[Congressional Record Volume 167, Number 140 (Thursday, August 5, 2021)]
[Senate]
[Pages S5960-S5962]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2574. Mrs. FEINSTEIN (for herself, Mr. Grassley, and Mr. Schatz)
submitted an amendment intended to be proposed to amendment SA 2137
proposed by Mr. Schumer (for Ms. Sinema (for herself, Mr. Portman, Mr.
Manchin, Mr. Cassidy, Mrs. Shaheen, Ms. Collins, Mr. Tester, Ms.
Murkowski, Mr. Warner, and Mr. Romney)) to the bill H.R. 3684, to
authorize funds for Federal-aid highways, highway safety programs, and
transit programs, and for other purposes; which was ordered to lie on
the table; as follows:
On page 1200, strike line 9, and all that follows through
page 1202, line 10, and insert the following:
Subtitle B--Cannabidiol and Marihuana Research Expansion
SEC. 25101. SHORT TITLE.
This subtitle may be cited as the ``Cannabidiol and
Marihuana Research Expansion Act''.
SEC. 25102. DEFINITIONS.
In this subtitle--
(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 subtitle;
(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.
CHAPTER 1--REGISTRATIONS FOR MARIHUANA RESEARCH
SEC. 25121. 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 25125 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. 25122. 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 25121 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--
[[Page S5961]]
``(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. 25123. 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 25125 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. 25124. 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. 25125. 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. 25126. 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.
[[Page S5962]]
CHAPTER 2--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIHUANA
SEC. 25141. 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 25142.
SEC. 25142. 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. 25143. 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 25102 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 25102 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 25102 of
the Cannabidiol and Marihuana Research Expansion Act) that
has been approved for--
``(A) medical research for drug development authorized
under section 25141 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.).''.
CHAPTER 3--DOCTOR-PATIENT RELATIONSHIP
SEC. 25161. 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.
CHAPTER 4--FEDERAL RESEARCH
SEC. 25181. 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).
Subtitle C--GAO Study
SEC. 25201. GAO STUDY ON IMPROVING THE EFFICIENCY OF TRAFFIC
SYSTEMS.
Not later than 1 year after the date of enactment of this
Act, the Comptroller General of the United States shall carry
out, and submit to Congress a report describing the results
of, a study on the potential societal benefits of improving
the efficiency of traffic systems.
______