[117th Congress Public Law 215]
[From the U.S. Government Publishing Office]
[[Page 136 STAT. 2257]]
Public Law 117-215
117th Congress
An Act
To expand research on cannabidiol and marijuana, and for other
purposes. <<NOTE: Dec. 2, 2022 - [H.R. 8454]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Medical
Marijuana and Cannabidiol Research Expansion Act.>>
SECTION 1. <<NOTE: 21 USC 801 note.>> SHORT TITLE; TABLE OF
CONTENTS.
(a) Short Title.--This Act may be cited as the ``Medical Marijuana
and Cannabidiol Research Expansion Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Definitions.
Sec. 3. Determination of budgetary effects.
TITLE I--REGISTRATIONS FOR MARIJUANA RESEARCH
Sec. 101. Marijuana research applications.
Sec. 102. Research protocols.
Sec. 103. Applications to manufacture marijuana for research.
Sec. 104. Adequate and uninterrupted supply.
Sec. 105. Security requirements.
Sec. 106. Prohibition against reinstating interdisciplinary review
process for non-NIH-funded researchers.
TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIJUANA
Sec. 201. Medical research on cannabidiol.
Sec. 202. Registration for the commercial production and distribution of
Food and Drug Administration-approved drugs.
TITLE III--DOCTOR-PATIENT RELATIONSHIP
Sec. 301. Doctor-patient relationship.
TITLE IV--FEDERAL RESEARCH
Sec. 401. Federal research.
SEC. 2. DEFINITIONS.
(a) <<NOTE: 21 USC 801 note.>> In General.--In this Act--
(1) the term ``appropriately registered'' means that an
individual or entity is registered under the Controlled
Substances Act (21 U.S.C. 801 et seq.) to engage in the type of
activity that is carried out by the individual or entity with
respect to a controlled substance on the schedule that is
applicable to cannabidiol or marijuana, as applicable;
(2) the term ``cannabidiol'' means--
(A) the substance, cannabidiol, as derived from
marijuana that has a delta-9-tetrahydrocannabinol level
that is greater than 0.3 percent; and
(B) the synthetic equivalent of the substance
described in subparagraph (A);
[[Page 136 STAT. 2258]]
(3) the terms ``controlled substance'', ``dispense'',
``distribute'', ``manufacture'', ``marijuana'', and
``practitioner'' have the meanings given such terms in section
102 of the Controlled Substances Act (21 U.S.C. 802), as amended
by this Act;
(4) the term ``covered institution of higher education''
means an institution of higher education (as defined in section
101 of the Higher Education Act of 1965 (20 U.S.C. 1001)) that--
(A)(i) has highest or higher research activity, as
defined by the Carnegie Classification of Institutions
of Higher Education; or
(ii) is an accredited medical school or an
accredited school of osteopathic medicine; and
(B) is appropriately registered under the Controlled
Substances Act (21 U.S.C. 801 et seq.);
(5) the term ``drug'' has the meaning given the term in
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)(1));
(6) the term ``medical research for drug development'' means
medical research that is--
(A) a preclinical study or clinical investigation
conducted in accordance with section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i))
or otherwise permitted by the Department of Health and
Human Services to determine the potential medical
benefits of marijuana or cannabidiol as a drug; and
(B) conducted by a covered institution of higher
education, practitioner, or manufacturer that is
appropriately registered under the Controlled Substances
Act (21 U.S.C. 801 et seq.); and
(7) the term ``State'' means any State of the United States,
the District of Columbia, and any territory of the United
States.
(b) Updating Term.--Section 102(16) of the Controlled Substances Act
(21 U.S.C. 802(16)) is amended--
(1) in subparagraph (A), by striking ``the term `marihuana'
means'' and inserting ``the terms `marihuana' and `marijuana'
mean''; and
(2) in subparagraph (B), by striking ``The term `marihuana'
does not'' and inserting ``The terms `marihuana' and `marijuana'
do not''.
SEC. 3. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of complying with
the Statutory Pay-As-You-Go Act of 2010, shall be determined by
reference to the latest statement titled ``Budgetary Effects of PAYGO
Legislation'' for this Act, submitted for printing in the Congressional
Record by the Chairman of the House Budget Committee, provided that such
statement has been submitted prior to the vote on passage.
TITLE I--REGISTRATIONS FOR MARIJUANA RESEARCH
SEC. 101. MARIJUANA RESEARCH APPLICATIONS.
Section 303(f) of the Controlled Substances Act (21 U.S.C. 823(f))
is amended--
[[Page 136 STAT. 2259]]
(1) by redesignating paragraphs (1) through (5) as
subparagraphs (A) through (E), respectively;
(2) by striking ``(f) The Attorney General'' and inserting
``(f)(1) The Attorney General'';
(3) by striking ``Registration applications'' and inserting
the following:
``(2)(A) Registration applications'';
(4) by striking ``Article 7'' and inserting the following:
``(3) Article 7''; and
(5) by inserting after paragraph (2)(A), as so designated,
the following:
``(B)(i) The Attorney General shall register a practitioner to
conduct research with marijuana (including any derivative, extract,
preparation, and compound thereof) if--
``(I) the applicant's research protocol has been reviewed
and allowed--
``(aa) by the Secretary of Health and Human Services
under section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i));
``(bb) by the National Institutes of Health or
another Federal agency that funds scientific research;
or
``(cc) pursuant to sections 1301.18 and 1301.32 of
title 21, Code of Federal Regulations, or any successors
thereto; and
``(II) the applicant has demonstrated to the Attorney
General that there are effective procedures in place to
adequately safeguard against diversion of the controlled
substance for legitimate medical or scientific use pursuant to
section 105 of the Medical Marijuana and Cannabidiol Research
Expansion Act, including demonstrating that the security
measures are adequate for storing the quantity of marijuana the
applicant would be authorized to possess.
``(ii) <<NOTE: Determination.>> The Attorney General may deny an
application for registration under this subparagraph only if the
Attorney General determines that the issuance of the registration would
be inconsistent with the public interest. In determining the public
interest, the Attorney General shall consider the factors listed in--
``(I) subparagraphs (B) through (E) of paragraph (1); and
``(II) subparagraph (A) of paragraph (1), if the applicable
State requires practitioners conducting research to register
with a board or authority described in such subparagraph (A).
``(iii)(I) <<NOTE: Deadline.>> Not later than 60 days after the
date on which the Attorney General receives a complete application for
registration under this subparagraph, the Attorney General shall--
``(aa) approve the application; or
``(bb) request supplemental information.
``(II) For purposes of subclause (I), an application shall be deemed
complete when the applicant has submitted documentation showing that the
requirements under clause (i) are satisfied.
``(iv) <<NOTE: Deadline.>> Not later than 30 days after the date on
which the Attorney General receives supplemental information as
described in clause (iii)(I)(bb) in connection with an application
described in this subparagraph, the Attorney General shall approve or
deny the application.
``(v) If an application described in this subparagraph is denied,
the Attorney General shall provide a written explanation of the basis of
denial to the applicant.''.
[[Page 136 STAT. 2260]]
SEC. 102. RESEARCH PROTOCOLS.
(a) In General.--Paragraph (2)(B) of section 303(f) of the
Controlled Substances Act (21 U.S.C. 823(f)), as added by section 101 of
this Act, is further amended by adding at the end the following:
``(vi)(I) <<NOTE: Notifications. Deadlines.>> If the Attorney
General grants an application for registration under clause (i), the
registrant may amend or supplement the research protocol without
notification to, or review by, the Drug Enforcement Administration if
the registrant does not change--
``(aa) the quantity or type of marijuana or cannabidiol
(including any derivative, extract, preparation, and compound
thereof);
``(bb) the source of such marijuana or cannabidiol; or
``(cc) the conditions under which such marijuana or
cannabidiol is stored, tracked, or administered.
``(II)(aa) If a registrant under clause (i) seeks to change the type
of marijuana or cannabidiol (including any derivative, extract,
preparation, and compound thereof), the source of such marijuana or
cannabidiol, or the conditions under which such marijuana or cannabidiol
is stored, tracked, or administered, the registrant shall notify the
Attorney General via registered mail, or an electronic means permitted
by the Attorney General, not later than 30 days before implementing an
amended or supplemental research protocol.
``(bb) <<NOTE: Effective date.>> A registrant may proceed with an
amended or supplemental research protocol described in item (aa) if the
Attorney General does not explicitly object during the 30-day period
beginning on the date on which the Attorney General receives the notice
under item (aa).
``(cc) The Attorney General may only object to an amended or
supplemental research protocol under this subclause if additional
security measures are needed to safeguard against diversion or abuse.
``(dd) If a registrant under clause (i) seeks to address additional
security measures identified by the Attorney General under item (cc),
the registrant shall notify the Attorney General via registered mail, or
an electronic means permitted by the Attorney General, not later than 30
days before implementing an amended or supplemental research protocol.
``(ee) <<NOTE: Effective date.>> A registrant may proceed with an
amended or supplemental research protocol described in item (dd) if the
Attorney General does not explicitly object during the 30-day period
beginning on the date on which the Attorney General receives the notice
under item (dd).
``(III)(aa) If a registrant under clause (i) seeks to change the
quantity of marijuana needed for research and the change in quantity
does not impact the factors described in item (bb) or (cc) of subclause
(I) of this clause, the registrant shall notify the Attorney General via
registered mail or using an electronic means permitted by the Attorney
General.
``(bb) A notification under item (aa) shall include--
``(AA) the Drug Enforcement Administration registration
number of the registrant;
``(BB) the quantity of marijuana or cannabidiol already
obtained;
``(CC) the quantity of additional marijuana or cannabidiol
needed to complete the research; and
[[Page 136 STAT. 2261]]
``(DD) <<NOTE: Attestation.>> an attestation that the
change in quantity does not impact the source of the marijuana
or cannabidiol or the conditions under which the marijuana or
cannabidiol is stored, tracked, or administered.
``(cc) The Attorney General shall ensure that--
``(AA) any registered mail return receipt with respect to a
notification under item (aa) is submitted for delivery to the
registrant providing the notification not later than 3 days
after receipt of the notification by the Attorney General; and
``(BB) notice of receipt of a notification using an
electronic means permitted under item (aa) is provided to the
registrant providing the notification not later than 3 days
after receipt of the notification by the Attorney General.
``(dd)(AA) <<NOTE: Effective date.>> On and after the date
described in subitem (BB), a registrant that submits a notification in
accordance with item (aa) may proceed with the research as if the change
in quantity has been approved on such date, unless the Attorney General
notifies the registrant of an objection described in item (ee).
``(BB) The date described in this subitem is the date on which a
registrant submitting a notification under item (aa) receives the
registered mail return receipt with respect to the notification or the
date on which the registrant receives notice that the notification using
an electronic means permitted under item (aa) was received by the
Attorney General, as the case may be.
``(ee) A notification submitted under item (aa) shall be deemed to
be approved unless the Attorney General, not later than 10 days after
receiving the notification, explicitly objects based on a finding that
the change in quantity--
``(AA) does impact the source of the marijuana or
cannabidiol or the conditions under which the marijuana or
cannabidiol is stored, tracked, or administered; or
``(BB) necessitates that the registrant implement additional
security measures to safeguard against diversion or abuse.
``(IV) Nothing in this clause shall limit the authority of the
Secretary of Health and Human Services over requirements related to
research protocols, including changes in--
``(aa) the method of administration of marijuana or
cannabidiol;
``(bb) the dosing of marijuana or cannabidiol; and
``(cc) the number of individuals or patients involved in
research.''.
(b) <<NOTE: 21 USC 823 note.>> Regulations.--Not later than 1 year
after the date of enactment of this Act, the Attorney General shall
promulgate regulations to carry out the amendment made by this section.
SEC. 103. APPLICATIONS TO MANUFACTURE MARIJUANA FOR RESEARCH.
(a) In General.--Section 303 of the Controlled Substances Act (21
U.S.C. 823), as amended by sections 101 and 102 of this Act, is further
amended--
(1) by redesignating subsections (c) through (k) as
subsections (d) through (l), respectively;
(2) by inserting after subsection (b) the following:
``(c)(1)(A) <<NOTE: Notice. Federal
Register, publication. Deadline.>> As it relates to applications to
manufacture marijuana for research purposes, when the Attorney General
places a notice in the Federal Register to increase the number of
entities registered under this Act to manufacture marijuana to supply
appropriately
[[Page 136 STAT. 2262]]
registered researchers in the United States, the Attorney General shall,
not later than 60 days after the date on which the Attorney General
receives a completed application--
``(i) approve the application; or
``(ii) request supplemental information.
``(B) For purposes of subparagraph (A), an application shall be
deemed complete when the applicant has submitted documentation showing
each of the following:
``(i) The requirements designated in the notice in the
Federal Register are satisfied.
``(ii) The requirements under this Act are satisfied.
``(iii) The applicant will limit the transfer and sale of
any marijuana manufactured under this subsection--
``(I) to researchers who are registered under this
Act to conduct research with controlled substances in
schedule I; and
``(II) for purposes of use in preclinical research
or in a clinical investigation pursuant to an
investigational new drug exemption under 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).
``(iv) The applicant will transfer or sell any marijuana
manufactured under this subsection only with prior, written
consent for the transfer or sale by the Attorney General.
``(v) The applicant has completed the application and review
process under subsection (a) for the bulk manufacture of
controlled substances in schedule I.
``(vi) The applicant has established and begun operation of
a process for storage and handling of controlled substances in
schedule I, including for inventory control and monitoring
security in accordance with section 105 of the Medical Marijuana
and Cannabidiol Research Expansion Act.
``(vii) The applicant is licensed by each State in which the
applicant will conduct operations under this subsection, to
manufacture marijuana, if that State requires such a license.
``(C) <<NOTE: Deadline.>> Not later than 30 days after the date on
which the Attorney General receives supplemental information requested
under subparagraph (A)(ii) with respect to an application, the Attorney
General shall approve or deny the application.
``(2) If an application described in this subsection is denied, the
Attorney General shall provide a written explanation of the basis of
denial to the applicant.'';
(3) in subsection (h)(2), as so redesignated, by striking
``subsection (f)'' each place it appears and inserting
``subsection (g)'';
(4) in subsection (j)(1), as so redesignated, by striking
``subsection (d)'' and inserting ``subsection (e)''; and
(5) in subsection (k), as so redesignated, by striking
``subsection (f)'' each place it appears and inserting
``subsection (g)''.
(b) Technical and Conforming Amendments.--
(1) The Controlled Substances Act (21 U.S.C. 801 et seq.) is
amended--
(A) in section 102 (21 U.S.C. 802)--
(i) in paragraph (52)(B)--
(I) by striking ``303(f)'' each
place it appears and inserting
``303(g)''; and
[[Page 136 STAT. 2263]]
(II) in clause (i), by striking
``(d), or (e)'' and inserting ``(e), or
(f)''; and
(ii) in paragraph (54), by striking ``303(f)''
each place it appears and inserting ``303(g)'';
(B) in section 302(g)(5)(A)(iii)(I)(bb) (21 U.S.C.
822(g)(5)(A)(iii)(I)(bb)), by striking ``303(f)'' and
inserting ``303(g)'';
(C) in section 304 (21 U.S.C. 824), by striking
``303(g)(1)'' each place it appears and inserting
``303(h)(1)'';
(D) in section 307(d)(2) (21 U.S.C. 827(d)(2)), by
striking ``303(f)'' and inserting ``303(g)'';
(E) in section 309A(a)(2) (21 U.S.C. 829a(a)(2)), in
the matter preceding subparagraph (A), by striking
``303(g)(2)'' and inserting ``303(h)(2)'';
(F) in section 311(h) (21 U.S.C. 831(h)), by
striking ``303(f)'' each place it appears and inserting
``303(g)'';
(G) in section 401(h)(2) (21 U.S.C. 841(h)(2)), by
striking ``303(f)'' each place it appears and inserting
``303(g)'';
(H) in section 403(c)(2)(B) (21 U.S.C.
843(c)(2)(B)), by striking ``303(f)'' and inserting
``303(g)''; and
(I) in section 512(c)(1) (21 U.S.C. 882(c)(1)) by
striking ``303(f)'' and inserting ``303(g)''.
(2) Section 1008(c) of the Controlled Substances Import and
Export Act (21 U.S.C. 958(c)) is amended--
(A) in paragraph (1), by striking ``303(d)'' and
inserting ``303(e)''; and
(B) in paragraph (2)(B), by striking ``303(h)'' and
inserting ``303(i)''.
(3) Title V of the Public Health Service Act (42 U.S.C.
290aa et seq.) is amended--
(A) in section 520E-4(c) (42 U.S.C. 290bb-36d(c)),
by striking ``303(g)(2)(B)'' and inserting
``303(h)(2)(B)''; and
(B) in section 544(a)(3) (42 U.S.C. 290dd-3(a)(3)),
by striking ``303(g)'' and inserting ``303(h)''.
(4) Title XVIII of the Social Security Act (42 U.S.C. 1395
et seq.) is amended--
(A) in section 1833(bb)(3)(B) (42 U.S.C.
1395l(bb)(3)(B)), by striking ``303(g)'' and inserting
``303(h)'';
(B) in section 1834(o)(3)(C)(ii) (42 U.S.C.
1395m(o)(3)(C)(ii)), by striking ``303(g)'' and
inserting ``303(h)''; and
(C) in section 1866F(c)(3)(C) (42 U.S.C. 1395cc-
6(c)(3)(C)), by striking ``303(g)'' and inserting
``303(h)''.
(5) Section 1903(aa)(2)(C)(ii) of the Social Security Act
(42 U.S.C. 1396b(aa)(2)(C)(ii)) is amended by striking
``303(g)'' each place it appears and inserting ``303(h)''.
SEC. 104. <<NOTE: 21 USC 823 note.>> ADEQUATE AND UNINTERRUPTED
SUPPLY.
(a) <<NOTE: Deadline. Assessment.>> In General.--On an annual
basis, the Attorney General, in consultation with the Secretary of
Health and Human Services, shall assess whether there is an adequate and
uninterrupted supply of marijuana, including of specific strains, for
research purposes.
(b) <<NOTE: Determination.>> Report to Congress.--If the Attorney
General, in consultation with the Secretary of Health and Human
Services, determines there is an inadequate or interrupted supply of
marijuana, including of specific strains for research purposes, the
Attorney General shall
[[Page 136 STAT. 2264]]
report to Congress within 60 days of the determination on at least--
(1) the factors contributing to the inadequate or
interrupted supply of marijuana;
(2) expected impacts of the inadequate or interrupted supply
on ongoing research protocols; and
(3) specific steps the Attorney General will take to restore
an adequate and uninterrupted supply of marijuana, including of
specific strains, for research purposes.
SEC. 105. <<NOTE: 21 USC 823 note.>> SECURITY REQUIREMENTS.
(a) In General.--An individual or entity engaged in researching
marijuana or its components shall store it in a securely locked,
substantially constructed cabinet.
(b) Requirements for Other Measures.--Any other security measures
required by the Attorney General to safeguard against diversion shall be
consistent with those required for practitioners conducting research on
other controlled substances in schedules I and II in section 202(c) of
the Controlled Substances Act (21 U.S.C. 812(c)) that have a similar
risk of diversion and abuse.
SEC. 106. <<NOTE: 42 USC 241 note.>> PROHIBITION AGAINST
REINSTATING INTERDISCIPLINARY REVIEW
PROCESS FOR NON-NIH-FUNDED RESEARCHERS.
The Secretary of Health and Human Services may not--
(1) reinstate the Public Health Service interdisciplinary
review process described in the guidance entitled ``Guidance on
Procedures for the Provision of Marijuana for Medical Research''
(issued on May 21, 1999); or
(2) require another review of scientific protocols that is
applicable only to research on marijuana or its components.
TITLE II--DEVELOPMENT OF FDA-APPROVED DRUGS USING CANNABIDIOL AND
MARIJUANA
SEC. 201. <<NOTE: 21 USC 823 note.>> MEDICAL RESEARCH ON
CANNABIDIOL.
Notwithstanding any provision of the Controlled Substances Act (21
U.S.C. 801 et seq.), the Safe and Drug-Free Schools and Communities Act
(20 U.S.C. 7101 et seq.), chapter 81 of title 41, United States Code, or
any other Federal law, an appropriately registered covered institution
of higher education, practitioner, or manufacturer may manufacture,
distribute, dispense, or possess marijuana or cannabidiol if the
marijuana or cannabidiol is manufactured, distributed, dispensed, or
possessed, respectively, for purposes of medical research for drug
development or subsequent commercial production in accordance with
section 202.
SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUCTION AND
DISTRIBUTION OF FOOD AND DRUG
ADMINISTRATION-APPROVED DRUGS.
The Attorney General shall register an applicant to manufacture or
distribute cannabidiol or marijuana for the purpose of commercial
production of a drug containing or derived from marijuana that is
approved by the Secretary of Health and Human Services under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), in
accordance with the applicable requirements
[[Page 136 STAT. 2265]]
under subsection (a) or (b) of section 303 of the Controlled Substances
Act (21 U.S.C. 823).
TITLE III--DOCTOR-PATIENT RELATIONSHIP
SEC. 301. <<NOTE: 21 USC 801 note.>> DOCTOR-PATIENT RELATIONSHIP.
It shall not be a violation of the Controlled Substances Act (21
U.S.C. 801 et seq.) for a State-licensed physician to discuss--
(1) the currently known potential harms and benefits of
marijuana derivatives, including cannabidiol, as a treatment
with the legal guardian of the patient of the physician if the
patient is a child; or
(2) the currently known potential harms and benefits of
marijuana and marijuana derivatives, including cannabidiol, as a
treatment with the patient or the legal guardian of the patient
of the physician if the patient is a legal adult.
TITLE IV--FEDERAL RESEARCH
SEC. 401. <<NOTE: 42 USC 284 note.>> FEDERAL RESEARCH.
(a) <<NOTE: Reports.>> In General.--Not later than 1 year after the
date of enactment of this Act, the Secretary of Health and Human
Services, in coordination with the Director of the National Institutes
of Health and the heads of other relevant Federal agencies, shall submit
to the Caucus on International Narcotics Control, the Committee on the
Judiciary, and the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce and the Committee
on the Judiciary of the House of Representatives a report on--
(1) the potential therapeutic effects of cannabidiol or
marijuana on serious medical conditions, including intractable
epilepsy;
(2) the potential effects of marijuana, including--
(A) the effect of increasing delta-9-
tetrahydrocannabinol levels on the human body and
developing adolescent brains; and
(B) the effect of various delta-9-
tetrahydrocannabinol levels on cognitive abilities, such
as those that are required to operate motor vehicles or
other heavy equipment; and
(3) <<NOTE: Recommenda- tions.>> the barriers associated
with researching marijuana or cannabidiol in States that have
legalized the use of such substances, which shall include--
(A) recommendations as to how such barriers might be
overcome, including whether public-private partnerships
or Federal-State research partnerships may or should be
implemented to provide researchers with access to
additional strains of marijuana and cannabidiol; and
(B) recommendations as to what safeguards must be in
place to verify--
(i) the levels of tetrahydrocannabinol,
cannabidiol, or other cannabinoids contained in
products obtained from such States is accurate;
and
(ii) that such products do not contain harmful
or toxic components.
[[Page 136 STAT. 2266]]
(b) Activities.--To the extent practicable, the Secretary of Health
and Human Services, either directly or through awarding grants,
contacts, or cooperative agreements, shall expand and coordinate the
activities of the National Institutes of Health and other relevant
Federal agencies to better determine the effects of cannabidiol and
marijuana, as outlined in the report submitted under paragraphs (1) and
(2) of subsection (a).
Approved December 2, 2022.
LEGISLATIVE HISTORY--H.R. 8454:
---------------------------------------------------------------------------
CONGRESSIONAL RECORD, Vol. 168 (2022):
July 26, considered and passed House.
Nov. 16, considered and passed Senate.
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