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<meta><dc:title>116 S 3201 ENR: To extend the temporary scheduling order for fentanyl-related substances, and for other purposes.</dc:title>
<dc:type>Senate Bill</dc:type><docNumber>3201</docNumber><citableAs>116 S 3201 ENR</citableAs>
<citableAs>116s3201enr</citableAs>
<citableAs>116 S. 3201 ENR</citableAs>
<dc:creator>United States Senate</dc:creator><dc:publisher>United States Government Publishing Office</dc:publisher><dc:format>text/xml</dc:format><dc:language>EN</dc:language><dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights><docStage>ENR</docStage>
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<congress>116</congress><session>2</session><publicPrivate>public</publicPrivate>
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<preface><dc:type>S.</dc:type><docNumber>3201</docNumber>

<congress style="-uslm-lc:I665502" value="116">One Hundred Sixteenth Congress of the United States of America</congress><session style="-uslm-lc:I665503" value="2">A T T  H  E S  E  C  O  N  D S  E  S  S  I  O  N</session>
<enrolledDateline style="-uslm-lc:I665504">Begun and held at the City of Washington on Friday, the third day of January, two thousand and twenty</enrolledDateline>
</preface>
<main>
<longTitle>
<docTitle class="centered fontsize18" style="-uslm-lc:I665505">An Act</docTitle>
<officialTitle class="centered fontsize8" style="-uslm-lc:I665511">To extend the temporary scheduling order for fentanyl-related substances, and for other purposes.<?GPOvSpace 08?></officialTitle>
</longTitle>
<enactingFormula style="-uslm-lc:I650120">  Be it enacted by the Senate and House of Representa­tives of the United States of America in Congress assembled,</enactingFormula>
<section id="d117234e62" identifier="/us/bill/116/s/3201/s1" style="-uslm-lc:I650146"><num value="1">SECTION 1. </num><heading>SHORT TITLE.</heading><content style="-uslm-lc:I650120">  This Act may be cited as the “<shortTitle role="act">Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act</shortTitle>”.</content></section>
<section id="d117234e72" identifier="/us/bill/116/s/3201/s2" style="-uslm-lc:I650141"><num value="2">SEC. 2. </num><heading>EXTENSION OF TEMPORARY ORDER FOR FENTANYL-RELATED SUBSTANCES.</heading><content style="-uslm-lc:I650120">  Notwithstanding any other provision of law, <ref href="/us/cfr/t21/s1308.11/h/30">section 1308.11(h)(30) of title 21, Code of Federal Regulations</ref>, shall remain in effect until May 6, 2021.</content></section>
<section id="d117234e82" identifier="/us/bill/116/s/3201/s3" style="-uslm-lc:I650141"><num value="3">SEC. 3. </num><heading>STUDY AND REPORT ON IMPACTS OF CLASSWIDE SCHEDULING.</heading><subsection class="indentUp0 firstIndent1 fontsize10" id="d117234e86" identifier="/us/bill/116/s/3201/s3/a" role="definitions" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="a">(a) </num><heading><inline class="smallCaps">Definition</inline>.—</heading><content>In this section, the term “<term>fentanyl-related substance</term>” has the meaning given the term in <ref href="/us/cfr/t21/s1308.11/h/30/i">section 1308.11(h)(30)(i) of title 21, Code of Federal Regulations</ref>.</content></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d117234e98" identifier="/us/bill/116/s/3201/s3/b" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="b">(b) </num><heading><inline class="smallCaps">GAO Report</inline>.—</heading><chapeau>The Comptroller General of the United States shall—</chapeau><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e106" identifier="/us/bill/116/s/3201/s3/b/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><content>conduct a study of the classification of fentanyl-related substances as schedule I controlled substances under the Controlled Substances Act (<ref href="/us/usc/t21/s801/etseq">21 U.S.C. 801 et seq.</ref>), research on fentanyl-related substances, and the importation of fentanyl-related substances into the United States; and</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e114" identifier="/us/bill/116/s/3201/s3/b/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>not later than 1 year after the date of enactment of this Act, submit a report on the results of the study conducted under paragraph (1) to—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e118" identifier="/us/bill/116/s/3201/s3/b/2/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>the Committee on the Judiciary of the Senate;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e122" identifier="/us/bill/116/s/3201/s3/b/2/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>the Committee on Health, Education, Labor, and Pensions of the Senate;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e126" identifier="/us/bill/116/s/3201/s3/b/2/C" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">(C) </num><content>the Caucus on International Narcotics Control of the Senate;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e130" identifier="/us/bill/116/s/3201/s3/b/2/D" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="D">(D) </num><content>the Committee on the Judiciary of the House of Representatives; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e134" identifier="/us/bill/116/s/3201/s3/b/2/E" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="E">(E) </num><content>the Committee on Energy and Commerce of the House of Representatives.</content></subparagraph></paragraph></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d117234e138" identifier="/us/bill/116/s/3201/s3/c" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="c">(c) </num><heading><inline class="smallCaps">Requirements</inline>.—</heading><chapeau>The Comptroller General, in conducting the study and developing the report required under subsection (b), shall—</chapeau><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e146" identifier="/us/bill/116/s/3201/s3/c/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>evaluate class control of fentanyl-related substances, including—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e150" identifier="/us/bill/116/s/3201/s3/c/1/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>the definition of the class of fentanyl-related substances in <ref href="/us/cfr/t21/s1308.11/h/30/i">section 1308.11(h)(30)(i) of title 21, Code of Federal Regulations</ref>, including the process by which the definition was formulated;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e158" identifier="/us/bill/116/s/3201/s3/c/1/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>the potential for classifying fentanyl-related substances with no, or low, abuse potential, or potential accepted medical use, as schedule I controlled substances when scheduled as a class; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e162" identifier="/us/bill/116/s/3201/s3/c/1/C" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">(C) </num><content>any known classification of fentanyl-related substances with no, or low, abuse potential, or potential accepted medical use, as schedule I controlled substances that has resulted from the scheduling action of the Drug Enforcement Administration that added paragraph (h)(30) to <ref href="/us/cfr/t21/s1308.11">section 1308.11 of title 21, Code of Federal Regulations</ref>;</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e170" identifier="/us/bill/116/s/3201/s3/c/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>review the impact or potential impact of controls on fentanyl-related substances on public health and safety, including on—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e174" identifier="/us/bill/116/s/3201/s3/c/2/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>diversion risks, overdose deaths, and law enforcement encounters with fentanyl-related substances; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e178" identifier="/us/bill/116/s/3201/s3/c/2/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>Federal law enforcement investigations and prosecutions of offenses relating to fentanyl-related substances;</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e182" identifier="/us/bill/116/s/3201/s3/c/3" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="3">(3) </num><content>review the impact of international regulatory controls on fentanyl-related substances on the supply of such substances to the United States, including by the Government of the People’s Republic of China;</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e186" identifier="/us/bill/116/s/3201/s3/c/4" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="4">(4) </num><content>review the impact or potential impact of screening and other interdiction efforts at points of entry into the United States on the importation of fentanyl-related substances into the United States;</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e190" identifier="/us/bill/116/s/3201/s3/c/5" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="5">(5) </num><chapeau>recommend best practices for accurate, swift, and permanent control of fentanyl-related substances, including—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e194" identifier="/us/bill/116/s/3201/s3/c/5/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>how to quickly remove from the schedules under the Controlled Substances Act substances that are determined, upon discovery, to have no abuse potential; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e198" identifier="/us/bill/116/s/3201/s3/c/5/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>how to reschedule substances that are determined, upon discovery, to have a low abuse potential or potential accepted medical use;</content></subparagraph></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e202" identifier="/us/bill/116/s/3201/s3/c/6" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="6">(6) </num><content>review the impact or potential impact of fentanyl-related controls by class on scientific and biomedical research; and</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e206" identifier="/us/bill/116/s/3201/s3/c/7" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="7">(7) </num><chapeau>evaluate the processes used to obtain or modify Federal authorization to conduct research with fentanyl-related substances, including by—</chapeau><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e210" identifier="/us/bill/116/s/3201/s3/c/7/A" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="A">(A) </num><content>identifying opportunities to reduce unnecessary burdens on persons seeking to research fentanyl-related substances;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e214" identifier="/us/bill/116/s/3201/s3/c/7/B" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="B">(B) </num><content>identifying opportunities to reduce any redundancies in the responsibilities of Federal agencies;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e218" identifier="/us/bill/116/s/3201/s3/c/7/C" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="C">(C) </num><content>identifying opportunities to reduce any inefficiencies related to the processes used to obtain or modify Federal authorization to conduct research with fentanyl-related substances;</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e222" identifier="/us/bill/116/s/3201/s3/c/7/D" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="D">(D) </num><content>identifying opportunities to improve the protocol review and approval process conducted by Federal agencies; and</content></subparagraph><subparagraph class="indentUp1 firstIndent1 fontsize10" id="d117234e226" identifier="/us/bill/116/s/3201/s3/c/7/E" style="-uslm-lc:I650124"><num style="-uslm-lc:emspace2" value="E">(E) </num><content>evaluating the degree, if any, to which establishing processes to obtain or modify a Federal authorization to conduct research with a fentanyl-related substance that are separate from the applicable processes for other schedule I controlled substances could exacerbate burdens or lead to confusion among persons seeking to research fentanyl-related substances or other schedule I controlled substances.</content></subparagraph></paragraph></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d117234e230" identifier="/us/bill/116/s/3201/s3/d" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="d">(d) </num><heading><inline class="smallCaps">Input From Certain Federal Agencies</inline>.—</heading><content>In conducting the study and developing the report under subsection (b), the Comptroller General shall consider the views of the Department of Health and Human Services and the Department of Justice.</content></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d117234e238" identifier="/us/bill/116/s/3201/s3/e" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="e">(e) </num><heading><inline class="smallCaps">Information From Federal Agencies</inline>.—</heading><content>Each Federal department or agency shall, in accordance with applicable procedures for the appropriate handling of classified information, promptly provide reasonable access to documents, statistical data, and any other information that the Comptroller General determines is necessary to conduct the study and develop the report required under subsection (b).</content></subsection><subsection class="indentUp0 firstIndent1 fontsize10" id="d117234e246" identifier="/us/bill/116/s/3201/s3/f" style="-uslm-lc:I650120"><num style="-uslm-lc:emspace2" value="f">(f) </num><heading><inline class="smallCaps">Input From Certain Non-Federal Entities</inline>.—</heading><chapeau>In conducting the study and developing the report under subsection (b), the Comptroller General shall consider the views of experts from certain non-Federal entities, including experts from—</chapeau><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e254" identifier="/us/bill/116/s/3201/s3/f/1" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="1">(1) </num><content>the scientific and medical research community;</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e258" identifier="/us/bill/116/s/3201/s3/f/2" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="2">(2) </num><content>the State and local law enforcement community; and</content></paragraph><paragraph class="indentUp1 firstIndent1 fontsize10" id="d117234e262" identifier="/us/bill/116/s/3201/s3/f/3" style="-uslm-lc:I650122"><num style="-uslm-lc:emspace2" value="3">(3) </num><content>the civil rights and criminal justice reform communities.</content></paragraph></subsection></section>
</main>
<signatures>
<signature><role style="-uslm-lc:I650114">Speaker of the House of Representatives.</role></signature>
<signature><role style="-uslm-lc:I650114">Vice President of the United States and  President of the Senate.</role></signature>
</signatures>
</bill>