[Congressional Record Volume 168, Number 53 (Thursday, March 24, 2022)]
[Senate]
[Pages S1778-S1783]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 5010. Mr. SANDERS (for himself and Mr. Johnson) submitted an 
amendment intended to be proposed to amendment SA 5002 proposed by Mr. 
Schumer to the bill H.R. 4521, to provide for a coordinated Federal 
research initiative to ensure continued United States leadership in 
engineering biology; which was ordered to lie on the table; as follows:

        Beginning on page 567, strike line 1 and all that follows 
     through page 568, line 17.
                                 ______
                                 
  SA 5011. Mr. SANDERS (for himself, Ms. Warren, and Ms. Baldwin) 
submitted an amendment intended to be

[[Page S1779]]

proposed to amendment SA 5002 proposed by Mr. Schumer to the bill H.R. 
4521, to provide for a coordinated Federal research initiative to 
ensure continued United States leadership in engineering biology; which 
was ordered to lie on the table; as follows:

        At the end of section 1002(a), add the following:
       (5) Conditions of receipt.--
       (A) Required agreement.--A covered entity to which the 
     Secretary of Commerce awards Federal financial assistance 
     under section 9902 of the William M. (Mac) Thornberry 
     National Defense Authorization Act for Fiscal Year 2021 (15 
     U.S.C. 4652) or paragraph (3) of this subsection with amounts 
     appropriated under this subsection shall enter into an 
     agreement that specifies that, during the 5-year period 
     immediately following the award of the Federal financial 
     assistance--
       (i) the covered entity will not--

       (I) repurchase an equity security that is listed on a 
     national securities exchange of the covered entity or any 
     parent company of the covered entity, except to the extent 
     required under a contractual obligation that is in effect as 
     of the date of enactment of this Act;
       (II) outsource or offshore jobs to a location outside of 
     the United States; or
       (III) abrogate existing collective bargaining agreements; 
     and

       (ii) the covered entity will remain neutral in any union 
     organizing effort.
       (B) Financial protection of government.--
       (i) In general.--The Secretary of Commerce may not award 
     Federal financial assistance to a covered entity under 
     section 9902 of the William M. (Mac) Thornberry National 
     Defense Authorization Act for Fiscal Year 2021 (15 U.S.C. 
     4652) or paragraph (3) of this subsection with amounts 
     appropriated under this subsection, unless--

       (I)(aa) the covered entity has issued securities that are 
     traded on a national securities exchange; and
       (bb) the Secretary of the Treasury receives a warrant or 
     equity interest in the covered entity; or
       (II) in the case of any covered entity other than a covered 
     entity described in subclause (I), the Secretary of the 
     Treasury receives, in the discretion of the Secretary of the 
     Treasury--

       (aa) a warrant or equity interest in the covered entity; or
       (bb) a senior debt instrument issued by the covered entity.
       (ii) Terms and conditions.--The terms and conditions of any 
     warrant, equity interest, or senior debt instrument received 
     under clause (i) shall be set by the Secretary of Commerce 
     and shall meet the following requirements:

       (I) Purposes.--Such terms and conditions shall be designed 
     to provide for a reasonable participation by the Secretary of 
     Commerce, for the benefit of taxpayers, in equity 
     appreciation in the case of a warrant or other equity 
     interest, or a reasonable interest rate premium, in the case 
     of a debt instrument.
       (II) Authority to sell, exercise, or surrender.--For the 
     primary benefit of taxpayers, the Secretary of Commerce may 
     sell, exercise, or surrender a warrant or any senior debt 
     instrument received under this subparagraph. The Secretary of 
     Commerce shall not exercise voting power with respect to any 
     shares of common stock acquired under this subparagraph.
       (III) Sufficiency.--If the Secretary of Commerce determines 
     that a covered entity cannot feasibly issue warrants or other 
     equity interests as required by this subparagraph, the 
     Secretary of Commerce may accept a senior debt instrument in 
     an amount and on such terms as the Secretary of Commerce 
     deems appropriate.

                                 ______
                                 
  SA 5012. Mr. SANDERS submitted an amendment intended to be proposed 
to amendment SA 5002 proposed by Mr. Schumer to the bill H.R. 4521, to 
provide for a coordinated Federal research initiative to ensure 
continued United States leadership in engineering biology; which was 
ordered to lie on the table; as follows:

       In division B, at the end of title V insert the following:

     SEC. __. WORKER OWNERSHIP, READINESS, AND KNOWLEDGE.

       (a) Definitions.--In this section:
       (1) Existing program.--The term ``existing program'' means 
     a program, designed to promote employee ownership and 
     employee participation in business decisionmaking, that 
     exists on the date on which the Secretary is carrying out a 
     responsibility authorized under this section.
       (2) Initiative.--The term ``Initiative'' means the Employee 
     Ownership and Participation Initiative established under 
     subsection (b).
       (3) New program.--The term ``new program'' means a program, 
     designed to promote employee ownership and employee 
     participation in business decisionmaking, that does not exist 
     on the date on which the Secretary is carrying out a 
     responsibility authorized under this section.
       (4) Secretary.--The term ``Secretary'' means the Secretary 
     of Labor.
       (5) State.--The term ``State'' has the meaning given the 
     term under section 3 of the Workforce Innovation and 
     Opportunity Act (29 U.S.C. 3102).
       (b) Employee Ownership and Participation Initiative.--
       (1) Establishment.--The Secretary of Labor shall establish 
     within the Department of Labor an Employee Ownership and 
     Participation Initiative to promote employee ownership and 
     employee participation in business decisionmaking.
       (2) Functions.--In carrying out the Initiative, the 
     Secretary shall--
       (A) support within the States existing programs designed to 
     promote employee ownership and employee participation in 
     business decisionmaking; and
       (B) facilitate within the States the formation of new 
     programs designed to promote employee ownership and employee 
     participation in business decisionmaking.
       (3) Duties.--To carry out the functions enumerated in 
     paragraph (2), the Secretary shall--
       (A) support new programs and existing programs by--
       (i) making Federal grants authorized under subsection (d); 
     and
       (ii)(I) acting as a clearinghouse on techniques employed by 
     new programs and existing programs within the States, and 
     disseminating information relating to those techniques to the 
     programs; or
       (II) funding projects for information gathering on those 
     techniques, and dissemination of that information to the 
     programs, by groups outside the Department of Labor; and
       (B) facilitate the formation of new programs, in ways that 
     include holding or funding an annual conference of 
     representatives from States with existing programs, 
     representatives from States developing new programs, and 
     representatives from States without existing programs.
       (c) Programs Regarding Employee Ownership and 
     Participation.--
       (1) Establishment of program.--Not later than 180 days 
     after the date of enactment of this Act, the Secretary shall 
     establish a program to encourage new programs and existing 
     programs within the States to foster employee ownership and 
     employee participation in business decisionmaking throughout 
     the United States.
       (2) Purpose of program.--The purpose of the program 
     established under paragraph (1) is to encourage new and 
     existing programs within the States that focus on--
       (A) providing education and outreach to inform employees 
     and employers about the possibilities and benefits of 
     employee ownership, business ownership succession planning, 
     and employee participation in business decisionmaking, 
     including providing information about financial education, 
     employee teams, open-book management, and other tools that 
     enable employees to share ideas and information about how 
     their businesses can succeed;
       (B) providing technical assistance to assist employee 
     efforts to become business owners, to enable employers and 
     employees to explore and assess the feasibility of 
     transferring full or partial ownership to employees, and to 
     encourage employees and employers to start new employee-owned 
     businesses;
       (C) training employees and employers with respect to 
     methods of employee participation in open-book management, 
     work teams, committees, and other approaches for seeking 
     greater employee input; and
       (D) training other entities to apply for funding under this 
     subsection, to establish new programs, and to carry out 
     program activities.
       (3) Program details.--The Secretary may include, in the 
     program established under paragraph (1), provisions that--
       (A) in the case of activities described in paragraph 
     (2)(A)--
       (i) target key groups, such as retiring business owners, 
     senior managers, unions, trade associations, community 
     organizations, and economic development organizations;
       (ii) encourage cooperation in the organization of workshops 
     and conferences; and
       (iii) prepare and distribute materials concerning employee 
     ownership and participation, and business ownership 
     succession planning;
       (B) in the case of activities described in paragraph 
     (2)(B)--
       (i) provide preliminary technical assistance to employee 
     groups, managers, and retiring owners exploring the 
     possibility of employee ownership;
       (ii) provide for the performance of preliminary feasibility 
     assessments;
       (iii) assist in the funding of objective third-party 
     feasibility studies and preliminary business valuations, and 
     in selecting and monitoring professionals qualified to 
     conduct such studies; and
       (iv) provide a data bank to help employees find legal, 
     financial, and technical advice in connection with business 
     ownership;
       (C) in the case of activities described in paragraph 
     (2)(C)--
       (i) provide for courses on employee participation; and
       (ii) provide for the development and fostering of networks 
     of employee-owned companies to spread the use of successful 
     participation techniques; and
       (D) in the case of training described in paragraph (2)(D)--
       (i) provide for visits to existing programs by staff from 
     new programs receiving funding under this section; and
       (ii) provide materials to be used for such training.
       (4) Guidance.--The Secretary shall issue formal guidance, 
     for recipients of grants awarded under subsection (d) and 
     one-stop partners (as defined in section 3 of the Workforce 
     Innovation and Opportunity Act (29

[[Page S1780]]

     U.S.C. 3102)) affiliated with the workforce development 
     systems (as so defined) of the States, proposing that 
     programs and other activities funded under this section be--
       (A) proactive in encouraging actions and activities that 
     promote employee ownership of, and participation in, 
     businesses; and
       (B) comprehensive in emphasizing both employee ownership 
     of, and participation in, businesses so as to increase 
     productivity and broaden capital ownership.
       (d) Grants.--
       (1) In general.--In carrying out the program established 
     under subsection (c), the Secretary may make grants for use 
     in connection with new programs and existing programs within 
     a State for any of the following activities:
       (A) Education and outreach as provided in subsection 
     (c)(2)(A).
       (B) Technical assistance as provided in subsection 
     (c)(2)(B).
       (C) Training activities for employees and employers as 
     provided in subsection (c)(2)(C).
       (D) Activities facilitating cooperation among employee-
     owned firms.
       (E) Training as provided in subsection (c)(2)(D) for new 
     programs provided by participants in existing programs 
     dedicated to the objectives of this section, except that, for 
     each fiscal year, the amount of the grants made for such 
     training shall not exceed 10 percent of the total amount of 
     the grants made under this section.
       (2) Amounts and conditions.--The Secretary shall determine 
     the amount and any conditions for a grant made under this 
     subsection. The amount of the grant shall be subject to 
     paragraph (6), and shall reflect the capacity of the 
     applicant for the grant.
       (3) Applications.--Each entity desiring a grant under this 
     subsection shall submit an application to the Secretary at 
     such time, in such manner, and accompanied by such 
     information as the Secretary may reasonably require.
       (4) State applications.--Each State may sponsor and submit 
     an application under paragraph (3) on behalf of any local 
     entity consisting of a unit of State or local government, 
     State-supported institution of higher education, or nonprofit 
     organization, meeting the requirements of this section.
       (5) Applications by entities.--
       (A) Entity applications.--If a State fails to support or 
     establish a program pursuant to this section during any 
     fiscal year, the Secretary shall, in the subsequent fiscal 
     years, allow local entities described in paragraph (4) from 
     that State to make applications for grants under paragraph 
     (3) on their own initiative.
       (B) Application screening.--Any State failing to support or 
     establish a program pursuant to this section during any 
     fiscal year may submit applications under paragraph (3) in 
     the subsequent fiscal years but may not screen applications 
     by local entities described in paragraph (4) before 
     submitting the applications to the Secretary.
       (6) Limitations.--A recipient of a grant made under this 
     subsection shall not receive, during a fiscal year, in the 
     aggregate, more than the following amounts:
       (A) For fiscal year 2023, $300,000.
       (B) For fiscal year 2024, $330,000.
       (C) For fiscal year 2025, $363,000.
       (D) For fiscal year 2026, $399,300.
       (E) For fiscal year 2027, $439,200.
       (7) Annual report.--For each year, each recipient of a 
     grant under this subsection shall submit to the Secretary a 
     report describing how grant funds allocated pursuant to this 
     subsection were expended during the 12-month period preceding 
     the date of the submission of the report.
       (e) Evaluations.--The Secretary is authorized to reserve 
     not more than 10 percent of the funds appropriated for a 
     fiscal year to carry out this section, for the purposes of 
     conducting evaluations of the grant programs identified in 
     subsection (d) and to provide related technical assistance.
       (f) Reporting.--Not later than the expiration of the 36-
     month period following the date of enactment of this Act, the 
     Secretary shall prepare and submit to Congress a report--
       (1) on progress related to employee ownership and 
     participation in businesses in the United States; and
       (2) containing an analysis of critical costs and benefits 
     of activities carried out under this section.
       (g) Authorizations of Appropriations.--
       (1) In general.--There are authorized to be appropriated 
     for the purpose of making grants pursuant to subsection (d) 
     the following:
       (A) For fiscal year 2023, $4,000,000.
       (B) For fiscal year 2024, $7,000,000.
       (C) For fiscal year 2025, $10,000,000.
       (D) For fiscal year 2026, $13,000,000.
       (E) For fiscal year 2027, $16,000,000.
       (2) Administrative expenses.--There are authorized to be 
     appropriated for the purpose of funding the administrative 
     expenses related to the Initiative, for each of fiscal years 
     2023 through 2027, an amount not in excess of the lesser of--
       (A) $350,000; or
       (B) 5.0 percent of the maximum amount available under 
     paragraph (1) for that fiscal year.
                                 ______
                                 
  SA 5013. Mr. LEE (for himself, Mr. Rubio, Mr. Lankford, and Mr. 
Johnson) submitted an amendment intended to be proposed by him to the 
bill H.R. 7108, to suspend normal trade relations treatment for the 
Russian Federation and the Republic of Belarus, and for other purposes; 
which was ordered to lie on the table; as follows:

       Strike section 6 and insert the following:

     SEC. 6. REAUTHORIZATION OF SANCTIONS WITH RESPECT TO HUMAN 
                   RIGHTS VIOLATIONS.

       Section 1265 of the Global Magnitsky Human Rights 
     Accountability Act (Subtitle F of title XII of Public Law 
     114-328; 22 U.S.C. 2656 note) is amended by striking ``6 
     years'' and inserting ``12 years''.
                                 ______
                                 
  SA 5014. Mr. SCHUMER (for Mr. Boozman (for himself, Mr. Wyden, Mr. 
Blumenthal, and Mr. Kelly)) proposed an amendment to the bill S. 2102, 
to amend title 38, United States Code, to direct the Under Secretary 
for Health of the Department of Veterans Affairs to provide mammography 
screening for veterans who served in locations associated with toxic 
exposure; as follows:

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Dr. Kate Hendricks Thomas 
     Supporting Expanded Review for Veterans In Combat 
     Environments Act'' or the ``Dr. Kate Hendricks Thomas SERVICE 
     Act''.

     SEC. 2. REVISION OF BREAST CANCER MAMMOGRAPHY POLICY OF 
                   DEPARTMENT OF VETERANS AFFAIRS TO PROVIDE 
                   MAMMOGRAPHY SCREENING FOR VETERANS WHO SERVED 
                   IN LOCATIONS ASSOCIATED WITH TOXIC EXPOSURE.

       (a) In General.--Section 7322 of title 38, United States 
     Code, is amended--
       (1) in subsection (a), by striking ``The'' and inserting 
     ``In General.--The'';
       (2) in subsection (b)--
       (A) by striking ``The'' and inserting ``Standards for 
     Screening.--The''; and
       (B) in paragraph (2)(B), by inserting ``a record of service 
     in a location and during a period specified in subsection 
     (d),'' after ``risk factors,''; and
       (3) by adding at the end the following new subsections:
       ``(c) Eligibility for Screening for Veterans Exposed to 
     Toxic Substances.--The Under Secretary for Health shall 
     ensure that, under the policy developed under subsection (a), 
     any veteran who, during active military, naval, or air 
     service, was deployed in support of a contingency operation 
     in a location and during a period specified in subsection 
     (d), is eligible for a mammography screening by a health care 
     provider of the Department.
       ``(d) Locations and Periods Specified.--(1) The locations 
     and periods specified in this subsection are the following:
       ``(A) Iraq during following periods:
       ``(i) The period beginning on August 2, 1990, and ending on 
     February 28, 1991.
       ``(ii) The period beginning on March 19, 2003, and ending 
     on such date as the Secretary determines burn pits are no 
     longer used in Iraq.
       ``(B) The Southwest Asia theater of operations, other than 
     Iraq, during the period beginning on August 2, 1990, and 
     ending on such date as the Secretary determines burn pits are 
     no longer used in such location, including the following 
     locations:
       ``(i) Kuwait.
       ``(ii) Saudi Arabia.
       ``(iii) Oman.
       ``(iv) Qatar.
       ``(C) Afghanistan during the period beginning on September 
     11, 2001, and ending on such date as the Secretary determines 
     burn pits are no longer used in Afghanistan.
       ``(D) Djibouti during the period beginning on September 11, 
     2001, and ending on such date as the Secretary determines 
     burn pits are no longer used in Djibouti.
       ``(E) Syria during the period beginning on September 11, 
     2001, and ending on such date as the Secretary determines 
     burn pits are no longer used in Syria.
       ``(F) Jordan during the period beginning on September 11, 
     2001, and ending on such date as the Secretary determines 
     burn pits are no longer used in Jordan.
       ``(G) Egypt during the period beginning on September 11, 
     2001, and ending on such date as the Secretary determines 
     burn pits are no longer used in Egypt.
       ``(H) Lebanon during the period beginning on September 11, 
     2001, and ending on such date as the Secretary determines 
     burn pits are no longer used in Lebanon.
       ``(I) Yemen during the period beginning on September 11, 
     2001, and ending on such date as the Secretary determines 
     burn pits are no longer used in Yemen.
       ``(J) Such other locations and corresponding periods as set 
     forth by the Airborne Hazards and Open Burn Pit Registry 
     established under section 201 of the Dignified Burial and 
     Other Veterans' Benefits Improvement Act of 2012 (Public Law 
     112-260; 38 U.S.C. 527 note).
       ``(K) Such other locations and corresponding periods as the 
     Secretary, in collaboration with the Secretary of Defense, 
     may determine appropriate in a report submitted under 
     paragraph (2).
       ``(2) Not later than two years after the date of the 
     enactment of the Dr. Kate Hendricks Thomas Supporting 
     Expanded Review for Veterans In Combat Environments Act, and 
     not less frequently than once every two years thereafter, the 
     Secretary of Veterans Affairs, in collaboration with the 
     Secretary of Defense, shall submit to Congress a report

[[Page S1781]]

     specifying other locations and corresponding periods for 
     purposes of paragraph (1)(K).
       ``(3) A location under this subsection shall not include 
     any body of water around or any airspace above such location.
       ``(4) In this subsection, the term `burn pit' means an area 
     of land that--
       ``(A) is used for disposal of solid waste by burning in the 
     outdoor air; and
       ``(B) does not contain a commercially manufactured 
     incinerator or other equipment specifically designed and 
     manufactured for the burning of solid waste.''.
       (b) Report on Breast Cancer Rates for Veterans Deployed to 
     Certain Areas.--Not later than two years after the date of 
     the enactment of this Act, the Secretary of Veterans Affairs 
     shall submit to the Committee on Veterans' Affairs of the 
     Senate and the Committee on Veterans' Affairs of the House of 
     Representatives a report that compares the rates of breast 
     cancer among members of the Armed Forces deployed to the 
     locations and during the periods specified in section 7322(d) 
     of title 38, United States Code, as added by subsection (a), 
     as compared to members of the Armed Forces who were not 
     deployed to those locations during those periods and to the 
     civilian population.
                                 ______
                                 
  SA 5015. Mr. SCHUMER (for Mrs. Feinstein) proposed an amendment to 
the bill S. 253, 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 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

[[Page S1782]]

     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:
       ``(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 (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
       (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

[[Page S1783]]

     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--
       ``(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).

                          ____________________