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<dc:title>117 S1457 IS: Support, Treatment, and Overdose Prevention of Fentanyl Act of 2021</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2021-04-29</dc:date>
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<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>117th CONGRESS</congress><session>1st Session</session><legis-num>S. 1457</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20210429">April 29, 2021</action-date><action-desc><sponsor name-id="S369">Mr. Markey</sponsor> (for himself, <cosponsor name-id="S366">Ms. Warren</cosponsor>, <cosponsor name-id="S316">Mr. Whitehouse</cosponsor>, <cosponsor name-id="S354">Ms. Baldwin</cosponsor>, and <cosponsor name-id="S370">Mr. Booker</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To establish programs to address addiction and overdoses caused by illicit fentanyl and other opioids, and for other purposes. </official-title></form><legis-body style="OLC" display-enacting-clause="yes-display-enacting-clause" id="HF813B440EF284ECB96D26F3DD79CD51E"><section section-type="section-one" id="HAC8B7F7AEEF240CAA7B858874534C654"><enum>1.</enum><header>Short title; table of contents</header><subsection id="HDDF107A570CB4F1C92BEEDBA7670D59F"><enum>(a)</enum><header>Short title</header><text>This Act may be cited as the <quote><short-title>Support, Treatment, and Overdose Prevention of Fentanyl Act of 2021</short-title></quote> or the <quote><short-title>STOP Fentanyl Act of 2021</short-title></quote>.</text></subsection><subsection id="H0024F8864A9145EAA0D79D5D73058A77"><enum>(b)</enum><header>Table of contents</header><text>The table of contents for this Act is as follows:</text><toc><toc-entry level="section" idref="HAC8B7F7AEEF240CAA7B858874534C654">Sec. 1. Short title; table of contents.</toc-entry><toc-entry level="section" idref="HF89536CA17C8431BADF24F51A11EF693">Sec. 2. Definitions.</toc-entry><toc-entry level="section" idref="HD868C14DB13741AF9FE68A2D85180C84">Sec. 3. Findings.</toc-entry><toc-entry level="title" idref="H472AD2052A9E41B1803363F4A9E58289">TITLE I—Fentanyl Research and Education</toc-entry><toc-entry level="section" idref="HB162A46343F04245A455769346FCB23B">Sec. 101. Enhanced fentanyl surveillance.</toc-entry><toc-entry level="section" idref="H3FCD1F4AF7CC466F9D0B05826CBC5801">Sec. 102. Collection of overdose data.</toc-entry><toc-entry level="section" idref="H70593FAF66CF4E8FBC1BC0C151355DF2">Sec. 103. Fentanyl detection.</toc-entry><toc-entry level="section" idref="HB765E335E2F34008872B47D1ACDBBA6D">Sec. 104. GAO report on international mail and cargo screening.</toc-entry><toc-entry level="section" idref="H661C9D2E431A40B7A149916C9AA5880B">Sec. 105. Contingency management program.</toc-entry><toc-entry level="title" idref="HF5B3064DDE9541B38DB0D819A6722530">TITLE II—Overdose Prevention and Substance Use Disorder Treatment Programs</toc-entry><toc-entry level="section" idref="H5B2F054856134EEE93DEB6A54C611466">Sec. 201. NAM report on overdose prevention centers.</toc-entry><toc-entry level="section" idref="HCFE2662C12B643E58F0DC8498F7DBEFC">Sec. 202. Naloxone.</toc-entry><toc-entry level="section" idref="HC9F4590B92E848C8BB8A7730AF93164E">Sec. 203. Good Samaritan immunity.</toc-entry><toc-entry level="section" idref="H5E050A09C58242C1A4F4000C03EB9676">Sec. 204. Medication-assisted treatment.</toc-entry><toc-entry level="section" idref="H40DEBAA00151495783E427D925012B8C">Sec. 205. Telehealth for substance use disorder treatment.</toc-entry><toc-entry level="section" idref="H661F0B4AEA5E4DD083A7FE140E5BF344">Sec. 206. Grant program on harms of drug misuse.</toc-entry><toc-entry level="section" idref="H62F59E25F88F4040B822AF828EDFE137">Sec. 207. Opioid treatment education.</toc-entry><toc-entry level="title" idref="HF60EFEC615A947A1B23F6BAD91009B9C">TITLE III—Public Health Data and Training Support for Fentanyl Detection</toc-entry><toc-entry level="section" idref="H3DEAD5EAFE344A3B8AAFD22CB3F56E8E">Sec. 301. Public health support for law enforcement.</toc-entry><toc-entry level="section" idref="H67037E4ADC784CCFB98AC188301191C9">Sec. 302. Report on countries that produce synthetic drugs.</toc-entry><toc-entry level="section" idref="H0DE3CE16B7314377958B6DEEAEF51C5A">Sec. 303. Grants to improve public health surveillance in forensic laboratories.</toc-entry></toc></subsection></section><section id="HF89536CA17C8431BADF24F51A11EF693"><enum>2.</enum><header>Definitions</header><text display-inline="no-display-inline">In this Act, except as otherwise provided:</text><paragraph id="H81B258652E9245DABB07050A6168EFDB"><enum>(1)</enum><text>The term <term>Assistant Secretary</term> means the Assistant Secretary for Mental Health and Substance Use.</text></paragraph><paragraph id="HFF4C11C38AA94DA28E0B6A99A2FC2BD7"><enum>(2)</enum><text>The term <term>Secretary</term> means the Secretary of Health and Human Services.</text></paragraph><paragraph id="HE132125B5E4F44F697EE1E66ACEE0BEF"><enum>(3)</enum><text display-inline="yes-display-inline">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 (or successor regulations).</text></paragraph></section><section id="HD868C14DB13741AF9FE68A2D85180C84"><enum>3.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds the following: </text><paragraph id="H88A233ED2F3D461BA966184D2FB033D5"><enum>(1)</enum><text>The opioid epidemic has led to a rise in overdose deaths across the Nation.</text></paragraph><paragraph id="H4F99F40EF255425CAD31FF79E09815EF"><enum>(2)</enum><text>In 2017, the number of overdose deaths involving opioids, including fentanyl, was 6 times higher than in 1999.</text></paragraph><paragraph id="H9D8CCD9FB3144FDD929E457CD3C4BADF"><enum>(3)</enum><text>The age-adjusted rate of drug overdose deaths involving synthetic opioids other than methadone increased by 10 percent from 2017 to 2018.</text></paragraph><paragraph id="HF302AD33F4D048AB8C32FF9842B6888B"><enum>(4)</enum><text display-inline="yes-display-inline">The COVID–19 pandemic has been associated with substance use. According to the Centers for Disease Control and Prevention (CDC), 13 percent of surveyed adults had started or increased substance use to cope with stress or emotions related to COVID–19.</text></paragraph><paragraph id="HDB39B3B07B1647B3BE7E8EE55888E7D7"><enum>(5)</enum><text>Federal agencies, along with Federal, State, and local lawmakers, have worked together to respond to the rise in overdose deaths through increased funding and targeted policy initiatives.</text></paragraph><paragraph id="H9380438940564E7C8906C2EBA9CFBA78"><enum>(6)</enum><text>This includes the successful passage of the Comprehensive Addiction and Recovery Act of 2016 (CARA), the 21st Century Cures Act, and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT for Patient and Communities Act).</text></paragraph><paragraph id="HD1EAE658F6B44C33A39E2FA9C5929C37"><enum>(7)</enum><text>These efforts have helped prevent, treat, and combat the opioid epidemic, but the rise in overdose deaths involving synthetic opioids like fentanyl means that not all communities are seeing a reduction in fatalities.</text></paragraph><paragraph id="H6F01ACFE8CAC4861B232D4F2A8E1A1CE"><enum>(8)</enum><text>Drug overdose deaths in the United States involving fentanyl have risen from 2011 through 2016, growing from 1,600 fentanyl overdose related deaths in 2011 and 2012 to 18,000 deaths in 2016.</text></paragraph><paragraph id="HADE7BA540C7747F293C58C78F34A9895"><enum>(9)</enum><text>This rise in fentanyl overdose related deaths has disproportionately impacted communities of color.</text></paragraph><paragraph id="H55F3A7D500D5425CBA3719ADF50583BD"><enum>(10)</enum><text display-inline="yes-display-inline">According to the Centers for Disease Control and Prevention (CDC), drug overdose death rates involving fentanyl for non-Hispanic African Americans had the largest annual percentage increase from 2011 to 2016 at 140.6 percent per year, followed by Hispanic persons at 118.3 percent per year. Fentanyl-involved overdose rates for non-Hispanic White persons increased by 108.8 percent from 2013 to 2016.</text></paragraph><paragraph id="HC9E259B011294582B5656E173187B420"><enum>(11)</enum><text>According to the CDC, rates of drug overdose deaths involving fentanyl increased exponentially from 2011 through 2016 for most regions of the United States.</text></paragraph><paragraph id="HD3350D3FDB4D49D199EDB76A99E22B8C"><enum>(12)</enum><text display-inline="yes-display-inline">Fentanyl is increasingly being identified in nonopioid substances, like methamphetamine and cocaine.</text></paragraph><paragraph id="HADB71AA2F579450089A965F3B9C09477"><enum>(13)</enum><text>By 2017, over half of heroin and cocaine overdose death records involved synthetic opioids.</text></paragraph><paragraph id="HB0EF8299744F44B5B7320A07CDB3F8A7"><enum>(14)</enum><text>Previous policies to counter the widespread use of illicit substances through tougher sentencing guidelines disproportionately impact communities of color.</text></paragraph><paragraph id="H49CFFBCC6971421E8F3D392623E7EA1E"><enum>(15)</enum><text>There is a growing need for a comprehensive plan focused on monitoring, researching, treating, and preventing fentanyl overdose deaths.</text></paragraph><paragraph id="H3255FA11E57641FB8B1B5316B216391E"><enum>(16)</enum><text>Taking a public health approach to reversing overdose death trends and promoting equity should emphasize increasing research and expanding access to treatment.</text></paragraph></section><title id="H472AD2052A9E41B1803363F4A9E58289"><enum>I</enum><header>Fentanyl Research and Education</header><section id="HB162A46343F04245A455769346FCB23B"><enum>101.</enum><header>Enhanced fentanyl surveillance</header><subsection id="H80388982C1934193BBB4926FF41000DB"><enum>(a)</enum><header>In general</header><text>The Director of the Centers for Disease Control and Prevention shall enhance the drug surveillance program of the Centers by—</text><paragraph id="H2735AD77D1D140BBBFAAF8DAD25F11EA"><enum>(1)</enum><text>expanding such surveillance program to include all 50 States, the territories of the United States, and all Tribes and Tribal organizations;</text></paragraph><paragraph id="HD1DCCC66A0424BA5B28D97F8F20D5C29"><enum>(2)</enum><text display-inline="yes-display-inline">increasing and accelerating the collection of data on fentanyl, fentanyl-related substances, other synthetic opioids, and new emerging drugs of abuse, including related overdose data from medical examiners and drug treatment admissions and information regarding drug seizures; and</text></paragraph><paragraph id="H6A65C4FE045D4F37AC466F4DCEA8E4BB"><enum>(3)</enum><text display-inline="yes-display-inline">utilizing available and emerging information on fentanyl, fentanyl-related substances, other synthetic opioids, and new emerging drugs of abuse, including information from—</text><subparagraph id="H6C031D19AFCB4F1AA4B11DFB415D0510"><enum>(A)</enum><text>the National Drug Early Warning System;</text></subparagraph><subparagraph id="HD07DF8071A6C4E36ABD1DE341508FEA5"><enum>(B)</enum><text>State and local public health authorities;</text></subparagraph><subparagraph id="HB6B177675CBC487FBCEA8335950560D8"><enum>(C)</enum><text>Federal, State, and local public health laboratories; and</text></subparagraph><subparagraph id="HADBCB49A7F8A42A2B5BCD7389B11FAD0"><enum>(D)</enum><text>drug seizures by Federal, State, and local law enforcement agencies, including information from the National Seizure System and the National Forensic Laboratory Information System of the Drug Enforcement Administration.</text></subparagraph></paragraph></subsection><subsection id="HFA9E3887E158458A988C4188EAC974F0"><enum>(b)</enum><header>Information sharing</header><text>The Director of the Centers for Disease Control and Prevention shall share the information collected through the drug surveillance program of the Centers with entities including the Office of National Drug Control Policy, State and local public health agencies, and Federal, State, and local law enforcement agencies.</text></subsection><subsection id="H021CD085867A4FA8871B800C2EE8546C"><enum>(c)</enum><header>Law enforcement reporting</header><text>Each Federal law enforcement agency shall report information on all drug seizures by that agency to the Drug Enforcement Administration for inclusion in the National Seizure System.</text></subsection><subsection id="H9B0BAFBF72E444ACAD7F4A5162F37B99"><enum>(d)</enum><header>GAO report</header><text>Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall—</text><paragraph id="H56264CECCE6049A999034E628EF55CD0"><enum>(1)</enum><text>publish a report analyzing how Federal agencies can improve their collection, reporting, sharing, and analytic use of drug seizure data across Federal agencies and with State and local governments; and</text></paragraph><paragraph id="H5851C668835E474AAF0BEACC4A097535"><enum>(2)</enum><text>include in such report an analysis of how well available data on drug seizures can measure progress toward reducing drug trafficking into and within the country, as outlined in strategies such as the National Drug Control Strategy of the Office of National Drug Control Policy.</text></paragraph></subsection><subsection id="HAE030ED7A6404E2CAD125CC3DC9CAA57"><enum>(e)</enum><header>Authorization of appropriations</header><text>To carry out this section, there is authorized to be appropriated $125,000,000 for each of fiscal years 2022 through 2026.</text></subsection></section><section commented="no" id="H3FCD1F4AF7CC466F9D0B05826CBC5801"><enum>102.</enum><header>Collection of overdose data</header><subsection commented="no" id="H1F0636274A8F42C78679C9293D331BBD"><enum>(a)</enum><header>In general</header><text>Not later than one year after the date of enactment of this Act, the Secretary shall conduct a study on how to most efficiently track overdoses by type of drug, including fentanyl.</text></subsection><subsection commented="no" id="H4D1B0FB8AD4D42ECBB0001D9F02FCA9E"><enum>(b)</enum><header>Grant program</header><paragraph commented="no" id="HE89747367BF0454A8D2274D01FFB9882"><enum>(1)</enum><header>In general</header><text>Upon completion of the study under subsection (a), and taking into consideration the results of such study, the Secretary shall award grants to States to facilitate the collection of data with respect to fentanyl-involved overdoses.</text></paragraph><paragraph id="H11748BA387DD45D08DDD13A83883AFA2"><enum>(2)</enum><header>Requirement</header><text>As a condition on receipt of a grant under this subsection, an applicant shall agree to share the data collected pursuant to the grant with the Centers for Disease Control and Prevention.</text></paragraph><paragraph commented="no" id="H5C7DF69D1EAC41BFAFD6B25168F2D579"><enum>(3)</enum><header>Preference</header><text>In awarding grants under this subsection, the Secretary shall give preference to applicants whose grant proposals demonstrate the greatest need for collecting timely and accurate data on overdoses.</text></paragraph></subsection></section><section id="H70593FAF66CF4E8FBC1BC0C151355DF2"><enum>103.</enum><header>Fentanyl detection</header><subsection id="H7A8929B39A0F47918F38E09C8AE20058"><enum>(a)</enum><header>Testing of contaminants</header><paragraph id="H7B60FDFEF284439AA3568D35F0D20681"><enum>(1)</enum><header>In general</header><text>The Secretary, acting through the Assistant Secretary and in coordination with the Director of the Centers for Disease Control and Prevention, shall establish a pilot program through which 5 entities, in 5 States representing diverse regions, use chemical screening devices to identify contaminants, including fentanyl and fentanyl-related substances, in illicit street drugs.</text></paragraph><paragraph id="H9BFC6C2208274B3F802230D1BE303241"><enum>(2)</enum><header>Evaluation</header><text display-inline="yes-display-inline">Not later than the end of fiscal year 2025, the Secretary shall—</text><subparagraph id="HF58C8C1AAB2C4C18B5DE22A951990336"><enum>(A)</enum><text>complete an evaluation of the most effective ways of expanding the pilot program under this subsection to decrease rates of overdose; and</text></subparagraph><subparagraph id="H7ECBA82022524E2BBE04019A65DE86C0"><enum>(B)</enum><text>submit a report to the appropriate congressional committees on the results of such evaluation.</text></subparagraph></paragraph><paragraph id="HF147A0729FB4489B9B35308E814139AE"><enum>(3)</enum><header>Definition</header><text> In this subsection, the term <term>chemical screening device</term> means an infrared spectrophotometer, mass spectrometer, nuclear magnetic resonance spectrometer, Raman spectrophotometer, ion mobility spectrometer, or any other device or other technology that is able to determine the presence of, or identify, one or more contaminants in illegal street drugs.</text></paragraph><paragraph id="HF653BC3238C743A6BFD36BDB2C08643B"><enum>(4)</enum><header>Authorization of appropriations</header><text>To carry out this subsection, there is authorized to be appropriated $5,000,000 for each of fiscal years 2022 through 2026.</text></paragraph></subsection><subsection id="HC9A5CB58C6AE4DF0B06816EAD98258E0"><enum>(b)</enum><header>Research into technologies</header><paragraph id="HF0568E8168F947C89044F9CFCBE088A9"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall conduct or support research for the development or improvement of portable and affordable technologies related to testing drugs for fentanyl and fentanyl-related substances, including chemical screening device methods.</text></paragraph><paragraph id="H11A648655E714B15A0FEC363230AFA2F"><enum>(2)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this subsection, there is authorized to be appropriated $25,000,000 for each of fiscal years 2022 through 2026.</text></paragraph></subsection></section><section id="HB765E335E2F34008872B47D1ACDBBA6D"><enum>104.</enum><header>GAO report on international mail and cargo screening</header><text display-inline="no-display-inline">Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report reviewing the impact of illicit fentanyl and fentanyl-related substances imported through international mail and cargo, including discussion of the following:</text><paragraph id="H5E50A445A7014BD58739425B9E565761"><enum>(1)</enum><text display-inline="yes-display-inline">The volume of fentanyl and fentanyl-related substances being imported into the United States by means of international mail and cargo.</text></paragraph><paragraph id="H16989763D37647F68EC97755DA3DC3D0"><enum>(2)</enum><text>The potential impact of increased screening for illicit fentanyl and fentanyl-related substances on—</text><subparagraph id="H86410AEDE789474183FCD98573CDDCA5"><enum>(A)</enum><text>deterring drug trafficking in the United States;</text></subparagraph><subparagraph id="H99B13A1DC42D4915A885A0792C60247A"><enum>(B)</enum><text display-inline="yes-display-inline">interdicting fentanyl and fentanyl-related substances that were manufactured outside of the United States and intended, or attempted, to be imported into the United States;</text></subparagraph><subparagraph id="HB84412A9D8F842EBBD8FA3B5D17EC6DA"><enum>(C)</enum><text display-inline="yes-display-inline">the number of Federal criminal prosecutions based on the manufacture, distribution, or possession of fentanyl or fentanyl-related substances, disaggregated by demographic data, including sex, race, and ethnicity, of the offender;</text></subparagraph><subparagraph id="H4EEEC9507679462A8731D16F5A6D79B3"><enum>(D)</enum><text>the charges brought in prosecutions described in subparagraph (C);</text></subparagraph><subparagraph id="H032A61852D7F4D29B3B939EBFAC72367"><enum>(E)</enum><text>the impacts of prosecutions described in subparagraph (C) on reducing demand for, and availability to users of, fentanyl and fentanyl-related substances; and</text></subparagraph><subparagraph id="H609B920363554E5281BBF361BECF44FF"><enum>(F)</enum><text display-inline="yes-display-inline">the development of new fentanyl-related substances.</text></subparagraph></paragraph><paragraph id="H9590AFAEF39F4A259B31264DB0ED29DA" commented="no" display-inline="no-display-inline"><enum>(3)</enum><text>The need for non-invasive technology in screening for fentanyl and fentanyl-related substances, taking into account the findings under paragraphs (1) and (2).</text></paragraph></section><section id="H661C9D2E431A40B7A149916C9AA5880B"><enum>105.</enum><header>Contingency management program</header><subsection id="H639685CF53CC4FC9AFD98D6A3661C0C5"><enum>(a)</enum><header>In general</header><text>The Secretary shall—</text><paragraph id="HD3635EC6222A4D1A840F39A076B3D587"><enum>(1)</enum><text>develop and implement a program of using contingency management principles to discourage the use of illicit drugs; and</text></paragraph><paragraph id="HB209AE541BF54373ABCE55924C45943A"><enum>(2)</enum><text>as part of such program use incentive-based interventions—</text><subparagraph id="H7A6BA70673034DACBC9F50F158B3CA4F"><enum>(A)</enum><text>to increase substance misuse treatment retention; and</text></subparagraph><subparagraph id="H05D351DDB0224157BC75DA2224E06976"><enum>(B)</enum><text display-inline="yes-display-inline">to promote adherence to treatment goals, including negative urinalysis.</text></subparagraph></paragraph></subsection><subsection id="H25458CFDCFBF473BBE01568699AAADBB"><enum>(b)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there is authorized to be appropriated $25,000,000 for each of fiscal years 2022 through 2026.</text></subsection></section></title><title id="HF5B3064DDE9541B38DB0D819A6722530"><enum>II</enum><header>Overdose Prevention and Substance Use Disorder Treatment Programs</header><section id="H5B2F054856134EEE93DEB6A54C611466"><enum>201.</enum><header>NAM report on overdose prevention centers</header><text display-inline="no-display-inline">Not later than one year after the date of enactment of this Act, the Comptroller General of the United States shall enter into an arrangement with the National Academy of Medicine (or, if the Academy declines, another appropriate entity) to—</text><paragraph id="HAE1BB090C55642CCAA4AC25014DCC7E1"><enum>(1)</enum><text display-inline="yes-display-inline">submit to Congress a report on overdose prevention centers; and</text></paragraph><paragraph id="H71C6BE3F926F4752930C327FB0D5A983"><enum>(2)</enum><text>include in such report—</text><subparagraph id="H9777CC71D1CA4171B5FEA2C5FFD88186"><enum>(A)</enum><text display-inline="yes-display-inline">a review of the effectiveness of legally authorized overdose prevention centers in the United States and abroad on lowering overdose deaths; and</text></subparagraph><subparagraph id="HAD730012DCB64124B74E9AFC10FB2795"><enum>(B)</enum><text display-inline="yes-display-inline">an assessment of the effectiveness of overdose prevention centers on improving access to medication-assisted treatment and recovery services.</text></subparagraph></paragraph></section><section id="HCFE2662C12B643E58F0DC8498F7DBEFC"><enum>202.</enum><header>Naloxone</header><subsection id="HD3B994554DC04FBC9DCDC6190DFBFCD2"><enum>(a)</enum><header>Naloxone pricing transparency</header><paragraph id="H9E1EEF077C5D4C29BB7F23F61795E75B"><enum>(1)</enum><header>Reporting requirement</header><text>Not later than the date that is one year after the date of enactment of this Act, and annually thereafter, to better understand how research and development costs, manufacturing and marketing costs, acquisitions, Federal investments, revenues and sales, and other factors influence drug prices, each manufacturer of naloxone or any other drug approved by the Food and Drug Administration for opioid overdose reversal shall report to the Secretary—</text><subparagraph id="H89026F1B840F4D8090B03B54A0BDF3E3"><enum>(A)</enum><text>with respect to naloxone (or such other drug)—</text><clause id="H75344F9ABE8A4C6D8E534F51F49DDD16"><enum>(i)</enum><text>total expenditures of the manufacturer on—</text><subclause id="H2828CB73BCB24962B058CC2A3C506C71"><enum>(I)</enum><text>materials and manufacturing for such drug;</text></subclause><subclause id="HB44F7C2361F64BB5B48F78223137C52F"><enum>(II)</enum><text>acquiring patents and licensing; and</text></subclause><subclause id="H2D577EF03D24442FAA9026B6FBA37EAD"><enum>(III)</enum><text>costs to purchase or acquire the drug from another company, if applicable;</text></subclause></clause><clause id="H81186F3816164F67AED525FC4B9D2FB7"><enum>(ii)</enum><text>the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from Federal funds;</text></clause><clause id="H8FF8E2BCB9DE4FE5A6038F8AEC99048B"><enum>(iii)</enum><text>the total expenditures of the manufacturer on research and development for such drug;</text></clause><clause id="H8DFC82D4670441A8B94895F490CA6E3C"><enum>(iv)</enum><text>the total revenue and net profit generated from the applicable drug for each calendar year since drug approval;</text></clause><clause id="HF3AF826E22114C21B8A8417BC4EEA1E1"><enum>(v)</enum><text>the total expenditures of the manufacturer that are associated with marketing and advertising for such drug;</text></clause><clause id="H1F71F9412E1A427090F76584DED8FA5B"><enum>(vi)</enum><text>the wholesale acquisition cost for such drug;</text></clause><clause id="H84CD09EB65D94279BACF0477E675B22F"><enum>(vii)</enum><text>the average out-of-pocket cost of such drug to the consumer; and</text></clause><clause id="H1A4DCA6DF6F7498C8E9A8CF77CF9363C"><enum>(viii)</enum><text>patient utilization rates for such drug; and</text></clause></subparagraph><subparagraph id="H02BCAC0AE8A943999FE80D856EB0296C"><enum>(B)</enum><text>additional information specific to the manufacturer as the Secretary may require, to include at a minimum—</text><clause id="HD05B5630EC7B49BAA71C539950109B0A"><enum>(i)</enum><text>the total revenue and net profit of the manufacturer for the reporting period;</text></clause><clause id="H09CE222859AE4DDB8983D12F6DAA2C0D"><enum>(ii)</enum><text>metrics used to determine executive compensation; and</text></clause><clause id="H76565A326FC24FB482850E93BF915FE2"><enum>(iii)</enum><text>any additional information related to drug pricing decisions of the manufacturer, such as total expenditures on—</text><subclause id="HEC63963D1E8A4BEC8658C0BD9786D58B"><enum>(I)</enum><text>drug research and development; or</text></subclause><subclause id="HE7F00DCB354B470CAE4B204E05BBDB82"><enum>(II)</enum><text>clinical trials on drugs that failed to receive approval by the Food and Drug Administration.</text></subclause></clause></subparagraph></paragraph><paragraph id="HDB1F12DC43574ABD8C546062CF4FC406"><enum>(2)</enum><header>Reporting period</header><text>The reporting period for the reports under paragraph (1) shall be as follows:</text><subparagraph id="H3F4CEFEF16D445D3B49FFB7737CEE531"><enum>(A)</enum><text>For the initial report under paragraph (1), the 10-year period preceding the report.</text></subparagraph><subparagraph id="HB8CA75C0B29C432D86A2B4782919CF6D"><enum>(B)</enum><text>For subsequent reports, the 12-month period preceding the respective reports.</text></subparagraph></paragraph><paragraph id="H353E7A36647F4EF2B54A3B8D1EC3D916"><enum>(3)</enum><header>Publicly available</header><subparagraph id="HC6F8C94DD1D24E089B2E9B0AF1C91323"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), not later than 30 days after receiving the information under paragraph (1), the Secretary shall post on the internet website of the Centers for Medicare &amp; Medicaid Services the information reported under paragraph (1) in written format and using language that is easily understandable by beneficiaries under titles XVIII and XIX of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395</external-xref> et seq.; 1396 et seq.).</text></subparagraph><subparagraph id="H5278930A37B549059CE63D98E91C35F2"><enum>(B)</enum><header>Exclusion of proprietary information</header><text>The Secretary shall exclude proprietary information, such as trade secrets and intellectual property, submitted by the manufacturer under paragraph (1) from the posting described in subparagraph (A).</text></subparagraph></paragraph></subsection><subsection id="H65569876C6CF4D56A444A35E889A15CB"><enum>(b)</enum><header>Study on classification of naloxone as a prescription drug</header><text>The Commissioner of Food and Drugs shall—</text><paragraph id="H91F82B0E88E24B899EAB5A2BE27446C3"><enum>(1)</enum><text display-inline="yes-display-inline">not later one year after the date of enactment of this Act, determine whether naloxone should remain subject to the requirements of section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)(1)</external-xref>) or be reclassified as an over-the-counter drug; and</text></paragraph><paragraph id="HE7EE1336E9A74AE395CC4EC810DFE795"><enum>(2)</enum><text>take such actions as may be appropriate, consistent with such determination.</text></paragraph></subsection></section><section id="HC9F4590B92E848C8BB8A7730AF93164E"><enum>203.</enum><header>Good Samaritan immunity</header><subsection commented="no" id="HAE63B323026D499F9DF17D1403B9ABC4"><enum>(a)</enum><header>Limitation on civil liability for individuals who administer opioid overdose reversal drugs</header><paragraph commented="no" id="HC81479B3EB4C4469AF754794AB46C059"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, except as provided in paragraph (2), no individual shall be liable in any Federal or State proceeding for harm caused by the emergency administration of an opioid overdose reversal drug to an individual who has or reasonably appears to have suffered an overdose from heroin or another opioid, if—</text><subparagraph id="HB7CE824BEBA146959FCF7586602A7300"><enum>(A)</enum><text display-inline="yes-display-inline">the individual who administers the opioid overdose reversal drug obtained the drug from—</text><clause id="H7642780F3CAA40AEB3181CCB836C4539"><enum>(i)</enum><text>a health care professional as part of an opioid overdose prevention program; or</text></clause><clause id="HC3480A45BDBB48ECB9FF709EDDBD0891"><enum>(ii)</enum><text>any source as permitted under applicable State law; or</text></clause></subparagraph><subparagraph id="HB6F2779DC1784B9FAD5CC5BF43F81114"><enum>(B)</enum><text display-inline="yes-display-inline">the individual administers the opioid overdose reversal drug in good faith. </text></subparagraph></paragraph><paragraph id="HE72B2B2F7F5E467BB14C663CB875EB2E"><enum>(2)</enum><header>Exception</header><text>Paragraph (1) shall not apply to an individual if the harm was caused by the gross negligence or reckless misconduct of the individual who administers the drug.</text></paragraph><paragraph id="H9B7EC0ED21904EE1AB02ADE9DE42587B"><enum>(3)</enum><header>Definitions</header><text>In this subsection:</text><subparagraph id="H5522C0591EDE41888E68E523A0135844"><enum>(A)</enum><text display-inline="yes-display-inline">The term <term>health care professional</term> means a person licensed by a State to prescribe prescription drugs.</text></subparagraph><subparagraph id="H7E11594770AD43FF9E042C06E9856D74"><enum>(B)</enum><text display-inline="yes-display-inline">The term <term>opioid overdose reversal drug</term> means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) that is indicated for the partial or complete reversal of the pharmacological effects of an opioid overdose in the human body.</text></subparagraph><subparagraph id="HC3FA227F348744B3B4589EDE5876FD4E"><enum>(C)</enum><text display-inline="yes-display-inline">The term <term>opioid overdose prevention program</term> means a program operated by a local health department, harm reduction or other community-based organization, substance abuse treatment organization, law enforcement agency, fire department, other first responder department, or voluntary association, or a program funded by a Federal, State, or local government, that works to prevent opioid overdoses by in part providing opioid overdose reversal drugs and education—</text><clause id="HA6C14F8FEF8441648F2C258D7771DD8A"><enum>(i)</enum><text>to individuals at risk of experiencing an opioid overdose; or</text></clause><clause id="HF7A2E6216A1949EBA22A0A9A340BA276"><enum>(ii)</enum><text>to an individual in a position to assist another individual at risk of experiencing an opioid overdose.</text></clause></subparagraph></paragraph></subsection><subsection commented="no" id="H0500CF2B7BB1473EBD7D58395E692610"><enum>(b)</enum><header>Immunity from liability</header><paragraph commented="no" id="HC8BA5464D3254E339E90E21D0138AAA5"><enum>(1)</enum><header>In general</header><text>An individual who, in good faith and in a timely manner—</text><subparagraph commented="no" id="H72ADF1C16EDC4028A62A3243204F1774"><enum>(A)</enum><text display-inline="yes-display-inline">seeks medical assistance for another individual who is experiencing a drug overdose shall not be cited, arrested, prosecuted, criminally liable, or subject to any sanction for a violation of a condition of supervised release under section 404 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/844">21 U.S.C. 844</external-xref>) for the possession or use of a controlled substance, or under any other provision of Federal law regulating the misuse of prescription drugs, as a result of seeking such medical assistance; or</text></subparagraph><subparagraph commented="no" id="H975F13FB7DBD4E159E6ABDB818C47FD1"><enum>(B)</enum><text display-inline="yes-display-inline">seeks medical assistance for himself or herself for a drug overdose, or is the subject of a request for medical assistance described in subparagraph (A), shall not be cited, arrested, prosecuted, criminally liable, or subject to any sanction for a violation of a condition of supervised release, under section 404 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/844">21 U.S.C. 844</external-xref>) for the possession or use of a controlled substance, or under any other provision of Federal law regulating the misuse of prescription drugs, as a result of seeking such medical assistance.</text></subparagraph></paragraph><paragraph commented="no" id="HCA158C3D46204B3FAD35FA1A76303FAB"><enum>(2)</enum><header>Preemption</header><text display-inline="yes-display-inline">This subsection preempts the laws of a State or any political subdivision of a State to the extent that such laws are inconsistent with this section, unless such laws provide greater protection from liability.</text></paragraph><paragraph commented="no" id="HD8E0869F50104E5A95A8FCE23E01EDE4"><enum>(3)</enum><header>Definitions</header><text>In this section:</text><subparagraph commented="no" id="HF1E86ABF3ED64DCBAB6D9777B42268D3"><enum>(A)</enum><text>The term <term>controlled substance</term> has the meaning given the term in section 102 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/802">21 U.S.C. 802</external-xref>).</text></subparagraph><subparagraph commented="no" id="HB75D2A2909C7470C94E749175D9795AD"><enum>(B)</enum><text>The term <term>drug overdose</term> means an acute condition resulting from or believed to be resulting from the use of a controlled substance, which an individual, who is not a health care professional, would reasonably believe requires medical assistance.</text></subparagraph><subparagraph commented="no" id="H91F07B22B94E47BE963C9741A45DCBF0"><enum>(C)</enum><text>The term <term>prescription drug</term> means a drug subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)(1)</external-xref>). </text></subparagraph><subparagraph commented="no" id="HB9AC17F8B2F148CD9AF016796FF1E0DB"><enum>(D)</enum><text>The terms <term>seeks medical assistance</term> and <term>seeking such medical assistance</term> include—</text><clause commented="no" id="HCD5EB79A9D9845BCBBB4211399E6A711"><enum>(i)</enum><text>reporting a drug or alcohol overdose or other medical emergency to a law enforcement authority, the 9–1–1 system, a poison control center, or a medical provider;</text></clause><clause commented="no" id="HCF3B8A154DCF49279551C576C7846850"><enum>(ii)</enum><text>assisting another individual who is making a report described in clause (i); or</text></clause><clause commented="no" id="H9435F9596D514D0D8D839C7A9913ADD6"><enum>(iii)</enum><text>providing care to someone who is experiencing a drug or alcohol overdose or other medical emergency while awaiting the arrival of medical assistance.</text></clause></subparagraph></paragraph></subsection><subsection commented="no" id="H183699468D9C44A784F2A54887AABA2A"><enum>(c)</enum><header>Seeking assistance as a mitigating factor</header><text>Section 3553 of title 18, United States Code, is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="H0F4E89379C8846088B56B68B20FFB1A9"><enum>(1)</enum><text>by redesignating subsection (g) as subsection (h); and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="HFCABA84543CB42749D0F3D4116412274"><enum>(2)</enum><text>by inserting after subsection (f) the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H0790555CF2474124816134B6CF23D6FA"><subsection commented="no" id="HDF7C9EBA70B943C096DFB113CD05C32B"><enum>(g)</enum><header>Seeking medical assistance</header><paragraph commented="no" id="H7F424E98EB644330B9247473A8777372"><enum>(1)</enum><header>In general</header><text>Notwithstanding any other provision of law, in imposing a sentence pursuant to guidelines promulgated by the United States Sentencing Commission under section 994 of title 28 against a defendant convicted of an offense as a result of seeking medical assistance for another individual who is experiencing a drug overdose, or for himself or herself for a drug overdose, other than an offense described in section 203(b)(1)(A) of the <short-title>STOP Fentanyl Act of 2021</short-title>, the court shall consider the act of seeking medical assistance as a mitigating factor.</text></paragraph><paragraph commented="no" id="HA6AC8C98C7604A5EB627556CE8F9A85D"><enum>(2)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this subsection, the terms <term>drug overdose</term> and <term>seeking medical assistance</term> have the meanings given to such terms in section 203(b) of the <short-title>STOP Fentanyl Act of 2021</short-title>.</text></paragraph></subsection><after-quoted-block>. </after-quoted-block></quoted-block></paragraph></subsection></section><section commented="no" id="H5E050A09C58242C1A4F4000C03EB9676"><enum>204.</enum><header>Medication-assisted treatment</header><subsection commented="no" id="HAD0D2414AE274B678D514F5B9046CF8E"><enum>(a)</enum><header>Opioid treatment program regulations</header><paragraph commented="no" id="HB346DF6A78E448E584849CCC2CFD544B"><enum>(1)</enum><header>Definition</header><text display-inline="yes-display-inline">In this subsection, the term <term>opioid treatment program</term> means a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication registered under section 303(g)(1) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(1)</external-xref>).</text></paragraph><paragraph commented="no" id="H16ADF91098094414915601E0E20E12F0"><enum>(2)</enum><header>Elimination of patient eligibility requirement</header><text display-inline="yes-display-inline">The Secretary shall amend section 8.12(e)(1) of title 42, Code of Federal Regulations (and such other regulations in part 8 of such title 42 as may be necessary) to eliminate the requirement that the person became addicted at least 1 year before admission for maintenance treatment under an opioid treatment program.</text></paragraph><paragraph commented="no" id="H23286AAFBD8E41E4B7929DB578DD2CA0"><enum>(3)</enum><header>Survey</header><subparagraph commented="no" id="H056145941CDF4603B27DDA1E933E9B47"><enum>(A)</enum><header>In general</header><text>Not later than one year after the date of enactment of this Act, the Assistant Secretary shall—</text><clause commented="no" id="HA373AEE942504B93A548C5B3ADFEE88F"><enum>(i)</enum><text>complete a survey of the use in opioid treatment programs of <quote>take-home</quote> prescription medications; and</text></clause><clause commented="no" id="H36E385DECFFB4C4E9208D919F333A234"><enum>(ii)</enum><text>submit a report to Congress on the findings of the survey.</text></clause></subparagraph><subparagraph commented="no" id="H3F0DF4BA37F944BC9E546FEB2234F505"><enum>(B)</enum><header>Required assessment</header><text display-inline="yes-display-inline">The survey under paragraph (1) shall assess—</text><clause commented="no" id="HEAC2773FC64340E19C887705C5E3AF47"><enum>(i)</enum><text>the frequency of use of <quote>take-home</quote> medication, as allowed under section 8.12(i) of title 42, Code of Federal Regulations;</text></clause><clause commented="no" id="H19F75787DCB24DA1B0D05E4A7F6984BD"><enum>(ii)</enum><text>the extent to which the limitations on doses for <quote>take-home</quote> use listed in section 8.12(i)(3)(i), (ii), (iii), and (iv) of such title 42 unduly burden treatment of individuals with opioid use disorder; and</text></clause><clause commented="no" id="H52D9DCAF07FF4C90A47B950F3C0B12E1"><enum>(iii)</enum><text>whether and how individuals receiving medications for <quote>take-home</quote> use receive all services listed in section 8.12(f) of such title 42.</text></clause></subparagraph></paragraph></subsection><subsection commented="no" id="HD302A1B8EAC740AFA7A987EFF7999A42"><enum>(b)</enum><header>Treatment in rural and underserved populations</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Assistant Secretary shall complete a study and submit a report to Congress on ways in which the Substance Abuse and Mental Health Services Administration can provide and support health services, including treatment for substance use disorders, to individuals in rural (including agricultural) and medically underserved communities (as defined in section 799B of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/295p">42 U.S.C. 295p</external-xref>)), taking into account the following:</text><paragraph commented="no" id="HC9958788741C48A2AC2285DD8DAD7475"><enum>(1)</enum><text>Stigma.</text></paragraph><paragraph commented="no" id="H4ACB83EA503B4C9AB8F4E2E6F475CB78"><enum>(2)</enum><text>Using data.</text></paragraph><paragraph commented="no" id="H3AA7A44FFED84F7D8A597EBDFD9871A2"><enum>(3)</enum><text>Telemedicine.</text></paragraph><paragraph commented="no" id="H3EE7FA31970345C7915F9C87F6879F9B"><enum>(4)</enum><text>Managing fiscal resources in a community impacted by addiction.</text></paragraph><paragraph commented="no" id="H959DA94F83AE4924A44EA5D8AB5A8704"><enum>(5)</enum><text>Workforce development.</text></paragraph><paragraph commented="no" id="HFE87B6F150D94ADAB8FDD95D4FB78C16"><enum>(6)</enum><text>Broadband.</text></paragraph><paragraph commented="no" id="H9F812ABDB79844BDAF8518C38CE5CC3C"><enum>(7)</enum><text>Overcoming economic challenges.</text></paragraph><paragraph commented="no" id="HE71B1A06F5A44527A5846D7601CDC0A7"><enum>(8)</enum><text>Prevention.</text></paragraph><paragraph commented="no" id="H2DF5FC5AFA62432E814D72590B5AA9C8"><enum>(9)</enum><text>Transportation.</text></paragraph><paragraph commented="no" id="H30EE8B09875A4132916811BED42A7E2F"><enum>(10)</enum><text>Nutritional services.</text></paragraph><paragraph commented="no" id="H8F2309A429B641D395FDEBAC68B98096"><enum>(11)</enum><text>Medication-assisted treatment.</text></paragraph><paragraph commented="no" id="H925344383CB5409AA2C48F4B6A0D50EC"><enum>(12)</enum><text>Educating law enforcement personnel about addiction.</text></paragraph><paragraph commented="no" id="H607163B12963455892ECD03D7D42E0C4"><enum>(13)</enum><text>Drug courts.</text></paragraph><paragraph commented="no" id="H12EA8186F95A4F868B94BD8942728AF0"><enum>(14)</enum><text>Educating the faith community about addiction.</text></paragraph><paragraph commented="no" id="H1B2C5A2A0FD94E5AA6DF2220AF5DCC48"><enum>(15)</enum><text>Recovery support.</text></paragraph><paragraph commented="no" id="HB7C62CAF925F425DA058A4EA96601369"><enum>(16)</enum><text>Housing.</text></paragraph><paragraph id="H2539C8E4A4994EFC83DC7E749E5EE16A"><enum>(17)</enum><text>Harm reduction services.</text></paragraph></subsection><subsection commented="no" id="HFDC063C8B58C4EAFBB077070C961399D"><enum>(c)</enum><header>Prisons and medication-Assisted treatment</header><paragraph commented="no" id="HE8B0AF093C4442E7BAEE4051938A3540"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Director of the Bureau of Prisons shall establish a program to offer—</text><subparagraph commented="no" id="H90C7B39CFD2A49B6B05D59FCA8990D67"><enum>(A)</enum><text display-inline="yes-display-inline">medication-assisted treatment for opioid use disorder to individuals in the custody of the Bureau of Prisons and include in such treatment all drugs that are approved by the Food and Drug Administration to treat opioid use disorder; and</text></subparagraph><subparagraph commented="no" id="H578A61D3E5A84501A8688412D81C0F03"><enum>(B)</enum><text display-inline="yes-display-inline">withdrawal management services to individuals in the custody of the Bureau of Prisons to provide a comprehensive treatment approach to substance use disorders.</text></subparagraph></paragraph><paragraph commented="no" id="HB6A0FDCD32DE4B499EF1F9106D0FFE73"><enum>(2)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this subsection, there is authorized to be appropriated to the Director of the Bureau of Prisons $150,000,000 for each of fiscal years 2022 through 2026.</text></paragraph></subsection><subsection commented="no" id="HE71A261890E34A60810AC061512E69D4"><enum>(d)</enum><header>Residential substance abuse treatment for State prisoners</header><text>Section 1904(d) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/34/10424">34 U.S.C. 10424(d)</external-xref>) is amended—</text><paragraph id="HE119914071A44603A3082AC7F5CF0578"><enum>(1)</enum><text>by striking <quote>means</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H69B545A194CB4C56ACDAEF163937A6CF"><paragraph id="H1736A88B17BC480AB3466E036CC19515"><enum>(1)</enum><text display-inline="yes-display-inline">means</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph><paragraph id="HE98A79E509AA4156A562D987EA048CDC"><enum>(2)</enum><text>by striking the period at the end and inserting <quote>; and</quote>; and</text></paragraph><paragraph id="H55813B35C48F40D284C16400967E3A98"><enum>(3)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HDAA5F2B2A0D849BB904475E1B5FF6447"><paragraph id="H9BEA5BD28C004C6081B77BD67E450694"><enum>(2)</enum><text display-inline="yes-display-inline">includes any such course of comprehensive individual and group substance abuse treatment services using medication-assisted treatment for opioid use disorder (including the use of any drug approved or licensed by the Food and Drug Administration for such treatment).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section><section section-type="subsequent-section" id="H40DEBAA00151495783E427D925012B8C"><enum>205.</enum><header>Telehealth for substance use disorder treatment</header><text display-inline="no-display-inline">Section 309(e)(2) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/829">21 U.S.C. 829(e)(2)</external-xref>) is amended—</text><paragraph id="H73A5044FDF5B49C495ADBD4F04E11E56"><enum>(1)</enum><text>in subparagraph (A)(i)—</text><subparagraph id="H2393981605AC40A995A57CD62F1D7AAC"><enum>(A)</enum><text>by striking <quote>at least 1 in-person medical evaluation</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="yes-display-inline" id="HC7B783E743D84926A468AA9661328E15"><text>at least—</text><subclause id="H456D309F14984BBD976939A91B30F4CC"><enum>(I)</enum><text>1 in-person medical evaluation</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph><subparagraph id="H01009765D5A445FB9221486EBEA43172"><enum>(B)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H28D9D4F4B7D842F3B36B7908A07100ED"><subclause id="H300EF74D1B6D4C1ABFFFE093B65EF1BE"><enum>(II)</enum><text>for purposes of prescribing a controlled substance in schedule III or IV, 1 telehealth evaluation; or</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="HFFE264F99ED74F5C81266C522AD10D33"><enum>(2)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="H1F7E395763AE472FB057CE0DEB0BB1D3"><subparagraph id="H9EC04C90FA3D40F095B42D8BECE62A11"><enum>(D)</enum><clause commented="no" display-inline="yes-display-inline" id="H0CB2443AC640442696DE6847B84859B0"><enum>(i)</enum><text>The term <term>telehealth evaluation</term> means a medical evaluation that is conducted in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient using a telecommunications system referred to in section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>) that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site practitioner.</text></clause><clause commented="no" display-inline="no-display-inline" id="HD376BEAEDDB748C2AE8A0E35FD2B906F" indent="up1"><enum>(ii)</enum><text>Nothing in clause (i) shall be construed to imply that 1 telehealth evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.</text></clause><clause id="H7FC5F673A11249AFAEBD75F5E5C6F32A" indent="up1"><enum>(iii)</enum><text>A practitioner who prescribes the drugs or combination of drugs that are covered under section 303(g)(2)(C) using the authority under subparagraph (A)(i)(II) of this paragraph shall adhere to nationally recognized evidence-based guidelines for the treatment of patients with opioid use disorders and a diversion control plan, as those terms are defined in section 8.2 of title 42, Code of Federal Regulations, as in effect on the date of enactment of this subparagraph.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section><section id="H661F0B4AEA5E4DD083A7FE140E5BF344"><enum>206.</enum><header>Grant program on harms of drug misuse</header><subsection id="HE6C421FC9D7D4D7E95FA7F7E4463E5DA"><enum>(a)</enum><header>In general</header><text>The Assistant Secretary, in consultation with the Director of the Centers for Disease Control and Prevention, shall award grants to States, political subdivisions of States, Tribes, Tribal organizations, and community-based entities to support the delivery of overdose prevention, syringe services programs, and other harm reduction services that address the harms of drug misuse, including by—</text><paragraph id="H8165A09542AC4F45B779D3E529D16456"><enum>(1)</enum><text>preventing and controlling the spread of infectious diseases, such as HIV/AIDS and viral hepatitis, and the consequences of such diseases for individuals with substance use disorder;</text></paragraph><paragraph id="HED6BAEE515F847FF827BBCCFFB1C270E"><enum>(2)</enum><text>distributing opioid antagonists, such as naloxone, to individuals at risk of overdose;</text></paragraph><paragraph id="H6C1843CAB53848ADA4A8AC79565AEC25"><enum>(3)</enum><text>connecting individuals at risk for, or with, a substance use disorder to overdose education, counseling, and health education; and</text></paragraph><paragraph id="H019BD762F3CD46F98D1577176D5A56EA"><enum>(4)</enum><text>encouraging such individuals to take steps to reduce the negative personal and public health impacts of substance use or misuse.</text></paragraph></subsection><subsection id="HD6B87FF98C8540918373A441B140EEE7"><enum>(b)</enum><header>Considerations</header><text>In awarding grants under this section, the Assistant Secretary shall prioritize grants to applicants that are—</text><paragraph id="HDE6D57201FBC4D9C942CD0C2EC8D696D"><enum>(1)</enum><text>culturally specific organizations, Tribal behavioral health and substance use disorder providers, or organizations that are intentional about serving populations where COVID–19 has had the most impact; or </text></paragraph><paragraph id="H1F2CFB85DA48485C90D7E79ED19192D0"><enum>(2)</enum><text>proposing to serve areas with—</text><subparagraph id="H04FDA1774FE2464F860A43ED22FE9E4C"><enum>(A)</enum><text>a higher proportion of the population who meet criteria for dependence on, or abuse of, illicit drugs;</text></subparagraph><subparagraph id="H5EC9539321064F7EA4B96BB53C1CC377"><enum>(B)</enum><text>a higher drug overdose death rate;</text></subparagraph><subparagraph id="H8611F118772B4B65885E3F3A4F5AEFE7"><enum>(C)</enum><text>a greater telemedicine infrastructure need; and</text></subparagraph><subparagraph id="H407FDE038AF14B22B6CF261435C74F17"><enum>(D)</enum><text>a greater behavioral health and substance use disorder workforce need. </text></subparagraph></paragraph></subsection><subsection id="H58B8152EAAAD46DBB9F56DA1F7273803"><enum>(c)</enum><header>Use of grant awards</header><text>A recipient of a grant under this section may use such grant funds for the following purposes:</text><paragraph id="HA5D0ED97A059476D87262BC1F42EC9F2"><enum>(1)</enum><text>Adapt, maintain, and expand essential services provided by harm reduction service organizations to address the risks of COVID–19, drug overdose, and contraction of infectious disease.</text></paragraph><paragraph id="H0ED418567D8348A1860DDF2B9ACAF443"><enum>(2)</enum><text>Maintain or hire staff.</text></paragraph><paragraph id="H24F803F5423E409DAD9FBC6169578894"><enum>(3)</enum><text>Support program operational costs, including staff, rent, and vehicle purchase or maintenance.</text></paragraph><paragraph id="HDC37EAC873A7459EA393D3A3FB387B2A"><enum>(4)</enum><text>Program supplies.</text></paragraph><paragraph id="H60F6DD3A389640B29522E06E0264F793"><enum>(5)</enum><text>Support and case management services.</text></paragraph></subsection><subsection id="H086020CA72E84740B3DDEBD3ECC29EAF"><enum>(d)</enum><header>Authorization of appropriations</header><text>To carry out this section, there is authorized to be appropriated $50,000,000 for fiscal year 2022, to remain available until expended.</text></subsection></section><section id="H62F59E25F88F4040B822AF828EDFE137"><enum>207.</enum><header>Opioid treatment education</header><subsection id="HD91F90ABE8D94F349EE1DD4342284467"><enum>(a)</enum><header>In general</header><text>The Secretary shall award grants to States and local governmental entities to provide education to stakeholders, including health care providers, criminal justice professionals, and substance use disorder treatment personnel, on the current state of research on treatment for opioid dependence, including—</text><paragraph id="HAA3C136432674AE2AF07B47A8CFBB427"><enum>(1)</enum><text>the use of opioid agonists or partial agonists; and</text></paragraph><paragraph id="HEEDA35F4BFE94F89B197717AAE2E8033"><enum>(2)</enum><text>the potential benefits of the use of opioid agonists or partial agonists for affected individuals.</text></paragraph></subsection><subsection id="HA301510F9D7A472A9798C9F3A400AE19"><enum>(b)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there is authorized to be appropriated $100,000,000 for each of fiscal years 2022 through 2026.</text></subsection></section></title><title id="HF60EFEC615A947A1B23F6BAD91009B9C"><enum>III</enum><header>Public Health Data and Training Support for Fentanyl Detection</header><section id="H3DEAD5EAFE344A3B8AAFD22CB3F56E8E"><enum>301.</enum><header>Public health support for law enforcement</header><subsection id="HE446C9FBC3844EA089682000D49F37FA"><enum>(a)</enum><header>Support for fentanyl detection and handling</header><text>The Secretary, in consultation with the Attorney General, shall establish a program to provide to Federal, State, and local law enforcement agencies public health training on how to detect and handle fentanyl.</text></subsection><subsection id="HA1EAE7A45D954DBDB430821CF1B66B46"><enum>(b)</enum><header>Evidence-Based</header><text display-inline="yes-display-inline">The program under subsection (a) shall comply with evidence-based guidelines, including the <quote>Fentanyl Safety Recommendations for First Responders</quote> (or any successor guidelines) of the Office of National Drug Control Policy.</text></subsection><subsection id="H93B93BB4E7DE4CD4B49A2D6D13BB354C"><enum>(c)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2022 through 2026.</text></subsection></section><section id="H67037E4ADC784CCFB98AC188301191C9"><enum>302.</enum><header>Report on countries that produce synthetic drugs</header><text display-inline="no-display-inline">Not later than 1 year after the date of enactment of this Act, the Secretary of State shall submit to Congress a report—</text><paragraph id="H5119ADF85DCC49F3B87FE84B051EE4CB"><enum>(1)</enum><text>identifying the countries the Secretary determines are the principal producers of synthetic drugs trafficked into the United States;</text></paragraph><paragraph id="H06D5883833BF48D0B09C7639240F5D04"><enum>(2)</enum><text>assessing how and why those countries are producing such drugs; and</text></paragraph><paragraph id="H46CC13ED5AC6408C97156F84D6234D05"><enum>(3)</enum><text>describing measures the Secretary plans to take to reduce the flow of such drugs into the United States.</text></paragraph></section><section commented="no" id="H0DE3CE16B7314377958B6DEEAEF51C5A"><enum>303.</enum><header>Grants to improve public health surveillance in forensic laboratories</header><text display-inline="no-display-inline">Title I of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/34/10101">34 U.S.C. 10101</external-xref> et seq.) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="HC557528126264C90BAB3B1B38B2F74B0"><part commented="no" id="HECAB04B71D3D4B98BC669F3EED1D8538"><enum>PP</enum><header>Confronting the Use of Heroin, Fentanyl, and Associated Synthetic Drugs</header><section commented="no" id="HCD624B39CB52418A9DC45868834A1BDB"><enum>3061.</enum><header>Authority to make grants to address public safety through improved forensic laboratory data</header><subsection commented="no" id="H97DC88B7AA974D7FB0F0B89A147C887A"><enum>(a)</enum><header>Purpose</header><text>The purpose of this section is to assist States and units of local government in—</text><paragraph commented="no" id="HA53C53A1596D4BE4BB1A001136419C9B"><enum>(1)</enum><text display-inline="yes-display-inline">carrying out programs to improve surveillance of seized heroin, fentanyl, and associated synthetic drugs to enhance public health; and</text></paragraph><paragraph commented="no" id="HC4F4BF5A7E0B4E81B053288D0D93CDA1"><enum>(2)</enum><text>improving the ability of State, tribal, and local government institutions to carry out such programs.</text></paragraph></subsection><subsection commented="no" id="HB6563B79F8FE4D96BFFF421E08699466"><enum>(b)</enum><header>Grant authorization</header><text display-inline="yes-display-inline">The Attorney General, acting through the Director of the Bureau of Justice Assistance, may make grants to States and units of local government to improve surveillance of seized heroin, fentanyl, and associated synthetic drugs to enhance public health.</text></subsection><subsection commented="no" id="H76523BA9C0BB41438729254852609203"><enum>(c)</enum><header>Grant projects To improve surveillance of seized heroin, fentanyl, and associated synthetic drugs</header><text>Grants made under subsection (b) shall be used for programs, projects, and other activities to—</text><paragraph commented="no" id="H0532E2DA79B344DEB07C8FE2F4342067"><enum>(1)</enum><text>reimburse State, local, or other forensic science laboratories to help address backlogs of untested samples of heroin, fentanyl, and associated synthetic drugs;</text></paragraph><paragraph commented="no" id="HFB7E0D0F7BF848D5BF2157328006202B"><enum>(2)</enum><text>reimburse State, local, or other forensic science laboratories for procuring equipment, technology, or other support systems if the applicant for the grant demonstrates to the satisfaction of the Attorney General that expenditures for such purposes would result in improved efficiency of laboratory testing and help prevent future backlogs;</text></paragraph><paragraph id="H0A18EA91EFE54153808C7053499158E6"><enum>(3)</enum><text display-inline="yes-display-inline">reimburse State, local, or other forensic science laboratories for improved, real-time data exchange with the Centers for Disease Control and Prevention on fentanyl, fentanyl-related substances, and other synthetic drugs present in the local communities; and</text></paragraph><paragraph commented="no" id="H64E810A7FE8F46D1AB772B57874382A9"><enum>(4)</enum><text>support State, tribal, and local health department services deployed to address the use of heroin, fentanyl, and associated synthetic drugs.</text></paragraph></subsection><subsection commented="no" id="H8F4E70C0F5A240A583F6B77D7518E5CD"><enum>(d)</enum><header>Limitation</header><text>Not less than 60 percent of the amounts made available to carry out this section shall be awarded for the purposes under paragraph (1) or (2) of subsection (c).</text></subsection><subsection commented="no" id="HAC47C6993BA84CE183E8D8AA25324C3E"><enum>(e)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2022 and 2023.</text></subsection><subsection commented="no" id="H7F7B2EB71880422493952C28804475E1"><enum>(f)</enum><header>Allocation</header><paragraph commented="no" id="H55F0CBF668AC4EB7BF2732FBD3D13639"><enum>(1)</enum><header>Population allocation</header><text>Seventy-five percent of the amount made available to carry out this section in a fiscal year shall be allocated to each State that meets the requirements of section 2802 so that each State shall receive an amount that bears the same ratio to the 75 percent of the total amount made available to carry out this section for that fiscal year as the population of the State bears to the population of all States.</text></paragraph><paragraph commented="no" id="HF1A94C40BEAD4F5AA6B5D44E51244052"><enum>(2)</enum><header>Discretionary allocation</header><text display-inline="yes-display-inline">Twenty-five percent of the amount made available to carry out this section in a fiscal year shall be allocated pursuant to the discretion of the Attorney General for competitive grants to States or units of local government with high rates of primary treatment admissions for heroin and other opioids, for use by State or local law enforcement agencies.</text></paragraph><paragraph commented="no" id="H95AE9B55524541B0B646A905027B4EEA"><enum>(3)</enum><header>Minimum requirement</header><text>Each State shall receive not less than 0.6 percent of the amount made available to carry out this section in each fiscal year.</text></paragraph><paragraph commented="no" id="H5629802849E84CBE8914757EE703D652"><enum>(4)</enum><header>Certain territories</header><subparagraph commented="no" id="HCE2D883651B542DB902D4DC309D91E95"><enum>(A)</enum><header>In general</header><text>For purposes of the allocation under this section, American Samoa and the Commonwealth of the Northern Mariana Islands shall be considered as 1 State.</text></subparagraph><subparagraph commented="no" id="HD9EB6B6A7CB6434D89BB15F886D1BE52"><enum>(B)</enum><header>Allocation amongst certain territories</header><text>For purposes of subparagraph (A), 67 percent of the amount allocated shall be allocated to American Samoa and 33 percent shall be allocated to the Commonwealth of the Northern Mariana Islands.</text></subparagraph></paragraph></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block></section></title></legis-body></bill> 

