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<dc:title>116 S3201 : Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
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<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>
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<distribution-code display="yes">II</distribution-code><congress>116th CONGRESS</congress><session>2d Session</session><legis-num>S. 3201</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date>January 16, 2020</action-date><action-desc><sponsor name-id="S293">Mr. Graham</sponsor> (for himself, <cosponsor name-id="S221">Mrs. Feinstein</cosponsor>, <cosponsor name-id="S253">Mr. Durbin</cosponsor>, <cosponsor name-id="S153">Mr. Grassley</cosponsor>, <cosponsor name-id="S388">Ms. Hassan</cosponsor>, <cosponsor name-id="S287">Mr. Cornyn</cosponsor>, and <cosponsor name-id="S306">Mr. Menendez</cosponsor>) introduced the following bill; which was read twice, considered, read the third time, and passed</action-desc></action><legis-type>A BILL</legis-type><official-title>To extend the temporary scheduling order for fentanyl-related substances, and for other purposes.</official-title></form>
	<legis-body>
 <section id="idCDD497A65404452D9421D504DA4E6A7B" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act</short-title></quote>.</text> </section><section id="id4d77b57748b84cb38a8c05f8f5bf9351" section-type="subsequent-section"><enum>2.</enum><header>Extension of temporary order for fentanyl-related substances</header><text display-inline="no-display-inline">Notwithstanding any other provision of law, section 1308.11(h)(30) of title 21, Code of Federal Regulations, shall remain in effect until May 6, 2021.</text>
		</section><section id="ida31f4663c6744aa3ba72708eaf978783"><enum>3.</enum><header>Study and report on impacts of classwide scheduling</header>
 <subsection id="id68d74537386b4dc68936b70035b4a9ea"><enum>(a)</enum><header>Definition</header><text>In this section, the term <term>fentanyl-related substance</term> has the meaning given the term in section 1308.11(h)(30)(i) of title 21, Code of Federal Regulations.</text>
 </subsection><subsection id="id331e4c11ec1b44788509f33453c2dd37"><enum>(b)</enum><header>GAO report</header><text>The Comptroller General of the United States shall—</text> <paragraph id="id42b7d5c07f0d4500b527beb41b8eead2"><enum>(1)</enum><text>conduct a study of the classification of fentanyl-related substances as schedule I controlled substances under the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/801">21 U.S.C. 801</external-xref> et seq.), research on fentanyl-related substances, and the importation of fentanyl-related substances into the United States; and</text>
 </paragraph><paragraph id="id64E55C756B3743A18D4DC755D8206E97"><enum>(2)</enum><text>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—</text>
 <subparagraph id="id81DF816C560848E28AC1CC5B6C0F881F"><enum>(A)</enum><text>the Committee on the Judiciary of the Senate;</text> </subparagraph><subparagraph id="idEBB8ED618B264673992943C2D3EA334A"><enum>(B)</enum><text>the Committee on Health, Education, Labor, and Pensions of the Senate;</text>
 </subparagraph><subparagraph id="idBCD117EFEE0B43A5829649C45ECA6F32"><enum>(C)</enum><text>the Caucus on International Narcotics Control of the Senate;</text> </subparagraph><subparagraph id="idF94A5A081ABC4174847EE6BD5C9C1F20"><enum>(D)</enum><text>the Committee on the Judiciary of the House of Representatives; and</text>
 </subparagraph><subparagraph id="idC2E1738CC4234B99B3A6E6AF0D29F530"><enum>(E)</enum><text>the Committee on Energy and Commerce of the House of Representatives.</text> </subparagraph></paragraph></subsection><subsection id="idf86a61ca91f04e3086e5de6612d0ce41"><enum>(c)</enum><header>Requirements</header><text>The Comptroller General, in conducting the study and developing the report required under subsection (b), shall—</text>
 <paragraph id="id5f5c805a10624567bc03f96d1e8c0694"><enum>(1)</enum><text>evaluate class control of fentanyl-related substances, including—</text> <subparagraph id="id5b0fe3dbe666425c9e53f5c5f51f63d3"><enum>(A)</enum><text>the definition of the class of fentanyl-related substances in section 1308.11(h)(30)(i) of title 21, Code of Federal Regulations, including the process by which the definition was formulated;</text>
 </subparagraph><subparagraph id="idd00b6223c5614e188ce56aac75d57cb0"><enum>(B)</enum><text>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</text>
 </subparagraph><subparagraph id="id54414583b9004ce39128ade030746c75"><enum>(C)</enum><text>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 section 1308.11 of title 21, Code of Federal Regulations;</text>
 </subparagraph></paragraph><paragraph id="idd51c2d2516294c4e812a8e9313dfe86b"><enum>(2)</enum><text>review the impact or potential impact of controls on fentanyl-related substances on public health and safety, including on—</text>
 <subparagraph id="id3234554F76534EC885FE5422A6805330"><enum>(A)</enum><text>diversion risks, overdose deaths, and law enforcement encounters with fentanyl-related substances; and</text>
 </subparagraph><subparagraph id="id93aad27736094be9b29fcd2470e0cdb0"><enum>(B)</enum><text>Federal law enforcement investigations and prosecutions of offenses relating to fentanyl-related substances;</text>
 </subparagraph></paragraph><paragraph id="id669a4d4eb2474d1f918594c15a781f10"><enum>(3)</enum><text>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;</text>
 </paragraph><paragraph id="idcb1f16103c1c4261b64df44e3ae75e70"><enum>(4)</enum><text>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;</text>
 </paragraph><paragraph id="id1da8085003bf43aaba26cf25129d513b"><enum>(5)</enum><text>recommend best practices for accurate, swift, and permanent control of fentanyl-related substances, including—</text>
 <subparagraph id="ide078e6dd861a4383997db19cf67179b6"><enum>(A)</enum><text>how to quickly remove from the schedules under the Controlled Substances Act substances that are determined, upon discovery, to have no abuse potential; and</text>
 </subparagraph><subparagraph id="id76720bb008bc4c578b0cfbdae84902e6"><enum>(B)</enum><text>how to reschedule substances that are determined, upon discovery, to have a low abuse potential or potential accepted medical use;</text>
 </subparagraph></paragraph><paragraph id="idb6fa6028e115437b8dfe729e17da201e"><enum>(6)</enum><text>review the impact or potential impact of fentanyl-related controls by class on scientific and biomedical research; and</text>
 </paragraph><paragraph id="id380309502c2749a08489086dd1c6db60"><enum>(7)</enum><text>evaluate the processes used to obtain or modify Federal authorization to conduct research with fentanyl-related substances, including by—</text>
 <subparagraph id="idc3740c4abdc649f7b6268125275c54a4"><enum>(A)</enum><text>identifying opportunities to reduce unnecessary burdens on persons seeking to research fentanyl-related substances;</text>
 </subparagraph><subparagraph id="ide1e19ae73df645ecb7420d258cd1c767"><enum>(B)</enum><text>identifying opportunities to reduce any redundancies in the responsibilities of Federal agencies;</text> </subparagraph><subparagraph id="idb5726b7f1e884de49ddb9e42581e1202"><enum>(C)</enum><text>identifying opportunities to reduce any inefficiencies related to the processes used to obtain or modify Federal authorization to conduct research with fentanyl-related substances;</text>
 </subparagraph><subparagraph id="id212254A682D143E1A81897A073A643D6"><enum>(D)</enum><text>identifying opportunities to improve the protocol review and approval process conducted by Federal agencies; and</text>
 </subparagraph><subparagraph id="idf3e442c7aa9b483f83f33afdc4042129"><enum>(E)</enum><text>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.</text>
 </subparagraph></paragraph></subsection><subsection id="idc66b3545aa364549b262ef461263bf2e"><enum>(d)</enum><header>Input from certain Federal agencies</header><text>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.</text>
 </subsection><subsection id="idF2E2FD0D71C44BFB857AA8AF28661558"><enum>(e)</enum><header>Information from Federal agencies</header><text>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).</text>
 </subsection><subsection id="idd3f1d4dbbab44b25834edadbcf3ecad1"><enum>(f)</enum><header>Input from certain non-Federal entities</header><text>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—</text>
 <paragraph id="id20775fe2992044c3873f819b52f87a02"><enum>(1)</enum><text>the scientific and medical research community;</text> </paragraph><paragraph id="idafcd3b943c6444a98306112e5da77bc5"><enum>(2)</enum><text>the State and local law enforcement community; and</text>
 </paragraph><paragraph id="id8a6366b221184bbc83e3951e64d5f9c3"><enum>(3)</enum><text>the civil rights and criminal justice reform communities.</text></paragraph></subsection></section></legis-body></bill> 

