 212 (Tuesday, December 15, 2020)]
[Senate]
[Pages S7504-S7507]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2708. Mr. SASSE (for Mrs. Feinstein (for herself and Mr. 
Grassley)) proposed an amendment to the bill S. 2032, to expand 
research on the cannabidiol and marihuana; as follows:

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the 
     ``Cannabidiol and Marihuana 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.

             TITLE I--REGISTRATIONS FOR MARIHUANA RESEARCH

Sec. 101. Marihuana research applications.
Sec. 102. Research protocols.
Sec. 103. Applications to manufacture marihuana 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 
                               MARIHUANA

Sec. 201. Medical research on cannabidiol.
Sec. 202. Registration for the commercial production and distribution 
              of Food and Drug Administration approved drugs.
Sec. 203. Importation of cannabidiol for research purposes.

                 TITLE III--DOCTOR-PATIENT RELATIONSHIP

Sec. 301. Doctor-patient relationship.

                       TITLE IV--FEDERAL RESEARCH

Sec. 401. Federal research.

     SEC. 2. DEFINITIONS.

       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 marihuana, as applicable;
       (2) the term ``cannabidiol'' means--
       (A) the substance, cannabidiol, as derived from marihuana 
     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'', ``marihuana'', and 
     ``practitioner'' have the meanings given such terms in 
     section 102 of the

[[Page S7505]]

     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 marihuana 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.

             TITLE I--REGISTRATIONS FOR MARIHUANA RESEARCH

     SEC. 101. MARIHUANA 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 marihuana if--
       ``(I) the applicant's research protocol--
       ``(aa) 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 Cannabidiol and Marihuana Research 
     Expansion Act, including demonstrating that the security 
     measures are adequate for storing the quantity of marihuana 
     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 amended 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), the registrant may amend or 
     supplement the research protocol without reapplying if the 
     registrant does not change--
       ``(aa) the quantity or type of drug;
       ``(bb) the source of the drug; or
       ``(cc) the conditions under which the drug is stored, 
     tracked, or administered.
       ``(II)(aa) If a registrant under clause (i) seeks to change 
     the type of drug, the source of the drug, or conditions under 
     which the drug 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 marihuana 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 marihuana already obtained;
       ``(CC) the quantity of additional marihuana needed to 
     complete the research; and
       ``(DD) an attestation that the change in quantity does not 
     impact the source of the drug or the conditions under which 
     the drug 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 drug or the conditions 
     under which the drug 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 marihuana;
       ``(bb) the dosing of marihuana; 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 MARIHUANA FOR RESEARCH.

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

[[Page S7506]]

       ``(c)(1)(A) As it relates to applications to manufacture 
     marihuana for research purposes, if the Attorney General 
     places a notice in the Federal Register to increase the 
     number of entities registered under this Act to manufacture 
     marihuana 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 marihuana 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 marihuana 
     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 Cannabidiol 
     and Marihuana Research Expansion Act.
       ``(vii) The applicant is licensed by each State in which 
     the applicant will conduct operations under this subsection, 
     to manufacture marihuana, 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 (16)(B)--

       (I) in clause (i), by striking ``or'' at the end;
       (II) by redesignating clause (ii) as (iii); and
       (III) by inserting after clause (i) the following:

       ``(ii) the synthetic equivalent of hemp-derived cannabidiol 
     that contains less than 0.3 percent tetrahydrocannabinol; 
     or'';
       (ii) 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

       (iii) 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. ADEQUATE AND UNINTERRUPTED SUPPLY.

       On an annual basis, the Attorney General shall assess 
     whether there is an adequate and uninterrupted supply of 
     marihuana, including of specific strains, for research 
     purposes.

     SEC. 105. SECURITY REQUIREMENTS.

       (a) In General.--An individual or entity engaged in 
     researching marihuana 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 marihuana or its components.

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

     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, a practitioner, or a manufacturer may manufacture, 
     distribute, dispense, or possess marihuana or cannabidiol if 
     the marihuana 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 marihuana for the 
     purpose of commercial production of a drug containing or 
     derived from marihuana 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).

     SEC. 203. IMPORTATION OF CANNABIDIOL FOR RESEARCH PURPOSES.

       The Controlled Substances Import and Export Act (21 U.S.C. 
     951 et seq.) is amended--
       (1) in section 1002(a) (21 U.S.C. 952(a))--
       (A) in paragraph (1), by striking ``and'' at the end;
       (B) in paragraph (2)(C), by inserting ``and'' after 
     ``uses,''; and
       (C) inserting before the undesignated matter following 
     paragraph (2)(C) the following:
       ``(3) such amounts of marihuana or cannabidiol (as defined 
     in section 2 of the Cannabidiol and Marihuana Research 
     Expansion Act) as are--
       ``(A) approved for medical research for drug development 
     (as such terms are defined in section 2 of the Cannabidiol 
     and Marihuana Research Expansion Act), or
       ``(B) necessary for registered manufacturers to manufacture 
     drugs containing marihuana or cannabidiol that have been 
     approved for use by the Commissioner of Food and Drugs under 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.),''; and
       (2) in section 1007 (21 U.S.C. 957), by amending subsection 
     (a) to read as follows:
       ``(a)(1) Except as provided in paragraph (2), no person 
     may--
       ``(A) import into the customs territory of the United 
     States from any place outside thereof (but within the United 
     States), or import into the United States from any place 
     outside thereof, any controlled substance or list I chemical, 
     or
       ``(B) export from the United States any controlled 
     substance or list I chemical,
     unless there is in effect with respect to such person a 
     registration issued by the Attorney General under section 
     1008, or unless such person is exempt from registration under 
     subsection (b).
       ``(2) Paragraph (1) shall not apply to the import or export 
     of marihuana or cannabidiol (as defined in section 2 of the 
     Cannabidiol and Marihuana Research Expansion Act) that has 
     been approved for--

[[Page S7507]]

       ``(A) medical research for drug development authorized 
     under section 201 of the Cannabidiol and Marihuana Research 
     Expansion Act; or
       ``(B) use by registered manufacturers to manufacture drugs 
     containing marihuana or cannabidiol that have been approved 
     for use by the Commissioner of Food and Drugs under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.).''.

                 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 
     marihuana 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 
     marihuana and marihuana 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 
     marihuana on serious medical conditions, including 
     intractable epilepsy;
       (2) the potential effects of marihuana, 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 marihuana 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 marihuana 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 marihuana, as 
     outlined in the report submitted under paragraphs (1) and (2) 
     of subsection (a).

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