116 HR 14 IH: Commitment to Defeat the Virus and Keep America Healthy Act U.S. House of Representatives 2020-10-30 text/xml EN 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.
I 116th CONGRESS2d Session H. R. 14 IN THE HOUSE OF REPRESENTATIVES October 30, 2020 Mr. Hudson (for himself, Mr. McCarthy, Mr. Walden, Mr. Brady, and Ms. Granger) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Transportation and Infrastructure, the Judiciary, Ways and Means, the Budget, and Science, Space, and Technology, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To increase the Federal commitment to defeating the virus that causes COVID–19 and prepare for future pandemics, and for other purposes.
1.
Short title
This Act may be cited as the Commitment to Defeat the Virus and Keep America Healthy Act.
2.
Table of contents
The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Title I—Pandemic Preparedness and Response Subtitle A—Clarifying the Role of the Department of Health and Human Services During Public Health Emergencies Sec. 1001. Lead agency for Federal public health and medical response to public health emergencies. Sec. 1002. Deployment by the Secretary of Health and Human Services of National Strategic Stockpile. Sec. 1003. Authority and responsibilities of the Federal Emergency Management Agency regarding the Strategic National Stockpile. Subtitle B—Reagan-Udall Foundation and Foundation for the National Institutes of Health Sec. 1011. Reagan-Udall Foundation and Foundation for the National Institutes of Health. Subtitle C—Protections for Good Samaritan Health Professionals Sec. 1021. Limitation on liability for volunteer health care professionals. Sec. 1022. Sense of the Congress. Subtitle D—Medical Sheltering Sec. 1031. Reducing the spread of COVID–19 through payments to States to lease hotels to temporarily house eligible individuals. Subtitle E—CDC campaign on COVID–19 awareness Sec. 1041. COVID–19 public awareness campaign. Subtitle F—Protecting Children from COVID–19 Sec. 1051. Study on children’s role in transmitting SARS–CoV–2. Subtitle G—Ensuring Understanding of COVID–19 Sec. 1061. Study on the impact of COVID–19. Subtitle H—Safeguarding Therapeutics Sec. 1071. Authority to destroy counterfeit devices. Sec. 1072. Determination of budgetary effects. Subtitle I—Advisory Committee on Immunization Practices Sec. 1081. Expedited meeting of ACIP for COVID–19 vaccines. Subtitle J—Improvements to Transparency of the Pricing of Diagnostic Testing for COVID–19 Sec. 1091. Improvements to transparency of the pricing of diagnostic testing for COVID–19. Title II—Domestic Manufacturing and Supply Chain Subtitle A—Sustained On-Shore Manufacturing Capacity for Public Health Emergencies Sec. 2001. Sustained on-shore manufacturing capacity for public health emergencies. Subtitle B—Manufacturing API, Drugs, and Excipients in America Sec. 2011. Report to Congress on barriers to domestic manufacturing of medical products and supplies. Sec. 2012. Enhancing intra-agency coordination and public health assessment with regard to compliance activities. Sec. 2013. Encouraging international harmonization. Sec. 2014. Mutual recognition agreements for inspections and review activities. Sec. 2015. Enhancing transparency of drug facility inspection timelines. Sec. 2016. Advanced manufacturing technologies program. Subtitle C—Improving the American Drug Supply Chain Sec. 2021. Study and reporting on domestic and foreign production. Subtitle D—Essential Medicines Strategic Stockpile Sec. 2031. Pilot program on ensuring medication supply stability. Subtitle E—National Centers of Excellence in Continuous Pharmaceutical Manufacturing Sec. 2041. National Centers of Excellence in Continuous Pharmaceutical Manufacturing. Title III—Strategic National Stockpile Improvements Subtitle A—Stockpiling for America’s Future Endeavors Sec. 3001. Strategic National Stockpile. Subtitle B—Stockpile Inventory Modernization Sec. 3011. Reimbursable transfers. Subtitle C—Equipment Maintenance Sec. 3021. Equipment maintenance. Subtitle D—Medical Supplies for Pandemics Sec. 3031. Supply chain flexibility manufacturing pilot. Subtitle E—State Stockpile Readiness Sec. 3041. Grants for State strategic stockpiles. Subtitle F—Process Improvements and Reports Sec. 3051. GAO study on the feasibility and benefits of user fee agreements. Sec. 3052. Action reporting. Sec. 3053. Improved, transparent processes. Subtitle G—Strategic National Stockpile Funding Sec. 3061. Authorization of appropriations. Title IV—Public Health Infrastructure Improvements Subtitle A—Public Health Infrastructure Modernization Sec. 4001. Public health data system transformation. Subtitle B—Modernizing infectious disease data collection Sec. 4011. Modernizing infectious disease data collection. Subtitle C—Diagnostic Testing for Public Health Labs Sec. 4021. Grants for public health laboratories to acquire high-throughput diagnostic equipment. Subtitle D—Rapid Testing for Communities Sec. 4031. Grants for same-day point-of-care clinical laboratory diagnostic testing in communities. Subtitle E—Public Health Workforce Loan Repayment Sec. 4041. Public Health Workforce Loan Repayment Program. Subtitle F—Vaccine Awareness and Disease Prevention Sec. 4051. Improving awareness of disease prevention. Subtitle G—Protecting the Health of America’s Older Adults During COVID–19 & Beyond Sec. 4061. National COVID–19 Resource Center for Older Adults. Sec. 4062. Healthy Aging Program. Sec. 4063. Authorization of appropriations. Subtitle H—Expanding Capacity for Health Outcomes Sec. 4071. Expanding capacity for health outcomes. Subtitle I—Community Readiness Sec. 4081. Grants for research on, or establishing, wastewater surveillance and other early warning systems. Title V—Addressing COVID–19 Health Disparities Subtitle A—Tribal Health Data Improvement Sec. 5001. Collection and availability of health data with respect to Indian Tribes. Sec. 5002. Improving health statistics reporting with respect to Indian Tribes. Subtitle B—Tribal Medical Supplies Stockpile Access Sec. 5011. Provision of items to Indian programs and facilities. Subtitle C—Native American Suicide Prevention Sec. 5021. Native American suicide prevention. Subtitle D—Pursuing Equity in Mental Health Part 1—Health Equity and Accountability Sec. 5031. Integrated Health Care Demonstration Program. Sec. 5032. Addressing racial and ethnic minority mental health disparities research gaps. Sec. 5033. Health professions competencies to address racial and ethnic minority mental health disparities. Sec. 5034. Racial and ethnic minority behavioral and mental health outreach and education strategy. Sec. 5035. Additional funds for National Institutes of Health. Sec. 5036. Additional funds for National Institute on Minority Health and Health Disparities. Part 2—Other provisions Sec. 5037. Reauthorization of Minority Fellowship Program. Sec. 5038. Study on the Effects of Smartphone and Social Media Use on Adolescents. Sec. 5039. Technical correction. Subtitle E—Maternal Health Quality Improvement Sec. 5041. Innovation for maternal health. Sec. 5042. Training for health care providers. Sec. 5043. Study on training to reduce and prevent discrimination. Sec. 5044. Perinatal quality collaboratives. Sec. 5045. Integrated services for pregnant and postpartum women. Sec. 5046. Improving rural maternal and obstetric care data. Sec. 5047. Rural obstetric network grants. Sec. 5048. Telehealth network and telehealth resource centers grant programs. Sec. 5049. Rural maternal and obstetric care training demonstration. Title VI—Addressing the Impacts of COVID–19 on Mental Health Subtitle A—Creating Resources To Improve Situations of Inherent Severity Sec. 6001. Set-aside for evidence-based crisis care services. Subtitle B—Emergency Mental Health and Substance Use Training and Technical Assistance Center Sec. 6011. Emergency mental health and substance use training and technical assistance center. Subtitle C—Suicide Prevention Grants Sec. 6021. Syndromic surveillance of self-harm behaviors program. Sec. 6022. Grants to provide self-harm and suicide prevention services. Subtitle D—Effective Suicide Screening in the Emergency Department Sec. 6031. Program to improve the care provided to patients in the emergency department who are at risk of suicide. Subtitle E—Suicide Prevention Lifeline Improvement Sec. 6041. Suicide Prevention Lifeline. Sec. 6042. Pilot program on innovative technologies. Sec. 6043. HHS study and report. Sec. 6044. GAO study and report. Sec. 6045. Definition. Subtitle F—Campaign To Prevent Suicide Sec. 6051. National Suicide Prevention Lifeline. Sec. 6052. National suicide prevention media campaign. Subtitle G—Helping Emergency Responders Overcome Sec. 6061. Data system to capture national public safety officer suicide incidence. Sec. 6062. Peer-support behavioral health and wellness programs within fire departments and emergency medical service agencies. Sec. 6063. Health care provider behavioral health and wellness programs. Sec. 6064. Development of resources for educating mental health professionals about treating fire fighters and emergency medical services personnel. Sec. 6065. Best practices and other resources for addressing posttraumatic stress disorder in public safety officers. Subtitle H—Behavioral Health Intervention Guidelines Sec. 6071. Best practices for behavioral intervention teams. Subtitle I—Suicide Training and Awareness Nationally Delivered for Universal Prevention Sec. 6081. Student suicide awareness and prevention training. Sec. 6082. Effective date. Title VII—Addressing the Impacts of COVID–19 on Substance Use Disorders Subtitle A—Easy Medication Access and Treatment for Opioid Addiction Sec. 7001. Dispensation of narcotic drugs for the purpose of relieving acute withdrawal symptoms from opioid use disorder. Subtitle B—Access to Remote Behavioral Health Treatment Sec. 7011. Registration of qualified community mental health centers. Subtitle C—PDMP Pilot Program Sec. 7021. Pilot program for integrating substance use disorder and behavioral health treatment locator tool into State prescription drug monitoring programs. Subtitle D—Family Support Services for Addiction Sec. 7031. Family support services for individuals struggling with substance use disorder. Subtitle E—Block, Report, And Suspend Suspicious Shipments Sec. 7041. Clarification of process for registrants to exercise due diligence upon discovering a suspicious order. Subtitle F—Debarment Enforcement of Bad Actor Registrants Sec. 7051. Debarment of certain registrants. Subtitle G—Ensuring Compliance Against Opioid Diversion Sec. 7061. Modification, transfer, and termination of registration to manufacture, distribute, or dispense controlled substances. Subtitle H—Opioid Prescription Verification Sec. 7071. Materials for training pharmacists on certain circumstances under which a pharmacist may decline to fill a prescription. Sec. 7072. Incentivizing States to facilitate responsible, informed dispensing of controlled substances. Subtitle I—Suspicious Order Identification Sec. 7081. Strengthening ARCOS. Sec. 7082. Suspicious Orders Task Force. Subtitle J—Stop the Importation and Manufacturing of Synthetic Analogues Sec. 7091. Establishment of schedule A. Sec. 7092. Temporary and permanent scheduling of schedule A substances. Sec. 7093. Penalties. Sec. 7094. False labeling of schedule A controlled substances. Sec. 7095. Registration requirements for importers and exporters of schedule A substances. Sec. 7096. Additional conforming amendments. Sec. 7097. Sentencing review. Sec. 7098. Rules of construction. Sec. 7099. Clarification of certain registration requirements related to research. Sec. 7100. Review of research registration process. Title VIII—Tax Incentives to Improve Health Care Sec. 8001. Domestic medical and drug manufacturing credit. Sec. 8002. Qualifying advanced medical manufacturing equipment credit. Sec. 8003. New medical research expenditure component of credit for increasing research activities. Sec. 8004. Refundable portion of research credit for small businesses engaging in specified medical research. Sec. 8005. Exception from passive loss rules for investments in specified medical research small business pass-thru entities. Sec. 8006. Temporary carryover for health and dependent care flexible spending arrangements. Sec. 8007. Increase in exclusion for employer-provided dependent care assistance. Sec. 8008. Temporary increase in contribution limits for health savings accounts. Sec. 8009. Temporary allowance of payments for employment-related expenses under health savings accounts. Sec. 8010. Treatment of direct primary care service arrangements. Sec. 8011. Allow both spouses to make catch-up contributions to the same HSA account. Sec. 8012. Repeal of ceiling on deductible and out-of-pocket expenses under a high deductible health plan. Sec. 8013. On-site employee clinics. Sec. 8014. Adjustment of medical expense deduction. Sec. 8015. Healthy workplace tax credit. Title IX—Medicare Provisions Subtitle A—Telehealth Sec. 9001. Removing certain geographic and originating site restrictions on the furnishing of telehealth services under the Medicare program. Sec. 9002. Making permanent FQHC and RHC telehealth payments. Sec. 9003. Expanding the list of practitioners eligible to furnish telehealth services. Sec. 9004. Allowing for the provision of telehealth services via audio-only telecommunications systems. Sec. 9005. Making permanent the safe harbor for absence of deductible for telehealth. Sec. 9006. Removing requirement for face-to-face visits between home dialysis patients and physicians. Sec. 9007. Report on telehealth payment integrity. Sec. 9008. Increasing funding for review of telehealth claims. Sec. 9009. Telehealth resources. Subtitle B—Protecting Access to Innovation During COVID–19 Sec. 9011. Authorizing the extension of pass-through status under the Medicare program for certain drugs and devices impacted by COVID–19. Subtitle C—Reducing Unnecessary Senior Hospitalizations Sec. 9021. SNF-based provision of preventive acute care and hospitalization reduction program. Title X—Appropriations Sec. 10001. Appropriations. Subtitle A—Health programs Subtitle B—General provisions–This Title
<enum>I</enum><header>Pandemic Preparedness and Response</header> <subtitle id="H917866F551674E60B9FE7198ED0C827B"><enum>A</enum><header>Clarifying the Role of the Department of Health and Human Services During Public Health Emergencies</header> <section id="H1D10EB9EBED5434AA12AB516558F7980"><enum>1001.</enum><header>Lead agency for Federal public health and medical response to public health emergencies</header><text display-inline="no-display-inline">Section 2801 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh">42 U.S.C. 300hh</external-xref>) is amended—</text> <paragraph id="H4402B7F5FE2A4DDB99F5E31A39ACB4AD"><enum>(1)</enum><text>in subsection (a), by inserting after <quote>shall lead all Federal public health and medical response to public health emergencies and incidents</quote> the following: <quote>(including emergencies and disasters declared by the President pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act)</quote>; and</text></paragraph> <paragraph id="H436BB05DCBB14F268D2FFD1737506704"><enum>(2)</enum><text>in subsection (b), by inserting after <quote>shall assume operational control of emergency public health and medical response assets, as necessary, in the event of a public health emergency</quote> the following: <quote>or in the event of an emergency or disaster declared by the President under the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act</quote>. </text></paragraph></section> <section id="HD295BB04C4AB4989ABE567D47009C7AA"><enum>1002.</enum><header>Deployment by the Secretary of Health and Human Services of National Strategic Stockpile</header><text display-inline="no-display-inline">Section 319F–2(a)(3)(F) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)(F)) is amended by striking <quote>as required by</quote> and inserting <quote>in consultation with</quote>.</text></section> <section id="HC3C3ACED64E943D6B279B5044282C6AB" section-type="subsequent-section"><enum>1003.</enum><header>Authority and responsibilities of the Federal Emergency Management Agency regarding the Strategic National Stockpile</header><text display-inline="no-display-inline">The Homeland Security Act of 2002 is amended—</text> <paragraph id="H0E3939AC951A43E9AB0E35B09E280ED7"><enum>(1)</enum><text>in subparagraph (A) of section 503(b)(2) (<external-xref legal-doc="usc" parsable-cite="usc/6/313">6 U.S.C. 313(b)(2)</external-xref>), by inserting <quote>, in coordination with relevant Federal agencies,</quote> after <quote>lead</quote>; and</text></paragraph> <paragraph id="HA594E0F8E303443DAECB90D5C49E27E8"><enum>(2)</enum><text>in subparagraph (D) of section 504(a)(3) (<external-xref legal-doc="usc" parsable-cite="usc/6/314">6 U.S.C. 314(a)(3)</external-xref>), by striking <quote>requiring</quote> and inserting <quote>, at the direction of the Secretary of Health and Human Services, assisting in</quote>.</text></paragraph></section></subtitle> <subtitle id="H78B9327CB9E74F668B3686A4401155F5"><enum>B</enum><header>Reagan-Udall Foundation and Foundation for the National Institutes of Health</header> <section id="H925B4CFD99F04E40A59FF08BE533F6E9"><enum>1011.</enum><header>Reagan-Udall Foundation and Foundation for the National Institutes of Health</header> <subsection id="HC59FF7A5C77D4A5A9E014B230709298C"><enum>(a)</enum><header>Reagan-Udall Foundation for the Food and Drug Administration</header><text>Section 770(n) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379dd">21 U.S.C. 379dd(n)</external-xref>) is amended by striking <quote>$500,000 and not more than $1,250,000</quote> and inserting <quote>$1,250,000 and not more than $5,000,000</quote>.</text></subsection> <subsection id="H0DD0DFF717E34794954B6DEB38C343FA" commented="no" display-inline="no-display-inline"><enum>(b)</enum><header>Foundation for the National Institutes of Health</header><text>Section 499(l) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290b">42 U.S.C. 290b(l)</external-xref>) is amended by striking <quote>$500,000 and not more than $1,250,000</quote> and inserting <quote>$1,250,000 and not more than $5,000,000</quote>. </text></subsection></section></subtitle> <subtitle id="HBE41EF4762514B4CA9348316A4CB4934"><enum>C</enum><header>Protections for Good Samaritan Health Professionals</header> <section id="H7474E5C468724D69920D97B40A72965B"><enum>1021.</enum><header>Limitation on liability for volunteer health care professionals</header> <subsection id="H4CC954DA1FDF4AEDB970E34D48F2B449"><enum>(a)</enum><header>In general</header><text>Title II of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/202">42 U.S.C. 202</external-xref> et seq.) is amended by inserting after section 224 the following:</text> <quoted-block id="HD551F913CA3342E5862EEA19831E3178" style="OLC"> <section id="H902C038D16524854B6A6D08EF3125FC9"><enum>224A.</enum><header>Limitation on liability for volunteer health care professionals</header> <subsection id="H0A3B72898B284F6BBEFF2665A554DBBA"><enum>(a)</enum><header>Limitation on liability</header><text>Except as provided in subsection (b), a health care professional shall not be liable under Federal or State law for any harm caused by an act or omission of the professional in the provision of health care services if—</text> <paragraph id="HC744EBF9373D4F968BA11E24CA7B85D9"><enum>(1)</enum><text>the professional is serving, for purposes of responding to a disaster, as a volunteer; and</text></paragraph> <paragraph id="HD12FC414492345659D22BCC5B01CD292"><enum>(2)</enum><text>the act or omission occurs—</text> <subparagraph id="H0BFD92178E65437B9467043DB0B05108"><enum>(A)</enum><text>during the period of the disaster, as determined under the laws listed in subsection (d)(1);</text></subparagraph> <subparagraph id="HBCF22F87348643358CE31EB5DE6CB8AB"><enum>(B)</enum><text display-inline="yes-display-inline">in the State or States for which the disaster is declared;</text></subparagraph> <subparagraph id="H06054FA82E6647FAAB97CF67E78F0B21"><enum>(C)</enum><text>in the health care professional’s capacity as a volunteer;</text></subparagraph> <subparagraph id="H73A7A8CB832E47BAB1A06D28E2DEC314"><enum>(D)</enum><text>in the course of providing services that are within the scope of the license, registration, or certification of the volunteer, as defined by the State of licensure, registration, or certification; and</text></subparagraph> <subparagraph id="HFBB656A9C787412E974FE62DD048A80D"><enum>(E)</enum><text>in a good faith belief that the individual being treated is in need of health care services.</text></subparagraph></paragraph></subsection> <subsection id="H2EC88028639940049F10C329FCFB4591"><enum>(b)</enum><header>Exceptions</header><text>Subsection (a) does not apply if—</text> <paragraph id="H0EADBEB0DBD94D6A815F3BC7CA7B558C"><enum>(1)</enum><text>the harm was caused by an act or omission constituting willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious flagrant indifference to the rights or safety of the individual harmed by the health care professional; or</text></paragraph> <paragraph id="H4D48F2EAEBF940A2820209812881794B"><enum>(2)</enum><text>the health care professional rendered the health care services under the influence (as determined pursuant to applicable State law) of alcohol or an intoxicating drug.</text></paragraph></subsection> <subsection id="H2669133AC7654864A846E3AED4F80E75"><enum>(c)</enum><header>Preemption</header> <paragraph id="H8AE7674C3E844B8DA70A5FF66393F0CD"><enum>(1)</enum><header>In general</header><text>This section 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 id="H2479DFC1E14D46AB8DEB4E00A4E9F309"><enum>(2)</enum><header>Volunteer Protection Act</header><text>Protections afforded by this section are in addition to those provided by the Volunteer Protection Act of 1997.</text></paragraph></subsection> <subsection id="HCF906CE032D7448C8915394C7529A7C1"><enum>(d)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HA9FE4AC2332540E7A6EF7FC6557E135F"><enum>(1)</enum><text>The term <term>disaster</term> means—</text> <subparagraph id="H2320A4DFDDAB4BA1BB236F3ACF8551D6"><enum>(A)</enum><text>a national emergency declared by the President under the National Emergencies Act;</text></subparagraph> <subparagraph id="HBD1E46FE229949BEB05546A4E53E464A"><enum>(B)</enum><text>an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act; or</text></subparagraph> <subparagraph id="H41FFF8B65FAD4DF084DEED8909A24246"><enum>(C)</enum><text display-inline="yes-display-inline">a public health emergency that is determined by the Secretary under section 319 of this Act with respect to one or more States specified in such determination—</text> <clause id="HBDE95030911C48C69108192A0B04D158"><enum>(i)</enum><text>during only the initial period covered by such determination; and</text></clause> <clause id="H066BD0A05F8C4677BF1DAE9E70357F80"><enum>(ii)</enum><text>excluding any period covered by a renewal of such determination.</text></clause></subparagraph></paragraph> <paragraph id="HB13C266F552240C38FC2C3D9BC803E67"><enum>(2)</enum><text>The term <term>harm</term> includes physical, nonphysical, economic, and noneconomic losses.</text></paragraph> <paragraph id="H9D28462B34E24FCB98D277B6410843F6"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>health care professional</term> means an individual who is licensed, registered, or certified under Federal or State law to provide health care services.</text></paragraph> <paragraph id="H7759A5B5DD534EEA94682DE89BE953AF"><enum>(4)</enum><text>The term <term>health care services</term> means any services provided by a health care professional, or by any individual working under the supervision of a health care professional, that relate to—</text> <subparagraph id="HAB5BB48911FC45F0A6581D9FC42ABDBF"><enum>(A)</enum><text>the diagnosis, prevention, or treatment of any human disease or impairment; or</text></subparagraph> <subparagraph id="H7AECB68BBD364A12B6ECBB158753451A"><enum>(B)</enum><text>the assessment or care of the health of a human being.</text></subparagraph></paragraph> <paragraph id="H069496A0871C49649D5D484820FC41A8"><enum>(5)</enum><text>The term <term>State</term> includes each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and any other territory or possession of the United States.</text></paragraph> <paragraph id="H84F3E55236DF417A9ADD133D76095457"><enum>(6)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="HB051932870EA45A39A9C8C613719AD3C"><enum>(A)</enum><text>The term <term>volunteer</term> means a health care professional who, with respect to the health care services rendered, does not receive—</text> <clause id="HDF0D37460D1F4A75B3B4400505D09662" indent="up1"><enum>(i)</enum><text>compensation; or</text></clause> <clause id="HEEAF50178CEB444093899EBF6173A62A" indent="up1"><enum>(ii)</enum><text>any other thing of value in lieu of compensation, in excess of $500 per year.</text></clause></subparagraph> <subparagraph id="H7C235D0DB5334DC4ADBF183160B51CFA" indent="up1"><enum>(B)</enum><text>For purposes of subparagraph (A), the term <term>compensation</term>—</text> <clause id="HFA0D57B842574D81B1B48B094388975E"><enum>(i)</enum><text>includes payment under any insurance policy or health plan, or under any Federal or State health benefits program; and</text></clause> <clause id="H4224A088730B496E9250D2C1FF3AA431"><enum>(ii)</enum><text>excludes—</text> <subclause id="H2100630FEA5046349163FCE599C8D3AC"><enum>(I)</enum><text>reasonable reimbursement or allowance for expenses actually incurred;</text></subclause> <subclause id="HF11E67C989004F8F87577F75754B31D1"><enum>(II)</enum><text>receipt of paid leave; and</text></subclause> <subclause id="H1DB2BDB24CDD409C9BDFBA06C651EF1A"><enum>(III)</enum><text>receipt of items to be used exclusively for rendering the health services in the health care professional’s capacity as a volunteer described in subsection (a)(1).</text></subclause></clause></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H3DED07E6A511453A816FFE1AE43B028E"><enum>(b)</enum><header>Effective date</header> <paragraph id="HC7F9676BCBB549E282B630E04DB83EDD"><enum>(1)</enum><header>In general</header><text>Section 224A of the Public Health Service Act, as added by subsection (a), shall take effect 90 days after the date of the enactment of this Act.</text></paragraph> <paragraph id="HB45540A935194AAB90415234E2A78761"><enum>(2)</enum><header>Application</header><text>Section 224A of the Public Health Service Act, as added by subsection (a), applies to a claim for harm only if the act or omission that caused such harm occurred on or after the effective date described in paragraph (1).</text></paragraph></subsection></section> <section id="HA8B18EA43FE349D1AE5BCEC6AF382198"><enum>1022.</enum><header>Sense of the Congress</header><text display-inline="no-display-inline">It is the sense of Congress that—</text> <paragraph id="H55560E7AD6E04C4E909DA96663A61A34"><enum>(1)</enum><text>health care professionals should be encouraged to register with the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR–VHP), and States should employ online registration with the promptest processing possible of such registrations to foster the rapid deployment and utilization of volunteer health care professionals following a disaster;</text></paragraph> <paragraph id="H4CF2F222D675447FAF7802A3A1C3DED4"><enum>(2)</enum><text>Federal and State agencies and licensing boards should cooperate to facilitate the timely movement of properly licensed volunteer health care professionals to areas affected by a disaster; and</text></paragraph> <paragraph id="H0CCC51EC40394C6A9C62818A292061E0"><enum>(3)</enum><text>the appropriate licensing entities should verify the licenses of volunteer health care professionals serving disaster victims as soon as is reasonably practical following a disaster.</text></paragraph></section></subtitle> <subtitle id="H7412E51D141941C1B47A29B42B476231"><enum>D</enum><header>Medical Sheltering</header> <section id="H0E310AA0FCDF429F9B3BA56B25BEA820"><enum>1031.</enum><header>Reducing the spread of COVID–19 through payments to States to lease hotels to temporarily house eligible individuals</header> <subsection id="HE42844E120BF4E899DB94B7A28BD591E"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services may make payments to States to lease hotels to temporarily house, on a voluntary basis, eligible individuals.</text></subsection> <subsection id="H4819E7AD1C70466C9E9F133748E8A794"><enum>(b)</enum><header>Formula</header><text>The Secretary shall allocate the amount appropriated to carry out this section pursuant to a formula developed by the Secretary that—</text> <paragraph id="H2609311D9203444D86F6307B2DE1057F"><enum>(1)</enum><text>distributes the amount among the States that—</text> <subparagraph id="HD9D06F98A2F54255B988456E42862181"><enum>(A)</enum><text>submit applications in accordance with subsection (c); and</text></subparagraph> <subparagraph id="H4FA8FFB59A9543028BFF64C134B6FDBD"><enum>(B)</enum><text>are determined by the Secretary to need such payments; and</text></subparagraph></paragraph> <paragraph id="H966EF55BCAEC49DBAA6CC868B3AB4DE5"><enum>(2)</enum><text>takes into consideration—</text> <subparagraph id="HF9AC7E26BD3C4BC79603FC9C6615D10C"><enum>(A)</enum><text>the number of active cases of individuals infected with COVID–19 in the applying State relative to the overall population of the State; and</text></subparagraph> <subparagraph id="H23130A65BE604AD78BEE3775FBCC9217"><enum>(B)</enum><text>the average income of individuals in the applying State relative to the average income of individuals in the United States.</text></subparagraph></paragraph></subsection> <subsection id="HD5BAE9418BCC4101803E972D3451D512"><enum>(c)</enum><header>Applications</header> <paragraph id="H615E23A01C56499C814DF96122B3F3EE"><enum>(1)</enum><header>In general</header><text>To seek a payment under this section, a State shall submit an application to the Secretary at such time, in such manner, and containing such information and assurances as the Secretary may require.</text></paragraph> <paragraph id="H2B6917B411434DEAA705F304CDD5FC0A"><enum>(2)</enum><header>Process</header><text>The Secretary shall—</text> <subparagraph id="H9AE2FD553994448C9768F9803589B67D"><enum>(A)</enum><text>not later than 15 days after the date of enactment of this Act, publish the process for States to apply for payments under this section; and</text></subparagraph> <subparagraph id="HDBB7E6C4ABE44D62BA360A391CD2F327"><enum>(B)</enum><text>not later than 15 days after the submission of an application in accordance with such process, approve or disapprove the application.</text></subparagraph></paragraph> <paragraph id="HD2D3E87838D04CB1A32D6110B54F79E1"><enum>(3)</enum><header>Contents</header><text>The Secretary shall require the application of a State under this section to include—</text> <subparagraph id="H22130C7DDDC2465181C98E2B70EE56C7"><enum>(A)</enum><text>a plan for leasing hotels as described in subsection (a);</text></subparagraph> <subparagraph id="H7E97CE91B5E64BFE8115E0E069100A48"><enum>(B)</enum><text>health guidelines which the State will require to be implemented to protect the staff of the hotels;</text></subparagraph> <subparagraph id="HA4F3A3F858CE4503A8E1711EE1F9967F"><enum>(C)</enum><text>the rates to be paid to lease the hotels;</text></subparagraph> <subparagraph id="HBFFCBF5E954844BC8BF0B9905C09ED8F"><enum>(D)</enum><text>a plan to ensure that the hotels each have—</text> <clause id="HC4DD682EE8414BDDAE0DA8585E410608"><enum>(i)</enum><text>workplace safety standards for their staff;</text></clause> <clause id="H8FDAE7CE10034DFFBE1F574DB8EB2277"><enum>(ii)</enum><text>proper personal protective equipment and sanitation supplies;</text></clause> <clause id="HDB9B2D6E398145D9B86E66E4F54AD3E7"><enum>(iii)</enum><text>a cleaning protocol for rooms and facilities; and</text></clause> <clause id="H29611CE5584F4C9DB723B2EA1F22696E"><enum>(iv)</enum><text>at least one qualified health care professional onsite or on call to monitor the health of individuals being housed at the hotels;</text></clause></subparagraph> <subparagraph id="HFB6C2AC4B1334DAB906FDE8E5CAEC1AA"><enum>(E)</enum><text>a plan to feed and provide other necessary materials to individuals described in subsection (a) at the hotels, including medications and hygiene products, without letting such individuals leave their rooms or accept visitors;</text></subparagraph> <subparagraph id="H7871B12CABBD41D18DBCB5404622C16F"><enum>(F)</enum><text display-inline="yes-display-inline">a plan to assist the hotels in removing individuals who attempt to continue their stay after the allotted time; </text></subparagraph> <subparagraph id="H2C3E35A0844A4A64A4408D5A31667135"><enum>(G)</enum><text>a plan for hospital networks, local health departments, and the hotels to coordinate on the exchange and protection of patient information in accordance with other applicable law;</text></subparagraph> <subparagraph id="H5BFC130DAD4242AA99C075851FB89696"><enum>(H)</enum><text display-inline="yes-display-inline">a plan to effectively communicate the State’s program funded through this section to racial and ethnic minority groups and low-income communities; and</text></subparagraph> <subparagraph id="H28AB4F0F733349A18E4EEF20B6341A22"><enum>(I)</enum><text>each funding assurance listed in subsection (e).</text></subparagraph></paragraph></subsection> <subsection id="H77E8735DC4074A5299F6258158E62E43"><enum>(d)</enum><header>No responsibility for diet or administration of medicine</header><text display-inline="yes-display-inline">Notwithstanding subsection (c)(3)(E), a contract between a State and a hotel pursuant to this section shall not make the hotel responsible for the diet of, or the administration of medications to, individuals described in subsection (a).</text></subsection> <subsection id="H90F9A6DCF2424EDFAED51B88AF7BD1E1"><enum>(e)</enum><header>Funding assurances</header><text>As a condition on receipt of a payment of this section, a State shall give such assurances as the Secretary may require that—</text> <paragraph id="H65D73C8C5C6B4D7A92F19C4C1AA0DE7D"><enum>(1)</enum><text>each contract between the State and a hotel pursuant to this section will be entered into on a voluntary basis, and no hotel will be required by the State to participate in the program under this section;</text></paragraph> <paragraph id="H6C8FD99ED51346DDAC8FDAECED3AFC02"><enum>(2)</enum><text>individuals described in subsection (a) will not be charged for their lodging at a hotel pursuant to this section, except that such individuals may be required to reimburse the costs of receiving food and beverages;</text></paragraph> <paragraph id="HD439365E0B1940B2A76B9B38BAE42053"><enum>(3)</enum><text>individuals described in subsection (a) will retain the option of self-isolating at home (including the option of checking out early and returning to their homes) rather than being required to stay at a hotel funded pursuant to this section;</text></paragraph> <paragraph id="H1437B667DFC848B3B8F5397F7F22E2B9"><enum>(4)</enum><text>before an individual is allowed to stay at a hotel pursuant to this section, the individual will be required to present, in such form and manner as may be required by the local department of health, documentation from a physician that the individual meets the criteria described in subsection (a);</text></paragraph> <paragraph id="HAE1C263364E04686BAB8E45C9FD7D796"><enum>(5)</enum><text display-inline="yes-display-inline">any non-transient homeless population residing at a hotel will not be displaced for purposes of entering into or carrying out a contract between the State and the hotel under this section; and</text></paragraph> <paragraph id="H914FF39436DC4E02A746B3EDE28BC71A" commented="no"><enum>(6)</enum><text>the State will pay (from funds provided to the State under this section or from other State funds)—</text> <subparagraph id="H56B235E3894146B18C35FD3C7083423F" commented="no"><enum>(A)</enum><text>at least 40 percent of the costs of the personal protective equipment and sanitation supplies needed by individuals staying at a hotel pursuant to this section and the staff of such hotel; and</text></subparagraph> <subparagraph id="H4E2BF60D14864763BD4C2708D01533DF" commented="no"><enum>(B)</enum><text>all of the costs of having one or more qualified health care professionals described in subsection (c)(3)(D)(iii) for the provision of monitoring described in such subsection (whether by being onsite or on call).</text></subparagraph></paragraph></subsection> <subsection id="HD48452F108C34735B0D1277D35BF4C7D"><enum>(f)</enum><header>Review</header><text>At the conclusion of the program under this section, the Inspector General of the Department of Health and Human Services shall—</text> <paragraph id="HA40539774BD94ED69199B2D9AB73668D"><enum>(1)</enum><text>review the program and activities of each State funded pursuant to this section; and</text></paragraph> <paragraph id="H2EE6CDCC2E3242C8828B0650610C6C51"><enum>(2)</enum><text>submit a report on the results of the review to—</text> <subparagraph id="H563C45C9686F406DBF891C181761EB40"><enum>(A)</enum><text>the Committee on Energy and Commerce and the Committee on Ways and Means of the House of Representatives; and</text></subparagraph> <subparagraph id="HCE116F91902A4F1FA8D21B041B8FCA69"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate.</text></subparagraph></paragraph></subsection> <subsection id="H72FD596CFEAF496090C514489BA837A3" commented="no"><enum>(g)</enum><header>Liability protection</header> <paragraph id="H4E16D68966424FBD9D9678BC01065DE9" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided under paragraph (2), a hotel or member of the staff shall not be liable under Federal or State law for—</text> <subparagraph id="H69C23551A6D24F7C999F00AC1A07E0C2" commented="no"><enum>(A)</enum><text>any harm caused by an act or omission in the provision of hotel services pursuant to this section; or</text></subparagraph> <subparagraph id="H1A3DC101BD0E45DBB2A091C5710B9F5F" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">failing to keep an individual who is staying at a hotel pursuant to this section isolated from people other than the staff of the hotel and any qualified health care professional described in subsection (c)(3)(D)(iii). </text></subparagraph></paragraph> <paragraph id="H1CB48D0B4CA04A3AAFD233E5BBAB1266" commented="no"><enum>(2)</enum><header>Exception</header><text display-inline="yes-display-inline">Paragraph (1) does not apply in the case that the harm was caused by an act or omission constituting willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious flagrant indifference to the rights or safety of the individual harmed. </text></paragraph></subsection> <subsection id="H0D56E0FBC1AA45AEB24D0A68D6090F53"><enum>(h)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H062FDC4FE44A49E28C78127B5077D969"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>eligible individual</term> means an individual who is unable to self-isolate at home, does not require inpatient or outpatient health care treatment, and—</text> <subparagraph id="HB245073A15714FA0B531F59ADC3B7312"><enum>(A)</enum><text display-inline="yes-display-inline">has a laboratory-confirmed case of COVID–19;</text></subparagraph> <subparagraph id="H73CF4A288D0D41B4911B6DE963909E15"><enum>(B)</enum><text>has a presumptive positive case of COVID–19; or</text></subparagraph> <subparagraph id="HF97992BD74674AF09BA121A16B227F88"><enum>(C)</enum><text>is a person under investigation who is displaying symptoms of COVID–19.</text></subparagraph></paragraph> <paragraph id="H5B29B7001DA544E88675DF03523E4C79"><enum>(2)</enum><text>The terms <term>Indian tribe</term> and <term>tribal organization</term> have the meanings given to those terms in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>).</text></paragraph> <paragraph id="H0425E59C927F4960A322C2F3E625E182"><enum>(3)</enum><text>The term <term>Secretary</term> means the Secretary of Health and Human Services.</text></paragraph> <paragraph id="H9D25D33A35D049D896BC5C8587E628E6"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>State</term> includes each of 50 States, the District of Columbia, each Indian Tribe and tribal organization, Guam, American Samoa, the United States Virgin Islands, the Commonwealth of Puerto Rico, and the Commonwealth of the Northern Mariana Islands.</text></paragraph></subsection> <subsection id="H4C1E6D4AB06A4328AD0B5F29C7D31858"><enum>(i)</enum><header>Funding</header><text>To carry out this section, there is authorized to be appropriated $1,000,000,000, to remain available through the earlier of—</text> <paragraph id="H1393E5100CDE45E286AA9A7EC18A20AB"><enum>(1)</enum><text>the end of calendar year 2021; or</text></paragraph> <paragraph id="H625653805E1D4FD38CC4EC9B9C78ED73"><enum>(2)</enum><text>the end of the emergency period (as defined in section 1135(g)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5(g)(1)(B)</external-xref>)). </text></paragraph></subsection></section></subtitle> <subtitle id="HFC06E9EB8DB2490193ED043AC558F678"><enum>E</enum><header>CDC campaign on COVID–19 awareness</header> <section id="HDE4701DD3A5744C7A007606CA060ACE7" section-type="subsequent-section"><enum>1041.</enum><header>COVID–19 public awareness campaign</header><text display-inline="no-display-inline">The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other offices and agencies, as appropriate, shall award competitive grants or contracts to one or more public or private entities to carry out a national campaign that is multilingual and culturally competent and based on available scientific evidence to increase awareness and knowledge of COVID–19, including reducing stigma associated with COVID–19 and improving information on the availability of diagnostic testing and other related services at community health centers.</text></section></subtitle> <subtitle id="HB967D8BD81FE4B91B8E90786F03CB520"><enum>F</enum><header>Protecting Children from COVID–19</header> <section id="HD3AF7A90926D43318A835FBA97387CFD"><enum>1051.</enum><header>Study on children’s role in transmitting SARS–CoV–2</header> <subsection id="HE5619F8CB17C48C7995042E33A280E4C"><enum>(a)</enum><header>Study</header> <paragraph id="HACEC6FBA5CDE4D3796B189EF2F8B741D"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>), in coordination with the heads of agencies of the Department of Health and Human Services and experts from outside of the Department, as appropriate, shall complete a study on children’s role in transmitting SARS–CoV–2.</text></paragraph> <paragraph id="H3622D26B9D3F44F190C1BD44F86B6AA5"><enum>(2)</enum><header>Issues to be studied</header><text>The study under paragraph (1) shall address—</text> <subparagraph id="H035985B41F5041499EC620DAE09DFB77"><enum>(A)</enum><text>the transmissibility of COVID–19 from child to child, child to adult, and adult to child;</text></subparagraph> <subparagraph id="H40C83123DDB2446E982003D157E41FB6"><enum>(B)</enum><text>the vulnerability of children, especially those with underlying health conditions, to severe illness as such vulnerability relates to COVID–19;</text></subparagraph> <subparagraph id="H1CBDC9DE0DDE4B6488B4BD4914D38484"><enum>(C)</enum><text>the vulnerability of adults, especially those with underlying health conditions, who send their children back to school; and</text></subparagraph> <subparagraph id="H404EA1D523454BADA3AE6A31B3FAE1EE"><enum>(D)</enum><text>the vulnerability of adults, especially those with underlying health conditions, who interact with children who may be asymptomatic but infectious.</text></subparagraph></paragraph> <paragraph id="HEFF7A8E05C8F47DBB5B5E154EB4DB3A2"><enum>(3)</enum><header>Considerations</header><text display-inline="yes-display-inline">In carrying out the study under paragraph (1), the Secretary shall—</text> <subparagraph id="HBD7047AFDDB445D1BF75086C312DDDF8"><enum>(A)</enum><text>take into consideration the best available science, including as provided by the National Academy of Sciences; and</text></subparagraph> <subparagraph id="H3C37FDD5B1024830AEDB6DCD8F2100E0"><enum>(B)</enum><text display-inline="yes-display-inline">ensure that such study includes consideration of children who are members of racial or ethnic minority groups.</text></subparagraph></paragraph></subsection> <subsection id="H60FD0DE78BD841399E142163B34F02CE"><enum>(b)</enum><header>Reporting</header><text display-inline="yes-display-inline">The Secretary shall submit a report to the Congress on children’s role in transmitting SARS–CoV–2. The report shall include the results of the study under subsection (a).</text></subsection> <subsection id="H8E26723A8940453C98E72C7832012E50"><enum>(c)</enum><header>Dissemination of best practices</header><text display-inline="yes-display-inline">The Secretary shall disseminate to stakeholders best practices for protecting children and adults in educational settings. The first best practices disseminated pursuant to the preceding sentence shall include any best practices for protecting children and adults in educational settings identified through the study under subsection (a).</text></subsection> <subsection id="H2BC4CC7CFC8241F2B620C3D891EF7D6A"><enum>(d)</enum><header>Definition</header><text>In this section, the term <term>emergency period</term> has the meaning given to such term in section 1135(g)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5(g)(1)(B)</external-xref>).</text></subsection></section></subtitle> <subtitle id="H60C53340315E4E2599597FFA56087914"><enum>G</enum><header>Ensuring Understanding of COVID–19</header> <section id="H0996C391EE894B218E860B2608CF6A7F"><enum>1061.</enum><header>Study on the impact of COVID–19</header><text display-inline="no-display-inline">Part A of title IV of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/281">42 U.S.C. 281</external-xref> et seq.) is amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H89203558E71547D69BF4C179EDF3E8F7"> <section id="H93139CD6B7244F04AF1F8284A40551F7"><enum>404O.</enum><header>Study on the impact of COVID–19</header> <subsection id="H157C16F7BF54432792CD0316B7B09DA5"><enum>(a)</enum><header>In general</header><text>The Secretary shall conduct a longitudinal study, over not less than 10 years, on the full impact of COVID–19 on infected individuals, including both short-term and long-term health impacts. </text></subsection> <subsection id="H1E2FDEFA9B6C4745BC4F3C1DA43D96FF"><enum>(b)</enum><header>Timing</header><text>The Secretary shall begin enrolling patients in the study under this section not later than 6 months after the date of enactment of this section. </text></subsection> <subsection id="HD7BCAA319B284125BB116AD5653856AA"><enum>(c)</enum><header>Requirements</header><text>The study under this section shall—</text> <paragraph id="HFC3F2B32FE244BBD895F85074D6BCADA"><enum>(1)</enum><text>be nationwide;</text></paragraph> <paragraph id="H659DE4529C064E72BEA89B61400FA1B7"><enum>(2)</enum><text>include diversity of enrollees to account for gender, age, race, ethnicity, geography, comorbidities, and underrepresented populations, including pregnant and lactating women;</text></paragraph> <paragraph id="H0BF332F0D5184E25AE97B0F242AF4560"><enum>(3)</enum><text>study individuals who were infected with COVID–19 who experienced mild symptoms, such individuals who experienced moderate symptoms, and such individuals who experienced severe symptoms;</text></paragraph> <paragraph id="H3696E73D2EE44BCDA7363C39FCD7E345"><enum>(4)</enum><text>monitor the health outcomes and symptoms of individuals who were infected with COVID–19, or had prenatal exposure to COVID–19, including lung capacity and function, and immune response, taking into account any pharmaceutical interventions such individuals may have received; </text></paragraph> <paragraph id="H4E139A06B14948D7A162EC4695C2EA59"><enum>(5)</enum><text display-inline="yes-display-inline">monitor the mental health outcomes of individuals infected with COVID–19, taking into account any interventions that affected mental health; and</text></paragraph> <paragraph id="H65B1FA3F96404C5B8901272E616F5D0E"><enum>(6)</enum><text>monitor individuals enrolled in the study not less frequently that twice per year after the first year of the individual's infection with COVID–19.</text></paragraph></subsection> <subsection id="HFCE604A1C6434258B5352BDC4BC1708A"><enum>(d)</enum><header>Public-Private research network</header><text>For purposes of carrying out the study under this section, the Director of NIH may develop a network of public-private research partners, provided that all research, including the research carried out through any such partner, is available publicly.</text></subsection> <subsection id="HA8BA173DC6A149838ECF4722D5B0D707"><enum>(e)</enum><header>Summaries of findings</header><text>The Director of NIH shall make public a summary of findings under this section not less frequently than once every 3 months for the first 2 years of the study, and not less frequently than every 6 months thereafter. Such summaries may include information about how the findings of the study under this section compare with findings from research conducted abroad.</text></subsection> <subsection id="HF6DBDE4C3BD049C385878EEB93F0A95E"><enum>(f)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated such sums as may be necessary to carry out this section.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H65EA82046E5A4CF3AC94CC059AE8E76A"><enum>H</enum><header>Safeguarding Therapeutics</header> <section id="H06C5C5B8E9DE47FF8E9F3CE479468E65"><enum>1071.</enum><header>Authority to destroy counterfeit devices</header> <subsection id="HADD765AA992D4F43A4E5F18BFB7B2381"><enum>(a)</enum><header>In general</header><text>Section 801(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C. 381(a)</external-xref>) is amended—</text> <paragraph id="H32CBF285D4ED4C8886078C8165486FC1"><enum>(1)</enum><text>in the fourth sentence, by inserting <quote>or counterfeit device</quote> after <quote>counterfeit drug</quote>; and</text></paragraph> <paragraph id="HC949F29F362542B7AC58252A50280134"><enum>(2)</enum><text>by striking <quote>The Secretary of the Treasury shall cause the destruction of</quote> and all that follows through <quote>liable for costs pursuant to subsection (c).</quote> and inserting the following: <quote>The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations, except that the Secretary of Health and Human Services may destroy, without the opportunity for export, any drug or device refused admission under this section, if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation pursuant to section 498(a)(1) of the Tariff Act of 1930 (<external-xref legal-doc="usc" parsable-cite="usc/19/1498">19 U.S.C. 1498(a)(1)</external-xref>)) and was not brought into compliance as described under subsection (b). The Secretary of Health and Human Services shall issue regulations providing for notice and an opportunity to appear before the Secretary of Health and Human Services and introduce testimony, as described in the first sentence of this subsection, on destruction of a drug or device under the seventh sentence of this subsection. The regulations shall provide that prior to destruction, appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug or device. Where the Secretary of Health and Human Services provides notice and an opportunity to appear and introduce testimony on the destruction of a drug or device, the Secretary of Health and Human Services shall store and, as applicable, dispose of the drug or device after the issuance of the notice, except that the owner and consignee shall remain liable for costs pursuant to subsection (c).</quote>.</text></paragraph></subsection> <subsection id="H3D6B14197C6844EDB3CD5EEE8785E3D9"><enum>(b)</enum><header>Definition</header><text>Section 201(h) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(h)</external-xref>) is amended—</text> <paragraph id="HD995B28A6BC14AB6A887862D002478E8"><enum>(1)</enum><text>by redesignating subparagraphs (1), (2), and (3) as clauses (A), (B), and (C), respectively; and</text></paragraph> <paragraph id="H4600ABAD1F0F42AEAC03A7BB5C5D1557"><enum>(2)</enum><text>after making such redesignations—</text> <subparagraph id="H63FF851D628547789D2273F50C20A7B9"><enum>(A)</enum><text>by striking <quote>(h) The term</quote> and inserting <quote>(h)(1) The term</quote>; and</text></subparagraph> <subparagraph id="HA46E4118E5CE46038FD724BA56AD4F86"><enum>(B)</enum><text>by adding at the end the following:</text> <quoted-block id="H54837D7153674F8988D86E463C3785A5" style="OLC"> <paragraph id="H965DD09D8869409E926867F8C7C69FE9" indent="up1"><enum>(2)</enum><text>The term <term>counterfeit device</term> means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark, imprint, or symbol, or any likeness thereof, or is manufactured using a design, of a device manufacturer, packer, or distributor other than the person or persons who in fact manufactured, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, packer, or distributor.</text></paragraph> <paragraph id="H11321EF38F14441C84961F4A1428F5F4" indent="up1"><enum>(3)</enum><text>For purposes of subparagraph (2)—</text> <subparagraph id="H784B15DCCA9C43F7911F850C9CDA734A"><enum>(A)</enum><text>the term <term>manufactured</term> refers to any of the following activities: manufacture, preparation, propagation, compounding, assembly, or processing; and</text></subparagraph> <subparagraph id="H603BB9B19162432CB0BCE14461C4E743"><enum>(B)</enum><text>the term <term>manufacturer</term> means a person who is engaged in any of the activities listed in clause (A).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection></section> <section id="H1B7631E464EF4B42BEE331716DFFE269"><enum>1072.</enum><header>Determination of budgetary effects</header><text display-inline="no-display-inline">The budgetary effects of this subtitle, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled <quote>Budgetary Effects of PAYGO Legislation</quote> for this subtitle, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.</text></section></subtitle> <subtitle id="HC41DBAA8006C4A85A18A39B00CD45594"><enum>I</enum><header>Advisory Committee on Immunization Practices</header> <section id="HEDB562970AAE420A92E40F1E8D627E40"><enum>1081.</enum><header>Expedited meeting of ACIP for COVID–19 vaccines</header> <subsection id="H5F1F2A7808384DA4A20DD103192B37A1"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Notwithstanding section 3091 of the 21st Century Cures Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-4">21 U.S.C. 360bbb–4</external-xref> note), the Advisory Committee on Immunization Practices shall meet and issue a recommendation with respect to a vaccine that is intended to prevent or treat COVID–19 not later than 15 business days after the date on which such vaccine is licensed under section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) or authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-3">21 U.S.C. 360bbb–3</external-xref>).</text></subsection> <subsection id="H4DD91371C0EB49B4BB34E6A658C30CDE"><enum>(b)</enum><header>Definition</header><text>In this section, the term <term>Advisory Committee on Immunization Practices</term> means the Advisory Committee on Immunization Practices established by the Secretary of Health and Human Services pursuant to section 222 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/217a">42 U.S.C. 217a</external-xref>), acting through the Director of the Centers for Disease Control and Prevention.</text></subsection></section></subtitle> <subtitle id="H8699D2A02B7641878E42A315081B3AE7"><enum>J</enum><header>Improvements to Transparency of the Pricing of Diagnostic Testing for COVID–19</header> <section id="HC46EFD7775104E59B7624BC1A8F09AA0"><enum>1091.</enum><header>Improvements to transparency of the pricing of diagnostic testing for COVID–19</header> <subsection id="HA3E5E97F84E242C8A82749632DC6D7EE"><enum>(a)</enum><header>In general</header><text>Section 3202 of the CARES Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/136">Public Law 116–136</external-xref>) is amended—</text> <paragraph id="H4DCDEA85176345E194B88328C96F1FFB"><enum>(1)</enum><text>in subsection (b)—</text> <subparagraph id="H37651E4594EC44449795B6C175A8CD6E"><enum>(A)</enum><text>in the heading, by inserting <quote><header-in-text level="subsection" style="OLC">and Related Items and Services</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Diagnostic Testing for COVID–19</header-in-text></quote>;</text></subparagraph> <subparagraph id="HAC9FC66E90744A3EB63E0D0BC5C806B7"><enum>(B)</enum><text>in paragraph (1)—</text> <clause id="HB2E2022904CC4E3AAC29D182E8DEAC1F"><enum>(i)</enum><text>by striking <quote>a diagnostic test for COVID–19</quote> and inserting <quote>a test, item, or service described in section 6001(a) of division F of the Families First Coronavirus Response Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/127">Public Law 116–127</external-xref>)</quote>; and</text></clause> <clause id="H834ADA0FFF0943DAA7E709F8AD83BF7E"><enum>(ii)</enum><text>by striking <quote>such test</quote> and inserting <quote>such test, item, or service</quote>; and</text></clause></subparagraph> <subparagraph id="H3BCC9E9769454249AE30F5DC6226808B"><enum>(C)</enum><text>in paragraph (2), by striking <quote>a diagnostic test for COVID–19</quote> and inserting <quote>a test, item, or service described in section 6001(a) of division F of the Families First Coronavirus Response Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/127">Public Law 116–127</external-xref>)</quote>; and</text></subparagraph></paragraph> <paragraph id="HA07825622AEA41C3892DCADD7243FD8C"><enum>(2)</enum><text>by adding at the end the following new subsections:</text> <quoted-block id="H8BF0F01F0AF9465DB13FF23DE3CC5A25" style="OLC"> <subsection id="H575431E2F1A8419CBE0B650D546DE365"><enum>(c)</enum><header>Improvements to transparency policy</header> <paragraph id="HD1489DE1CBF04F339798FAB65B053725"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 30 days after the date of the enactment of this subsection, the Secretary of Health and Human Services shall survey providers subject to the requirement under subsection (b) regarding the cash prices referred to in such subsection.</text></paragraph> <paragraph id="HCD50D254001F4C3B807D0042471C003D"><enum>(2)</enum><header>Representative sample</header><text>In carrying out paragraph (1), the Secretary shall survey a sample of providers that is representative of the diversity of sizes, geographic locations, and care settings (such as hospitals, laboratories, and independent freestanding emergency departments) in which diagnostic testing for COVID–19 is performed.</text></paragraph> <paragraph id="HAF0501B35BEF41CAAA19C79DBA85B8D8"><enum>(3)</enum><header>Consumer complaints</header><text>The Secretary shall ensure that consumers have a method to submit complaints to the Department of Health and Human Services that identify providers that—</text> <subparagraph id="HEECF35CDC3D446308B5F57DD0C931EA4"><enum>(A)</enum><text>may be in violation of subsection (b); and</text></subparagraph> <subparagraph id="HE58336267ED54EBB82B6FBFFAF32BF09"><enum>(B)</enum><text>have not made public a cash price in accordance with such subsection.</text></subparagraph></paragraph></subsection> <subsection id="H36FE086834E8411DBA79EC7E8D8873DE"><enum>(d)</enum><header>Public report</header><text>Not later than 60 days after the date of the enactment of this subsection, the Secretary of Health and Human Services shall publish on the internet website of the Department of Health and Human Services a report on cash prices for items and services published under subsection (b)(1) during the period beginning on the date of the enactment of this Act and ending on the date of the enactment of this subsection, which shall include—</text> <paragraph id="H67EE6942C2AA4CAEAA0983E03247DCA6"><enum>(1)</enum><text>the percentage of providers that comply with the requirement under such subsection;</text></paragraph> <paragraph id="H01D3ABFE8AE547DEA3B3E21A1AA09CA7"><enum>(2)</enum><text>the average cash price for each such item and service published under such subsection; and</text></paragraph> <paragraph id="H493E26ED4AC342DBA807F2A91DCA4132"><enum>(3)</enum><text>any providers identified pursuant to paragraph (2) or (3) of subsection (c) and found to be in violation of such requirement.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section></subtitle> <enum>II</enum><header>Domestic Manufacturing and Supply Chain</header> <subtitle id="H3B3BE254725D4C208F972CEB07AD6507"><enum>A</enum><header>Sustained On-Shore Manufacturing Capacity for Public Health Emergencies</header> <section id="H92BC7ECD32884D80991B85EA174EDD6D"><enum>2001.</enum><header>Sustained on-shore manufacturing capacity for public health emergencies</header> <subsection id="HC15F507B20F9417FB01E82FC682BA8A5"><enum>(a)</enum><header>In general</header><text>Section 319L of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-7e">42 U.S.C. 247d–7e</external-xref>) is amended—</text> <paragraph id="H0314D92353744F89AEE1935956B49D67"><enum>(1)</enum><text>in subsection (a)(6)(B)—</text> <subparagraph id="HA2C7115C2FAE49B0B63F41767DD93C85"><enum>(A)</enum><text>by redesignating clauses (iv) and (v) as clauses (v) and (vi), respectively;</text></subparagraph> <subparagraph id="H6239BC69FC904EB8B1381B3E8AA00DB5"><enum>(B)</enum><text>by inserting after clause (iii), the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H7B9D86E6A9004BF9B8418240E91C89F1"> <clause id="H2351D99DFC724A09858C41CA0150C325"><enum>(iv)</enum><text>activities to support domestic manufacturing surge capacity of products or platform technologies, including manufacturing capacity and capabilities to utilize platform technologies to provide for flexible manufacturing initiatives;</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph> <subparagraph id="H5B847DFD7C2545029FE7879CDA5E31DF"><enum>(C)</enum><text>in clause (vi) (as so redesignated), by inserting <quote>manufacture,</quote> after <quote>improvement,</quote>;</text></subparagraph></paragraph> <paragraph id="H109CFEF484754EB39B6E153211139294"><enum>(2)</enum><text>in subsection (b)—</text> <subparagraph id="H583D79E3298F46FDAC8670608DF71746"><enum>(A)</enum><text>in the first sentence of paragraph (1), by inserting <quote>support for domestic manufacturing surge capacity,</quote> after <quote>initiatives for innovation,</quote>; and</text></subparagraph> <subparagraph id="HABC844CFEFB1442F8B9D7AB9E1F38475"><enum>(B)</enum><text>in paragraph (2)—</text> <clause id="H5DA0484EA7894370B1F90D95274F9BE8"><enum>(i)</enum><text>in subparagraph (B), by striking <quote>and</quote> at the end;</text></clause> <clause id="H016F71D7BACC4DFBB440BEDEF65A4C8D"><enum>(ii)</enum><text>by redesignating subparagraph (C) as subparagraph (D); and </text></clause> <clause id="H6CB1F895E6F847E5BE7811D2C37C706F"><enum>(iii)</enum><text>by inserting after subparagraph (B), the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H38C9B9EDEE3E4CC28ACC9454E8EF94A8"> <subparagraph id="HC223C6EA39DC47FB870EFC5B2164DC27"><enum>(C)</enum><text>activities to support manufacturing surge capacities and capabilities to increase the availability of existing medical countermeasures and utilize existing novel platforms to manufacture new medical countermeasures to meet manufacturing demands to address threats that pose a significant level of risk to national security; and</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block></clause></subparagraph></paragraph> <paragraph id="HD2323854814B4A879D3F8FA97BF92391"><enum>(3)</enum><text>in subsection (c)—</text> <subparagraph id="H90AF2108FFEA4B8AB18382C2F2AD1B0F"><enum>(A)</enum><text>in paragraph (2)—</text> <clause id="H7632F50FB57B465283C84F34DE920434"><enum>(i)</enum><text>in subparagraph (C), by striking <quote>and</quote> at the end;</text></clause> <clause id="H556A5AA432AE46DA85ADFF467CD01B79"><enum>(ii)</enum><text>in subparagraph (D), by striking the period and inserting <quote>; and</quote>; and</text></clause> <clause id="HE2514D601F2C431695D91B8FDFC1F397"><enum>(iii)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H87B5468B362A49F9B83EBDA206888E85"> <subparagraph id="HEE2A8912674049079F079DB49B6D8E69"><enum>(E)</enum><text>promoting domestic manufacturing surge capacity and capabilities for countermeasure advanced research and development, including facilitating contracts to support flexible or surge manufacturing.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph> <subparagraph id="H6B72369EC61B4E89A17DB53A2A53FFEF"><enum>(B)</enum><text>in paragraph (4)—</text> <clause id="H367CF048B783416599611137F37A8DBD"><enum>(i)</enum><text>in subparagraph (B)—</text> <subclause id="HF47E146552A14B28B640FD3B5CE6FAF5"><enum>(I)</enum><text>in clause (iii), by striking <quote>and</quote> at the end;</text></subclause> <subclause id="H0EA31B5936F041AA9BEFDA3B630BB14E"><enum>(II)</enum><text>in clause (iv), by striking the period and inserting <quote>; and</quote>; and</text></subclause> <subclause id="H1D6A06E8C464435BBFE91616892DD72C"><enum>(III)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H784427593ACB496B97205AE7966210B2"> <clause id="H81C341D932264A40B8BC27C2DD5EEE10"><enum>(v)</enum><text>support and maintain domestic manufacturing surge capacity and capabilities, including through contracts to support flexible or surge manufacturing, to ensure that additional production of countermeasures is available in the event that the Secretary determines there is such a need for additional production.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></subclause></clause> <clause id="H665572FE68B64B43ACE13FDCB998BFE4"><enum>(ii)</enum><text>in subparagraph (D)—</text> <subclause id="HE70B05723BD74456AA2E6A899D0200B8"><enum>(I)</enum><text>in clause (ii), by striking <quote>and</quote> at the end;</text></subclause> <subclause id="H9033BF20D3FD4F36A39D51580BBA5D08"><enum>(II)</enum><text>by redesignating clause (iii) as clause (iv); and</text></subclause> <subclause id="H4FAE00E0EC184FDF8C6899075B3C9C34"><enum>(III)</enum><text>by inserting after clause (ii) the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HB32C7FCD8033451F93E568ED815C89D5"> <clause id="H3BA942664709459B86B145D6B6AD4AB8"><enum>(iii)</enum><text>research to advance manufacturing capacities and capabilities for medical countermeasures and platform technologies that may be utilized for medical countermeasures; and</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause> <clause id="HA7F047219603404FBE34B2270B596D79"><enum>(iii)</enum><text>in subparagraph (E), by striking clause (ix); and</text></clause></subparagraph> <subparagraph id="HA5C610901FE14D65BB555A145B0C4970"><enum>(C)</enum><text>in paragraph (7)(C)(i), by striking <quote>up to 100 highly qualified individuals, or up to 50 percent of the total number of employees, whichever is less,</quote> and inserting <quote>75 percent of the total number of employees</quote>;</text></subparagraph></paragraph> <paragraph id="H0BB3D2DEC2E74E63A0AE8D9072B217D3"><enum>(4)</enum><text>in subsection (e)(1)—</text> <subparagraph id="HDA196F385F0144419B60D7CEF7929B24"><enum>(A)</enum><text>by redesignating subparagraphs (B) through (D) as subparagraphs (C) through (E), respectively; and</text></subparagraph> <subparagraph id="H23698B738AC14739AD281BD97D295077"><enum>(B)</enum><text>by inserting after subparagraph (A), the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H9CB30862DF6C48F3AA0CE867EB390598"> <subparagraph id="HFD7B9F1A8A7F48B6AC5D70E662DBB993"><enum>(B)</enum><header>Temporary flexibility</header><text>During a public health emergency under section 319, the Secretary shall be provided with an additional 60 business days to comply with information requests for the disclosure of information under section 552 of title 5, United States Code, related to the activities under this section (unless such activities are otherwise exempt under subparagraph (A)).</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H393F6C80107140669C39F1F19C36A300"><enum>(5)</enum><text>in subsection (f)—</text> <subparagraph id="H360A82B52A49472FA7CD2337828D03E2"><enum>(A)</enum><text>in paragraph (1), by striking <quote>Not later than 180 days after the date of enactment of this subsection</quote> and inserting <quote>Not later than 180 days after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title></quote>; and</text></subparagraph> <subparagraph id="HBED4D96B4F744F99A22280333AACA44C"><enum>(B)</enum><text>in paragraph (2), by striking <quote>Not later than 1 year after the date of enactment of this subsection</quote> and inserting <quote>Not later than 1 year after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title></quote>.</text></subparagraph></paragraph></subsection> <subsection id="H0ADA06B06A49440892D25A35B8A6C02E"><enum>(b)</enum><header>Medical Countermeasure Innovation Partner</header><text>The restrictions under section 202 of division A of the Further Consolidated Appropriations Act, 2020 (<external-xref legal-doc="public-law" parsable-cite="pl/116/94">Public Law 116–94</external-xref>), or any other provision of law imposing a restriction on salaries of individuals related to a previous appropriation to the Department of Health and Human Services, shall not apply with respect to salaries paid pursuant to an agreement under the medical countermeasure innovation partner program under section 319L(c)(4)(E) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(4)(E)). </text></subsection></section></subtitle> <subtitle id="HD3A3039C54484DB8A7E1D74DFCDFB8B4"><enum>B</enum><header>Manufacturing API, Drugs, and Excipients in America</header> <section id="HF54E191B8B5C4E5BAB1ECC8FCC8E7C1F"><enum>2011.</enum><header>Report to Congress on barriers to domestic manufacturing of medical products and supplies</header> <subsection id="H2BCD8D54D54843959BD2B6D23E374341"><enum>(a)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than January 1, 2021, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on barriers to domestic manufacturing of active pharmaceutical ingredients, drugs, and devices that are manufactured outside of the United States.</text></subsection> <subsection id="HF0CEC755746B49EC9413A0AF2B914599"><enum>(b)</enum><header>Contents</header><text>Such report shall—</text> <paragraph id="HB9467A23F4864EDBBD7F97EE29685DC2"><enum>(1)</enum><text>identify factors that limit or otherwise discourage the domestic manufacturing of active pharmaceutical ingredients, drugs, and devices that are currently manufactured outside of the United States, including any Federal, State, local, or Tribal laws and regulations that hinder domestic manufacturing opportunities; and</text></paragraph> <paragraph id="HB69D942868D74FC0881FDB8573912DB2"><enum>(2)</enum><text>recommend specific strategies to overcome the challenges identified under paragraph (1), including strategies—</text> <subparagraph id="HD826BB9E87E440B483605A08F6566301"><enum>(A)</enum><text>to develop effective incentives for domestic manufacturing; and</text></subparagraph> <subparagraph id="HB01DB5773FBA43EB917869D7BB398FB5"><enum>(B)</enum><text>to make changes to laws or regulations that hinder domestic manufacturing opportunities.</text></subparagraph></paragraph></subsection> <subsection id="H9D08F707BD3A4EC0B18C06591E353E9D"><enum>(c)</enum><header>Consultation</header><text>In carrying out the report under subsection (a), the Secretary shall consult with—</text> <paragraph id="H9889BA9AD1C94867BD8F061C4B909D00"><enum>(1)</enum><text>the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Department of Defense, the Department of Commerce, the Department of State, the Department of Veterans Affairs, the Department of Justice, and any other Federal agencies as appropriate; and</text></paragraph> <paragraph id="H9D9B55DDE6D74D68A8FF4F847ACA868B"><enum>(2)</enum><text>relevant stakeholders, including drug, device, and active pharmaceutical ingredient manufacturers, and other entities, as appropriate. </text></paragraph></subsection> <subsection id="H70B7C16B35394CE3A5C919C789FDED93"><enum>(d)</enum><header>Definition</header><text display-inline="yes-display-inline">In this section, the term <term>active pharmaceutical ingredient</term> has the meaning given to such term in section 207.1 of title 21, Code of Federal Regulations (and any successor regulations).</text></subsection> <subsection id="H7A8C61F9594D44A297C563FD83C4D1EF"><enum>(e)</enum><header>Publication</header><text>The Secretary shall make the report under subsection (a) available on the public website of the Department of Health and Human Services.</text></subsection></section> <section id="HF708289CABA34F3789A79C4A618DC7DD"><enum>2012.</enum><header>Enhancing intra-agency coordination and public health assessment with regard to compliance activities</header> <subsection id="H6EA65865CE014C39B3F006A6D562CAFB"><enum>(a)</enum><header>Benefit/Risk framework</header> <paragraph id="H7504BE3220EF41CEB35B0140354E8E46"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Paragraph (2) of section 704(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374(b)</external-xref>) is amended by adding at the end the following: <quote>The Secretary shall ensure timely and effective coordination among such offices regarding the reviews of such report and the alignment of any feedback regarding such report, and any corrective or preventive actions in response to such report, after consideration of the benefits and risks to the public health, patient safety, the drug supply and drug supply chain, and timely patient access to drugs.</quote>.</text></paragraph> <paragraph id="H5AAAADF310E94C88890EADBE6CEEE554"><enum>(2)</enum><header>Annual reporting</header><text display-inline="yes-display-inline">Subsection (b) of section 704 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="HE16ECF78FA4C48A69AE33B397A1C7367" display-inline="no-display-inline"> <paragraph id="H1D75A79E19BE412F97EB6A3FA4053FBB" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">On an annual basis, the Secretary shall prepare a report on the utilization of the framework described in paragraph (2) and post such report on the public website of the Food and Drug Administration.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="HB67DF51311524D3DB12E21F90494D0D6"><enum>(3)</enum><header>Applicability</header><text>The amendments made by paragraphs (1) and (2) shall take effect on the effective date described in section 3112 of the CARES Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/136">Public Law 116–136</external-xref>), after executing the amendments made by such section 3112, and shall apply beginning on the date that is 1 year after the date of enactment of this Act.</text></paragraph></subsection> <subsection id="H30CFD6811F9A44188F4ED07F872C65A0"><enum>(b)</enum><header>Public meeting</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall publish in the Federal Register a notice of a public meeting to be held no later than six months after the date of enactment of this Act to discuss and obtain input and recommendations from public stakeholders, including patient advocates, consumers, regulated industry, and health care providers, regarding the contents of a benefit/risk framework described in section 704(b)(2) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a), that supports a safe, stable, redundant drug supply chain.</text></subsection> <subsection id="HB67A2C0BBACA48599204359475E27DBE"><enum>(c)</enum><header>Guidance</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall—</text> <paragraph id="H7E5699553A664408B892292296D98AB2"><enum>(1)</enum><text>not later than one year after the date on which the public meeting described in subsection (b) is held, issue draft guidance regarding the goals and implementation of a benefit/risk framework described in subsection (b); and</text></paragraph> <paragraph id="HDB04B552ED394C22AD1FFEDF703B96BE"><enum>(2)</enum><text>not later than two years after such date of enactment, issue final guidance with respect to the implementation of such a framework.</text></paragraph></subsection></section> <section id="H0BAB36DEC5B3476FA9AD619EDB908BC5"><enum>2013.</enum><header>Encouraging international harmonization</header> <subsection id="H6FA9F865927144E39747A875DF18BCE5"><enum>(a)</enum><header>GAO study</header><text display-inline="yes-display-inline">Not later than one year after the date of enactment of this Act, the Comptroller General of the United States shall issue a report evaluating—</text> <paragraph id="H4235A93C6C454E4D833FE6B1DD9A7D57"><enum>(1)</enum><text>the consistency with which the International Conference on Harmonisation (in this section referred to as <quote>ICH</quote>) guidelines on good manufacturing practices, including ICH Guidelines Q8–11, are being implemented by drug regulatory authorities across countries and international regions;</text></paragraph> <paragraph id="H305558801B674F61918DB18B8A809CDC"><enum>(2)</enum><text display-inline="yes-display-inline">whether domestic active pharmaceutical ingredient manufacturers (including any such contract manufacturers) are provided sufficient opportunity to participate with regulatory authorities in the development of guidelines prior to implementation; </text></paragraph> <paragraph id="H0AD3AC31D93349E197574C5329D3FC8B"><enum>(3)</enum><text>whether divergence from ICH guidelines or differing regulatory standards or requirements by drug regulatory authorities across countries and international regions creates—</text> <subparagraph id="HF6B2E64EA4A6486D99EE4ED5E410F1F7"><enum>(A)</enum><text>inefficiencies in drug manufacturing;</text></subparagraph> <subparagraph id="H7B4BF1FBBA6B4BDDA049637732980D76"><enum>(B)</enum><text>incompatible requirements that can contribute to or exacerbate drug shortages; and</text></subparagraph> <subparagraph id="HF6D4B9D3C05E410CA59A47306EB18917"><enum>(C)</enum><text>the most common areas of divergence between ICH guidelines and regulatory standards and requirements by drug regulatory authorities across countries and international regions that, if rectified, may reduce the inefficiencies and incompatibilities identified pursuant to subparagraphs (A) and (B).</text></subparagraph></paragraph></subsection> <subsection id="HF18F5B5627FB46ADA2ADC1E27085A120"><enum>(b)</enum><header>International training program</header><text display-inline="yes-display-inline">Not later than two years after the date of enactment of this Act, informed by the needs identified in the report issued pursuant to subsection (a), the Secretary of Health and Human Services, in conjunction with drug regulatory authorities across countries and international regions and the ICH, shall develop and implement a training program for drug regulatory authorities across countries and international regions to promote consistent application of and reduce divergence from ICH guidelines on good manufacturing practices.</text></subsection></section> <section id="H703A41C69BDC42409EE2EC4AE7A260E5"><enum>2014.</enum><header>Mutual recognition agreements for inspections and review activities</header> <subsection id="H12D4482857784DE3B27D6F2038D649AF"><enum>(a)</enum><header>Mutual Recognition of Inspections</header><text>Pursuant to section 809 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/384e">21 U.S.C. 384e</external-xref>), the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall establish or expand initiatives for mutual sharing of review and inspection findings between drug regulatory authorities across countries and international regions, such as through the Pharmaceutical Cooperation Inspection Scheme, the Mutual Recognition Agreement with the European Union, and the Australia-Canada-Singapore-Switzerland Consortium, to—</text> <paragraph id="H09741335B5D14407823A876233E0565A"><enum>(1)</enum><text>reduce the potential for duplicative regulatory evaluation of medical products regulated by the Food and Drug Administration; and</text></paragraph> <paragraph id="H079A8A1E38D542ADBEA65A497F118F01"><enum>(2)</enum><text>more constructively allocate appropriations to the Food and Drug Administration, including those attributable to user fees, to harmonized regulatory processes.</text></paragraph></subsection> <subsection id="HE86A151E979D4BE4B973C429A13E5D43"><enum>(b)</enum><header>Additional countries, regions, and evaluation</header><text>In carrying out subsection (a), the Secretary may expand the initiatives to include—</text> <paragraph id="HA11066B198B545C6AD67E6688EFB161A"><enum>(1)</enum><text>additional countries and geographic regions with established and competent regulatory frameworks; and</text></paragraph> <paragraph id="HB3B74010A8CA43B4B74406090B5C6497"><enum>(2)</enum><text>additional types of regulatory evaluation, including with respect to—</text> <subparagraph id="HE2E6AF1DDE33475FB93AD96ED2178B75"><enum>(A)</enum><text>good manufacturing practice inspections; and</text></subparagraph> <subparagraph id="H20854A071E33477C9797B086C58EF267"><enum>(B)</enum><text>approval of changes to the manufacturing of drugs for which an approval or licensure is in effect 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>) or section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text></subparagraph></paragraph></subsection> <subsection id="H231EB138028746E8A6531B2DC2A71421"><enum>(c)</enum><header>Implementation framework</header> <paragraph id="H5B6379606DDD45D0A58D5B512F7F9448"><enum>(1)</enum><header>Publication</header><text>Not later than one year after the date of enactment of this Act, the Secretary shall publish an implementation framework for the agreements to share review and inspection findings under subsection (a) on the public website of the Food and Drug Administration.</text></paragraph> <paragraph id="H0A1FC9A3AA10440281F5AC255DB35399"><enum>(2)</enum><header>Contents</header><text>The implementation framework under this subsection shall—</text> <subparagraph id="H66F33B9E20964B578267CF2480F6B59F"><enum>(A)</enum><text>include the timeline for establishing or expanding initiatives described in subsection (a);</text></subparagraph> <subparagraph id="H8215F7EC52EA4890B2BCFFF6B17EFED0"><enum>(B)</enum><text>describe additional types of regulatory processes that will become subject to such initiatives;</text></subparagraph> <subparagraph id="H7661637E746F4E83AD9AD8AC83EC4835"><enum>(C)</enum><text>specify the countries and geographic regions where such initiatives will be established or expanded; and</text></subparagraph> <subparagraph id="H1ED7CBA55E644BD985C2100F57ACD49F"><enum>(D)</enum><text>identify additional opportunities and challenges for expanding mutual recognition agreements in drug and biologic regulation.</text></subparagraph></paragraph></subsection> <subsection id="HCAA43AE3C7DB4E54852EEC44167FB6FA"><enum>(d)</enum><header>Annual reporting</header> <paragraph id="H82A9E78EB23A485EB33511263D8D6F7D"><enum>(1)</enum><header>In general</header><text>Not later than the end of calendar year 2020 and annually thereafter, the Secretary shall publish a report on the public website of the Food and Drug Administration on the utilization of agreements described in subsection (c)(1) in the previous fiscal year.</text></paragraph> <paragraph id="HB8FAD4D4244C4802ADD06D75147E949D"><enum>(2)</enum><header>Contents</header><text>The report under paragraph (1) shall include each of the following:</text> <subparagraph id="H241D4B81780646A6A16360AE5A045651"><enum>(A)</enum><text>The total number of establishments that are registered under section 510(i) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360</external-xref>) and located outside of the United States, and of these establishments, the number in each region of interest.</text></subparagraph> <subparagraph id="HF7D2CD5C213C45A1AAC732940A8B5796"><enum>(B)</enum><text>The total number of inspections conducted at establishments described in subparagraph (A).</text></subparagraph> <subparagraph id="HAE14DF82A27D450986047EDA3B9690C6"><enum>(C)</enum><text>Of the inspections described in subparagraph (B), the total number of inspections in each of region of interest.</text></subparagraph> <subparagraph id="H6ED2D475AE7E41AC8C5A896F21FF4E02"><enum>(D)</enum><text>Of the inspections in each region of interest reported pursuant to subparagraph (C), the number of inspections in each FDA inspection category.</text></subparagraph> <subparagraph id="H9EC5DA43393349988D051B84C23C4311"><enum>(E)</enum><text display-inline="yes-display-inline">Of the number of inspections reported under each of subparagraphs (B), (C), and (D)—</text> <clause id="H847612CC805E4CE4BCF9DC2EA759870C"><enum>(i)</enum><text>the number of inspections which have been conducted pursuant to an agreement described in subsection (c)(1); and</text></clause> <clause id="H60B74D45624144CF853D7E2BC82CF31C"><enum>(ii)</enum><text>the number of inspections which have been conducted by employees or other agents of the Food and Drug Administration.</text></clause></subparagraph></paragraph> <paragraph id="H441A15E173414D60B54BE4A665A7E04E"><enum>(3)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this subsection:</text> <subparagraph id="H90F53BDEF31C4EEFB488E4F40E6DF4FB"><enum>(A)</enum><text> The term <term>region of interest</term> refers to China, India, the European Union, and any other geographic region as determined appropriate by the Secretary.</text></subparagraph> <subparagraph id="H7E43F007C4A145A1A133FC818EF1D299"><enum>(B)</enum><text>The term <term>FDA inspection category</term> means refers to the following inspection categories:</text> <clause id="H97CDA87A429146CBADC2E16E0726FC80"><enum>(i)</enum><text>Inspections to support an approval of a drug 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>) or section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text></clause> <clause id="H48B98C0F124246D1BFD2D3C2F6A91817"><enum>(ii)</enum><text>Good manufacturing practice inspections.</text></clause> <clause id="H4A2F5CA4161E45E99C56C8599BFA18C6"><enum>(iii)</enum><text>For-cause inspections.</text></clause></subparagraph></paragraph></subsection></section> <section id="H54CCDFAE07F144118763EF3CE2D6CFFB"><enum>2015.</enum><header>Enhancing transparency of drug facility inspection timelines</header><text display-inline="no-display-inline">Section 902 of the FDA Reauthorization Act of 2017 (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref> note) is amended to read as follows:</text> <quoted-block id="HB41E409CF6D2429FBE6F70B34EB2FECE" style="OLC"> <section id="H556F510A124D444FB2AFB16C15047840"><enum>902.</enum><header>Annual report on inspections</header><text display-inline="no-display-inline">Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the public website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under subsection (c) or (j) of 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>), approval of a device under section 515 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e">21 U.S.C. 360e</external-xref>), or clearance of a device under section 510(k) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360(k)</external-xref>) that were conducted during the previous calendar year. Such information shall include the following:</text> <paragraph id="H6F4D946CD51D46DCA3AF6BBE610E7213"><enum>(1)</enum><text>The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, and the median time from the beginning of an inspection to the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374(b)</external-xref>), including—</text> <subparagraph id="H8AA598DBD4BE4330B9BF4AB6A6EA1F84"><enum>(A)</enum><text display-inline="yes-display-inline">the median time for drugs described in 505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(11)(A)(i)</external-xref>);</text></subparagraph> <subparagraph id="HF9E2A30704A14D0F87FD4F11E2DC31D0"><enum>(B)</enum><text>the median time for drugs described in section 506C(a) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356c">21 U.S.C. 356c(a)</external-xref>) only; and</text></subparagraph> <subparagraph id="H4B7F10C8C265401FA481D831E64BAE5F"><enum>(C)</enum><text>the median time for drugs on the drug shortage list in effect under section 506E of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356f">21 U.S.C. 356f</external-xref>).</text></subparagraph></paragraph> <paragraph id="H1B2D8718EB0843E49D21191E9256FB1C"><enum>(2)</enum><text>The median time from the issuance of a report pursuant to such section 704(b) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated, including the median time for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).</text></paragraph> <paragraph id="H7DD2AF45F75C425C9C50326C1DA74924"><enum>(3)</enum><text>The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting to resolution of the regulatory or enforcement action indicated for inspections for which the Secretary concluded that such action was indicated.</text></paragraph> <paragraph id="HF24435FB051A494C9D9B681A9EDF00CC"><enum>(4)</enum><text display-inline="yes-display-inline">The number of times that a facility was issued a report pursuant to such section 704(b) and approval of an application was delayed due to the issuance of a withhold recommendation, including the number of such times for each category of drugs listed in subparagraphs (A) through (C) of paragraph (1).</text></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="HBCC0A8A2B98C4D44B2F45677B6BAAC8D"><enum>2016.</enum><header>Advanced manufacturing technologies program</header><text display-inline="no-display-inline">Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351</external-xref> et seq.) is amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H47220B245F2643848FE732906DA639BC"> <section id="HBABC4D75F1144C3687D8BAA5C2BE9037"><enum>524B.</enum><header>Advanced manufacturing technologies program</header> <subsection id="H579C23E0B7A04302918578BBEC58F8BB"><enum>(a)</enum><header>In general</header><text>Not later than 1 year after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, the Secretary shall continue in effect the program to evaluate new drug manufacturing technologies that are included in an application, or supplement to an application, for a drug under subsection (b) or (j) of section 505 of this Act or for a biological product submitted under subsection (a) or (k) of section 351 of the Public Health Service Act.</text></subsection> <subsection id="H30D2B9FB3EB144B9BFFAD59221AE47D9"><enum>(b)</enum><header>Designation</header><text>The Secretary shall designate a method of manufacturing a drug as an advanced manufacturing technology under this section if the drug manufacturer demonstrates that such technology is likely to—</text> <paragraph id="HE334B43753184D9F8913A61196EB9328"><enum>(1)</enum><text>prevent or resolve a drug shortage;</text></paragraph> <paragraph id="H89DDE77033F74E209CAFE6AD3E591311"><enum>(2)</enum><text>maintain an adequate supply of critical medications for national emergencies; or</text></paragraph> <paragraph id="H237A20B086B54CEFA2DBDE86701F9190"><enum>(3)</enum><text>promote the adoption of innovative approaches to drug product design and manufacturing.</text></paragraph></subsection> <subsection id="HB1C441673A104E11870CB6E526C2E5FF"><enum>(c)</enum><header>Consultation</header><text>If the Secretary designates a method of manufacturing as an advanced manufacturing technology under this section, the Secretary shall take actions to expedite the development and implementation of such method of manufacture for purposes of approval of the application under subsection (c) or (j) of section 505 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act, which may include, as appropriate—</text> <paragraph id="HACA5BEB3A5F84CFB8E05F8BF3F8738E5"><enum>(1)</enum><text>holding meetings between the sponsor of the application and appropriate Food and Drug Administration staff throughout the development of the technology;</text></paragraph> <paragraph id="H378581582E2B4963BC959409D10D37B2"><enum>(2)</enum><text>providing timely advice to, and interactive communication with, the sponsor regarding the development of the technology; and</text></paragraph> <paragraph id="HC46F59BF8AFD436FBA14D67F9DC08057"><enum>(3)</enum><text>involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing.</text></paragraph></subsection> <subsection id="HFF0A6C8BDCE74CADBB55227235E785EE"><enum>(d)</enum><header>Evaluation of an Advanced Manufacturing Technology</header> <paragraph id="H636A049537924CF388608BE75DE40554"><enum>(1)</enum><header>Package</header><text>A sponsor who receives designation of an advanced manufacturing technology under this section shall provide the Secretary with a package of scientific evidence supporting the implementation of the advanced manufacturing technology in a particular context-of-use.</text></paragraph> <paragraph id="HD13EAEEB986B418A83B067A977E78D06"><enum>(2)</enum><header>Evaluation</header><text>Within 90 days of receiving the package, the Secretary shall determine whether a designated advanced manufacturing technology is validated for the proposed context of use based on the scientific merit the supporting evidence provided by the sponsor.</text></paragraph> <paragraph id="H4364B955314B4180B5F398F6115B281E"><enum>(3)</enum><header>Effect of Approval</header><text>Upon approval, the same sponsor may rely upon the advanced manufacturing technology for use across multiple manufacturing product lines within the same context-of-use without having to re-submit data to the Secretary validating the underlying technology.</text></paragraph></subsection> <subsection id="HF179D93AF006456695DC628CB4914A6F"><enum>(e)</enum><header>Implementation and Reporting</header> <paragraph id="H82E4F8E99CD94C83A98D16D3D5071A29"><enum>(1)</enum><header>Public meeting</header><text>The Secretary shall publish in the Federal Register a notice of a public meeting to be held no later than 1 year after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title> to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of, and a suitable framework and procedures and requirements for, the program under this section.</text></paragraph> <paragraph id="H4A9E0CA5CA254C759E1895200970883C"><enum>(2)</enum><header>Program guidance</header><text>The Secretary shall—</text> <subparagraph id="H8EED340BB0CC4463B38687073077AAEB"><enum>(A)</enum><text>not later than 1 year after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, issue draft guidance regarding the goals and implementation of the program under this section; and</text></subparagraph> <subparagraph id="H207BEC8C59BD469DB58753EE6F2EAF12"><enum>(B)</enum><text>not later than 2 years after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, issue final guidance with respect to the implementation of such program.</text></subparagraph></paragraph> <paragraph id="H41518DB53895414D85D7F3FB85808820"><enum>(3)</enum><header>Report</header><text>The Secretary shall make available on the public website of the Food and Drug Administration an annual report on the progress of the program under this section.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="HB0E93A905B234D7DBEF7F8B3D42B87E3"><enum>C</enum><header>Improving the American Drug Supply Chain</header> <section id="HE85F99774EB7462D9C2F36BA006BCF7E"><enum>2021.</enum><header>Study and reporting on domestic and foreign production</header> <subsection id="HC744AE5EFEC74B7599BEC3342A00B5CD"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this section as the <quote>National Academies</quote>) under which, not later than 24 months after the date of enactment of this Act, the National Academies will—</text> <paragraph id="H32CFC20863364521B26FB15612AFA1CD"><enum>(1)</enum><text>study the current and historical production of drugs and key ingredients thereof (including active pharmaceutical ingredients) in the United States and in foreign countries;</text></paragraph> <paragraph id="HE7C220277187460BB6FF929C10FD2B88"><enum>(2)</enum><text display-inline="yes-display-inline">formulate recommendations for promoting increased production of drugs and key ingredients thereof (including active pharmaceutical ingredients) in the United States; and</text></paragraph> <paragraph id="HD791F4ABBCEB4164B425ECEE362698C8"><enum>(3)</enum><text display-inline="yes-display-inline">in a manner that does not compromise national security or disclose trade secrets or other confidential commercial information that is subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, submit a report to the Congress on—</text> <subparagraph id="H9DD3AC6B0B7E4B138B1ECF2E94DBDDE8"><enum>(A)</enum><text>the findings and conclusions of the study under paragraph (1); and</text></subparagraph> <subparagraph id="HE46C18616CE04D168A4F58AE183DA492"><enum>(B)</enum><text>the recommendations under paragraph (2).</text></subparagraph></paragraph></subsection> <subsection id="HF734F5146E374E718B1FDD1AE174FAC2"><enum>(b)</enum><header>Study topics</header><text>The study pursuant to subsection (a)(1) shall include—</text> <paragraph id="H43747E1D93E0468D8078FAB191B5AE21"><enum>(1)</enum><text>evaluation of—</text> <subparagraph id="HFA24BCDBE53F404D8118C71E87FE38CF"><enum>(A)</enum><text>the extent to which production of drugs for use in the United States and key ingredients thereof (including active pharmaceutical ingredients) takes place in the United States; and</text></subparagraph> <subparagraph id="H03FBFBBD717849C1A6A2A87EF2899D2C"><enum>(B)</enum><text>the extent to which such production takes place in foreign countries;</text></subparagraph></paragraph> <paragraph id="HA87BFC752CC14FF89B37695394D1149D"><enum>(2)</enum><text>identification of the foreign countries in which such production takes place;</text></paragraph> <paragraph id="HE3732591C350487D80BCAA4E3952D92E"><enum>(3)</enum><text>evaluation of historical changes in the countries in which such production takes place;</text></paragraph> <paragraph id="HB5356DC520CF49D08F10FC83F37B8EFD"><enum>(4)</enum><text>determination of the reasons why such production takes place in foreign countries, including why such production takes place in particular foreign countries, including consideration of—</text> <subparagraph id="H44F1926D3FE04239B5FF324F3F2F4057"><enum>(A)</enum><text>the reasons for historical migration of such production to foreign countries, or from foreign countries to other foreign countries or the United States;</text></subparagraph> <subparagraph id="HF26C9DA17876436B91F88D355373E9B7"><enum>(B)</enum><text>economic factors, including economic impediments to domestic production and incentives for foreign production; and</text></subparagraph> <subparagraph id="HEF3CC26FF02D4403A0AB0C5E3A4B87DD"><enum>(C)</enum><text>regulatory, intellectual property, international trade, and other legal and policy factors; and</text></subparagraph></paragraph> <paragraph id="H56281858AA254F08A6975D7DACECCAB1"><enum>(5)</enum><text>evaluation of the benefits of redundancies in the supply chain of drugs in the United States in the event of a public health emergency.</text></paragraph></subsection> <subsection id="H08050A4B23BC41178A184E149FBED56B"><enum>(c)</enum><header>Recommendations</header><text>The agreement under subsection (a) shall—</text> <paragraph id="HE26B141FAEA84C5598FC943249DE856C"><enum>(1)</enum><text display-inline="yes-display-inline">provide for inclusion in the recommendations under subsection (a)(2) of measures (which may include statutory, regulatory, and other policy changes) that should be taken—</text> <subparagraph id="HE860BB4E98AA4C6081BA0ADA2B42C3F4"><enum>(A)</enum><text display-inline="yes-display-inline">to encourage the domestic production of drugs for use in the United States and key ingredients thereof (including active pharmaceutical ingredients); or</text></subparagraph> <subparagraph id="H9D27CDA195384DADBD89587E8E380335"><enum>(B)</enum><text>to otherwise reduce the risks to the availability of drugs in the United States in the event of a public health emergency; and</text></subparagraph></paragraph> <paragraph id="H472876301F5D46FC9E3E7087F17832C1"><enum>(2)</enum><text>require consideration, in developing such recommendations, of—</text> <subparagraph id="H875457985F5441ACB8049014BE701A7A"><enum>(A)</enum><text>factors affecting the production of drugs, including—</text> <clause id="H9564D00C9D034474912515DF5667C6A0"><enum>(i)</enum><text>access to skilled labor;</text></clause> <clause id="HC1DE0D9C75334DCCB08B3147C527DBAF"><enum>(ii)</enum><text>the cost of raw materials, the cost of energy, and related costs;</text></clause> <clause id="HF9B575E3CF8C45B6887C3DD905910780"><enum>(iii)</enum><text>taxes and other incentives; and</text></clause> <clause id="HAC9B40C5B79448368DBFACE0ABFC3B97"><enum>(iv)</enum><text>the effects of regulations; and</text></clause></subparagraph> <subparagraph id="H865B52E65C2047B19428F5C2AB67BCE6"><enum>(B)</enum><text>the costs and consequences of implementing, or failing to implement, each such recommendation.</text></subparagraph></paragraph></subsection> <subsection id="H46A0BE647A3549BC91782B98F88682F4"><enum>(d)</enum><header>Input</header><text>The agreement under subsection (a) shall require—</text> <paragraph id="H706940B826014505820F8308677644C1"><enum>(1)</enum><text>consideration of input from the Department of Health and Human Services, the Department of Commerce, and, as appropriate, other Federal agencies; and</text></paragraph> <paragraph id="H32DFF4C087A04418B80E7F0EF7936B89"><enum>(2)</enum><text>consultation with relevant stakeholders, which—</text> <subparagraph id="HDF9E376CD8AE462EAED3730288124A12"><enum>(A)</enum><text>may include conducting public meetings and other forms of engagement, as appropriate; </text></subparagraph> <subparagraph id="H07473E05B5284D0B959F114CACAAA4D5"><enum>(B)</enum><text>shall include consultation with experts in—</text> <clause id="H8AF4C8F94E3B4E699629D5BF0F7AB619"><enum>(i)</enum><text>the manufacturing of drugs;</text></clause> <clause id="HAB8695F33AE34569B58534C6F725D2FE"><enum>(ii)</enum><text>pharmaceutical industry business and economics;</text></clause> <clause id="HC22A11F1E87A4768813C83840D91FCDB"><enum>(iii)</enum><text>drug purchasing, pricing, and reimbursement;</text></clause> <clause id="H375FF58286B84B49846181302F815FE7"><enum>(iv)</enum><text>regulatory and intellectual property issues affecting drug manufacturing;</text></clause> <clause id="H00D096F219964764A122F8534A0D13EC"><enum>(v)</enum><text>economics;</text></clause> <clause id="HCC2B88C55CEE4D6EAD878CC8BC9A856E"><enum>(vi)</enum><text>international trade policy; and</text></clause> <clause id="HB9436BEC577E418FAC001251758E92D2"><enum>(vii)</enum><text>emergency planning; and</text></clause></subparagraph> <subparagraph id="H028BC9A883E34F59837D4051CA833AAF"><enum>(C)</enum><text>may include consultation with other entities with experience in drug manufacturing and pricing, as appropriate.</text></subparagraph></paragraph></subsection> <subsection id="H46E45049DC874846936C9AB356CF8A16"><enum>(e)</enum><header>Definitions</header><text>In this section, the term <term>drug</term> has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>).</text></subsection></section></subtitle> <subtitle id="HBA46DA488CA148599D11F7CE867716F4"><enum>D</enum><header>Essential Medicines Strategic Stockpile</header> <section id="H3547364A162E4DDA83FD09B62041E77F"><enum>2031.</enum><header>Pilot program on ensuring medication supply stability</header><text display-inline="no-display-inline">Part D of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b">42 U.S.C. 254b</external-xref> et seq.) is amended by adding at the end the following new subpart:</text> <quoted-block id="H341128098AF645C98DACB6B989288F89" style="OLC"> <subpart id="H6D451A3F7C144A5DB3611D14D6C8FA98"><enum>XIII</enum><header>Ensuring Medication Supply Stability</header> <section id="H93772E4634B14230B07D850E1B782C77"><enum>340J.</enum><header>Ensuring medication supply stability</header> <subsection id="HEC0EA685894746E1B3A499CD8DD5967C"><enum>(a)</enum><header>Award of contracts</header><text display-inline="yes-display-inline">Beginning not later than January 1, 2021, the Secretary shall award contracts to eligible entities to each implement and test the effectiveness of acquiring, maintaining, managing, and distributing a stockpile that—</text> <paragraph id="HB56CB13326144708957356BE458A134B"><enum>(1)</enum><text>consists of generic drugs at risk of shortage; and</text></paragraph> <paragraph id="H701B4203B36D47C18712290D4F4DECF3"><enum>(2)</enum><text>is of sufficient quantity to ensure that customers in the United States of the respective eligible entity have access to such drugs for at least 6 months (as specified by the Secretary based on the historic demand for those drugs).</text></paragraph></subsection> <subsection id="HD8ACDE528AFD4F0C9843FA323B30A26A"><enum>(b)</enum><header>Selection of drugs</header> <paragraph id="HA27082152CBB4908ACA5EDB9AB8753B0"><enum>(1)</enum><header>In general</header><text>The Secretary shall—</text> <subparagraph id="H3C4FB916B5B54670B263DAE068EA21E5"><enum>(A)</enum><text>select not more than 50 types of drugs that may be included by eligible entities in a stockpile pursuant to a contract under this section; </text></subparagraph> <subparagraph id="H340AD094E89641D9A2986EEF48A0F25D"><enum>(B)</enum><text>maintain an up-to-date list of such drugs; and</text></subparagraph> <subparagraph id="H0FF007F12D534505BA78A4EC669E46FC"><enum>(C)</enum><text>make such list publicly available.</text></subparagraph></paragraph> <paragraph id="HF95024D13E554ED1AC6C2D73345D26DD"><enum>(2)</enum><header>Choice of eligible entities</header><text>A contract awarded to an eligible entity under this section need not require the stockpile of the eligible entity to include all 50 types of drugs listed pursuant to paragraph (1).</text></paragraph></subsection> <subsection id="HBEC8C6D9601140678BDC1A679B7FF561"><enum>(c)</enum><header>Sufficient quantity</header><text display-inline="yes-display-inline">For each generic drug in a stockpile maintained pursuant to subsection (a), the Secretary shall specify the quantity of such drug that is sufficient for purposes of such subsection to ensure that consumers in the United States of the respective eligible entity have access to such drug for at least 6 months.</text></subsection> <subsection id="H0599EB783E4F4A9591F11E48DC33AB75"><enum>(d)</enum><header>Duration; liquidation of inventory</header> <paragraph id="H38DA6834663644F593512BDF383D7A17"><enum>(1)</enum><header>Duration</header><text>A contract awarded under this section shall be for a term of no more than 3 years.</text></paragraph> <paragraph id="H88C4F14F70564B23B760B53D1312E138"><enum>(2)</enum><header>Liquidation of inventory</header><text>A drug held in a stockpile pursuant to a contract under this section may be liquidated by the eligible entity at the end of the period of the contract.</text></paragraph></subsection> <subsection id="H07D5371DCF41464C9C1159F52FBDE92F"><enum>(e)</enum><header>Stockpile requirements</header> <paragraph id="H77B8E928FDBA45419199F9D7AC0FD439"><enum>(1)</enum><header>Ensuring availability of unexpired products</header><text display-inline="yes-display-inline">Each eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage shall—</text> <subparagraph id="HF10A63A2C9664BC18937FB44354A5AE3"><enum>(A)</enum><text>ensure that each drug maintained in the stockpile has an expiration date at least 1 year beyond the current date; and</text></subparagraph> <subparagraph id="H4E23284F07CF423181082107CFFBA45F"><enum>(B)</enum><text>to comply with subparagraph (A)—</text> <clause id="HD22BFAEA25C24416A835EFDAB8AFFE5D"><enum>(i)</enum><text>sell drugs in the stockpile through normal commercial channels and replace those drugs; or</text></clause> <clause id="HF457FB6B077B43FA8C9039E6EF2D5F15"><enum>(ii)</enum><text>if there is no commercial market for a drug in the stockpile, dispose of the drug, report such disposal to the Secretary, and replace the drug.</text></clause></subparagraph></paragraph> <paragraph id="H8E988B24B047444B9BA21F2D0085A18D"><enum>(2)</enum><header>Management of stockpile</header> <subparagraph id="HEED98571236242C69B1DEAE971FA8C98"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Each eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage shall—</text> <clause id="H4374F693FB3441B6A420FB7183EFE874"><enum>(i)</enum><text>acquire not later than 6 months following the date the contract is awarded, and maintain thereafter, a 6-month supply of each type of drug the eligible entity has contracted to stockpile, which 6-month supply shall be in addition to the average levels of inventory held by such eligible entity over the previous year for such drug; and</text></clause> <clause id="HF8D29A71330A4C5BB0744EF984CBC59F"><enum>(ii)</enum><text>if it is not possible to comply with clause (i), notify the Secretary, citing the reason why it is not possible and the expected time of acquisition of the drug.</text></clause></subparagraph> <subparagraph id="H0AAC4A6AF3C84E749D5421BC925F8478"><enum>(B)</enum><header>Inventory management</header><text display-inline="yes-display-inline">Each eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage shall manage inventory to ensure that drugs in the stockpile are efficiently cycled to the commercial market and—</text> <clause id="HDF81C292D4F54F419FB92CE2B99BA296"><enum>(i)</enum><text>may stockpile inventory at the eligible entity’s distribution center with specified inventory amounts virtually reserved for the Federal Government with constant cycling to reduce product expiration; or</text></clause> <clause id="H314CC275F3654BE292BED7A23075BE83"><enum>(ii)</enum><text>may store stockpiled inventory separately in a different location and replace drugs in the stockpile inventory with the same drug with newer dating.</text></clause></subparagraph> <subparagraph id="HF6E8C18D1DFE47FC9877BD2F488309AC"><enum>(C)</enum><header>Insufficient funds</header><text>If amounts available to an eligible entity through contracts under this section are not sufficient to acquire or maintain a 6-month supply of any drug in the stockpile of the eligible entity funded under this section, the eligible entity—</text> <clause id="HE4031998FBB943CC8304380F0657BF39"><enum>(i)</enum><text>may acquire and maintain less than a 6-month supply, but in no case less than a 3-month supply; and</text></clause> <clause id="HEED5943A0C934F1D81C67C45D1FE1AFF"><enum>(ii)</enum><text>shall submit a report to the Secretary identifying—</text> <subclause id="HE5A4659BEF6140B1B35F514964B8012F"><enum>(I)</enum><text>each such drug; and</text></subclause> <subclause id="H6B59AD79683B4EF1866608047CA4C56F"><enum>(II)</enum><text>the reasons why such amounts are not sufficient to acquire or maintain a 6-month supply.</text></subclause></clause></subparagraph> <subparagraph id="HE1061275AE394CCB860299F009A8241C"><enum>(D)</enum><header>Annual audits</header><text>Not more than annually, the Secretary may request a physical audit count of the inventories of all eligible entities with a contract under this section to validate that each such entity is maintaining the appropriate amount of stockpiled inventory.</text></subparagraph></paragraph> <paragraph id="HDC3C629761AC49868DF0F81F3BAB6F2B"><enum>(3)</enum><header>Periodic product review</header> <subparagraph id="H72976BBCD16A41C1B6916CDEF3C48558"><enum>(A)</enum><header>Use of proceeds</header><text display-inline="yes-display-inline">An eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage shall use the proceeds of the sale of any drugs in the stockpile to purchase drugs for the stockpile in accordance with this section.</text></subparagraph> <subparagraph id="H67BA9B3FCB0F42BF86A2299EB809FEDC"><enum>(B)</enum><header>Market inflation or deflation</header><text display-inline="yes-display-inline">In the case of market inflation or deflation affecting the price of a drug in the stockpile of an eligible entity maintained pursuant to a contract under this section, the contract shall ensure that the Federal Government does not profit or suffer loss on items of such drug as a result of such inflation or deflation.</text></subparagraph></paragraph> <paragraph id="HDF500EB95767481C9749881A63E5DDE5"><enum>(4)</enum><header>Reporting</header><text>Each eligible entity with a contract under this section shall submit reports at such time and in such manner as the Secretary may require regarding—</text> <subparagraph id="H8CB063F488674C6EBEBF6A5F74351B6D"><enum>(A)</enum><text>current inventory levels of stockpiled drugs at a drug level; </text></subparagraph> <subparagraph id="H116EB5FA76A2481D99BA47F4E9EAB0D5"><enum>(B)</enum><text>indicators of current inventory levels of stockpiled drugs relative to acceptable minimums; and</text></subparagraph> <subparagraph id="HE4D68FDFD40F4F6CA73CB5292E00B2BF"><enum>(C)</enum><text>such other matters as the Secretary determines appropriate.</text></subparagraph></paragraph></subsection> <subsection id="H657684BA88CE41B080B1157622D2BB6F"><enum>(f)</enum><header>Contract terms</header> <paragraph id="H9420FBCCC41A45FF9D94F9699678F13F"><enum>(1)</enum><header>Payment of monthly fees for management</header><text display-inline="yes-display-inline">Subject to paragraph (2), the Secretary shall pay to each eligible entity with a contract under this section for a stockpile of generic drugs at risk of shortage appropriate monthly fees for the management of the stockpile.</text></paragraph> <paragraph id="H9AEBD535A82747DC86EAEF328ECB6B91"><enum>(2)</enum><header>Payment conditioned on stockpile adequacy</header> <subparagraph id="H069CED1BEEF4497DAA81F7ABAB4F8A8B"><enum>(A)</enum><header>In general</header><text>Except as provided in subparagraph (B), each contract with an eligible entity under this section shall provide that no payment under the contract may be made until the entity demonstrates to the Secretary that the entity has stockpiled such portion of the total quantity of drugs to be stockpiled under the contract as the Secretary determines to be acceptable for payment.</text></subparagraph> <subparagraph id="H01CFA8CCBE0F4B0F89536CC96B76F284"><enum>(B)</enum><header>Exceptions for advance payments</header> <clause id="H5CCC91D9D4F8409BB916EF104C21EC42"><enum>(i)</enum><header>In general</header><text>A contract under this section may provide that, if the Secretary determines (in the Secretary’s discretion) that an advance payment, partial payment for significant milestones, or payment to increase capacity is necessary to ensure success of the terms of the contract, the Secretary shall pay, in advance of delivery, an amount not to exceed 10 percent of the total contract amount to be paid to the eligible entity by the Secretary pursuant to the contract over the full period of the contract.</text></clause> <clause id="HF4F65C1A20F24E6088938EBE0B0A1B52"><enum>(ii)</enum><header>Cost of capital</header><text>A contract under this section may provide for payments to compensate the contracting eligible entity for additional capital requirements related to the additional inventory to be maintained.</text></clause> <clause id="H01729C16AF3748B2B0A13559B6FFA894"><enum>(iii)</enum><header>Timing</header><text>The Secretary shall, to the extent practicable, make any determination under clause (i) to make an advance payment at the same time as the issuance of a solicitation.</text></clause> <clause id="H0A1BA3BFE5A447D580D554591B986EC8"><enum>(iv)</enum><header>Repayment</header><text>If the Secretary makes an advance payment pursuant to clause (i), the Secretary shall require the eligible entity receiving such advance payment to repay it if there is a failure to perform by the eligible entity.</text></clause></subparagraph></paragraph> <paragraph id="H97C8E6012DFF4B6E94AD6EC76CDBD9B1"><enum>(3)</enum><header>Termination</header> <subparagraph id="H8C6201820B284EE48DEA1A443EA01BB3"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), nothing in this section shall be construed as affecting the rights of eligible entities under provisions of statute or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.</text></subparagraph> <subparagraph id="H18E2F59E8DAF4EEE841C3D949E2E2B14"><enum>(B)</enum><header>Liquidation of stockpile</header><text>If a contract under this section is terminated, the eligible entity with the contract shall liquidate the drugs comprising the stockpile funded through the contract and return to the Government any amounts owed in relation to such drugs, but shall collect the management fees associated with such liquidation.</text></subparagraph></paragraph></subsection> <subsection id="H10D7256818FF4A5CB1A5C99110A483AA"><enum>(g)</enum><header>Congressional oversight</header> <paragraph id="H07A78A7F84C44BCA964B48ADF3C614B7"><enum>(1)</enum><header>Independent evaluation and report</header><text>Not later than 1 year after the date of enactment of this section and annually thereafter, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate congressional committees a report, concerning the program under this section.</text></paragraph> <paragraph id="H72E9D8FBC7014521B91F823AD8D3E9BF"><enum>(2)</enum><header>Contents of report</header><text>The report under paragraph (1) shall review, assess, and provide recommendations, as appropriate, on the following:</text> <subparagraph id="H93FFA8F4B103452EBB96C14AF9999270"><enum>(A)</enum><text>Details on likely costs and resultant savings as compared to a stockpiling method that does not incorporate perpetual inventory cycling.</text></subparagraph> <subparagraph id="H70B49283FA174E5080EDF6105D730247"><enum>(B)</enum><text>Identification of drawdowns from the stockpile, as evidence of market shortage avoidance.</text></subparagraph> <subparagraph id="H089E53ED9C82441DB0B4E19588EFDABF"><enum>(C)</enum><text>The allocation of drugs included in the stockpiles funded pursuant to this section to the customers of the eligible entities with contracts under this section.</text></subparagraph> <subparagraph id="HD4283C46B8BC49BDA900E66B8CCBA3F3"><enum>(D)</enum><text>The degree to which eligible entities with contracts under this section fulfilled their obligations under such contracts.</text></subparagraph></paragraph></subsection> <subsection id="HDE60DFA25C7D4C71BE72CE7AEED5390D"><enum>(h)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HC5B0C264E0414E4E8A423DAD1F453907" commented="no"><enum>(1)</enum><text>The term <term>eligible entity</term> means an entity that meets each of the following criteria:</text> <subparagraph id="H40F30D94E004473EA995AA25A9B846D3" commented="no"><enum>(A)</enum><text>The entity is licensed or registered in accordance with applicable Federal and State law and in good standing with respect to such licensure or registration.</text></subparagraph> <subparagraph id="HA620141383D24CC394E0B4F0FE3DDE89" commented="no"><enum>(B)</enum><text>The entity agrees—</text> <clause id="HAC46B1A626A5423DBEA9C0E75CB3C4F4"><enum>(i)</enum><text>to purchase all drugs to be maintained in its stockpile funded under this section directly from the manufacturers of the drugs or the exclusive distributors of such manufacturers; or</text></clause> <clause id="HD64D752492C2444F9A17B95DC1AB1FC7"><enum>(ii)</enum><text display-inline="yes-display-inline">in the case of an entity that is a co-op or chain pharmacy warehouse—</text> <subclause id="HB464205ABE3946728FDFAC0CFFCA6A7C"><enum>(I)</enum><text>to purchase drugs to be maintained in its stockpile funded under this section from an authorized distributor; and</text></subclause> <subclause id="H9675376708784692BC39831960D09467"><enum>(II)</enum><text>distribute those drugs only to its member pharmacies.</text></subclause></clause></subparagraph> <subparagraph id="HDB281692FAF440D081D3E5D73EC94CDB" commented="no"><enum>(C)</enum><text>The entity holds a verified authorized wholesale distributor certification issued by the National Association of Boards of Pharmacy.</text></subparagraph> <subparagraph id="H78BB61C0618445DC828D091FD5DCEF74" commented="no"><enum>(D)</enum><text>The entity sells more than 90 percent of its drugs to dispensers.</text></subparagraph> <subparagraph id="H5887177BF91C4AC195E78B0414FC99A0" commented="no"><enum>(E)</enum><text>The entity agrees to distribute inventory from its stockpile funded under this section only to dispensers that are customers of the entity.</text></subparagraph></paragraph> <paragraph id="H1D5E61F81E7C4008A5B0E5E744A97E24"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>generic drug at risk of shortage</term> means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) that—</text> <subparagraph id="H2BAAB26F8CAC46BEAE39D62D8B798831"><enum>(A)</enum><text>is approved pursuant to section 505(j) of such Act;</text></subparagraph> <subparagraph id="H9E16A440AE1345378504AA0CEF35DB68"><enum>(B)</enum><text>is included in the World Health Organization’s most recent Model List of Essential Medicines;</text></subparagraph> <subparagraph id="HFDFACDFB5CDA4152B8F1C78A3C12B08F"><enum>(C)</enum><text display-inline="yes-display-inline">is included, at any point during the preceding 36 months, on the drug shortage list in effect under section 506E of the Federal Food, Drug, and Cosmetic Act; and</text></subparagraph> <subparagraph id="H6EC00042BC834BB58467FB6FBBAB0583"><enum>(D)</enum><text>is manufactured by 3 or fewer persons that are registered under section 510 of the Federal Food, Drug, and Cosmetic Act for purposes of such manufacture.</text></subparagraph></paragraph></subsection> <subsection id="H5FB39DE28C514B84AE032973652B22C1"><enum>(i)</enum><header>Authorization of appropriations</header><text>To carry out this section, there is authorized to be appropriated $120,000,000 for fiscal years 2021 through 2023, to remain available until expended.</text></subsection></section></subpart><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H220F7DDBCB9C48D9BD86E6B01767EF86"><enum>E</enum><header>National Centers of Excellence in Continuous Pharmaceutical Manufacturing</header> <section id="H9BEEEFCC38B747459BA7D1A5204BDB11"><enum>2041.</enum><header>National Centers of Excellence in Continuous Pharmaceutical Manufacturing</header> <subsection id="HEA1E518E6B7E4CEBB5067CF49769405B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 3016 of the 21st Century Cures Act (<external-xref legal-doc="usc" parsable-cite="usc/21/399h">21 U.S.C. 399h</external-xref>) is amended to read as follows:</text> <quoted-block id="H91232E60930A41AB99BC1B9D4A789809"> <section id="HB6321BFFAA7E4846B47836EA826E12AC"><enum>3016.</enum><header>National Centers of Excellence in Continuous Pharmaceutical Manufacturing</header> <subsection id="H621F842B6B1F4BB39FE54E5B5227B7B3"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs—</text> <paragraph commented="no" id="H9D0F338CB644428595660D2332A7FFFA"><enum>(1)</enum><text display-inline="yes-display-inline">shall solicit and, beginning not later than one year after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, receive requests from institutions of higher education to be designated as a National Center of Excellence in Continuous Pharmaceutical Manufacturing (in this section referred to as a <quote>National Center of Excellence</quote>) to support the advancement and development of continuous manufacturing; and</text></paragraph> <paragraph commented="no" id="HF49ADB58DCDD4F76A623709F021C1A52"><enum>(2)</enum><text display-inline="yes-display-inline">shall so designate any institution of higher education that—</text> <subparagraph commented="no" id="H934461AB98D148D79DEF153AFF28E1F1"><enum>(A)</enum><text>requests such designation; and</text></subparagraph> <subparagraph commented="no" id="H74E4EFE3F5ED408E896A29D9AEFD75E2"><enum>(B)</enum><text>meets the criteria specified in subsection (c).</text></subparagraph></paragraph></subsection> <subsection id="H04BBB37293404F38A8E0986AF02AFEC1"><enum>(b)</enum><header>Request for designation</header><text display-inline="yes-display-inline"><italic></italic>A request for designation under subsection (a) shall be made to the Secretary at such time, in such manner, and containing such information as the Secretary may require. Any such request shall include a description of how the institution of higher education meets or plans to meet each of the criteria specified in subsection (c).</text></subsection> <subsection id="HE50DD3DE93D54451B05A8D7458986942"><enum>(c)</enum><header>Criteria for designation described</header><text>The criteria specified in this subsection with respect to an institution of higher education are that the institution has, as of the date of the submission of a request under subsection (a) by such institution—</text> <paragraph id="H2515009495074FA3A91FB0A7EB8DD0F7"><enum>(1)</enum><text display-inline="yes-display-inline">physical and technical capacity for research and development of continuous manufacturing;</text></paragraph> <paragraph id="H5A9F77DBF5D84C39AE6D39C8F01E0E77"><enum>(2)</enum><text display-inline="yes-display-inline">manufacturing knowledge-sharing networks with other institutions of higher education, large and small pharmaceutical manufacturers, generic and nonprescription manufacturers, contract manufacturers, and other entities;</text></paragraph> <paragraph id="H0A31ACFD6B68452C87B8E9A33229A07A"><enum>(3)</enum><text>proven capacity to design and demonstrate new, highly effective technology for use in continuous manufacturing;</text></paragraph> <paragraph id="HA277A5EAB900406688012151B22B3E7A"><enum>(4)</enum><text display-inline="yes-display-inline">a track record for creating and transferring knowledge with respect to continuous manufacturing;</text></paragraph> <paragraph id="HD808759C7B2246B983046C27EEC9EF16"><enum>(5)</enum><text display-inline="yes-display-inline">the potential to train a future workforce for research on and implementation of advanced manufacturing and continuous manufacturing<italic></italic>; and</text></paragraph> <paragraph id="H3DCC0100D3EF409B9B126B04B8BFF857"><enum>(6)</enum><text display-inline="yes-display-inline">experience in participating in and leading a continuous manufacturing technology partnership with other institutions of higher education, large and small pharmaceutical manufacturers, generic and nonprescription manufacturers, contract manufacturers, and other entities—</text> <subparagraph id="H427A12D84FE64C63895DA7F743A11A9F"><enum>(A)</enum><text>to support companies with continuous manufacturing in the United States;</text></subparagraph> <subparagraph id="H90A53C73182A4D51B92B880F386A4263"><enum>(B)</enum><text display-inline="yes-display-inline">to support Federal agencies with technical assistance, which may include regulatory and quality metric guidance as applicable, for advanced manufacturing and continuous manufacturing;</text></subparagraph> <subparagraph id="H9E0A3136A1784A819A055EF77FE9669A"><enum>(C)</enum><text display-inline="yes-display-inline">with respect to continuous manufacturing, to organize and conduct research and development activities needed to create new and more effective technology, capture and disseminate expertise, create intellectual property, and maintain technological leadership;</text></subparagraph> <subparagraph id="H020084CBE898465FA55A20BB0ED29CDA"><enum>(D)</enum><text display-inline="yes-display-inline">to develop best practices for designing continuous manufacturing; and</text></subparagraph> <subparagraph id="HF4D4B6F5E5914B7BAD16543C9782FD12"><enum>(E)</enum><text display-inline="yes-display-inline">to assess and respond to the workforce needs for continuous manufacturing, including the development of training programs if needed.</text></subparagraph></paragraph></subsection> <subsection id="H2541E9DE52C24EAAA88DEB867B14CB85"><enum>(d)</enum><header>Termination of designation</header><text>The Secretary may terminate the designation of any National Center of Excellence designated under this section if the Secretary determines such National Center of Excellence no longer meets the criteria specified in subsection (c). Not later than 60 days before the effective date of such a termination, the Secretary shall provide written notice to the National Center of Excellence, including the rationale for such termination.</text></subsection> <subsection id="HF93DBFFFF4694D6189AAD130F12C916F"><enum>(e)</enum><header>Conditions for designation</header><text>As a condition of designation as a National Center of Excellence under this section, the Secretary shall require that an institution of higher education enter into an agreement with the Secretary under which the institution agrees—</text> <paragraph id="H11F2BAFD89444B9DAEE2A202252CBEDB"><enum>(1)</enum><text display-inline="yes-display-inline">to collaborate directly with the Food and Drug Administration to publish the reports required by subsection (g);</text></paragraph> <paragraph id="HEDA2D54DEFF54BD5B6398F0A58330D9E"><enum>(2)</enum><text>to share data with the Food and Drug Administration regarding best practices and research generated through the funding under subsection (f);</text></paragraph> <paragraph id="H3257A146E60D433DA925CD359D698A87"><enum>(3)</enum><text display-inline="yes-display-inline">to develop, along with industry partners (which may include large and small biopharmaceutical manufacturers, generic and nonprescription manufacturers, and contract manufacturers) and another institution or institutions designated under this section, if any, a roadmap for developing a continuous manufacturing workforce;</text></paragraph> <paragraph id="HC5572C9BD7D447F8B48B503D68190CF2"><enum>(4)</enum><text>to develop, along with industry partners and other institutions designated under this section, a roadmap for strengthening existing, and developing new, relationships with other institutions; and</text></paragraph> <paragraph id="H636325E1C0924D87AF8B4E5427619F81"><enum>(5)</enum><text display-inline="yes-display-inline">to provide an annual report to the Food and Drug Administration regarding the institution’s activities under this section, including a description of how the institution continues to meet and make progress on the criteria listed in subsection (c).</text></paragraph></subsection> <subsection id="HAA6E62D789E6400988C2ED7590CADF29"><enum>(f)</enum><header>Funding</header> <paragraph id="HB659AB80050A4EFE8A24FBC342F2A8B0"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall award funding, through grants, contracts, or cooperative agreements, to the National Centers of Excellence designated under this section for the purpose of studying and recommending improvements to continuous manufacturing, including such improvements as may enable the Centers—</text> <subparagraph id="H1DC95B3140F046F5A92BD8FFD2BA00F0"><enum>(A)</enum><text>to continue to meet the conditions specified in subsection (e); and</text></subparagraph> <subparagraph id="HEDF6175EE23444A2B88DE684D0C19D42"><enum>(B)</enum><text>to expand capacity for research on, and development of, continuing manufacturing.</text></subparagraph></paragraph> <paragraph id="H0D2EDF75DAC94F8F9B7294859B7B2808"><enum>(2)</enum><header>Consistency with FDA mission</header><text display-inline="yes-display-inline">As a condition on receipt of funding under this subsection, a National Center of Excellence shall agree to consider any input from the Secretary regarding the use of funding that would—</text> <subparagraph id="H0CA8162C46DA4BD58F7B6A70AEAD679F"><enum>(A)</enum><text>help to further the advancement of continuous manufacturing through the National Center of Excellence; and</text></subparagraph> <subparagraph id="H386785F58173415C865B810CA8371B12"><enum>(B)</enum><text>be relevant to the mission of the Food and Drug Administration.</text></subparagraph></paragraph> <paragraph id="HEAE88A02EA9C4D89A3685E613A5697C6"><enum>(3)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated to carry out this subsection $80,000,000 for the period of fiscal years 2021 through 2025.</text></paragraph> <paragraph id="H85597EC6C1904607AC7DAED71E477D6A"><enum>(4)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed as precluding a National Center for Excellence designated under this section from receiving funds under any other provision of this Act or any other Federal law.</text></paragraph></subsection> <subsection id="H463BCA460CC94621A3C70AEA73DA214D"><enum>(g)</enum><header>Annual review and reports</header> <paragraph id="H8013028C08E9493985B0387FAB09AADD"><enum>(1)</enum><header>Annual report</header><text display-inline="yes-display-inline">Beginning not later than one year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall—</text> <subparagraph id="H14F185D04866425E88DC1E55847F8DBB"><enum>(A)</enum><text>submit to Congress a report describing the activities, partnerships and collaborations, Federal policy recommendations, previous and continuing funding, and findings of, and any other applicable information from, the National Centers of Excellence designated under this section; and</text></subparagraph> <subparagraph id="HAEE6A85491A145BE91608520B4D62B5F"><enum>(B)</enum><text>make such report available to the public in an easily accessible electronic format on the website of the Food and Drug Administration.</text></subparagraph></paragraph> <paragraph id="H4D11B41C073644EAB41C87C2A3F707D9"><enum>(2)</enum><header>Review of national centers of excellence and potential designees</header><text>The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such National Centers of Excellence continue to meet the criteria for designation under this section.</text></paragraph> <paragraph id="H15AF1194663145DFA0CD1DE06C619FB1"><enum>(3)</enum><header>Report on long-term vision of FDA role</header><text display-inline="yes-display-inline">Not later than 2 years after the date on which the first designation is made under subsection (a), the Secretary, in consultation with the National Centers of Excellence designated under this section, shall submit a report to the Congress on the long-term vision of the Department of Health and Human Services on the role of the Food and Drug Administration in supporting continuous manufacturing, including—</text> <subparagraph commented="no" id="HF8AE58A228DC4740BD38C1FAE4BFA220"><enum>(A)</enum><text>a national framework of principles related to the implementation and regulation of continuous manufacturing; </text></subparagraph> <subparagraph id="H9FCE2B42587646078AC3872D954CF377"><enum>(B)</enum><text display-inline="yes-display-inline">a plan for the development of Federal regulations and guidance for how advanced manufacturing and continuous manufacturing can be incorporated into the development of pharmaceuticals and regulatory responsibilities of the Food and Drug Administration; and</text></subparagraph> <subparagraph id="H1C8EBB2095DB4588B2A4EEC00A16BD15"><enum>(C)</enum><text display-inline="yes-display-inline">appropriate feedback solicited from the public, which may include other institutions, large and small biopharmaceutical manufacturers, generic and nonprescription manufacturers, and contract manufacturers.</text></subparagraph></paragraph></subsection> <subsection id="H6BB65832C9F047E082663D89144C6EA2"><enum>(h)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H096BDDBA834649D9B8045DE39576CDA5"><enum>(1)</enum><header>Advanced manufacturing</header><text display-inline="yes-display-inline">The term <term>advanced manufacturing</term> means an approach for the manufacturing of pharmaceuticals that incorporates novel technology, or uses an established technique or technology in a new or innovative way (such as continuous manufacturing where the input materials are continuously transformed within the process by two or more unit operations) that enhances drug quality or improves the manufacturing process.</text></paragraph> <paragraph id="H3517622CE1724A2882B6BE3DA7D8D942"><enum>(2)</enum><header>Continuous manufacturing</header><text>The term <term>continuous manufacturing</term>—</text> <subparagraph id="H08C860D88A7B4573A104EA68C5E9374B"><enum>(A)</enum><text>means a process where the input materials are continuously fed into and transformed within the process, and the processed output materials are continuously removed from the system; and</text></subparagraph> <subparagraph id="H0AEE10FD79164BC49B6F385046A0F6EE"><enum>(B)</enum><text>consists of an integrated process that consists of a series of two or more unit operations.</text></subparagraph></paragraph> <paragraph id="H95D786508F9A43028E6E42D48BFEACE3"><enum>(3)</enum><header>Institution of higher education</header><text>The term <term>institution of higher education</term> has the meaning given such term in section 101(a) of the Higher Education Act of 1965 (<external-xref legal-doc="usc" parsable-cite="usc/20/1001">20 U.S.C. 1001(a)</external-xref>).</text></paragraph> <paragraph id="HB1209CF8550445279A1F94D9C3A09FD4"><enum>(4)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H0FB863926ED144F3ADEA0EB7DCBB137A"><enum>(b)</enum><header>Transition rule</header><text display-inline="yes-display-inline">Section 3016 of the 21st Century Cures Act (<external-xref legal-doc="usc" parsable-cite="usc/21/399h">21 U.S.C. 399h</external-xref>), as in effect on the day before the date of the enactment of this section, shall apply with respect to grants awarded under such section before such date of enactment.</text></subsection></section></subtitle> <enum>III</enum><header>Strategic National Stockpile Improvements</header> <subtitle id="H4DF4347CDEB94EC192EE770A0D193A4D"><enum>A</enum><header>Stockpiling for America’s Future Endeavors</header> <section id="H884A02BE1A93412FA66F9A585164CA5D"><enum>3001.</enum><header>Strategic National Stockpile</header><text display-inline="no-display-inline">Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)) is amended by adding at the end the following: </text> <quoted-block style="OLC" id="HF03A6DEFEBBF4274A7EA113B045E2EE8" display-inline="no-display-inline"> <paragraph id="H924D2AFD83B845A49A6F4759478DA4AD"><enum>(6)</enum><header>Acceptance of gifts</header> <subparagraph id="H50EC6B37EEB142B0ABA48A8C236017B1"><enum>(A)</enum><header>In general</header><text>The Secretary may, without further appropriation and without fiscal year limitation, accept, use, and dispose of gifts, bequests, or devises of money, services, or property, both real and personal, for the purpose of carrying out this subsection. Any such gift, bequest, or devise of money and proceeds from sales of other property received as a gift, bequest, or devise shall be deposited in the Treasury and shall be available for obligation and expenditure upon order of the Secretary.</text></subparagraph> <subparagraph id="H95D0DEDB2ACD47EDAEE34E3E22F4459F"><enum>(B)</enum><header>Limitations</header> <clause id="H28BA0D66E95443A788941B7F8A1C4E10"><enum>(i)</enum><header>Compromising integrity</header><text>The Secretary may not accept a gift, bequest, or devise under this paragraph if the Secretary determines that the use of the property or services would compromise the integrity or appearance of integrity of—</text> <subclause id="H45E3D6DD885941BE862761F57AEFFADB"><enum>(I)</enum><text>a program of the Department of Health and Human Services; or</text></subclause> <subclause id="HB32504310B2C498696767B524D96D0FF"><enum>(II)</enum><text>an individual involved in a program of the Department.</text></subclause></clause> <clause id="H11157F21A1FB403B951E74E78BCE1EA8"><enum>(ii)</enum><header>Unapproved products</header><text>The Secretary may accept a drug or device (as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) as part of a gift, bequest, or devise under this paragraph only if such drug or device is—</text> <subclause id="HF1907D348E1740A28535CEB12FCF46C9"><enum>(I)</enum><text>a drug that is approved under section 505 of such Act, that meets the requirements for marketing under section 505G of such Act, or that is licensed under section 351 of this Act;</text></subclause> <subclause id="H37D9DD565F4A437995288C579A34EBEA"><enum>(II)</enum><text>a device that is approved under section 515 of the Federal Food, Drug, and Cosmetic Act, that is classified under section 513(f)(2) of such Act, that is licensed under section 351 of this Act, that is cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act, or for which a report is not required under such section 510(k);</text></subclause> <subclause id="HA473DA6DE35B42F9A334E3996EAD458D"><enum>(III)</enum><text>authorized for emergency use in accordance with section 564 or 564A of the Federal Food, Drug, and Cosmetic Act or prepositioned for use in accordance with section 564B of such Act;</text></subclause> <subclause id="HBD14FBC828F243CE8B0AF65DB9445A07"><enum>(IV)</enum><text>authorized for investigational use under section 505, 512, or 520 of the Federal Food, Drug, and Cosmetic Act or section 351 of this Act;</text></subclause> <subclause id="H73D9216CC4484FD995E7C6EAC5A8CDF3"><enum>(V)</enum><text>determined by the Commissioner of Food and Drugs to be appropriate for use, without approval, licensure, authorization, or clearance, to respond to a shortage or potential shortage situation; or</text></subclause> <subclause id="H2F4C84AB1FF84947A805D84BD40E780C"><enum>(VI)</enum><text>a respiratory protective device approved and determined to be a priority, as described in section 319F–3(i)(1)(D) of this Act.</text></subclause></clause></subparagraph> <subparagraph id="HD07D30BDE61C448C87D8C0B6972C304C"><enum>(C)</enum><header>Report</header> <clause id="H022E4462E80A49408325D4203DF5731C"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate an annual report disclosing—</text> <subclause id="HC71CAD8547C64BA8A6EA524340B08A75"><enum>(I)</enum><text display-inline="yes-display-inline">any gift, bequest, or devise that was accepted under this paragraph during the year covered by the report;</text></subclause> <subclause id="H7AFC47FC841E4570AA3384DDFA6A41F4"><enum>(II)</enum><text>how the gifts, bequests, and devises contribute to the mission of the stockpile; and</text></subclause> <subclause id="H11F32131501C4B729897EFDB99D9C36E"><enum>(III)</enum><text>the amount of Federal savings that were generated from the acceptance of the gifts, bequests, and devises.</text></subclause></clause> <clause id="HEDF608A129264390B2F7415F87BDE299"><enum>(ii)</enum><header>Publication</header><text>Each report required under clause (i) shall be made publicly available.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="HEB1F896F9F194710944BC4D35ACD380E"><enum>B</enum><header>Stockpile Inventory Modernization</header> <section id="H41964599BA174938ABAAAFB014B75EAA"><enum>3011.</enum><header>Reimbursable transfers</header><text display-inline="no-display-inline">Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)), as amended by section 3001, is further amended by adding at the end the following: </text> <quoted-block style="OLC" id="HD136C12514C744E9A8E5C608E460C884" display-inline="no-display-inline"> <paragraph id="H5E6FA3DE6EFE4EFAB8CDE4D6CAB41909"><enum>(7)</enum><header>Transfers and reimbursements</header> <subparagraph id="H13677DFED30542E6B2BD396444582998"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Without regard to <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/40/5">chapter 5</external-xref> of title 40, United States Code, the Secretary may transfer to any Federal department or agency, on a reimbursable basis, any drugs, vaccines and other biological products, medical devices, and other supplies in the stockpile if—</text> <clause id="HCC4265CC800E4C90ADFB0F949D444C4D"><enum>(i)</enum><text>the transferred supplies are less than one year from expiry;</text></clause> <clause id="H8E1610D741B64D24A5E56F2BF2122648"><enum>(ii)</enum><text>the stockpile is able to replenish the supplies, as appropriate; and</text></clause> <clause id="H0099A3CDC8494666BAA41A5D3CA8A957"><enum>(iii)</enum><text>the Secretary decides the transfer is in the best interest of the United States Government.</text></clause></subparagraph> <subparagraph id="H4C6BE4B797A4436FBF1527C9C2DB227E"><enum>(B)</enum><header>Use of reimbursement</header><text display-inline="yes-display-inline">Reimbursement derived from the transfer of supplies pursuant to subparagraph (A) may, to the extent and in the amounts made available in advance in appropriations Acts, be used by the Secretary to carry out this section. Funds made available pursuant to the preceding sentence are in addition to any other funds that may be made available for such purpose.</text></subparagraph> <subparagraph id="H0CE3D9F27BD94CAEA192732CB28E6D3F"><enum>(C)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">This paragraph shall not be construed to preclude transfers of products in the stockpile under other authorities.</text></subparagraph> <subparagraph id="H99E57990B1E641CC9B8AFCDC1ABD6CF6"><enum>(D)</enum><header>Report</header><text>Not later than September 30, 2022, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on each transfer made under this paragraph and the amount received by the Secretary in exchange for that transfer.</text></subparagraph> <subparagraph id="H1BBD6F0F2EF44C62A15924FCADA3614B"><enum>(E)</enum><header>Sunset</header><text>The authority to make transfers under this paragraph shall cease to be effective on September 30, 2023. </text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H3EA1040970E04E1385CF7FC576349FD6"><enum>C</enum><header>Equipment Maintenance</header> <section id="H8B8EA5B171E44D3586A5C3AA0EB685F6" section-type="subsequent-section"><enum>3021.</enum><header>Equipment maintenance</header><text display-inline="no-display-inline">Section 319F–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6b">42 U.S.C. 247d–6b</external-xref>) is amended—</text> <paragraph id="HA514E29E0398412BB7F515E821773A3C"><enum>(1)</enum><text>in subsection (a)(3)—</text> <subparagraph id="HE9634DB6EEE84DF29F10DA292D943610"><enum>(A)</enum><text>in subparagraph (I), by striking <quote>; and</quote> and inserting a semicolon;</text></subparagraph> <subparagraph id="HC0E4EC10FC454C47A996302494708044"><enum>(B)</enum><text>in subparagraph (J), by striking the period at the end and inserting a semicolon; and</text></subparagraph> <subparagraph id="HF69AFEFD458C474AB0E6B1136A0BB2B6"><enum>(C)</enum><text>by inserting the following new subparagraph at the end:</text> <quoted-block style="OLC" id="H4BE8A7DB6B27476095C96E765EAB251F" display-inline="no-display-inline"> <subparagraph id="HAC7CBA4E0AE9402380980982060467F2"><enum>(K)</enum><text display-inline="yes-display-inline">ensure contents of the stockpile remain in good working order and, as appropriate, conduct maintenance services on contents of the stockpile; and</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H7024EE235A4849F4B74976AB559EA78B"><enum>(2)</enum><text>in subsection (c)(7)(B), by adding at the end the following new clause:</text> <quoted-block style="OLC" id="HA7CA6EEBC6AD42FB887AE66908BD57FF" display-inline="no-display-inline"> <clause id="HDD866EFE036D4EFFA54C2DBD8C9BD079"><enum>(ix)</enum><header>Equipment maintenance service</header><text display-inline="yes-display-inline">In carrying out this section, the Secretary may enter into contracts for the procurement of equipment maintenance services. </text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section></subtitle> <subtitle id="H6CC1AB5126C148D9BB4DB6C91FE34161"><enum>D</enum><header>Medical Supplies for Pandemics</header> <section id="HF3BF6CEFFEC64995B2F52F585C4FF351"><enum>3031.</enum><header>Supply chain flexibility manufacturing pilot</header> <subsection id="H4E1B8A92DEFF4DF6B824A24E637EF90E"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 319F–2(a)(3) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)), as amended by section 3012, is further amended by adding at the end the following new subparagraph:</text> <quoted-block style="OLC" id="H2D1704D407174F60B806E908F7792AE5" display-inline="no-display-inline"> <subparagraph id="H5FC6DC1D37084D92A0C91F811DA217A1"><enum>(L)</enum><text display-inline="yes-display-inline">enhance medical supply chain elasticity and establish and maintain domestic reserves of critical medical supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, and other medical devices (including diagnostic tests)<italic></italic>) by—</text> <clause id="H609293C5C4FC4BD191646360DB1DE4FF"><enum>(i)</enum><text>increasing emergency stock of critical medical supplies; </text></clause> <clause id="HAB930FD356324F3EA427CEED77BF6BC0"><enum>(ii)</enum><text>geographically diversifying domestic production of such medical supplies, as appropriate;</text></clause> <clause id="H16EA3B3196FF4685891F9AE36899D4E2"><enum>(iii)</enum><text>entering into cooperative agreements or partnerships with respect to manufacturing lines, facilities, and equipment for the domestic production of such medical supplies; and</text></clause> <clause id="H6C32C4EBE8234F0FA8DDB8EAFB75D35F"><enum>(iv)</enum><text display-inline="yes-display-inline">managing, either directly or through cooperative agreements with manufacturers and distributors, domestic reserves established under this subparagraph by refreshing and replenishing stock of such medical supplies.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H16E2D3BFCC924E88A68934AFB401BF0B"><enum>(b)</enum><header>Reporting; sunset</header><text display-inline="yes-display-inline">Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)), as amended by section 3011, is further amended by adding at the end the following:</text> <quoted-block style="OLC" id="HB360F6E029A94187B1E7D19AD41A3550" display-inline="no-display-inline"> <paragraph id="HD8B9EBDF7880434C9C9F60A37C857E9C"><enum>(8)</enum><header>Reporting</header><text display-inline="yes-display-inline">Not later than September 30, 2022, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the details of each cooperative agreement or partnership entered into under paragraph (3)(L), including the amount expended by the Secretary on each such cooperative agreement or partnership.</text></paragraph> <paragraph id="H40869B4CCC554FBDAAE0263956226193"><enum>(9)</enum><header>Sunset</header><text display-inline="yes-display-inline">The authority to enter into cooperative agreements or partnerships pursuant to paragraph (3)(L) shall cease to be effective on September 30, 2023.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H61D51DAFEAA543B4B3429C849349F46E"><enum>(c)</enum><header>Funding</header><text display-inline="yes-display-inline">Section 319F–2(f) of the Public Health Service Act (42 U.S.C. 247d–6b(f)) is amended by adding at the end the following:</text> <quoted-block style="OLC" id="HFF066993F0E14574AC55B2DCDA122864" display-inline="no-display-inline"> <paragraph id="HA1BFAADE1A3B475292632944CAE01982"><enum>(3)</enum><header>Supply chain elasticity</header> <subparagraph id="HCF46AF083B934760B041BC35A6CB1A61"><enum>(A)</enum><header>In general</header><text>For the purpose of carrying out subsection (a)(3)(L), there is authorized to be appropriated $500,000,000 for each of fiscal years 2021 through 2023, to remain available until expended.</text></subparagraph> <subparagraph id="HA882F675A0A04A109928B6B5F4EACE70" commented="no"><enum>(B)</enum><header>Relation to other amounts</header><text display-inline="yes-display-inline">The amount authorized to be appropriated by subparagraph (A) for the purpose of carrying out subsection (a)(3)(L) is in addition to any other amounts available for such purpose.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section></subtitle> <subtitle id="HA357CADE44044C529FDDA561D3D70744"><enum>E</enum><header>State Stockpile Readiness</header> <section id="H4E7BBE12242249D3AC7B844CD4B6FC90"><enum>3041.</enum><header>Grants for State strategic stockpiles</header><text display-inline="no-display-inline">Title III of the Public Health Service Act is amended by inserting after section 319F–4 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6e">42 U.S.C. 247d–6e</external-xref>) the following new section:</text> <quoted-block style="OLC" id="HDD0A75126D8349F483C043E8DF918EF9" display-inline="no-display-inline"> <section id="H5AB91B6A7BAA4244A228D71624A5848C"><enum>319F–5.</enum><header>Grants for State strategic stockpiles</header> <subsection id="HFF079F6293EA410384B78E5F9796F189"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may establish a pilot program consisting of awarding grants to States to expand or maintain a strategic stockpile of commercially available drugs, devices, personal protective equipment, and other products deemed by the State to be essential in the event of a public health emergency.</text></subsection> <subsection id="HEEBF808310724009930014E0AEABEF72"><enum>(b)</enum><header>Allowable use of funds</header> <paragraph id="H2920063ACF5241629A8051605D11BB22"><enum>(1)</enum><header>Uses</header><text>A State receiving a grant under this section may use the grant funds to—</text> <subparagraph id="HC38E4E7E20694B178E4F8F1B2A83086D"><enum>(A)</enum><text>acquire commercially available products listed pursuant to paragraph (2) for inclusion in the State’s strategic stockpile;</text></subparagraph> <subparagraph id="HA3A8BB92AABF462BB27D70A909B17D47"><enum>(B)</enum><text>store, maintain, and distribute products in such stockpile; and</text></subparagraph> <subparagraph id="HD02110D18A1340C7B89AD43DD43599E2"><enum>(C)</enum><text display-inline="yes-display-inline">conduct planning in connection with such activities.</text></subparagraph></paragraph> <paragraph id="H13564E44E2894D998330FE8962773EBE"><enum>(2)</enum><header>List</header><text>The Secretary shall develop and publish a list of the products that are eligible, as described in subsection (a), for inclusion in a State’s strategic stockpile using funds received under this section.</text></paragraph> <paragraph id="HEBAA3D34FFE845E7916B5CD69180C48B"><enum>(3)</enum><header>Consultation</header><text>In developing the list under paragraph (2) and otherwise determining the allowable uses of grant funds under this section, the Secretary shall consult with States and relevant stakeholders, including public health organizations.</text></paragraph></subsection> <subsection id="H64AC20C5080340438ACF23128C7E3E09"><enum>(c)</enum><header>Funding requirement</header><text display-inline="yes-display-inline">The Secretary may not obligate or expend any funds to award grants or fund any previously awarded grants under this section for a fiscal year unless the total amount made available to carry out section 319F–2 for such fiscal year is equal to or greater than the total amount of funds made available to carry out section 319F–2 for fiscal year 2020.</text></subsection> <subsection id="HAE97D433FB2148BBAB23702AE9E4BF88"><enum>(d)</enum><header>Matching funds</header> <paragraph id="HE169CA4E03FD4BC79E0F7CF03AB21DA4"><enum>(1)</enum><header>In general</header><text>With respect to the costs of expanding and maintaining a strategic stockpile through a grant under this section, as a condition on receipt of the grant, a State shall make available (directly) non-Federal contributions in cash toward such costs in an amount that is equal to not less than the amount of Federal funds provided through the grant. </text></paragraph> <paragraph id="HCDFB628F771C45BE81896ABCE9547383"><enum>(2)</enum><header>Waiver</header><text>The Secretary may waive the requirement of paragraph (1) with respect to a State for the first two years of the State receiving a grant under this section if the Secretary determines that such waiver is needed for the State to establish a strategic stockpile described in subsection (a).</text></paragraph></subsection> <subsection id="HC8F50EE407CD4902A435D61C3D100DE9"><enum>(e)</enum><header>Technical assistance</header><text>The Secretary shall provide technical assistance to States in establishing, expanding, and maintaining a stockpile described in subsection (a).</text></subsection> <subsection id="HA36D8877319F4C2B85BF989C5475619A"><enum>(f)</enum><header>Definition</header><text>In this section, the term <term>drug</term> has the meaning given to that term in section 201 of the Federal Food, Drug, and Cosmetic Act.</text></subsection> <subsection id="HB405E61501114CD2877C278D0A439ADF"><enum>(g)</enum><header>Authorization of appropriations</header><text>To carry out this section, there is authorized to be appropriated $3,500,000,000 for each of fiscal years 2021 through 2023, to remain available until expended.</text></subsection> <subsection id="H0485FB53FD1C44C39C540DD3D70C5884"><enum>(h)</enum><header>Sunset</header><text>The authority vested by this section terminates at the end of fiscal year 2023.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="HF1ABD1D7DBD444F4952378E1DE8E4EE4"><enum>F</enum><header>Process Improvements and Reports</header> <section id="H7988001FF32A429FBFA7F311A9DEFF24"><enum>3051.</enum><header>GAO study on the feasibility and benefits of user fee agreements</header> <subsection id="HCA1DD28C5C884C0FB4DD7A81560050A3"><enum>(a)</enum><header>In general</header><text>The Comptroller General of the United States shall conduct a study to investigate the feasibility of establishing user fees to offset certain Federal costs attributable to the procurement of single-source materials for the Strategic National Stockpile under section 319F–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6b">42 U.S.C. 247d–6b</external-xref>) and distributions of such materials from the Stockpile. In conducting this study, the Comptroller General shall consider, to the extent information is available—</text> <paragraph id="H8BE6E7B8724D4FA88605653FBDB218DA"><enum>(1)</enum><text>whether entities receiving such distributions generate profits from those distributions;</text></paragraph> <paragraph id="H305455AE7F4448568AAFC8184EE31587"><enum>(2)</enum><text>any Federal costs attributable to such distributions;</text></paragraph> <paragraph id="H8B8C4DFFD5DA49BD96BC8E9BE81F6924"><enum>(3)</enum><text>whether such user fees would provide the Secretary with funding to potentially offset procurement costs of such materials for the Strategic National Stockpile; and</text></paragraph> <paragraph id="H2DC5E729B1444A53891D58012E3B2AFD"><enum>(4)</enum><text>any other issues the Comptroller General identifies as relevant.</text></paragraph></subsection> <subsection id="H3801671E349044C292345C48010F541B"><enum>(b)</enum><header>Report</header><text>Not later than February 1, 2023, the Comptroller General of the United States shall submit to the Congress a report on the findings and conclusions of the study under subsection (a).</text></subsection></section> <section id="HA58CEF984F184C8C89F88A2790E54136" commented="no" section-type="subsequent-section"><enum>3052.</enum><header>Action reporting</header> <subsection id="H185F962C5090411CA7D7E2566F946AF4" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services or the Assistant Secretary for Preparedness and Response, in consultation with the Administrator of the Federal Emergency Management Agency, shall—</text> <paragraph id="H7DE108A6533F4A7C9BE37D6B978984AE" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">not later than 30 days after the date of enactment of this Act, issue a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate regarding all State, local, Tribal, and territorial requests for supplies from the Strategic National Stockpile related to COVID–19; and</text></paragraph> <paragraph id="H523340D91F4B46DF8C000A2C8CF6F5AB" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">not less than every 30 days thereafter through the end of the emergency period (as such term is defined in section 1135(g)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5(g)(1)(B)</external-xref>)), submit to such committees an updated version of such report.</text></paragraph></subsection> <subsection id="HC516FD37E25F4290ACFC6CB295A3ACB5" commented="no"><enum>(b)</enum><header>Reporting period</header> <paragraph id="H73F6EB6D8EF14ADEAB728342D6B7C3CD" commented="no"><enum>(1)</enum><header>Initial report</header><text>The initial report under subsection (a) shall address all requests described in such subsection made during the period—</text> <subparagraph id="HBE9BA30F80134C68B8581E603C6C0CC2" commented="no"><enum>(A)</enum><text>beginning on January 31, 2020; and</text></subparagraph> <subparagraph id="HE6E8EA522BE44874B8EB3A58630BC841" commented="no"><enum>(B)</enum><text>ending on the date that is 30 days before the date of submission of the report.</text></subparagraph></paragraph> <paragraph id="H59AB0961AF104B1B9693030137DE53E0" commented="no"><enum>(2)</enum><header>Updates</header><text display-inline="yes-display-inline">Each update to the report under subsection (a) shall address all requests described in such subsection made during the period—</text> <subparagraph id="H907C9C54BD214FE392BE245F7F68D948" commented="no"><enum>(A)</enum><text>beginning at the end of the previous reporting period under this section; and</text></subparagraph> <subparagraph id="H1BEAB545702C4237BF72905A3FE174DA" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">ending on the date that is 30 days before the date of submission of the updated report.</text></subparagraph></paragraph></subsection> <subsection id="HC16D3655345D42D5B815C9132D74B1F4" commented="no"><enum>(c)</enum><header>Contents of report</header><text>The report under subsection (a) (and updates thereto) shall include—</text> <paragraph id="H20737CBB7FC2463BAC5026BC8483F0E1" commented="no"><enum>(1)</enum><text>the details of each request described in such subsection, including—</text> <subparagraph id="HD206ED32D1F24D6CB981CD6F4772F1D4" commented="no"><enum>(A)</enum><text>the specific medical countermeasures, devices, personal protective equipment, and other materials requested; and</text></subparagraph> <subparagraph id="HCC3A34E47A1F483D939D7485A26B7AFE" commented="no"><enum>(B)</enum><text>the amount of such materials requested; and</text></subparagraph></paragraph> <paragraph id="H004296D6142D419CA5FDD087F2250025" commented="no"><enum>(2)</enum><text>the outcomes of each request described in subsection (a), including—</text> <subparagraph id="HEA1011CD34C945E481E3F088E712C00F" commented="no"><enum>(A)</enum><text>whether the request was wholly fulfilled, partially fulfilled, or denied;</text></subparagraph> <subparagraph id="H506EDEF9F15040EEB9603416A2F507B4"><enum>(B)</enum><text display-inline="yes-display-inline">if the request was wholly or partially fulfilled, the fulfillment amount; and</text></subparagraph> <subparagraph id="HC08CC3E3FBF948A5840121B83F4E983A" commented="no"><enum>(C)</enum><text>if the request was partially fulfilled or denied, a rationale for such outcome.</text></subparagraph></paragraph></subsection></section> <section id="H666B955A50F94402A8DBE0D5F4798AA3" commented="no" section-type="subsequent-section"><enum>3053.</enum><header>Improved, transparent processes</header> <subsection id="HE38378742EF54D77BAE0151E326DDFA9" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than January 1, 2021, the Secretary of Health and Human Services shall develop and implement improved, transparent processes for the use and distribution of drugs, vaccines and other biological products, medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests) in the Strategic National Stockpile under section 319F–2 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-6b">42 U.S.C. 247d–6b</external-xref>) (in this section referred to as the <quote>Stockpile</quote>).</text></subsection> <subsection id="H7B0D677704CE4FE7995A239668CB6845" commented="no"><enum>(b)</enum><header>Processes</header><text>The processes developed under subsection (a) shall include—</text> <paragraph id="H3E18C8B86D97433C85D0432FDA714864" commented="no"><enum>(1)</enum><text>the form and manner in which States, localities, Tribes, and territories are required to submit requests for supplies from the Stockpile;</text></paragraph> <paragraph id="H8D1C86BA30AD4E04AE29C3B578FC7CC7" commented="no"><enum>(2)</enum><text>the criteria used by the Secretary of Health and Human Services in responding to such requests, including the reasons for fulfilling or denying such requests;</text></paragraph> <paragraph id="H3F5AC8208F01433ABEA83D16F0027363" commented="no"><enum>(3)</enum><text>what circumstances result in prioritization of distribution of supplies from the Stockpile to States, localities, Tribes, or territories; </text></paragraph> <paragraph id="H1EFA281AE3814C9AB2215D0F2CEAC399" commented="no"><enum>(4)</enum><text display-inline="yes-display-inline">clear plans for future, urgent communication between the Secretary and States, localities, Tribes, and territories regarding the outcome of such requests; and</text></paragraph> <paragraph id="H9237765AD0984E7493D589C54216B046"><enum>(5)</enum><text display-inline="yes-display-inline">any differences in the processes developed under subsection (a) for geographically related emergencies, such as weather events, and national emergencies, such as pandemics.</text></paragraph></subsection> <subsection id="H42B96536BD1A41D493C6236EA0CD5263"><enum>(c)</enum><header>Classification</header><text display-inline="yes-display-inline">The processes developed under subsection (a) shall be unclassified to the greatest extent possible consistent with national security. The Secretary of Health and Human Services may classify portions of such processes as necessary to protect national security.</text></subsection> <subsection id="HF6FCFFF0E4D8458E93015AE77556719E" commented="no"><enum>(d)</enum><header>Report to Congress</header><text display-inline="yes-display-inline">Not later than January 1, 2021, the Secretary of Health and Human Services shall—</text> <paragraph id="HB2450A9FA5A6410D95223AFC4F14CDED" commented="no"><enum>(1)</enum><text>submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate regarding the improved, transparent processes developed under this section;</text></paragraph> <paragraph id="H472C2473E89843C0B07BC3D39934F197" commented="no"><enum>(2)</enum><text>include in such report recommendations for opportunities for communication (by telebriefing, phone calls, or in-person meetings) between the Secretary and States, localities, Tribes, and territories regarding such improved, transparent processes; and</text></paragraph> <paragraph id="H597AA4C564174FEDB0C1E941F8CCA247"><enum>(3)</enum><text display-inline="yes-display-inline">submit such report in unclassified form to the greatest extent possible, except that the Secretary may include a classified appendix if necessary to protect national security.</text></paragraph></subsection></section></subtitle> <subtitle id="HF03D43AD19D04A8EB970AD335A420D24"><enum>G</enum><header>Strategic National Stockpile Funding</header> <section id="H57CC74F4260C40B7BEE3166D80139386"><enum>3061.</enum><header>Authorization of appropriations</header><text display-inline="no-display-inline">Section 319F–2(f)(1) of the Public Health Service Act (42 U.S.C. 247d–6b(f)(1)) is amended by striking <quote>$610,000,000 for each of fiscal years 2019 through 2023</quote> and inserting <quote>$705,000,000 for each of fiscal years 2021 through 2023</quote>.</text></section></subtitle> <enum>IV</enum><header>Public Health Infrastructure Improvements </header> <subtitle id="H23561F463C9E43A9A28B8B39FC26CFFE"><enum>A</enum><header>Public Health Infrastructure Modernization</header> <section id="H663599DA430148C38E908DD682D06638"><enum>4001.</enum><header>Public health data system transformation</header><text display-inline="no-display-inline">Subtitle C of title XXVIII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31</external-xref> et seq.) is amended by adding at the end the following:</text> <quoted-block id="H08C8AF56524C4B8EBA792622557800A6" style="OLC"> <section id="HBD6EDFB404524ACB846A7B675A12F77F"><enum>2822.</enum><header>Public health data system transformation</header> <subsection id="H5D6B080621DD4CA6B892368D7E5CDCC8"><enum>(a)</enum><header>Expanding CDC and public health department capabilities</header> <paragraph id="HEFF013860CF5453992C089201F32C82A"><enum>(1)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—</text> <subparagraph id="H6327470DF3924E5CAB456CC865751132"><enum>(A)</enum><text>conduct activities to expand, enhance, and improve public health data systems used by the Centers for Disease Control and Prevention, related to the interoperability and improvement of such systems (including with respect to preparedness for, prevention and detection of, and response to public health emergencies); and</text></subparagraph> <subparagraph id="HEB7E5AE54FA640038528BC1B676CB4AD"><enum>(B)</enum><text display-inline="yes-display-inline">award grants or cooperative agreements to State, local, Tribal, or territorial public health departments for the expansion and modernization of public health data systems, to assist public health departments in—</text> <clause id="H52CA69486E1A4B4E8986351C7F2B853B"><enum>(i)</enum><text>assessing current data infrastructure capabilities and gaps to improve consistency in data collection, storage, and analysis, and as appropriate to improve dissemination of public health-related information;</text></clause> <clause id="HF7AE35DA3EF04C38B9F068C5B656CED0"><enum>(ii)</enum><text>improving secure public health data collection, transmission, exchange, maintenance, and analysis;</text></clause> <clause id="H10F9C1710DD74E878876A0110DB92FAA"><enum>(iii)</enum><text display-inline="yes-display-inline">improving the secure exchange of data between the Centers for Disease Control and Prevention, State, local, Tribal, and territorial public health departments, public health organizations, and health care providers, including—</text> <subclause id="H2CBA28FDA5F84EA88401F83CB13C542C"><enum>(I)</enum><text>between public health officials in multiple jurisdictions within a State; and</text></subclause> <subclause id="HB6691911AA484D7BA2FCEEF8CEECEDE4"><enum>(II)</enum><text>by simplifying and supporting reporting by health care providers pursuant to State law, including through the use of health information technology;</text></subclause></clause> <clause id="HD9F3AA0A8B8241D49672F7EAF01322DA"><enum>(iv)</enum><text>enhancing the interoperability of public health data systems (including systems created or accessed by public health departments) with health information technology, including with health information technology certified under section 3001(c)(5);</text></clause> <clause id="H64227D14C3A74F2CAC8C023CE19E7629"><enum>(v)</enum><text>supporting and training public health data systems, data science, and informatics personnel;</text></clause> <clause id="H6F4A96BB41D24C91831721B22A06B9C5"><enum>(vi)</enum><text>supporting earlier disease and health condition detection, such as through near real-time data monitoring, to support rapid public health responses;</text></clause> <clause id="H2EDB51832EFF4E27931752D5BCCD9ACC"><enum>(vii)</enum><text>supporting activities within the applicable jurisdiction related to the expansion and modernization of electronic case reporting; and</text></clause> <clause id="HEBA83D5FEC774A3E8A5EAEDE5F2F7546"><enum>(viii)</enum><text>developing and disseminating information related to the use and importance of public health data.</text></clause></subparagraph></paragraph> <paragraph id="HD20291E9F31844EF8E9E86F30309EFFB"><enum>(2)</enum><header>Data standards</header><text>In carrying out paragraph (1), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, as appropriate and in coordination with the Office of the National Coordinator for Health Information Technology, designate data and technology standards (including standards for interoperability) for public health data systems, with deference given to standards published by consensus-based standards development organizations with public input and voluntary consensus-based standards bodies.</text></paragraph> <paragraph id="H0F39F9B2EDF44B1EBC8671CE6065479B"><enum>(3)</enum><header>Public-private partnerships</header><text display-inline="yes-display-inline">The Secretary may develop and utilize public-private partnerships for technical assistance, training, and related implementation support for State, local, Tribal, and territorial public health departments, and the Centers for Disease Control and Prevention, on the expansion and modernization of electronic case reporting and public health data systems, as applicable.</text></paragraph></subsection> <subsection id="H8411F964DB9047D1BCC679C39EE33331"><enum>(b)</enum><header>Requirements</header> <paragraph id="H62F6296CA56D426B97D0B12595659F28"><enum>(1)</enum><header>Health information technology standards</header><text>The Secretary may not award a grant or cooperative agreement under subsection (a)(1)(B) unless the applicant uses or agrees to use standards endorsed by the National Coordinator for Health Information Technology pursuant to section 3001(c)(1) or adopted by the Secretary under section 3004.</text></paragraph> <paragraph id="H13FE3F00D6574D0BBA5989CB02BEDFB4"><enum>(2)</enum><header>Waiver</header><text>The Secretary may waive the requirement under paragraph (1) with respect to an applicant if the Secretary determines that the activities under subsection (a)(1)(B) cannot otherwise be carried out within the applicable jurisdiction.</text></paragraph> <paragraph id="HD3E516607F1C4900B2479A55727EB248"><enum>(3)</enum><header>Application</header><text>A State, local, Tribal, or territorial health department applying for a grant or cooperative agreement under this section shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include information describing—</text> <subparagraph id="H028AF6CB551E4E21B6218391989A9141"><enum>(A)</enum><text>the activities that will be supported by the grant or cooperative agreement; and</text></subparagraph> <subparagraph id="HC715FD9F19304751ACF0A8000872B13B"><enum>(B)</enum><text>how the modernization of the public health data systems involved will support or impact the public health infrastructure of the health department, including a description of remaining gaps, if any, and the actions needed to address such gaps.</text></subparagraph></paragraph></subsection> <subsection id="HE0AE42AB9B1D4CA7A6D536B00FEEA2DD"><enum>(c)</enum><header>Strategy and implementation plan</header><text>Not later than 180 days after the date of enactment of this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a coordinated strategy and an accompanying implementation plan that identifies and describes the measures the Secretary will utilize to—</text> <paragraph id="HD9110E7F4D8E4D64A0B5F700258256B5"><enum>(1)</enum><text>update and improve public health data systems used by the Centers for Disease Control and Prevention; and</text></paragraph> <paragraph id="H2EA99FF2C0834DE59CA79C89358E663B"><enum>(2)</enum><text>carry out the activities described in this section to support the improvement of State, local, Tribal, and territorial public health data systems.</text></paragraph></subsection> <subsection id="H6E231450C3CE42578016C26DFC878947"><enum>(d)</enum><header>Consultation</header><text display-inline="yes-display-inline">In carrying out this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall consult with State, local, Tribal, and territorial public health departments, professional medical and public health associations, associations representing hospitals or other health care entities, health information technology experts, and other appropriate public or private entities.</text></subsection> <subsection id="H3F26A4AE612047B18FDF08EEDEEECE6C"><enum>(e)</enum><header>Report to Congress</header><text>Not later than 1 year after the date of enactment of this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—</text> <paragraph id="HEE3B86C2031B485B82B2532AB2FE5E0C"><enum>(1)</enum><text>a description of any barriers to—</text> <subparagraph id="HA07C8DBEF6854D1BA879D33A89BB0CFA"><enum>(A)</enum><text>public health authorities implementing interoperable public health data systems and electronic case reporting;</text></subparagraph> <subparagraph id="H4D235684BB3240FDBDE3BF94EE127C67"><enum>(B)</enum><text>the exchange of information pursuant to electronic case reporting; or</text></subparagraph> <subparagraph id="HC7F72978EBAA468BA944453F1A74D14E"><enum>(C)</enum><text>reporting by health care providers using such public health data systems, as appropriate, and pursuant to State law;</text></subparagraph></paragraph> <paragraph id="H31C6BC615D74410788E02B4DC8D245A8"><enum>(2)</enum><text>an assessment of the potential public health impact of implementing electronic case reporting and interoperable public health data systems; and</text></paragraph> <paragraph id="H5182CC3C3005456FBE812C32FC52BF1D"><enum>(3)</enum><text>a description of the activities carried out pursuant to this section.</text></paragraph></subsection> <subsection id="H9AADBC04AEF04CDD9928890B6FAD47BB"><enum>(f)</enum><header>Electronic case reporting</header><text>In this section, the term <term>electronic case reporting</term> means the automated identification, generation, and bilateral exchange of reports of health events among electronic health record or health information technology systems and public health authorities.</text></subsection> <subsection id="HD705CF52464045FC9551E9C414B1DC14"><enum>(g)</enum><header>Authorization of appropriations</header><text>To carry out this section, there is authorized to be appropriated $100,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="HBC66FDDEE0904DA8A27F1BD23A3538DC"><enum>B</enum><header>Modernizing infectious disease data collection</header> <section id="HCACE99C636A4457DA16361AD95E9E395"><enum>4011.</enum><header>Modernizing infectious disease data collection</header> <subsection id="H33032DEA25134E7BB4CAEFD655464E18"><enum>(a)</enum><header>Improving infectious disease data collection</header><text display-inline="yes-display-inline">Section 319D of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4</external-xref>) is amended—</text> <paragraph id="HBD340F0CF7354B5A88A7616D05162771"><enum>(1)</enum><text>in subsection (c)—</text> <subparagraph id="H359D733B8B4E4E38A71B21E3A47E4EF7"><enum>(A)</enum><text>in paragraph (3)(A)(iv), by inserting <quote>(such as commercial, academic, and other hospital laboratories)</quote> after <quote>clinical laboratories</quote>;</text></subparagraph> <subparagraph id="H5D11CB447A474967B53F94D08FE0D41D"><enum>(B)</enum><text>in paragraph (5)—</text> <clause id="H746213050A3A4D399BB47BF513F484BC"><enum>(i)</enum><text>in subparagraph (A)—</text> <subclause id="HD35C6F4D0B5F415B9609A54E6E6D83D8"><enum>(I)</enum><text>in the matter preceding clause (i), by striking <quote>and operating</quote> and inserting <quote>, operating, and updating</quote>;</text></subclause> <subclause id="H0A3169B274794B6587D538B33FB8592C"><enum>(II)</enum><text>in clause (iv), by striking <quote>and</quote> at the end;</text></subclause> <subclause id="HA6CAE81162054E03963ADACFE7F46308"><enum>(III)</enum><text>in clause (v), by striking the period and inserting <quote>; and</quote>; and</text></subclause> <subclause id="H772B60867C254C0DB281F12487C408E8"><enum>(IV)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H00A846DCA356415889109A80D77F2C88"> <clause id="H894CA567F1A045A6B71B34FDB84E6F62"><enum>(vi)</enum><text>integrate and update applicable existing Centers for Disease Control and Prevention data systems and networks in collaboration with State, local, tribal, and territorial public health officials, including public health surveillance and disease detection systems.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause> <clause id="H7DFED2E5235F4A03A8A5D0042390BD3A"><enum>(ii)</enum><text>in subparagraph (B)—</text> <subclause id="HCE7033256B304B79B1A4BC363EB24326"><enum>(I)</enum><text>in clause (i), by inserting <quote>and 60 days after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title></quote> after <quote>Innovation Act of 2019</quote>;</text></subclause> <subclause id="H125DCCAEC6AC4D699ADAC9EC541C3F6F"><enum>(II)</enum><text>in clause (ii), by inserting <quote>epidemiologists, clinical microbiologists, pathologists and laboratory experts, experts in health information technology, privacy, and data security</quote> after <quote>forecasting);</quote>; and</text></subclause> <subclause id="H240644BCA24C420CA415CBC4A246A7B7"><enum>(III)</enum><text>in clause (iii)—</text> <item id="HE9B6D2D215CA4F8983F934DF55AF39C6"><enum>(aa)</enum><text>in subclause (V), by striking <quote>and</quote> at the end;</text></item> <item id="HBA2324934D4D4D63891DAFC1636B1F3C"><enum>(bb)</enum><text>in subclause (VI), by striking the period; and</text></item> <item id="H4804A2B823704C6489D915594900F2D9"><enum>(cc)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HFAE2553F50CB44FC867EC7265F9F353D"> <subclause id="HB56752634F654D45A2E1802E94D05C85"><enum>(VII)</enum><text>strategies to integrate laboratory and epidemiology systems and capabilities to conduct rapid and accurate laboratory tests;</text></subclause> <subclause id="H313E110FA9DE4F3982AC1D8FB04C1476"><enum>(VIII)</enum><text>strategies to improve the collection and reporting of appropriate, aggregated, deidentified demographic data to inform responses to public health emergencies, including identification of at-risk populations and to address health disparities; and</text></subclause> <subclause id="HF3EDC95B133F42D9B7FEAE4D108569C8"><enum>(IX)</enum><text>strategies to improve the electronic exchange of health information between State and local health departments and health care providers and facilities to improve public health surveillance.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></item></subclause></clause></subparagraph> <subparagraph id="HF34C87857BB549A8AB85E3008E405A43"><enum>(C)</enum><text>in paragraph (6)—</text> <clause id="HFFAC53B4F7FC4754884330BE7B573766"><enum>(i)</enum><text>in subparagraph (A)—</text> <subclause id="HFA04EF7489CC40379DFBB32B0333A2CD"><enum>(I)</enum><text>in clause (iii)—</text> <item id="HB3D26B22D8B14A3C8532F7F1D7142259"><enum>(aa)</enum><text>in subclause (III), by striking <quote>and</quote> at the end;</text></item> <item id="HC7DD2A37372C46EAAEC660E877FC648F"><enum>(bb)</enum><text>in subclause (IV), by inserting <quote>, including the ability to conduct and report on rapid and accurate laboratory testing during a public health emergency</quote> before the semicolon; and</text></item> <item id="HA261C4DCC9F640DC8D25B812570ABCE0"><enum>(cc)</enum><text>by adding at the end the following: </text> <quoted-block style="OLC" display-inline="no-display-inline" id="H3304A2E324994A4F906BA41CA8058B0E"> <subclause id="HD809428D56D94C598690179807AAFE9B"><enum>(V)</enum><text>improve coordination and collaboration, as appropriate, with other Federal departments; and</text></subclause> <subclause id="HA8DCB0E7DBE64C358443D9955DFBC68E"><enum>(VI)</enum><text>implement applicable lessons learned from recent public health emergencies to address gaps in situational awareness and biosurveillance capabilities, including an evaluation of ways to improve the collection and reporting of aggregated, deidentified demographic data to inform public health preparedness and response</text></subclause><after-quoted-block>;</after-quoted-block></quoted-block></item></subclause> <subclause id="HC98A864F2D204765B201156C97C95263"><enum>(II)</enum><text>in clause (iv), by striking <quote>and</quote> at the end;</text></subclause> <subclause id="H6503EE7EC4A3416097D7FFD3DA91D5F2"><enum>(III)</enum><text>in clause (v), by striking the period and inserting <quote>including a description of how such steps will further the goal of improving awareness of and timely responses to emerging infectious disease threats; and</quote>; and</text></subclause> <subclause id="H5E5F107D89A24B2591F02D79432073EC"><enum>(IV)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HC4D478A17C4040DD8943B304498EFAB6"> <clause id="H3A459D7595624904AE0ED47FB1174592"><enum>(vi)</enum><text>identifies and demonstrates measurable steps the Secretary will take to further develop and integrate infectious disease detection, including expanding capabilities to conduct rapid and accurate diagnostic laboratory testing during a public health emergency, and improve coordination and collaboration with State, local, Tribal, and territorial public health officials, clinical laboratories (including commercial, hospital and academic laboratories), and other entities with expertise in public health surveillance.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></subclause></clause> <clause id="H9300B9248FFD4480A2A03BCCFD953593"><enum>(ii)</enum><text>by redesignating subparagraph (B) as subparagraph (C); and</text></clause> <clause id="H7C60B33A52AA45D5A30535EA4E54D377"><enum>(iii)</enum><text>by inserting after subparagraph (A), the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HFCC68FC8A1104814B17EC1CBF2B659B4"> <subparagraph id="H2991E39F8D65417BAA6D730F3DA75EF3"><enum>(B)</enum><header>Reports</header> <clause id="HBF95F807A5BA4C01AD4B7F6A484E6E99"><enum>(i)</enum><header>In general</header><text>Not later than 1 month after date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, and as provided for in clause (ii), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the status of the Department of Health and Human Services’ biosurveillance modernization and assessment progress with respect to emerging infectious disease threats.</text></clause> <clause id="H18DF58C9757A41D1B54C961AD83BB320"><enum>(ii)</enum><header>Additional reports</header><text>During the 2-year period beginning on the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, the Secretary shall provide additional reports under clause (i) every 90 days after the submission of the initial report under such clause. The Secretary shall provide such reports annually thereafter. The Secretary may provide such additional reports less frequently, but not less frequently than every 180 days, during an ongoing public health emergency or another significant infectious disease outbreak.</text></clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph></paragraph> <paragraph id="H875956076A0B4F229F894B4B602F476A"><enum>(2)</enum><text>in subsection (d)—</text> <subparagraph id="H6330EDFD29984F3BB7F1C9E980EB8786"><enum>(A)</enum><text>in paragraph (2)(C), by inserting <quote>, including any public-private partnerships entered into to improve such capacity</quote> before the semicolon; and</text></subparagraph> <subparagraph id="HC035A0F6C919469AAEAA16AF9EC7D8C6"><enum>(B)</enum><text>in paragraph (3)—</text> <clause id="H86D7784690CF459EBB4209EF15CFACA1"><enum>(i)</enum><text>in subparagraph (B), by striking <quote>and</quote> at the end;</text></clause> <clause id="H1C224C5030CE4478A8C93CF8785ECE8E"><enum>(ii)</enum><text>in subparagraph (C), by striking the period and inserting <quote>; and</quote>; and</text></clause> <clause id="H2AE4836E63924BCB8D07878116FFBAA8"><enum>(iii)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H9ACF46D570C341B783DF262A6016FEAC"> <subparagraph id="HCFF3EE40359C422AB5B2EE29389FAE40"><enum>(D)</enum><text>may establish, enhance, or maintain a system or network for the collection of data to provide for early detection of infectious disease outbreaks, near real-time access to relevant electronic data and integration of electronic data and information from public health and other appropriate sources, such as laboratories, hospitals, and epidemiology systems, to enhance the capability to conduct rapid and accurate diagnostic laboratory tests to provide for disease detection.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph></paragraph> <paragraph id="H526D0805DA9647D0BEC4BA646D627494"><enum>(3)</enum><text>in subsection (f)(1)(A), by inserting <quote>pathologists, clinical microbiologists, laboratory professionals, epidemiologists,</quote> after <quote>forecasting),</quote>; and</text></paragraph> <paragraph id="H724C1BB080E04A13B497F80E0F12430E"><enum>(4)</enum><text>in subsection (h), by adding at the end the following: <quote>Such evaluation shall include identification of any gaps in biosurveillance and situational awareness capabilities identified related to recent public health emergencies, any immediate steps taken to address such gaps, and any long-term plans to address such gaps, including steps related to activities authorized under this section.</quote>.</text></paragraph></subsection> <subsection id="HAC03B09416764E0B88B71FD1868195DB"><enum>(b)</enum><header>National health security strategy</header><text display-inline="yes-display-inline">Section 2802(b)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-1">42 U.S.C. 300hh–1(b)(2)</external-xref>) is amended—</text> <paragraph id="H0C50AC953F944C41B9C579DF9903CAB8"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (A), by inserting <quote>such as by integrating laboratory and epidemiology systems and capability to conduct rapid and accurate laboratory tests,</quote> after <quote>detection, identification,</quote>; and</text></paragraph> <paragraph id="H50EB3ABC4E284F16B40C4D9EF2235006"><enum>(2)</enum><text>in subparagraph (B), by inserting <quote>laboratory testing,</quote> after <quote>services and supplies,</quote>.</text></paragraph></subsection> <subsection id="HD58FDF4F74924B8A9AF86053D8FE414B"><enum>(c)</enum><header>Epidemiology-Laboratory capacity grants</header><text display-inline="yes-display-inline">Section 2821(a) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31(a)</external-xref>) is amended—</text> <paragraph id="H7D2BE026A3E749BBB899C58DD4593F27"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking <quote>and</quote>;</text></paragraph> <paragraph id="HBF1A672F0E334770BAD19028BE87BA40"><enum>(2)</enum><text>in paragraph (4), by striking the period and inserting <quote>; and</quote>; and</text></paragraph> <paragraph id="HB44CB0A099054FADB25394830358E9AA"><enum>(3)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H71DBC06CA892474B89BC0258F2062F36"> <paragraph id="HC7BFFA84149D4CB4BD60D435B9310428"><enum>(5)</enum><text>supporting activities of State and local public health departments related to biosurveillance and disease detection, which may include activities related to section 319D, as appropriate.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section></subtitle> <subtitle id="HA3EC79D99CCD4950B8BE6031C77A9926"><enum>C</enum><header>Diagnostic Testing for Public Health Labs</header> <section id="H994656F60E024876899FCF40A1D5F34A"><enum>4021.</enum><header>Grants for public health laboratories to acquire high-throughput diagnostic equipment</header><text display-inline="no-display-inline">Section 2821 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31</external-xref>) is amended—</text> <paragraph id="HFB982075751A43468F983619414B950C"><enum>(1)</enum><text>by redesignating subsection (b) as subsection (c);</text></paragraph> <paragraph id="H638E65FB70ED4C3BBB3A8578FF05CE49"><enum>(2)</enum><text>by inserting after subsection (a) the following new subsection:</text> <quoted-block id="H3AE767D42F714207B8DC5D4884E14936" style="OLC"> <subsection id="H098097FD508F466486E09DDD04018060"><enum>(b)</enum><header>Grants for public health laboratories To acquire high-Throughput diagnostic equipment</header> <paragraph id="H63F8B49618714056ABD31AE5A8E461DE"><enum>(1)</enum><header>Grants</header><text display-inline="yes-display-inline">The Secretary shall award grants to eligible entities to assist such entities in purchasing high-throughput diagnostic equipment and related supplies and in hiring and training staff to use such equipment.</text></paragraph> <paragraph id="H5D903EA3FE0B44659CBCA2AFAC4CD38C"><enum>(2)</enum><header>Eligibility</header><text>To be eligible for a grant under paragraph (1), an entity shall—</text> <subparagraph id="H820FE7C3E1EB4610AF473536A6F60E25"><enum>(A)</enum><text>be—</text> <clause id="HDCF5111D97F340C5BBD303DE1E760190"><enum>(i)</enum><text>a State, local, or Tribal public health laboratory;</text></clause> <clause id="H007D5B4267444675AD8AD8F4584701F1"><enum>(ii)</enum><text>a laboratory within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention;</text></clause> <clause id="H5D382D10C506455889257627B52FB83A"><enum>(iii)</enum><text>a laboratory not described in clause (i) or (ii) that the Secretary determines (at the Secretary’s discretion) provides population-based testing for the prevention and control of infectious, communicable, genetic, or chronic diseases; or</text></clause> <clause id="HF26ECEC3C9384BFCA798778ED9D765E6"><enum>(iv)</enum><text>a consortium of 2 or more entities described in any of clauses (i) through (iii); and</text></clause></subparagraph> <subparagraph id="H673CF4E291684839AD4BE84DA0DA154B"><enum>(B)</enum><text>submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require.</text></subparagraph></paragraph> <paragraph id="H71FF75680A184C3591EF2F2913E8E81C"><enum>(3)</enum><header>Use of funds</header><text display-inline="yes-display-inline">Amounts received through a grant under this subsection shall be used—</text> <subparagraph id="HB583DD29CCF241B682F28AF057402EDD"><enum>(A)</enum><text>to purchase high-throughput diagnostic equipment and such materials as are necessary to administer, store, and process applicable tests, including diagnostic and serological tests; and</text></subparagraph> <subparagraph id="H8481934D3C8345FBABBF8EC0AC0F9E31"><enum>(B)</enum><text>to hire and train staff to use such equipment.</text></subparagraph></paragraph> <paragraph id="H87B48A5126E3464B8FB5D9DDA340F291"><enum>(4)</enum><header>Amount of grant</header><text>The amount of a grant under paragraph (1) may not exceed $2,000,000, except in the case of eligible entity described in paragraph (2)(A)(iv).</text></paragraph> <paragraph id="H2A8B64C862AC40F89C40F0F3E631F60D"><enum>(5)</enum><header>High-throughput diagnostic equipment defined</header><text display-inline="yes-display-inline">In this subsection, the term <term>high-throughput diagnostic equipment</term> means legally marketed equipment and supplies capable of performing multichannel analysis for use in clinical laboratory diagnostic testing.</text></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="H96DE634CB7DB4AAC86C40AFFA537294B"><enum>(3)</enum><text>in subsection (c), as so redesignated—</text> <subparagraph id="HBDF7B87E26F248A4A017B3DB8EAAD7A9"><enum>(A)</enum><text>by redesignating paragraphs (1), (2), and (3) as subparagraphs (A), (B), and (C), respectively, and moving the margin of each such redesignated subparagraph 2 ems to the right;</text></subparagraph> <subparagraph id="HE459B727233D4C9C8A9A177382D2F487"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>There are authorized to be appropriated to carry out this section</quote> and inserting the following:</text> <quoted-block style="OLC" id="H2842973CF3E24F688E52E299548DBA2A" display-inline="no-display-inline"> <paragraph id="H5538312E66FE4F8B86808347A3E3515E"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">There are authorized to be appropriated to carry out subsection (a)</text></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph> <subparagraph id="H4A19BA9A86FB4DE7977E1C49FF9C053A"><enum>(C)</enum><text>by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="H61FAD98F00664C60A77BDB68D36D7022" display-inline="no-display-inline"> <paragraph id="HEC47B9490230401C880D0826D40B85DE"><enum>(2)</enum><header>Authorization of appropriations</header> <subparagraph id="H77A1A38E057341AD82654922FC035D67"><enum>(A)</enum><header>In general</header><text>For the purpose of carrying out subsection (b), there is authorized to be appropriated $250,000,000 for fiscal year 2021, to remain available until expended.</text></subparagraph> <subparagraph id="H59DD22264F0448508FF130FAC3697B8E"><enum>(B)</enum><header>Administrative expenses</header><text>Of the amount made available to carry out subsection (b) for any fiscal year, the Secretary may not use more than 5 percent of such amount for the expenses of administering subsection (b).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></section></subtitle> <subtitle id="HEF4F9E39E39C4E7295F43E5E5D12983F"><enum>D</enum><header>Rapid Testing for Communities</header> <section id="H2DB0A1862C074374B44BC9D15A5263B7" section-type="subsequent-section"><enum>4031.</enum><header>Grants for same-day point-of-care clinical laboratory diagnostic testing in communities</header><text display-inline="no-display-inline">Section 2821 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31</external-xref>) is amended—</text> <paragraph id="HEE3C0004F8494F7E926C7EE679A5055F"><enum>(1)</enum><text>by redesignating subsection (c), as redesignated by section 4021, as subsection (d);</text></paragraph> <paragraph id="HDA37DE204C0B425782962CA2662DF135"><enum>(2)</enum><text>by inserting after subsection (b), as added by section 4021, the following new subsection:</text> <quoted-block id="H6A480F5CD01E40ADB0172E77279ABF90" style="OLC"> <subsection id="H64BDE24B792D42E89DC79681BB323D5C"><enum>(c)</enum><header>Grants for same-Day point-of-Care clinical laboratory diagnostic testing in communities</header> <paragraph id="H90651C1DC35E4C04ADD107E1E15525EB"><enum>(1)</enum><header>Grants</header><text display-inline="yes-display-inline">The Secretary shall award grants to eligible entities to assist such entities in acquiring legally marketed equipment and supplies capable of performing same-day clinical laboratory diagnostic testing in a point-of-care setting.</text></paragraph> <paragraph id="H2C99C24BB9E645EC8EDDFCBD5EC9DDF8"><enum>(2)</enum><header>Eligibility</header><text>To be eligible for a grant under paragraph (1), an entity shall—</text> <subparagraph id="H6F1727A034B24288BCC189A875067CC8"><enum>(A)</enum><text>be—</text> <clause id="H61BDBDCC0E88482EA32F6B4DCE034FB7"><enum>(i)</enum><text>a hospital;</text></clause> <clause id="H351EE7BC063246A786E910F71586DF8C"><enum>(ii)</enum><text>a primary care facility;</text></clause> <clause id="H2FCA3328E14548DE8221EAAA88D5FF85"><enum>(iii)</enum><text>a clinic;</text></clause> <clause id="H08A7FA1167F3486299E78AEB28E3F37E"><enum>(iv)</enum><text>a physician; or</text></clause> <clause id="H319DE9AA7F194F62A2D926D00EABFFF7"><enum>(v)</enum><text>another type of health care provider as the Secretary may define; and</text></clause></subparagraph> <subparagraph id="H3C74BD3AB565482A9DB7C8B613DF71E5"><enum>(B)</enum><text>submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may reasonably require.</text></subparagraph></paragraph> <paragraph id="HBC473F56DA4E4C0C97F1368A665FEB92"><enum>(3)</enum><header>Use of funds</header><text display-inline="yes-display-inline">Amounts received through a grant under this subsection shall be used to purchase legally marketed rapid diagnostic equipment and such materials as are necessary to administer, store, and process same-day clinical laboratory diagnostic testing in a point-of-care setting, including diagnostic and serological tests.</text></paragraph> <paragraph id="H26996CF6B988401AAEA575791E7CFF55"><enum>(4)</enum><header>Amount of grant</header><text>The amount of a grant under paragraph (1) may not exceed $20,000.</text></paragraph> <paragraph id="H7730049BB7154E7783240C1A08F18BEA"><enum>(5)</enum><header>Priority in making awards</header><text>In awarding grants under paragraph (1), the Secretary shall give priority to eligible entities providing services to—</text> <subparagraph id="HC058E8D2871A4577808AD8C550214D15"><enum>(A)</enum><text>medically underserved populations (as defined in section 330(b)(3)) in rural areas; and</text></subparagraph> <subparagraph id="H37CB81FC9DEC4AFB90302B82B7D778CC"><enum>(B)</enum><text>all other areas.</text></subparagraph></paragraph></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="HCF6926E0601249C1B262EA1096459ED2"><enum>(3)</enum><text>by adding at the end of subsection (d), as redesignated, the following new paragraph:</text> <quoted-block style="OLC" id="H98027E4F4DAD45FBB1356E2A836409A5" display-inline="no-display-inline"> <paragraph id="HD5D65A2E14F5484EA863D306CE848E35"><enum>(3)</enum><header>Authorization of Appropriations</header> <subparagraph id="H9F2BB9C9F82441438405EB81F9A5D8C7"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">For the purpose of carrying out subsection (c), there is authorized to be appropriated $500,000,000 for fiscal year 2021, to remain available until expended.</text></subparagraph> <subparagraph id="HC13D0000DC5C4D25BF859F32DB403EAE"><enum>(B)</enum><header>Administrative expenses</header><text>Of the amount made available to carry out subsection (c) for any fiscal year, the Secretary may not use more than 5 percent of such amount for the expenses of administering this section.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section></subtitle> <subtitle id="H838D5AD49D3F4DB79F42A7AB55A36C15"><enum>E</enum><header>Public Health Workforce Loan Repayment</header> <section id="HD6E9F7F007E940F3A25C676EB784DC1B"><enum>4041.</enum><header>Public Health Workforce Loan Repayment Program</header><text display-inline="no-display-inline">Part D of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b">42 U.S.C. 254b</external-xref> et seq.), as amended by section 2031, is further amended by adding at the end the following new subpart:</text> <quoted-block style="OLC" id="H34DB8188D2144121BBD3B4908DCFA718" display-inline="no-display-inline"> <subpart id="H9107656EC1A647E78F7C4FF9F1897952"><enum>XIV</enum><header>Public Health Workforce</header> <section id="HD765ABA3B12E41D6AB83F935AB3C421E" commented="no"><enum>340K.</enum><header>Loan Repayment Program</header> <subsection id="HAB4930DDA2F34F72B763D72475CB36E4" commented="no"><enum>(a)</enum><header>Establishment</header><text>The Secretary of Health and Human Services shall establish a program to be known as the Public Health Workforce Loan Repayment Program (referred to in this section as the <quote>Program</quote>) to assure an adequate supply of and encourage recruitment of public health professionals to eliminate critical public health workforce shortages in local, State, and Tribal public health agencies.</text></subsection> <subsection id="HBFEE65DFFF7F429D9425E9C68C0351CC" commented="no"><enum>(b)</enum><header>Eligibility</header><text>To be eligible to participate in the Program, an individual shall—</text> <paragraph id="H1D7023AFDC73487781E86E8C439CFFA9" commented="no"><enum>(1)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="HF26FF468DD8747EAA21E7EEC9C5E3796"><enum>(A)</enum><text>be accepted for enrollment, or be enrolled, as a student in an accredited academic educational institution in a State or territory in the final year of a course of study or program leading to a public health or health professions degree or certificate and have accepted employment with a local, State, or Tribal public health agency, or a related training fellowship, as recognized by the Secretary, to commence upon graduation; or</text></subparagraph> <subparagraph id="HB09B17EF74144F809994FFAA3697CD44" indent="up1" commented="no"><enum>(B)</enum> <clause commented="no" display-inline="yes-display-inline" id="HAB4627C0D8B04EEAB3B066DCD991C831"><enum>(i)</enum><text>have graduated, during the preceding 10-year period, from an accredited educational institution in a State or territory and received a public health or health professions degree or certificate; and</text></clause> <clause id="H088C95DFF47547E3BAB13EB44FDBCD17" indent="up1" commented="no"><enum>(ii)</enum><text>be employed by, or have accepted employment with, a local, State, or Tribal public health agency or a related training fellowship, as recognized by the Secretary;</text></clause></subparagraph></paragraph> <paragraph id="H0BF96E89E0AD44188A1A0118DB16C104" commented="no"><enum>(2)</enum><text>be a United States citizen; </text></paragraph> <paragraph id="HE5F05A177CEB474FB892C9EA2FB9346A" commented="no"><enum>(3)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="H60A1C91A9FA8431789375C9C4C421711"><enum>(A)</enum><text>submit an application to the Secretary to participate in the Program; and</text></subparagraph> <subparagraph id="H8F0E857CBB7A4778AA0466BE19D9C17D" indent="up1" commented="no"><enum>(B)</enum><text>execute a written contract as required in subsection (c); and</text></subparagraph></paragraph> <paragraph id="HC55A701D430F4E63AC82C259374A5F54" commented="no"><enum>(4)</enum><text display-inline="yes-display-inline">not have received, for the same service, a reduction of loan obligations under section 428J, 428K, 428L, 455(m), or 460 of the Higher Education Act of 1965 (<external-xref legal-doc="usc" parsable-cite="usc/20/1078-10">20 U.S.C. 1078–10</external-xref>, 1078–11, 1078–12, 1087e(m), and 1087j).</text></paragraph></subsection> <subsection id="H14A91AC875DD466FBF6B8DB77B20D93B" commented="no"><enum>(c)</enum><header>Contract</header><text>The written contract referred to in subsection (b)(3)(B) between the Secretary and an individual shall contain—</text> <paragraph id="H65D98F0FD50E432682CD37D15407F6B4" commented="no"><enum>(1)</enum><text>an agreement on the part of the Secretary that the Secretary will repay, on behalf of the individual, loans incurred by the individual in the pursuit of the relevant degree or certificate in accordance with the terms of the contract;</text></paragraph> <paragraph id="H81AB8DD4216C4DAD84B45EECC1075ABA" commented="no"><enum>(2)</enum><text>an agreement on the part of the individual that the individual will serve in the full-time employment of a local, State, or Tribal public health agency or a related fellowship program in a position related to the course of study or program for which the contract was awarded for a period of time equal to the greater of—</text> <subparagraph id="H1AE86665004C4F0A8E1505574231AEBB" commented="no"><enum>(A)</enum><text>3 years; or</text></subparagraph> <subparagraph id="HF087A7C1819E48528C72392C40C78E36" commented="no"><enum>(B)</enum><text>such longer period of time as determined appropriate by the Secretary and the individual;</text></subparagraph></paragraph> <paragraph id="H562FD80D7E924F4582ECB1368122CA1B" commented="no"><enum>(3)</enum><text>an agreement, as appropriate, on the part of the individual to relocate to a priority service area (as determined by the Secretary) in exchange for an additional loan repayment incentive amount to be determined by the Secretary;</text></paragraph> <paragraph id="H960801B72F97451880FDD614BDDAA236" commented="no"><enum>(4)</enum><text>a provision that any financial obligation of the United States arising out of a contract entered into under this section and any obligation of the individual that is conditioned thereon, is contingent on funds being appropriated for loan repayments under this section;</text></paragraph> <paragraph id="HCE9CF28279AD41A199EB507A17B65FE1" commented="no"><enum>(5)</enum><text>a statement of the damages to which the United States is entitled, under this section for the individual’s breach of the contract; and</text></paragraph> <paragraph id="HA56999FEF7DB472F8CF73D444FEB0D9D" commented="no"><enum>(6)</enum><text>such other statements of the rights and liabilities of the Secretary and of the individual as the Secretary determines appropriate, not inconsistent with this section.</text></paragraph></subsection> <subsection id="HBB7ED305943B4A39AA6BC972DB9CDFA4" commented="no"><enum>(d)</enum><header>Payments</header> <paragraph id="H163C2CCAD9664C11A24F53F5124019C6" commented="no"><enum>(1)</enum><header>In general</header><text>A loan repayment provided for an individual under a written contract referred to in subsection (b)(3)(B) shall consist of payment, in accordance with paragraph (2), on behalf of the individual of the principal, interest, and related expenses on government and commercial loans received by the individual regarding the undergraduate or graduate education of the individual (or both), which loans were made for tuition expenses incurred by the individual.</text></paragraph> <paragraph id="HC05E897C21024E7F86BE50D9EE211BC3" commented="no"><enum>(2)</enum><header>Payments for years served</header><text>For each year of service that an individual contracts to serve pursuant to subsection (c)(2), the Secretary may pay not more than $35,000 on behalf of the individual for loans described in paragraph (1). With respect to participants under the Program whose total eligible loans are less than $105,000, the Secretary shall pay an amount that does not exceed ⅓ of the eligible loan balance for each year of such service of such individual.</text></paragraph> <paragraph id="HB5251F2EEF55488F9760E48F176CB298" commented="no"><enum>(3)</enum><header>Tax liability</header><text>For the purpose of providing reimbursements for tax liability resulting from payments under paragraph (2) on behalf of an individual, the Secretary shall, in addition to such payments, make payments to the individual in an amount not to exceed 39 percent of the total amount of loan repayments made for the taxable year involved.</text></paragraph></subsection> <subsection id="HE7D9BE13EEE740D6967FAB810E63EA4F" commented="no"><enum>(e)</enum><header>Postponing obligated service</header><text>With respect to an individual receiving a degree or certificate from a health professions or other related school, the date of the initiation of the period of obligated service may be postponed as approved by the Secretary.</text></subsection> <subsection id="H8A67CD57F0874F6391782D149F3C2AF4" commented="no"><enum>(f)</enum><header>Breach of contract</header><text>An individual who fails to comply with the contract entered into under subsection (c) shall be subject to the same financial penalties as provided for under section 338E of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254o">42 U.S.C. 254o</external-xref>) for breaches of loan repayment contracts under section 338B of such Act (42 U.S.C. section 254l–1).</text></subsection> <subsection id="H281C64D30CC54F8F85A149D5C7958DAC" commented="no"><enum>(g)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated to carry out this section—</text> <paragraph id="HC3C71F34F0234B6B9D003A3BD98C966C" commented="no"><enum>(1)</enum><text>$100,000,000 for fiscal year 2021; and</text></paragraph> <paragraph id="H6FA7D45E47264D558D522A76CDDC8C54" commented="no"><enum>(2)</enum><text>$75,000,000 for each of fiscal years 2022 through 2026.</text></paragraph></subsection></section></subpart><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H01F21E99A95D46BBAB1F2E19CC28DDA2"><enum>F</enum><header>Vaccine Awareness and Disease Prevention</header> <section id="H8EB207AF3C80442E957CFCEEE9E66F85"><enum>4051.</enum><header>Improving awareness of disease prevention</header> <subsection id="H7A6812BBF4944A3798D67558ED5D3262"><enum>(a)</enum><header>In general</header><text>The Public Health Service Act is amended by striking section 313 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/245">42 U.S.C. 245</external-xref>) and inserting the following:</text> <quoted-block id="HA4AECAD9425742CBAD16926E0B776433" style="OLC"> <section id="H86E9B4C93CE049D19728AAE5C4734690"><enum>313.</enum><header>Public awareness campaign on the importance of vaccinations</header> <subsection id="H5918CA14E36449C493110E8AF98FBCD8"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other offices and agencies, as appropriate, shall award competitive grants or contracts to one or more public or private entities to carry out a national, evidence-based campaign to increase awareness and knowledge of the safety and effectiveness of vaccines for the prevention and control of diseases, combat misinformation about vaccines, and disseminate scientific and evidence-based vaccine-related information, with the goal of increasing rates of vaccination across all ages, as applicable, particularly in communities with low rates of vaccination, to reduce and eliminate vaccine-preventable diseases.</text></subsection> <subsection id="H43820950E31148E18F8F7DF8D6BD0830"><enum>(b)</enum><header>Consultation</header><text>In carrying out the campaign under this section, the Secretary shall consult with appropriate public health and medical experts, including the National Academy of Medicine and medical and public health associations and nonprofit organizations, in the development, implementation, and evaluation of the evidence-based public awareness campaign.</text></subsection> <subsection id="H58D3B91C66EC443FA2730C951ADAC950"><enum>(c)</enum><header>Requirements</header><text>The campaign under this section shall—</text> <paragraph id="H30B251E69442457B8E6EBA5527AF04F0"><enum>(1)</enum><text>be a nationwide, evidence-based media and public engagement initiative;</text></paragraph> <paragraph id="HE599F6B459994737B84177F7AC37E223"><enum>(2)</enum><text>include the development of resources for communities with low rates of vaccination, including culturally and linguistically appropriate resources, as applicable;</text></paragraph> <paragraph id="H526596F367974A81B810FABE18B85410"><enum>(3)</enum><text>include the dissemination of vaccine information and communication resources to public health departments, health care providers, and health care facilities, including such providers and facilities that provide prenatal and pediatric care;</text></paragraph> <paragraph id="HD6D949814E764C20A6FC4ABD54880D2F"><enum>(4)</enum><text>be complementary to, and coordinated with, any other Federal, State, local, or Tribal efforts, as appropriate; and</text></paragraph> <paragraph id="H12B74BF7DAC045EF9986222EA62A632D"><enum>(5)</enum><text>assess the effectiveness of communication strategies to increase rates of vaccination.</text></paragraph></subsection> <subsection id="H8106B67469B14A12B3E5EDCFCE28AC91"><enum>(d)</enum><header>Additional activities</header><text>The campaign under this section may—</text> <paragraph id="H01F02AD73EF949B486BD254B54B05914"><enum>(1)</enum><text>include the use of television, radio, the internet, and other media and telecommunications technologies;</text></paragraph> <paragraph id="HE432611CECAF438EB8F3110AE697BD2A"><enum>(2)</enum><text>include the use of in-person activities;</text></paragraph> <paragraph id="H8DB965512B42402B99718850AA6B704A"><enum>(3)</enum><text>be focused to address specific needs of communities and populations with low rates of vaccination; and</text></paragraph> <paragraph id="H6EA0E76D629A41C490D114D52BC21B18"><enum>(4)</enum><text>include the dissemination of scientific and evidence-based vaccine-related information, such as—</text> <subparagraph id="H7590C4228623422FB907221C898C62EC"><enum>(A)</enum><text>advancements in evidence-based research related to diseases that may be prevented by vaccines and vaccine development;</text></subparagraph> <subparagraph id="HA3874048E25F41AC931496BD80FFA3D6"><enum>(B)</enum><text>information on vaccinations for individuals and communities, including individuals for whom vaccines are not recommended by the Advisory Committee for Immunization Practices, and the effects of low vaccination rates within a community on such individuals;</text></subparagraph> <subparagraph id="HEFE133BE2E9A4C74BA934030350CC0CA"><enum>(C)</enum><text>information on diseases that may be prevented by vaccines; and</text></subparagraph> <subparagraph id="H1E206A5E4DDA4C4E9F6A61875BD38817"><enum>(D)</enum><text>information on vaccine safety and the systems in place to monitor vaccine safety.</text></subparagraph></paragraph></subsection> <subsection id="HEA89372D944A4F25AF976248CBEE7632"><enum>(e)</enum><header>Evaluation</header><text>The Secretary shall—</text> <paragraph id="H69F62FF0C2A247E28B42A7694B4E9A77"><enum>(1)</enum><text>establish benchmarks and metrics to quantitatively measure and evaluate the awareness campaign under this section;</text></paragraph> <paragraph id="HBA0F4D33E8A8438D83662C1EADB52827"><enum>(2)</enum><text>conduct qualitative assessments regarding the awareness campaign under this section; and</text></paragraph> <paragraph id="H7F7C4C85D8E9405695EFE51E1D9868C5"><enum>(3)</enum><text>prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives an evaluation of the awareness campaign under this section.</text></paragraph></subsection> <subsection id="HD42EA0875130446EA111B024904FA8B0"><enum>(f)</enum><header>Supplement not supplant</header><text>Funds appropriated under this section shall be used to supplement and not supplant other Federal, State, and local public funds provided for activities described in this section.</text></subsection> <subsection id="H3E12D06F93784911A19F407990241C6D"><enum>(g)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section and subsections (k) and (n) of section 317 $10,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H1E46E31EB88346188E65F3A343A72FB7"><enum>(b)</enum><header>Grants To address vaccine-Preventable diseases</header><text>Section 317 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b">42 U.S.C. 247b</external-xref>) is amended—</text> <paragraph id="HE071F7F7A77746E8B4F4E1F521F5B906"><enum>(1)</enum><text>in subsection (k)(1)—</text> <subparagraph id="H28F74C1F2DE040F386A2F58EC4D43737"><enum>(A)</enum><text>in subparagraph (C), by striking <quote>; and</quote> and inserting a semicolon;</text></subparagraph> <subparagraph id="H30476E43161640729B5D8A1655B17830"><enum>(B)</enum><text>in subparagraph (D), by striking the period and inserting a semicolon; and</text></subparagraph> <subparagraph id="H325DBDE2C89843CF9A4EEE5874A28FED"><enum>(C)</enum><text>by adding at the end the following:</text> <quoted-block id="HE0748DB69D0A49A2AFB631086E27E5A1" style="OLC"> <subparagraph id="H465ECB0ED9A74742BC392A872AAC243B"><enum>(E)</enum><text>planning, implementation, and evaluation of activities to address vaccine-preventable diseases, including activities to—</text> <clause id="H8BCC583413FD45669E94B64E5889B389"><enum>(i)</enum><text>identify communities at high risk of outbreaks related to vaccine-preventable diseases, including through improved data collection and analysis;</text></clause> <clause id="HEECFD604AC52465AA4C4625D88443233"><enum>(ii)</enum><text>pilot innovative approaches to improve vaccination rates in communities and among populations with low rates of vaccination;</text></clause> <clause id="H77F9C2360F2C4648A5917AD1D94DCE41"><enum>(iii)</enum><text>reduce barriers to accessing vaccines and evidence-based information about the health effects of vaccines;</text></clause> <clause id="HC291DB590BB14138977C81902D28E812"><enum>(iv)</enum><text>partner with community organizations and health care providers to develop and deliver evidence-based interventions, including culturally and linguistically appropriate interventions, to increase vaccination rates;</text></clause> <clause id="HBEB41F4F1BB7404CB7EA38B6FF0AA271"><enum>(v)</enum><text>improve delivery of evidence-based, vaccine-related information to parents and others; and</text></clause> <clause id="H2A4593FF0195411EA03A7C5CF60366D6"><enum>(vi)</enum><text>improve the ability of State, local, Tribal, and territorial public health departments to engage communities at high risk for outbreaks related to vaccine-preventable diseases, in coordination, as appropriate, with local educational agencies, as defined in section 8101 of the Elementary and Secondary Education Act of 1965; and</text></clause></subparagraph> <subparagraph id="H5E532C94D2814F178761FCD825D37C70"><enum>(F)</enum><text>research related to strategies for improving awareness of scientific and evidence-based, vaccine-related information, including for communities with low rates of vaccination, in order to understand barriers to vaccination, improve vaccination rates, and assess the public health outcomes of such strategies.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="HDFAE6956F3094F599580F7ADFB9298EA"><enum>(2)</enum><text>by adding at the end the following:</text> <quoted-block id="H6137B89239444C56B3CF831E60A3B9B6" style="OLC"> <subsection id="HE7005B9A53A545B58D89756B3051883F"><enum>(n)</enum><header>Vaccination data</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall expand and enhance, and, as appropriate, establish and improve, programs and conduct activities to collect, monitor, and analyze vaccination coverage data to assess levels of protection from vaccine-preventable diseases, including by assessing factors contributing to underutilization of vaccines and variations of such factors, and identifying communities at high risk of outbreaks associated with vaccine-preventable diseases.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HAED156232A1A412FAEC4A1BF4793EB17"><enum>(c)</enum><header>Supplemental grant funds</header><text>Section 330(d)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b">42 U.S.C. 254b</external-xref>) is amended—</text> <paragraph id="H56ECBD43B439448F8F96AAA6260AADB0"><enum>(1)</enum><text>in subparagraph (F), by striking <quote>and</quote> at the end;</text></paragraph> <paragraph id="H51B72AF7699C4A61AAA8AF1A5AB9AC6A"><enum>(2)</enum><text>in subparagraph (G), by striking the period and inserting <quote>; and</quote>; and</text></paragraph> <paragraph id="H95156651781F4E88A1E48EC4AD0FF660"><enum>(3)</enum><text>by adding at the end the following:</text> <quoted-block id="HC153236306B3473F8BC23D211409A14E" style="OLC"> <subparagraph id="H7BE802F1886B4440BB121B9BAB628A3D"><enum>(H)</enum><text>improving access to recommended immunizations.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H96B3716DA86042889E2C4035F5B5F723"><enum>(d)</enum><header>Update of 2015 NVAC report</header><text>The National Vaccine Advisory Committee established under section 2105 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-5">42 U.S.C. 300aa–5</external-xref>) shall, as appropriate, update the report entitled, <quote>Assessing the State of Vaccine Confidence in the United States: Recommendations from the National Vaccine Advisory Committee</quote>, approved by the National Vaccine Advisory Committee on June 10, 2015, with respect to factors affecting childhood vaccination.</text></subsection></section></subtitle> <subtitle id="H7744C4C8E090452380028D4D1963634D"><enum>G</enum><header>Protecting the Health of America’s Older Adults During COVID–19 & Beyond</header> <section id="H5EA90325F55546E881595706E74783CC"><enum>4061.</enum><header>National COVID–19 Resource Center for Older Adults</header> <subsection id="HB744B89533A64F9799F3A851597E18EF"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services (in this subtitle referred to as the <quote>Secretary</quote>) shall establish within the Office of the Assistant Secretary for Health a National COVID–19 Resource Center for Older Adults (in this section referred to as the <quote>Center</quote>) to identify, curate, and disseminate, promising and proven practices and tools for the care of older adults in their homes, community-based care settings, hospitals, and nursing and acute care facilities.</text></subsection> <subsection id="HCF57F2C6082740E0A9B1F7E067BAA5EF"><enum>(b)</enum><header>Involvement by Federal departments and all levels of government</header><text display-inline="yes-display-inline">The Center shall—</text> <paragraph id="H554FB3DB693E466AA975F4841ECB9F68"><enum>(1)</enum><text>be advised by a team of senior officials from—</text> <subparagraph id="H5407B747613C45F2A6F9210FFD3375C6"><enum>(A)</enum><text>agencies across the Department of Health and Human Services, including the Administration for Community Living (including the Administration on Aging), the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Health Resources and Services Administration, the Indian Health Service, and the Office of Minority Health in the Office of the Secretary; and</text></subparagraph> <subparagraph id="HB73F0D6B0972493EA3E167014010CBF1"><enum>(B)</enum><text>other Federal departments, including the Department of Housing and Urban Development and the Department of Veterans Affairs; and</text></subparagraph></paragraph> <paragraph id="H29130B00D2C64FC5B1668C7FA7CDE9C0" commented="no"><enum>(2)</enum><text>collaborate with State and local governments, Indian tribes and Tribal organizations, and nonprofit organizations.</text></paragraph></subsection> <subsection id="HF37F3E3A7DFF4637907F68E9EA5EC6DB"><enum>(c)</enum><header>Activities</header><text>The Center shall perform the following activities:</text> <paragraph id="H42E9E1DA079C47E48EEB46A382978CB0"><enum>(1)</enum><text>Develop a set of best practices for older adult health and well-being during and beyond the period of the COVID–19 pandemic, including such best practices with respect to the following focus areas:</text> <subparagraph id="HA6310FA878A04A788E2F612CBCC6ECE7"><enum>(A)</enum><text>Providing specialized services to overcome the risks associated with social isolation, such as additional resources for home-delivered meals and other nutrition programs to provide not only food but also face-to-face interactions.</text></subparagraph> <subparagraph id="H0981BBADA9824DC5A279A2BFDAE5AACC"><enum>(B)</enum><text>Streamlining and improving access to screening, testing, and health care services and resources, and prioritizing venues older adults can reach.</text></subparagraph> <subparagraph id="H98D90E08280E4BE5A81CE37303795200"><enum>(C)</enum><text>Expanding the use of telemedicine, including the provision of technology to execute televisits that safely and comprehensively address older adults’ health care needs.</text></subparagraph> <subparagraph id="HDD670293AB00434A8DAECC1B847C4746"><enum>(D)</enum><text>Supporting family caregivers, including those with additional responsibilities for homebound individuals.</text></subparagraph> <subparagraph id="H533FAA3555934763AAC288E7EEB54B01"><enum>(E)</enum><text display-inline="yes-display-inline">Reducing disparities among underserved populations.</text></subparagraph> <subparagraph id="H4108A75C2C374FA5B70A2C60887BFB88"><enum>(F)</enum><text>Developing cross-sector collaborative efforts.</text></subparagraph></paragraph> <paragraph id="H0983F0AE2BC04A8194A567C8963B0229"><enum>(2)</enum><text display-inline="yes-display-inline">Create and disseminate tools, technical assistance, training, and funding to State, local, Tribal, and territorial governments to adopt best practices developed under subparagraphs (E) and (F) of paragraph (1).</text></paragraph> <paragraph id="H74C687659BE742D59DBFD351EF08CCE8" commented="no"><enum>(3)</enum><text display-inline="yes-display-inline">Establish mechanisms for providing training and technical assistance to State, local, Tribal, and territorial governments to ensure that complementary cross-sector activities are replicated at the State, local, Tribal, and territorial levels.</text></paragraph> <paragraph id="HE154883F4E6E4E8DA35EC8660794E90D"><enum>(4)</enum><text>Facilitate the development of learning networks of practitioners at the hospital, nursing facility, and community levels to disseminate the best practices developed under paragraph (1) and ensure implementation of such best practices to reduce morbidity and mortality of older adults affected by COVID–19.</text></paragraph> <paragraph id="H2D5A38BC9F1649428A6F42FAC31EB899"><enum>(5)</enum><text>Identify and disseminate approaches that strengthen public health and health care system capacity to serve older Americans with regard to health issues during and beyond the COVID–19 pandemic.</text></paragraph></subsection></section> <section id="H3B766C5992174011AF059312B6BA0F1B"><enum>4062.</enum><header>Healthy Aging Program</header> <subsection id="HD4F8FD329AFA4F00A9CBCE5078D65E09"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a Healthy Aging Program for the purpose of promoting the health and well-being of older adults by—</text> <paragraph id="HFCE6EB1BF2184BABBC2050C978339416"><enum>(1)</enum><text>improving the coordination of public health interventions that promote the health and well-being of older adults;</text></paragraph> <paragraph id="H43EFF1CE92B6415F9D06A9C340577670"><enum>(2)</enum><text>disseminating and implementing evidence-based best practices and programs with respect to promoting the health and well-being of older adults; and</text></paragraph> <paragraph id="HEDDA6FE08C55407AB605188C2FCBF5CB"><enum>(3)</enum><text>coordinating multisectoral efforts to promote the health and well-being of older adults across governmental and nongovernmental health and related agencies.</text></paragraph></subsection> <subsection id="H33143B4E26F94F4F8573A690DF3FADFF"><enum>(b)</enum><header>Activities</header><text>For the purpose described in subsection (a), the Secretary shall design the Healthy Aging Program to carry out the following activities:</text> <paragraph id="H297EFB438F2B4755A4C6B0F55ACCF4EE"><enum>(1)</enum><text display-inline="yes-display-inline">Regularly assess the health-related needs of older adults and promote policies addressing those needs through evidence-based public health interventions to promote overall health and well-being among older adults and reduce health care costs.</text></paragraph> <paragraph id="H266F8F40D9B142B39CE91F694AD81418"><enum>(2)</enum><text>Identify disparities in health among vulnerable populations of older adults.</text></paragraph> <paragraph id="HBEECFFA6D917472E8EC6A094F033E7D1"><enum>(3)</enum><text>Identify gaps in existing public health programs and policies that focus on older adults.</text></paragraph> <paragraph id="HEBD72CE906AF4FCABDC735F535DAA30B"><enum>(4)</enum><text>Promote public health partnerships with aging and other sector stakeholders to ensure nonduplication of efforts and increase efficiency by working collaboratively across sectors.</text></paragraph> <paragraph id="HDE753E9FCE744B60ACB1E1E809BCBACF"><enum>(5)</enum><text>Work with multisectoral agencies to improve emergency preparedness plans and activities for vulnerable older adult populations.</text></paragraph> <paragraph id="H6A718B1EAB6344F7B5451C7873ED955E"><enum>(6)</enum><text>Coordinate efforts to promote the health of older adults with the Administration for Community Living, other Federal departments and agencies, and nonprofit organizations.</text></paragraph> <paragraph id="HA8F7085209E847319F65C6C454421797"><enum>(7)</enum><text>Identify resources and evidence-based programs available to local and State health departments, including resources and programs that could be coordinated across sectors, to address the health and well-being of older adults.</text></paragraph></subsection> <subsection id="HCD17281A75314E3ABC78D4A3350092CC"><enum>(c)</enum><header>Grants to health departments</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants or cooperative agreements to eligible health departments to carry out any of the following activities:</text> <paragraph id="H3B0E7714F05D4CFC9B8E7C9852B4C2A9"><enum>(1)</enum><text>Improving availability of data on the older adult population, including through data-sharing with elder affairs agencies.</text></paragraph> <paragraph id="HCCEE6F8872A34FF587FEBCCCDEC0B78C"><enum>(2)</enum><text>Linking the health care sector with the community services sector (including aging services and supports) to coordinate and promote community-based prevention services.</text></paragraph> <paragraph id="H16CAD48488874E35B1E94065E4A879AE"><enum>(3)</enum><text>Ensuring that State and local emergency preparedness plans and activities address the special needs of older adults, particularly the most vulnerable populations.</text></paragraph> <paragraph id="HF766EB01B27E49128C4E75E59E338012"><enum>(4)</enum><text>Training State and local public health personnel to implement or adapt evidence-based and innovative health promotion and disease prevention programs and policies.</text></paragraph> <paragraph id="H21C660502D1843FD809ADD6305B6BA64"><enum>(5)</enum><text>Improving community conditions and addressing social determinants to promote health and well-being and foster independence among older adults, such as efforts to advance age-friendly communities and dementia-friendly communities.</text></paragraph></subsection> <subsection id="HFAB795C9BFF54284B1AE9A8445DD53C3"><enum>(d)</enum><header>Technical assistance</header><text>The Secretary shall (directly or through grants, cooperative agreements, or contracts) provide technical assistance to eligible health departments in carrying out activities described in subsection (c).</text></subsection> <subsection id="H56F219EFDDB842D6881682B4207A7230"><enum>(e)</enum><header>Evaluations</header><text>The Secretary shall (directly or through grants, cooperative agreements, or contracts) provide for the evaluation of activities carried out under subsections (a), (b), and (c) in order to determine the extent to which such activities have been effective in carrying out the purpose described in subsection (a), including the effects of such activities on addressing health disparities.</text></subsection> <subsection id="HBC612401653D461F895368AC81223A96"><enum>(f)</enum><header>Definition</header><text display-inline="yes-display-inline">In this section, the term <term>eligible health department</term> means a health department of a State, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, a Tribe (as defined in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>)), or a large city (as defined by the Director of the Centers for Disease Control and Prevention for purposes of this section).</text></subsection></section> <section id="HAA180193ED654830A6B5BCA7CA562EB8"><enum>4063.</enum><header>Authorization of appropriations</header><text display-inline="no-display-inline">There is authorized to be appropriated—</text> <paragraph id="H0B777C3BDB3342FF99D0013F3326D669"><enum>(1)</enum><text display-inline="yes-display-inline">$10,000,000 for the period of fiscal years 2021 through 2025 to carry out section 4061, to remain available until September 30, 2025; and</text></paragraph> <paragraph id="H994C8AF585B54841BDD443E03353E457"><enum>(2)</enum><text>$20,000,000 for each of fiscal years 2021 through 2025 to carry out section 4062, including for grants under section 4062(c), to remain available until September 30, 2025.</text></paragraph></section></subtitle> <subtitle id="H812F13342AA8468497F4F7DB66DE8A23"><enum>H</enum><header>Expanding Capacity for Health Outcomes</header> <section id="H239C9DDE60B24E879C886A602E6E4AF0"><enum>4071.</enum><header>Expanding capacity for health outcomes</header><text display-inline="no-display-inline">Title III of the Public Health Service Act is amended by inserting after section 330M (<external-xref legal-doc="usc" parsable-cite="usc/42/254c-19">42 U.S.C. 254c–19</external-xref>) the following:</text> <quoted-block id="H30C8D092FB2A492A9D384DB300CC902C" style="OLC"> <section id="H8FC182CDC8D747FF83FB57938C9B20B8"><enum>330N.</enum><header>Expanding capacity for health outcomes</header> <subsection id="H959C5163BD094BA1A33C8316136386C9"><enum>(a)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HD2AA7382FC064D7686DB62FD79A0BAFD"><enum>(1)</enum><header>Eligible entity</header><text>The term <term>eligible entity</term>—</text> <subparagraph id="HC02090A8DC8D483B88AA24D695A92508"><enum>(A)</enum><text>means an entity that provides, or supports the provision of, health care services—</text> <clause id="H8443259ED585404BAA2547BC78CB7AB1"><enum>(i)</enum><text>in rural areas, frontier areas, health professional shortage areas, or medically underserved areas; or</text></clause> <clause id="HFEEFDA8AC2D344BAAB24AA460F8AED10"><enum>(ii)</enum><text>to medically underserved populations or Native Americans, including Indian Tribes, Tribal organizations, or urban Indian organizations; and</text></clause></subparagraph> <subparagraph id="H813D3181A77B4ECD81828608AD5A1745"><enum>(B)</enum><text>may include entities leading, or capable of leading, a technology-enabled collaborative learning and capacity building model or engaging in technology-enabled collaborative training of participants in such model.</text></subparagraph></paragraph> <paragraph id="HFD1579982C7247188BD371F3ABD39E97"><enum>(2)</enum><header>Health professional shortage area</header><text>The term <term>health professional shortage area</term> means a health professional shortage area designated under section 332.</text></paragraph> <paragraph id="H4993AF1461884F0EBF8EF293101AC074"><enum>(3)</enum><header>Indian tribe</header><text>The terms <term>Indian Tribe</term> and <term>Tribal organization</term> have the meanings given the terms <term>Indian tribe</term> and <term>tribal organization</term> in section 4 of the Indian Self-Determination and Education Assistance Act.</text></paragraph> <paragraph id="H9361B560A2DA46839BD1B2343A459083"><enum>(4)</enum><header>Medically underserved population</header><text>The term <term>medically underserved population</term> has the meaning given the term in section 330(b)(3).</text></paragraph> <paragraph id="HF7B574AC016541ED88E21CB1B89265EA"><enum>(5)</enum><header>Native Americans</header><text>The term <term>Native Americans</term> has the meaning given such term in section 736 and includes Indian Tribes and Tribal organizations.</text></paragraph> <paragraph id="HE93898A89B4847FA989C2197C82670F3"><enum>(6)</enum><header>Technology-enabled collaborative learning and capacity building model</header><text>The term <term>technology-enabled collaborative learning and capacity building model</term> means a distance health education model that connects health care professionals, and particularly specialists, with multiple other health care professionals through simultaneous interactive videoconferencing for the purpose of facilitating case-based learning, disseminating best practices, and evaluating outcomes.</text></paragraph> <paragraph id="HC8205209938342DE9CA7680C40DC3248"><enum>(7)</enum><header>Urban Indian organization</header><text display-inline="yes-display-inline">The <quote>urban Indian organization</quote> has the meaning given the term <term>Urban Indian organization</term> in section 4 of the Indian Health Care Improvement Act.</text></paragraph></subsection> <subsection id="H0BE627FBD47A455AAA835E371C91517D"><enum>(b)</enum><header>Program established</header><text>The Secretary shall, as appropriate, award grants to evaluate, develop, and, as appropriate, expand the use of technology-enabled collaborative learning and capacity building models, to improve retention of health care providers and increase access to health care services, such as those to address chronic diseases and conditions, infectious diseases, mental health, substance use disorders, prenatal and maternal health, pediatric care, pain management, palliative care, and other specialty care in rural areas, frontier areas, health professional shortage areas, or medically underserved areas and for medically underserved populations or Native Americans, including Indian Tribes and Tribal organizations.</text></subsection> <subsection id="HE266A232FA954F2590EA63BF7BE81FB4"><enum>(c)</enum><header>Use of funds</header> <paragraph id="HB703B3ACD5EA40AF913EAB7F5D6400F9"><enum>(1)</enum><header>In general</header><text>Grants awarded under subsection (b) shall be used for—</text> <subparagraph id="HEA4AF30261DA4401B68B24DAD9070B43"><enum>(A)</enum><text>the development and acquisition of instructional programming, and the training of health care providers and other professionals that provide or assist in the provision of services through models described in subsection (b), such as training on best practices for data collection and leading or participating in such technology-enabled activities consistent with technology-enabled collaborative learning and capacity building models;</text></subparagraph> <subparagraph id="HF6EE3C95B9F24CE683616146AAC51F8E"><enum>(B)</enum><text>information collection and evaluation activities to study the impact of such models on patient outcomes and health care providers, and to identify best practices for the expansion and use of such models; or</text></subparagraph> <subparagraph id="HF3C4BC0DB6AC4B268E22D16B61034E12"><enum>(C)</enum><text>other activities consistent with achieving the objectives of the grants awarded under this section, as determined by the Secretary.</text></subparagraph></paragraph> <paragraph id="H4860CC72EAC740D89420048D20BA3BD8"><enum>(2)</enum><header>Other uses</header><text>In addition to any of the uses under paragraph (1), grants awarded under subsection (b) may be used for—</text> <subparagraph id="HBA1C402D39BF47068C52A190D0B97724"><enum>(A)</enum><text>equipment to support the use and expansion of technology-enabled collaborative learning and capacity building models, including for hardware and software that enables distance learning, health care provider support, and the secure exchange of electronic health information; or</text></subparagraph> <subparagraph id="HD7AC504FC12043B48E01EDE08F024E76"><enum>(B)</enum><text>support for health care providers and other professionals that provide or assist in the provision of services through such models.</text></subparagraph></paragraph></subsection> <subsection id="H853EF5BC1D394B858B0017079B87863D"><enum>(d)</enum><header>Length of grants</header><text>Grants awarded under subsection (b) shall be for a period of up to 5 years.</text></subsection> <subsection id="H27C04C0B04A847AEBAB0C08C2A271B75"><enum>(e)</enum><header>Grant requirements</header><text>The Secretary may require entities awarded a grant under this section to collect information on the effect of the use of technology-enabled collaborative learning and capacity building models, such as on health outcomes, access to health care services, quality of care, and provider retention in areas and populations described in subsection (b). The Secretary may award a grant or contract to assist in the coordination of such models, including to assess outcomes associated with the use of such models in grants awarded under subsection (b), including for the purpose described in subsection (c)(1)(B).</text></subsection> <subsection id="H8C0E0477E1E74064B7A95BAB305F0A76"><enum>(f)</enum><header>Application</header><text>An eligible entity that seeks to receive a grant under subsection (b) shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require. Such application shall include plans to assess the effect of technology-enabled collaborative learning and capacity building models on patient outcomes and health care providers.</text></subsection> <subsection id="HD7E5255A456D4938BDB1483BC0A6FFCD"><enum>(g)</enum><header>Access to broadband</header><text>In administering grants under this section, the Secretary may coordinate with other agencies to ensure that funding opportunities are available to support access to reliable, high-speed internet for grantees.</text></subsection> <subsection id="H1AEC182AD0B344249D77FE96B82E79D5"><enum>(h)</enum><header>Technical assistance</header><text>The Secretary shall provide (either directly through the Department of Health and Human Services or by contract) technical assistance to eligible entities, including recipients of grants under subsection (b), on the development, use, and evaluation of technology-enabled collaborative learning and capacity building models in order to expand access to health care services provided by such entities, including for medically underserved areas and to medically underserved populations or Native Americans, including Indian Tribes and Tribal organizations.</text></subsection> <subsection id="H0E2C662E2C964D29BA151B3719BEC4E8"><enum>(i)</enum><header>Research and evaluation</header><text>The Secretary, in consultation with stakeholders with appropriate expertise in such models, shall develop a strategic plan to research and evaluate the evidence for such models. The Secretary shall use such plan to inform the activities carried out under this section.</text></subsection> <subsection id="HA99516D88D8A41008BAE939DD820AD8D"><enum>(j)</enum><header>Report by Secretary</header><text>Not later than 4 years after the date of enactment of this section, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and post on the internet website of the Department of Health and Human Services, a report including, at minimum—</text> <paragraph id="H8784BAB66772458CA669D75FAE33A8BA"><enum>(1)</enum><text>a description of any new and continuing grants awarded to entities under subsection (b) and the specific purpose and amounts of such grants;</text></paragraph> <paragraph id="H0088FEC9675949FDBFF4538FDCD5B9CB"><enum>(2)</enum><text>an overview of—</text> <subparagraph commented="no" id="H58F58B5F2911406B9AB024FC97796450"><enum>(A)</enum><text>the evaluations conducted under subsection (b);</text></subparagraph> <subparagraph id="HC7A30883E350424C8FD64CF98481AC06"><enum>(B)</enum><text>technical assistance provided under subsection (h); and</text></subparagraph> <subparagraph id="HC737559E026C42D3B609B9A7D45D70CC"><enum>(C)</enum><text>activities conducted by entities awarded grants under subsection (b); and</text></subparagraph></paragraph> <paragraph id="HABE7769D61E247E4B8282055637BD353"><enum>(3)</enum><text display-inline="yes-display-inline">a description of any significant findings or developments related to patient outcomes or health care providers and best practices for eligible entities expanding, using, or evaluating technology-enabled collaborative learning and capacity building models, including through the activities described in subsection (h).</text></paragraph></subsection> <subsection id="H29FA9BF065DD4388B3902FD7F4DE5D75"><enum>(k)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated to carry out this section, $20,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="HAB94468B44E446F689B42BF010BE80C8"><enum>I</enum><header>Community Readiness</header> <section id="HD6BA6CB294994C3A984BDB54B3CD2D4B"><enum>4081.</enum><header>Grants for research on, or establishing, wastewater surveillance and other early warning systems</header><text display-inline="no-display-inline">Subtitle C of title XXVIII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300hh-31">42 U.S.C. 300hh–31</external-xref> et seq.) is amended by adding at the end the following: </text> <quoted-block id="HF8F367FD25A04324972E42A7CF4FCD37"> <section id="H4DDA355DBE224C9BB055E59A1EF22DCE"><enum>2823.</enum><header>Grants for research on, or establishing, wastewater surveillance and other early warning systems</header> <subsection id="H926DD73C039841899E3F575C79EBBC55"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, in consultation with the Administrator of the Environmental Protection Agency, may award grants to eligible entities to conduct research on, or to establish, a wastewater surveillance or other early warning system through—</text> <paragraph id="H8C9B9A22B08C476F8C98DEAB5D0696C6"><enum>(1)</enum><text>wastewater testing;</text></paragraph> <paragraph id="HEBCDCD9FAEB44735845D5CFB263E7414"><enum>(2)</enum><text>temperature tracking to monitor axillary body temperature; and</text></paragraph> <paragraph id="HEF8D70BF15474411BC959CE76D37CDBD"><enum>(3)</enum><text>other methods deemed permissible by the Secretary and Administrator.</text></paragraph></subsection> <subsection id="H59DE3688DEF2412CAD958FF6E91D9721"><enum>(b)</enum><header>Permissible uses of funds</header><text display-inline="yes-display-inline">A grant recipient under this section may use grant funds to support the activities described in subsection (a), including by—</text> <paragraph id="HD6D37EB2384745D0892436B306B32765"><enum>(1)</enum><text>paying for data-centric services that can detect infectious diseases before positive cases or hospitalizations; </text></paragraph> <paragraph id="HBAAF593F8D774E579431E113D0B033AB"><enum>(2)</enum><text display-inline="yes-display-inline">entering into contracts with private companies to implement early warning detection methods; or</text></paragraph> <paragraph id="H8CF650AAAC2C4AF9AE8587C640C1C858"><enum>(3)</enum><text display-inline="yes-display-inline">funding research to study early warning detection methods. </text></paragraph></subsection> <subsection id="H44AFCDC207004F0CA3ED50481A838D56"><enum>(c)</enum><header>Priority</header><text display-inline="yes-display-inline">In selecting grant recipients under this section, the Secretary shall give priority to eligible entities proposing to conduct research on, or to establish, wastewater surveillance or other early warning system in one or more areas that—</text> <paragraph id="HB5CF9A9D01E648C2A7523834B61FDCF7"><enum>(1)</enum><text display-inline="yes-display-inline">are (or include one or more areas that are) a hot spot; or</text></paragraph> <paragraph id="H1E9CF68CD9EE401AA4D12987989C4350"><enum>(2)</enum><text>a higher percentage of vulnerable populations than the national average.</text></paragraph></subsection> <subsection id="HD167296E10A14F00B7EF98A79C7BCDBA"><enum>(d)</enum><header>Federal privacy requirements</header><text>Nothing in this section shall be construed to supersede any Federal privacy or confidentiality requirement, including the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 and section 543 of this Act.</text></subsection> <subsection id="H7A089FD97279401EB7A4507216BE80FD"><enum>(e)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H74CFE205A55E4F44B1DC2B51AE23A739"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>Administrator</term> means the Administrator of the Environmental Protection Agency.</text></paragraph> <paragraph id="HBBE3A38D2CBB4B5F97A5E8A0558B0C04"><enum>(2)</enum><text>The term <term>eligible entity</term> means—</text> <subparagraph id="HD0D5134D1C1C4166920BBA880120782D"><enum>(A)</enum><text display-inline="yes-display-inline">a State government;</text></subparagraph> <subparagraph id="HD4FC30BC163945F9B19DBC3CDE2B35DD"><enum>(B)</enum><text>a local government;</text></subparagraph> <subparagraph id="H274B5DC119D5487D8B92CEFCB4CC1937"><enum>(C)</enum><text>a Tribal government; </text></subparagraph> <subparagraph id="HD2175DBB75B94CAE9E8C86AC7EC90C50"><enum>(D)</enum><text>an entity that conducts health research; and</text></subparagraph> <subparagraph id="H8431A6F655304D6582E22A9B6976BE4C"><enum>(E)</enum><text>an academic institution. </text></subparagraph></paragraph> <paragraph id="H8FDD2CCCDE1B434998233A798D480689"><enum>(3)</enum><text>The term <term>emergency period</term> has the meaning given to that term in section 1135(g)(1)(B) of the Social Security Act.</text></paragraph> <paragraph id="H9E959F7FC16240B68BDB58C07217C497"><enum>(4)</enum><text>The term <term>hot spot</term> means a geographic area where the rate of infection with a particular pathogen exceeds the national average.</text></paragraph> <paragraph id="HB4A9C942E93E43DCA28BD9E01337689D"><enum>(5)</enum><text>The term <term>local government</term> means a county, municipality, town, township, village, parish, borough, or other unit of general local government.</text></paragraph> <paragraph id="H00DB6D1889F749E2912217FD54826C0C"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>Secretary</term> means the Secretary of Health and Human Services.</text></paragraph> <paragraph id="H2EBB72CCF6AA4888A92B188B70220EA8"><enum>(7)</enum><text display-inline="yes-display-inline">The term <term>State</term> means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, and the Trust Territory of the Pacific Islands. </text></paragraph> <paragraph id="H39BF8D4CA0D44AB2B183BDFAC158C0D7"><enum>(8)</enum><text>The term <term>vulnerable population</term> means people at increased risk of severe illness.</text></paragraph></subsection> <subsection id="H171435A2838B4442A9E9FAEC3AB3D869"><enum>(f)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there are authorized to be appropriated $18,000,000 for each of fiscal years 2021 through 2025. </text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <enum>V</enum><header>Addressing COVID–19 Health Disparities </header> <subtitle id="HD3619AEBBDCD4C33BDF0B556A749B891"><enum>A</enum><header>Tribal Health Data Improvement</header> <section id="H98A11325C6D14C16818AE779542194A7"><enum>5001.</enum><header>Collection and availability of health data with respect to Indian Tribes</header> <subsection id="H0048D1FE3FB84697838B5184021C9D97"><enum>(a)</enum><header>Data collection</header><text display-inline="yes-display-inline">Section 3101(a)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300kk">42 U.S.C. 300kk(a)(1)</external-xref>) is amended—</text> <paragraph id="HDD0CA468150245C8BE78FCD3F7D3A88E"><enum>(1)</enum><text>by striking <quote>, by not later than 2 years after the date of enactment of this title,</quote>; and</text></paragraph> <paragraph id="HE3481569701741588D2057E10E8EF4C1"><enum>(2)</enum><text>in subparagraph (B), by inserting <quote>Tribal,</quote> after <quote>State,</quote>.</text></paragraph></subsection> <subsection id="HC6D85C3F22EE42A6B40111EE320B3D6A"><enum>(b)</enum><header>Data reporting and dissemination</header><text display-inline="yes-display-inline">Section 3101(c) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300kk">42 U.S.C. 300kk(c)</external-xref>) is amended—</text> <paragraph id="H0C9FFAB01F6842FF8D3964C8FDD642EC"><enum>(1)</enum><text>by amending subparagraph (F) of paragraph (1) to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H20F219FD71B6479294946EB9F690919D"> <subparagraph id="HEEBED536166B46A3A5295575F33AAAB8" commented="no"><enum>(F)</enum><text display-inline="yes-display-inline">the Indian Health Service, Indian Tribes, Tribal organizations, and epidemiology centers authorized under the Indian Health Care Improvement Act;</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="HA803E6FD709A4027AA228E9075167DFF"><enum>(2)</enum><text>in paragraph (3), by inserting <quote>Indian Tribes, Tribal organizations, and epidemiology centers,</quote> after <quote>Federal agencies,</quote>.</text></paragraph></subsection> <subsection id="H630D3B8AC3C544CDA167E4B199474029"><enum>(c)</enum><header>Protection and sharing of data</header><text display-inline="yes-display-inline">Section 3101(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300kk">42 U.S.C. 300kk(e)</external-xref>) is amended by adding at the end the following new paragraphs:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H6F94C8036988491EA9A3E4C4C2B49850"> <paragraph id="HD9E59D71C77E4149BCE4BC7D18800499" commented="no"><enum>(3)</enum><header>Data sharing strategy</header><text display-inline="yes-display-inline">With respect to data access for Tribal epidemiology centers and Tribes, the Secretary shall create a data sharing strategy that takes into consideration recommendations by the Secretary’s Tribal Advisory Committee for—</text> <subparagraph id="H0588576520EE42638E6D34A10EC72018"><enum>(A)</enum><text>ensuring that Tribal epidemiology centers and Indian Tribes have access to the data sources necessary to accomplish their public health responsibilities; and</text></subparagraph> <subparagraph id="H87DA958475A14242BC6A63ADDF040FDA"><enum>(B)</enum><text>protecting the privacy and security of such data.</text></subparagraph></paragraph> <paragraph id="HE051C6802B2E4FE3B12AFAD378272520"><enum>(4)</enum><header>Tribal public health authority</header> <subparagraph id="H1F33CB866C7D490EACF18311F958ACA1"><enum>(A)</enum><header>Availability</header><text display-inline="yes-display-inline">Beginning not later than 180 days after the date of the enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, the Secretary shall make available to the entities listed in subparagraph (B) all data that is collected pursuant to this title with respect to health care and public health surveillance programs and activities, including such programs and activities that are federally supported or conducted, so long as—</text> <clause id="H6E7CE11430BB4E2FB4C295CC0C6478FC"><enum>(i)</enum><text>such entities request the data pursuant to statute; and</text></clause> <clause id="H63DACC436CF640C8A000DC0986FE5F34"><enum>(ii)</enum><text>the data is requested for use—</text> <subclause id="H4DFC5DC856954A40BE876DEA0361C4C5"><enum>(I)</enum><text>consistent with Federal law and obligations; and</text></subclause> <subclause id="H4D788B0E64E94476A702116A8DDA9402"><enum>(II)</enum><text>to satisfy a particular purpose or carry out a specific function consistent with the purpose for which the data was collected.</text></subclause></clause></subparagraph> <subparagraph id="HFC0999EA1A684FFDBE89F89AD9ABDA86"><enum>(B)</enum><header>Entities</header><text>The entities listed in this subparagraph are—</text> <clause id="H916A2216983649178502A5EEEDFAC761"><enum>(i)</enum><text>the Indian Health Service;</text></clause> <clause id="HB27F4452CB5A4F6C82776EE8691712DE"><enum>(ii)</enum><text display-inline="yes-display-inline">Indian Tribes and Tribal organizations; and</text></clause> <clause id="H04D6ACD0E0EC42688B5318543991E40C"><enum>(iii)</enum><text display-inline="yes-display-inline">epidemiology centers.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H3CCF2BF5F1BF498CA000520A0717C225"><enum>(d)</enum><header>Technical updates</header><text display-inline="yes-display-inline">Section 3101 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300kk">42 U.S.C. 300kk</external-xref>) is amended—</text> <paragraph id="HAC9C7CED85134E9C902DB84C089369C9"><enum>(1)</enum><text>by striking subsections (g) and (h); and</text></paragraph> <paragraph id="H1870D7E4753444ECBFC2ACBE1476858B"><enum>(2)</enum><text>by redesignating subsection (i) as subsection (h).</text></paragraph></subsection> <subsection id="H607DA17BD94B47A4A1ABE94501006907"><enum>(e)</enum><header>Definitions</header><text display-inline="yes-display-inline">After executing the amendments made by subsection (d), section 3101 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300kk">42 U.S.C. 300kk</external-xref>) is amended by inserting after subsection (f) the following new subsection:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HE1635DFF4B51490C8B765D8E36A89744"> <subsection id="H329804A8F9BF49D8B44851B1BFC127E1"><enum>(g)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section:</text> <paragraph id="H36F7768E01AF419095A06BC8F0D90261"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>epidemiology center</term> means an epidemiology center established under section 214 of the Indian Health Care Improvement Act, including such Tribal epidemiology centers serving Indian Tribes regionally and any Tribal epidemiology center serving Urban Indian organizations nationally.</text></paragraph> <paragraph id="H342E7A2349714BB8950E98F07D73C24D"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>Indian Tribe</term> has the meaning given to the term <term>Indian tribe</term> in section 4 of the Indian Self-Determination and Education Assistance Act.</text></paragraph> <paragraph id="HCD4DEFFFE3D14CDAA5C38AE858CCF173"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>Tribal organization</term> has the meaning given to the term <term>tribal organization</term> in section 4 of the of the Indian Self-Determination and Education Assistance Act.</text></paragraph> <paragraph id="HE5066CB15AE3403B99DEC4B8F5A13839" commented="no"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>Urban Indian organization</term> has the meaning given to that term in section 4 of the Indian Health Care Improvement Act.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HCAB600B2481A4F5A8C5B6407E647C6C5"><enum>(f)</enum><header>Technical correction</header><text display-inline="yes-display-inline">Section 3101(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300kk">42 U.S.C. 300kk(b)</external-xref>) is amended by striking <quote><header-in-text level="subsection" style="OLC">Data analysis.—</header-in-text></quote> and all that follows through <quote>For each federally</quote> and inserting <quote><header-in-text level="subsection" style="OLC">Data analysis.—</header-in-text>For each federally</quote>.</text></subsection></section> <section id="HF5C3F8FE8D784A1DA80ABCF4AB8615BE"><enum>5002.</enum><header>Improving health statistics reporting with respect to Indian Tribes</header> <subsection id="H88B0A2DDD01B412EA272525E730BE2C7"><enum>(a)</enum><header>Technical aid to States and localities</header><text display-inline="yes-display-inline">Section 306(d) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/242k">42 U.S.C. 242k(d)</external-xref>) is amended by inserting <quote>, Indian Tribes, Tribal organizations, and epidemiology centers</quote> after <quote>jurisdictions</quote>.</text></subsection> <subsection id="H272F432B78DC4AE5A3B3C6914633E2E2"><enum>(b)</enum><header>Cooperative health statistics system</header><text display-inline="yes-display-inline">Section 306(e)(3) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/242k">42 U.S.C. 242k(e)(3)</external-xref>) is amended by inserting <quote>, Indian Tribes, Tribal organizations, and epidemiology centers</quote> after <quote>health agencies</quote>.</text></subsection> <subsection id="HA2E9D70F098D47AEA4927F95DA8B329C"><enum>(c)</enum><header>Federal-State-Tribal cooperation</header><text display-inline="yes-display-inline">Section 306(f) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/242k">42 U.S.C. 242k(f)</external-xref>) is amended—</text> <paragraph id="H1407F3C92E4F47C2A183BF3CF510F5BC"><enum>(1)</enum><text>by inserting <quote>the Indian Health Service,</quote> before <quote>the Departments of Commerce</quote>;</text></paragraph> <paragraph id="H7DD7A0916E774B74958B29BA752B4F6B"><enum>(2)</enum><text>by inserting a comma after <quote>the Departments of Commerce and Labor</quote>; </text></paragraph> <paragraph id="H18B7E5A0079C4C40AEE7EC3ADB95F08E"><enum>(3)</enum><text>by inserting <quote>, Indian Tribes, Tribal organizations, and epidemiology centers</quote> after <quote>State and local health departments and agencies</quote>; and</text></paragraph> <paragraph id="H78CEE3E5957F4143B8F49773DE185803"><enum>(4)</enum><text>by striking <quote>he shall</quote> and inserting <quote>the Secretary shall</quote>.</text></paragraph></subsection> <subsection id="HA3AF669605114421B4B23F959308EFD8"><enum>(d)</enum><header>Registration area records</header><text display-inline="yes-display-inline">Section 306(h)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/242k">42 U.S.C. 242k(h)(1)</external-xref>) is amended—</text> <paragraph id="HFED0B68555F0485B8FE5124DBEA93958"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>in his discretion</quote> and inserting <quote>in the discretion of the Secretary</quote>; and</text></paragraph> <paragraph id="H359F2A1292F943D1BE454C18A6B32F8B" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>Hispanics, Asian Americans, and Pacific Islanders</quote> and inserting <quote>American Indians and Alaska Natives, Hispanics, Asian Americans, and Native Hawaiian and other Pacific Islanders</quote>.</text></paragraph></subsection> <subsection id="H062A2A958987440EAF706DA6C66AA855"><enum>(e)</enum><header>National Committee on Vital and Health Statistics</header><text display-inline="yes-display-inline">Section 306(k) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/242k">42 U.S.C. 242k(k)</external-xref>) is amended—</text> <paragraph id="H484E8BCB205A45E8B3CA78FA6E212C55"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking <quote>, not later than 60 days after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996,</quote> each place it appears; and</text></paragraph> <paragraph id="HBE824A44EFCD4B70A3AEC36B32827DEE"><enum>(2)</enum><text>in paragraph (7), by striking <quote>Not later than 1 year after the date of the enactment of the Health Insurance Portability and Accountability Act of 1996, and annually thereafter, the Committee shall</quote> and inserting <quote>The Committee shall, on an biennial basis,</quote>.</text></paragraph></subsection> <subsection id="H2CC6567A64A54C17AF01C8C422ACABED"><enum>(f)</enum><header>Grants for assembly and analysis of data on ethnic and racial populations</header><text display-inline="yes-display-inline">Section 306(m)(4) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/242k">42 U.S.C. 242k(m)(4)</external-xref>) is amended—</text> <paragraph id="HB654068703F449B69681FF9709D8BAA6"><enum>(1)</enum><text>in subparagraph (A)—</text> <subparagraph id="HCE899A79AA4948CCA7665EFF49E28B13"><enum>(A)</enum><text>by striking <quote>Subject to subparagraph (B), the</quote> and inserting <quote>The</quote>; and</text></subparagraph> <subparagraph id="H021CBA801DB34D3EA833496D81647802"><enum>(B)</enum><text>by striking <quote>and major Hispanic subpopulation groups and American Indians</quote> and inserting <quote>, major Hispanic subgroups, and American Indians and Alaska Natives</quote>; and</text></subparagraph></paragraph> <paragraph id="HA6A8789B40C540CA85373AFD7815EDB6"><enum>(2)</enum><text display-inline="yes-display-inline">by amending subparagraph (B) to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HB1015B8436C449DB959C01CF9E63933D"> <subparagraph id="HEECA36D7AE954EA2A54A7AF5AC4CC0F7" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">In carrying out subparagraph (A), with respect to American Indians and Alaska Natives, the Secretary shall—</text> <clause id="H2BA390564811462DB3E8BB1318460881"><enum>(i)</enum><text display-inline="yes-display-inline">consult with Indian Tribes, Tribal organizations, the Tribal Technical Advisory Group of the Centers for Medicare & Medicaid Services maintained under section 5006(e) of the American Recovery and Reinvestment Act of 2009, and the Tribal Advisory Committee established by the Centers for Disease Control and Prevention, in coordination with epidemiology centers, to develop guidelines for State and local health agencies to improve the quality and accuracy of data with respect to the birth and death records of American Indians and Alaska Natives;</text></clause> <clause id="HB993A8AC9774479C95AFA7D4090FCD46"><enum>(ii)</enum><text display-inline="yes-display-inline">confer with Urban Indian organizations to develop guidelines for State and local health agencies to improve the quality and accuracy of data with respect to the birth and death records of American Indians and Alaska Natives;</text></clause> <clause id="HBCF0BDC13CA6442987D3D3C4064FA0EB"><enum>(iii)</enum><text display-inline="yes-display-inline">enter into cooperative agreements with Indian Tribes, Tribal organizations, Urban Indian organizations, and epidemiology centers to address misclassification and undersampling of American Indians and Alaska Natives with respect to—</text> <subclause id="H96A739F6F8CE42B5B8E1D461E1649B54"><enum>(I)</enum><text>birth and death records; and</text></subclause> <subclause id="H48C903C0DA084EFBA7B80480E61353FE"><enum>(II)</enum><text display-inline="yes-display-inline">health care and public health surveillance systems, including, but not limited to, data with respect to chronic and infectious diseases, unintentional injuries, environmental health, child and adolescent health, maternal health and mortality, foodborne and waterborne illness, reproductive health, and any other notifiable disease or condition;</text></subclause></clause> <clause id="H4E01DC7B259247F7B6530554BB30EADC"><enum>(iv)</enum><text display-inline="yes-display-inline">encourage States to enter into data sharing agreements with Indian Tribes, Tribal organizations, and epidemiology centers to improve the quality and accuracy of public health data; and</text></clause> <clause id="H025970BFCB26443EBDE6036945D4C571"><enum>(v)</enum><text display-inline="yes-display-inline">not later than 180 days after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, and biennially thereafter, issue a report on the following:</text> <subclause id="H0150C2E0516B40AFBB322066CA8111D0"><enum>(I)</enum><text>Which States have data sharing agreements with Indian Tribes, Tribal organizations, Urban Indian organizations, and Tribal epidemiology centers to improve the quality and accuracy of health data.</text></subclause> <subclause id="H2E7BE962900948FD90342FC76C42AEDA"><enum>(II)</enum><text>What the Centers for Disease Control and Prevention is doing to encourage States to enter into data sharing agreements with Indian Tribes, Tribal organizations, Urban Indian organizations, and Tribal epidemiology centers to improve the quality and accuracy of health data.</text></subclause> <subclause id="HC07EA90E7417473AACF93AE229281B09"><enum>(III)</enum><text>Best practices and guidance for States, Indian Tribes, Tribal organizations, Urban Indian organizations, and Tribal epidemiology centers that wish to enter into data sharing agreements.</text></subclause> <subclause id="H06016ACD9F6A475DB60F9557E5BDA763"><enum>(IV)</enum><text>Best practices and guidance for local, State, Tribal, and Federal uniform standards for the collection of data on race and ethnicity.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HFFC2BC797E324CE9B2B500C223C87D59"><enum>(g)</enum><header>Definitions</header><text display-inline="yes-display-inline">Section 306 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/242k">42 U.S.C. 242k</external-xref>) is amended—</text> <paragraph id="HD3134E006F8B4DD5BFE38DFA84B76D36"><enum>(1)</enum><text>by redesignating subsection (n) as subsection (o); and</text></paragraph> <paragraph id="HCF5CD5A920A5424BA2A2569E19B1E31E"><enum>(2)</enum><text>by inserting after subsection (m) the following:</text> <quoted-block style="traditional" display-inline="no-display-inline" id="H400B4CB21A3B44E89197DF65B172FA1E"> <subsection id="H305CF9CA347948199B470E89D2518056"><enum>(n)</enum><text>In this section:</text> <paragraph id="H740C9C172F2C49B7816DCF57E73E920A"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>epidemiology center</term> means an epidemiology center established under section 214 of the Indian Health Care Improvement Act, including such Tribal epidemiology centers serving Indian Tribes regionally and any Tribal epidemiology center serving Urban Indian organizations nationally.</text></paragraph> <paragraph id="H252C346B40E844EB93659C395574D58A"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>Indian Tribe</term> has the meaning given to the term <term>Indian tribe</term> in section 4 of the Indian Self-Determination and Education Assistance Act.</text></paragraph> <paragraph id="H151F92090F5949849CA19DAB9B4C2123"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>Tribal organization</term> has the meaning given to the term <term>tribal organization</term> in section 4 of the Indian Self-Determination and Education Assistance Act.</text></paragraph> <paragraph id="HD5705153133748CC80FE3EC1F120F9AD"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>Urban Indian organization</term> has the meaning given to that term in section 4 of the Indian Health Care Improvement Act.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H3B7EA5EB571445AEA9B7F799A3DABAC7"><enum>(h)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">Section 306(o) of the Public Health Service Act, as redesignated by subsection (g), is amended to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H9C476F1A79EC43D78465D7CF754FF35C"> <subsection id="HA25917884AFD470AA53A6BC4C72FC600"><enum>(o)</enum> <paragraph commented="no" display-inline="yes-display-inline" id="H748526F0AA5E41B088879813FFC3A5F2"><enum>(1)</enum><text display-inline="yes-display-inline">To carry out this section, there is authorized to be appropriated $185,000,000 for each of the fiscal years 2021 through 2025.</text></paragraph> <paragraph id="H14FA193FE7D44EFC8528AF769B0E8BAE" indent="up1"><enum>(2)</enum><text>Of the amount authorized to be appropriated to carry out this section for a fiscal year, the Secretary shall not use more than 10 percent for the combined costs of—</text> <subparagraph id="H22A94BA4A03B4538B4719913BC2042B6"><enum>(A)</enum><text>administration of this section; and</text></subparagraph> <subparagraph id="H283A37C8C96B4C559E8D5A429DBBA85F"><enum>(B)</enum><text>carrying out subsection (m)(2).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section></subtitle> <subtitle id="H7A9CFF04BFE0409E89C3E722C36B0C6E"><enum>B</enum><header>Tribal Medical Supplies Stockpile Access</header> <section id="HF243ADB7F4554155B56974C8A6FFB279"><enum>5011.</enum><header>Provision of items to Indian programs and facilities</header> <subsection id="H9E3AD8B1113F46FB9465EA49F985E21F"><enum>(a)</enum><header>Strategic national stockpile</header><text>Section 319F–2(a)(3)(G) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(3)(G)) is amended by inserting <quote>, and, in the case that the Secretary deploys the stockpile under this subparagraph, ensure that appropriate drugs, vaccines and other biological products, medical devices, and other supplies are deployed by the Secretary directly to health programs or facilities operated by the Indian Health Service, an Indian tribe, a tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>)), or an inter-tribal consortium (as defined in section 501 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5381">25 U.S.C. 5381</external-xref>)) or through an urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), while avoiding duplicative distributions to such programs or facilities</quote> before the semicolon.</text></subsection> <subsection id="HE82681DF7F5C4B369636200C3F90D92B"><enum>(b)</enum><header>Distribution of qualified pandemic or epidemic products to IHS facilities</header><text>Title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/241">42 U.S.C. 241</external-xref> et seq.), as amended by section 3015, is further amended by inserting after section 319F–5 the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H7C564775A16244028C11575A7A97E968"> <section id="H317E38A3002D481381896B3AC68D87B4"><enum>319F–6.</enum><header>Distribution of qualified pandemic or epidemic products to Indian programs and facilities</header><text display-inline="no-display-inline">In the case that the Secretary distributes qualified pandemic or epidemic products (as defined in section 319F–3(i)(7)) to States or other entities, the Secretary shall ensure that, as appropriate, such products are distributed directly to health programs or facilities operated by the Indian Health Service, an Indian tribe, a tribal organization (as those terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5304">25 U.S.C. 5304</external-xref>)), or an inter-tribal consortium (as defined in section 501 of the Indian Self-Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/5381">25 U.S.C. 5381</external-xref>)) or through an urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), while avoiding duplicative distributions to such programs or facilities.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section></subtitle> <subtitle id="H0337A8C150784CE1A1F196B1F1727D50"><enum>C</enum><header>Native American Suicide Prevention</header> <section id="H61930AE787904240ADEFDE3FCA22C732"><enum>5021.</enum><header>Native American suicide prevention</header><text display-inline="no-display-inline">Section 520E(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-36">42 U.S.C. 290bb–36(b)</external-xref>) is amended by inserting after paragraph (3) the following:</text> <quoted-block id="H2719B5A7BD9C49C69826ECEFDE1F04BC" style="OLC"> <paragraph id="HBD4D5E44F861444DB48F7B2F30B5C70F"><enum>(4)</enum><header>Consultation</header><text>A State applying for a grant or cooperative agreement under this section shall, in the development and implementation of a statewide early intervention strategy, consult or confer with entities described in paragraph (1)(C) in such State.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="HA953D1329AC04A1085FD54F1C2A05C91"><enum>D</enum><header>Pursuing Equity in Mental Health</header> <part id="H0AA55996ED7442FDA319AB222F75FE22"><enum>1</enum><header>Health Equity and Accountability</header> <section commented="no" id="H188A16F200624A4FBBA6DE73BC8E3E9F"><enum>5031.</enum><header>Integrated Health Care Demonstration Program</header><text display-inline="no-display-inline">Part D of title V of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290dd">42 U.S.C. 290dd</external-xref> et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H38C6DC7C72AF4516ACA1830B51DD60D5" style="OLC"> <section commented="no" id="HAED1E9B5C85B4FBEA60DA545DE1AAD3B"><enum>554.</enum><header>Interprofessional health care teams for provision of behavioral health care in primary care settings</header> <subsection commented="no" id="H25291949ACB7494593D6290CE19210BC"><enum>(a)</enum><header>Grants</header><text display-inline="yes-display-inline">The Secretary shall award grants to eligible entities for the purpose of establishing interprofessional health care teams that provide behavioral health care.</text></subsection> <subsection commented="no" id="H76BC7B3692474FEFBED5FF933CC163E2"><enum>(b)</enum><header>Eligible entities</header><text display-inline="yes-display-inline">To be eligible to receive a grant under this section, an entity shall be a federally qualified health center (as defined in section 1861(aa) of the Social Security Act), rural health clinic, or behavioral health program, serving a high proportion of individuals from racial and ethnic minority groups (as defined in section 1707(g)).</text></subsection> <subsection id="H8DEEB8F5DACD4595897B8BD1D1EC87BC"><enum>(c)</enum><header>Scientifically based</header><text display-inline="yes-display-inline">Integrated health care funded through this section shall be scientifically based, taking into consideration the results of the most recent peer-reviewed research available.</text></subsection> <subsection commented="no" id="HF235C5A123B243A99745C7EE9CF32C9B"><enum>(d)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there is authorized to be appropriated $20,000,000 for each of the first 5 fiscal years following the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section commented="no" id="HC4DFA9B9420F4B019B58D5B4EB9C51E3"><enum>5032.</enum><header>Addressing racial and ethnic minority mental health disparities research gaps</header><text display-inline="no-display-inline">Not later than 6 months after the date of the enactment of this Act, the Director of the National Institutes of Health shall enter into an arrangement with the National Academies of Sciences, Engineering, and Medicine (or, if the National Academies of Sciences, Engineering, and Medicine decline to enter into such an arrangement, the Patient-Centered Outcomes Research Institute, the Agency for Healthcare Research and Quality, or another appropriate entity)—</text> <paragraph id="H98465F33FC194171A970D22343FE2D53"><enum>(1)</enum><text>to conduct a study with respect to mental health disparities in racial and ethnic minority groups (as defined in section 1707(g) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300u-6">42 U.S.C. 300u–6(g)</external-xref>)); and</text></paragraph> <paragraph id="H261BE5F927C7486EB2B531689ECAA5BB"><enum>(2)</enum><text>to submit to the Congress a report on the results of such study, including—</text> <subparagraph id="H77215CE284B543D28FD35C658D71A0EB"><enum>(A)</enum><text>a compilation of information on the dynamics of mental disorders in such racial and ethnic minority groups; and</text></subparagraph> <subparagraph id="H4FD684128690488AB715CE56A47B6669"><enum>(B)</enum><text display-inline="yes-display-inline">a compilation of information on the impact of exposure to community violence, adverse childhood experiences, structural racism, and other psychological traumas on mental disorders in such racial and minority groups.</text></subparagraph></paragraph></section> <section id="H6A5C84DC6C6E468EA0B7A49F0090C07E"><enum>5033.</enum><header>Health professions competencies to address racial and ethnic minority mental health disparities</header> <subsection id="H28F19FC579CD4905A6F6B7A8036287AC"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall award grants to qualified national organizations for the purposes of—</text> <paragraph id="H1EC1805C5CE54D349B9BAF0BA3BB72F8"><enum>(1)</enum><text display-inline="yes-display-inline">developing, and disseminating to health professional educational programs best practices or core competencies addressing mental health disparities among racial and ethnic minority groups for use in the training of students in the professions of social work, psychology, psychiatry, marriage and family therapy, mental health counseling, and substance misuse counseling; and</text></paragraph> <paragraph id="HEC3AD299EAEF4093AEE29C5BD34433A8"><enum>(2)</enum><text display-inline="yes-display-inline">certifying community health workers and peer wellness specialists with respect to such best practices and core competencies and integrating and expanding the use of such workers and specialists into health care to address mental health disparities among racial and ethnic minority groups.</text></paragraph></subsection> <subsection id="HF00A719AA2B2422FAAE6FB2040751037"><enum>(b)</enum><header>Best practices; core competencies</header><text>Organizations receiving funds under subsection (a) may use the funds to engage in the following activities related to the development and dissemination of best practices or core competencies described in subsection (a)(1):</text> <paragraph id="H98E733A77B8A4EB1A269AB03FE3B3CAD"><enum>(1)</enum><text>Formation of committees or working groups comprised of experts from accredited health professions schools to identify best practices and core competencies relating to mental health disparities among racial and ethnic minority groups.</text></paragraph> <paragraph id="HE1616F143BB34398ABB4DAE0FA8EF107"><enum>(2)</enum><text>Planning of workshops in national fora to allow for public input into the educational needs associated with mental health disparities among racial and ethnic minority groups.</text></paragraph> <paragraph id="H75CD9EDB19FF422FA563B81C892D2ACE"><enum>(3)</enum><text>Dissemination and promotion of the use of best practices or core competencies in undergraduate and graduate health professions training programs nationwide.</text></paragraph> <paragraph id="H9A7A9D90A3B8494CA55B59B7DBD590A3"><enum>(4)</enum><text display-inline="yes-display-inline">Establishing external stakeholder advisory boards to provide meaningful input into policy and program development and best practices to reduce mental health disparities among racial and ethnic minority groups.</text></paragraph></subsection> <subsection id="HC31A31DA68B340F2A1711D60EF7BD422"><enum>(c)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H62F8ED1A6FF544D191742578B332D64C"><enum>(1)</enum><header>Qualified national organization</header><text display-inline="yes-display-inline">The term <term>qualified national organization</term> means a national organization that focuses on the education of students in one or more of the professions of social work, psychology, psychiatry, marriage and family therapy, mental health counseling, and substance misuse counseling.</text></paragraph> <paragraph id="H920B0186756A4485B90630914D25AC3C"><enum>(2)</enum><header>Racial and ethnic minority group</header><text display-inline="yes-display-inline">The term <term>racial and ethnic minority group</term> has the meaning given to such term in section 1707(g) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300u-6">42 U.S.C. 300u–6(g)</external-xref>).</text></paragraph></subsection></section> <section id="H148AD96976B24D4CA334EE66015D753B"><enum>5034.</enum><header>Racial and ethnic minority behavioral and mental health outreach and education strategy</header><text display-inline="no-display-inline">Part D of title V of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290dd">42 U.S.C. 290dd</external-xref> et seq.), as amended by section 5031, is further amended by adding at the end the following new section:</text> <quoted-block id="H40DAC998C3EA417698598A4E03A30EF3" style="OLC"> <section id="HD0EEDE2BD28C4191BCB26AE31A880B94"><enum>555.</enum><header>Behavioral and mental health outreach and education strategy</header> <subsection id="H735224C4652544CCB1C2F3F1543F0538"><enum>(a)</enum><header>In general</header><text>The Secretary shall, in consultation with advocacy and behavioral and mental health organizations serving racial and ethnic minority groups, develop and implement an outreach and education strategy to promote behavioral and mental health and reduce stigma associated with mental health conditions and substance abuse among racial and ethnic minority groups. Such strategy shall—</text> <paragraph id="H97F31090B80D411E916B86D106224416"><enum>(1)</enum><text>be designed to—</text> <subparagraph id="H6E148547A6C149A99272A8B9655B2FE1"><enum>(A)</enum><text>meet the diverse cultural and language needs of the various racial and ethnic minority groups; and</text></subparagraph> <subparagraph id="H33CC2C915E6A484781BEBDAAA7809DD4"><enum>(B)</enum><text>be developmentally and age-appropriate;</text></subparagraph></paragraph> <paragraph id="HE13702DBFF714ACCBD6F15B733C8BDD2"><enum>(2)</enum><text display-inline="yes-display-inline">increase awareness of symptoms of mental illnesses common among such groups, taking into account differences within at-risk subgroups;</text></paragraph> <paragraph id="H0B22D27C6CFF41239592CB8888856421"><enum>(3)</enum><text>provide information on evidence-based, culturally and linguistically appropriate and adapted interventions and treatments;</text></paragraph> <paragraph id="H4DD413B1880D4035AFF532CD19418DAE"><enum>(4)</enum><text>ensure full participation of, and engage, both consumers and community members in the development and implementation of materials; and</text></paragraph> <paragraph id="H14E2E8E1364F4954BF3E6F12C37DBDED"><enum>(5)</enum><text>seek to broaden the perspective among both individuals in these groups and stakeholders serving these groups to use a comprehensive public health approach to promoting behavioral health that addresses a holistic view of health by focusing on the intersection between behavioral and physical health.</text></paragraph></subsection> <subsection id="H3271AD77AEDA42C485065AA6866920F8"><enum>(b)</enum><header>Reports</header><text display-inline="yes-display-inline">Beginning not later than 1 year after the date of the enactment of this section and annually thereafter, the Secretary shall submit to Congress, and make publicly available, a report on the extent to which the strategy developed and implemented under subsection (a) increased behavioral and mental health outcomes associated with mental health conditions and substance abuse among racial and ethnic minority groups.</text></subsection> <subsection id="H373A7B9EAC764BC18E27EE66BA1461C2"><enum>(c)</enum><header>Definition</header><text>In this section, the term <term>racial and ethnic minority group</term> has the meaning given to that term in section 1707(g).</text></subsection> <subsection id="HF2A4611C24B84FADA10883D40CCBC081"><enum>(d)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">There is authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H675D3EFBEC914A7C99539E7A3BC10BEA"><enum>5035.</enum><header>Additional funds for National Institutes of Health</header> <subsection id="HB10F551BBC444568A445E67631C0830E"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">In addition to amounts otherwise authorized to be appropriated to the National Institutes of Health, there is authorized to be appropriated to such Institutes $100,000,000 for each of fiscal years 2021 through 2025 to build relations with communities and conduct or support clinical research, including clinical research on racial or ethnic disparities in physical and mental health.</text></subsection> <subsection id="HFAFEEBC1623A42F794C6800FB750C936"><enum>(b)</enum><header>Definition</header><text>In this section, the term <term>clinical research</term> has the meaning given to such term in section 409 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284d">42 U.S.C. 284d</external-xref>).</text></subsection></section> <section id="H53AB44A1A579412FBE9E8C29175C9084"><enum>5036.</enum><header>Additional funds for National Institute on Minority Health and Health Disparities</header><text display-inline="no-display-inline">In addition to amounts otherwise authorized to be appropriated to the National Institute on Minority Health and Health Disparities, there is authorized to be appropriated to such Institute $650,000,000 for each of fiscal years 2021 through 2025.</text></section></part> <part id="H3271CA21CAD94F44AA60DAA0DB547E04"><enum>2</enum><header>Other provisions</header> <section id="HF55B79BA73914A38A0455CD23D72D011"><enum>5037.</enum><header>Reauthorization of Minority Fellowship Program</header><text display-inline="no-display-inline">Section 597(c) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/297ll">42 U.S.C. 297ll(c)</external-xref>) is amended by striking <quote>$12,669,000 for each of fiscal years 2018 through 2022</quote> and inserting <quote>$25,000,000 for each of fiscal years 2021 through 2025</quote>.</text></section> <section id="HE2B2E3FBBEDA4AA4A9B7A71B08FFEF80"><enum>5038.</enum><header>Study on the Effects of Smartphone and Social Media Use on Adolescents</header> <subsection id="H466D916C4820483E8320DBF32A8D2D86"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall conduct or support research on—</text> <paragraph id="H5CC9B3F27E4E4F2DA60B74E38D6A59BB"><enum>(1)</enum><text>smartphone and social media use by adolescents; and</text></paragraph> <paragraph id="H262008AF841D4A22B048F64FCE99D039"><enum>(2)</enum><text>the effects of such use on—</text> <subparagraph id="HE6A70713E3214E8F8AB73AECA8702C6A"><enum>(A)</enum><text display-inline="yes-display-inline">emotional, behavioral, and physical health and development; and</text></subparagraph> <subparagraph id="H33C3E99968E64D17B339B6E07A11C755"><enum>(B)</enum><text display-inline="yes-display-inline">disparities in minority and underserved populations.</text></subparagraph></paragraph></subsection> <subsection id="HD9A9C47DBA9641C6A7235E0A47F2C856"><enum>(b)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than 5 years after the date of the enactment of this Act, the Secretary shall submit to the Congress, and make publicly available, a report on the findings of research described in this section.</text></subsection></section> <section id="HA438F5C6D6F240D38232AEF6C1A483EE"><enum>5039.</enum><header>Technical correction</header><text display-inline="no-display-inline">Title V of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290aa">42 U.S.C. 290aa</external-xref> et seq.) is amended—</text> <paragraph id="H3A1813EB30DF46B6B1A5B9BFEBD7A3C1"><enum>(1)</enum><text>by redesignating the second section 550 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290ee-10">42 U.S.C. 290ee–10</external-xref>) (relating to Sobriety Treatment And Recovery Teams) as section 553; and</text></paragraph> <paragraph id="H95C8F17C0AAF4A4A8600EE4281E7AFC4"><enum>(2)</enum><text>by moving such section 553, as so redesignated, so as to appear after section 552 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290ee-7">42 U.S.C. 290ee–7</external-xref>).</text></paragraph></section></part></subtitle> <subtitle id="H7028B3BCBE654354B813442D3675F3AF"><enum>E</enum><header>Maternal Health Quality Improvement</header> <section id="H72CADC6BFA244C65A2CEAC844001684C"><enum>5041.</enum><header>Innovation for maternal health</header><text display-inline="no-display-inline">Part D of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254b">42 U.S.C. 254b</external-xref> et seq.), as amended by section 4071, is further amended—</text> <paragraph id="HE578006FB49142F4988285F0BDA40EA2"><enum>(1)</enum><text>in the section designation of section 330M of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254c-19">42 U.S.C. 254c–19</external-xref>) by inserting a period after <quote>330M</quote>; and</text></paragraph> <paragraph id="HD9989BCC7D3E4FB0B221DF2823084A60"><enum>(2)</enum><text>by inserting after section 330N of such Act, as inserted by section 4071, the following:</text> <quoted-block id="H2C1AE59B674044248BF4463289C4F4B1" style="OLC"> <section id="HE08569C4671F4F52887D9DBBA8337991"><enum>330O.</enum><header>Innovation for maternal health</header> <subsection id="H823C9D71863E4374896C2403E66D771C"><enum>(a)</enum><header>In general</header><text>The Secretary, in consultation with experts representing a variety of clinical specialties, State, Tribal, or local public health officials, researchers, epidemiologists, statisticians, and community organizations, shall establish or continue a program to award competitive grants to eligible entities for the purposes of—</text> <paragraph id="HB50D752707C44984A4FE7399F0F95984"><enum>(1)</enum><text>identifying, developing, or disseminating best practices to improve maternal health care quality and outcomes, eliminate preventable maternal mortality and severe maternal morbidity, and improve infant health outcomes, which may include—</text> <subparagraph id="H4204203842E24A65B364BB1C519FB1A3"><enum>(A)</enum><text>information on evidence-based practices to improve the quality and safety of maternal health care in hospitals and other health care settings of a State or health care system, including by addressing topics commonly associated with health complications or risks related to prenatal care, labor care, birthing, and postpartum care;</text></subparagraph> <subparagraph id="HA331EDD0EE1E4604A41689E71A70D7F0"><enum>(B)</enum><text>best practices for improving maternal health care based on data findings and reviews conducted by a State maternal mortality review committee that address topics of relevance to common complications or health risks related to prenatal care, labor care, birthing, and postpartum care; and</text></subparagraph> <subparagraph id="HF6F93854B9484715BB646D6C2AF8B31D"><enum>(C)</enum><text>information on addressing determinants of health that impact maternal health outcomes for women before, during, and after pregnancy;</text></subparagraph></paragraph> <paragraph id="H8C2DA999751E4DB78A639C28DFE6FEBC"><enum>(2)</enum><text>collaborating with State maternal mortality review committees to identify issues for the development and implementation of evidence-based practices to improve maternal health outcomes and reduce preventable maternal mortality and severe maternal morbidity;</text></paragraph> <paragraph id="HF4B31F94E25044CD86CF9E0E8C78C6A4"><enum>(3)</enum><text>providing technical assistance and supporting the implementation of best practices identified pursuant to paragraph (1) to entities providing health care services to pregnant and postpartum women; and</text></paragraph> <paragraph id="H504ECC49FDA4411E820D14C2A58A2A04"><enum>(4)</enum><text>identifying, developing, and evaluating new models of care that improve maternal and infant health outcomes, which may include the integration of community-based services and clinical care.</text></paragraph></subsection> <subsection id="HD8D3154C8870497C834581EF1228F011"><enum>(b)</enum><header>Eligible entities</header><text>To be eligible for a grant under subsection (a), an entity shall—</text> <paragraph id="H8DCCE5E6646E45D297C29F24B0FD4B3B"><enum>(1)</enum><text>submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require; and</text></paragraph> <paragraph id="HCF528C3F434E4119AAD05D94DBC87AE0"><enum>(2)</enum><text>demonstrate in such application that the entity is capable of carrying out data-driven maternal safety and quality improvement initiatives in the areas of obstetrics and gynecology or maternal health.</text></paragraph></subsection> <subsection id="HEEB82AA8362B441CB67D4C48CDC47263"><enum>(c)</enum><header>Authorization of appropriations</header><text>To carry out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="HB420BCBC629947839653E5726FC69573"><enum>5042.</enum><header>Training for health care providers</header><text display-inline="no-display-inline">Title VII of the Public Health Service Act is amended by striking section 763 (<external-xref legal-doc="usc" parsable-cite="usc/42/294p">42 U.S.C. 294p</external-xref>) and inserting the following:</text> <quoted-block id="H2C39DDD1FF31490A98F6D83092692006" style="OLC"> <section id="H390B639C226245F58B991300853FC91D"><enum>763.</enum><header>Training for health care providers</header> <subsection id="HB7DB2AB31CF348298632ADB46FF93E0A"><enum>(a)</enum><header>Grant program</header><text>The Secretary shall establish a program to award grants to accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other health professional training programs for the training of health care professionals to reduce and prevent discrimination (including training related to implicit and explicit biases) in the provision of health care services related to prenatal care, labor care, birthing, and postpartum care.</text></subsection> <subsection id="H55BFFD812F9D4F95934457E04286ACCB"><enum>(b)</enum><header>Eligibility</header><text>To be eligible for a grant under subsection (a), an entity described in such subsection shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.</text></subsection> <subsection id="H9A445D60444B41668433F43BEEB0F28E"><enum>(c)</enum><header>Reporting requirement</header><text>Each entity awarded a grant under this section shall periodically submit to the Secretary a report on the status of activities conducted using the grant, including a description of the impact of such training on patient outcomes, as applicable.</text></subsection> <subsection id="HF9D5495F2655418887CF78E8499C4380"><enum>(d)</enum><header>Best practices</header><text>The Secretary may identify and disseminate best practices for the training of health care professionals to reduce and prevent discrimination (including training related to implicit and explicit biases) in the provision of health care services related to prenatal care, labor care, birthing, and postpartum care.</text></subsection> <subsection id="H07B1A27088144B77A6F4428051051354"><enum>(e)</enum><header>Authorization of appropriations</header><text>To carry out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H8181F1F375AF490A8454391E2197AC37"><enum>5043.</enum><header>Study on training to reduce and prevent discrimination</header><text display-inline="no-display-inline">Not later than 2 years after date of enactment of this Act, the Secretary of Health and Human Services shall, through a contract with an independent research organization, conduct a study and make recommendations for accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other health professional training programs, on best practices related to training to reduce and prevent discrimination, including training related to implicit and explicit biases, in the provision of health care services related to prenatal care, labor care, birthing, and postpartum care.</text></section> <section id="H12B38995AA29433C91F029BA3E5FAF5B"><enum>5044.</enum><header>Perinatal quality collaboratives</header><text display-inline="no-display-inline">Section 317K(a)(2) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-12">42 U.S.C. 247b–12(a)(2)</external-xref>) is amended by adding at the end the following:</text> <quoted-block id="H5A11858768AF49FC87E2D6034DD4074D" style="OLC"> <subparagraph id="H8CB94EDBD50E41458CD8549CEAD2CCB0"><enum>(E)</enum> <clause commented="no" display-inline="yes-display-inline" id="HC579026F72884DC8B6605B67C1BCF9E3"><enum>(i)</enum><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other offices and agencies, as appropriate, shall establish or continue a competitive grant program for the establishment or support of perinatal quality collaboratives to improve perinatal care and perinatal health outcomes for pregnant and postpartum women and their infants. A State, Indian Tribe, or Tribal organization may use funds received through such grant to—</text> <subclause id="HF2AE4350FE3941AA8D505B08EC1473F8" indent="up1"><enum>(I)</enum><text>support the use of evidence-based or evidence-informed practices to improve outcomes for maternal and infant health;</text></subclause> <subclause id="HEA3C213A2A6D406D8E4D6D51BEBF0E94" indent="up1"><enum>(II)</enum><text>work with clinical teams; experts; State, local, and, as appropriate, Tribal public health officials; and stakeholders, including patients and families, to identify, develop, or disseminate best practices to improve perinatal care and outcomes; and</text></subclause> <subclause id="HD64F8D0E55A3477AAE936F37172E27C8" indent="up1"><enum>(III)</enum><text>employ strategies that provide opportunities for health care professionals and clinical teams to collaborate across health care settings and disciplines, including primary care and mental health, as appropriate, to improve maternal and infant health outcomes, which may include the use of data to provide timely feedback across hospital and clinical teams to inform responses, and to provide support and training to hospital and clinical teams for quality improvement, as appropriate.</text></subclause></clause> <clause id="H22A8B3277DB8468B8A4FC63B376E453A" indent="up1"><enum>(ii)</enum><text>To be eligible for a grant under clause (i), an entity shall submit to the Secretary an application in such form and manner and containing such information as the Secretary may require.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="HCBB2A18A6BA0412A8C26E672ED3A364B"><enum>5045.</enum><header>Integrated services for pregnant and postpartum women</header> <subsection id="HE9B68EC8C08A4944B0946B4FB5D6A791"><enum>(a)</enum><header>Grants</header><text>Title III of the Public Health Service Act is amended by inserting after section 330O of such Act, as added by section 5041, the following:</text> <quoted-block id="H182F99184C474E1F89BCF98F8E7B9B55" style="OLC"> <section id="H0AF5C5ECE0CB4AC887B68BB478BCC772"><enum>330P.</enum><header>Integrated services for pregnant and postpartum women</header> <subsection id="HED6A1F7459214BEC95A42D9CC88B29EE"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary may award grants to States, Indian Tribes, and Tribal organizations for the purpose of establishing or operating evidence-based or innovative, evidence-informed programs to deliver integrated health care services to pregnant and postpartum women to optimize the health of women and their infants, including to reduce adverse maternal health outcomes, pregnancy-related deaths, and related health disparities (including such disparities associated with racial and ethnic minority populations), and, as appropriate, by addressing issues researched under subsection (b)(2) of section 317K.</text></subsection> <subsection id="HBD045E722F4C4CE0B1FF30E949ADFB56"><enum>(b)</enum><header>Integrated services for pregnant and postpartum women</header> <paragraph id="H2B4C3E7FF62C4968A2EEA9F1468CE9E9"><enum>(1)</enum><header>Eligibility</header><text>To be eligible to receive a grant under subsection (a), a State, Indian Tribe, or Tribal organization shall work with relevant stakeholders that coordinate care (including coordinating resources and referrals for health care and social services) to develop and carry out the program, including—</text> <subparagraph id="H4B12788B4AEF4D67A97470FF3EF7FF71"><enum>(A)</enum><text>State, Tribal, and local agencies responsible for Medicaid, public health, social services, mental health, and substance use disorder treatment and services;</text></subparagraph> <subparagraph id="HA29A54C23C574D7EBCB5D1B7C6593E08"><enum>(B)</enum><text>health care providers who serve pregnant and postpartum women; and</text></subparagraph> <subparagraph id="HDE0D42DA484D4194AA502D2A0FA324F8"><enum>(C)</enum><text>community-based health organizations and health workers, including providers of home visiting services and individuals representing communities with disproportionately high rates of maternal mortality and severe maternal morbidity, and including individuals representing racial and ethnic minority populations.</text></subparagraph></paragraph> <paragraph id="H7259716589DA4709A56A12CACFD8A75F"><enum>(2)</enum><header>Terms</header> <subparagraph id="H813A66F8B10C42FE9064578594A2B341"><enum>(A)</enum><header>Period</header><text>A grant awarded under subsection (a) shall be made for a period of 5 years. Any supplemental award made to a grantee under subsection (a) may be made for a period of less than 5 years.</text></subparagraph> <subparagraph id="H1F495FA802954924966C6C4B7B86A484"><enum>(B)</enum><header>Preference</header><text>In awarding grants under subsection (a), the Secretary shall—</text> <clause id="H452A32A946E141169C3A2893CCAE2D03"><enum>(i)</enum><text>give preference to States, Indian Tribes, and Tribal organizations that have the highest rates of maternal mortality and severe maternal morbidity relative to other such States, Indian Tribes, or Tribal organizations, respectively; and</text></clause> <clause id="H76B704C9264547CE95B7D431CB160C0B"><enum>(ii)</enum><text>shall consider health disparities related to maternal mortality and severe maternal morbidity, including such disparities associated with racial and ethnic minority populations.</text></clause></subparagraph> <subparagraph id="HF1B3A70ACF7F4106BF62847F64FBA825"><enum>(C)</enum><header>Priority</header><text>In awarding grants under subsection (a), the Secretary shall give priority to applications from up to 15 entities described in subparagraph (B)(i).</text></subparagraph> <subparagraph id="HB3737C88C55946C89D1CEBA6F849D482"><enum>(D)</enum><header>Evaluation</header><text>The Secretary shall require grantees to evaluate the outcomes of the programs supported under the grant.</text></subparagraph></paragraph></subsection> <subsection id="H7CA94ED5BE824260B8F5EDAC87B8082F"><enum>(c)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this section, the terms <term>Indian Tribe</term> and <term>Tribal organization</term> have the meanings given the terms <term>Indian tribe</term> and <term>tribal organization</term>, respectively, in section 4 of the Indian Self-Determination and Education Assistance Act.</text></subsection> <subsection id="H935566D41F3246CEA6D3FDE5270FCEB5"><enum>(d)</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 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HF8EB8F28C9EE4A08B350E3FF8E7F29DF"><enum>(b)</enum><header>Report on grant outcomes and dissemination of best practices</header> <paragraph id="H686455D7FE5B4711B51D7845FE4180A2"><enum>(1)</enum><header>Report</header><text>Not later than February 1, 2026, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that describes—</text> <subparagraph id="H8020BAB50F5645E18DD50F2450EAC4EA"><enum>(A)</enum><text>the outcomes of the activities supported by the grants awarded under the amendment made by this section on maternal and child health;</text></subparagraph> <subparagraph id="H1790BA659D21473C8B1081A034F9EBE6"><enum>(B)</enum><text>best practices and models of care used by recipients of grants under such amendment; and</text></subparagraph> <subparagraph id="HB03C916243EC4E6693D6B793DB16779B"><enum>(C)</enum><text>obstacles identified by recipients of grants under such amendment, and strategies used by such recipients to deliver care, improve maternal and child health, and reduce health disparities.</text></subparagraph></paragraph> <paragraph id="H523DB4ECAAE7495BA2E2CEF1DC820BB7"><enum>(2)</enum><header>Dissemination of best practices</header><text>Not later than August 1, 2026, the Secretary of Health and Human Services shall disseminate information on best practices and models of care used by recipients of grants under the amendment made by this section (including best practices and models of care relating to the reduction of health disparities, including such disparities associated with racial and ethnic minority populations, in rates of maternal mortality and severe maternal morbidity) to relevant stakeholders, which may include health providers, medical schools, nursing schools, relevant State, Tribal, and local agencies, and the general public.</text></paragraph></subsection></section> <section id="H761F694F99304A0FB8798D2C35727B6A"><enum>5046.</enum><header>Improving rural maternal and obstetric care data</header> <subsection id="HE0E96D101462440AA51E4E1761B7F83E"><enum>(a)</enum><header>Maternal mortality and morbidity activities</header><text>Section 301(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/241">42 U.S.C. 241(e)</external-xref>) is amended by inserting <quote>, preventable maternal mortality and severe maternal morbidity,</quote> after <quote>delivery</quote>.</text></subsection> <subsection id="H17077301E9674AF4937A6AC52FF7A806"><enum>(b)</enum><header>Office of women’s health</header><text>Section 310A(b)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/242s">42 U.S.C. 242s(b)(1)</external-xref>) is amended by striking <quote>and sociocultural contexts,</quote> and inserting <quote>sociocultural (including among American Indians, Native Hawaiians, and Alaska Natives), and geographical contexts</quote>.</text></subsection> <subsection id="HD64F8E107E344BCCBCC43A2077DB5457"><enum>(c)</enum><header>Safe motherhood</header><text>Section 317K of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-12">42 U.S.C. 247b–12</external-xref>) is amended—</text> <paragraph id="HA4B790B453C14178B686DFE0E2ADBFF3"><enum>(1)</enum><text>in subsection (a)(2)(A), by inserting <quote>, including improving collection of data on race, ethnicity, and other demographic information</quote> before the period; and</text></paragraph> <paragraph id="HDC33288CB2614CF1BADF020B3A7C3A92"><enum>(2)</enum><text>in subsection (b)(2)—</text> <subparagraph id="H57A10E827D5D490CAFE168C2DBB50DCD"><enum>(A)</enum><text>in subparagraph (L), by striking <quote>and</quote> at the end;</text></subparagraph> <subparagraph id="H0E180BD83AD345CEA27547AB59DF75D6"><enum>(B)</enum><text>by redesignating subparagraph (M) as subparagraph (N); and</text></subparagraph> <subparagraph id="H91463941D4D147A4872760FCFF144DB6"><enum>(C)</enum><text>by inserting after subparagraph (L) the following:</text> <quoted-block id="H26DF4A96A6C34D6DB96D1248A1701EF1" style="OLC"> <subparagraph id="H556712C02C9F40D2A4DA80E98372D297"><enum>(M)</enum><text>an examination of the relationship between maternal health and obstetric services in rural areas and outcomes in delivery and postpartum care; and</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection> <subsection id="HACD85AD6523A46AEA43AA8032CB509F9"><enum>(d)</enum><header>Office of research on women’s health</header><text>Section 486 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/287d">42 U.S.C. 287d</external-xref>) is amended—</text> <paragraph id="HEFF46F6B2C54403A8E2D9E298CCD752C"><enum>(1)</enum><text>in subsection (b), by amending paragraph (3) to read as follows:</text> <quoted-block id="HAD0D4BE6DAA74F11AA3B96A699E8B3F5" style="OLC"> <paragraph id="HC75F13CDCF0E4100BFA274F13CC87469"><enum>(3)</enum><text>carry out paragraphs (1) and (2) with respect to—</text> <subparagraph id="H7DCD9D9CD1984EA7A1B1D5E3A217E7C2"><enum>(A)</enum><text>the aging process in women, with priority given to menopause; and</text></subparagraph> <subparagraph id="H3FB2ED2C8CFC47B18F53DA9CA0EB4EB4"><enum>(B)</enum><text>pregnancy, with priority given to deaths related to preventable maternal mortality and severe maternal morbidity;</text></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="H1C0E14DA9B6F438FA55176896F720831"><enum>(2)</enum><text>in subsection (d)(4)(A)(iv), by inserting <quote>, including preventable maternal morbidity and severe maternal morbidity</quote> before the semicolon.</text></paragraph></subsection></section> <section id="H658D9C945FE7442B87068B6D5EDD0864"><enum>5047.</enum><header>Rural obstetric network grants</header><text display-inline="no-display-inline">The Public Health Service Act is amended by inserting after section 330A–1 (<external-xref legal-doc="usc" parsable-cite="usc/42/254c-1a">42 U.S.C. 254c–1a</external-xref>) the following:</text> <quoted-block id="HA674BA23B7504281B2322148818A21AC" style="OLC"> <section id="H3F241D88B6374CC9B17CC862C5AB5DE5"><enum>330A–2.</enum><header>Rural obstetric network grants</header> <subsection id="H102C6EF5CA884DBB85A7F1829E6687ED"><enum>(a)</enum><header>Program established</header><text>The Secretary shall award grants or cooperative agreements to eligible entities to establish collaborative improvement and innovation networks (referred to in this section as <quote>rural obstetric networks</quote>) to improve maternal and infant health outcomes and reduce preventable maternal mortality and severe maternal morbidity by improving maternity care and access to care in rural areas, frontier areas, maternity care health professional target areas, or jurisdictions of Indian Tribes and Tribal organizations.</text></subsection> <subsection id="HCE7EDDB339374583A26EFD0EB983A160"><enum>(b)</enum><header>Use of funds</header><text>Grants or cooperative agreements awarded pursuant to this section shall be used for the establishment or continuation of collaborative improvement and innovation networks to improve maternal health in rural areas by improving infant health and maternal outcomes and reducing preventable maternal mortality and severe maternal morbidity. Rural obstetric networks established in accordance with this section may—</text> <paragraph id="H5418BDC1E9514A7AA6A9EC197AA2D322"><enum>(1)</enum><text display-inline="yes-display-inline">develop a network to improve coordination and increase access to maternal health care and assist pregnant women in the areas described in subsection (a) with accessing and utilizing maternal and obstetric care, including health care services related to prenatal care, labor care, birthing, and postpartum care to improve outcomes in birth and maternal mortality and morbidity;</text></paragraph> <paragraph id="HC72518EC35214F6DA5B875F2A9AAD070"><enum>(2)</enum><text display-inline="yes-display-inline">identify and implement evidence-based and sustainable delivery models for maternal and obstetric care (including health care services related to prenatal care, labor care, birthing, and postpartum care for women in the areas described in subsection (a)), including home visiting programs and culturally appropriate care models that reduce health disparities;</text></paragraph> <paragraph id="H43A531E7F99442758FC0E29C5A7B55A7"><enum>(3)</enum><text>develop a model for maternal health care collaboration between health care settings to improve access to care in areas described in subsection (a), which may include the use of telehealth;</text></paragraph> <paragraph id="HA70B6F9ED5C14289AF46BBE1487C62AB"><enum>(4)</enum><text>provide training for professionals in health care settings that do not have specialty maternity care;</text></paragraph> <paragraph id="H53FD0E4F211540A3930FC0DB0AFDCE69"><enum>(5)</enum><text>collaborate with academic institutions that can provide regional expertise and help identify barriers to providing maternal health care, including strategies for addressing such barriers; and</text></paragraph> <paragraph id="H1EBB0110160C44269438E2BC80AC87E0"><enum>(6)</enum><text>assess and address disparities in infant and maternal health outcomes, including among racial and ethnic minority populations and underserved populations in areas described in subsection (a).</text></paragraph></subsection> <subsection id="H38653F229A90408AAC4EBDEEE82B12CC"><enum>(c)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HCCD706BC4CD44E359854592587C4FFBC"><enum>(1)</enum><header>Eligible entities</header><text>The term <term>eligible entities</term> means entities providing maternal health care services in rural areas, frontier areas, or medically underserved areas, or to medically underserved populations or Indian Tribes or Tribal organizations.</text></paragraph> <paragraph id="H0AF0B21A8AB14EEAA7B7C4C13DED373E"><enum>(2)</enum><header>Frontier area</header><text>The term <term>frontier area</term> means a frontier county, as defined in section 1886(d)(3)(E)(iii)(III) of the Social Security Act.</text></paragraph> <paragraph id="HFA5290D0B5FC4828AE0AD8568247CDB3"><enum>(3)</enum><header>Indian Tribes; Tribal organization</header><text>The terms <term>Indian Tribe</term> and <term>Tribal organization</term> have the meanings given the terms <term>Indian tribe</term> and <term>tribal organization</term>, respectively, in section 4 of the Indian Self-Determination and Education Assistance Act.</text></paragraph> <paragraph id="HBA449C19F3464DF6958B1B5F594C319D"><enum>(4)</enum><header>Maternity care health professional target area</header><text>The term <term>maternity care health professional target area</term> has the meaning described in section 332(k)(2).</text></paragraph></subsection> <subsection id="HF67B990150294CEA856B6DB7A3F27EA5"><enum>(d)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section $3,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H6FB86D55ECAA44BE916CFE1193705F98"><enum>5048.</enum><header>Telehealth network and telehealth resource centers grant programs</header><text display-inline="no-display-inline">Section 330I of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/254c-14">42 U.S.C. 254c–14</external-xref>) is amended—</text> <paragraph id="HFEDA6DE459624BA092600DE8BC0FA39F"><enum>(1)</enum><text>in subsection (f)(3), by adding at the end the following:</text> <quoted-block id="H27BFD9FABBE740039C19A547FAF3EC4B" style="OLC"> <subparagraph id="H494D2F9B5AE34836AF49108722AC241A"><enum>(M)</enum><text>Providers of maternal care, including prenatal, labor care, birthing, and postpartum care services and entities operating obstetric care units.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="H92437696D3DD40ACB39C639CEFBAA677"><enum>(2)</enum><text>in subsection (h)(1)(B), by inserting <quote>labor care, birthing care, postpartum care,</quote> before <quote>or prenatal</quote>.</text></paragraph></section> <section id="HDFADB1E176D345CAB8864AAB3C1D142A"><enum>5049.</enum><header>Rural maternal and obstetric care training demonstration</header><text display-inline="no-display-inline">Subpart 1 of part E of title VII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/294n">42 U.S.C. 294n</external-xref> et seq.) is amended by adding at the end the following:</text> <quoted-block id="H1EAB488E340840FCA9DC60F6D20A38B3" style="OLC"> <section id="HBC56D7BECCEC4F728876F8786A3A1A74"><enum>764.</enum><header>Rural maternal and obstetric care training demonstration</header> <subsection id="H60E592D060C942C58B52FEEA9CEC15BC"><enum>(a)</enum><header>In general</header><text>The Secretary shall award grants to accredited schools of allopathic medicine, osteopathic medicine, and nursing, and other appropriate health professional training programs, to establish a training demonstration program to support—</text> <paragraph id="H76D5EED3ED3B492DB4980132F09092FB"><enum>(1)</enum><text>training for physicians, medical residents, fellows, nurse practitioners, physician assistants, nurses, certified nurse midwives, relevant home visiting workforce professionals and paraprofessionals, or other professionals who meet relevant State training and licensing requirements, as applicable, to provide maternal health care services in rural community-based settings; and</text></paragraph> <paragraph id="HE041D4FEB38A40BCB3F58B1CFCAD0A19"><enum>(2)</enum><text>developing recommendations for such training programs.</text></paragraph></subsection> <subsection id="HA1FB10B075E546DBB40D598810C6EFF2"><enum>(b)</enum><header>Application</header><text>To be eligible to receive a grant under subsection (a), an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.</text></subsection> <subsection id="H635533AD2CB64C07BDBC97247C76C341"><enum>(c)</enum><header>Activities</header> <paragraph id="H84A25AA00EED4CC4B1A6CC398340F5DF"><enum>(1)</enum><header>Training for health care professionals</header><text>A recipient of a grant under subsection (a)—</text> <subparagraph id="HD65270B7B49041E7B9E32523969F8AD5"><enum>(A)</enum><text>shall use the grant funds to plan, develop, and operate a training program to provide maternal health care in rural areas; and</text></subparagraph> <subparagraph id="H9B08885AE4EA4E8F96E76C05C34C229F"><enum>(B)</enum><text>may use the grant funds to provide additional support for the administration of the program or to meet the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or other units necessary to implement such training.</text></subparagraph></paragraph> <paragraph id="H2254FEDBFE76448CA1D0EE1A157A862B"><enum>(2)</enum><header>Training program requirements</header><text>The recipient of a grant under subsection (a) shall ensure that training programs carried out under the grant are evidence-based and address improving maternal health care in rural areas, and such programs may include training on topics such as—</text> <subparagraph id="H411CDCB7E4AE4A6A8C04C739B6EF5D2E"><enum>(A)</enum><text>maternal mental health, including perinatal depression and anxiety;</text></subparagraph> <subparagraph id="HAA259933F5D9420CAA5B12F2FA57A4AF"><enum>(B)</enum><text>substance use disorders;</text></subparagraph> <subparagraph id="H9C433DC0CCBB4421B8BE136C88A8BEE4"><enum>(C)</enum><text>social determinants of health that affect individuals living in rural areas; and</text></subparagraph> <subparagraph id="H8AC3006CE7C14665B628E5048492AEB7"><enum>(D)</enum><text>implicit and explicit bias.</text></subparagraph></paragraph></subsection> <subsection id="HACCCBDC66F934A40B5857D536CFE114D"><enum>(d)</enum><header>Evaluation and report</header> <paragraph id="H95FEC5BE6D3D45C88582631085B278CB"><enum>(1)</enum><header>Evaluation</header> <subparagraph id="HD4ABE24E81734A9A87CA964E779E4792"><enum>(A)</enum><header>In general</header><text>The Secretary shall evaluate the outcomes of the demonstration program under this section.</text></subparagraph> <subparagraph id="H9E3E72C9C231405EBA9D1F239D773746"><enum>(B)</enum><header>Data submission</header><text>Recipients of a grant under subsection (a) shall submit to the Secretary performance metrics and other related data in order to evaluate the program for the report described in paragraph (2).</text></subparagraph></paragraph> <paragraph id="HE9FAD12289B34375B899E954B619CB2A"><enum>(2)</enum><header>Report to Congress</header><text>Not later than January 1, 2025, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes—</text> <subparagraph id="H546B4BDA81A0487299882FAD783538B7"><enum>(A)</enum><text display-inline="yes-display-inline">an analysis of the effects of the demonstration program under this section on the quality, quantity, and distribution of maternal health care services, including health care services related to prenatal care, labor care, birthing, and postpartum care, and the demographics of the recipients of those services;</text></subparagraph> <subparagraph id="H0C54BA011B9C4ADA8D0F47D3197F3543"><enum>(B)</enum><text>an analysis of maternal and infant health outcomes (including quality of care, morbidity, and mortality) before and after implementation of the program in the communities served by entities participating in the demonstration program; and</text></subparagraph> <subparagraph id="H28810E81D447448D9CEDEAF1B0998334"><enum>(C)</enum><text>recommendations on whether the demonstration program should be continued.</text></subparagraph></paragraph></subsection> <subsection id="HA2FED5319F9E4558AD5C0885A81961EE"><enum>(e)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <enum>VI</enum><header>Addressing the Impacts of COVID–19 on Mental Health</header> <subtitle id="HE5BC2544279E4DC7B53530CE1FAEBB6A"><enum>A</enum><header>Creating Resources To Improve Situations of Inherent Severity</header> <section id="H06E9A2F6730F4D89B6A8836659633EE3"><enum>6001.</enum><header>Set-aside for evidence-based crisis care services</header><text display-inline="no-display-inline">Section 1920 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300x-9">42 U.S.C. 300x–9</external-xref>) is amended—</text> <paragraph id="H409387042BB54BDC99BA07B1770AA5BF"><enum>(1)</enum><text>in subsection (a), by striking <quote>$532,571,000 for each of fiscal years 2018 through 2022</quote> and inserting <quote>$532,571,000 for each of fiscal years 2018 through 2020, and $758,000,000 for each of fiscal years 2021 through 2022</quote>; and</text></paragraph> <paragraph id="H0035F42781904FB79E7412C63B47D0C4"><enum>(2)</enum><text>by adding at the end the following:</text> <quoted-block id="H7910CC3AC31540D0A9859A7A214FE6B8" style="OLC"> <subsection id="H3C3A355F827049CB86B838D5A8CD6441"><enum>(d)</enum><header>Crisis care</header> <paragraph id="H99E1170872404D6F83EA2EFDE817053D"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in paragraph (3), a State shall expend at least 5 percent of the amount the State receives pursuant to section 1911 for each fiscal year to support evidenced-based programs that address the crisis care needs of individuals with serious mental disorders, and children with serious mental and emotional disturbances.</text></paragraph> <paragraph id="H22D995EAD3844AC4B79FD60D262BD487"><enum>(2)</enum><header>Core elements</header><text display-inline="yes-display-inline">At the discretion of the single State agency responsible for the administration of the program of the State under a grant under section 1911, funds expended pursuant to paragraph (1) may be used to fund some or all of the core crisis care service components, delivered according to evidence-based principles, including the following:</text> <subparagraph id="HEE962C1C27314258A6A41186208795BF"><enum>(A)</enum><text>Crisis call centers.</text></subparagraph> <subparagraph id="H569C9150AFAD418290F00823ACA764F7"><enum>(B)</enum><text>24/7 mobile crisis services.</text></subparagraph> <subparagraph id="H92C8A26C9390429C9CEACDF6467448DE"><enum>(C)</enum><text>Crisis stabilization programs offering acute care or subacute care in a hospital or appropriately licensed facility, as determined by the Substance Abuse and Mental Health Services Administration, with referrals to inpatient or outpatient care.</text></subparagraph></paragraph> <paragraph id="H10E4AB326A9E4E999A8CB6B2EDC2EFE2"><enum>(3)</enum><header>State flexibility</header><text display-inline="yes-display-inline">In lieu of expending 5 percent of the amount the State receives pursuant to section 1911 for a fiscal year to support evidence-based programs as required by paragraph (1), a State may elect to expend not less than 10 percent of such amount to support such programs by the end of two consecutive fiscal years.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section></subtitle> <subtitle id="H7A7AB591CC2543B7937411F0AF1CB9AB"><enum>B</enum><header>Emergency Mental Health and Substance Use Training and Technical Assistance Center</header> <section section-type="subsequent-section" id="H812A4C39D05F469ABA8D373D5338A642"><enum>6011.</enum><header>Emergency mental health and substance use training and technical assistance center</header><text display-inline="no-display-inline">Subpart 3 of part B of title V of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-31">42 U.S.C. 290bb–31</external-xref> et seq.) is amended by inserting after section 520A (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-32">42 U.S.C. 290bb–32</external-xref>) the following:</text> <quoted-block style="OLC" id="H4C32DD4FB33144FB90BD66557F82D9C2"> <section id="H4805801927354C7E90A862422DFF56D5"><enum>520B.</enum><header>Emergency mental health and substance use training and technical assistance center</header> <subsection id="H9FC7663FB92649758BC45BCDEF282A9F"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">The Secretary, acting through the Assistant Secretary, shall establish or operate a center to be known as the Emergency Mental Health and Substance Use Training and Technical Assistance Center (referred to in this section as the <quote>Center</quote>) to provide technical assistance and support—</text> <paragraph id="H090583DB4173428483CC39B336971080"><enum>(1)</enum><text display-inline="yes-display-inline">to public or nonprofit entities seeking to establish or expand access to mental health and substance use prevention, treatment, and recovery support services, and increase awareness of such services; and</text></paragraph> <paragraph id="HB19C31D31C064564B5D3D4FFB3F43852"><enum>(2)</enum><text>to public health professionals, health care professionals and support staff, essential workers (as defined by a State, Tribe, locality, or territory), and members of the public to address the trauma, stress, and mental health needs associated with an emergency period. </text></paragraph></subsection> <subsection id="H87F8754EE1B24F2D9906829F3AF50018"><enum>(b)</enum><header>Assistance and support</header><text>The assistance and support provided under subsection (a) shall include assistance and support with respect to—</text> <paragraph id="HA51131FA6E584072A97FF128C38FE5B8"><enum>(1)</enum><text>training on identifying signs of trauma, stress, and mental health needs;</text></paragraph> <paragraph id="HAA793B58947743D69D0F2CAD3809CC14"><enum>(2)</enum><text>providing accessible resources to assist individuals and families experiencing trauma, stress, or other mental health needs during and after an emergency period;</text></paragraph> <paragraph id="HEE7ED0C6954E41B2AFFDC09E79839CC9"><enum>(3)</enum><text>providing resources for substance use disorder prevention, treatment, and recovery designed to assist individuals and families during and after an emergency period;</text></paragraph> <paragraph id="HADA1F82E954B469FB5B21083E9C6FFBC"><enum>(4)</enum><text>the provision of language access services, including translation services, interpretation, or other such services for individuals with limited English speaking proficiency or individuals with disabilities; and</text></paragraph> <paragraph id="H04F31FC410AC42F2B6C2304DC5AAE891"><enum>(5)</enum><text>evaluation and improvement, as necessary, of the effectiveness of such services provided by public or nonprofit entities.</text></paragraph></subsection> <subsection id="H65F27EF9E8204D41AB05FEBA3D2C4FA5"><enum>(c)</enum><header>Best practices</header><text>The Center shall periodically issue best practices for use by organizations seeking to provide mental health services or substance use disorder prevention, treatment, or recovery services, including best practices for the following special populations:</text> <paragraph id="H13F0E71C738A4454BE165CC2F76BC987"><enum>(1)</enum><text>Incarcerated individuals.</text></paragraph> <paragraph id="H9D1AAA3E0D6A413981DA51F469702707"><enum>(2)</enum><text>Children.</text></paragraph> <paragraph id="HFE2F3CBB0DF34A3A8C138356E5F87229"><enum>(3)</enum><text>Pregnant women.</text></paragraph> <paragraph id="H46277A35B925498CB139DAEC585FBB38"><enum>(4)</enum><text>Underserved populations.</text></paragraph> <paragraph id="H2644CCD70DA749A49301035DDEA64A2C"><enum>(5)</enum><text>Communities of color.</text></paragraph> <paragraph id="H23C6CB92B65D44D1ABBEA6BCB6EA1CA3"><enum>(6)</enum><text>Health care providers and essential workers.</text></paragraph></subsection> <subsection id="HC4C3B09BB0864701BCCBFD2D6FC8D574"><enum>(d)</enum><header>Emergency period</header><text display-inline="yes-display-inline">In this section, the term <term>emergency period</term> has the meaning given such term in section 1135(g)(1)(A) of the Social Security Act. </text></subsection> <subsection id="HEDE23549C17646A4A62413BE3863CED6"><enum>(e)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated to carry out this section $20,000,000 for each of fiscal years 2021 and 2022.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H83FE6401317545A3B9564CC03C06586B"><enum>C</enum><header>Suicide Prevention Grants</header> <section id="H0E20B37292264F27A5ED30EB2BE63AA0"><enum>6021.</enum><header>Syndromic surveillance of self-harm behaviors program</header><text display-inline="no-display-inline">Title III of the Public Health Service Act is amended by inserting after section 317U of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247b-23">42 U.S.C. 247b–23</external-xref>) the following:</text> <quoted-block display-inline="no-display-inline" id="H0C168612582641E98D7D9FC0D5A5AD19" style="OLC"> <section id="H59ADED021D794D93A940C4BBADEB25E9"><enum>317V.</enum><header>Syndromic surveillance of self-harm behaviors program</header> <subsection id="H5E6491653BAD4D3CA33422084FE5E4B8"><enum>(a)</enum><header>In general</header><text>The Secretary shall award grants to State, local, Tribal, and territorial public health departments for the expansion of surveillance of self-harm.</text></subsection> <subsection id="HCE0BC6F39FE14F348316857A8E309F88"><enum>(b)</enum><header>Data sharing by grantees</header><text display-inline="yes-display-inline">As a condition of receipt of such grant under subsection (a), each grantee shall agree to share with the Centers for Disease Control and Prevention in real time, to the extent feasible and as specified in the grant agreement, data on suicides and self-harm for purposes of—</text> <paragraph id="H5C4F0B5EF95544CF9611331519A0EE15"><enum>(1)</enum><text>tracking and monitoring self-harm to inform response activities to suicide clusters;</text></paragraph> <paragraph id="H9AA2807ED8F34F02BE2A4EA9054A280D"><enum>(2)</enum><text>informing prevention programming for identified at-risk populations; and</text></paragraph> <paragraph id="HAA8FE37318BF4CCAA0D88854D0B82367"><enum>(3)</enum><text>conducting or supporting research.</text></paragraph></subsection> <subsection id="H4C81BCEEFB3941E3AD26737FFA2CB633"><enum>(c)</enum><header>Disaggregation of data</header><text>The Secretary shall provide for the data collected through surveillance of self-harm under subsection (b) to be disaggregated by the following categories:</text> <paragraph id="H662C59CDAEEA471B95AC60B3DDDAD251"><enum>(1)</enum><text>Nonfatal self-harm data of any intent.</text></paragraph> <paragraph id="H7C5BD2E9AE044FAC9FCE1E7A7CC0D186"><enum>(2)</enum><text>Data on suicidal ideation.</text></paragraph> <paragraph id="H012B8C11D3DA4CD5A9AD4478F78CCC86"><enum>(3)</enum><text>Data on self-harm where there is no evidence, whether implicit or explicit, of suicidal intent.</text></paragraph> <paragraph id="H4B4E9B16A3034BD19285EEE52BD9600D"><enum>(4)</enum><text>Data on self-harm where there is evidence, whether implicit or explicit, of suicidal intent.</text></paragraph> <paragraph id="H79C8B04F8AC74213B9BE09E8B1036677"><enum>(5)</enum><text>Data on self-harm where suicidal intent is unclear based on the available evidence.</text></paragraph></subsection> <subsection id="H2593A9C591824EB78912DC3A9BADB860"><enum>(d)</enum><header>Priority</header><text>In making awards under subsection (a), the Secretary shall give priority to eligible entities that are—</text> <paragraph id="H94F858F6D23B499EB47CF10A7C129E22"><enum>(1)</enum><text display-inline="yes-display-inline">located in a State with an age-adjusted rate of nonfatal suicidal behavior that is above the national rate of nonfatal suicidal behavior, as determined by the Director of the Centers for Disease Control and Prevention;</text></paragraph> <paragraph id="H6512E708F8014CD49CC8D3BAF8AC0351"><enum>(2)</enum><text display-inline="yes-display-inline">serving an Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education Assistance Act) with an age-adjusted rate of nonfatal suicidal behavior that is above the national rate of nonfatal suicidal behavior, as determined through appropriate mechanisms determined by the Secretary in consultation with Indian Tribes; or</text></paragraph> <paragraph id="H858DC23E3F85467E808B0162D5A65123"><enum>(3)</enum><text>located in a State with a high rate of coverage of statewide (or Tribal) emergency department visits, as determined by the Director of the Centers for Disease Control and Prevention.</text></paragraph></subsection> <subsection id="HE36F16E3378E46C3A3C038762104D83D"><enum>(e)</enum><header>Geographic distribution</header><text>In making grants under this section, the Secretary shall make an effort to ensure geographic distribution, taking into account the unique needs of rural communities, including—</text> <paragraph id="HF787445093D14178BB436250CC21D1F9"><enum>(1)</enum><text>communities with an incidence of individuals with serious mental illness, demonstrated suicidal ideation or behavior, or suicide rates that are above the national average, as determined by the Assistant Secretary for Mental Health and Substance Use;</text></paragraph> <paragraph id="H84E5166F61EB4831BF72A69D23F6609B"><enum>(2)</enum><text>communities with a shortage of prevention and treatment services, as determined by the Assistant Secretary for Mental Health and Substance Use and the Administrator of the Health Resources and Services Administration; and</text></paragraph> <paragraph id="H608A630BFA8545C282264624FD58023F"><enum>(3)</enum><text>other appropriate community-level factors and social determinants of health such as income, employment, and education.</text></paragraph></subsection> <subsection id="H2EB2FDB7766F472592546A4D30EB91F0"><enum>(f)</enum><header>Period of participation</header><text>To be selected as a grant recipient under this section, a State, local, Tribal, or territorial public health department shall agree to participate in the program for a period of not less than 4 years.</text></subsection> <subsection id="HC7175EA8F6D244DDA205FC336C041C6E"><enum>(g)</enum><header>Technical assistance</header><text>The Secretary shall provide technical assistance and training to grantees for collecting and sharing the data under subsection (b).</text></subsection> <subsection id="H0C1EDA7FEBDB40399F40FF3EE4C7ABC2"><enum>(h)</enum><header>Data sharing by HHS</header><text>Subject to subsection (b), the Secretary shall, with respect to data on self-harm that is collected pursuant to this section, share and integrate such data through—</text> <paragraph id="H84BBB25DFF7C4AF185532CD6A0B2E318"><enum>(1)</enum><text>the National Syndromic Surveillance Program’s Early Notification of Community Epidemics (ESSENCE) platform (or any successor platform);</text></paragraph> <paragraph id="HA1F5C7A3BDFF4EBAA03ED97AB0031C7C"><enum>(2)</enum><text>the National Violent Death Reporting System, as appropriate; or</text></paragraph> <paragraph id="HA46E2E6F47F640F0B4F4A1E6E76C6D39"><enum>(3)</enum><text>another appropriate surveillance program, including such a program that collects data on suicides and self-harm among special populations, such as members of the military and veterans.</text></paragraph></subsection> <subsection id="H1E2BA6CB73264D6BB29F04C112ADD5C7"><enum>(i)</enum><header>Rule of construction regarding applicability of privacy protections</header><text>Nothing in this section shall be construed to limit or alter the application of Federal or State law relating to the privacy of information to data or information that is collected or created under this section.</text></subsection> <subsection id="H878D0AF5067E468DA1D67A909637B0A2"><enum>(j)</enum><header>Report</header> <paragraph id="H197886015664426C96499C4E2A60CA77"><enum>(1)</enum><header>Submission</header><text>Not later than 3 years after the date of enactment of this Act, the Secretary shall evaluate the suicide and self-harm syndromic surveillance systems at the Federal, State, and local levels and submit a report to Congress on the data collected under subsections (b) and (c) in a manner that prevents the disclosure of individually identifiable information, at a minimum, consistent with all applicable privacy laws and regulations.</text></paragraph> <paragraph id="H6D066AFF07A24F599188CEC05AF23586"><enum>(2)</enum><header>Contents</header><text>In addition to the data collected under subsections (b) and (c), the report under paragraph (1) shall include—</text> <subparagraph id="H712DBD672CE941ECBB3EF3F3B4FD33D6"><enum>(A)</enum><text>challenges and gaps in data collection and reporting;</text></subparagraph> <subparagraph id="H9D85E7C77A9546E598E707B4347769DA"><enum>(B)</enum><text>recommendations to address such gaps and challenges; and</text></subparagraph> <subparagraph id="HF49957268AB74F448E48F24EABA3C9B6"><enum>(C)</enum><text>a description of any public health responses initiated at the Federal, State, or local level in response to the data collected.</text></subparagraph></paragraph></subsection> <subsection commented="no" display-inline="no-display-inline" id="H9A8F5985FC774195B0B99D7F6425B36E"><enum>(k)</enum><header>Authorization of appropriations</header><text>To carry out this section, there are authorized to be appropriated $20,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H0636D19C698241D3B63F9B53039BC595"><enum>6022.</enum><header>Grants to provide self-harm and suicide prevention services</header><text display-inline="no-display-inline">Part B of title V of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290aa">42 U.S.C. 290aa</external-xref> et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H96ECE2C08E7A476DBEBC3349043896CA" style="OLC"> <section id="H9135F93D4B0E4E3D878B302EB76F3285"><enum>520N.</enum><header>Grants to provide self-harm and suicide prevention services</header> <subsection display-inline="no-display-inline" id="H58716194614A40D0A11D7F4A436B593E"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall award grants to hospital emergency departments to provide self-harm and suicide prevention services.</text></subsection> <subsection id="H212B7E4B57B44C359D3E17D6648528DB"><enum>(b)</enum><header>Activities supported</header> <paragraph id="HBA27C2C990374BFDA12BC8902CB67A2A"><enum>(1)</enum><header>In general</header><text>A hospital emergency department awarded a grant under subsection (a) shall use amounts under the grant to implement a program or protocol to better prevent suicide attempts among hospital patients after discharge, which may include—</text> <subparagraph id="HFF36282D3422461190F8787B92CA4951"><enum>(A)</enum><text display-inline="yes-display-inline">screening patients for self-harm and suicide in accordance with the standards of practice described in subsection (e)(1) and standards of care established by appropriate medical and advocacy organizations;</text></subparagraph> <subparagraph id="H49C027A712AC4AB48836BE11DDAE9EE7"><enum>(B)</enum><text display-inline="yes-display-inline">providing patients short-term self-harm and suicide prevention services in accordance with the results of the screenings described in subparagraph (A); and</text></subparagraph> <subparagraph id="HC14C10D88E214278BD4F9062AF6F7989"><enum>(C)</enum><text>referring patients, as appropriate, to a health care facility or provider for purposes of receiving long-term self-harm and suicide prevention services, and providing any additional follow up services and care identified as appropriate as a result of the screenings and short-term self-harm and suicide prevention services described in subparagraphs (A) and (B).</text></subparagraph></paragraph> <paragraph id="H5E56683F6EED4F9DABB47B5523CFF58A"><enum>(2)</enum><header>Use of funds to hire and train staff</header><text>Amounts awarded under subsection (a) may be used to hire clinical social workers, mental and behavioral health care professionals, and support staff as appropriate, and to train existing staff and newly hired staff to carry out the activities described in paragraph (1).</text></paragraph></subsection> <subsection id="H01184843717A466DB275C9241DCE40A9"><enum>(c)</enum><header>Grant terms</header><text display-inline="yes-display-inline">A grant awarded under subsection (a)—</text> <paragraph id="HEE3C163C7B274E64989B8D09E5FBA01F"><enum>(1)</enum><text>shall be for a period of 3 years; and</text></paragraph> <paragraph id="H0F45C008D4BC43FDBB891A5F6757C053"><enum>(2)</enum><text>may be renewed subject to the requirements of this section.</text></paragraph></subsection> <subsection id="H1E99469C143044A998DE7EC4CC40EB37"><enum>(d)</enum><header>Applications</header><text display-inline="yes-display-inline">A hospital emergency department seeking a grant under subsection (a) shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary may require.</text></subsection> <subsection display-inline="no-display-inline" id="H9A312A9D656146EC8DB033326597253A"><enum>(e)</enum><header>Standards of Practice</header> <paragraph id="H3166C11A24064859AEECD498C8D1AD63"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 180 days after the date of the enactment of this section, the Secretary shall develop standards of practice for screening patients for self-harm and suicide for purposes of carrying out subsection (b)(1)(C).</text></paragraph> <paragraph id="H59D05263BB454FF6A37D7A8878F2CA36"><enum>(2)</enum><header>Consultation</header><text>The Secretary shall develop the standards of practice described in paragraph (1) in consultation with individuals and entities with expertise in self-harm and suicide prevention, including public, private, and non-profit entities.</text></paragraph></subsection> <subsection id="H905348E27B334D0EA449F6D6CFE15DD5"><enum>(f)</enum><header>Reporting</header> <paragraph id="H963A15E1173E4028B2828FDF93FF12A0"><enum>(1)</enum><header>Reports to the Secretary</header> <subparagraph id="H89C9BE8909DD4A2186A73B76735D1E1C"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">A hospital emergency department awarded a grant under subsection (a) shall, at least quarterly for the duration of the grant, submit to the Secretary a report evaluating the activities supported by the grant.</text></subparagraph> <subparagraph id="H993B24CB02284E8689D8C45E94AE3DC5"><enum>(B)</enum><header>Matters to be included</header><text>The report required under subparagraph (A) shall include—</text> <clause id="H10B45955E4A440C3B970BFCBF55EC41A"><enum>(i)</enum><text>the number of patients receiving—</text> <subclause id="HA41D94F6DBA549C682A1A0EBB9EDC841"><enum>(I)</enum><text>screenings carried out at the hospital emergency department;</text></subclause> <subclause id="HFD74F47C80E14DBFACC15E5734AF3D09"><enum>(II)</enum><text display-inline="yes-display-inline">short-term self-harm and suicide prevention services at the hospital emergency department; and</text></subclause> <subclause id="H38F3C4E100204E96A27B502EE54FEB44"><enum>(III)</enum><text display-inline="yes-display-inline">referrals to health care facilities for the purposes of receiving long-term self-harm and suicide prevention;</text></subclause></clause> <clause id="H7D240D927B86409CBDD7C7CD31583475"><enum>(ii)</enum><text display-inline="yes-display-inline">information on the adherence of the hospital emergency department to the standards of practice described in subsection (f)(1); and</text></clause> <clause id="H6BECB7ECCB5242729A7381F1A9BEFAE6"><enum>(iii)</enum><text>other information as the Secretary determines appropriate to evaluate the use of grant funds.</text></clause></subparagraph></paragraph> <paragraph id="H7FAFB63636404121AD28560C5BBCBE80" commented="no"><enum>(2)</enum><header>Reports to Congress</header><text display-inline="yes-display-inline">Not later than 2 years after the date of the enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, and biennially thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the grant program under this section, including—</text> <subparagraph id="H3D528BF09E2B48ABB72CD221EB154380" commented="no"><enum>(A)</enum><text>a summary of reports received by the Secretary under paragraph (1); and</text></subparagraph> <subparagraph id="H07D31DCB1F6D4E4A9777196090503FB0" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">an evaluation of the program by the Secretary.</text></subparagraph></paragraph></subsection> <subsection id="HCA2C5DCD2594463C88ED893B0DF52299"><enum>(g)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">To carry out this section, there are authorized to be appropriated $30,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H2A437EA911074B7CB418DB65AB08BC21"><enum>D</enum><header>Effective Suicide Screening in the Emergency Department</header> <section id="H36183C7A02574777A3CE825794896BB5"><enum>6031.</enum><header>Program to improve the care provided to patients in the emergency department who are at risk of suicide</header><text display-inline="no-display-inline">Part P of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280g">42 U.S.C. 280g</external-xref> et seq.) is amended by adding at the end the following new section:</text> <quoted-block display-inline="no-display-inline" id="HD56D1BFB6B1644FF9EB4B7CB6E005D82" style="OLC"> <section id="H55B4763D775F4E33B2A14DB37950A21E"><enum>399V–7.</enum><header>Program to improve the care provided to patients in the emergency department who are at risk of suicide</header> <subsection id="HE4D2A34A9ADE4BA8A67AC7F4DBA07874"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall establish a program (in this section referred to as the <quote>Program</quote>) to improve the identification, assessment, and treatment of patients in emergency departments who are at risk for suicide, including by—</text> <paragraph id="H13ADFB59B8964953AEE298E947B327F6"><enum>(1)</enum><text>developing policies and procedures for identifying and assessing individuals who are at risk of suicide; and</text></paragraph> <paragraph id="H7580B8BE313A49A5BCDFFFF6D3DF9A70"><enum>(2)</enum><text>enhancing the coordination of care for such individuals after discharge.</text></paragraph></subsection> <subsection id="H8EA0DF344C6C4C9C92306881B2C376D9"><enum>(b)</enum><header>Grant establishment and participation</header> <paragraph id="H7F2813BD48454B8B9B1DCAD3C38066C0"><enum>(1)</enum><header>In general</header><text>In carrying out the Program, the Secretary shall award grants on a competitive basis to not more than 40 eligible health care sites described in paragraph (2).</text></paragraph> <paragraph id="HB020F46EACDE43FC9B95030703A430DE"><enum>(2)</enum><header>Eligibility</header><text>To be eligible for a grant under this section, a health care site shall—</text> <subparagraph id="H76D4DEED024B44DC964FA0520497AAC5"><enum>(A)</enum><text>submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may specify;</text></subparagraph> <subparagraph id="HFB18B7C70AB7442185027AF80A7EF5B7"><enum>(B)</enum><text display-inline="yes-display-inline">be a hospital (as defined in section 1861(e) of the Social Security Act);</text></subparagraph> <subparagraph id="H997198CF0512496490FFC87475E06EFF"><enum>(C)</enum><text>have an emergency department; and</text></subparagraph> <subparagraph id="H88CCAA92EDA4420888685D9A7C6288D7"><enum>(D)</enum><text>deploy onsite health care or social service professionals to help connect and integrate patients who are at risk of suicide with treatment and mental health support services.</text></subparagraph></paragraph> <paragraph id="H62D57FFCA5EA4F49B1C5F7FA3F9C94CC"><enum>(3)</enum><header>Preference</header><text>In awarding grants under this section, the Secretary may give preference to eligible health care sites described in paragraph (2) that meet at least one of the following criteria:</text> <subparagraph id="H5F7A223AF60D462E857CDCE4131431B8"><enum>(A)</enum><text>The eligible health care site is a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act).</text></subparagraph> <subparagraph id="H70EB028C8C0F44818271F5579D46C0E6"><enum>(B)</enum><text display-inline="yes-display-inline">The eligible health care site is a sole community hospital (as defined in section 1886(d)(5)(D)(iii) of the Social Security Act).</text></subparagraph> <subparagraph id="HC313CC55AF3B407B8660DD17D9D06DFC"><enum>(C)</enum><text display-inline="yes-display-inline">The eligible health care site is operated by the Indian Health Service, by an Indian tribe or tribal organization (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), or by an urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act).</text></subparagraph> <subparagraph id="HEC2251A3146E41CF92657904F3EF59EA"><enum>(D)</enum><text>The eligible health care site is located in a geographic area with a suicide rate that is higher than the national rate, as determined by the Secretary based on the most recent data from the Centers for Disease Control and Prevention.</text></subparagraph></paragraph></subsection> <subsection id="HB1A599F9852B434199E351CE5C8E0491"><enum>(c)</enum><header>Period of grant</header><text>A grant awarded to an eligible health care site under this section shall be for a period of at least 2 years.</text></subsection> <subsection id="H926E1008038B41E583135C290E3E08FE"><enum>(d)</enum><header>Grant uses</header> <paragraph id="HA80633E7A0694B548D35C1A034E96C92"><enum>(1)</enum><header>Required uses</header><text>A grant awarded under this section to an eligible health care site shall be used for the following purposes:</text> <subparagraph id="H1ED0358533BD4B3584ED6BC229B13034"><enum>(A)</enum><text>To train emergency department health care professionals to identify, assess, and treat patients who are at risk of suicide.</text></subparagraph> <subparagraph id="H9E876119C87C4CC9A7C8B6DA6DBDCCEF"><enum>(B)</enum><text>To establish and implement policies and procedures for emergency departments to improve the identification, assessment and treatment of individuals who are at risk of suicide.</text></subparagraph> <subparagraph id="HA4C92A6DE50A477EBB5A75FB3BEBDF8E"><enum>(C)</enum><text>To establish and implement policies and procedures with respect to care coordination, integrated care models, or referral to evidence-based treatment to be used upon the discharge from the emergency department of patients who are at risk of suicide.</text></subparagraph></paragraph> <paragraph id="H9693C35DAFC9481395617E1010733289"><enum>(2)</enum><header>Additional permissible uses</header><text>In addition to the required uses listed in paragraph (1), a grant awarded under this section to an eligible health care site may be used for any of the following purposes:</text> <subparagraph id="H4CAA20E255C84A5290205C7B3AFA72CE"><enum>(A)</enum><text>To hire emergency department psychiatrists, psychologists, nurse practitioners, counselors, therapists, or other licensed health care and behavioral health professionals specializing in the treatment of individuals at risk of suicide.</text></subparagraph> <subparagraph id="HA3345B0231034D30846A99FD2674A33F"><enum>(B)</enum><text>To develop and implement best practices for the follow-up care and long-term treatment of individuals who are at risk of suicide.</text></subparagraph> <subparagraph id="H449B86616D004305A715A37A86719490"><enum>(C)</enum><text>To increase the availability of and access to evidence-based treatment for individuals who are at risk of suicide, including through telehealth services and strategies to reduce the boarding of these patients in emergency departments.</text></subparagraph> <subparagraph id="H21CE74100C5E49DF8ED6E7ED1BCB868F"><enum>(D)</enum><text>To offer consultation with and referral to other supportive services that provide evidence-based treatment and recovery for individuals who are at risk of suicide.</text></subparagraph></paragraph></subsection> <subsection id="HD276105CE023449A93373F1D8013A0A4"><enum>(e)</enum><header>Reporting requirements</header> <paragraph id="HB881B4BD69C4483DA81328337E4D72BD"><enum>(1)</enum><header>Reports by grantees</header><text>Each eligible health care site receiving a grant under this section shall submit to the Secretary an annual report for each year for which the grant is received on the progress of the program funded through the grant. Each such report shall include information on—</text> <subparagraph id="HC897F8EDBF304E1D80BE662D71A01BE1"><enum>(A)</enum><text>the number of individuals screened in the site’s emergency department for being at risk of suicide;</text></subparagraph> <subparagraph id="H3F2D748B036049D8AFC4640A869674E6"><enum>(B)</enum><text display-inline="yes-display-inline">the number of individuals identified in the site’s emergency department as being—</text> <clause id="H9FB1E3FA817044389D2885717BEF58D4"><enum>(i)</enum><text>survivors of an attempted suicide; or</text></clause> <clause id="H87135504DFED4AFFA6277B4AD103A14C"><enum>(ii)</enum><text>are at risk of suicide;</text></clause></subparagraph> <subparagraph id="H10D812CEB83C4D7BB8277EC492CBE1C8"><enum>(C)</enum><text display-inline="yes-display-inline">the number of individuals who are identified in the site’s emergency department as being at risk of suicide by a health care or behavioral health professional hired pursuant to subsection (d)(2)(A);</text></subparagraph> <subparagraph id="H4B28D0C6B2214506A98C0769CEA98682"><enum>(D)</enum><text>the number of individuals referred by the site’s emergency department to other treatment facilities, the types of such other facilities, and the number of such individuals admitted to such other facilities pursuant to such referrals;</text></subparagraph> <subparagraph id="HF3FEB007E986452B8FF54F789371765D"><enum>(E)</enum><text>the effectiveness of programs and activities funded through the grant in preventing suicides and suicide attempts; and</text></subparagraph> <subparagraph id="HA466ACA348944B0ABD33A41ED80522A5"><enum>(F)</enum><text>any other relevant additional data regarding the programs and activities funded through the grant.</text></subparagraph></paragraph> <paragraph id="HD9C5649A292349A083A973CC5B1A1C3C"><enum>(2)</enum><header>Report by Secretary</header><text>Not later than one year after the end of fiscal year 2025, the Secretary shall submit to Congress a report that includes—</text> <subparagraph id="HEFE220910389474C88BBECFF0E680E7C"><enum>(A)</enum><text>findings on the Program;</text></subparagraph> <subparagraph id="HC167A4FB4A534FE2B99960DECB4FA648"><enum>(B)</enum><text>overall patient outcomes achieved through the Program;</text></subparagraph> <subparagraph id="H05FD8B84C81343CD82B623B554D262D4"><enum>(C)</enum><text>an evaluation of the effectiveness of having a trained health care or behavioral health professional onsite to identify, assess, and treat patients who are at risk of suicide; and</text></subparagraph> <subparagraph id="HABE41833FF174AEF8D146D08BB25F425"><enum>(D)</enum><text>a compilation of policies, procedures, and best practices established, developed, or implemented by grantees under this section.</text></subparagraph></paragraph></subsection> <subsection id="H95F35CA655DB45FB97E20C7FCC419003"><enum>(f)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated to carry out this section $20,000,000 for the period of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="HB5BB171F27B84BD3A0E7079B785314FB"><enum>E</enum><header>Suicide Prevention Lifeline Improvement</header> <section commented="no" id="HD16C4EAF48F84DB5A091E21B0F9F57E9" section-type="subsequent-section"><enum>6041.</enum><header>Suicide Prevention Lifeline</header> <subsection id="H9E52FBDE9DFA4D1BA8C1AA9E4903B8C8"><enum>(a)</enum><header>Plan</header><text display-inline="yes-display-inline">Section 520E–3 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-36c">42 U.S.C. 290bb–36c</external-xref>) is amended—</text> <paragraph id="H444469F07E654CEDB1CB7D4409120401"><enum>(1)</enum><text>by redesignating subsection (c) as subsection (e); and</text></paragraph> <paragraph id="H2F37E5D3A0574C049335304498D46509"><enum>(2)</enum><text>by inserting after subsection (b) the following:</text> <quoted-block display-inline="no-display-inline" id="H7090455DC3B04124BD1F32223F9303BC" style="OLC"> <subsection id="HB8937609644F474298B3CABBB6C664D5"><enum>(c)</enum><header>Plan</header> <paragraph id="HE3ED88340C5A4FC08001D72FB2A76016"><enum>(1)</enum><header>In general</header><text>For purposes of maintaining the suicide prevention hotline under subsection (b)(2), the Secretary shall develop and implement a plan to ensure the provision of high-quality service.</text></paragraph> <paragraph id="H4CD4987D6AD74C3DA1189029ED753714"><enum>(2)</enum><header>Contents</header><text>The plan required by paragraph (1) shall include the following:</text> <subparagraph id="H7B8D86B9F1954B1DB9FB3FD8F1FBDCA1"><enum>(A)</enum><text>Quality assurance provisions, including—</text> <clause id="HA2EBEE2F1E994CC8BA36A0F916083825"><enum>(i)</enum><text>clearly defined and measurable performance indicators and objectives to improve the responsiveness and performance of the hotline, including at backup call centers; and</text></clause> <clause id="H08AF60AC78CE4B3F826D9BE4EF421CC2"><enum>(ii)</enum><text>quantifiable timeframes to track the progress of the hotline in meeting such performance indicators and objectives.</text></clause></subparagraph> <subparagraph id="H26CD5DE275154255852AE10FA4256E2F"><enum>(B)</enum><text>Standards that crisis centers and backup centers must meet—</text> <clause id="H6D8A6385ABB042B6A5987774641FEB64"><enum>(i)</enum><text>to participate in the network under subsection (b)(1); and</text></clause> <clause id="H94A7FEC287AB493983D6D66748134E59"><enum>(ii)</enum><text display-inline="yes-display-inline">to ensure that each telephone call, online chat message, and other communication received by the hotline, including at backup call centers, is answered in a timely manner by a person, consistent with the guidance established by the American Association of Suicidology or other guidance determined by the Secretary to be appropriate.</text></clause></subparagraph> <subparagraph id="HB1B15701D4F64A86BB17DB0DA80F42CD"><enum>(C)</enum><text display-inline="yes-display-inline">Guidelines for crisis centers and backup centers to implement evidence-based practices including with respect to followup and referral to other health and social services resources.</text></subparagraph> <subparagraph id="H1252235FF2724F0BB8325988F6132114"><enum>(D)</enum><text>Guidelines to ensure that resources are available and distributed to individuals using the hotline who are not personally in a time of crisis but know of someone who is.</text></subparagraph> <subparagraph id="HCB3BC2A0A78149D7BC4A48060F7E3460"><enum>(E)</enum><text>Guidelines to carry out periodic testing of the hotline, including at crisis centers and backup centers, during each fiscal year to identify and correct any problems in a timely manner.</text></subparagraph> <subparagraph id="H772C6EBFFB8A4FE99177DA514FF68849"><enum>(F)</enum><text display-inline="yes-display-inline">Guidelines to operate in consultation with the State department of health, local governments, Indian tribes, and tribal organizations.</text></subparagraph></paragraph> <paragraph id="H4E2BE1C7F293413DA85F440EF068FE76"><enum>(3)</enum><header>Initial plan; updates</header><text>The Secretary shall—</text> <subparagraph id="H7565F38BF9AF438B9ED462CE9E2AB322"><enum>(A)</enum><text display-inline="yes-display-inline">not later than 6 months after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, complete development of the initial version of the plan required by paragraph (1), begin implementation of such plan, and make such plan publicly available; and</text></subparagraph> <subparagraph id="HA27CD097D88E4FF4B1476FD7EC5976A3"><enum>(B)</enum><text>periodically thereafter, update such plan and make the updated plan publicly available.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H4D375EF93C234C90AB6A295206F4028C"><enum>(b)</enum><header>Transmission of data to CDC</header><text display-inline="yes-display-inline">Section 520E–3 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-36c">42 U.S.C. 290bb–36c</external-xref>) is amended by inserting after subsection (c) of such section, as added by subsection (a) of this section, the following:</text> <quoted-block display-inline="no-display-inline" id="H277CF35FE5C64A6DAF5BB65552C44DB5" style="OLC"> <subsection id="H430E4238FED74A58A05B68A4392808D5"><enum>(d)</enum><header>Transmission of data to CDC</header><text display-inline="yes-display-inline">The Secretary shall formalize and strengthen agreements between the National Suicide Prevention Lifeline program and the Centers for Disease Control and Prevention to transmit any necessary epidemiological data from the program to the Centers, including local call center data, to assist the Centers in suicide prevention efforts.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H0497CE0D84134864AFAEBE8C4773C99C"><enum>(c)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">Subsection (e) of section 520E–3 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-36c">42 U.S.C. 290bb–36c</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="HB936DF2ADAAC4337BB07033C0671A25F" style="OLC"> <subsection id="H8BB8AC71FBDD487F96EC5F24B4DCD5E8"><enum>(e)</enum><header>Authorization of appropriations</header> <paragraph id="HAA268A7014F54ACDBDC56E97C62DC59B"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">To carry out this section, there are authorized to be appropriated $50,000,000 for each of fiscal years 2021 through 2023.</text></paragraph> <paragraph id="H6DAD7D73A45341B291CF0E4C83C3DFEE"><enum>(2)</enum><header>Allocation</header><text display-inline="yes-display-inline">Of the amount authorized to be appropriated by paragraph (1) for each of fiscal years 2021 through 2023, at least 80 percent shall be made available to crisis centers.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="H4223F6C83FFF48C6807E8CA506E51008"><enum>6042.</enum><header>Pilot program on innovative technologies</header> <subsection id="HFFDAA733B9C544B7B5CB09FB7AD23D70"><enum>(a)</enum><header>Pilot program</header> <paragraph id="H27D99180A08640CB97449CB3E02D19DB"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, shall carry out a pilot program to research, analyze, and employ various technologies and platforms of communication (including social media platforms, texting platforms, and email platforms) for suicide prevention in addition to the telephone and online chat service provided by the Suicide Prevention Lifeline.</text></paragraph> <paragraph id="H391B3A9DB6D440488AC0DD7306A88789"><enum>(2)</enum><header>Authorization of appropriations</header><text>To carry out paragraph (1), there is authorized to be appropriated $5,000,000 for the period of fiscal years 2021 and 2022.</text></paragraph></subsection> <subsection id="H59DAA294084C4C93B81FD5088DB6A8F5"><enum>(b)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than 24 months after the date on which the pilot program under subsection (a) commences, the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, shall submit to the Congress a report on the pilot program. With respect to each platform of communication employed pursuant to the pilot program, the report shall include—</text> <paragraph id="HED72E73ADBEB48F3AA834C6BE6EAE57E"><enum>(1)</enum><text>a full description of the program;</text></paragraph> <paragraph id="H793F58699E874F71B7B591491114CF2F"><enum>(2)</enum><text>the number of individuals served by the program;</text></paragraph> <paragraph id="H3BA838F6549F4EBCA4EC48434E6D93B1"><enum>(3)</enum><text>the average wait time for each individual to receive a response;</text></paragraph> <paragraph id="H28F8DCF6E34A416CAE2A76D3E11E7896"><enum>(4)</enum><text>the cost of the program, including the cost per individual served; and</text></paragraph> <paragraph id="H38E84850B6AD487D82C5B0E9D7F0C5A1"><enum>(5)</enum><text>any other information the Secretary determines appropriate.</text></paragraph></subsection></section> <section id="H4ED1A4811999411E97EF58A351591F30"><enum>6043.</enum><header>HHS study and report</header><text display-inline="no-display-inline">Not later than 24 months after the Secretary of Health and Human Services begins implementation of the plan required by section 520E–3(c) of the Public Health Service Act, as added by section 6041(a)(2) of this subtitle, the Secretary shall—</text> <paragraph id="H6003BC6AE66F4BDA92DD818EAAF662F5"><enum>(1)</enum><text>complete a study on—</text> <subparagraph id="H8A3B3B6D71F34014B3DF4FF96F3DC2EF"><enum>(A)</enum><text>the implementation of such plan, including the progress towards meeting the objectives identified pursuant to paragraph (2)(A)(i) of such section 520E–3(c) by the timeframes identified pursuant to paragraph (2)(A)(ii) of such section 520E–3(c); and</text></subparagraph> <subparagraph id="H5A55D44514A143C19958B205347C0DFA"><enum>(B)</enum><text display-inline="yes-display-inline">in consultation with the Director of the Centers for Disease Control and Prevention, options to expand data gathering from calls to the Suicide Prevention Lifeline in order to better track aspects of usage such as repeat calls, consistent with applicable Federal and State privacy laws; and</text></subparagraph></paragraph> <paragraph id="HA809D014927F4187A87782FB26110A21"><enum>(2)</enum><text>submit a report to the Congress on the results of such study, including recommendations on whether additional legislation or appropriations are needed.</text></paragraph></section> <section id="HA8A008FC37FA4267AA57F2E81A2DFFD2"><enum>6044.</enum><header>GAO study and report</header> <subsection id="H34510C16957D411A9E6E356D7BC7E370"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 24 months after the Secretary of Health and Human Services begins implementation of the plan required by section 520E–3(c) of the Public Health Service Act, as added by section 6041(a)(2) of this subtitle, the Comptroller General of the United States shall—</text> <paragraph id="HF8F85DE489444637B2867AFC8B431DB0"><enum>(1)</enum><text display-inline="yes-display-inline">complete a study on the Suicide Prevention Lifeline; and</text></paragraph> <paragraph id="H41A336135C204847B0D132E190D5C3B6"><enum>(2)</enum><text>submit a report to the Congress on the results of such study.</text></paragraph></subsection> <subsection id="H4D570032A52C4DB5B961D7742A49AF9F"><enum>(b)</enum><header>Issues To be studied</header><text display-inline="yes-display-inline">The study required by subsection (a) shall address—</text> <paragraph id="HC66B6B76B9BD433EB08AFEEB729F3762"><enum>(1)</enum><text>the feasibility of geolocating callers to direct calls to the nearest crisis center;</text></paragraph> <paragraph id="H29C5D725E10A423893160D0991740C40"><enum>(2)</enum><text display-inline="yes-display-inline">operation shortcomings of the Suicide Prevention Lifeline;</text></paragraph> <paragraph id="HBA0289FFD8C54A58A42044093ACEB9EF"><enum>(3)</enum><text>geographic coverage of each crisis call center;</text></paragraph> <paragraph id="HC115D1EBF2274317A96233A2DCB64129"><enum>(4)</enum><text>the call answer rate of each crisis call center;</text></paragraph> <paragraph id="HAB78A1E80B7045DD938A90BB46AC7D95"><enum>(5)</enum><text>the call wait time of each crisis call center;</text></paragraph> <paragraph id="H560FE1483506422085E51EE8D51761D4"><enum>(6)</enum><text>the hours of operation of each crisis call center;</text></paragraph> <paragraph id="HFD986BE2D89E4FC08F79B694508D87DD"><enum>(7)</enum><text>funding avenues of each crisis call center;</text></paragraph> <paragraph id="HA3A41F05100D4A6486ED4992F2754E98"><enum>(8)</enum><text display-inline="yes-display-inline">the implementation of the plan under section 520E–3(c) of the Public Health Service Act, as added by section 6041(a) of this subtitle, including the progress towards meeting the objectives identified pursuant to paragraph (2)(A)(i) of such section 520E–3(c) by the timeframes identified pursuant to paragraph (2)(A)(ii) of such section 520E–3(c); and</text></paragraph> <paragraph id="H39889BDBFCAE44F8A911641C79FDBD0D"><enum>(9)</enum><text>service to individuals requesting a foreign language speaker, including—</text> <subparagraph id="H20D4ABF256874CAA883E436532BA6593"><enum>(A)</enum><text>the number of calls or chats the Lifeline receives from individuals speaking a foreign language;</text></subparagraph> <subparagraph id="H7BCCAAC9F8EF422A940AF874E4264FA0"><enum>(B)</enum><text>the capacity of the Lifeline to handle these calls or chats; and</text></subparagraph> <subparagraph id="H2B15E83B1E85409B823DDB328389EE48"><enum>(C)</enum><text>the number of crisis centers with the capacity to serve foreign language speakers, in house.</text></subparagraph></paragraph></subsection> <subsection id="HACC85B04E3DB4CC7946993769B1467FD"><enum>(c)</enum><header>Recommendations</header><text>The report required by subsection (a) shall include recommendations for improving the Suicide Prevention Lifeline, including recommendations for legislative and administrative actions.</text></subsection></section> <section id="H3E54508B1C7E43E79D80AF5488B9F1DA"><enum>6045.</enum><header>Definition</header><text display-inline="no-display-inline">In this subtitle, the term <term>Suicide Prevention Lifeline</term> means the suicide prevention hotline maintained pursuant to section 520E–3 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-36c">42 U.S.C. 290bb–36c</external-xref>).</text></section></subtitle> <subtitle id="HC38DFDBB1E044A069C644D12E5AD6601" commented="no"><enum>F</enum><header>Campaign To Prevent Suicide</header> <section commented="no" id="HAECEDB979B564C90B3FC0FE7A7747F46"><enum>6051.</enum><header>National Suicide Prevention Lifeline</header><text display-inline="no-display-inline">Section 520E–3(b)(2) of the Public Health Service Act (42 U.S.C. 290bb–36c(b)(2)) is amended by inserting after <quote>suicide prevention hotline</quote> the following: <quote>, which, beginning not later than one year after the date of the enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, shall be a 3-digit nationwide toll-free telephone number,</quote>.</text></section> <section id="H4C881C6F93474D18A93B75EDA9FC08C6" section-type="subsequent-section" commented="no"><enum>6052.</enum><header>National suicide prevention media campaign</header> <subsection id="H39E0C7C98900418CB7FD0A4489973159" commented="no"><enum>(a)</enum><header>National suicide prevention media campaign</header> <paragraph id="HB1828BEF51DF4FDEA15E0EF1B1DF33C2" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than the date that is three years after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>), in coordination with the Assistant Secretary for Mental Health and Substance Use (referred to in this section as the <quote>Assistant Secretary</quote>) and the Director of the Centers for Disease Control and Prevention (referred to in this section as the <quote>Director</quote>), shall conduct a national suicide prevention media campaign (referred to in this section as the <quote>national media campaign</quote>), in accordance with the requirements of this section, for purposes of—</text> <subparagraph id="H4FE6229F66884D36A4FF61566C4F26A9" commented="no"><enum>(A)</enum><text>preventing suicide in the United States;</text></subparagraph> <subparagraph id="H69E765BBDF384807A83F8E59498BB056" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">educating families, friends, and communities on how to address suicide and suicidal thoughts, including when to encourage individuals with suicidal risk to seek help; and</text></subparagraph> <subparagraph id="HDB2AF2ED25044152952962E63C4BD7DF" commented="no"><enum>(C)</enum><text display-inline="yes-display-inline">increasing awareness of suicide prevention resources of the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration (including the suicide prevention hotline maintained under section 520E–3 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-36c">42 U.S.C. 290bb–36c</external-xref>)), any suicide prevention mobile application of the Centers for Disease Control and Prevention or the Substance Abuse Mental Health Services Administration, and other support resources determined appropriate by the Secretary.</text></subparagraph></paragraph> <paragraph id="HCF8D72A7DFC2431EB686387C2608F26E" commented="no"><enum>(2)</enum><header>Additional consultation</header><text display-inline="yes-display-inline">In addition to coordinating with the Assistant Secretary and the Director under this section, the Secretary shall consult with, as appropriate, State, local, Tribal, and territorial health departments, primary health care providers, hospitals with emergency departments, mental and behavioral health services providers, crisis response services providers, first responders, suicide prevention and mental health professionals, patient advocacy groups, survivors of suicide attempts, and representatives of television and social media platforms in planning the national media campaign to be conducted under paragraph (1).</text></paragraph></subsection> <subsection id="H1B81925714F54FE99FD14A73FE59CEF9" commented="no"><enum>(b)</enum><header>Target audiences</header> <paragraph id="H942E3BBDC80A4A79A72A42543FA0EE43" commented="no"><enum>(1)</enum><header>Tailoring advertisements and other communications</header><text display-inline="yes-display-inline">In conducting the national media campaign under subsection (a)(1), the Secretary may tailor culturally competent advertisements and other communications of the campaign across all available media for a target audience (such as a particular geographic location or demographic) across the lifespan.</text></paragraph> <paragraph commented="no" id="HD4874535185844F7852740ACC003BF8E"><enum>(2)</enum><header>Targeting certain local areas</header><text display-inline="yes-display-inline">The Secretary shall, to the maximum extent practicable, use amounts made available under subsection (f) for media that targets individuals in local areas with higher suicide rates.</text></paragraph></subsection> <subsection id="H9ED149EE431E4932A4F12DB04077D7D0" commented="no"><enum>(c)</enum><header>Use of funds</header> <paragraph id="HCEDD81B88893431EB971BA064180F7D1" commented="no"><enum>(1)</enum><header>Required uses</header> <subparagraph id="H3A578033D102465BAE4917757840583A" commented="no"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall, to the extent reasonably feasible with the funds made available under subsection (f), carry out the following, with respect to the national media campaign:</text> <clause id="H5742F4F7F9444CD99640586337CCA69B" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">The purchase of advertising time and space, including the strategic planning for, and accounting of, any such purchase.</text></clause> <clause id="H394D8D3A7D5B492892AD98521338CF03" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">Creative services and talent costs.</text></clause> <clause id="HB61E723D9B1A460D86A75A6BE45B1813" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">Advertising production costs.</text></clause> <clause id="H4666C259121E40FE802D57D25F71D6E8" commented="no"><enum>(iv)</enum><text display-inline="yes-display-inline">Testing and evaluation of advertising.</text></clause> <clause id="H015F766F497B46F38AB32860A9204D7D" commented="no"><enum>(v)</enum><text display-inline="yes-display-inline">Evaluation of the effectiveness of the national media campaign.</text></clause> <clause id="HF85502D881E242A9ADB7E5A5D6B31303" commented="no"><enum>(vi)</enum><text display-inline="yes-display-inline">Operational and management expenses.</text></clause> <clause id="H17E08516A96249879950130D60265543" commented="no"><enum>(vii)</enum><text>The creation of an educational toolkit for television and social media platforms to use in discussing suicide and raising awareness about how to prevent suicide.</text></clause></subparagraph> <subparagraph id="HB95F3D8728534C42BF6828EDBAE24115" commented="no"><enum>(B)</enum><header>Specific requirements</header> <clause id="H105127B2855C42F98071A62FF9EA8164" commented="no"><enum>(i)</enum><header>Testing and evaluation of advertising</header><text>In testing and evaluating advertising under subparagraph (A)(iv), the Secretary shall test all advertisements after use in the national media campaign to evaluate the extent to which such advertisements have been effective in carrying out the purposes of the national media campaign.</text></clause> <clause id="HAAD0AB0F87F94F8B855242847F46D5E4" commented="no"><enum>(ii)</enum><header>Evaluation of effectiveness of national media campaign</header><text display-inline="yes-display-inline">In evaluating the effectiveness of the national media campaign under subparagraph (A)(v), the Secretary shall take into account—</text> <subclause commented="no" id="H2E58B652B0EE402EAF0189CC60ACEB7E"><enum>(I)</enum><text display-inline="yes-display-inline">the number of unique calls that are made to the suicide prevention hotline maintained under section 520E–3 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-36c">42 U.S.C. 290bb–36c</external-xref>) and assess whether there are any State and regional variations with respect to the capacity to answer such calls;</text></subclause> <subclause id="HAAF21E5FFF3D4921A88F7B95AC39CE05" commented="no"><enum>(II)</enum><text>the number of unique encounters with suicide prevention and support resources of the Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration and assess engagement with such suicide prevention and support resources;</text></subclause> <subclause commented="no" id="H1D938CED170244A6BB2947C3B670776C"><enum>(III)</enum><text>whether the national media campaign has contributed to increased awareness that suicidal individuals should be engaged, rather than ignored; and</text></subclause> <subclause id="H3288AE8E8EA34D1C94C6669D813E5DF8" commented="no"><enum>(IV)</enum><text display-inline="yes-display-inline">such other measures of evaluation as the Secretary determines are appropriate.</text></subclause></clause></subparagraph></paragraph> <paragraph id="H8738751ED28C46108292AAE6B0C0D6FA" commented="no"><enum>(2)</enum><header>Optional uses</header><text display-inline="yes-display-inline">The Secretary may use amounts made available under subsection (f) for the following, with respect to the national media campaign:</text> <subparagraph id="HE5DC3521AB6B4D9E85847F92F8FE0C4A" commented="no"><enum>(A)</enum><text display-inline="yes-display-inline">Partnerships with professional and civic groups, community-based organizations, including faith-based organizations, and Government or Tribal organizations that the Secretary determines have experience in suicide prevention, including the Substance Abuse and Mental Health Services Administration and the Centers for Disease Control and Prevention.</text></subparagraph> <subparagraph id="H401B8B465B2343AF9AC7861906886614" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">Entertainment industry outreach, interactive outreach, media projects and activities, public information, news media outreach, outreach through television programs, and corporate sponsorship and participation.</text></subparagraph></paragraph></subsection> <subsection id="HB8D01B96E5EC4BBA96C104B82FA187C9" commented="no"><enum>(d)</enum><header>Prohibitions</header><text display-inline="yes-display-inline">None of the amounts made available under subsection (f) may be obligated or expended for any of the following:</text> <paragraph id="H97E09BB5809B4F5D8BC2A158CB66222F" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">To supplant current suicide prevention campaigns.</text></paragraph> <paragraph id="H50BB574ABB19412E9FC7DED13E0835C1" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">For partisan political purposes, or to express advocacy in support of or to defeat any clearly identified candidate, clearly identified ballot initiative, or clearly identified legislative or regulatory proposal.</text></paragraph></subsection> <subsection commented="no" id="H89E59524D389409AB510795A8AE295E2"><enum>(e)</enum><header>Report to Congress</header><text display-inline="yes-display-inline">Not later than 18 months after implementation of the national media campaign has begun, the Secretary, in coordination with the Assistant Secretary and the Director, shall, with respect to the first year of the national media campaign, submit to Congress a report that describes—</text> <paragraph commented="no" id="H63E4FB2B0115429C9094305823B1D94F"><enum>(1)</enum><text display-inline="yes-display-inline">the strategy of the national media campaign and whether specific objectives of such campaign were accomplished, including whether such campaign impacted the number of calls made to lifeline crisis centers and the capacity of such centers to manage such calls;</text></paragraph> <paragraph commented="no" id="HE6128A597C96451F9C33A1FFD3075851"><enum>(2)</enum><text display-inline="yes-display-inline">steps taken to ensure that the national media campaign operates in an effective and efficient manner consistent with the overall strategy and focus of the national media campaign;</text></paragraph> <paragraph commented="no" id="HC1753BF5121E490D9B8028AE65DD421B"><enum>(3)</enum><text display-inline="yes-display-inline">plans to purchase advertising time and space;</text></paragraph> <paragraph commented="no" id="H2BE44CC30A0F4150A3CB0211C14FE220"><enum>(4)</enum><text display-inline="yes-display-inline">policies and practices implemented to ensure that Federal funds are used responsibly to purchase advertising time and space and eliminate the potential for waste, fraud, and abuse; and</text></paragraph> <paragraph commented="no" id="H7ADBA37B0E8C40A5B7FDFB4DD0632649"><enum>(5)</enum><text display-inline="yes-display-inline">all contracts entered into with a corporation, a partnership, or an individual working on behalf of the national media campaign.</text></paragraph></subsection> <subsection commented="no" id="HF988ABF441E54EF382A9CF377FB0F374"><enum>(f)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">For purposes of carrying out this section, there is authorized to be appropriated $10,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section></subtitle> <subtitle id="H77EB387C40554CAB8737C36B2BD8D054"><enum>G</enum><header>Helping Emergency Responders Overcome</header> <section id="H2E333B8FE19347BEB97F29D3557066E2"><enum>6061.</enum><header>Data system to capture national public safety officer suicide incidence</header><text display-inline="no-display-inline">The Public Health Service Act is amended by inserting before section 318 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247c">42 U.S.C. 247c</external-xref>) the following:</text> <quoted-block id="H48984E253F1340B7999F5E51EEAE38DD" style="OLC"> <section id="HAA5FB5BB75654CDF8DFE644417EF005E"><enum>317W.</enum><header>Data system to capture national public safety officer suicide incidence</header> <subsection id="HD97BF03E8FE34C5CA9C4DB7A90467E4D"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, in coordination with the Director of the Centers for Disease Control and Prevention and other agencies as the Secretary determines appropriate, shall—</text> <paragraph id="HDAE94F74A15A40E9A2D68737E7F15931"><enum>(1)</enum><text>develop and maintain a data system, to be known as the Public Safety Officer Suicide Reporting System, for the purposes of—</text> <subparagraph id="H41BC9C04B76547A8A486EF552F6BCBCF"><enum>(A)</enum><text>collecting data on the suicide incidence among public safety officers; and</text></subparagraph> <subparagraph id="H14B3A7F0BEA14E5EA1199258FC296A8B"><enum>(B)</enum><text>facilitating the study of successful interventions to reduce suicide among public safety officers; and</text></subparagraph></paragraph> <paragraph id="H3A38730BAB04473A8E308596F59E28EC"><enum>(2)</enum><text>integrate such system into the National Violent Death Reporting System, so long as the Secretary determines such integration to be consistent with the purposes described in paragraph (1).</text></paragraph></subsection> <subsection id="H97A2CC33629E4297A9CF03BDB6BBA8F1"><enum>(b)</enum><header>Data collection</header><text>In collecting data for the Public Safety Officer Suicide Reporting System, the Secretary shall, at a minimum, collect the following information:</text> <paragraph id="H3E12A4D1D1D54C0E998305136B6DCE5F"><enum>(1)</enum><text>The total number of suicides in the United States among all public safety officers in a given calendar year.</text></paragraph> <paragraph id="HEE19EBEA9FA24AC0A3B002C665F817F3"><enum>(2)</enum><text>Suicide rates for public safety officers in a given calendar year, disaggregated by—</text> <subparagraph id="HAAE0B3AAABA5434F86C95D776A78D547"><enum>(A)</enum><text>age and gender of the public safety officer;</text></subparagraph> <subparagraph id="H66E8BDED42584FF1AD25297552B511CC"><enum>(B)</enum><text>State;</text></subparagraph> <subparagraph id="HB701DDAD71F9467BAA1DABB9703B0A53"><enum>(C)</enum><text display-inline="yes-display-inline">occupation; including both the individual’s role in their public safety agency and their primary occupation in the case of volunteer public safety officers;</text></subparagraph> <subparagraph id="HF98E83192F89484C814C4014346C7D52"><enum>(D)</enum><text display-inline="yes-display-inline">where available, the status of the public safety officer as volunteer, paid-on-call, or career; and</text></subparagraph> <subparagraph id="HF0D4DAB420244847B38260C22923CF2E"><enum>(E)</enum><text>status of the public safety officer as active or retired.</text></subparagraph></paragraph></subsection> <subsection id="HFB75C1C7B0FC460D8905359A6FD51CA2"><enum>(c)</enum><header>Consultation during development</header><text display-inline="yes-display-inline">In developing the Public Safety Officer Suicide Reporting System, the Secretary shall consult with non-Federal experts to determine the best means to collect data regarding suicide incidence in a safe, sensitive, anonymous, and effective manner. Such non-Federal experts shall include, as appropriate, the following:</text> <paragraph id="H676C2739DC20412F83DB94C15CA8E6AD"><enum>(1)</enum><text>Public health experts with experience in developing and maintaining suicide registries.</text></paragraph> <paragraph id="HF34A9DF08FAD4A719430D0D11A4B4048"><enum>(2)</enum><text>Organizations that track suicide among public safety officers.</text></paragraph> <paragraph id="H7EDA86407EFB4C3B8D5D3DFA2EDDAB3D"><enum>(3)</enum><text>Mental health experts with experience in studying suicide and other profession-related traumatic stress.</text></paragraph> <paragraph id="H38C8017EE70A417D9B8405AC457F4EFE"><enum>(4)</enum><text>Clinicians with experience in diagnosing and treating mental health issues.</text></paragraph> <paragraph id="H4EA0456BC5E84651BA74828A6BBE466C"><enum>(5)</enum><text>Active and retired volunteer, paid-on-call, and career public safety officers.</text></paragraph> <paragraph id="HFB1875A3EED84607949BC67C531F6C35"><enum>(6)</enum><text display-inline="yes-display-inline">Relevant national police, and fire and emergency medical services, organizations.</text></paragraph></subsection> <subsection id="H7D7ED087000C4F5CAB8F70715F03F179"><enum>(d)</enum><header>Data privacy and security</header><text>In developing and maintaining the Public Safety Officer Suicide Reporting System, the Secretary shall ensure that all applicable Federal privacy and security protections are followed to ensure that—</text> <paragraph id="H602427BE0A704A778195216E57B5323A"><enum>(1)</enum><text>the confidentiality and anonymity of suicide victims and their families are protected, including so as to ensure that data cannot be used to deny benefits; and</text></paragraph> <paragraph id="H69C35B20A18D42A9A8E7E7773F501EE4"><enum>(2)</enum><text>data is sufficiently secure to prevent unauthorized access.</text></paragraph></subsection> <subsection id="HF1A1F06CF26143D783833568F514E9FF"><enum>(e)</enum><header>Reporting</header> <paragraph id="H8BFF3E6710864AC6AE6E4A9B9E4CEDAD"><enum>(1)</enum><header>Annual report</header><text>Not later than 2 years after the date of enactment of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title>, and biannually thereafter, the Secretary shall submit a report to the Congress on the suicide incidence among public safety officers. Each such report shall—</text> <subparagraph id="H9EBAE7789BAD480EA9B712D741EF748A"><enum>(A)</enum><text>include the number and rate of such suicide incidence, disaggregated by age, gender, and State of employment;</text></subparagraph> <subparagraph id="H69D41252437244F2A482D6909C30969F"><enum>(B)</enum><text display-inline="yes-display-inline">identify characteristics and contributing circumstances for suicide among public safety officers;</text></subparagraph> <subparagraph id="H498E920DB24646A58768EFEE4C0C4736"><enum>(C)</enum><text>disaggregate rates of suicide by—</text> <clause id="HEDB8BA5D69344035BF098292974FFF03"><enum>(i)</enum><text>occupation;</text></clause> <clause id="HAADFABCE5E5A410383502E039E49C867"><enum>(ii)</enum><text>status as volunteer, paid-on-call, or career; and</text></clause> <clause id="H5EB2303EBE24490A9D9C0E1D1D8BE808"><enum>(iii)</enum><text>status as active or retired;</text></clause></subparagraph> <subparagraph id="HC1B5801C1D9046CCAA73E0ED96F23EB4"><enum>(D)</enum><text>include recommendations for further study regarding the suicide incidence among public safety officers;</text></subparagraph> <subparagraph id="HF2F29BA338E04FCB9ECA743FC77DA711"><enum>(E)</enum><text>specify in detail, if found, any obstacles in collecting suicide rates for volunteers and include recommended improvements to overcome such obstacles;</text></subparagraph> <subparagraph id="H547DD6C93DD54064901E8E077261B9C2"><enum>(F)</enum><text>identify options for interventions to reduce suicide among public safety officers; and</text></subparagraph> <subparagraph id="HA26EB359335243DA8F8188C9C61335B1"><enum>(G)</enum><text display-inline="yes-display-inline">describe procedures to ensure the confidentiality and anonymity of suicide victims and their families, as described in subsection (d)(1).</text></subparagraph></paragraph> <paragraph id="H8D4183F0606C41FA9C75FC5C2053DA61"><enum>(2)</enum><header>Public availability</header><text>Upon the submission of each report to the Congress under paragraph (1), the Secretary shall make the full report publicly available on the website of the Centers for Disease Control and Prevention.</text></paragraph></subsection> <subsection id="H7A3265AD25794993BDCE4C6ECB8E398F"><enum>(f)</enum><header>Definition</header><text>In this section, the term <term>public safety officer</term> means—</text> <paragraph id="H09A1303B872541C98C47556C61410C4C"><enum>(1)</enum><text>a public safety officer as defined in section 1204 of the Omnibus Crime Control and Safe Streets Act of 1968; or</text></paragraph> <paragraph id="H4950D145B02142438B8765988634A397"><enum>(2)</enum><text>a public safety telecommunicator as described in detailed occupation 43–5031 in the Standard Occupational Classification Manual of the Office of Management and Budget (2018).</text></paragraph></subsection> <subsection id="H79880CBEBFA34166A658402B8E19BBA9"><enum>(g)</enum><header>Prohibited use of information</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, if an individual is identified as deceased based on information contained in the Public Safety Officer Suicide Reporting System, such information may not be used to deny or rescind life insurance payments or other benefits to a survivor of the deceased individual.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H55E4869662A64395811199EFEC9075E5"><enum>6062.</enum><header>Peer-support behavioral health and wellness programs within fire departments and emergency medical service agencies</header> <subsection id="HF2932D89A75044F8B34264A2E64B97FB"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Part B of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/243">42 U.S.C. 243</external-xref> et seq.) is amended by adding at the end the following:</text> <quoted-block id="H31DE0AECB8B4498DA74416721FE0220B" style="OLC"> <section commented="no" id="HCBF93ABC191546FD93CD127C1B196590"><enum>320B.</enum><header>Peer-support behavioral health and wellness programs within fire departments and emergency medical service agencies</header> <subsection commented="no" id="H41F596B1578E4AFB91FFD1F719DDEDC0"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall award grants to eligible entities for the purpose of establishing or enhancing peer-support behavioral health and wellness programs within fire departments and emergency medical services agencies.</text></subsection> <subsection commented="no" id="H4B8ED768C8C9483D851CA422EFB98C0E"><enum>(b)</enum><header>Program description</header><text>A peer-support behavioral health and wellness program funded under this section shall—</text> <paragraph commented="no" id="H7F4C2DAEF3E64830903978458FE1E347"><enum>(1)</enum><text display-inline="yes-display-inline">use career and volunteer members of fire departments or emergency medical services agencies to serve as peer counselors;</text></paragraph> <paragraph commented="no" id="H07D5938D2A204E79AF25D5DF114BC88E"><enum>(2)</enum><text display-inline="yes-display-inline">provide training to members of career, volunteer, and combination fire departments or emergency medical service agencies to serve as such peer counselors;</text></paragraph> <paragraph commented="no" id="H1121E9CD2481466DA6DDABE5E261EA2B"><enum>(3)</enum><text>purchase materials to be used exclusively to provide such training; and</text></paragraph> <paragraph commented="no" id="H362E6206E75C49CE84D1B9E1066177EB"><enum>(4)</enum><text>disseminate such information and materials as are necessary to conduct the program.</text></paragraph></subsection> <subsection commented="no" id="HC36B631D5D844D74B84547CA9B31F7FD"><enum>(c)</enum><header>Definition</header><text>In this section:</text> <paragraph commented="no" id="HB82247AC86B14621B778BB7433E9EA5A"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>eligible entity</term> means a nonprofit organization with expertise and experience with respect to the health and life safety of members of fire and emergency medical services agencies.</text></paragraph> <paragraph id="H96D4DDCD0DDD4690A588287EFC260731"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>member</term>—</text> <subparagraph id="H885C061980AC43C6B08EA31B62EB2AAF"><enum>(A)</enum><text display-inline="yes-display-inline">with respect to an emergency medical services agency, means an employee, regardless of rank or whether the employee receives compensation (as defined in section 1204(7) of the Omnibus Crime Control and Safe Streets Act of 1968); and</text></subparagraph> <subparagraph id="H0A3FEA3D62C4454AA553A734B2637A49"><enum>(B)</enum><text display-inline="yes-display-inline">with respect to a fire department, means any employee, regardless of rank or whether the employee receives compensation, of a Federal, State, Tribal, or local fire department who is responsible for responding to calls for emergency service.</text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H7312A3E7FB774EF88ECF543E109B4006"><enum>(b)</enum><header>Technical correction</header><text display-inline="yes-display-inline">Effective as if included in the enactment of the Children’s Health Act of 2000 (<external-xref legal-doc="public-law" parsable-cite="pl/106/310">Public Law 106–310</external-xref>), the amendment instruction in section 1603 of such Act is amended by striking <quote>Part B of the Public Health Service Act</quote> and inserting <quote>Part B of title III of the Public Health Service Act</quote>.</text></subsection></section> <section id="H53B90FBCEF3241ECBBE3787DCE816BCA"><enum>6063.</enum><header>Health care provider behavioral health and wellness programs</header><text display-inline="no-display-inline">Part B of title III of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/243">42 U.S.C. 243</external-xref> et seq.), as amended by section 6062, is further amended by adding at the end the following:</text> <quoted-block style="OLC" id="H2882476E16564060B3661474AA00249B" display-inline="no-display-inline"> <section id="H22AE024D6B7C4958BFECBCB75ACBEB72"><enum>320C.</enum><header>Health care provider behavioral health and wellness programs</header> <subsection id="H7D92F520F79B4EF1A9C1D0EF211F6688"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall award grants to eligible entities for the purpose of establishing or enhancing behavioral health and wellness programs for health care providers.</text></subsection> <subsection id="H0FA69201BA9546E58CA08E7EA5DDEA4E"><enum>(b)</enum><header>Program description</header><text display-inline="yes-display-inline">A behavioral health and wellness program funded under this section shall—</text> <paragraph id="HE17B2CDF318E4DC89F590E9F71698D56"><enum>(1)</enum><text display-inline="yes-display-inline">provide confidential support services for health care providers to help handle stressful or traumatic patient-related events, including counseling services and wellness seminars; </text></paragraph> <paragraph id="H2315BC6C1BFA4F0BBE4DF6AF5B65F4C1"><enum>(2)</enum><text display-inline="yes-display-inline">provide training to health care providers to serve as peer counselors to other health care providers;</text></paragraph> <paragraph id="H502EF6FE711149DDA1E3792B19810A56"><enum>(3)</enum><text>purchase materials to be used exclusively to provide such training; and</text></paragraph> <paragraph id="HB773823C92B64362A019FDB5E63E22E4"><enum>(4)</enum><text>disseminate such information and materials as are necessary to conduct such training and provide such peer counseling.</text></paragraph></subsection> <subsection id="H0FC8A8129E4B45B7A095C70E20E66CF9"><enum>(c)</enum><header>Definitions</header><text>In this section, the term <term>eligible entity</term> means a hospital, including a critical access hospital (as defined in section 1861(mm)(1) of the Social Security Act) or a disproportionate share hospital (as defined under section 1923(a)(1)(A) of such Act), a federally qualified health center (as defined in section 1905(1)(2)(B) of such Act), or any other health care facility.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H83653098ABDD4F56B417EF0CBA8FD597"><enum>6064.</enum><header>Development of resources for educating mental health professionals about treating fire fighters and emergency medical services personnel</header> <subsection id="H8ED9D56CF2F74F9990AF8644F4D22F15"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Administrator of the United States Fire Administration, in consultation with the Secretary of Health and Human Services, shall develop and make publicly available resources that may be used by the Federal Government and other entities to educate mental health professionals about—</text> <paragraph id="H28D6D6FEFF73420F95B702D4B0420C6D"><enum>(1)</enum><text display-inline="yes-display-inline">the culture of Federal, State, Tribal, and local career, volunteer, and combination fire departments and emergency medical services agencies;</text></paragraph> <paragraph id="HEF5DDAA6699243758C30B0B323132BCE"><enum>(2)</enum><text display-inline="yes-display-inline">the different stressors experienced by firefighters and emergency medical services personnel, supervisory firefighters and emergency medical services personnel, and chief officers of fire departments and emergency medical services agencies;</text></paragraph> <paragraph id="HEB3A849762DA4818B05F014ECF4FEFEB"><enum>(3)</enum><text display-inline="yes-display-inline">challenges encountered by retired firefighters and emergency medical services personnel; and</text></paragraph> <paragraph id="H2D7F779CD9D84CA6A9CB87AFC83256CE"><enum>(4)</enum><text display-inline="yes-display-inline">evidence-based therapies for mental health issues common to firefighters and emergency medical services personnel within such departments and agencies.</text></paragraph></subsection> <subsection id="H180F1F1D3BBA431FB42049E13256D0D0"><enum>(b)</enum><header>Consultation</header><text>In developing resources under subsection (a), the Administrator of the United States Fire Administration and the Secretary of Health and Human Services shall consult with national fire and emergency medical services organizations.</text></subsection> <subsection id="H13753D6EC9C74A728CFE4869B7FE4350"><enum>(c)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H7B02C8B2FD95449F86F658DD7EA7E98D"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>firefighter</term> means any employee, regardless of rank or whether the employee receives compensation, of a Federal, State, Tribal, or local fire department who is responsible for responding to calls for emergency service.</text></paragraph> <paragraph id="H7B5FD6067EBB41D5942FA47CDF439942"><enum>(2)</enum><text>The term <term>emergency medical services personnel</term> means any employee, regardless of rank or whether the employee receives compensation, as defined in section 1204(7) of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/34/10284">34 U.S.C. 10284(7)</external-xref>).</text></paragraph> <paragraph id="HA5018D6C220041D6AB5C1A01F76AE372"><enum>(3)</enum><text>The term <term>chief officer</term> means any individual who is responsible for the overall operation of a fire department or an emergency medical services agency, irrespective of whether such individual also serves as a firefighter or emergency medical services personnel.</text></paragraph></subsection></section> <section id="HDAA4AB27F1CC49C4A9B097E16BA36CFF"><enum>6065.</enum><header>Best practices and other resources for addressing posttraumatic stress disorder in public safety officers</header> <subsection id="H2C60094707DD426EACF0D6F093DAC3E5"><enum>(a)</enum><header>Development; updates</header><text>The Secretary of Health and Human Services shall—</text> <paragraph id="HC943F77C23AD4837A4D7936D7643D2B5"><enum>(1)</enum><text>develop and assemble evidence-based best practices and other resources to identify, prevent, and treat posttraumatic stress disorder and co-occurring disorders in public safety officers; and</text></paragraph> <paragraph id="HE154315A547B46FAB45858EB83D5A7B2"><enum>(2)</enum><text>reassess and update, as the Secretary determines necessary, such best practices and resources, including based upon the options for interventions to reduce suicide among public safety officers identified in the annual reports required by section 317W(e)(1)(F) of the Public Health Service Act, as added by section 6061 of this subtitle.</text></paragraph></subsection> <subsection id="H67B0CA3B79A241289C87BF863B08D5E6"><enum>(b)</enum><header>Consultation</header><text>In developing, assembling, and updating the best practices and resources under subsection (a), the Secretary of Health and Human Services shall consult with, at a minimum, the following:</text> <paragraph id="H1A37B0F4C802428C969CE7147C16CBAE"><enum>(1)</enum><text>Public health experts.</text></paragraph> <paragraph id="H6ACA7F85F9DB4ABCB108D45449A20AAE"><enum>(2)</enum><text>Mental health experts with experience in studying suicide and other profession-related traumatic stress.</text></paragraph> <paragraph id="H7C73FF4F410440D7AD7E6290FB2AA9CD"><enum>(3)</enum><text>Clinicians with experience in diagnosing and treating mental health issues.</text></paragraph> <paragraph id="H66156238B8764320B4106EFA660F4D60"><enum>(4)</enum><text display-inline="yes-display-inline">Relevant national police, fire, and emergency medical services organizations.</text></paragraph></subsection> <subsection id="HDBFFB6A742EA4F3883095C4F1FF63EB6"><enum>(c)</enum><header>Availability</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services shall make the best practices and resources under subsection (a) available to Federal, State, and local fire, law enforcement, and emergency medical services agencies.</text></subsection> <subsection id="H1025E071A4274C338A52B8B32BF6E0C0"><enum>(d)</enum><header>Federal training and development programs</header><text>The Secretary of Health and Human Services shall work with Federal departments and agencies, including the United States Fire Administration, to incorporate education and training on the best practices and resources under subsection (a) into Federal training and development programs for public safety officers.</text></subsection> <subsection id="HC11D5A4B54ED48B6A20E2184D7310207"><enum>(e)</enum><header>Definition</header><text>In this section, the term <term>public safety officer</term> means—</text> <paragraph id="H8E04E0069981431D9DD432019D9793A2"><enum>(1)</enum><text>a public safety officer as defined in section 1204 of the Omnibus Crime Control and Safe Streets Act of 1968 (<external-xref legal-doc="usc" parsable-cite="usc/34/10284">34 U.S.C. 10284</external-xref>); or</text></paragraph> <paragraph id="HDD297C80A62F438FAB8BDF6B4C7F9B06"><enum>(2)</enum><text>a public safety telecommunicator as described in detailed occupation 43–5031 in the Standard Occupational Classification Manual of the Office of Management and Budget (2018).</text></paragraph></subsection></section></subtitle> <subtitle id="H452A7D6DEA754D6EA257088A60E14D5F"><enum>H</enum><header>Behavioral Health Intervention Guidelines</header> <section id="H02A2DD1B325D4A38AA4ADCB0C373A823"><enum>6071.</enum><header>Best practices for behavioral intervention teams</header><text display-inline="no-display-inline">The Public Health Service Act is amended by inserting after section 520G of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-38">42 U.S.C. 290bb–38</external-xref>) the following new section:</text> <quoted-block display-inline="no-display-inline" id="H522F9AAFB798482C83CDEF7B8AF81E58" style="OLC"> <section id="H40A5A80D6407414FA2B7F4D32839FCC2"><enum>520H.</enum><header>Best practices for behavioral intervention teams</header> <subsection id="H7960414931A244428D2C45968B6F7268"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary, acting through the Assistant Secretary, shall develop and periodically update—</text> <paragraph id="HF37B4861241E451BACF90656E803AAA8"><enum>(1)</enum><text>best practices to assist elementary schools, secondary schools, and institutions of higher education in establishing and using behavioral intervention teams; and</text></paragraph> <paragraph id="HB0F62A84A22C458B9A09A433E1CE37E1"><enum>(2)</enum><text display-inline="yes-display-inline">a list of evidence-based threat assessment training providers to assist personnel in elementary schools, secondary schools, and institutions of higher education in implementing such best practices, including with respect to training behavioral intervention teams.</text></paragraph></subsection> <subsection id="H3CA1CEBA6A8046EBB14E029CA2FC0C3C"><enum>(b)</enum><header>Elements</header><text>The best practices under subsection (a)(1) shall include guidance on the following:</text> <paragraph id="HA33790AEE30D43CCAAE5798EB0A50305"><enum>(1)</enum><text display-inline="yes-display-inline">How behavioral intervention teams can operate effectively from an evidence-based, objective perspective while protecting the constitutional and civil rights of individuals, including any individual of concern.</text></paragraph> <paragraph id="H77BF60F248DD4AE5AACC185DF1BB0ACD"><enum>(2)</enum><text display-inline="yes-display-inline">The use of behavioral intervention teams to identify individuals of concern, implement interventions, and manage risk through the framework of the school’s or institution’s rules or code of conduct, as applicable.</text></paragraph> <paragraph id="HD747BA2D568543DEA13FB4D37AC9DA76"><enum>(3)</enum><text display-inline="yes-display-inline">How behavioral intervention teams can, when assessing an individual of concern—</text> <subparagraph id="H1D4FB297711D4F8B93ED929C1AACE0A9"><enum>(A)</enum><text display-inline="yes-display-inline">seek training on evidence-based, threat-assessment rubrics;</text></subparagraph> <subparagraph id="H63C66C555D5546A9A90B6F73B23BEF5D"><enum>(B)</enum><text>ensure that such teams—</text> <clause id="H92E5296645EA4F7BA069D0ACB88A43D5"><enum>(i)</enum><text>have adequately trained, diverse stakeholders with varied expertise; and</text></clause> <clause id="H01ED5672FF3A48DDA14C0D6C05167210"><enum>(ii)</enum><text>use cross validation by a wide-range of individual perspectives on the team; and</text></clause></subparagraph> <subparagraph id="HB80F76476B384528BA48372B207D78D1"><enum>(C)</enum><text display-inline="yes-display-inline">use violence risk assessment.</text></subparagraph></paragraph> <paragraph id="H6FDFD71517834DD0AA52A0D905033231"><enum>(4)</enum><text>How behavioral intervention teams can avoid—</text> <subparagraph id="HDF9CF0F3EEF649D1ACC0277263DDBF2A"><enum>(A)</enum><text display-inline="yes-display-inline">attempting to predict future behavior by the concept of pre-crime;</text></subparagraph> <subparagraph id="H2FDF6F774AED4B148D8ACD3849769EDC"><enum>(B)</enum><text display-inline="yes-display-inline">inappropriately using a mental health assessment;</text></subparagraph> <subparagraph id="H10922AE2E7E446768E736599E8B4EA36"><enum>(C)</enum><text>inappropriately limiting or restricting law enforcement’s jurisdiction over criminal matters;</text></subparagraph> <subparagraph id="HD97FE5244E134382B7818A7997A5A1D3"><enum>(D)</enum><text display-inline="yes-display-inline">attempting to substitute the behavioral intervention process in place of a criminal process, or impede a criminal process, when an individual of concern’s behavior has potential criminal implications;</text></subparagraph> <subparagraph id="HE8D06EF1790141BC9375E41FBD9EA262"><enum>(E)</enum><text display-inline="yes-display-inline">endangering an individual’s privacy by failing to ensure that all applicable Federal and State privacy laws are fully complied with; or</text></subparagraph> <subparagraph id="H9EDFBC66205E4C7C95926E603338340D"><enum>(F)</enum><text display-inline="yes-display-inline">creating school-to-prison pipelines.</text></subparagraph></paragraph></subsection> <subsection id="H34ABCB16FEB84928BC29CB9669E71401"><enum>(c)</enum><header>Consultation</header><text display-inline="yes-display-inline">In carrying out subsection (a)(1), the Secretary shall consult with—</text> <paragraph id="HF1F9C4FD1BB1467AB08FCC2B1272DE16"><enum>(1)</enum><text>the Secretary of Education;</text></paragraph> <paragraph id="HC5F11FFE19354248A04CA546AA32AEB5"><enum>(2)</enum><text>the Director of the National Threat Assessment Center of the Department of Homeland Security;</text></paragraph> <paragraph id="H10433CB8949E42A797D252DA34FD6FAC"><enum>(3)</enum><text>the Attorney General of the United States; and</text></paragraph> <paragraph id="H591EE4D706F5425E8E6FE0C6E707305D"><enum>(4)</enum><text>as appropriate, relevant stakeholders including—</text> <subparagraph id="HB006422DAFC14FD3BDCE0F72CC8813C1"><enum>(A)</enum><text>teachers and other educators, principals, school administrators, school board members, school psychologists, mental health professionals, and parents of elementary school and secondary school students;</text></subparagraph> <subparagraph id="HA9D23623788848428A5D1245E3A4EA94"><enum>(B)</enum><text>local law enforcement agencies and campus law enforcement administrators;</text></subparagraph> <subparagraph id="H1C0E93ADF1774939940C42CA7A465FF8"><enum>(C)</enum><text>mental health mobile crisis providers;</text></subparagraph> <subparagraph id="HAE2663C9057D4D6DA0507DD3A1B17881"><enum>(D)</enum><text>child and adolescent psychiatrists; and</text></subparagraph> <subparagraph id="HEDB424562D044D5DB05825B70E07960A"><enum>(E)</enum><text>other education and mental health professionals.</text></subparagraph></paragraph></subsection> <subsection id="H86D8EBEFFFD547A9A3488DA41C59525D"><enum>(d)</enum><header>Publication</header><text>Not later than 2 years after the date of enactment of this section, the Secretary shall publish the best practices under subsection (a)(1) and the list under subsection (a)(2) on a publicly accessible website of the Department of Health and Human Services.</text></subsection> <subsection id="H402D7F5C8F1443F89B8DB83DD086BE85"><enum>(e)</enum><header>Technical assistance</header><text display-inline="yes-display-inline">The Secretary shall provide technical assistance to institutions of higher education, elementary schools, and secondary schools to assist such institutions and schools in implementing the best practices under subsection (a).</text></subsection> <subsection id="HC21B4AABD8134EF9A77558D95AA536F8"><enum>(f)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H6C7A56FEF48843418FA127BD1C906378"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>behavioral intervention team</term> means a team of qualified individuals who—</text> <subparagraph id="H3B217BEA16524B92938DAEC23473EFA5"><enum>(A)</enum><text display-inline="yes-display-inline">are responsible for identifying and assessing individuals of concern; and</text></subparagraph> <subparagraph id="H481B8871BAC24B60BE60985B7CF820CE"><enum>(B)</enum><text display-inline="yes-display-inline">develop and facilitate implementation of evidence-based interventions to mitigate the threat of harm to self or others posed by individuals of concern and address the mental and behavioral health needs of individuals of concern to reduce such threat.</text></subparagraph></paragraph> <paragraph id="HF9376534522247C1919C2C4F3C2AA451"><enum>(2)</enum><text display-inline="yes-display-inline">The terms <term>elementary school</term>, <term>parent</term>, and <term>secondary school</term> have the meanings given to such terms in section 8101 of the Elementary and Secondary Education Act of 1965 (<external-xref legal-doc="usc" parsable-cite="usc/20/7801">20 U.S.C. 7801</external-xref>).</text></paragraph> <paragraph id="H36B0518CFBAE4B128436E85006DE18FD"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>individual of concern</term> means an individual whose behavior indicates a potential threat to self or others.</text></paragraph> <paragraph id="HBD21AE13AA3244EBA83EDE2C91B09AA2"><enum>(4)</enum><text>The term <term>institution of higher education</term> has the meaning given to such term in section 102 of the Higher Education Act of 1965 (<external-xref legal-doc="usc" parsable-cite="usc/20/1002">20 U.S.C. 1002</external-xref>).</text></paragraph> <paragraph id="HD84B3F6F46B54FE1A0CB9245C2412947"><enum>(5)</enum><text display-inline="yes-display-inline">The term <term>mental health assessment</term> means an evaluation, primarily focused on diagnosis, determining the need for involuntary commitment, medication management, and on-going treatment recommendations.</text></paragraph> <paragraph id="HC1880280A6104E57856B4105C11F6232"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>pre-crime</term> means law-enforcement efforts and strategies to deter crime by predicting when and where criminal activity will occur.</text></paragraph> <paragraph id="HEC88C448B7EB4A35B2F340F462E91E19"><enum>(7)</enum><text display-inline="yes-display-inline">The term <term>violence risk assessment</term> refers to a broad determination of the potential risk of violence based on evidence-based literature.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H11D4FE6994364D12B97083DE73A566A8"><enum>I</enum><header>Suicide Training and Awareness Nationally Delivered for Universal Prevention</header> <section id="H2466741FD21B43729581AD8B86CCA4B8"><enum>6081.</enum><header>Student suicide awareness and prevention training</header> <subsection id="HB85828D0043B4018BA7267D7ECFD2996"><enum>(a)</enum><header>In general</header><text>Title V of the Public Health Service Act is amended by inserting after section 520A of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-32">42 U.S.C. 290bb–32</external-xref>) the following:</text> <quoted-block id="H5099050AF1BD4069B4B9BEFF9C35E1C5" style="OLC"> <section id="H8F8EA3A056C54FD48FD6286CC9E9F698"><enum>520B.</enum><header>Student suicide awareness and prevention training policies</header> <subsection id="HA0BC5FE468FF44199E3DB25B7CCCAF1F"><enum>(a)</enum><header>In general</header><text>As a condition on receipt of funds under section 520A, each State educational agency, local educational agency, and Tribal educational agency that receives such funds, directly or through a State or Indian Tribe, for activities to be performed within secondary schools, including the Project AWARE State Education Agency Grant Program, shall—</text> <paragraph id="HC9680418C2B143D38F064C488625FA8C"><enum>(1)</enum><text>establish and implement a school-based student suicide awareness and prevention training policy;</text></paragraph> <paragraph id="H96F1EFB55E9B46D89880A45993909F1B"><enum>(2)</enum><text>consult with stakeholders (including principals, teachers, parents, local Tribal officials, and other school leaders) in the development of the policy under subsection (a)(1); and</text></paragraph> <paragraph id="HE3F3B1DB83144BB9A9BBB87AAE56997E"><enum>(3)</enum><text>collect and report information in accordance with subsection (c).</text></paragraph></subsection> <subsection id="H4836D7C8288444CC8E4A537948D7F87F"><enum>(b)</enum><header>School-Based student suicide awareness and prevention training policy</header><text>A school-based student suicide awareness and prevention training policy implemented pursuant to subsection (a)—</text> <paragraph id="HC73795861F5E45CA8FEA0785FD5A1234"><enum>(1)</enum><text>shall be evidence-based;</text></paragraph> <paragraph id="HC2367C2FA9074806BB073343072FCE9F"><enum>(2)</enum><text display-inline="yes-display-inline">shall be culturally and linguistically appropriate; </text></paragraph> <paragraph id="H262EB177E71B4E1CAC829D26B3F1FC16"><enum>(3)</enum><text>shall provide evidence-based training to students in grades 6 through 12, in coordination with school-based mental health service providers as defined in section 4102(6) of the Elementary and Secondary Education Act of 1965, if applicable, regarding—</text> <subparagraph id="HC429AA7DBB224080B971E3303C35B332"><enum>(A)</enum><text>suicide education and awareness, including warning signs of self-harm or suicidal ideation;</text></subparagraph> <subparagraph id="H539CCB5B0698436D89BAF4E04FA1AB77"><enum>(B)</enum><text>methods that students can use to seek help for themselves and others; and</text></subparagraph> <subparagraph id="HB6FA379C19D84D588CFAC654EFDE3DEC"><enum>(C)</enum><text>student resources for suicide awareness and prevention;</text></subparagraph></paragraph> <paragraph id="H0818477EC49540BE85972161BB04A84D"><enum>(4)</enum><text>shall provide for retraining of such students every school year;</text></paragraph> <paragraph id="H4FD8C47BCBA243E18A6A08C200E22867"><enum>(5)</enum><text>may last for such period as the State educational agency, local educational agency, or Tribal educational agency involved determines to be appropriate; </text></paragraph> <paragraph id="H66EE936042644C988DC912E30FF9EA0D"><enum>(6)</enum><text>may be implemented through any delivery method, including in-person trainings, digital trainings, or train-the-trainer models; and</text></paragraph> <paragraph id="HB9D9D888E1264046A1ED111B40CFD51C"><enum>(7)</enum><text display-inline="yes-display-inline">may include discussion of comorbidities or risk factors for suicidal ideation or self-harm, including substance misuse, sexual or physical abuse, mental illness, or other evidence-based comorbidities and risk factors.</text></paragraph></subsection> <subsection id="HE15A585156FC481EAEAC87E5C8F4D3DE"><enum>(c)</enum><header>Collection of information and reporting</header><text display-inline="yes-display-inline">Each State educational agency, local educational agency, and Tribal educational agency that receives funds under section 520A shall, with respect to each school served by the agency, collect and report to the Secretary the following information:</text> <paragraph id="HEE4AEDA509594D338C31DBEAD5269A7E"><enum>(1)</enum><text>The number of student trainings conducted.</text></paragraph> <paragraph id="HA9316C74E3F649B89966108E46CF1179"><enum>(2)</enum><text>The number of students trained, disaggregated by age and grade level.</text></paragraph> <paragraph id="H57C8C27D9EAD4DB0B4BBEA1D1A8E1E86"><enum>(3)</enum><text>The number of help-seeking reports made by students after implementation of such policy.</text></paragraph></subsection> <subsection id="H9DB3501B60794B51B01626034B58819C"><enum>(d)</enum><header>Evidence-Based program listing</header><text>The Secretary of Health and Human Services shall coordinate with the Secretary of Education to make publicly available the policies established by State educational agencies, local educational agencies, and Tribal educational agencies pursuant to this section and the training that is available to students and teams pursuant to such policies, including identification of whether such training is available to trainees at no cost.</text></subsection> <subsection id="H5626AAE5B68945F4B49016D479BEC45C"><enum>(e)</enum><header>Implementation timeline</header><text display-inline="yes-display-inline">A State educational agency, local educational agency, or Tribal educational agency shall establish and begin implementation of the policies required by subsection (a)(1) not later than the beginning of the third fiscal year following the date of enactment of this section for which the agency receives funds under section 520A.</text></subsection> <subsection id="H9F397F4BCE604AF4BF1495B88F77182C"><enum>(f)</enum><header>Definitions</header><text>In this section and section 520B–1:</text> <paragraph id="H6692DF73CD9744C38B30A7D7D640B1E5"><enum>(1)</enum><text>The term <term>evidence-based</term> has the meaning given to such term in section 8101 of the Elementary and Secondary Education Act of 1965.</text></paragraph> <paragraph id="HAEC2BCD75A3B4D7CBFF00CBF37A11FE7"><enum>(2)</enum><text>The term <term>local educational agency</term> has the meaning given to such term in section 8101 of the Elementary and Secondary Education Act of 1965.</text></paragraph> <paragraph id="HB0733B73BDBF49BE830153D97EE4AC8D"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>State educational agency</term> has the meaning given to such term in section 8101 of the Elementary and Secondary Education Act of 1965.</text></paragraph> <paragraph id="HA89B6A2446B1411F9A6BF6B07BF895B1"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>Tribal educational agency</term> has the meaning given to the term <term>tribal educational agency</term> in section 6132 of the Elementary and Secondary Education Act of 1965.</text></paragraph></subsection></section> <section id="H496BA764D0464998A3FF571F33524583"><enum>520B–1.</enum><header>Best practices for student suicide awareness and prevention training</header><text display-inline="no-display-inline">The Secretary of Health and Human Services, in consultation with the Secretary of Education and the Bureau of Indian Education, shall—</text> <paragraph id="H00137B22EF6D4F0086D1AB7AAEFF0043"><enum>(1)</enum><text>publish best practices for school-based student suicide awareness and prevention training, pursuant to section 520B, that are based on—</text> <subparagraph id="HFCD6AC9C1C5540B392029ABC6E03CAAA"><enum>(A)</enum><text>evidence-based practices; and</text></subparagraph> <subparagraph id="H6D2B50366B134563A49BAAD39DDCB912"><enum>(B)</enum><text display-inline="yes-display-inline">input from relevant Federal agencies, national organizations, Indian Tribes and Tribal organizations, and related stakeholders;</text></subparagraph></paragraph> <paragraph id="H5A3D8ED604134CEDBBA8E767B79E25A7"><enum>(2)</enum><text>publish guidance, based on the best practices under paragraph (1), to provide State educational agencies, local educational agencies, and Tribal educational agencies with information on student suicide awareness and prevention best practices;</text></paragraph> <paragraph id="H4E3511EB30FF44E3B77C032F971E14AB"><enum>(3)</enum><text>disseminate such best practices to State educational agencies, local educational agencies, and Tribal educational agencies; and</text></paragraph> <paragraph id="H9B2AE4E537EF47B0A63358D2C6467C46"><enum>(4)</enum><text>provide technical assistance to State educational agencies, local educational agencies, and Tribal educational agencies.</text></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="H126CC62521EA4FC5A113CB18F91DC13A"><enum>6082.</enum><header>Effective date</header><text display-inline="no-display-inline">The amendments made by this subtitle shall only apply with respect to applications for assistance under section 520A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290bb-32">42 U.S.C. 290bb–32</external-xref>) that are submitted after the date of enactment of this Act.</text></section></subtitle> <enum>VII</enum><header>Addressing the Impacts of COVID–19 on Substance Use Disorders</header> <subtitle id="H0C09DAFB68394A0C8494A7D357F62A4D"><enum>A</enum><header>Easy Medication Access and Treatment for Opioid Addiction</header> <section id="H1AB77F826C314F23AB3E8BCD68B75DC1" section-type="subsequent-section"><enum>7001.</enum><header>Dispensation of narcotic drugs for the purpose of relieving acute withdrawal symptoms from opioid use disorder</header><text display-inline="no-display-inline">Not later than 180 days after the date of enactment of this Act, the Attorney General shall revise section 1306.07(b) of title 21, Code of Federal Regulations, so that practitioners, in accordance with applicable State, Federal, or local laws relating to controlled substances, are allowed to dispense not more than a three-day supply of narcotic drugs to one person or for one person’s use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both).</text></section></subtitle> <subtitle id="HA21D8BBD68B1403D8408578A90A95647"><enum>B</enum><header>Access to Remote Behavioral Health Treatment</header> <section id="HA90E9EF82E9C42FD8E05829E91D65E77"><enum>7011.</enum><header>Registration of qualified community mental health centers</header> <subsection id="H53D4E2AD31EE49D3BF97D7028D599504"><enum>(a)</enum><header>Definitions</header><text display-inline="yes-display-inline">Section 102 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/802">21 U.S.C. 802</external-xref>) is amended—</text> <paragraph id="HCC4606107E0C4E7EAEB9B94BED40C604"><enum>(1)</enum><text display-inline="yes-display-inline">by striking paragraph (54)(A)(i) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H19D65C83181944FE9EFE6338C6362F1C" style="OLC"> <clause commented="no" display-inline="no-display-inline" id="H19BCE42CB062410F91C5828214DA7C84" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">while the patient is being treated by, and physically located in—</text> <subclause commented="no" display-inline="no-display-inline" id="HD86B3D878EB2477FB0FF1FFB2CE4E9C5"><enum>(I)</enum><text display-inline="yes-display-inline">a hospital or clinic registered under section 303(f); or</text></subclause> <subclause commented="no" display-inline="no-display-inline" id="H6C0FDD9358784A7B82007FF3E2D41ED0"><enum>(II)</enum><text display-inline="yes-display-inline">a qualified community mental health center registered under section 303(l); and</text></subclause></clause><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> <paragraph id="HEE67F1EADF0641BFBA4E39C138586DD1"><enum>(2)</enum><text>by redesignating paragraph (58) as paragraph (59);</text></paragraph> <paragraph id="H9BA7B9F1BC8A4BCD95FC3473519DC5B3"><enum>(3)</enum><text>by redesignating the second paragraph (57) (as added by section 401(a) of the First Step Act of 2018 (<external-xref legal-doc="public-law" parsable-cite="pl/115/391">Public Law 115–391</external-xref>)) as paragraph (58); and</text></paragraph> <paragraph id="HFD33642A851B4417A1784FD5BEEB014D"><enum>(4)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HC32607BF68DD4739A3EE69947774FCD8" style="OLC"> <paragraph id="H284275FBA4494B8AA5535D9875E919F1" indent="up1"><enum>(60)</enum><text display-inline="yes-display-inline">The term <term>qualified community mental health center</term> means a facility that—</text> <subparagraph id="HA54B194D64B449FAA22CE6EAF72125B8"><enum>(A)</enum> <clause commented="no" display-inline="yes-display-inline" id="H8B8F95D3F3D74901BF4E00D7088A419D"><enum>(i)</enum><text display-inline="yes-display-inline">meets the criteria specified in section 1913(c) of the Public Health Service Act to be considered a community mental health center; or</text></clause> <clause id="H1596EBA682334DFEAF7C2FFCEA8147AE" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">meets the criteria specified pursuant to section 223 of the Protecting Access to Medicare Act of 2014 to be considered a certified community behavioral health clinic; and</text></clause></subparagraph> <subparagraph id="HA085CF42E5024A65952316F89255122A"><enum>(B)</enum><text>is licensed, operated, authorized, certified, or otherwise recognized by a State government.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H545E9871D9D542BD8C8B1A852D53ED90"><enum>(b)</enum><header>Registration</header><text>Section 303 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H531218C12BD94327978D1DEF3579632E" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="HCF1B8C2A2E4941BC9F9839555781078B"><enum>(l)</enum><header>Qualified community mental health centers</header> <paragraph commented="no" display-inline="no-display-inline" id="H821850439735453795A6FC4743FE82B1"><enum>(1)</enum><header>Registration</header><text display-inline="yes-display-inline">The Attorney General shall register qualified community mental health centers to administer controlled substances through the practice of telemedicine.</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H14EA9C31F90540168B4B94D134331224"><enum>(2)</enum><header>Denial of applications</header><text display-inline="yes-display-inline">The Attorney General may deny an application for registration under paragraph (1) if the Attorney General determines that the registration would be inconsistent with the public interest after considering—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HAB2CCEFD369647F3B5FDDD3C35488090"><enum>(A)</enum><text>any recommendation by the licensing board or professional disciplinary authority of the State in which the applicant is located;</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H54288EE1136641C6931BD8181EBB1112"><enum>(B)</enum><text>the experience of the applicant in treating patients;</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H34550BA639E14982AFDFBBDEFFC5A34F"><enum>(C)</enum><text>any conviction of an employee of the applicant under Federal or State law relating to treatment of patients;</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H216AF222ADE74F01AC752D3356906B82"><enum>(D)</enum><text>the compliance of the applicant with applicable Federal, State, or local laws relating to treatment of patients; and</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H6F991F17EC85423EB44B8183AD4D768A"><enum>(E)</enum><text>any other conduct by the applicant that may threaten the public’s health and safety.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HE2989A5D5BF14ADAB1EB76169800599B"><enum>(c)</enum><header>Report to Congress</header><text>Not later than 60 days after the date of enactment of this Act, the Attorney General of the United States shall submit to the Congress a plan for implementation of the amendments made by subsections (a) and (b).</text></subsection> <subsection id="H1F6B0FBBB999488EAADF2F0DFCD354C4"><enum>(d)</enum><header>Delayed applicability</header><text display-inline="yes-display-inline">The amendments made by subsections (a) and (b) apply beginning on the date that is 120 days after the date of enactment of this Act.</text></subsection></section></subtitle> <subtitle id="HCDD009FB8B1340EAA0010B4FA35D1F49"><enum>C</enum><header>PDMP Pilot Program</header> <section id="H90D9C4961ECF443B966A7C74158B5432"><enum>7021.</enum><header>Pilot program for integrating substance use disorder and behavioral health treatment locator tool into State prescription drug monitoring programs</header> <subsection id="H7138498462DD46C88EC78929DA6A3A79"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services, in consultation with the Assistant Secretary for Mental Health and Substance Use, shall establish and implement a pilot program in which the Secretary awards grants to, or enters into cooperative agreements with, not more than 5 eligible States to test the feasibility and outcomes of integrating a substance use disorder and behavioral health treatment locator tool into the State’s prescription drug monitoring program.</text></subsection> <subsection id="H94A2965CF8504B918228EE5650ACB1DE"><enum>(b)</enum><header>Grant establishment and participation</header> <paragraph id="H2ACC534BB9674E2CB154A7486415F159"><enum>(1)</enum><header>In general</header><text>In carrying out the pilot program under this section, the Secretary shall, on a competitive basis, award grants to, or enter into cooperative agreements with, not more than 5 eligible States.</text></paragraph> <paragraph id="H9B42BA8681E740DE9C6F4755562DA3AA"><enum>(2)</enum><header>Eligibility</header><text>To be eligible for a grant under this section, a State shall demonstrate to the Secretary’s satisfaction that the State is making progress in integrating the State’s PDMP with electronic health records and health information technology infrastructure.</text></paragraph> <paragraph id="HDC85859BA20440DD8E444ABB04FC7110"><enum>(3)</enum><header>Preference</header><text>In awarding grants under this section, the Secretary shall give preference to eligible States described in paragraph (2) whose rates of death due to drug overdose per population of 100,000 are in the top quartile according to the most recent data of the Centers for Disease Control and Prevention.</text></paragraph></subsection> <subsection id="H764C3D08D9424D98ABBF986957C20EE4"><enum>(c)</enum><header>Period of grant</header><text>A grant awarded to an eligible entity under this section shall be for a period of 2 years.</text></subsection> <subsection id="H72450822FFC24033A8B661AC490627C8"><enum>(d)</enum><header>Grant uses</header> <paragraph id="H2D970B601FE7496C877AC9609F0F8DF4"><enum>(1)</enum><header>Required uses</header><text>A grant awarded under this section to an eligible State shall be used for both of the following purposes:</text> <subparagraph id="H3EDEA8293FD842B1912A865C5656F8DA"><enum>(A)</enum><text display-inline="yes-display-inline">To integrate a substance use disorder and behavioral health treatment locator tool into the PDMP.</text></subparagraph> <subparagraph id="HD294CE30D48F4BDA9614795C3C6A6010"><enum>(B)</enum><text display-inline="yes-display-inline">To develop and disseminate guidance for health care providers on how to consult and share information obtained through the substance use disorder and behavioral health treatment locator tool when a patient’s PDMP information indicates possible misuse of a controlled substance.</text></subparagraph></paragraph> <paragraph id="H51E6664EF1DF4A31BA7315881EC743A7"><enum>(2)</enum><header>Additional permissible uses</header><text>A grant awarded under this section to an eligible State may be used for any of the following additional purposes:</text> <subparagraph id="H20C380A6EBFE4C6799B3367F60A844ED"><enum>(A)</enum><text display-inline="yes-display-inline">To integrate a substance use disorder and behavioral health treatment locator tool into the PDMP that incorporates direct referral capabilities that enable the health care provider—</text> <clause id="H4252E5A2892D465F93BABEAE9F3E1ED6"><enum>(i)</enum><text>to refer a patient to treatment or for an assessment; and</text></clause> <clause id="H212C6883DA8D4290B566310BDDD4FD76"><enum>(ii)</enum><text display-inline="yes-display-inline">consistent with the protection of information by Federal and State privacy laws and security rules, receive feedback about the patient’s engagement with such treatment or assessment.</text></clause></subparagraph> <subparagraph id="H256BBB215F084BC0A8B91C570BC9FBE6"><enum>(B)</enum><text display-inline="yes-display-inline">To integrate a substance use disorder and behavioral health treatment locator tool into the PDMP that provides information regarding the current capacity of inpatient or outpatient treatment resources of a health care provider.</text></subparagraph></paragraph></subsection> <subsection id="H916CF5B4B3584A0BA8D9511842D2836C"><enum>(e)</enum><header>Reporting requirements</header> <paragraph id="H9E87D2AFD0594667BDBC344DAE9E45C9"><enum>(1)</enum><header>Reports by States</header><text>Each eligible State that participates in the pilot program under this section shall submit to the Secretary an annual report for each year of the pilot program that includes information on—</text> <subparagraph id="HE6A2B5BC55C3420D81499FD814293C65"><enum>(A)</enum><text display-inline="yes-display-inline">the number of health care providers and health facilities with access to the substance use disorder and behavioral health treatment locator tool;</text></subparagraph> <subparagraph id="HDAACDE7259544CB28E083A9D450EC1D2"><enum>(B)</enum><text>the number of individuals referred to treatment with the assistance of the locator tool;</text></subparagraph> <subparagraph id="HB32F431CEC754147A8148E24034286CB"><enum>(C)</enum><text display-inline="yes-display-inline">aggregate, de-identified patient data related to the type of treatment located by the locator tool, how often patients followed through on seeking such treatment, and the average duration of such treatment, to the extent collected by the State;</text></subparagraph> <subparagraph id="H2891B0CFCBE14DF29C760897BD456CC0"><enum>(D)</enum><text>feedback from providers with access to the locator tool on usability and any impact on outcomes;</text></subparagraph> <subparagraph id="HB81AD8A69FB446AF85E4FD6FCEAC3532"><enum>(E)</enum><text display-inline="yes-display-inline">recommendations to improve the usability and efficacy of a substance use disorder and behavioral health treatment locator tool within the PDMP; and</text></subparagraph> <subparagraph id="H8C679FF5824C412F8FCB1DBA8574412E"><enum>(F)</enum><text>additional information and reporting metrics as determined by the Secretary.</text></subparagraph></paragraph> <paragraph id="H60FEBF7ECE8448F587BE3EB348560BCD"><enum>(2)</enum><header>Report by Secretary</header><text>Not less than 180 days after the conclusion of the pilot program under this section, the Secretary shall submit to the Congress a report on the findings of the program, including—</text> <subparagraph id="H58C5E6ABC90F4A8B9382D0714B323CAE"><enum>(A)</enum><text>outcomes reported by the participating States;</text></subparagraph> <subparagraph id="HB697BB24E52D460AAE6A73742F7BEE51"><enum>(B)</enum><text display-inline="yes-display-inline">findings on the suitability of including a substance use disorder and behavioral health treatment locator tool within State PDMPs; and</text></subparagraph> <subparagraph id="HAEC6C0AA252547F6B240AEF208251F2C"><enum>(C)</enum><text display-inline="yes-display-inline">recommendations on best practices for integrating a substance use disorder and behavioral health treatment locator tool within State PDMPs.</text></subparagraph></paragraph></subsection> <subsection id="H34E887EFD8B8465193EAA025550931C4"><enum>(f)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H44E7FA3B99D04602874345EF9E3FD365"><enum>(1)</enum><text>The term <term>prescription drug monitoring program</term> or <term>PDMP</term> has the meaning given to the term <term>PDMP</term> in section 399O of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280g-3">42 U.S.C. 280g–3</external-xref>).</text></paragraph> <paragraph id="H1A55B4F37AC04F46A85DD221A71C8F9E"><enum>(2)</enum><text>The term <term>Secretary</term> means the Secretary of Health and Human Services.</text></paragraph></subsection> <subsection id="HBEADD87945A44A1991000256657E0B4D"><enum>(g)</enum><header>Authorization of appropriations</header><text>To carry out this section, there are authorized to be appropriated $2,500,000 for each of fiscal years 2021 and 2022.</text></subsection></section></subtitle> <subtitle id="H4ADD246039F54476B0E27D7C36027B44"><enum>D</enum><header>Family Support Services for Addiction</header> <section id="H107A12390B75410EB76BC5F59508E132"><enum>7031.</enum><header>Family support services for individuals struggling with substance use disorder</header><text display-inline="no-display-inline">Part D of title V of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290dd">42 U.S.C. 290dd</external-xref> et seq.) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HA0D1A61971AE4258BD3AF37A598D21DF" style="OLC"> <section id="HF5A8C69CE790428BB41CAF154C945A23"><enum>553.</enum><header>Family support services for individuals struggling with substance use disorder</header> <subsection id="H106CB3F1B15848C4B4A3D95A06D1F96E"><enum>(a)</enum><header>Definitions</header><text>In this section—</text> <paragraph id="HE23DB82DF78B44899D4DAFA023BEC16A"><enum>(1)</enum><text>the term <term>family community organization</term> means an independent nonprofit organization that—</text> <subparagraph id="HD54CCE66D1A940CB8BA9707E091ABA39"><enum>(A)</enum><text>mobilizes resources within and outside of the community of families with individuals living with addiction, to provide a support network, education, and evidence-informed tools for families and loved ones of individuals struggling with substance use disorders; and</text></subparagraph> <subparagraph id="H7FB7CFB34ACC4DD0BBF7062DE27C2FBD"><enum>(B)</enum><text>is governed by experts in the field of addiction, which may include—</text> <clause id="HE745B6A8ED964F86A11061A7D534D016"><enum>(i)</enum><text>experts in evidence-informed interventions for family members;</text></clause> <clause id="H7744EDED575346E3B66CEF4E3E244701"><enum>(ii)</enum><text>experts in the impact of addiction on family systems;</text></clause> <clause id="HCCBA32F606DC4795B131F74D60135442"><enum>(iii)</enum><text>families who have experience with substance use disorders and addiction; and</text></clause> <clause id="H60AA4F90AFDF41C9A2D294A0423B4FCE"><enum>(iv)</enum><text>other experts in the field of addiction; and</text></clause></subparagraph></paragraph> <paragraph id="H086050DE63CB49CD81D9C3D4BED0E7E3"><enum>(2)</enum><text>the term <term>family support services</term> means resources or programs that support families that include an individual with substance use disorder.</text></paragraph></subsection> <subsection id="H36B9DEAAA57E4DA3AD3A16D1A5921F40"><enum>(b)</enum><header>Grants authorized</header><text>The Secretary shall award grants to family community organizations to enable such organizations to develop, expand, and enhance evidence-informed family support services.</text></subsection> <subsection id="HEF0BBF445E2A4238AAD2CE85AB3CC82B"><enum>(c)</enum><header>Federal share</header><text>The Federal share of the costs of a program funded by a grant under this section may not exceed 85 percent.</text></subsection> <subsection id="H76207A4C3EDF4C27ADD870C5C250BB21"><enum>(d)</enum><header>Use of funds</header><text>Grants awarded under subsection (b)—</text> <paragraph id="H5F9A6E65CFEB4E40AC724D04D84F3322"><enum>(1)</enum><text>shall be used to develop, expand, and enhance community and statewide evidence-informed family support services; and</text></paragraph> <paragraph id="H4ED40A1DD04D4C4BB5A7A8820A41A7B3"><enum>(2)</enum><text>may be used to—</text> <subparagraph id="HBE11A329489F4BA3A5648526233BE381"><enum>(A)</enum><text>build connections between family support networks, including providing technical assistance between family community organizations and peer support networks, and with other family support services, focused on enhancing knowledge of evidence-informed interventions for family members and loved ones of individuals living with substance use disorders and reducing harm by educating service providers on current evidence regarding addiction and the family, including—</text> <clause id="HE52B03644C374F20A8E8585C9A8BEF39"><enum>(i)</enum><text>behavioral health providers, including such providers focused specifically on family and couples therapy in the context of addiction;</text></clause> <clause id="HC16196CCFBDA4232BAA7B42FB7C295C1"><enum>(ii)</enum><text>primary care providers;</text></clause> <clause id="HC5397294F64E47DC89CFF5C095135D07"><enum>(iii)</enum><text>providers of foster care services or support services for grandparents, guardians, and other extended family impacted by addiction; and</text></clause> <clause id="HCEBE2DA89175435BAF24053C63141DDC"><enum>(iv)</enum><text>other family support services that connect to community resources for individuals with substance use disorders, including non-clinical community services;</text></clause></subparagraph> <subparagraph id="H4C2420CF4C3E47878139C0F1E029F7CA"><enum>(B)</enum><text>reduce stigma associated with the family of individuals with substance use disorders by improving knowledge about addiction and its treatment, providing compassionate support, and dispelling myths that perpetuate such stigma;</text></subparagraph> <subparagraph id="HD0FABF21F2C8409BAABFA3217C73030D"><enum>(C)</enum><text>conduct outreach on issues relating to substance use disorders and family support, which may include education, training, and resources with respect to—</text> <clause id="H18776FE23B74485AA60B1C9D340BF8B3"><enum>(i)</enum><text>building a resilience- and strengths-based approach to prevention of, and living with, addiction in the family;</text></clause> <clause id="H5E2DFCC6A3B14AE5A19E82E72672D78D"><enum>(ii)</enum><text>identifying the signs of substance use disorder;</text></clause> <clause id="HD06E872E30254199B70D3554AFB8DF46"><enum>(iii)</enum><text>adopting an approach that minimizes harm to all family members; and</text></clause> <clause id="H2B39B67E58C64BB1AA6BE3340E995B29"><enum>(iv)</enum><text>families of individuals with a substance use disorder, including with respect to—</text> <subclause id="HE1C234E178FB414A822C9CD059C230B9"><enum>(I)</enum><text>navigating the treatment and recovery systems;</text></subclause> <subclause id="H80CBFCA0DCAA4C7498DEA1EC4AAD9635"><enum>(II)</enum><text>paying for addiction treatment;</text></subclause> <subclause id="H2673E25A20ED47D8AF802880E014A1F3"><enum>(III)</enum><text>education about substance use disorder; and</text></subclause> <subclause id="H1E83630470674C09B65D2451DC4278FD"><enum>(IV)</enum><text>avoiding predatory treatment programs; and</text></subclause></clause></subparagraph> <subparagraph id="H1F047A490E6B4EC981472BD9DBD5B559"><enum>(D)</enum><text>connect families to evidence-informed peer support programs.</text></subparagraph></paragraph></subsection> <subsection id="HCE06AF16E13E4791AE48474B207BD885"><enum>(e)</enum><header>Data reporting and program oversight</header><text>With respect to a grant awarded under subsection (a), not later than 90 days after the end of the first year of the grant period, and annually thereafter for the duration of the grant period, the entity shall submit data, as appropriate and to the extent practicable, to the Secretary regarding—</text> <paragraph id="H051CAE8BEF5743168A30BD84FB59DAE5"><enum>(1)</enum><text>the programs and activities funded by the grant;</text></paragraph> <paragraph id="H9B3701F3B4694611AF41E6EFB8D76160"><enum>(2)</enum><text>health outcomes of the population of individuals with a substance use disorder who received services through programs supported by the grant, as evaluated by an independent program evaluator through the use of outcomes measures, as determined by the Secretary; and</text></paragraph> <paragraph id="HE6489C8F2F7E4FA3B5E0B46614D2BD03"><enum>(3)</enum><text>any other information that the secretary may require for the purpose of ensuring that the grant recipient is complying with all the requirements of the grant.</text></paragraph></subsection> <subsection id="H19809915ABF34078AC58A22D538BC25D"><enum>(f)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2021 through 2025.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="HFA8DBF89BC434545A6EFB59C5C976787"><enum>E</enum><header>Block, Report, And Suspend Suspicious Shipments</header> <section id="H28707DEC120D4EFDB5835C6F5407643B"><enum>7041.</enum><header>Clarification of process for registrants to exercise due diligence upon discovering a suspicious order</header> <subsection id="H9A8ECD86B70C4EAD865B363FA9A3AF2C"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Paragraph (3) of section 312(a) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/832">21 U.S.C. 832(a)</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H7662CF1B1EAE4C0695E61DB4ED34C7B3" style="OLC"> <paragraph id="HA6BF8D68E55044C0937AEFB560B9F2BF"><enum>(3)</enum><text display-inline="yes-display-inline">upon discovering a suspicious order or series of orders—</text> <subparagraph id="HED28BF96FF8742369C36C6C78C09ED8C"><enum>(A)</enum><text>exercise due diligence;</text></subparagraph> <subparagraph id="H84414451C899471A8E6FF086B0C6E973"><enum>(B)</enum><text>establish and maintain (for not less than a period to be determined by the Administrator of the Drug Enforcement Administration) a record of the due diligence that was performed;</text></subparagraph> <subparagraph id="H0F6794FF6D114A8CBA58FE1550B6B7F5"><enum>(C)</enum><text>decline to fill the order or series of orders if the due diligence fails to resolve all of the indicators that gave rise to the suspicion that filling the order or series of orders would cause a violation of this title by the registrant or the prospective purchaser; and</text></subparagraph> <subparagraph id="H40C14189198149AD83AFF9094DF1EF84"><enum>(D)</enum><text>notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration for the area in which the registrant is located or conducts business of—</text> <clause id="HA1FA1ADD35C4455CAEC957BEF4222262"><enum>(i)</enum><text>each suspicious order or series of orders discovered by the registrant; and</text></clause> <clause id="H00E016119F764752B0A3D7652C5BCE45"><enum>(ii)</enum><text>the indicators giving rise to the suspicion that filling the order or series of orders would cause a violation of this title by the registrant or the prospective purchaser.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H285B23EFB0FE40F792975334B36E224B"><enum>(b)</enum><header>Applicability</header><text display-inline="yes-display-inline">Section 312(a)(3) of the Controlled Substances Act, as amended by subsection (a), shall apply beginning on the day that is 6 months after the date of enactment of this Act. Until such day, section 312(a)(3) of the Controlled Substances Act shall apply as such section 312(a)(3) was in effect on the day before the date of enactment of this Act.</text></subsection> <subsection id="HD61EC502B84D4BF5901C702ACCAD923F"><enum>(c)</enum><header>Regulations</header><text display-inline="yes-display-inline">The Attorney General shall, issue regulations specifying, for purposes of paragraph (3) of section 312(a) of the Controlled Substances Act, as added by subsection (a), the indicators that give rise to a suspicion that filling an order or series of orders would cause a violation of title III of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/801">21 U.S.C. 801</external-xref> et seq.) by a registrant or a prospective purchaser.</text></subsection></section></subtitle> <subtitle id="HD455C44C22574AFF944D87D42D839DCB"><enum>F</enum><header>Debarment Enforcement of Bad Actor Registrants</header> <section id="H86EAD51A0E7D4C2493B5DBC9846D6952"><enum>7051.</enum><header>Debarment of certain registrants</header><text display-inline="no-display-inline">Section 304 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/824">21 U.S.C. 824</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HD427F48939B8487CB2D18B1258BF7266" style="traditional"> <subsection id="H9EE9B40BBFF04F89B985971473B4B1DE"><enum>(h)</enum><text display-inline="yes-display-inline">The Attorney General may issue an order to prohibit, conditionally or unconditionally, and permanently or for such period as the Attorney General may determine, any person from being registered under this title to manufacture, distribute, or dispense a controlled substance or a list I chemical, if the Attorney General finds that—</text> <paragraph id="HFB30CD1EF00C4C29A757700D03FA3259"><enum>(1)</enum><text display-inline="yes-display-inline">such person meets or has met any of the conditions for suspension or revocation of registration under subsection (a); and</text></paragraph> <paragraph id="H87C92ABB97244BBE9F170CEFE587DA3D"><enum>(2)</enum><text display-inline="yes-display-inline">such person has a history of prior suspensions or revocations of registration.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H1C86BDF91F094DC98D3873C316B79736"><enum>G</enum><header>Ensuring Compliance Against Opioid Diversion</header> <section id="H4AC21427AE874F5A9D351E54269B38DA"><enum>7061.</enum><header>Modification, transfer, and termination of registration to manufacture, distribute, or dispense controlled substances</header><text display-inline="no-display-inline">Subsection (a) of section 302 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/822">21 U.S.C. 822</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block display-inline="no-display-inline" id="H5B31CF96F05B4F0290DDC880F06AF64A" style="OLC"> <paragraph id="H1FC6281BE1944314B7A2CB9AD191C45E" indent="up1"><enum>(3)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="H21C8FBB32EEC4B248C701707181CB6CF"><enum>(A)</enum><text display-inline="yes-display-inline">Except as provided in subparagraph (C), the registration of any registrant under this title to manufacture, distribute, or dispense controlled substances or list I chemicals terminates if and when such registrant—</text> <clause id="HA619E7052773401489C7BA92E525C7F1" indent="up1"><enum>(i)</enum><text>dies;</text></clause> <clause id="H3441EEC2CAB94F05996971CB1DA7DDAB" indent="up1"><enum>(ii)</enum><text>ceases legal existence;</text></clause> <clause id="HC347BF3C2CB84E91884B1F0C98C0E091" indent="up1"><enum>(iii)</enum><text>discontinues business or professional practice; or</text></clause> <clause id="H6EE81653E5764121AACAC2AA5CEAA194" indent="up1"><enum>(iv)</enum><text>surrenders such registration.</text></clause></subparagraph> <subparagraph id="H92700ACA11344549871240629F9C3BE3" indent="up1"><enum>(B)</enum><text>In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact.</text></subparagraph> <subparagraph id="H0E219EBFED474E6DA3311D7CBA47EF56" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">No registration under this title to manufacture, distribute, or dispense controlled substances or list I chemicals, and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not manufacture, distribute, or dispense controlled substances or list I chemicals pursuant to such registration until the Attorney General receives such written consent.</text></subparagraph> <subparagraph id="H8F96A8494E2447F2BAFEC0A84F507079" indent="up1"><enum>(D)</enum><text>In the case of a registrant under this title to manufacture, distribute, or dispense controlled substances or list I chemicals desiring to discontinue business or professional practice altogether or with respect to controlled substances and list I chemicals (without assigning or transferring such business or professional practice to another entity), such registrant shall return to the Attorney General for cancellation—</text> <clause id="H4A3E8CEED17E4811859E65E5EB42ADAF"><enum>(i)</enum><text>the registrant’s certificate of registration;</text></clause> <clause id="H976E229714AA4BE4922C8E1B55EBBBC5"><enum>(ii)</enum><text>any unexecuted order forms in the registrant’s possession; and</text></clause> <clause id="H538D0196C446442BB5602D1C04CD5943"><enum>(iii)</enum><text>any other documentation that the Attorney General may require.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H7EE6FBA095D048DE94654C737F1FD842"><enum>H</enum><header>Opioid Prescription Verification</header> <section id="H2FFC4C75A8354AAF8FB4A31421213101"><enum>7071.</enum><header>Materials for training pharmacists on certain circumstances under which a pharmacist may decline to fill a prescription</header> <subsection id="H3E5573E4F57E4B59B446E0D384E61DF3"><enum>(a)</enum><header>Updates to materials</header><text display-inline="yes-display-inline">Section 3212(a) of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="public-law" parsable-cite="pl/115/271">Public Law 115–271</external-xref>) is amended by striking <quote>Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate</quote> and inserting <quote>The Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate not later than 1 year after the date of enactment of this Act, and update periodically thereafter</quote>.</text></subsection> <subsection id="H0F845279B3CA4FC085D4CEA85A2A54F3"><enum>(b)</enum><header>Materials included</header><text display-inline="yes-display-inline">Section 3212(b) of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="public-law" parsable-cite="pl/115/271">Public Law 115–271</external-xref>) is amended—</text> <paragraph id="HBBBFFE664A4B4C209DC8D70457474055"><enum>(1)</enum><text>by redesignating paragraphs (1) and (2) as paragraphs (2) and (3), respectively; and</text></paragraph> <paragraph id="H57DF9A53D2374C9FADE0831AFB353DDF"><enum>(2)</enum><text>by inserting before paragraph (2), as so redesignated, the following new paragraph:</text> <quoted-block display-inline="no-display-inline" id="H51EC45CA0C9E4E3FBC8B6B50445BA0DA" style="OLC"> <paragraph id="HDCC5BA0BC74F4E778FC94BEB950B99F1"><enum>(1)</enum><text display-inline="yes-display-inline">pharmacists on how to verify the identity of individuals picking up prescriptions;</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HC03660247D194329A94FB6ADA093BE4C"><enum>(c)</enum><header>Materials for training on verification of identity</header><text display-inline="yes-display-inline">Section 3212 of the SUPPORT for Patients and Communities Act (<external-xref legal-doc="public-law" parsable-cite="pl/115/271">Public Law 115–271</external-xref>) is amended by adding at the end the following new subsection:</text> <quoted-block id="H70878EF56B17492185E18F424DF11942" style="OLC"> <subsection id="H772BCFCB7D52497BA7F5BB2757D9E539"><enum>(d)</enum><header>Materials for training on verification of identity of individuals picking up prescribed medications</header><text>Not later than 6 months after the date of enactment of this subsection, the Secretary of Health and Human Services, after seeking stakeholder input in accordance with subsection (c), shall—</text> <paragraph id="H5FD95DC3DF9F4F5D925FB90B0383B7F9"><enum>(1)</enum><text>update the materials developed under subsection (a) to include information for pharmacists on how to verify the identity of individuals picking up prescribed medications; and</text></paragraph> <paragraph id="HA1DF734A10F54341BC42CF6F1C895685"><enum>(2)</enum><text>disseminate, as appropriate, the updated materials.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="HA4709F890C464F2FA5EB24E9E31E3B59"><enum>7072.</enum><header>Incentivizing States to facilitate responsible, informed dispensing of controlled substances</header> <subsection id="H43CBF03692FE4DFAB0EF6980CABDB7EC"><enum>(a)</enum><header>In general</header><text>Section 392A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-1">42 U.S.C. 280b–1</external-xref>) is amended—</text> <paragraph id="HA72FCC018C59492980519F4AA42659A2"><enum>(1)</enum><text>by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and</text></paragraph> <paragraph id="HF553183CCD8D43E4A0DB76EACCFE4436"><enum>(2)</enum><text>by inserting after subsection (b) the following new subsection:</text> <quoted-block id="H1FB93DE98DD94A859FD1E622D532C23E" style="OLC"> <subsection id="H7A3AE0DFFEA7423CB099C1B464B9FBC1"><enum>(c)</enum><header>Preference</header><text>In determining the amounts of grants awarded to States under subsections (a) and (b), the Director of the Centers for Disease Control and Prevention may give preference to States in accordance with such criteria as the Director may specify and may choose to give preference to States that—</text> <paragraph id="H6F4B7A94044949D4BFAC8FEF4FE292C6"><enum>(1)</enum><text>maintain a prescription drug monitoring program;</text></paragraph> <paragraph id="H0DE3F87E8F97488AAC9A2AB0AAEBAB05"><enum>(2)</enum><text>require dispensers of controlled substances in schedule II, III, or IV to verify the identity of the person who picks up a prescribed medication by requiring such person to present a photo identification card that is valid as determined by the respective State; and</text></paragraph> <paragraph id="H11ACCD112C0F48BB80C92950E75D6A6E"><enum>(3)</enum><text>require dispensers of such controlled substances to enter certain information about the purchase of such controlled substances into the respective State’s prescription drug monitoring program, including—</text> <subparagraph id="HCC3B90DE85084EFB9B5F688D66F1DAAD"><enum>(A)</enum><text>the National Drug Code or, in the case of compounded medications, compound identifier;</text></subparagraph> <subparagraph id="H82BDB9F17CEB4CFF932BEAB4EA3C5D63"><enum>(B)</enum><text>the quantity dispensed;</text></subparagraph> <subparagraph id="HB4632F1599AD4E5B8E630DD5C5A74546"><enum>(C)</enum><text>the name of the patient;</text></subparagraph> <subparagraph id="H1B91BEDBB7B645E490F7FADEB677FA79"><enum>(D)</enum><text>the name of the ultimate user;</text></subparagraph> <subparagraph id="H392AF94896364E12930CDC896373FBF4"><enum>(E)</enum><text>the name of the person who picks up the controlled substance, if different from the patient and ultimate user; and</text></subparagraph> <subparagraph id="H50BC8D05602E4652B49BDF148BBE782C"><enum>(F)</enum><text>the date filled.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HFB256CF2F0DE4652BE2A70E7AA9D2D48"><enum>(b)</enum><header>Definitions</header><text>Subsection (d) of section 392A of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/280b-1">42 U.S.C. 280b–1</external-xref>), as redesignated by subsection (a)(1), is amended to read as follows:</text> <quoted-block id="HAC384389BBB14970BDDFC521B3815034" style="OLC"> <subsection id="H03D76541CE3C48C7B59E0DB3A6D49085"><enum>(d)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HA4A8A70AFD90419B81A8B0B0C9AA95C8"><enum>(1)</enum><header>Controlled substance</header><text>The term <term>controlled substance</term> has the meaning given that term in section 102 of the Controlled Substances.</text></paragraph> <paragraph id="H94502A400ADD419CB9B2106E88D30268"><enum>(2)</enum><header>Dispenser</header><text>The term <term>dispenser</term> means a physician, pharmacist, or other person that dispenses a controlled substance to an ultimate user.</text></paragraph> <paragraph id="H0EA503290B2448D4BFEFB6958030837A"><enum>(3)</enum><header>Indian tribe</header><text>The term <term>Indian tribe</term> has the meaning given that term in section 4 of the Indian Self-Determination and Education Assistance Act.</text></paragraph> <paragraph id="H25C87E191CA14DEDAF58EAE7A8789AA6"><enum>(4)</enum><header>State</header><text>The term <term>State</term> means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States.</text></paragraph> <paragraph id="H13D13FC7F5A44210BB73C1577614574A"><enum>(5)</enum><header>Ultimate user</header><text>The term <term>ultimate user</term> means a person who has obtained from a dispenser, and who possesses, a controlled substance for the person’s own use, for the use of a member of the person’s household, or for the use of an animal.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section></subtitle> <subtitle id="H22B0279E95BD44498D0912E676A19342"><enum>I</enum><header>Suspicious Order Identification</header> <section id="H0EB5843C56EF423584B9F5036CCFE10B"><enum>7081.</enum><header>Strengthening ARCOS</header><text display-inline="no-display-inline">Section 307(d) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/827">21 U.S.C. 827(d)</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H4953253023DB428989FA5AEAF17C40E2" style="OLC"> <paragraph id="HB0D93588EDD8417B84679BD2322CA099" indent="up1"><enum>(1)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="H396D2FFF05994D8090D0928C3B7BB6D2"><enum>(A)</enum><text>Every registrant under section 303 shall and in such form as the Attorney General may require, make reports in electronic format to the Attorney General of every sale, delivery, or other disposal (other than by dispensing by a practitioner) by the registrant of any controlled substance, identifying by the registration number assigned under this title the person or establishment (unless exempt from registration under section 302(d)) to whom such sale, delivery, or other disposal was made.</text></subparagraph> <subparagraph id="H22CB5EF2013E4314ACBBFEAC12101B4E" indent="up1"><enum>(B)</enum><text>Every registrant shall make each report required under subparagraph (A)—</text> <clause id="H2AA1339B2AF34588BAE5304F6BBB64D6"><enum>(i)</enum><text>not later than 30 days after the sale, delivery, or other disposal; or</text></clause> <clause id="HD19B67E2FC8E48148C32F260A6D98899"><enum>(ii)</enum><text>after the date on which the real-time reporting system is established under section 7082(e)(3) of the <short-title>Commitment to Defeat the Virus and Keep America Healthy Act</short-title> is implemented, in real time.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="HB80EE6FEB3584776BAD5E7D2A81F3FBD"><enum>7082.</enum><header>Suspicious Orders Task Force</header> <subsection id="HE65C2DA47F4D48AAB728E48E899C83B8"><enum>(a)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="H965A263A03694D35BDD0BB14B7EF9BE3"><enum>(1)</enum><header>Administrator</header><text>The term <term>Administrator</term> means the Administrator of the Drug Enforcement Administration.</text></paragraph> <paragraph id="H9EC611FA5D3F4FC385B293FC7F695E65"><enum>(2)</enum><header>Controlled substance; distributor; manufacturer</header><text>The terms <term>controlled substance</term>, <term>distributor</term>, and <term>manufacturer</term> have the meanings given those terms 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></paragraph> <paragraph id="H67459C5A9C5B4788BAF86A746E78A2FA"><enum>(3)</enum><header>Real time</header><text>The term <term>real time</term> means with as little delay as technically and economically feasible, as determined by the Attorney General following the program designed under subsection (e)(1), but not to exceed 24 hours.</text></paragraph> <paragraph id="H129C5DAC708A4A898A10040180B13DAF"><enum>(4)</enum><header>Registrant</header><text>The term <term>registrant</term>—</text> <subparagraph id="HD9A159DEF61B4E6AA1B3479640C29E90"><enum>(A)</enum><text>means a person registered under section 303 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823</external-xref>); and</text></subparagraph> <subparagraph id="HC039D80B645F41CF882F6B2036EFF564"><enum>(B)</enum><text>does not include practitioner.</text></subparagraph></paragraph></subsection> <subsection id="H7253B2092A8F4504BC7CA3FC181E89F8"><enum>(b)</enum><header>Establishment</header><text>The Attorney General, in consultation with the Director of the Office of National Drug Control Policy and the Secretary of Health and Human Services, shall establish a Suspicious Order Monitoring Task Force (referred to in this section as the <quote>Task Force</quote>).</text></subsection> <subsection id="HB8E5C1D2A3A24037851960E9EFC001CC"><enum>(c)</enum><header>Composition</header> <paragraph id="HDF89A089B18C401D9E5C164A2700C0CC"><enum>(1)</enum><header>In general</header><text>The Task Force shall be composed of appropriate personnel from—</text> <subparagraph id="H5C775F92437C4476BD241D2A1DE2DF61"><enum>(A)</enum><text>the Department of Justice;</text></subparagraph> <subparagraph id="HF6E23A5A4C78488BAC058C0801D25B81"><enum>(B)</enum><text>the Drug Enforcement Administration;</text></subparagraph> <subparagraph id="H9316043DD18C46E29D68FFD3A88A230D"><enum>(C)</enum><text>the Office of National Drug Control Policy;</text></subparagraph> <subparagraph id="HBA362A7F44974977A56A7F6015E34C63"><enum>(D)</enum><text>the National Institute of Standards and Technology; and</text></subparagraph> <subparagraph id="HF5984AC934F94115B08839ED6A929338"><enum>(E)</enum><text>other appropriate Federal, State, and local law enforcement and regulatory agencies with experience in investigating and prosecuting illegal transactions of controlled substances as determined by the Attorney General, in consultation with the Secretary of Health and Human Services.</text></subparagraph></paragraph> <paragraph id="HF4866924EBD142EEB30E9CB15A514C2A"><enum>(2)</enum><header>Consultants</header><text>The Task Force shall consult with—</text> <subparagraph id="H3B6B3DF34B8E4DAFA969FD2E3EFA2A2E"><enum>(A)</enum><text>industry members, including—</text> <clause id="H23C9A909D18E42C9A61C1D4B5A751277"><enum>(i)</enum><text>data analytic professionals;</text></clause> <clause id="HCD22D044D36849D0B4BFB631DC08F642"><enum>(ii)</enum><text>community pharmacies that dispense controlled substances;</text></clause> <clause id="H54356DE825874900A97B75D20F9D1BAD"><enum>(iii)</enum><text>chain pharmacies that dispense controlled substances;</text></clause> <clause id="HB788DDBDE8844803A4DB1F16CEEA37B3"><enum>(iv)</enum><text>distributors of controlled substances;</text></clause> <clause id="H389625CAB1C04C60B15C615A1C969467"><enum>(v)</enum><text>manufacturers of controlled substances;</text></clause> <clause id="HE9D4226F737C4C329116A58F770AE37A"><enum>(vi)</enum><text>State and local public health officials; and</text></clause> <clause id="H075050796B644917801C6CD461735AB1"><enum>(vii)</enum><text>other relevant industry professionals; and</text></clause></subparagraph> <subparagraph commented="no" id="H8FF1595319554C91BE1B4B3D5299B023"><enum>(B)</enum><text>relevant industry regulators and entities that utilize real-time reporting of transactions, orders, or other activities with the goal of identifying suspicious activity, such as appropriate personnel from the Financial Crimes Enforcement Network and money transfer industry professionals.</text></subparagraph></paragraph></subsection> <subsection id="HB94AB762A3CD4820AD6C747F3DE9954B"><enum>(d)</enum><header>Meetings</header> <paragraph id="H91669301690D4517B7720ED75F74773C"><enum>(1)</enum><header>In general</header><text>The Task Force shall meet not less frequently than 4 times per year and at such other times as may be determined necessary by the Task Force.</text></paragraph> <paragraph id="H3DD78A7CE5E64F49B1B0B8EAC131CB55"><enum>(2)</enum><header>Initial meeting</header><text>Not later than 60 days after the date of enactment of this Act, the Task Force shall hold the initial meeting of the Task Force.</text></paragraph></subsection> <subsection id="H574F795301EE49AB9DBE60F5D6EF62D7"><enum>(e)</enum><header>Preliminary order evaluation program</header> <paragraph id="HB7F9B316D7544FEF9D4B89995554D594"><enum>(1)</enum><header>In general</header> <subparagraph id="H83C780E8354A4A83AAE0A2254CFDCEAF"><enum>(A)</enum><header>Design</header><text>Not later than 60 days after the date on which the Task Force holds the initial meeting required under subsection (d)(2), the Task Force shall begin to design a program in accordance with paragraph (2).</text></subparagraph> <subparagraph id="H9AC541C4E1FC4DE9AEE128B2DD9BF362"><enum>(B)</enum><header>Purpose</header><text>The program described in subparagraph (A) shall be designed to share necessary data, in a limited capacity, with registrants in order to provide registrants with information to identify suspicious ordering in real time.</text></subparagraph> <subparagraph id="H98C9F2C71DC8433C816D60463BB5CBF5"><enum>(C)</enum><header>Deadline for completion</header><text>Not later than 8 months after the date of enactment of this Act, the Task Force shall complete the design required under subparagraph (A).</text></subparagraph></paragraph> <paragraph id="H27FFC989306C46C093B42A03491BAAFB"><enum>(2)</enum><header>Requirements</header> <subparagraph id="H9EC9D89956CF498B95A2023389FFD69F"><enum>(A)</enum><header>In general</header><text>The program required under paragraph (1) shall establish a process for—</text> <clause id="HE9713E8A94DD43A7AA0A11C6F1161FFF"><enum>(i)</enum><text>transitioning to a requirement to report in real time to the Attorney General under section 307(d) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/827">21 U.S.C. 827(d)</external-xref>) every sale, delivery, or other disposal by a registrant of any controlled substance;</text></clause> <clause id="H4BF32580BF8E477F974C671105C6D569"><enum>(ii)</enum><text>limited sharing in real time of Automation of Reports and Consolidated Orders System (commonly known as <quote>ARCOS</quote>) data with registrants to share necessary data, in a limited capacity, with registrants in order to provide registrants with information to identify suspicious ordering in real time; and</text></clause> <clause id="HEF944F2CC54544EDA41CED1BE155C6AC"><enum>(iii)</enum><text>ensuring data privacy, data de-identification, protection of trade secrets and purchasing history.</text></clause></subparagraph> <subparagraph id="H45A089DB29514DF99A0A78FA8B812092"><enum>(B)</enum><header>Other considerations</header><text>In designing the program under paragraph (1), the Task Force shall take into consideration—</text> <clause id="H35EE648BBFDB482D80416E5F2F322A74"><enum>(i)</enum><text>the inclusion of a waiver process for pharmacies and other registrants unable to transmit orders electronically on the date of enactment of this Act;</text></clause> <clause id="H336A468254424042B3AF455DFB5A4417"><enum>(ii)</enum><text>a mechanism to ensure that the costs of running the program are not passed through to customers of registrants, unless the registrants are customers of other registrants;</text></clause> <clause id="H2A78F21CBE3B4AAA875AC118C36B71FC"><enum>(iii)</enum><text>technical requirements for ensuring that registrants may access all relevant de-identified data, with output provided in a standard database file format; and</text></clause> <clause id="HC970E65F3C96444AB054EA73393E1CF6"><enum>(iv)</enum><text>a mechanism to ensure that the program required to be designed under subparagraph (A) is updated based on feedback from industry members and other relevant entities.</text></clause></subparagraph></paragraph> <paragraph id="HA30948C13D224A7499672ED72339E3DD"><enum>(3)</enum><header>Implementation</header><text>Not later than 1 year after the date of enactment of this Act, the Attorney General shall—</text> <subparagraph id="H483FA252EAE44392AB34B59628BB8449"><enum>(A)</enum><text>implement the program designed under paragraph (1) to collect and share in real time data for registrants to evaluate the orders of controlled substances from distributors to manufacturers and from pharmacies to distributors; or</text></subparagraph> <subparagraph id="H639CF6AB473A49D393E38B84DB90B2B5"><enum>(B)</enum><text>otherwise implement a program to collect and share in real time data for drug manufacturers and distributors, by providing access to anonymized information to help drug manufacturers and distributors identify, report, and stop suspicious orders of controlled substances and reduce diversion rates.</text></subparagraph></paragraph> <paragraph id="H7EF153BEDDB248109B93B1DD1F15BBC6"><enum>(4)</enum><header>Recommended statutory and regulatory changes</header><text>In designing the program required under paragraph (1), the Task Force—</text> <subparagraph id="H42CD192775B24E8F9C2945F0B7871F5C"><enum>(A)</enum><text>shall submit to the Attorney General any recommendations for necessary amendments to regulations of the Department of Justice relating to the requirements for ordering schedule II controlled substances, so as to allow uniform electronic ordering of controlled substances in schedules II, III, IV, and V electronically through the program; and</text></subparagraph> <subparagraph id="HC0DF906098134DBCAAF377DD4B959520"><enum>(B)</enum><text>may submit to Congress any recommendations for necessary legislative changes so that a real-time data analytics solution can be used across the United States.</text></subparagraph></paragraph> <paragraph id="H42E07AC5DC3043D1AB4D84C02DEF3ACD"><enum>(5)</enum><header>Responsibility of registrants</header><text>All registered drug manufacturers and distributors shall be responsible for reviewing any information made available by the Attorney General and complying with any regulations regarding the program designed under paragraph (1) and implemented under paragraph (3).</text></paragraph></subsection> <subsection id="H4F19712D0B684BDBADEF18C1AE343188"><enum>(f)</enum><header>Funding</header> <paragraph id="H8AD88E0B45EF4556A978A98D61F8D992"><enum>(1)</enum><header>In general</header><text>The Attorney General, acting through the Administrator, shall use amounts collected as fees for distributors and registrants under section 303 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823</external-xref>) and section 1007 of the Controlled Substances Import and Export Act (<external-xref legal-doc="usc" parsable-cite="usc/21/957">21 U.S.C. 957</external-xref>) to carry out this section.</text></paragraph> <paragraph id="H1B8B4DE94FA44F53A32F086011DBA392"><enum>(2)</enum><header>Offset</header> <subparagraph id="H6D166A0E1AC54BE1A28C544A0772638F"><enum>(A)</enum><header>In general</header><text>The Administrator may, on an equal basis and in accordance with subparagraph (B), increase the fees described in paragraph (1) for distributors and registrants to the extent necessary to defray the costs of this section.</text></subparagraph> <subparagraph id="H25470F86D5D647AAB9C1672E9ECE3463"><enum>(B)</enum><header>Tiered fee</header><text>The Administrator shall establish a tiered user fee for distributors and registrants in proportion to the volume of sales and purchases.</text></subparagraph></paragraph></subsection> <subsection id="H75EEAE15698041D980A2016B503C87D0"><enum>(g)</enum><header>Applicability of FACA</header> <paragraph id="HF8D1A029B5B046A5AE0CDD374777362A"><enum>(1)</enum><header>In general</header><text>Except as provided in paragraph (2), the Federal Advisory Committee Act (5 U.S.C. App.) shall apply to the Task Force.</text></paragraph> <paragraph id="HC86AA88D5CE543DB9D91AB3838B2E3DC"><enum>(2)</enum><header>Termination</header><text>The Task Force shall terminate on the date on which the program is fully implemented under subsection (e)(3).</text></paragraph></subsection> <subsection id="H5B3646D2376B48878558FAD05267BD9C"><enum>(h)</enum><header>Rules of construction</header><text>Nothing in this subtitle shall be construed as relieving any manufacturer, distributor, or other registrant from the responsibilities of the manufacturer, distributor, or other registrant, as the case may be, to—</text> <paragraph id="HCEBFCA2036D849DC96076113BD566AA8"><enum>(1)</enum><text>identify, stop, and report suspicious orders;</text></paragraph> <paragraph id="HBC0D87A320744A2EADB7B6E795CA43D4"><enum>(2)</enum><text>maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823</external-xref>); and</text></paragraph> <paragraph id="HB742F97631534E2DB723C9334A50DE36"><enum>(3)</enum><text>comply with the requirements established in section 1301.74(b) of title 21, Code of Federal Regulations, or any successor regulation thereto, with respect to suspicious orders.</text></paragraph></subsection></section></subtitle> <subtitle id="H6277EE17033E473AA2A8A922D4226119"><enum>J</enum><header>Stop the Importation and Manufacturing of Synthetic Analogues</header> <section id="H76971A82611649F2A7779DE5C4CDDBD7"><enum>7091.</enum><header>Establishment of schedule A</header><text display-inline="no-display-inline">Section 202 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/812">21 U.S.C. 812</external-xref>) is amended—</text> <paragraph id="HC42CFA8F62A34F03974F48778601258C"><enum>(1)</enum><text>in subsection (a), by striking <quote>five schedules of controlled substances, to be known as schedules I, II, III, IV, and V</quote> and inserting <quote>six schedules of controlled substances, to be known as schedules I, II, III, IV, V, and A</quote>;</text></paragraph> <paragraph id="H36EFFCA2D2A942468EFA4014A0E32EDF"><enum>(2)</enum><text>in subsection (b), by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H7DCAA10157334C17943D7F534872615D" style="OLC"> <paragraph commented="no" display-inline="no-display-inline" id="HD5E5A69D67DA4C3384A1EAEA4FA5FF58" indent="up1"><enum>(6)</enum><header display-inline="yes-display-inline">Schedule A</header> <subparagraph commented="no" display-inline="no-display-inline" id="H41D576C54A1D4D158B42B8FB02280B66"><enum>(A)</enum><header>In general</header><text>The drug or substance—</text> <clause commented="no" display-inline="no-display-inline" id="H61455C38FA1F4CDC8EEDFA77F9C061CA"><enum>(i)</enum><text>is or has been imported, or is offered for import, into the United States;</text></clause> <clause id="H6B6AC64CA11C4C208610D4255DD6EF6B"><enum>(ii)</enum><text>has—</text> <subclause commented="no" display-inline="no-display-inline" id="HA7A0A582517F47EF858DD52C6A93D182"><enum>(I)</enum><text>a chemical structure that is substantially similar to the chemical structure of a controlled substance in schedule I, II, III, IV, or V; and</text></subclause> <subclause commented="no" display-inline="no-display-inline" id="H67A3038093AC47B28E9CB4B60AE413A5"><enum>(II)</enum><text>an actual or predicted stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I, II, III, IV, or V; and</text></subclause></clause> <clause commented="no" display-inline="no-display-inline" id="H55AF9480D2484D2789D8C4D0253C75E6"><enum>(iii)</enum><text>is not—</text> <subclause commented="no" display-inline="no-display-inline" id="HB81F1510B18D45179839C9E7D131743E"><enum>(I)</enum><text>listed or otherwise included in any other schedule in this section or by regulation of the Attorney General; and</text></subclause> <subclause commented="no" display-inline="no-display-inline" id="H070F99AD478C4EAF98163E19E631AAE5"><enum>(II)</enum><text>with respect to a particular person, subject to an exemption that is in effect for investigational use, for that person, 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>) to the extent conduct with respect to such substance is pursuant to such exemption.</text></subclause></clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H8D2303A6B1D74AAFBE6E8990E3C9E0EE"><enum>(B)</enum><header>Predicted stimulant, depressant, or hallucinogenic effect</header><text>For purposes of this paragraph, a predicted stimulant, depressant, or hallucinogenic effect on the central nervous system may be based on—</text> <clause id="HB1A96DC0B4BE4CE18770555A44B92C47"><enum>(i)</enum> <subclause commented="no" display-inline="yes-display-inline" id="H91D14760258E4137925FD87D0A89F0B0"><enum>(I)</enum><text>the chemical structure; and</text></subclause> <subclause id="H1A575DF878C64071BB1A74150C98269E" indent="up1"><enum>(II)</enum> <item commented="no" display-inline="yes-display-inline" id="H26C6D76CDAE9426B9345D2C2D961B7D5"><enum>(aa)</enum><text>the structure activity relationships; or</text></item> <item id="H99A9F771F7C34E8DAA2FB113B1D07802" indent="up1"><enum>(bb)</enum><text>binding receptor assays and other relevant scientific information about the substance;</text></item></subclause></clause> <clause id="HA6DE17C366164286B45292A53C61F2E0"><enum>(ii)</enum> <subclause commented="no" display-inline="yes-display-inline" id="HA35DCDE61BDE436EAF493B2E34AE7D85"><enum>(I)</enum><text>the current or relative potential for abuse of the substance; and</text></subclause> <subclause id="HA2F3C34A60DC484286677D76D87CBF9B" indent="up1"><enum>(II)</enum><text>the clandestine importation, manufacture, or distribution, or diversion from legitimate channels, of the substance; or</text></subclause></clause> <clause id="H6E0EC1B88CEC404C9B23A61C3EE8132E"><enum>(iii)</enum><text>the capacity of the substance to cause a state of dependence, including physical or psychological dependence that is similar to or greater than that of a controlled substance in schedule I, II, III, IV, or V.</text></clause></subparagraph></paragraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="HB303969A40104CF4B912FC9FA2E3F199"><enum>(3)</enum><text>in subsection (c)—</text> <subparagraph id="H41C26A5B4D824BC4877B3429D57301D4"><enum>(A)</enum><text>in the matter preceding schedule I, by striking <quote>IV, and V</quote> and inserting <quote>IV, V, and A</quote>; and</text></subparagraph> <subparagraph id="HD5F928B36D074D19948A3CCD9C781E2F"><enum>(B)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HD95940DBFB4844ECA7D0CF50E562906F" style="traditional"> <section id="H8060EAEE5FC54D1FBDCB336298418DA4" section-type="undesignated-section"><header>Schedule A</header><text>Any substance temporarily or permanently scheduled by the Attorney General in accordance with section 201(k).</text></section><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></section> <section id="H281159D72C5446F2BB2EDA3EC762DEA8"><enum>7092.</enum><header>Temporary and permanent scheduling of schedule A substances</header><text display-inline="no-display-inline">Section 201 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/811">21 U.S.C. 811</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H24B41E6CCAAF4E19A986DCC831CD1188" style="traditional"> <subsection id="H062D3D724DB34F088144638FBDBFD0B1"><enum>(k)</enum><header>Temporary and permanent scheduling of schedule A substances</header> <paragraph id="HC59C43DAA8044F259BEF376C43DCEAB4"><enum>(1)</enum><header>In general</header><text>The Attorney General may issue a temporary order adding a drug or substance to schedule A if the Attorney General finds that—</text> <subparagraph id="HA3545624FDFA44DDA26B421F633D50AA"><enum>(A)</enum><text>the drug or other substance satisfies the criteria for being considered a schedule A substance; and</text></subparagraph> <subparagraph id="H52B63234F53A4677A6FBBEF5ECF655A9"><enum>(B)</enum><text>adding such drug or substance to schedule A will assist in preventing abuse of the drug or other substance.</text></subparagraph></paragraph> <paragraph id="H59F433C7D5294A7CB643248B78D693C2"><enum>(2)</enum><header>Duration of temporary scheduling order</header><text>A temporary scheduling order issued under paragraph (1) shall—</text> <subparagraph id="H572FC6E3D9D441B3B5C919510798DAA4"><enum>(A)</enum><text>not take effect until 30 days after the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued; and</text></subparagraph> <subparagraph id="HCE512E61FDDD4EF0BBCF6879710A2D84"><enum>(B)</enum><text>expire not later than 5 years after the date on which the order becomes effective, except that the Attorney General may, during the pendency of proceedings under paragraph (5), extend the temporary scheduling order for up to 180 days.</text></subparagraph></paragraph> <paragraph id="H4F06073D48284E1CA6FAE537C856AB96"><enum>(3)</enum><header>Effect of issuance of permanent scheduling order</header><text>A temporary scheduling order issued under paragraph (1) shall be vacated upon the issuance of a permanent order issued under paragraph (5) with regard to the same substance, or upon the subsequent issuance of any scheduling order under this section.</text></paragraph> <paragraph commented="no" id="HCAE2008C7198455AA266BDE407F8EAFD"><enum>(4)</enum><header>Limitation on judicial review</header><text>A temporary scheduling order issued under paragraph (1) shall not be subject to judicial review.</text></paragraph> <paragraph id="HAA76D384DAB94A8AA6A66AE670289B6C"><enum>(5)</enum><header>Permanent scheduling order</header> <subparagraph id="HB306A3916DF84555BCEC912627D2F65D"><enum>(A)</enum><header>In general</header><text>Except as provided in subparagraph (B), not earlier than 3 years after the date on which the Attorney General issues an order temporarily scheduling a drug or substance under this subsection, the Attorney General may, by rule, issue a permanent order adding the drug or other substance to schedule A if such drug or substance satisfies the criteria for being considered a schedule A substance.</text></subparagraph> <subparagraph id="HF2788A816E4445B7A78ADE547572ED39"><enum>(B)</enum><header>Limitation</header><text>If the Secretary of Health and Human Services has determined, based on relevant scientific studies and necessary data requested by the Secretary of Health and Human Services and gathered by the Attorney General, that a drug or other substance that has been temporarily placed in schedule A does not have sufficient potential for abuse to warrant control in any schedule, and provides written notice of such determination to the Attorney General, the Attorney General—</text> <clause id="H5F7641A9BE504EE5BF724A18B7C3D19E"><enum>(i)</enum><text>may not issue a permanent scheduling order under subparagraph (A); and</text></clause> <clause id="H7BAB086E954F46D3935F28F7CB1BA360"><enum>(ii)</enum><text>not later than 30 days after the date on which the Attorney General receives such notice, shall issue an order immediately terminating the temporary scheduling order for the drug or other substance.</text></clause></subparagraph></paragraph> <paragraph id="HEAAB7D1CE1774FFFBC0C49423F02FDA5"><enum>(6)</enum><header>Notice to HHS</header><text>Before initiating proceedings under paragraph (1), the Attorney General shall transmit notice of a temporary order proposed to be issued to the Secretary of Health and Human Services. In issuing an order under paragraph (1), the Attorney General shall take into consideration any comments submitted by the Secretary of Health and Human Services in response to a notice transmitted pursuant to this paragraph.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section> <section commented="no" id="HA834FFCF35194080A1D10261CCC6D13E"><enum>7093.</enum><header>Penalties</header><text display-inline="no-display-inline">Section 1010 of the Controlled Substances Import and Export Act (<external-xref legal-doc="usc" parsable-cite="usc/21/960">21 U.S.C. 960</external-xref>) is amended—</text> <paragraph commented="no" id="HD10D190D22954D83AC3A5977A167BC9A"><enum>(1)</enum><text>in subsection (a), by inserting <quote>or a drug or substance in schedule A</quote> after <quote>controlled substance</quote> each place it appears; and</text></paragraph> <paragraph commented="no" id="H9DDE41D14AFD4ECF9203881F0B20A6D4"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b), by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H190CAE7002E942AE8A0C0A077B04A9E5" style="OLC"> <paragraph id="H0B4E6F221AFD4B06B5F7A0B5C7923F74" indent="up1"><enum>(8)</enum><text>In the case of a violation under subsection (a) involving a controlled substance in schedule A, the person committing such violation shall be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment for any term of years or for life, a fine not to exceed the greater of that authorized in accordance with the provisions of title 18, United States Code, or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both. If any person commits such a violation after a prior conviction for a felony drug offense has become final, such person shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment for any term of years or for life, a fine not to exceed the greater of twice that authorized in accordance with the provisions of title 18, United States Code, or $2,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, or both. Notwithstanding section 3583 of title 18, United States Code, any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of not less than 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of not less than 6 years in addition to such term of imprisonment. Notwithstanding the prior sentence, and notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any person sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="H00252477C0C649C9B7B630453A6F90D2"><enum>7094.</enum><header>False labeling of schedule A controlled substances</header> <subsection id="HBB99649EDF144E84A14950F9ABAE9C82"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 305 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/825">21 U.S.C. 825</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H390D9D9BC7084643955ADE4A163572BB" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="HF6BEDE455D9E4C00A2EBE0301891BF23"><enum>(f)</enum><header display-inline="yes-display-inline">False labeling of schedule A controlled substances</header> <paragraph commented="no" display-inline="no-display-inline" id="H8ECA3EA6A15A4C94A3AC21CA5626C8ED"><enum>(1)</enum><text display-inline="yes-display-inline">It shall be unlawful to import or export, with intent to manufacture, distribute, or dispense, a schedule A substance or product containing a schedule A substance, unless the substance or product bears a label clearly identifying a schedule A substance or product containing a schedule A substance by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC).</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HBDA1EB7CA683460DB86BE55FB81663D9"><enum>(2)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="HA6D170454D494F75A332931270F2A916"><enum>(A)</enum><text display-inline="yes-display-inline">A product described in subparagraph (B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act.</text></subparagraph> <subparagraph commented="no" id="H61CFAA1F059B40059C149ACDE767079A" indent="up1"><enum>(B)</enum><text>A product is described in this subparagraph if the product—</text> <clause commented="no" id="HA675A9546D6444EE9E46CA0773699466"><enum>(i)</enum><text>is the subject of an approved application as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act; or</text></clause> <clause commented="no" id="H4D3E5B8207784FB2A03459C0166976F8"><enum>(ii)</enum><text>is exempt from the provisions of section 505 of such Act relating to new drugs because—</text> <subclause commented="no" id="H734E7372CD9B4F17A99D63C04D972882"><enum>(I)</enum><text>it is intended solely for investigational use as described in section 505(i) of such Act; and</text></subclause> <subclause commented="no" id="H4562E71C71B4491290D0A3F66877A9D4"><enum>(II)</enum><text>such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new drug application.</text></subclause></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HE58EA61AEDD749A9AD1F577E412F3E2B"><enum>(b)</enum><header>Penalties</header><text>Section 402 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/842">21 U.S.C. 842</external-xref>) is amended—</text> <paragraph id="HF4BB4E5F8CDA46558BA1D38DAE9CBC68"><enum>(1)</enum><text>in subsection (a)—</text> <subparagraph id="HCA286CF375C84C30BCF7E594CCBB2023"><enum>(A)</enum><text>in paragraph (16), by striking <quote>or</quote> at the end;</text></subparagraph> <subparagraph id="H520A646CC465492498F524DF690EEB1C"><enum>(B)</enum><text>by redesignating paragraph (17) as paragraph (18); and</text></subparagraph> <subparagraph id="H7609CD8D0F3A455D86559CC86A252A4D"><enum>(C)</enum><text>by inserting after paragraph (16) the following:</text> <quoted-block display-inline="no-display-inline" id="HD07B93EC6CCA456F9CF6A3A311422568" style="OLC"> <paragraph id="H4E8FA06562794A5DB6B852EED15B0638" indent="up1"><enum>(17)</enum><text>to violate section 305(f); or</text></paragraph><after-quoted-block>; and </after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H64B49F406863477FBC281218FA945271"><enum>(2)</enum><text>in subsection (c)—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HAF2AE70AC01C4730BE24F7134AFE1C29"><enum>(A)</enum><text>in paragraph (1)—</text> <clause commented="no" display-inline="no-display-inline" id="HDCBE4DC174F14991A3210E6E81039E8C"><enum>(i)</enum><text>in subparagraph (B)(i), by striking <quote>(17)</quote> and inserting <quote>(18)</quote>; and</text></clause> <clause commented="no" display-inline="no-display-inline" id="H93216960E5C0418FA62E6CA94B9E2365"><enum>(ii)</enum><text>in subparagraph (C), by inserting <quote>or (17)</quote> after <quote>paragraph (16)</quote> each place it appears; and</text></clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H02548B130094423698E63F4D814AE758"><enum>(B)</enum><text>in paragraph (2)(D), by striking <quote>(17)</quote> and inserting <quote>(18)</quote>.</text></subparagraph></paragraph></subsection></section> <section id="H0CD3AB5F16BD4E50B9D92AB82ACB68B0"><enum>7095.</enum><header>Registration requirements for importers and exporters of schedule A substances</header><text display-inline="no-display-inline">Section 1008 of the Controlled Substances Import and Export Act (<external-xref legal-doc="usc" parsable-cite="usc/21/958">21 U.S.C. 958</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HEF30E68B1ECA4B3B843CFA212596EF68" style="OLC"> <subsection commented="no" display-inline="no-display-inline" id="H77C154D058D64BC588A250FFEA32FE72"><enum>(j)</enum> <paragraph commented="no" display-inline="yes-display-inline" id="H4D40845795224A3DB30B305CDD0F6665"><enum>(1)</enum><text display-inline="yes-display-inline">The Attorney General shall register an applicant to import or export a schedule A substance if—</text> <subparagraph commented="no" display-inline="no-display-inline" id="HEE7E0EDEF3A14F9CA62F8E7E2B1DE475" indent="up1"><enum>(A)</enum><text display-inline="yes-display-inline">the applicant demonstrates that the schedule A substance will be used for research, analytical, or industrial purposes approved by the Attorney General; and</text></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="HBAC38A6D0A2E492D8CDFB583D8507961" indent="up1"><enum>(B)</enum><text>the Attorney General determines that such registration is consistent with the public interest and with the United States obligations under international treaties, conventions, or protocols in effect on the date of enactment of this subsection.</text></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H472243389C814F5380D46163CDCD7AE5" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">In determining the public interest under paragraph (1)(B), the Attorney General shall consider—</text> <subparagraph commented="no" id="HAE0AA74260C44A4B8695F0EC9C5BE966"><enum>(A)</enum><text display-inline="yes-display-inline">maintenance of effective controls against diversion of particular controlled substances and any controlled substance in schedule A compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;</text></subparagraph> <subparagraph commented="no" id="H591286A5BB7D49B29FB429034634F3BC"><enum>(B)</enum><text>compliance with applicable State and local law;</text></subparagraph> <subparagraph commented="no" id="H21F143B55A3C4408BB0BFF4FBAC02E9E"><enum>(C)</enum><text>promotion of technical advances in the art of manufacturing substances described in subparagraph (A) and the development of new substances;</text></subparagraph> <subparagraph commented="no" id="HD1BE4964E5F64D95BB676DCB1849395B"><enum>(D)</enum><text>prior conviction record of applicant under Federal and State laws relating to the importation, manufacture, distribution, or dispensing of substances described in subparagraph (A);</text></subparagraph> <subparagraph commented="no" id="H589C7DE999B44C84819BB769620ED10F"><enum>(E)</enum><text>past experience in the importation and manufacture of controlled substances, and the existence in the establishment of effective control against diversion; and</text></subparagraph> <subparagraph commented="no" id="HD265EFD395D541D4A10EAFBEAE988708"><enum>(F)</enum><text>such other factors as may be relevant to and consistent with the public health and safety.</text></subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H6197987CC28647AFB95D0D087413F02E" indent="up1"><enum>(3)</enum><text>If an applicant is registered to import or export a controlled substance in schedule I or II under subsection (a), the applicant shall not be required to apply for a separate registration under this subsection.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section> <section commented="no" id="H861BD9EDD1984B6F8BEF21F59C93F323"><enum>7096.</enum><header>Additional conforming amendments</header><text display-inline="no-display-inline">The Controlled Substances Import and Export Act (<external-xref legal-doc="usc" parsable-cite="usc/21/951">21 U.S.C. 951</external-xref> et seq.) is amended—</text> <paragraph id="H52F58AA72F904A48AC7EA6DD5CF57A57"><enum>(1)</enum><text>in section 1002(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/952">21 U.S.C. 952(a)</external-xref>)—</text> <subparagraph id="H6287D3673FA640D1A6CB2E37C66E4907"><enum>(A)</enum><text>in the matter preceding paragraph (1), by inserting <quote>or drug or substance in schedule A</quote> after <quote>schedule I or II</quote>; and</text></subparagraph> <subparagraph id="H47F2CD82677E4102B887E47C7A3CD57A"><enum>(B)</enum><text>in paragraph (2), by inserting <quote>or drug or substances in schedule A</quote> after <quote>schedule I or II</quote>;</text></subparagraph></paragraph> <paragraph id="H8ABDCB5914104A0B91F7733BA546AC74"><enum>(2)</enum><text>in section 1003 (<external-xref legal-doc="usc" parsable-cite="usc/21/953">21 U.S.C. 953</external-xref>)—</text> <subparagraph id="H3AA35A4F1C0B4CB08C4D00E23F5D1E33"><enum>(A)</enum><text>in subsection (c), in the matter preceding paragraph (1), by inserting <quote>or drug or substance in schedule A</quote> after <quote>schedule I or II</quote>; and</text></subparagraph> <subparagraph id="HB5DFFCF12F334A0BA9461D81D700E916"><enum>(B)</enum><text>in subsection (d), by inserting <quote>or drug or substance in schedule A</quote> after <quote>schedule I or II</quote>;</text></subparagraph></paragraph> <paragraph id="H36A49E3385AF45469EC9A85A5CCDFA22"><enum>(3)</enum><text>in section 1004(1) (<external-xref legal-doc="usc" parsable-cite="usc/21/954">21 U.S.C. 954(1)</external-xref>), in the matter preceding subparagraph (A), by inserting <quote>or drug or substance in schedule A</quote> after <quote>schedule I</quote>;</text></paragraph> <paragraph id="HC3530FA9757B4BE2AFF16CAEE2C4BDC7"><enum>(4)</enum><text>in section 1005 (<external-xref legal-doc="usc" parsable-cite="usc/21/955">21 U.S.C. 955</external-xref>), by inserting <quote>or drug or substance in schedule A</quote> after <quote>schedule I or II</quote>; and</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H6A2383DFAFAA4661AF692C2E49C4C93D"><enum>(5)</enum><text display-inline="yes-display-inline">in section 1009(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/959">21 U.S.C. 959(a)</external-xref>), by inserting <quote>or drug or substance in schedule A</quote> after <quote>schedule I or II</quote>.</text></paragraph></section> <section commented="no" display-inline="no-display-inline" id="HD12250A128394AA1BA59056FA3D4BE88"><enum>7097.</enum><header>Sentencing review</header> <subsection commented="no" display-inline="no-display-inline" id="HD70A8825265D4E58A14D8EBDC00CF16C"><enum>(a)</enum><header>Covered offense defined</header><text>In this section, the term <term>covered offense</term> means an offense involving a schedule A substance for which the penalty was established under section 7093 or 7094 of this subtitle.</text></subsection> <subsection commented="no" display-inline="no-display-inline" id="HBFF1FDF77AC24217B32F7D52CCF4BC26"><enum>(b)</enum><header>Sentencing review</header> <paragraph commented="no" display-inline="no-display-inline" id="H8953F611CE674C85A583DC5E12364CE7"><enum>(1)</enum><header>Petition for review</header><text>If a schedule A substance that is temporarily or permanently scheduled under section 201(k) of the Controlled Substances Act, as added by this subtitle, is subsequently descheduled or rescheduled on a schedule with lower penalties, any individual convicted of a covered offense involving such schedule A substance who is awaiting sentencing or is still serving a term of imprisonment for such covered offense on the date of the descheduling or rescheduling may petition the court that imposed the sentence for a sentencing reduction hearing for such covered offense.</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HBC14719485994D98ABC989ED83821FB5"><enum>(2)</enum><header>Sentencing review</header><text>Not later than 30 days after the date on which a petition is filed under paragraph (1), the court shall conduct a sentencing reduction hearing and may modify the sentence of the petitioner as if the descheduling or rescheduling described in paragraph (1) had been in effect on the date the covered offense was committed.</text></paragraph></subsection></section> <section id="H6DC2584752FE4C0F8DDFB732F4444398"><enum>7098.</enum><header>Rules of construction</header><text display-inline="no-display-inline">Nothing in this subtitle, or the amendments made by this subtitle, may be construed to limit—</text> <paragraph id="H313C0C0363564AED9A75A945C855603E"><enum>(1)</enum><text>the prosecution of offenses involving controlled substance analogues under the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/801">21 U.S.C. 801</external-xref> et seq.); or</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="HA8D1F2CE602C4D2B925C5C9ABF3A5533"><enum>(2)</enum><text>the authority of the Attorney General to temporarily or permanently schedule, reschedule, or decontrol controlled substances under provisions of section 201 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/811">21 U.S.C. 811</external-xref>) that are in effect on the day before the date of enactment of this Act.</text></paragraph></section> <section id="H75A462A5719E46078362E02B2AAEEC77"><enum>7099.</enum><header>Clarification of certain registration requirements related to research</header> <subsection id="H4BC89F098F614D1283CD7EA92A2A74BD"><enum>(a)</enum><header>Exception for agents or employees of registered researchers</header><text>Section 302(c) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/822">21 U.S.C. 822(c)</external-xref>) is amended in paragraph (1) by striking <quote>or dispenser</quote> and inserting <quote>dispenser, or researcher</quote>.</text></subsection> <subsection id="H83DD97472E87486AB722837606385E48"><enum>(b)</enum><header>Conforming amendment</header><text>Section 102(3) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/802">21 U.S.C. 802(3)</external-xref>) is amended by striking <quote>or dispenser</quote> and inserting <quote>dispenser, or researcher</quote>.</text></subsection> <subsection id="HCB54EE582EE74E1C8AA4E93526D4E4DC"><enum>(c)</enum><header>Single registration for contiguous research sites</header><text>Section 302(e) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/822">21 U.S.C. 822(e)</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block id="H9198E67652774DCBAFD0BF5B1ADE40BC" style="OLC"> <paragraph id="HFA79E6FE0943477B98C8B7FE1E902F49"><enum>(3)</enum><text>Notwithstanding paragraph (1), a person registered to conduct research with a controlled substance under section 303(f) may conduct such research under a single registration if such research occurs exclusively on a single, contiguous campus and the registrant notifies the Attorney General in writing of all sites on the campus where the research will be conducted or where the controlled substance will be stored or administered. The registrant must so notify the Attorney General prior to conducting research at such additional sites.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H1C2CC8DA082B4015876B4BBDA37337A9"><enum>(d)</enum><header>New inspection not required in certain situations</header><text>Section 303(f) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(f)</external-xref>) is amended—</text> <paragraph id="HD9D0C1E4EDCC4664BFF3ECF9B36A0C3D"><enum>(1)</enum><text>by redesignating paragraphs (1) through (5) as subparagraphs (A) through (E), respectively, and by moving the margins of such subparagraphs two ems to the right; </text></paragraph> <paragraph id="H8367F19B5C6D480496B48CCB6AB351EB"><enum>(2)</enum><text>by striking <quote>(f) The</quote> and inserting <quote>(f)(1) The</quote>; and</text></paragraph> <paragraph id="HEE3925D2E31B49789D132612ADC72B7A"><enum>(3)</enum><text>by adding at the end, after the matter following subparagraph (E), as so redesignated, the following new paragraph:</text> <quoted-block id="H0832DB6190424F24B9B152E7837A86AB" style="OLC"> <paragraph id="HB4FDF2B209844FDF822E1A90BA531067" indent="up1"><enum>(2)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="HA1083742774048D681D561874ED0706B"><enum>(A)</enum><text>If a person is registered to conduct research with a controlled substance and applies for a registration, or a modification of a registration to conduct research with a second controlled substance that is in the same schedule or in a schedule with a higher numerical designation, a new inspection by the Attorney General of the registered location is not required.</text></subparagraph> <subparagraph id="H3A6B4269E96E4250AE7FBFCDB5DE903E" indent="up1"><enum>(B)</enum><text>Nothing in this paragraph shall prohibit the Attorney General from conducting any inspection if the Attorney General deems it necessary.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H4BBC95EADFA4437A8F25554A31FB6A79"><enum>(e)</enum><header>Continuation of research on substances newly added to schedule I; authority To conduct research with other substances in schedule I</header><text>Section 302 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/822">21 U.S.C. 822</external-xref>) is amended by adding at the end the following new subsection:</text> <quoted-block id="H5ABC773AC2294B5797A47BCACD82BA06" style="OLC"> <subsection id="H31658D3B9CE745D58CA052D39711E097"><enum>(h)</enum><header>Continuation of research on substances newly added to schedule I; authority To conduct research with other substances in schedule I</header> <paragraph id="H11EE9CEBC3524B5F8E1DAC3CF4BB2312"><enum>(1)</enum><text>If a person is conducting research on a substance at the time the substance is added to schedule I, and such person is already registered to conduct research with a controlled substance in schedule I or II then—</text> <subparagraph id="HFC3D383F33EB43A1B917DC476FE7FB07"><enum>(A)</enum><text>the person shall, within 30 days of the scheduling of the newly scheduled substance, submit a completed application for registration or modification of existing registration, to conduct research on such substance, in accordance with the regulations issued by the Attorney General;</text></subparagraph> <subparagraph id="H57637B345F8F43C9A550C523DEC64E74"><enum>(B)</enum><text>the person may, notwithstanding subsections (a) and (b), continue to conduct the research on such substance until the application referred to in subparagraph (A) is withdrawn by the applicant or until the Attorney General serves on the applicant an order to show cause proposing the denial of the application pursuant to section 304(c); and</text></subparagraph> <subparagraph id="HAB7F9C3E0ACE4F4FB1DD27326106203F"><enum>(C)</enum><text>if the Attorney General serves such an order to show cause and the applicant requests a hearing, such hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time if so requested by the applicant.</text></subparagraph></paragraph> <paragraph id="H84505838106A473E9EFC7D7FCFF7E3E9"><enum>(2)</enum> <subparagraph commented="no" display-inline="yes-display-inline" id="H597A17D3507C4E5D88EFC04D0EB3BFAD"><enum>(A)</enum><text>A person who is registered to conduct research with a controlled substance in schedule I may, notwithstanding subsections (a) and (b), conduct research with another controlled substance in schedule I, provided the following conditions are met:</text> <clause id="H0F2C885FB1DF4562B170DDEE7DFDDB39" indent="up1"><enum>(i)</enum><text>The person has applied for a modification of the person’s registration to authorize research with such other controlled substance in accordance with the regulations issued by the Attorney General.</text></clause> <clause id="H30C1AC06DEF24ABCB4135A78E0D57166" indent="up1"><enum>(ii)</enum><text>The Attorney General has obtained verification from the Secretary that the research protocol submitted with the application is meritorious.</text></clause> <clause id="H10CCED68A7FA454A94CE087567357EAA" indent="up1"><enum>(iii)</enum><text>The Attorney General has determined that such activity is consistent with United States obligations under the Single Convention on Narcotic Drugs, 1961. The Attorney General shall make such determination not later than 30 days after receiving the application referred to in clause (i).</text></clause></subparagraph> <subparagraph id="HD051D0BDDB214E4ABF5C0BE8FD3BE217" indent="up1"><enum>(B)</enum><text>Nothing in this section shall be construed to alter the authority of the Attorney General to initiate proceedings to deny, suspend, or revoke any registration in accordance with sections 303 and 304.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H67C0C6C3C00541339DF1A4448DA40373"><enum>(f)</enum><header>Treatment of certain activities as coincident to research</header><text>Section 302 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/822">21 U.S.C. 822</external-xref>), as amended by subsection (d), is further amended by adding at the end the following new subsection:</text> <quoted-block id="H9AC102BA1F474C2080D491FC3E44ED51" style="OLC"> <subsection id="H685F722822874100988AAC02E721FFD8"><enum>(i)</enum><header>Treatment of certain activities as coincident to research</header> <paragraph id="HEAB7D9EC5E384920AC070ACE9C46F04C"><enum>(1)</enum><header>In general</header><text>Except as specified in paragraph (2), a person who is registered to perform research with a controlled substance may perform the following activities with small quantities of that substance, as set forth in the relevant statement or protocol filed with the application for registration approved by the Attorney General without being required to obtain a manufacturing registration:</text> <subparagraph id="H4F86E841DBFA47119264958614306CD8"><enum>(A)</enum><text>Processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with the approved research protocol.</text></subparagraph> <subparagraph id="H9EC29324ED334671BDBACEFFCE38DB79"><enum>(B)</enum><text>Dosage form development for the purpose of satisfying regulatory requirements implemented by the Food and Drug Administration for submitting an investigational new drug application.</text></subparagraph></paragraph> <paragraph id="H48FFA3292C1647D3923A3E31119BC199"><enum>(2)</enum><header>Exception regarding marihuana</header><text>The authority under paragraph (1) does not include authority to grow marihuana.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="H647896F7E6EB4F6CBFE2D380F79C1E53"><enum>7100.</enum><header>Review of research registration process</header> <subsection id="H2A2EE86767EE43188EFE449138A35D3A"><enum>(a)</enum><header>Review</header><text display-inline="yes-display-inline">Not later than one year after the date of the enactment of this section, the Attorney General and the Secretary of Health and Human Services shall conduct a review of the processes used to obtain or modify Federal authorization to conduct research with controlled substances, including—</text> <paragraph id="HA07C8373F39A4463BA278A2CD32AAC1D" display-inline="no-display-inline"><enum>(1)</enum><text>an evaluation of the impacts of the amendments made by section 7099 on the risk of the diversion of controlled substances used in research and related public safety considerations; and</text></paragraph> <paragraph id="H0EF0CBC54F3A4CB2BD01C41EE07E1CB1"><enum>(2)</enum><text>identification of opportunities to reduce any unnecessary burden on persons seeking registration, potential redundancies, and inefficiencies in the process to obtain or modify Federal authorization to conduct research with controlled substances, including the process for obtaining a registration under section 303 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823</external-xref>) and the process by which the Secretary of Health and Human Services reviews research protocols.</text></paragraph></subsection> <subsection id="H3845EB82F8C544A0AE083814A039AE99"><enum>(b)</enum><header>Guidance</header><text display-inline="yes-display-inline">Following the review described in subsection (a), the Attorney General and the Secretary of Health and Human Services shall, as appropriate, jointly issue guidance to registrants and potential registrants clarifying the process for registration under section 303 of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823</external-xref>).</text></subsection></section></subtitle> <enum>VIII</enum><header>Tax Incentives to Improve Health Care</header> <section id="H55BBC6BD131B4280830D60836BEE8085" section-type="subsequent-section"><enum>8001.</enum><header>Domestic medical and drug manufacturing credit</header> <subsection id="H0D8FFEBD0A4E45EFA1CB6F9B292AD55D"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subpart D of part IV of subchapter A of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/1">chapter 1</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:</text> <quoted-block style="OLC" id="HD4D776D58415439BBD186A69ACD4A321" display-inline="no-display-inline"> <section id="H7438B5718567460FB108625BC3AC2E87"><enum>45U.</enum><header>Domestic medical and drug manufacturing credit</header> <subsection id="H9BC0AD92777B4B9AA15D70A6E413A089"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of section 38, the domestic medical and drug manufacturing credit determined under this section for any taxable year is an amount equal to 10.5 percent of the lesser of—</text> <paragraph id="H5C9164F924544EB8B45A3526875724FE"><enum>(1)</enum><text>the qualified medical and drug manufacturing income of the taxpayer for the taxable year, or</text></paragraph> <paragraph id="H5D1DEC4A3D7544B0B39F7DBA3962C78A"><enum>(2)</enum><text display-inline="yes-display-inline">taxable income of the taxpayer for the taxable year.</text></paragraph></subsection> <subsection id="HE6239278BDC64630BD297CF29AD70600"><enum>(b)</enum><header>Credit limited to wages paid</header> <paragraph id="H7B3FBB4A6A2845D58A32AAE8847E4B99"><enum>(1)</enum><header>In general</header><text>The amount of the credit allowable under subsection (a) for any taxable year shall not exceed 50 percent of the W–2 wages of the taxpayer for the taxable year.</text></paragraph> <paragraph id="HFDE47B24AA22499DB8FF089AD198D505"><enum>(2)</enum><header>W–<enum-in-header>2</enum-in-header> wages</header><text>For purposes of this section—</text> <subparagraph id="H6FC977877A664680AF34982B42407B76"><enum>(A)</enum><header>In general</header><text>The term <term>W–2 wages</term> means, with respect to any person for any taxable year of such person, the sum of the amounts described in paragraphs (3) and (8) of section 6051(a) paid by such person with respect to employment of employees by such person during the calendar year ending during such taxable year.</text></subparagraph> <subparagraph id="H979B629D0B6E40D488FC4F5F787FDBDD"><enum>(B)</enum><header>Limitation to wages attributable to domestic production</header><text display-inline="yes-display-inline">Such term shall not include any amount which is not properly allocable to domestic medical and drug manufacturing gross receipts for purposes of subsection (c)(1).</text></subparagraph> <subparagraph id="HE98FE84BA5BA4A51A90DF93AE1749EBA"><enum>(C)</enum><header>Return requirement</header><text>Such term shall not include any amount which is not properly included in a return filed with the Social Security Administration on or before the 60th day after the due date (including extensions) for such return.</text></subparagraph></paragraph> <paragraph id="HB8A2E52BF6C84D16A7389428793A5F0A"><enum>(3)</enum><header>Acquisitions, dispositions, and short taxable years</header><text>The Secretary shall provide for the application of this subsection in cases of a short taxable year or where the taxpayer acquires, or disposes of, the major portion of a trade or business or the major portion of a separate unit of a trade or business during the taxable year.</text></paragraph></subsection> <subsection id="HBD854110E0784FF18A383E7AA60F3348"><enum>(c)</enum><header>Qualified medical and drug manufacturing income</header><text>For purposes of this section—</text> <paragraph id="H73739D1354494F51BED4A070CF88CDF3"><enum>(1)</enum><header>In general</header><text>The term <term>qualified medical and drug manufacturing income</term> for any taxable year means an amount equal to the excess (if any) of—</text> <subparagraph id="H299DE6D08F994153829405B10DABC2EF"><enum>(A)</enum><text>the taxpayer’s domestic medical and drug manufacturing gross receipts for the taxable year, over</text></subparagraph> <subparagraph id="H06FE2B1DCF674667856650F110624C48"><enum>(B)</enum><text>the sum of—</text> <clause id="H4E337E27828744B6BFA650DD0971C567"><enum>(i)</enum><text>the cost of goods sold that are allocable to such receipts, and</text></clause> <clause id="H079DB94858554EE1A0A023B169DDC01B"><enum>(ii)</enum><text>other expenses, losses, or deductions which are properly allocable to such receipts.</text></clause></subparagraph></paragraph> <paragraph id="H7B19AE6845E045F8BA14927E64709EF3"><enum>(2)</enum><header>Allocation method</header><text display-inline="yes-display-inline">The Secretary shall prescribe rules for the proper allocation of items described in paragraph (1)(B) for purposes of determining qualified medical and drug manufacturing income. Such rules shall provide for the proper allocation of items whether or not such items are directly allocable to domestic medical and drug manufacturing gross receipts.</text></paragraph> <paragraph id="H327B13DAF2AE4F8A991E8C25140C1164"><enum>(3)</enum><header>Special rules for determining costs</header> <subparagraph id="HBB4BA1E898A0487DA1F0EFE201C4F583"><enum>(A)</enum><header>In general</header><text>For purposes of determining costs under clause (i) of paragraph (1)(B), any item or service brought into the United States shall be treated as acquired by purchase, and its cost shall be treated as not less than its value immediately after it entered the United States.</text></subparagraph> <subparagraph id="H2AEC6772E4F248F88BE8FE71819337D8"><enum>(B)</enum><header>Exports for further manufacture</header><text>In the case of any property described in subparagraph (A) that had been exported by the taxpayer for further manufacture, the increase in cost or adjusted basis under subparagraph (A) shall not exceed the difference between the value of the property when exported and the value of the property when brought back into the United States after the further manufacture.</text></subparagraph></paragraph> <paragraph id="HC2D19B8613C34C6DAA73669E42A94095"><enum>(4)</enum><header>Domestic medical and drug manufacturing gross receipts</header> <subparagraph id="H9DA2FE4DCBEA43AA94619DE752EB0573"><enum>(A)</enum><header>In general</header><text>The term <term>domestic medical and drug manufacturing gross receipts</term> means the gross receipts of the taxpayer which are derived from any sale, exchange, or other disposition of—</text> <clause id="HBD5EE235EED540FDA73FA533FB789A91"><enum>(i)</enum><text>any active pharmaceutical ingredient, or </text></clause> <clause id="H95191D5E78D041A7AEF6BF8B991DC818"><enum>(ii)</enum><text>any qualified countermeasure,</text></clause><continuation-text continuation-text-level="subparagraph">which was manufactured or produced by the taxpayer in whole or in significant part within the United States. </continuation-text></subparagraph> <subparagraph id="H45A86741BCC44FCFA76FEB42E8F009C9"><enum>(B)</enum><header>Active pharmaceutical ingredient</header><text display-inline="yes-display-inline">The term <term>active pharmaceutical ingredient</term> means any substance or mixture of substances intended to be used in the manufacture of a drug product and (when so used) becomes an active ingredient in the drug product.</text></subparagraph> <subparagraph id="H953E0771D3EB4FFFB37E1A73B06BFCC4"><enum>(C)</enum><header>Qualified countermeasure</header><text display-inline="yes-display-inline">The term <term>qualified countermeasure</term> has the meaning given such term in section 319F–1(a)(2) of the Public Health Service Act (42 U.S.C. 247d–6a(a)(2)).”</text></subparagraph> <subparagraph id="HFBCE0E9B36EE40F693D6AC0B31E7932F"><enum>(D)</enum><header>Partnerships owned by expanded affiliated groups</header><text display-inline="yes-display-inline">For purposes of this paragraph, if all of the interests in the capital and profits of a partnership are owned by members of a single expanded affiliated group at all times during the taxable year of such partnership, the partnership and all members of such group shall be treated as a single taxpayer during such period.</text></subparagraph></paragraph></subsection> <subsection id="H3EF8F4A08CA14C38BA71D6DE4F28386D"><enum>(d)</enum><header>Definitions and Special Rules</header><text display-inline="yes-display-inline">For purposes of this section—</text> <paragraph id="HF95F2CAE6B3B4FE083F047E8FC8E8BF3"><enum>(1)</enum><header>Application of section to pass-thru entities</header> <subparagraph id="H9FDF4C1070AF479F8E0D528E989019C3"><enum>(A)</enum><header>Partnerships and s corporations</header><text>In the case of a partnership or S corporation—</text> <clause id="H0770BAC4B5864F0C8D8DCA386B251FB8"><enum>(i)</enum><text>this section shall be applied at the partner or shareholder level,</text></clause> <clause id="H927C76C8169142CCA0BD8DC0B1A8465D"><enum>(ii)</enum><text>each partner or shareholder shall take into account such person’s allocable share of each item described in subparagraph (A) or (B) of subsection (c)(1) (determined without regard to whether the items described in such subparagraph (A) exceed the items described in such subparagraph (B)), and</text></clause> <clause id="H2933695706274C9CA55F0A17FFF1A724"><enum>(iii)</enum><text>each partner or shareholder shall be treated for purposes of subsection (b) as having W–2 wages for the taxable year in an amount equal to such person’s allocable share of the W–2 wages of the partnership or S corporation for the taxable year (as determined under regulations prescribed by the Secretary).</text></clause></subparagraph> <subparagraph id="H38294F4853834BB3A39A13D362222E9A"><enum>(B)</enum><header>Trusts and estates</header><text>In the case of a trust or estate—</text> <clause id="H186D905E97FA458FA32C3F2AA7EDFC9B"><enum>(i)</enum><text>the items referred to in subparagraph (A)(ii) (as determined therein) and the W–2 wages of the trust or estate for the taxable year, shall be apportioned between the beneficiaries and the fiduciary (and among the beneficiaries) under regulations prescribed by the Secretary, and</text></clause> <clause id="HB7EC9E68E9B4437C9A487C99AED1AA0B"><enum>(ii)</enum><text>for purposes of paragraph (2), adjusted gross income of the trust or estate shall be determined as provided in section 67(e) with the adjustments described in such paragraph.</text></clause></subparagraph> <subparagraph id="H70AF98F20735429EA43601CDD77063C5"><enum>(C)</enum><header>Regulations</header><text>The Secretary may prescribe rules requiring or restricting the allocation of items and wages under this paragraph and may prescribe such reporting requirements as the Secretary determines appropriate.</text></subparagraph></paragraph> <paragraph id="H3155F2B6E7EB48BBBFC61919CFE513C6"><enum>(2)</enum><header>Application to individuals</header><text>In the case of an individual, subsection (a)(2) shall be applied by substituting <quote>adjusted gross income</quote> for <quote>taxable income</quote>. For purposes of the preceding sentence, adjusted gross income shall be determined after application of sections 86, 135, 137, 219, 221, 222, and 469.</text></paragraph> <paragraph id="HCEE9D8C663964D42AA3AACF4598D158B"><enum>(3)</enum><header>Special rule for affiliated groups</header> <subparagraph id="H89AB8D7E93C64FFE966CF54342801F7C"><enum>(A)</enum><header>In general</header><text>All members of an expanded affiliated group shall be treated as a single corporation for purposes of this section.</text></subparagraph> <subparagraph id="H8F46F132BA8249EE84D7B8ECB89BFC9C"><enum>(B)</enum><header>Expanded affiliated group</header><text>For purposes of this section, the term <term>expanded affiliated group</term> means an affiliated group as defined in section 1504(a), determined—</text> <clause id="H6C90B88CAAC54BBB82918E4E02264075"><enum>(i)</enum><text>by substituting <quote>more than 50 percent</quote> for <quote>at least 80 percent</quote> each place it appears, and</text></clause> <clause id="H67FFFBECC66640B4B2E68312F9BEDCFA"><enum>(ii)</enum><text>without regard to paragraphs (2) and (4) of section 1504(b).</text></clause></subparagraph> <subparagraph id="HD45BF00AB61D407CAB869FD0E1D298CB"><enum>(C)</enum><header>Allocation of credit</header><text display-inline="yes-display-inline">Except as provided in regulations, the credit under subsection (a) shall be allocated among the members of the expanded affiliated group in proportion to each member’s respective amount (if any) of qualified medical and drug manufacturing income.</text></subparagraph></paragraph> <paragraph id="H3F68F00D84FC4401BD4711CEFF9A8484"><enum>(4)</enum><header>Trade or business requirement</header><text>This section shall be applied by only taking into account items which are attributable to the actual conduct of a trade or business.</text></paragraph> <paragraph id="HF53E5AB96E2A4BECA6783C9685D05907"><enum>(5)</enum><header>Coordination with minimum tax</header><text display-inline="yes-display-inline">For purposes of determining alternative minimum taxable income under section 55, qualified medical and drug manufacturing income shall be determined without regard to any adjustments under sections 56 through 59.</text></paragraph> <paragraph id="H19431CBA73384B95920082279CB22408"><enum>(6)</enum><header>Unrelated business taxable income</header><text>For purposes of determining the tax imposed by section 511, subsection (a)(1)(B) shall be applied by substituting <quote>unrelated business taxable income</quote> for <quote>taxable income</quote>.</text></paragraph> <paragraph id="H68015C6110724F689B5D84951ECA06E7" commented="no"><enum>(7)</enum><header>Regulations</header><text display-inline="yes-display-inline">The Secretary shall prescribe such regulations as are necessary to carry out the purposes of this section, including regulations which prevent more than 1 taxpayer from being allowed a credit under this section with respect to any activity described in subsection (c)(4)(A).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HD2EED6D58F94470F8D5B29834D008F24"><enum>(b)</enum><header>Treatment under base erosion tax</header><text>Section 59A(b)(1)(B)(ii) of such Code is amended by striking <quote>plus</quote> at the end of subclause (I), by redesignating subclause (II) as subclause (III), and by inserting after subclause (I) the following new subclause: </text> <quoted-block style="OLC" id="HBC49D792373A4CB29038D44078126446" display-inline="no-display-inline"> <subclause id="HE070E6E711FC47F5A0A1888CA85913FD"><enum>(II)</enum><text display-inline="yes-display-inline">the credit allowed under section 38 for the taxable year which is properly allocable to the domestic medical and drug manufacturing credit determined under section 45U(a), plus</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H3F697AD84DA946A0B2E568D6E1AE8E1A"><enum>(c)</enum><header>Part of general business credit</header><text>Section 38(b) of such Code is amended by striking <quote>plus</quote> at the end of paragraph (32), by striking the period at the end of paragraph (33) and inserting <quote>, plus</quote>, and by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="HC1E08810177940759C8CEB0A4E3F2BCD" display-inline="no-display-inline"> <paragraph id="H653D091C06EF43F4A67B7A792A0A6E93"><enum>(34)</enum><text display-inline="yes-display-inline">the domestic medical and drug manufacturing credit determined under section 45U(a).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HC033F463282A4DAF8EB4FA1CC8571A4C"><enum>(d)</enum><header>Credit allowed against alternative minimum tax</header><text>Section 38(c)(4)(B) of such Code is amended by redesignating clauses (x) through (xii) as clauses (xi) through (xiii), respectively, and by inserting after clause (ix) the following new clause:</text> <quoted-block style="OLC" id="HBB32E199B0424B5E8768AB8F168DAAFF" display-inline="no-display-inline"> <clause id="H07680626B6F249E99D306328AA69580E"><enum>(x)</enum><text display-inline="yes-display-inline">the credit determined under section 45U,</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H8D2CA05853BA419685003B727D8A1532"><enum>(e)</enum><header>Clerical amendment</header><text display-inline="yes-display-inline">The table of sections for subpart D of part IV of subchapter A of chapter 1 of such Code is amended by adding at the end the following new item:</text> <quoted-block style="OLC" id="H880CE590E4A248998A739D2FFC84AAED" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 45U. Domestic medical and drug manufacturing credit.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H31C3871E435A42249A66BE1DEF5EB99D"><enum>(f)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after December 31, 2020. </text></subsection></section> <section id="HAE96EC67E92A45DFA86B2B76658B4F78" section-type="subsequent-section"><enum>8002.</enum><header>Qualifying advanced medical manufacturing equipment credit</header> <subsection id="HE412314BDEB74DFB8E8A757802030349"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subpart E of part IV of subchapter A of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/1">chapter 1</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new section: </text> <quoted-block style="OLC" id="HE21ACC3FC002493EA2261C75AB376751" display-inline="no-display-inline"> <section id="H5DF4DCB6569D4FD08986AE2E71F876F6"><enum>48D.</enum><header>Qualifying advanced medical manufacturing equipment credit</header> <subsection id="H108D97A3AB6B4A1DB7880A173966588D"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of section 46, the qualifying advanced medical manufacturing equipment credit determined under this section for any taxable year is the applicable percentage of the basis of any qualifying advanced medical manufacturing equipment placed in service during such taxable year.</text></subsection> <subsection id="H166DA7C77B6C4A3299578C4345248056"><enum>(b)</enum><header>Applicable percentage</header><text display-inline="yes-display-inline">For purposes of subsection (a), the applicable percentage is—</text> <paragraph id="H17A5366F8877488AB6A3675CB7FC7DB6"><enum>(1)</enum><text display-inline="yes-display-inline">30 percent in the case of equipment which is placed in service before January 1, 2028,</text></paragraph> <paragraph id="H5E4EE33E62E248B997A5D63E67A10E7C"><enum>(2)</enum><text display-inline="yes-display-inline">20 percent in the case of equipment which is placed in service during calendar year 2028,</text></paragraph> <paragraph id="H5764B2E72264497DAAD468F095B3FE85"><enum>(3)</enum><text display-inline="yes-display-inline">10 percent in the case of equipment which is placed in service during calendar year 2029, and </text></paragraph> <paragraph id="HEB2107A149CE4E1E8BDB353C1D2444FD"><enum>(4)</enum><text>0 percent in the case of equipment which is placed in service after December 31, 2029.</text></paragraph></subsection> <subsection id="H35324D6661BF4C4B819365D574F07D17"><enum>(c)</enum><header>Qualifying advanced medical manufacturing equipment</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>qualifying advanced medical manufacturing equipment</term> means property of a character subject to the allowance for depreciation—</text> <paragraph id="H4C44A4944E1C445390FDD038A8C10441"><enum>(1)</enum><text display-inline="yes-display-inline">which is machinery or equipment that is designed and used to manufacture a—</text> <subparagraph id="H4882FD3E5F7041E98BB01E7484997CBC"><enum>(A)</enum><text>drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act),</text></subparagraph> <subparagraph id="HA4345384F73C4EF4963A9CFC282D3E0C"><enum>(B)</enum><text>device (as such term is defined in section 201(h) of such Act), or</text></subparagraph> <subparagraph id="H820C6DF18E7D4E6FB3F6D34E63E2CCAC"><enum>(C)</enum><text>biological product (as such term is defined in section 351(i) of the Public Health Service Act), </text></subparagraph></paragraph> <paragraph id="H969B74A172DE428799B962A43ABC1766"><enum>(2)</enum><text display-inline="yes-display-inline">which has been identified by the Secretary (after consultation with the Secretary of Health and Human Services) as machinery or equipment that—</text> <subparagraph id="HBC8AD351478E4641BDE18B874E9CA527"><enum>(A)</enum><text>incorporates novel technology or uses an established technique or technology in a new or innovative way, or</text></subparagraph> <subparagraph id="H95FD2B3BF05B42CCBA09EB742D75BCE0"><enum>(B)</enum><text>that can improve medical product quality, address shortages of medicines, and speed time-to-market,</text></subparagraph></paragraph> <paragraph id="H54D5611501A14686A6C26B00AC1C0617"><enum>(3)</enum><text>which is placed in service in the United States by the taxpayer, and</text></paragraph> <paragraph id="H0BE71D2D05F240B7A047FA79ACC64FB6"><enum>(4)</enum><text>with respect to which depreciation is allowable.</text></paragraph></subsection> <subsection id="HD5CA4A51AA154921B45AD827A588496F"><enum>(d)</enum><header>Certain qualified progress expenditures rules made applicable</header><text display-inline="yes-display-inline">Rules similar to the rules of subsections (c)(4) and (d) of section 46 (as in effect on the day before the enactment of the Revenue Reconciliation Act of 1990) shall apply for purposes of this section.</text></subsection> <subsection id="HB5E087211E3349B9975A5CEF2ED461A1"><enum>(e)</enum><header>Regulations</header><text display-inline="yes-display-inline">The Secretary shall prescribe such regulations or other guidance as may be necessary to carry out the purposes of this section, including regulations which prevent abuse or fraud.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HE803B67116B14897974298C3D6B7F26A" display-inline="no-display-inline"><enum>(b)</enum><header>Treatment under base erosion tax</header><text>Section 59A(b)(1)(B)(ii) of such Code, as amended by section 8001 of this Act, is further amended by striking <quote>plus</quote> at the end of subclause (II), by redesignating subclause (III) as subclause (IV), and by inserting after subclause (II) the following new subclause: </text> <quoted-block style="OLC" id="H5B79F8336F1746889FE4C4D8841E6033" display-inline="no-display-inline"> <subclause id="H146B6A8466014D5BAAA4F0564784DC0B"><enum>(III)</enum><text display-inline="yes-display-inline">the credit allowed under section 46 for the taxable year which is properly allocable to the qualifying advanced medical manufacturing equipment credit determined under section 48D(a), plus</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H0D4B8370DBAD4F6BAB773AEF845D7EFF"><enum>(c)</enum><header>Part of investment credit</header><text>Section 46 of such Code is amended by striking <quote>and</quote> at the end of paragraph (5), by striking the period at the end of paragraph (6) and inserting <quote>, and</quote>, and by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="HE56E405EEC8E435BA1A34B65ED6F5A36" display-inline="no-display-inline"> <paragraph id="H142FB6AF66BC46D49C8EE076DC2B47DD"><enum>(7)</enum><text display-inline="yes-display-inline">the qualifying advanced medical manufacturing equipment credit.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H51DBE1DFC2C6456EAAAC3477ED5F7D90"><enum>(d)</enum><header>Clerical amendment</header><text display-inline="yes-display-inline">The table of sections for subpart D of part IV of subchapter A of chapter 1 of such Code is amended by adding at the end the following new item:</text> <quoted-block style="OLC" id="H362A6413249C42ABAD6044EC2CB3FD56" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 48D. Qualifying advanced medical manufacturing equipment credit.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H0DCEED2A3B974FF8A7742BE00C6AF999"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to periods after the date of the enactment of this section under rules similar to the rules of <external-xref legal-doc="usc" parsable-cite="usc/26/48">section 48(m)</external-xref> of the Internal Revenue Code of 1986 (as in effect on the date of the enactment fo the Revenue Reconciliation Act of 1990).</text></subsection></section> <section id="HEB7F47BEA9744BD4985A063CB15B011D" section-type="subsequent-section"><enum>8003.</enum><header>New medical research expenditure component of credit for increasing research activities</header> <subsection id="H4AD54893DED5415183E0120F1A60D154"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/41">Section 41(a)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>and</quote> at the end of paragraph (2), by striking the period at the end of paragraph (3) and inserting <quote>, and</quote>, and by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="HA27CA976C55D4D78A41969292C42793A" display-inline="no-display-inline"> <paragraph id="H786912738A064CEEB4D434AB5E26915F"><enum>(4)</enum><text display-inline="yes-display-inline">14 percent of specified medical research expenditures.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H239BE1CB7B5A47848077FD4D2DB74546"><enum>(b)</enum><header>Specified medical research expenditures</header><text>Section 41(f) of such Code is amended by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="H40808B88CF1C48AEA97ED10129993005" display-inline="no-display-inline"> <paragraph id="H1D44FAD65DFE4924A2E8F3834A7D6101"><enum>(7)</enum><header>Specified medical research expenditures</header> <subparagraph id="HA2560EC6310545A99D4C699094F190DD"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>specified medical research expenditures</term> means amounts paid or incurred for qualified research with respect to any qualified countermeasure.</text></subparagraph> <subparagraph id="HA9A2B3113A604CB0BBB658C38F4F0858"><enum>(B)</enum><header>Qualified countermeasure</header><text display-inline="yes-display-inline">The term <term>qualified countermeasure</term> has the meaning given to such term in section 319F–1(a)(2) of the Public Health Service Act (42 U.S.C. 247d–6a(a)(2)).</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H6C9C964B29DB42419D5F5261B566DE30"><enum>(c)</enum><header>Denial of double benefit</header> <paragraph id="HBF1023DEA6C742589C751690FDC1F1C4"><enum>(1)</enum><header>Taxable years beginning before January <enum-in-header>1, 2021</enum-in-header></header><text display-inline="yes-display-inline">In the case of specified medical research expenditures (as defined in section 41(f)(7) of such Code (as added by this section)) paid or incurred in taxable years beginning before January 1, 2021—</text> <subparagraph id="H205CA8181CEB43878DC8F7D938F715F3"><enum>(A)</enum><text>such expenditures shall be treated in the same manner as qualified research expenses and basic research expenses under section 280C(c)(1) of such Code (as in effect on the day before the enactment of the Tax Cuts and Jobs Act), and</text></subparagraph> <subparagraph id="HD61ECD2A6B6F40B9938AA7AE1C329CCF"><enum>(B)</enum><text>the amount determined under section 280C(c)(2)(A) (as in effect on such day) for the taxable year shall be increased by the amount of credit determined for the taxable year under section 41(a)(4) (as added by this section).</text></subparagraph></paragraph> <paragraph id="H5C199BD548C04542838646E0697992FA"><enum>(2)</enum><header>Taxable years beginning after December <enum-in-header>31, 2020</enum-in-header></header><text display-inline="yes-display-inline">Section 280C(c)(1) of such Code is amended by striking <quote>section 41(a)(1)</quote> and inserting <quote>paragraphs (1) and (4) of section 41(a)</quote>. </text></paragraph></subsection> <subsection id="H0741C6C5C1414641A184C3555B5FAC8B"><enum>(d)</enum><header>Conforming amendment</header><text>Section 41(f)(1) of such Code is amended by striking <quote>and amounts paid or incurred to energy research consortiums</quote> each place it appears and inserting <quote>, amounts paid or incurred to energy research consortiums, and specified medical research expenditures</quote>.</text></subsection> <subsection id="H07270E30AC0143678F72F7CC9ED26D97" commented="no"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to amounts paid or incurred after the date of the enactment of this Act, in taxable years ending after such date.</text></subsection></section> <section id="H0E5A8F96408E4BA38EA6EA59A12005F3" section-type="subsequent-section"><enum>8004.</enum><header>Refundable portion of research credit for small businesses engaging in specified medical research</header> <subsection id="H7C5DD2617D614167A54A993F2C4707F5"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/41">Section 41</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subsection:</text> <quoted-block style="OLC" id="HFCB067C0775F4A62A83A1F2A357C14FE" display-inline="no-display-inline"> <subsection id="H3E3BDA7DD4F64393BA75EB2ED29ED07F"><enum>(i)</enum><header>Refundable portion for small businesses engaging in specified medical research</header> <paragraph id="HDA5337A35ACD4E5386B6CB7205437C3E"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">At the election of a medical research small business, the portion of the credit determined under this section for the taxable year which is properly allocable to specified medical research shall be treated (other than for purposes of section 280C) as a credit allowed under subpart C (and not this subpart).</text></paragraph> <paragraph id="HF6EBE035A6ED49B88937256F47F563D4"><enum>(2)</enum><header>Medical research small business</header><text>For purposes of this subsection, the term <term>medical research small business</term> means any domestic C corporation—</text> <subparagraph id="H25696FCFF4BA4FBD8E56D5B63E79BB32"><enum>(A)</enum><text display-inline="yes-display-inline">which conducts any specified medical research during the taxable year, and</text></subparagraph> <subparagraph id="HA5BFA2F975634E99B43CF7B8B68FBCF5"><enum>(B)</enum><text>the gross receipts of which (determined under the rules of subsection (c)) for the taxable year do not exceed $1,000,000.</text></subparagraph></paragraph> <paragraph id="H1220DC32BDA44514B3B0B6C0659B0267"><enum>(3)</enum><header>Specified medical research</header><text display-inline="yes-display-inline">For purposes of this subsection, the term <term>specified medical research</term> means any qualified research with respect to qualified countermeasures (as defined in section 319F–1(a)(2) of the Public Health Service Act (42 U.S.C. 247d–6a(a)(2))).</text></paragraph> <paragraph id="H9DB2F78D00B141DFBE218092779DFD4F"><enum>(4)</enum><header>Election</header><text>Any election under this subsection for any taxable year—</text> <subparagraph id="HEA927099D8F44087B8D6FE13BCD9E01E"><enum>(A)</enum><text>shall specify the amount of the credit to which such election applies,</text></subparagraph> <subparagraph id="HFA50CEB5D38E43D98E8060D1F84F96ED"><enum>(B)</enum><text display-inline="yes-display-inline">shall be made on or before the due date (including extensions) of the return of tax for the taxable year,</text></subparagraph> <subparagraph id="H27C8645445F249F4BEDB932B970FEC0C"><enum>(C)</enum><text>may not be made for any taxable year with respect to any portion of the credit determined under this section with respect to which an election is made under subsection (h), and</text></subparagraph> <subparagraph id="HDE04B4C2D1394AB392259D357778FB4F"><enum>(D)</enum><text>may be revoked only with the consent of the Secretary.</text></subparagraph></paragraph> <paragraph id="H47FC3A9C49724E529ED539C8449ECCCA"><enum>(5)</enum><header>Regulations</header><text display-inline="yes-display-inline">The Secretary shall prescribe such regulations for purposes of this subsection as may be necessary or appropriate for determining proper allocation to specified medical research of the portion of any credit allowed to a taxpayer for a taxable year under this section.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HAA7802DA172C459B992FF043F0BE8760"><enum>(b)</enum><header>Conforming amendment</header><text>Section 1324(b) of title 31, United States Code, is amended by inserting <quote>41(i),</quote> after <quote>6428,</quote>.</text></subsection> <subsection id="H9CBDE7D8CFD24F4A9C6E27412AC31E9C"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after December 31, 2020.</text></subsection></section> <section id="HDA594CE4A56A43348BB9A809A7C23C96" section-type="subsequent-section"><enum>8005.</enum><header>Exception from passive loss rules for investments in specified medical research small business pass-thru entities</header> <subsection id="H590F662B58FC446682513D657562DD80"><enum>(a)</enum><header>In general</header><text>Subsection (c) of <external-xref legal-doc="usc" parsable-cite="usc/26/469">section 469</external-xref> of the Internal Revenue Code of 1986 is amended by redesignating paragraphs (4) through (7) as paragraphs (5) through (8), respectively, and by inserting after paragraph (3) the following new paragraph:</text> <quoted-block id="H1DD80BF5ADFF4636A1507C1F7E46EC97" style="OLC"> <paragraph id="H15F8D08A57D64B0E81284B87924E1DDE"><enum>(4)</enum><header>Specified medical research activities</header> <subparagraph id="H50E9941ED19C4BB287BDF2FA0FF4AA84"><enum>(A)</enum><header>In general</header><text>The term <term>passive activity</term> shall not include any qualified medical research activity of the taxpayer carried on by a specified medical research small business pass-thru entity.</text></subparagraph> <subparagraph id="H80A5ABE5F9844968A1F968E1D7CF962E"><enum>(B)</enum><header>Treatment of losses and deductions</header> <clause id="HE6A46B9E6EA74F2FABE8FB61A856AE18"><enum>(i)</enum><header>In general</header><text>Losses or deductions of a taxpayer in connection with qualified medical research activities carried on by a specified medical research small business pass-thru entity shall not be treated as losses or deductions, respectively, from a passive activity except as provided in clause (ii) and subparagraph (C).</text></clause> <clause id="H4B693ADE2C554446804896DE642334EC"><enum>(ii)</enum><header>Limitation</header><text display-inline="yes-display-inline">Clause (i) shall apply to losses and deductions of a taxpayer in connection with a specified medical small business pass-thru entity for a taxable year only to the extent that the aggregate losses and deductions of the taxpayer in connection with qualified medical research activities of such entity for such taxable year do not exceed the portion of the taxpayer’s adjusted basis in the taxpayer’s ownership interest in such entity that is attributable to money or other property contributed—</text> <subclause id="H7066809EF5F04C41BBC843E5ADF6D220"><enum>(I)</enum><text>in exchange for such ownership interest, and</text></subclause> <subclause id="HD02AE5DA9B0B43E79BB040917BDB68A7"><enum>(II)</enum><text>specifically for use in connection with qualified medical research activities.</text></subclause><continuation-text continuation-text-level="clause">For purposes of the preceding sentence, the taxpayer’s basis shall not include any portion of such basis which is attributable to an increase in a partner’s share of the liabilities of a partnership that is considered under section 752(a) as a contribution of money. </continuation-text></clause></subparagraph> <subparagraph id="H08F8F111BD564B2787FDD4D06EF11D79"><enum>(C)</enum><header>Treatment of carryovers</header><text>Subparagraph (B)(i) shall not apply to the portion of any loss or deduction that is carried over under subsection (b) into a taxable year other than the taxable year in which such loss or deduction arose.</text></subparagraph> <subparagraph id="H3A63BAFFC7114382882B95F454E0D89B"><enum>(D)</enum><header>Qualified medical research activity</header><text display-inline="yes-display-inline">For purposes of this paragraph, the term <term>qualified medical research activity</term> means any qualified research (within the meaning of section 41(d)) with respect to qualified countermeasures (as defined in section 319F–1(a)(2) of the Public Health Service Act (42 U.S.C. 247d–6a(a)(2))). </text></subparagraph> <subparagraph id="H0CD0266784F94F37A3477E2B23BDE1CE"><enum>(E)</enum><header>Specified medical research small business pass-thru entity</header><text>For purposes of this paragraph, the term <term>specified medical research small business pass-thru entity</term> means any domestic pass-thru entity for any taxable year if—</text> <clause id="H4D59FCE6C9D7433E98C43BBC389A002F"><enum>(i)</enum><text display-inline="yes-display-inline">more than 80 percent of such entity’s expenditures on qualified research for such taxable year are paid or incurred in connection with qualified medical research activities, and</text></clause> <clause id="H30A62DBFC5D6495BB9685B16229A4216"><enum>(ii)</enum><text>the gross receipts (as determined under the rules of section 41(h)(3)) of such entity for the taxable year (and each preceding taxable year) is less than $1,000,000. </text></clause></subparagraph> <subparagraph id="H63CDA6CC882740EFACB82192639126D1"><enum>(F)</enum><header>Capital expenditures taken into account for expenditures test</header><text>An expenditure shall not fail to be taken into account under subparagraph (E)(i) merely because such expenditure is chargeable to capital account.</text></subparagraph> <subparagraph id="HB9E58642D6A1424A95B7D4559A1BBD9E"><enum>(G)</enum><header>Pass-thru entity</header><text>For purposes of this paragraph, the term <term>pass-thru entity</term> means any partnership, S corporation, or other entity identified by the Secretary as a pass-thru entity for purposes of this paragraph.</text></subparagraph> <subparagraph id="H265FDC411B6541A381B51658D10D07DF"><enum>(H)</enum><header>Aggregation rules</header> <clause id="HB72B471583B94614A6DA90D06FDF4AA8"><enum>(i)</enum><header>In general</header><text>All persons treated as a single employer under subsection (a) or (b) of section 52, or subsection (m) or (o) of section 414, shall be treated as a single entity for purposes of subparagraphs (E) and (F)(iii).</text></clause> <clause id="H48270FD54B1241AB949512342F9A4781"><enum>(ii)</enum><header>Limitation where entity would not qualify</header><text display-inline="yes-display-inline">No entity shall be treated as a specified medical research small business pass-thru entity unless such entity qualifies as such both with and without the application of clause (i).</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HBA42A0F4EF204CC980F6353DF2594623"><enum>(b)</enum><header>Material participation not required</header><text>Paragraph (5) of <external-xref legal-doc="usc" parsable-cite="usc/26/469">section 469(c)</external-xref> of the Internal Revenue Code of 1986, as redesignated by subsection (a), is amended by striking <quote>and (3)</quote> in the heading and text and inserting <quote>, (3), and (4)</quote>.</text></subsection> <subsection id="H1A94CF661204481A9A065FE139586805"><enum>(c)</enum><header>Certain research-Related deductions and credits of specified medical research small business pass-Thru entities allowed for purposes of determining alternative minimum tax</header> <paragraph id="H05EE45902D7040E59A8B095E7313FAA0"><enum>(1)</enum><header>Deduction for research and experimental expenditures</header><text>Paragraph (2) of <external-xref legal-doc="usc" parsable-cite="usc/26/56">section 56(b)</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:</text> <quoted-block id="H44F7466FC6DF41F5972B973BF9A60343" style="OLC"> <subparagraph id="HD3015203DBAA46E39B46E5D06292812B"><enum>(E)</enum><header>Exception for specified medical research small business pass-thru entities</header><text display-inline="yes-display-inline">In the case of a specified medical research small business pass-thru entity (as defined in section 469(c)(4)), this paragraph shall not apply to any amount allowable as a deduction under section 174(a).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H18FD56A8AD044505A7FCF1DBCBF40C87"><enum>(2)</enum><header>Allowance of certain research-related credits</header><text>Subparagraph (B) of section 38(c)(4) of such Code is amended by redesignating clauses (ii) through (ix) as clauses (iii) through (x), respectively, and by inserting after clause (i) the following new clause:</text> <quoted-block id="H4CF10B62AEDA4996822DB4D12BBE6E8C" style="OLC"> <clause id="H00105D16A59E4BA6A45AD1332EF3F7CF"><enum>(ii)</enum><text>the credit of an individual taxpayer determined under section 41 to the extent attributable to a specified medical research small business pass-thru entity (as defined in section 469(c)(4)),</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H1AF75E34BC654D56B897DCBB158C6465"><enum>(d)</enum><header>Exception to limitation on pass-Thru of research credit</header><text>Subsection (g) of section 41 of such Code is amended by adding at the end the following: <quote>Paragraphs (2) and (4) shall not apply with respect to any specified medical research small business pass-thru entity (as defined in section 469(c)(4)).</quote>.</text></subsection> <subsection id="HFB71873E5BEE45D49ED6E219D293BBE3"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to losses and credits arising in taxable years beginning after December 31, 2020.</text></subsection></section> <section id="H06F6603F3D2744A5A8D858CBBC757B9A"><enum>8006.</enum><header>Temporary carryover for health and dependent care flexible spending arrangements</header> <subsection id="H378F61E3C15942D290FBD496997D2DAB"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">With respect to the 2020 plan year for any health flexible spending arrangement or any dependent care flexible spending arrangement, an employer may elect to amend its cafeteria plan to permit any unused amounts remaining in such flexible spending arrangement at the end of such plan year to be carried over to the 2021 plan year, pursuant to rules similar to the rules established for health flexible spending arrangements under Internal Revenue Service Notice 2013–71.</text></subsection> <subsection id="H16C1265E587B4EA78C7C19D682C34602"><enum>(b)</enum><header>Retroactive application</header><text>An employer shall be permitted to amend its cafeteria plan to effectuate the rule described in subsection (a), provided that such amendment—</text> <paragraph id="H48B5B079AC494863B6D8B44B60F2DCFF"><enum>(1)</enum><text>is adopted before January 1, 2021; and</text></paragraph> <paragraph id="H57E124B87A77434C9EC8D52ACFD01F75"><enum>(2)</enum><text>provides that the rule described in such subsection shall be in effect as of the first day of the 2020 plan year.</text></paragraph></subsection> <subsection id="HBBE80C759A60409D8FFDDAAA283C22E0"><enum>(c)</enum><header>Definitions</header><text>Any term used in this section which is also used in <external-xref legal-doc="usc" parsable-cite="usc/26/125">section 125</external-xref> of the Internal Revenue Code of 1986 or the regulations thereunder shall have the same meaning as when used in such section or regulations.</text></subsection></section> <section id="HC660901EEB4E44A9BCD14DA5A50C734A" commented="no" display-inline="no-display-inline" section-type="subsequent-section"><enum>8007.</enum><header display-inline="yes-display-inline">Increase in exclusion for employer-provided dependent care assistance</header> <subsection id="HE686325CC7A247CF96BFC9CFE497DBBB" commented="no" display-inline="no-display-inline"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/129">Section 129(a)(2)</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H1A9DD276D780476D8B2E4751D92AFB7E"> <subparagraph id="H59BAE75F03B843FF909E5D05969B6979"><enum>(D)</enum><header>Special rule for 2020 and 2021</header><text display-inline="yes-display-inline">In the case of any taxable year beginning during 2020 or 2021, subparagraph (A) shall be applied by substituting <quote>$10,500 ($5,250</quote> for <quote>$5,000 ($2,500</quote>.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H80B59D55DC894603BBE3A55A50F800F8" commented="no" display-inline="no-display-inline"><enum>(b)</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="yes-display-inline">The amendment made by this section shall apply to taxable years beginning after December 31, 2019.</text></subsection> <subsection id="H645C341EA3744D6EA8812E69C278EC5F" commented="no" display-inline="no-display-inline"><enum>(c)</enum><header>Retroactive plan amendments</header><text>A plan or other arrangement that otherwise satisfies all applicable requirements of sections 106, 125, and 129 of the Internal Revenue Code of 1986 (including any rules or regulations thereunder) shall not fail to be treated as a cafeteria plan or dependent care flexible spending arrangement merely because such plan or arrangement is amended pursuant to a provision under this section and such amendment is retroactive, if—</text> <paragraph id="H52D6551337BA4CC6A262E2EE6CBEB505" commented="no" display-inline="no-display-inline"><enum>(1)</enum><text>such amendment is adopted no later than the last day of the plan year in which the amendment is effective, and</text></paragraph> <paragraph id="HBA6DF45F85F545B6BDD17664DFB96DB6" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>the plan or arrangement is operated consistent with the terms of such amendment during the period beginning on the effective date of the amendment and ending on the date the amendment is adopted. </text></paragraph></subsection></section> <section id="H5D82145FF72449FA93D4344AE42850BD"><enum>8008.</enum><header>Temporary increase in contribution limits for health savings accounts</header> <subsection id="H3B7D9C1B00494BF89ADA6D6F33F30993"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(b)</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new paragraph:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H0845DCFE08C347C98137C6ED9092370C"> <paragraph id="H4BB1763165CF47588CB1585861ED76E8"><enum>(9)</enum><header>Increase in monthly limitations for taxable years 2020 and 2021</header><text>In the case of any month during a taxable year which begins after December 31, 2019, and before January 1, 2022, the dollar amount in effect under subparagraph (A) or (B) of paragraph (2) for such month shall be twice the amount otherwise applicable under such subparagraph, as determined—</text> <subparagraph id="HD79306863D21441F889B1F0DC292CFF2"><enum>(A)</enum><text>before application of paragraph (3),</text></subparagraph> <subparagraph id="H1A58F9B4634D4DC4A7701581B8F8B436"><enum>(B)</enum><text>after application of subsection (g), and</text></subparagraph> <subparagraph id="H521AC3966F3241E3AAEE9E9DD2F1CA0E"><enum>(C)</enum><text>without regard to this paragraph.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HBB4593E5A5294480B652B3816CB37C43"><enum>(b)</enum><header>Effective date</header><text>The amendment made by this section shall apply with respect to taxable years beginning after December 31, 2019.</text></subsection></section> <section id="HA90B4C5B4AA54ED894A68685B786ABD8"><enum>8009.</enum><header>Temporary allowance of payments for employment-related expenses under health savings accounts</header> <subsection id="HDB5940A9836740AEA90F960B51C9FBBF"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(d)(2)</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H572C0EA08DF0480AAA7DAF023AB47FAE"> <subparagraph id="HF33CC53DBEA349A6BAC085461C721157"><enum>(E)</enum><header>Inclusion of employment-related expenses for taxable years 2020 and 2021</header><text>In the case of any taxable year which begins after December 31, 2019, and before January 1, 2022, the term <term>qualified medical expenses</term> includes, with respect to an account beneficiary, any amounts paid by such beneficiary for employment-related expenses (as defined in section 21(b)(2)) which are incurred during such taxable year.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HC171C8EF6E1A4D19B9C09B74E7BB8830"><enum>(b)</enum><header>Conforming amendment</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/21">Section 21(c)</external-xref> of the Internal Revenue Code of 1986 is amended by inserting <quote>and any amounts paid or distributed out of a health savings account which are used exclusively to pay expenses described in section 223(d)(2)(E) which are incurred by the taxpayer during such taxable year</quote> before the period at the end of the second sentence.</text></subsection> <subsection id="H84FA19CF4B6E4787919FBE676BB26B35"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to taxable years beginning after December 31, 2019.</text></subsection></section> <section id="HC815EB00901146C99A69281799608E3D"><enum>8010.</enum><header>Treatment of direct primary care service arrangements</header> <subsection id="H7DF76489D8E24ECA91C782DA1E41C84B"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(c)(1)</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:</text> <quoted-block id="H345E8CE8541448038877A6AF50E49184" style="OLC"> <subparagraph id="H271D1164113F4871B578ABD8B0AD547C"><enum>(D)</enum><header>Treatment of direct primary care service arrangements</header> <clause id="H172EC739EEE2467A8C449DC251E7A94A"><enum>(i)</enum><header>In general</header><text>A direct primary care service arrangement shall not be treated as a health plan for purposes of subparagraph (A)(ii).</text></clause> <clause id="H2027964064994D1AAD09BB83F83281DA"><enum>(ii)</enum><header>Direct primary care service arrangement</header><text>For purposes of this paragraph—</text> <subclause id="HBCADCBB16F694385AC742612B5DA051E"><enum>(I)</enum><header>In general</header><text>The term <term>direct primary care service arrangement</term> means, with respect to any individual, an arrangement under which such individual is provided medical care (as defined in section 213(d)) consisting solely of primary care services provided by primary care practitioners (as defined in section 1833(x)(2)(A) of the Social Security Act, determined without regard to clause (ii) thereof), if the sole compensation for such care is a fixed periodic fee.</text></subclause> <subclause id="H0E3E8E455D7E4BDE9B0C00578DF97051"><enum>(II)</enum><header>Limitation</header><text>With respect to any individual for any month, such term shall not include any arrangement if the aggregate fees for all direct primary care service arrangements (determined without regard to this subclause) with respect to such individual for such month exceed $150 (twice such dollar amount in the case of an individual with any direct primary care service arrangement (as so determined) that covers more than one individual).</text></subclause></clause> <clause id="H2FA0B9B0F6F140E3A8498A9837B485FA"><enum>(iii)</enum><header>Certain services specifically excluded from treatment as primary care services</header><text>For purposes of this subparagraph, the term <term>primary care services</term> shall not include—</text> <subclause id="HDDC6FD9208414E22BE3D2635968238B7"><enum>(I)</enum><text>procedures that require the use of general anesthesia, and</text></subclause> <subclause id="HE8003AC3525548A087F7940190885F7E"><enum>(II)</enum><text>laboratory services not typically administered in an ambulatory primary care setting.</text></subclause><continuation-text continuation-text-level="clause">The Secretary, after consultation with the Secretary of Health and Human Services, shall issue regulations or other guidance regarding the application of this clause.</continuation-text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HB122B24C7A204163B51EC3CC84D61909"><enum>(b)</enum><header>Direct primary care service arrangement fees treated as medical expenses</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(d)(2)(C)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>or</quote> at the end of clause (iii), by striking the period at the end of clause (iv) and inserting <quote>, or</quote>, and by adding at the end the following new clause:</text> <quoted-block id="HA48E972636034A26BEE313A32800A39A" style="OLC"> <subsection id="HAD53E5BD508F40EC88E324EB03E4D056"><enum>(v)</enum><text>any direct primary care service arrangement.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H9452F72CFFBC46E5BA391569910A9C76"><enum>(c)</enum><header>Inflation adjustment</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(g)(1)</external-xref> of the Internal Revenue Code of 1986 is amended—</text> <paragraph id="HE83560275491402092361FC083B94A80"><enum>(1)</enum><text>by inserting <quote>, (c)(1)(D)(ii)(II),</quote> after <quote>(b)(2),</quote> each place such term appears, and</text></paragraph> <paragraph id="H4DD04BF27B574CB9B22291D9A9CA9D72"><enum>(2)</enum><text>in subparagraph (B), by inserting <quote>and (iii)</quote> after <quote>clause (ii)</quote> in clause (i), by striking <quote>and</quote> at the end of clause (i), by striking the period at the end of clause (ii) and inserting <quote>, and</quote>, and by inserting after clause (ii) the following new clause:</text> <quoted-block id="H3EA3D08807A047B79705FD68E5DB35B5" style="OLC"> <clause id="H51BB9114F9FA4C528F3B4A914039FC60"><enum>(iii)</enum><text>in the case of the dollar amount in subsection (c)(1)(D)(ii)(II) for taxable years beginning in calendar years after 2020, <quote>calendar year 2019</quote>.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H00EFC124C93D4AB1BFD599D33D11C9A5"><enum>(d)</enum><header>Reporting of direct primary care service arrangement fees on W–2</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/6051">Section 6051(a)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>and</quote> at the end of paragraph (16), by striking the period at the end of paragraph (17) and inserting <quote>, and</quote>, and by inserting after paragraph (17) the following new paragraph:</text> <quoted-block id="H9D7CAA0AB4464BE0B4C6217A29DCBCE6" style="OLC"> <paragraph id="HE6AEDCA3E3B34B14A2B5726C432A6B54"><enum>(18)</enum><text>in the case of a direct primary care service arrangement (as defined in section 223(c)(1)(D)(ii)) which is provided in connection with employment, the aggregate fees for such arrangement for such employee.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HADFCB478720940F8B380263321655F6E"><enum>(e)</enum><header>Effective date</header> <paragraph id="H249CA31EFFB74F539DCB16F069CF0B20"><enum>(1)</enum><header>In general</header><text>Except as provided under paragraph (2), the amendments made by this section shall apply to months beginning after December 31, 2019, in taxable years ending after such date.</text></paragraph> <paragraph id="H395B32F0E4944AE0A573D47B6E415704"><enum>(2)</enum><header>Inflation adjustment</header><text>The amendments made by subsection (c) shall apply to taxable years beginning in calendar years beginning after December 31, 2020.</text></paragraph></subsection></section> <section id="HF07A25FFF7614A92A89B155C5ECD50F4"><enum>8011.</enum><header>Allow both spouses to make catch-up contributions to the same HSA account</header> <subsection id="HAF40EB5CB4D04CD2B55A4B4EF0082FD6"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Paragraph (5) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(b)</external-xref> of the Internal Revenue Code of 1986 is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="HF2679071D2ED4FC4AC323E45B8365D04" style="OLC"> <paragraph display-inline="no-display-inline" id="H984EC37E91474963840ADEBBBE1D8253"><enum>(5)</enum><header>Special rule for married individuals with family coverage</header> <subparagraph id="HBBA01E3737C34B1CB0E19A7FA831616C"><enum>(A)</enum><header>In general</header><text>In the case of individuals who are married to each other, if both spouses are eligible individuals and either spouse has family coverage under a high deductible health plan as of the first day of any month—</text> <clause id="H09E0ADF6777949C68B7605B0B2886B3B"><enum>(i)</enum><text>the limitation under paragraph (1) shall be applied by not taking into account any other high deductible health plan coverage of either spouse (and if such spouses both have family coverage under separate high deductible health plans, only one such coverage shall be taken into account),</text></clause> <clause id="HD5985C3EDA24492790C6E2A23690766C"><enum>(ii)</enum><text>such limitation (after application of clause (i)) shall be reduced by the aggregate amount paid to Archer MSAs of such spouses for the taxable year, and</text></clause> <clause id="H40A6A8AE1C3542C98DE047C2E32FBE89"><enum>(iii)</enum><text>such limitation (after application of clauses (i) and (ii)) shall be divided equally between such spouses unless they agree on a different division.</text></clause></subparagraph> <subparagraph id="H3D18790FE1CD4C4D8E360E40BB393AA2"><enum>(B)</enum><header>Treatment of additional contribution amounts</header><text>If both spouses referred to in subparagraph (A) have attained age 55 before the close of the taxable year, the limitation referred to in subparagraph (A)(iii) which is subject to division between the spouses shall include the additional contribution amounts determined under paragraph (3) for both spouses. In any other case, any additional contribution amount determined under paragraph (3) shall not be taken into account under subparagraph (A)(iii) and shall not be subject to division between the spouses.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection commented="no" display-inline="no-display-inline" id="H11F6DAA2941143CBB10DCDC37C744603"><enum>(b)</enum><header>Effective date</header><text>The amendment made by this section shall apply to taxable years beginning after December 31, 2019.</text></subsection></section> <section id="H1DB4665C3A6642E6BAE605737DE7653A"><enum>8012.</enum><header>Repeal of ceiling on deductible and out-of-pocket expenses under a high deductible health plan</header> <subsection id="H9A72955943A3453BBBA55491C2C8C728"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Subparagraph (A) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)(2)</external-xref> of the Internal Revenue Code of 1986 is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H518241F4E06341C386C22A72DE689F8A" style="OLC"> <subparagraph id="H68E27C4F780948D1B37374C37A47F0DD"><enum>(A)</enum><header>High deductible health plan</header><text display-inline="yes-display-inline">The term <term>high deductible health plan</term> means a health plan which has an annual deductible which is not less than—</text> <clause id="H633114D441F947548A68C195330EAF6A"><enum>(i)</enum><text>$1,000 for self-only coverage, and</text></clause> <clause id="H61FD1CEF264D4D0FB19B9F4E8D3FA9C3"><enum>(ii)</enum><text>twice the dollar amount in clause (i) for family coverage.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H3E0BA27F526C4D3A9CCB0A6D39C731EC"><enum>(b)</enum><header>Conforming amendments</header> <paragraph id="HDE9AFCEB7F414F8CA32DAF85B488A1A5"><enum>(1)</enum><text>Subparagraph (D) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)(2)</external-xref> of the Internal Revenue Code of 1986 is amended to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HD76E7E73C47D4E1CA97908903C1CF73A"> <subparagraph id="H69572AA43BAE46B8B7F038DB1CDFF775"><enum>(D)</enum><header>Special rule for network plans</header><text>In the case of a plan using a network of providers, such plan's annual deductible for services provided outside of such network shall not be taken into account for purposes of subsection (b)(2).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H13A193E17F6441B1ABA55948DD4A12C3"><enum>(2)</enum><text>Clause (ii) of section 223(g)(1)(B) of such Code is amended by striking <quote>each dollar amount in subsection (c)(2)(A)</quote> and inserting <quote>the dollar amount in subsection (c)(2)(A)(i)</quote>.</text></paragraph></subsection> <subsection id="H73122B99B82F48E187C419C0027E949D"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to taxable years beginning after December 31, 2019. </text></subsection></section> <section id="H67F03074CAB84814B27CE7B023E35812"><enum>8013.</enum><header>On-site employee clinics</header> <subsection id="HFC54A93F674E490D89DE936FD429CF59"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Paragraph (1) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)</external-xref> of the Internal Revenue Code of 1986, as amended by section 8010 of this Act, is amended by adding at the end the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="HA2BC6D573F19420C828B967F57E334F5" style="OLC"> <subparagraph id="HFC6B5A16E44F4F3785ACC88D47CAE004"><enum>(E)</enum><header>Special rule for qualified items and services</header> <clause id="HDAD8E879FD824F91A163ABE7327F4571"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of subparagraph (A)(ii), an individual shall not be treated as covered under a health plan described in subclauses (I) and (II) of such subparagraph merely because the individual is eligible to receive, or receives, qualified items and services—</text> <subclause id="H4F6B628818F94CAFB8DDB795B072B5D0"><enum>(I)</enum><text>at a healthcare facility located at a facility owned or leased by the employer of the individual (or of the individual's spouse), or</text></subclause> <subclause id="HDB34CB8BD6CE44289558DA69058D3CA7"><enum>(II)</enum><text display-inline="yes-display-inline">at a healthcare facility operated primarily for the benefit of employees of the employer of the individual (or of the individual's spouse).</text></subclause></clause> <clause id="H77A946AC0009445E8A6D7CF0B8C65336"><enum>(ii)</enum><header>Qualified items and services defined</header><text display-inline="yes-display-inline">For purposes of this subparagraph, the term <term>qualified items and services</term> means the following:</text> <subclause id="H33E5267A32CF462DA7630DBE5E4C9A7C"><enum>(I)</enum><text display-inline="yes-display-inline">Physical examination.</text></subclause> <subclause id="H63FC325152434A71BA94F08CA0C47729"><enum>(II)</enum><text display-inline="yes-display-inline">Immunizations, including injections of antigens provided by employees.</text></subclause> <subclause id="H77EDF640E19F4333AE4827EC346B8A05"><enum>(III)</enum><text>Drugs or biologicals other than a prescribed drug (as such term is defined in section 213(d)(3)).</text></subclause> <subclause id="H4E231E475F434CC79373B0E97F8E5D45"><enum>(IV)</enum><text>Treatment for injuries occurring in the course of employment.</text></subclause> <subclause id="HAAEEB365860849A8BF9A96E5D8D95F05"><enum>(V)</enum><text>Preventive care for chronic conditions (as defined in clause (iv)).</text></subclause> <subclause id="H946F20EB283542EE91212EA4D363366D"><enum>(VI)</enum><text>Drug testing.</text></subclause> <subclause id="HC54DE4A8B103440C9995FBDD0872E417"><enum>(VII)</enum><text>Hearing or vision screenings and related services.</text></subclause></clause> <clause id="H4E7C96D412C54F0FB10894DFCDBC0BAA"><enum>(iii)</enum><header>Aggregation</header><text>For purposes of clause (i), all persons treated as a single employer under subsection (b), (c), (m), or (o) of section 414 shall be treated as a single employer.</text></clause> <clause id="H9F92F985D1094F25AB1A35875DBBF696"><enum>(iv)</enum><header>Preventive care for chronic conditions</header><text>For purposes of this subparagraph, the term <term>preventive care for chronic conditions</term> means any item or service specified in the Appendix of Internal Revenue Service Notice 2019–45 which is prescribed to treat an individual diagnosed with the associated chronic condition specified in such Appendix for the purpose of preventing the exacerbation of such chronic condition or the development of a secondary condition, including any amendment, addition, removal, or other modification made by the Secretary (pursuant to the authority granted to the Secretary under paragraph (2)(C)) to the items or services specified in such Appendix subsequent to the date of enactment of this subparagraph.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H0863F05BC91347F8B560DD1ACBAF519D" commented="no"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply to months in taxable years beginning after the date of enactment of this Act.</text></subsection></section> <section id="HCECF4BE771604780A24694A1ADA6D494"><enum>8014.</enum><header>Adjustment of medical expense deduction</header> <subsection id="HAE385696261741028507489B458273C8"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/213">Section 213</external-xref> of the Internal Revenue Code of 1986 is amended—</text> <paragraph id="H29820E9D753D4A9988AC1E979F16FEDE"><enum>(1)</enum><text>in subsection (a), by striking <quote>10 percent</quote> and inserting <quote>7.5 percent</quote>, and</text></paragraph> <paragraph id="H7E94F39E8A0542519A8EC9C498669622"><enum>(2)</enum><text>by striking subsection (f) and inserting the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H493FCE6EBC7B453B8D9E89A904118AD2"> <subsection id="H7C4B968595CD4BFA9B3006262B3405DA"><enum>(f)</enum><header>Temporary special rule</header><text>In the case of any taxable year beginning after December 31, 2019, and ending before January 1, 2022, subsection (a) shall be applied with respect to a taxpayer by substituting <quote>5 percent</quote> for <quote>7.5 percent</quote>.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H93847E2EB41F45BEA9129A6F5CB644FA"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after December 31, 2019.</text></subsection></section> <section id="HDB93FD7305D84ABA91B4E55DB0490C17" section-type="subsequent-section"><enum>8015.</enum><header>Healthy workplace tax credit</header> <subsection id="H07CD2964DE9D4555A4C3CFF7B0C3B3B8"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">In the case of an employer, there shall be allowed as a credit against applicable employment taxes for each calendar quarter an amount equal to 50 percent of the sum of—</text> <paragraph id="H31014CF71F7F46F482F029F8F5EA02E3"><enum>(1)</enum><text>the qualified employee protection expenses paid or incurred by the employer during such calendar quarter, </text></paragraph> <paragraph id="H3016FBB4C37B4E96B3E64D2E3A360E3B"><enum>(2)</enum><text>the qualified workplace reconfiguration expenses paid or incurred by the employer during such calendar quarter, </text></paragraph> <paragraph id="H358598DACF2245388B94BE4B855A1D2E"><enum>(3)</enum><text display-inline="yes-display-inline">the qualified workplace technology expenses paid or incurred by the employer during such calendar quarter, and</text></paragraph> <paragraph id="H04AF1CF2914F49B8A8E684BA267FDAC7"><enum>(4)</enum><text display-inline="yes-display-inline">the qualified workplace training expenses paid or incurred by the employer during such calendar quarter.</text></paragraph></subsection> <subsection id="H3C5423ED93714E0EAC4ACE42D51A5BCD"><enum>(b)</enum><header>Limitations and refundability</header> <paragraph id="H1BAE0C8CF8494113BB6EA20F2CF70408"><enum>(1)</enum><header>Overall dollar limitation on credit</header> <subparagraph id="H9C3216A9A9E64C3FAE2A57BC1EC4195B"><enum>(A)</enum><header>In general</header><text>The amount of the credit allowed under subsection (a) with respect to any employer for any calendar quarter shall not exceed the excess (if any) of—</text> <clause id="H26F5EC65B216430CADA4956C00DE6D7E"><enum>(i)</enum><text>the applicable dollar limit with respect to such employer for such calendar quarter, over</text></clause> <clause id="H1A91C3DC73534F2285B43E7A809BE76E"><enum>(ii)</enum><text>the aggregate credits allowed under subsection (a) with respect to such employer for all preceding calendar quarters.</text></clause></subparagraph> <subparagraph id="H00A5422213DA471EA257A0A9926F1781"><enum>(B)</enum><header>Applicable dollar limit</header><text>The term <term>applicable dollar limit</term> means, with respect to any employer for any calendar quarter, the sum of—</text> <clause id="H307F022515694336952DC11CBCD4F551"><enum>(i)</enum><text display-inline="yes-display-inline">$1,000, multiplied so much of the average number of employees employed by such employer during such calendar quarter as does not exceed 500, plus</text></clause> <clause id="H4EF6D2EC8F294166A9D51F4A33989252"><enum>(ii)</enum><text>$750, multiplied by so much of such average number of employees as exceeds 500 but does not exceed 1,000, plus</text></clause> <clause id="H3978099812D8400390E0406445BB98E9"><enum>(iii)</enum><text>$500, multiplied by so much of such average number of employees as exceeds 1,000.</text></clause></subparagraph></paragraph> <paragraph id="HE53ADDEF8FF74455A40931B085D5C886"><enum>(2)</enum><header>Credit limited to employment taxes</header><text>The credit allowed by subsection (a) with respect to any calendar quarter shall not exceed the applicable employment taxes (reduced by any credits allowed under subsections (e) and (f) of <external-xref legal-doc="usc" parsable-cite="usc/26/3111">section 3111</external-xref> of the Internal Revenue Code of 1986, sections 7001 and 7003 of the Families First Coronavirus Response Act, and section 2301 of the CARES Act) on the wages paid with respect to the employment of all the employees of the eligible employer for such calendar quarter.</text></paragraph> <paragraph id="HB7B28F8257E34E8CAAC7D8E21A31BE92"><enum>(3)</enum><header>Refundability of excess credit</header> <subparagraph id="HA657075CA78D4CCAAFD8CCD536ACB207"><enum>(A)</enum><header>In general</header><text>If the amount of the credit under subsection (a) exceeds the limitation of paragraph (2) for any calendar quarter, such excess shall be treated as an overpayment that shall be refunded under sections 6402(a) and 6413(b) of the Internal Revenue Code of 1986.</text></subparagraph> <subparagraph id="H6622CA5728074B6D8DC18315C32BA9C0"><enum>(B)</enum><header>Treatment of payments</header><text>For purposes of section 1324 of title 31, United States Code, any amounts due to the employer under this paragraph shall be treated in the same manner as a refund due from a credit provision referred to in subsection (b)(2) of such section.</text></subparagraph></paragraph></subsection> <subsection id="H6C28F8EE10444CB4A6ABB6045C34F175"><enum>(c)</enum><header>Qualified employee protection expenses</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>qualified employee protection expenses</term> means amounts paid or incurred by the employer for—</text> <paragraph id="H755F7DE9A6E149159B77C4F53095EA70"><enum>(1)</enum><text>testing employees of the employer for COVID–19 (including on a periodic basis),</text></paragraph> <paragraph id="H3FB69C49E06D4C45BDD97DBC8DF45E32"><enum>(2)</enum><text>equipment to protect employees of the employer from contracting COVID–19, including masks, gloves, and disinfectants, and</text></paragraph> <paragraph id="HF9962E62A52040ED90B099E9FE50F5F3"><enum>(3)</enum><text display-inline="yes-display-inline">cleaning products or services (whether provided by an employee of the taxpayer or a cleaning service provider) related to preventing the spread of COVID–19.</text></paragraph></subsection> <subsection id="H58AB0056493746FB8AF6C273B3C31686"><enum>(d)</enum><header>Qualified workplace reconfiguration expenses</header><text display-inline="yes-display-inline">For purposes of this section—</text> <paragraph id="H2E979E05E31849AB97AEE09BFD88C9D9"><enum>(1)</enum><header>In general</header><text>The term <term>qualified workplace reconfiguration expenses</term> means amounts paid or incurred by the employer to design and reconfigure retail space, work areas, break areas, or other areas that employees or customers regularly use in the ordinary course of the employer’s trade or business if such design and reconfiguration—</text> <subparagraph id="H7405C1A0D8694AF2842EFF3D1BC9CBD9"><enum>(A)</enum><text>has a primary purpose of preventing the spread of COVID–19,</text></subparagraph> <subparagraph id="HCC8A0079E73040D4A13C266CED5F1C9C"><enum>(B)</enum><text>is with respect to an area that is located in the United States and that is leased or owned by the employer,</text></subparagraph> <subparagraph id="H809A12A7D5F54979B6814D431E7E0CF3"><enum>(C)</enum><text>is consistent with the purpose of the property immediately before the reconfiguration,</text></subparagraph> <subparagraph id="H43578930818F4760A4C145C2F7D7C1DA"><enum>(D)</enum><text display-inline="yes-display-inline">is commensurate with the risks faced by the employees or customers or is consistent with recommendations made by the Centers for Disease Control and Prevention or the Occupational Safety and Health Administration,</text></subparagraph> <subparagraph id="H3A5B9561F62B477AA3661C6F40A1C571"><enum>(E)</enum><text>is completed pursuant to a reconfiguration plan and no comparable reconfiguration plan was in place before March 13, 2020, and</text></subparagraph> <subparagraph id="H7E94AC2650DE4AB7854CFB7F495C99DC"><enum>(F)</enum><text>is completed before January 1, 2021.</text></subparagraph></paragraph> <paragraph id="H4D7FA9B3EE5446AAAA53DB806070D93C"><enum>(2)</enum><header>Regulations</header><text display-inline="yes-display-inline">The Secretary shall prescribe such regulations and other guidance as may be necessary or appropriate to carry out the purposes of this subsection, including guidance defining primary purpose and reconfiguration plan.</text></paragraph></subsection> <subsection id="H68CCA79065954F5DA6BBB5D065C60BD9"><enum>(e)</enum><header>Qualified workplace technology expenses</header><text display-inline="yes-display-inline">For purposes of this section—</text> <paragraph id="H1B8829830AD74096B56276350659DE84"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>qualified workplace technology expenses</term> means amounts paid or incurred by the employer for technology systems that employees or customers use in the ordinary course of the employer’s trade or business if such technology system—</text> <subparagraph id="H8450564CA6CD4866AA28012EC47B0659"><enum>(A)</enum><text>has a primary purpose of preventing the spread of COVID–19,</text></subparagraph> <subparagraph id="H4C2F89B6CCC240FE9CAD9067736854D7"><enum>(B)</enum><text>is used for limiting physical contact between customers and employees in the United States,</text></subparagraph> <subparagraph id="H202FA280600748999227F8CBE76386D7"><enum>(C)</enum><text>is commensurate with the risks faced by the employees or customers or is consistent with recommendations made by the Centers for Disease Control and Prevention or the Occupational Safety and Health Administration,</text></subparagraph> <subparagraph id="H8A6E13AF7ED946068FE67194C18A2DD3"><enum>(D)</enum><text display-inline="yes-display-inline">is acquired by the taxpayer after March 12, 2020, and is not acquired pursuant to a written binding contract entered into before such date, and</text></subparagraph> <subparagraph id="HCB11A8F3C2C341A195E6D12AD2126823"><enum>(E)</enum><text>is placed in service by the taxpayer before January 1, 2021.</text></subparagraph></paragraph> <paragraph id="HE5DCF7001E2940719E32FDA8F9ADA97F"><enum>(2)</enum><header>Technology systems</header><text display-inline="yes-display-inline">The term <term>technology systems</term> means computer software (as defined in section 167(f)(1)) and qualified technological equipment (as defined in section 168(i)(2)).</text></paragraph> <paragraph id="H6D40BD016C074779813A014F54E45068"><enum>(3)</enum><header>Regulations</header><text>The Secretary shall prescribe such regulations and other guidance as may be necessary or appropriate to carry out the purposes of this subsection, including guidance defining primary purpose.</text></paragraph></subsection> <subsection id="HD3C044377DBA4B02BCFB44AAE616D3A9"><enum>(f)</enum><header>Qualified workplace training expenses</header><text display-inline="yes-display-inline">For purposes of this section, the term <term>qualified workplace training expenses</term> means amounts paid or incurred by the employer for education and training with respect to industry best practices that ensure—</text> <paragraph id="HB317E56759A649F08E14CF3DF528965F"><enum>(1)</enum><text>the health and safety of employees in the workplace with respect to COVID–19, and</text></paragraph> <paragraph id="H7869A24572E548F4898F9513EC4A9DF5"><enum>(2)</enum><text>the prevention of the spread of COVID–19 in the workplace.</text></paragraph></subsection> <subsection id="HD56AA345EA1846149FBE20521B464DCB"><enum>(g)</enum><header>Other definitions</header><text>For purposes of this section—</text> <paragraph id="HD900B1F8AAED4A3FB2F99DBA87D1942C"><enum>(1)</enum><header>Applicable employment taxes</header><text>The term <term>applicable employment taxes</term> means the following:</text> <subparagraph id="H636581623C6546148FE21EBFA0A5EF4E"><enum>(A)</enum><text>The taxes imposed under <external-xref legal-doc="usc" parsable-cite="usc/26/3111">section 3111(a)</external-xref> of the Internal Revenue Code of 1986.</text></subparagraph> <subparagraph id="HE1A34A1921AA42C8831CA581B2818156"><enum>(B)</enum><text>So much of the taxes imposed under section 3221(a) of such Code as are attributable to the rate in effect under section 3111(a) of such Code.</text></subparagraph></paragraph> <paragraph id="HE194A8E8F35746B185D76CA806EDC559"><enum>(2)</enum><header><enum-in-header>COVID–19</enum-in-header></header><text>Except where the context clearly indicates otherwise, any reference in this section to COVID–19 shall be treated as including a reference to the virus which causes COVID–19.</text></paragraph> <paragraph id="H0EBAC57134B44C8884239A29B00D2969"><enum>(3)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of the Treasury or the Secretary’s delegate.</text></paragraph> <paragraph id="H22760F2480164F02B8A798E38097C04D"><enum>(4)</enum><header>Other terms</header><text>Any term used in this section (other than subsection (b)(1)(B)) which is also used in chapter 21 or 22 of the Internal Revenue Code of 1986 shall have the same meaning as when used in such chapter.</text></paragraph></subsection> <subsection id="HEDB6D4A25E5249C0A729D87B787E7338" commented="no"><enum>(h)</enum><header>Certain governmental employers</header><text display-inline="yes-display-inline">This credit shall not apply to the Government of the United States, the government of any State or political subdivision thereof, or any agency or instrumentality of any of the foregoing.</text></subsection> <subsection id="HB36CABB950C643A9923FB90EBAC8F022"><enum>(i)</enum><header>Special rules</header> <paragraph id="HA61739BCEA1643BDBD71BB3C421636E8" display-inline="no-display-inline"><enum>(1)</enum><header>Aggregation rule</header><text>All persons treated as a single employer under subsection (a) or (b) of <external-xref legal-doc="usc" parsable-cite="usc/26/52">section 52</external-xref> of the Internal Revenue Code of 1986, or subsection (m) or (o) of section 414 of such Code, shall be treated as one employer for purposes of this section.</text></paragraph> <paragraph id="H331628A4007B4948B68732D9563E6862"><enum>(2)</enum><header>Denial of double benefit</header> <subparagraph id="HF4646C3F681444DBABE7B0903E8E8E4F"><enum>(A)</enum><header>In general</header><text>Rules similar to the rules of paragraphs (1) and (2) of section 280C(b) shall apply for purposes of this section.</text></subparagraph> <subparagraph id="HA229F7B605344F20AD6B6A5774F09137"><enum>(B)</enum><header>Expenses not taken into account more than once</header><text display-inline="yes-display-inline">Any qualified workplace reconfiguration expense or qualified workplace technology expense shall not be treated as a qualified employee protection expense and any qualified workplace technology expense shall not be treated as a qualified workplace reconfiguration expense.</text></subparagraph></paragraph> <paragraph id="H5D5942B69F7E41F0B5C1DAE02EEF1CED"><enum>(3)</enum><header>Third-party payors</header><text>Any credit allowed under this section shall be treated as a credit described in section 3511(d)(2) of such Code.</text></paragraph> <paragraph id="H9986DFA59A854D9FBF80A716961664C9"><enum>(4)</enum><header>Election not to have section apply</header><text>This section shall not apply with respect to any eligible employer for any calendar quarter if such employer elects (at such time and in such manner as the Secretary may prescribe) not to have this section apply.</text></paragraph></subsection> <subsection id="H7CD7D35418E046AA82F699CE0886BFCB" display-inline="no-display-inline"><enum>(j)</enum><header>Transfers to certain trust funds</header><text>There are hereby appropriated to the Federal Old-Age and Survivors Insurance Trust Fund and the Federal Disability Insurance Trust Fund established under section 201 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/401">42 U.S.C. 401</external-xref>) and the Social Security Equivalent Benefit Account established under section 15A(a) of the Railroad Retirement Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/45/231n-1">45 U.S.C. 231n–1(a)</external-xref>) amounts equal to the reduction in revenues to the Treasury by reason of this section (without regard to this subsection). Amounts appropriated by the preceding sentence shall be transferred from the general fund at such times and in such manner as to replicate to the extent possible the transfers which would have occurred to such Trust Fund or Account had this section not been enacted.</text></subsection> <subsection id="HDF5229D7818D433BAE7827F5C1978A22" display-inline="no-display-inline"><enum>(k)</enum><header>Treatment of deposits</header><text display-inline="yes-display-inline">The Secretary shall waive any penalty under <external-xref legal-doc="usc" parsable-cite="usc/26/6656">section 6656</external-xref> of the Internal Revenue Code of 1986 for any failure to make a deposit of any applicable employment taxes if the Secretary determines that such failure was due to the reasonable anticipation of the credit allowed under this section. </text></subsection> <subsection id="HFAE08DEC51684B0791700C5389FF4C36"><enum>(l)</enum><header>Regulations and guidance</header><text display-inline="yes-display-inline">The Secretary shall prescribe such regulations and other guidance as may be necessary or appropriate to carry out the purposes of this section, including—</text> <paragraph id="H7CD4DD18F5394E1DA0FD5C33492310C7"><enum>(1)</enum><text>with respect to the application of the credit under subsection (a) to third-party payors (including professional employer organizations, certified professional employer organizations, or agents under <external-xref legal-doc="usc" parsable-cite="usc/26/3504">section 3504</external-xref> of the Internal Revenue Code of 1986), regulations or other guidance allowing such payors to submit documentation necessary to substantiate the amount of the credit allowed under subsection (a), and</text></paragraph> <paragraph id="HF069AE6FB768464EB913DE970AD2E17F"><enum>(2)</enum><text display-inline="yes-display-inline">regulations or other guidance to prevent abusive transactions.</text></paragraph></subsection> <subsection id="HE3A0A9D562E54A3287C032AE3EBBB00A"><enum>(m)</enum><header>Application</header><text display-inline="yes-display-inline">This section shall only apply to amounts paid or incurred after March 12, 2020, and before January 1, 2021.</text></subsection></section> <enum>IX</enum><header>Medicare Provisions</header> <subtitle id="H5809FD3B01E04A668907BD73AF638DFA"><enum>A</enum><header>Telehealth</header> <section id="H8C92C46FB3714B2C9E2CE10046810D7F"><enum>9001.</enum><header>Removing certain geographic and originating site restrictions on the furnishing of telehealth services under the Medicare program</header><text display-inline="no-display-inline">Section 1834(m)(4)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(C)</external-xref>) is amended—</text> <paragraph id="H03481E9CF5FD42ACA4638A0F30E61353"><enum>(1)</enum><text>in clause (i), by inserting <quote>, with respect to services furnished on or after January 1, 2024,</quote> after <quote>telecommunications system and</quote>; and</text></paragraph> <paragraph id="HA84637EFB67D41B1B6616560BD288770"><enum>(2)</enum><text>in clause (ii)(X), by inserting <quote>, with respect to services furnished on or after January 1, 2024,</quote> after <quote>but</quote>. </text></paragraph></section> <section id="H20CE72F4A1C64192B27C299917FFAB1E"><enum>9002.</enum><header>Making permanent FQHC and RHC telehealth payments</header><text display-inline="no-display-inline">Section 1834(m)(6) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(8)</external-xref>), as so redesignated by section 2(7), is amended—</text> <paragraph id="HE0E0B6059864492F8DFC0362249FE270"><enum>(1)</enum><text>in the header, by striking <quote><header-in-text level="paragraph" style="OLC">during emergency period</header-in-text></quote>; </text></paragraph> <paragraph id="HE96DA991B2AA43A6878DFD3FCD83276C"><enum>(2)</enum><text>in subparagraph (A), in the matter preceding clause (i), by striking <quote>During</quote> and inserting <quote>With respect to services furnished on or after the first day of</quote>; and</text></paragraph> <paragraph id="HA26E8CDA9BA74FF9B6E6005D98365500"><enum>(3)</enum><text>in subparagraph (B)(i), by striking <quote>during such emergency period</quote>.</text></paragraph></section> <section id="H90E7A5A8B2B143D99AC9F10ABCFD79E1"><enum>9003.</enum><header>Expanding the list of practitioners eligible to furnish telehealth services</header><text display-inline="no-display-inline">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>) is amended—</text> <paragraph id="H0B6B2E3810C74C528E9F0F5BBEA6B61A"><enum>(1)</enum><text>in paragraph (1), by striking <quote>described in section 1842(b)(18)(C)</quote> and inserting <quote>as defined in paragraph (4)(E)</quote>;</text></paragraph> <paragraph id="H1249A9C461E24593A82FBB6B3C702FD9"><enum>(2)</enum><text>in paragraph (3)(B), by inserting <quote>described in subparagraph (C) of such section</quote> after <quote>practitioners</quote>; and</text></paragraph> <paragraph id="H5A4F2DAFA9234EEF824EAA335841C424"><enum>(3)</enum><text>in paragraph (4), by amending subparagraph (E) to read as follows:</text> <quoted-block style="OLC" id="HE2F2B0DA3F6A468AA36196E0CFFD6E2B" display-inline="no-display-inline"> <subparagraph id="HFCF21CC970DB4D48A16EDC4E3DBA1EAA"><enum>(E)</enum><header>Practitioner</header><text display-inline="yes-display-inline">The term <term>practitioner</term> means a practitioner described in section 1842(b)(18)(C) and includes, with respect to services furnished before January 1, 2024, any supplier (other than a physician) permitted to receive payment for a telehealth service under this section as of the date of the enactment of this subparagraph pursuant to a waiver in effect as of such date under section 1135. </text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> <section id="H79183D55373D4429B48A2C50A6303433"><enum>9004.</enum><header>Allowing for the provision of telehealth services via audio-only telecommunications systems</header><text display-inline="no-display-inline">Section 1834(m)(4) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)</external-xref>) is amended by adding at the end the following new subparagraph:</text> <quoted-block style="OLC" id="H4A4D3B97A9FB44BDAD57B1745FFAA5DB" display-inline="no-display-inline"> <subparagraph id="HDB75717DA922483C8C9E013F1A8EAEAA"><enum>(G)</enum><header>Telecommunications system</header> <clause id="H6494C72F1B624B03A9141F28653FCC17"><enum>(i)</enum><header>In general</header><text>The term <term>telecommunications system</term> includes, in the case of a telehealth service furnished by a qualified provider (as defined in clause (ii)) to an individual located at an originating site before January 1, 2024, a communications system consisting of only audio capabilities, but only if such individual does not have access to a communications system with audio-visual capabilities at such site.</text></clause> <clause id="H9BA64F4834F84C3A9FBE5D386710052E"><enum>(ii)</enum><header>Qualified provider</header><text>For purposes of clause (i), the term <term>qualified provider</term> means, with respect a telehealth service furnished to an individual, a physician or practitioner who—</text> <subclause id="H4FCF371D342E4327916B26D66EC29E62"><enum>(I)</enum><text>furnished to such individual an item or service (other than such telehealth service) for which payment was made under any group health plan (as defined in section 2791 of the Public Health Service Act), health insurance coverage (as so defined), Federal health care program (as defined in section 1128B(f)), or the health care program under <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/89">chapter 89</external-xref> of title 5, United States Code, during the 3-year period ending on the date such telehealth service was furnished; or</text></subclause> <subclause id="H15B3C34DC874486E82EB9F43383F6FD8"><enum>(II)</enum><text>is in the same practice (as determined by tax identification number) of a physician or practitioner who furnished such an item or service to such individual during such period.</text></subclause></clause></subparagraph><after-quoted-block>. </after-quoted-block></quoted-block></section> <section id="H07F54ABD1ECB40AFB48D5952C5CACC6F"><enum>9005.</enum><header>Making permanent the safe harbor for absence of deductible for telehealth</header> <subsection id="H8BFE8611992948798CF0AFE78B5A1496"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(c)(2)(E)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>In the case of plan years beginning on or before December 31, 2021, a</quote> and inserting <quote>A</quote>.</text></subsection> <subsection id="HDF7FE59FDCA544F2AB119021984E4E28"><enum>(b)</enum><header>Certain coverage disregarded</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(c)(1)(B)(ii)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>(in the case of plan years beginning on or before December 31, 2021)</quote>.</text></subsection></section> <section id="HF964C9CF058C49379707AA947FB5B71C"><enum>9006.</enum><header>Removing requirement for face-to-face visits between home dialysis patients and physicians</header> <subsection id="H1DD3C8A9F4AC45A4894411FB116F295B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1881(b)(3)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(3)(B)</external-xref>) is amended—</text> <paragraph id="H4C5D512750664532AAE264D3CF91DE6A"><enum>(1)</enum><text>in clause (i), by striking <quote>clauses (ii) and (iii)</quote> and inserting <quote>clause (ii)</quote>;</text></paragraph> <paragraph id="H5DB08FB34B604A84BF53E2502390EA0C"><enum>(2)</enum><text>in clause (ii), by inserting <quote>or (iv)</quote> after <quote>clause (iii)</quote>; </text></paragraph> <paragraph id="HEABE41D4AAE84C929A01DD764121A3E1"><enum>(3)</enum><text>by moving clause (iii) 6 ems to the left; and</text></paragraph> <paragraph id="HA161476F9D0C45129CA25EBAE4B5814A"><enum>(4)</enum><text>by adding at the end the following new clause:</text> <quoted-block style="OLC" id="HDE5CA27775C84DAB8B5282CA392F68A3" display-inline="no-display-inline"> <clause id="H7B35BB240E3147C0A3B9319C2B76A02C" indent="up3"><enum>(iv)</enum><text display-inline="yes-display-inline">Clause (ii) shall not apply to monthly end stage renal disease-related clinical assessments furnished before January 1, 2024, in the case of an individual who has received in-person training with respect to home dialysis.</text></clause><after-quoted-block>. </after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H8A380AED6F5F4A2283A6BBFEA0526B6D"><enum>(b)</enum><header>Waiver authority</header> <paragraph id="H1125DAEC92404EE192242B90D43D03A3"><enum>(1)</enum><header>In general</header><text>Notwithstanding any provision of section 1135 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5</external-xref>), the Secretary of Health and Human Services may, with respect to a specified waiver (as defined in paragraph (2)), continue such waiver in effect for any period of time before January 1, 2024.</text></paragraph> <paragraph id="H89332A93A7E44429B0CD610E0B63E9F8"><enum>(2)</enum><header>Definition</header><text display-inline="yes-display-inline">In this subsection, the term <term>specified waiver</term> means a waiver in effect on the date of the enactment of this Act that, with respect to any provision of title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395</external-xref> et seq.) that requires an in-person visit with a provider of services or supplier (as such terms are defined in section 1861 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x</external-xref>)) as a prerequisite for payment of any item or service under such title or for any other purpose, modifies such provision to allow such visit to be conducted through the use of telehealth.</text></paragraph></subsection></section> <section id="HD37762F94AC4416882C4C865C0CA87B6"><enum>9007.</enum><header>Report on telehealth payment integrity</header><text display-inline="no-display-inline">Not later than 1 year after the date of the enactment of this Act, the Inspector General of the Department of Health and Human Services shall review claims for payment for telehealth services furnished under the Medicare program during the emergency period described in section 1135(g)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5(g)(1)(B)</external-xref>) and submit to Congress a report on any instances of waste, fraud, or abuse identified through such review.</text></section> <section id="H6B3B4836BD7C4085842E50B7DF3F85A2"><enum>9008.</enum><header>Increasing funding for review of telehealth claims</header><text display-inline="no-display-inline">There are authorized to be appropriated to the Inspector General of the Department of Health and Human Services $10,000,000 for fiscal years 2021 through 2023 for purposes of conducting audits and other oversight activities with respect to payments made under 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>).</text></section> <section id="HDB8D9B11A76E4FDAA89185CCB731BDB8"><enum>9009.</enum><header>Telehealth resources</header><text display-inline="no-display-inline">Not later than 6 months after the last day of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5(g)(1)(B)</external-xref>), the Secretary of Health and Human Services shall develop and make available to physicians (as defined in section 1861(r) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(r)</external-xref>)) and practitioners (as defined in section 1834(m)(4)(E) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(E)</external-xref>)) educational resources and training sessions on requirements relating to the furnishing of telehealth services under section 1834(m) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>). </text></section></subtitle> <subtitle id="HD795F49B3BE44A3CA2482467BEFAB3DA" commented="no"><enum>B</enum><header>Protecting Access to Innovation During COVID–19</header> <section id="HD6CDBEEA4A2D4DCC8BFD1167FF6EBFD6" commented="no"><enum>9011.</enum><header>Authorizing the extension of pass-through status under the Medicare program for certain drugs and devices impacted by COVID–19</header><text display-inline="no-display-inline">Section 1833(t)(6) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(t)(6)</external-xref>) is amended by adding at the end the following new subparagraph:</text> <quoted-block style="OLC" id="HB185461507664818B20F3490AC5C8925" display-inline="no-display-inline"> <subparagraph id="H7F0DDDF365E04ED5939676E61BC0F596" commented="no"><enum>(K)</enum><header>Authority to extend pass-through status for certain drugs and devices impacted by COVID–19</header> <clause id="H9E7785DD96CE46D2B9EA1C51B47814BE" commented="no"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Notwithstanding the preceding provisions of this paragraph, in the case of an eligible drug or device (as defined in clause (iv)), if the Secretary determines, prior to or on the date of the expiration of pass-through status for such drug or device (or, in the case of such a drug or device whose pass-through status expired before the date of the enactment of this subparagraph, not later than 30 days after such date), that the cost of such drug or device is unable to be accurately calculated due to the effects of COVID–19, the Secretary may extend the pass-through status of such eligible drug or device in accordance with clause (ii).</text></clause> <clause id="H1ED26F3EE09546E9A013D62FE4E5531E" commented="no"><enum>(ii)</enum><header>Extension</header><text>The Secretary may extend the pass-through status of an eligible drug or device described in clause (i) with respect to which a determination has been made under such clause—</text> <subclause id="HE68D1F79EFE341F6862E6303038402CA" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">in the case of a drug or device whose period of pass-through status expired during the emergency period described in section 1135(g)(1)(B) before the date of the enactment of this subparagraph, for a period beginning on the first day after such period of up to the number of days occurring during such period during which such drug or device had pass-through status;</text></subclause> <subclause id="HE3B7037C38774AFDA51DF8C8021CEA08" commented="no"><enum>(II)</enum><text>in the case of a drug or device whose period of pass-through status would otherwise expire during such emergency period on or after such date of enactment—</text> <item id="H3D53E1E6191E4C31807ED7F4750C7161" commented="no"><enum>(aa)</enum><text>for the remainder of such period; and</text></item> <item id="HCFC23567879B4B9280DC1CB330439A06" commented="no"><enum>(bb)</enum><text>for a period beginning on the first day after such period of up to the number of days occurring during such period during which such drug or device had pass-through status (not taking into account any extension of such status pursuant to this subclause); and</text></item></subclause> <subclause id="H385322DBEF62469E84192843ABE639BA" commented="no"><enum>(III)</enum><text>in the case of a drug or device not described in subclause (I) or (II), by the number of days occurring during such emergency period during which such drug or device had pass-through status.</text></subclause></clause> <clause id="H1A917364778244F3956F3248276212EB" commented="no"><enum>(iii)</enum><header>Special rules for already-expired drugs and devices</header><text display-inline="yes-display-inline">In the case of an eligible drug or device described in clause (ii)(I) for which payment under this subsection was packaged into a payment for a covered OPD service (or group of services) and whose period of pass-through status is extended in accordance with such clause, the Secretary—</text> <subclause id="HE2739B522E5443E68AA9B26E32E97820" commented="no"><enum>(I)</enum><text>shall, for the period during which such extension is in effect for such drug or device—</text> <item id="H84990541D71A421B9CCED3BED5792DB9" commented="no"><enum>(aa)</enum><text display-inline="yes-display-inline">remove, during such period, the packaged costs of such drug or device (as determined by the Secretary) from the payment amount under this subsection for the covered OPD service (or group of services) with which it is packaged; and</text></item> <item id="HEB3B81A91EBE4FE2A57D8E4C46A2269E" commented="no"><enum>(bb)</enum><text display-inline="yes-display-inline">not make any adjustments to payment amounts under this subsection for a covered OPD service (or group of services) for which no costs were removed under subclause (I); and</text></item></subclause> <subclause id="H4D2DFD295F304DA5853F4CA54C194DF2" commented="no"><enum>(II)</enum><text display-inline="yes-display-inline">may not, when calculating the cost of such drug or device at the end of such extension, take into account claims for such drug or device made while such drug or device was so packaged.</text></subclause></clause> <clause id="H44C2B917D13743BCB51739463A4A8A3D" commented="no"><enum>(iv)</enum><header>Eligible drug or device defined</header><text>For purposes of this subparagraph, the term <term>eligible drug or device</term> means a drug, biological, or device with pass-through status in effect during any portion of the emergency period described in section 1135(g)(1)(B) that will not be (or was not) separately payable upon the expiration of such status, but only if, in the case of a drug or biological, such drug or biological—</text> <subclause id="HB431F2B4166841F7939B3D447CAEE228"><enum>(I)</enum><text display-inline="yes-display-inline">was payable based upon the wholesale acquisition cost of such drug or biological in lieu of the average sales price of such drug or biological on the first date of such emergency period; and</text></subclause> <subclause id="HC30E2F0DAEEB4775BA726A54C73E631B"><enum>(II)</enum><text display-inline="yes-display-inline">will be (or was) packaged into a payment for a covered OPD service (or group of services) upon expiration of such status.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <subtitle id="H59CF38F6EF0745F0ABF959782D3AF88C"><enum>C</enum><header>Reducing Unnecessary Senior Hospitalizations</header> <section id="HDD665E538BA840A68F67A2502F593DAD"><enum>9021.</enum><header>SNF-based provision of preventive acute care and hospitalization reduction program</header><text display-inline="no-display-inline">Title XVIII of the Social Security Act is amended by adding at the end the following new section:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H4DF09129F6974C68AA0F14C32886DE12"> <section id="H3E7A787BC90A4178B4A654CDD6DDAB64"><enum>1899C.</enum><header>SNF-based provision of preventive acute care and hospitalization reduction program</header> <subsection id="H031837E5B8FA4BC2B0E28DCD5666A575"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">There is established a program to be known as the <quote>SNF-based Provision of Preventive Acute Care and Hospitalization Reduction Program</quote> (in this section referred to as the <quote>Program</quote>), to be administered by the Secretary, for purposes of reducing unnecessary hospitalizations and emergency department visits by allowing qualified group practices (as defined in section 1877(h)(4)) on or after January 1, 2022, to furnish items and services identified under subsection (b)(3) to individuals entitled to benefits under part A and enrolled under part B residing in qualified skilled nursing facilities.</text></subsection> <subsection id="HD09755FF93F04EE59BADF88675EC3793"><enum>(b)</enum><header>Operation of Program</header><text display-inline="yes-display-inline">Under the Program, the Secretary shall provide for the following:</text> <paragraph id="HC39206AEC25A45D7BB6F68212FF4363E"><enum>(1)</enum><text>Certification of skilled nursing facilities as qualified skilled nursing facilities under subsection (c)(1).</text></paragraph> <paragraph id="HF5E9E3237CD34416A7F7A8E3CF8606FE"><enum>(2)</enum><text>Certification of group practices as qualified group practices under subsection (c)(2).</text></paragraph> <paragraph commented="no" id="H726C50963CED4424BC9485B000C8D08A"><enum>(3)</enum><text>Identification of minimum required nonsurgical items and services furnished at a hospital emergency department that may be safely furnished by a qualified group practice at a qualified skilled nursing facility under the Program, as determined as clinically appropriate by the Secretary, and that such qualified group practice shall offer to furnish under the Program.</text></paragraph> <paragraph id="H04D0B8611E2D4588BDA61C9B1A1060D8"><enum>(4)</enum><text>Annual identification of additional items and services furnished at a hospital emergency department that may be safely furnished by a qualified group practice at a qualified skilled nursing facility under the Program during a year and that such qualified group practice may offer to furnish under the Program during such year.</text></paragraph> <paragraph id="H75EEBE4F7F734FCCB085180E38AC7CEC"><enum>(5)</enum><text>Establishment of qualifications for nonphysician employees who may furnish such items and services at a qualified skilled nursing facility. Such qualifications shall include the requirement that such an employee—</text> <subparagraph id="HF80A2C7DACAA4AD197DD223C0045D300"><enum>(A)</enum><text>be certified in basic life support by a nationally recognized specialty board of certification or equivalent certification board; and</text></subparagraph> <subparagraph id="H4089235379AE456FB1CB14EEE3A6A7B9"><enum>(B)</enum><text>have—</text> <clause id="H011C9355ECB74EF8A62141642660E0B6"><enum>(i)</enum><text>clinical experience furnishing medical care—</text> <subclause id="HB8B3CC8314C84A1192C608D8DCDFB6D6"><enum>(I)</enum><text>in a skilled nursing facility;</text></subclause> <subclause id="H195E3C82B96D48ECBF36F44A22029DC4"><enum>(II)</enum><text>in a hospital emergency department setting; or</text></subclause> <subclause id="H5A338E7CB7AD4D858B14A1DA24EE3BF4"><enum>(III)</enum><text>as an employee of a provider or supplier of ambulance services; or</text></subclause></clause> <clause id="H9B0C4B172D174F68971CC93D7D598DB4"><enum>(ii)</enum><text>a certification in paramedicine.</text></clause></subparagraph></paragraph> <paragraph id="H1FF7C532861E4ADF9E1894238B694E9E"><enum>(6)</enum><text>Payment under this title for items and services identified under paragraph (3) or (4) furnished by such qualified group practices at such a facility in amounts determined under subsection (d).</text></paragraph></subsection> <subsection id="H2D1DE9EAF4664CE6BFEA966907BBFC9D"><enum>(c)</enum><header>Certifications</header> <paragraph id="HE6337B910F00482A824D7548A2898429"><enum>(1)</enum><header>Qualified skilled nursing facilities</header><text>For purposes of this section, the Secretary shall certify a skilled nursing facility as a qualified skilled nursing facility if the facility submits an application in a time and manner specified by the Secretary and meets the following requirements:</text> <subparagraph id="HB342E79D76C648368FF3E6D54260F6E9"><enum>(A)</enum><text display-inline="yes-display-inline">The facility has on-site diagnostic equipment necessary for a qualified group practice to furnish items and services under the Program and real-time audio and visual capabilities.</text></subparagraph> <subparagraph id="HC2224425DB29407BB2D3AA5B5D7DEFAE"><enum>(B)</enum><text>The facility has at least one individual who meets the qualifications described in paragraph (5) or a physician present 24 hours a day and 7 days a week to work with the qualified group practice. Such individual may be a member of the staff of the qualified skilled nursing facility or of the qualified group practice.</text></subparagraph> <subparagraph id="H6BF605C3A32D40E89D46ED76D22748C1"><enum>(C)</enum><text>The facility ensures that residents of such facility, upon entering such facility, are allowed to specify in an advanced care directive whether the resident wishes to receive items and services furnished at the facility under the Program in a case where communication with the resident is not possible.</text></subparagraph> <subparagraph id="H1E52A49FBE3A45348A95AF8849BB8401"><enum>(D)</enum><text>The facility ensures that individuals to be furnished such items and services under the Program at such facility have the opportunity, at their request, to instead be transported to a hospital emergency department.</text></subparagraph> <subparagraph id="H346FCA1112FF4AB089F0E9C6214777DC"><enum>(E)</enum><text>The facility is not part of the Special Focus Facility program of the Centers for Medicare & Medicaid Services (although the facility may, at the discretion of the Secretary, be a candidate for selection under such program).</text></subparagraph><continuation-text continuation-text-level="paragraph">Nothing in this paragraph shall affect the requirements under section 1819(b)(4). </continuation-text></paragraph> <paragraph id="H513536B247B546D291D636C03A3A6EF3"><enum>(2)</enum><header>Qualified group practices</header><text>For purposes of this section, the Secretary shall certify a group practice as a qualified group practice for a period of 3 years if the group practice submits an application in a time and manner specified by the Secretary and meets the following requirements:</text> <subparagraph commented="no" id="HFBF327BCBEC04EA7A6FED2A15576620C"><enum>(A)</enum><text display-inline="yes-display-inline">The group practice offers to furnish all minimum required items and services identified under subsection (b)(3) under the Program.</text></subparagraph> <subparagraph id="HC1435F7B801840689ADCA4542E2F2BD6"><enum>(B)</enum><text>The group practice submits a notification to the Secretary annually specifying which (if any) additional items and services identified under subsection (b)(4) for a year the group practice will offer to furnish for such year under the Program.</text></subparagraph> <subparagraph id="H80BD3954E28447728D3A8CA743A9A39C"><enum>(C)</enum><text>The group practice ensures that only individuals who meet the qualifications established under subsection (b)(5) or a physician who is part of such group practice may furnish such minimum required items and services and such additional items and services.</text></subparagraph> <subparagraph commented="no" id="H63AD35FC09364905BE51E79E4A28B5EF"><enum>(D)</enum><text>The group practice ensures that, in the case where such minimum required items and services or such additional items and services are furnished by such an individual, such individual furnishes such minimum required items and services or additional items and services under the supervision, either in-person or through the use of telehealth (not including store-and-forward technologies), of—</text> <clause commented="no" id="HD4659D7C33004DBDA52AAF10BAAC1A6E"><enum>(i)</enum><text>a physician—</text> <subclause commented="no" id="HC968E6159B8D4CD6882B3B61DDBD003C"><enum>(I)</enum><text>who is board certified or board eligible in emergency medicine, family medicine, geriatrics, or internal medicine; or</text></subclause> <subclause commented="no" id="H3A47F97B10714CE0ABC0476C0371E338"><enum>(II)</enum><text>who has been certified by a nationally recognized specialty board of certification or equivalent certification board in basic life support;</text></subclause></clause> <clause commented="no" id="H142663459B9E435E8882D65FD9A00591"><enum>(ii)</enum><text display-inline="yes-display-inline">a nurse practitioner who has been certified by a nationally recognized specialty board of certification or equivalent certification board in basic life support; or</text></clause> <clause commented="no" id="H9FE541A8D6F44928BADBF212BF6ECBD1"><enum>(iii)</enum><text display-inline="yes-display-inline">a physician assistant who has been certified by a nationally recognized specialty board of certification or equivalent certification board in basic life support.</text></clause></subparagraph> <subparagraph commented="no" id="HE6E930DD709946F8B28853A383BFFBB9"><enum>(E)</enum><text display-inline="yes-display-inline">With respect to any year in which the qualified group practice would participate in the Program, the Chief Actuary for the Centers for Medicare & Medicaid Services determines that such participation during such year will not result in total estimated expenditures under this title for such year being greater than total estimated expenditures under such title for such year without such participation.</text></subparagraph></paragraph></subsection> <subsection id="HC119993F743D4067AEB7EF46E9786492"><enum>(d)</enum><header>Payments</header> <paragraph id="HEB9597B7E2B64E128592D9E6C0DF9A57"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For 2022 and each subsequent year, the Secretary shall develop a schedule of payments to apply for items and services identified under paragraph (3) or paragraph (4) of subsection (b) furnished during such year under the Program. Such payments shall be in lieu of any other payments that may be made under this title for such items and services.</text></paragraph> <paragraph commented="no" id="H4083B7D7CD8B40B8B4F7D7A9F0BE11E8"><enum>(2)</enum><header>Shared savings</header><text>In the case of a year for which the Secretary determines that participation in the Program resulted in a reduction in expenditures under this title compared to what such expenditures would have been without such participation, the Secretary shall—</text> <subparagraph commented="no" id="H3C7D3A656D3F40FDADA2971351CF0673"><enum>(A)</enum><text>pay to such qualified group practice an amount equal to 37.5 percent of the estimated amount of such reduction; and</text></subparagraph> <subparagraph commented="no" id="H7234DC15A2E644209189418DE61C6530"><enum>(B)</enum><text>in the case of each qualified skilled nursing facility where such qualified group practice furnished items and services under the Program during such year—</text> <clause commented="no" id="H266E2FBF35044BEF8CA3FF96A08735C9"><enum>(i)</enum><text>if the qualified skilled nursing facility has at least a three-star rating under the Five Star Quality Rating System (or a successor system), pay to the facility an amount that bears the same ratio to 12.5 percent of the estimated amount of such reduction as the amount of expenditures under the Program for such items and services furnished with respect to individuals at such facility by such qualified group practice during such year bears to the total amount of expenditures under the Program for such items and services furnished with respect to all individuals by such qualified group practice during such year; and</text></clause> <clause commented="no" id="H63FB2B6EB70A47C495F63B04328A2887"><enum>(ii)</enum><text>in the case of a qualified skilled nursing facility that is not described in clause (i), retain in the Federal Hospital Insurance Trust Fund under section 1817 the amount that the facility would have been paid pursuant to clause (i) if the facility were described in such clause until such time as the facility has at least a three-star rating under the Five Star Quality Rating System (or a successor system), at which point the Secretary shall pay such amount to the facility. </text></clause></subparagraph></paragraph> <paragraph id="H249A4DF42EE44447947537E1E35F9BED"><enum>(3)</enum><header>Advanced alternative payment models</header><text>Paragraph (2) shall not apply to items and services furnished to an individual entitled to benefits under part A and enrolled under part B for whom shared savings would otherwise be attributed through an advanced alternative payment model as authorized under section 1115A or section 1899.</text></paragraph></subsection> <subsection id="H25C8F97A071A4EBCACB68427F5384EB8"><enum>(e)</enum><header>Evaluation</header> <paragraph id="H2EA317E07850478FA65BAFBBE6B93B12"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">With respect to a qualified group practice and a qualified skilled nursing facility, not later than 6 months after such group practice begins furnishing items and services under the Program (or, in the case of a qualified skilled nursing facility, not less than 6 months after a qualified group practice first furnishes such items and services at such facility), and not less than once every 2 years thereafter, the Secretary shall evaluate such qualified group practice and such qualified facility using information received under paragraph (2) on such criteria as determined appropriate by the Secretary.</text></paragraph> <paragraph id="HD230FF02C75742B39C402CFD15393819"><enum>(2)</enum><header>Reporting of information</header><text>In a time and manner specified by the Secretary, a qualified group practice and a qualified skilled nursing facility shall submit to the Secretary a report containing the following information with respect to items and services furnished under the Program during a reporting period (as specified by the Secretary):</text> <subparagraph id="HF2192D4BB8764E6393F3BF11B96C6D4A"><enum>(A)</enum><text>The number of individuals with respect to whom such group practice furnished such items and services in such period (or, in the case of a qualified skilled nursing facility, the number of individuals with respect to whom such a group practice furnished such items and services at such facility in such period).</text></subparagraph> <subparagraph id="HEC2231FCB60F44A7BB4F08007ED873E1"><enum>(B)</enum><text>The number of such individuals who were admitted to a hospital or treated in the emergency department of a hospital within 24 hours of being furnished such items and services.</text></subparagraph> <subparagraph id="H315D30ABB3FD4C1EAE360D41968C94E7"><enum>(C)</enum><text>Other information determined appropriate by the Secretary.</text></subparagraph></paragraph> <paragraph id="HC729E5F0260E4A528C33832BAE6DA0B2"><enum>(3)</enum><header>Loss of qualified certification</header> <subparagraph id="HD603450A696F47B8A91D98E2D0BDE2DD"><enum>(A)</enum><header>In general</header><text>Not later than 3 months after a determination described in this sentence is made, the Secretary may revoke the certification of a qualified skilled nursing facility or a qualified group practice made under subsection (c) if—</text> <clause id="H94D0D4E27C8948DD9603B98626B2D31D"><enum>(i)</enum><text>the Chief Actuary of the Centers for Medicare & Medicaid Services determines that the participation of such skilled nursing facility or such group practice in the Program during a year resulted in total expenditures under this title for such period being greater than total expenditures under such title would have been during such period without such participation; or</text></clause> <clause id="H59850E63D8D749D1BD8AD0EEE24BF172"><enum>(ii)</enum><text>a facility is selected for the Special Focus Facility program or, if the facility is a candidate for the Special Focus Facility program, the Secretary determines that the participation of such facility in the Program should be terminated.</text></clause></subparagraph> <subparagraph id="HD70300EE16FE4E3A8647652FE37481C5"><enum>(B)</enum><header>Exclusion from certification</header> <clause id="H8B7A16AED1B34C828AF5AF336897D5EE"><enum>(i)</enum><header>In general</header><text>In the case that the Secretary revokes the certification of a qualified skilled nursing facility or a qualified group practice under subparagraph (A), such skilled nursing facility or such group practice shall be ineligible for certification as a qualified skilled nursing facility or a qualified group practice (as applicable) under subsection (c) for the applicable period (as defined under clause (ii)).</text></clause> <clause id="H487EE3DA35294F40BA4EA7A546C28EE5"><enum>(ii)</enum><header>Applicable period defined</header><text>In this subparagraph, the term <term>applicable period</term> means—</text> <subclause id="H27C864B246FA47E2A1625B5E3D7C6CF4"><enum>(I)</enum><text>if the revocation of a facility or group practice under subparagraph (A) is due to the application of clause (i) of such subparagraph, a 1-year period beginning on the date of such revocation; and</text></subclause> <subclause id="HA8F23E4ACDC54C7597D4BAB685A8AA1C"><enum>(II)</enum><text>in the revocation of a facility under subparagraph (A) is due to the application of clause (ii) of such subparagraph, the period beginning on the date of such revocation and ending on the date on which the facility graduates from the Special Focus Facility program (or, in the case of a facility that is a candidate for such program, the date on which the facility is no longer such a candidate, as determined by the Secretary).</text></subclause></clause></subparagraph></paragraph></subsection> <subsection commented="no" display-inline="no-display-inline" id="H0BE434B54FB54C88A44A8C8CF743C0AF"><enum>(f)</enum><header>Determination of budget neutrality; termination of program</header> <paragraph commented="no" id="H981C1E4012844735AD2B72502AD52538"><enum>(1)</enum><header>Determination</header><text>Not later than July 1, 2027, the Chief Actuary of the Centers for Medicare & Medicaid Services shall determine whether the Program has resulted in an increase in total expenditures under this title with respect to the period beginning on January 1, 2022, and ending on December 31, 2026, compared to what such expenditures would have been during such period had the Program not been in operation.</text></paragraph> <paragraph commented="no" id="H8A5817B79B8C448D93F2FB78E9B7D8B6"><enum>(2)</enum><header>Termination</header><text>If the Chief Actuary makes a determination under paragraph (1) that the Program has resulted in an increase in total expenditures under this title, the Secretary shall terminate the Program as of January 1 of the first year beginning after such determination.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle> <enum>X</enum><header>Appropriations</header> <section id="H28E2C0D1F8FC4D938EEF74AF19EEB28D" display-inline="no-display-inline"><enum>10001.</enum><header>Appropriations</header><text display-inline="yes-display-inline">The following sums are hereby appropriated, out of any money in the Treasury not otherwise appropriated, for the fiscal year ending September 30, 2021, and for other purposes, namely:</text></section> <subtitle id="HAC4FA97C9CFC4A3F98C7B5E0FDEAA0C5"><enum>A</enum><header>Health programs</header><appropriations-major id="HC335803B46C54144ACD79E8AC9F20A18"><header>Department of Health and Human Services</header></appropriations-major><appropriations-major id="HFA213FF51A5F4FF69CDEAF1574B5E945"><header>Office of the Secretary</header></appropriations-major><appropriations-small id="H1E9E174183794EF98EFA310AA54BBB0D"><header>Public Health and Social Services Emergency Fund</header></appropriations-small><appropriations-small id="HF52347E097E74760B1AAD4481E0F7DB9"><header>(Including Transfer of Funds)</header><text display-inline="no-display-inline">For an additional amount for <quote>Public Health and Social Services Emergency Fund</quote>, $31,000,000,000, to remain available until September 30, 2025, to prevent, prepare for, and respond to coronavirus, domestically or internationally, including the development of necessary countermeasures and vaccines, prioritizing platform-based technologies with United States-based manufacturing capabilities, the purchase of vaccines, therapeutics, diagnostics, necessary medical supplies, as well as medical surge capacity, addressing blood supply chain, workforce modernization, telehealth access and infrastructure, initial advanced manufacturing, novel dispensing, enhancements to the United States Commissioned Corps, and other preparedness and response activities: <italic>Provided</italic>, That funds appropriated under this paragraph in this title may be used to develop and demonstrate innovations and enhancements to manufacturing platforms to support such capabilities: <italic>Provided further</italic>, That the Secretary of Health and Human Services shall purchase vaccines developed using funds made available under this paragraph in this title to respond to an outbreak or pandemic related to coronavirus in quantities determined by the Secretary to be adequate to address the public health need: <italic>Provided further</italic>, That products purchased by the Federal Government with funds made available under this paragraph in this title, including vaccines, therapeutics, and diagnostics, shall be purchased in accordance with Federal Acquisition Regulation guidance on fair and reasonable pricing: <italic>Provided further</italic>, That the Secretary may take such measures authorized under current law to ensure that vaccines, therapeutics, and diagnostics developed from funds provided in this title will be affordable in the commercial market: <italic>Provided further</italic>, That in carrying out the previous proviso, the Secretary shall not take actions that delay the development of such products: <italic>Provided further</italic>, That the Secretary shall ensure that protections remain for individuals enrolled in group or individual health care coverage with pre-existing conditions, including those linked to coronavirus: <italic>Provided further</italic>, That products purchased with funds appropriated under this paragraph in this title may, at the discretion of the Secretary of Health and Human Services, be deposited in the Strategic National Stockpile under section 319F–2 of the Public Health Service Act: <italic>Provided further</italic>, That of the amount appropriated under this paragraph in this title, not more than $2,000,000,000 shall be for the Strategic National Stockpile under section 319F–2(a) of such Act: <italic>Provided further</italic>, That funds appropriated under this paragraph in this title may be transferred to, and merged with, the fund authorized by section 319F–4, the Covered Counter measure Process Fund, of the Public Health Service Act: <italic>Provided further</italic>, That of the amount appropriated under this paragraph in this title, not more than $2,000,000,000, to remain available until September 30, 2023, shall be for activities to improve and sustain State medical stockpiles: <italic>Provided further</italic>, That of the amount appropriated under this paragraph in this title, $20,000,000,000 shall be available to the Biomedical Advanced Research and Development Authority for necessary expenses of manufacturing, production, and purchase, at the discretion of the Secretary, of vaccines, therapeutics, diagnostics, and small molecule active pharmaceutical ingredients, including the development, translation, and demonstration at scale of innovations in manufacturing platforms: <italic>Provided further</italic>, That funds in the previous proviso may be used for the construction or renovation of United States-based next generation manufacturing facilities, other than facilities owned by the United States Government: <italic>Provided further</italic>, That amounts provided in the eleventh proviso may be for necessary expenses related to the sustained on-shore manufacturing capacity for public health emergencies: <italic>Provided further</italic>, That of the amount appropriated under this paragraph in this title, $6,000,000,000 shall be for activities to plan, prepare for, promote, distribute, administer, monitor, and track coronavirus vaccines to ensure broad-based distribution, access, and vaccine coverage: <italic>Provided further</italic>, That the Secretary shall coordinate funding and activities outlined in the previous proviso through the Director of the Centers for Disease Control and Prevention: <italic>Provided further</italic>, That the Secretary, through the Director of the Centers for Disease Control and Prevention, shall report to the Committees on Appropriations of the House of Representatives and the Senate within 60 days of the date of enactment of this title on a comprehensive coronavirus vaccine distribution strategy and spend plan that includes how existing infrastructure will be leveraged, enhancements or new infrastructure that may be built, considerations for moving and storing vaccines, guidance for how States and health care providers should prepare for, store, and administer vaccines, nationwide vaccination targets, funding that will be distributed to States, how an informational campaign to both the public and health care providers will be executed, and how the vaccine distribution plan will focus efforts on high risk, underserved, and minority populations: <italic>Provided further</italic>, That such plan shall be updated and provided to the Committees on Appropriations of the House of Representatives and the Senate 90 days after submission of the first plan: <italic>Provided further</italic>, That the Secretary shall notify the Committees on Appropriations of the House of Representatives and the Senate 2 days in advance of any obligation in excess of $50,000,000, including contracts and interagency agreements, from funds provided in this paragraph in this title: <italic>Provided further</italic>, That funds appropriated under this paragraph in this title may be used for the construction, alteration, or renovation of nonfederally owned facilities for the production of vaccines, therapeutics, diagnostics, and medical supplies where the Secretary determines that such a contract is necessary to secure sufficient amounts of such supplies: <italic>Provided further</italic>, That not later than 30 days after enactment of this title, and every 30 days thereafter until funds are expended, the Secretary shall report to the Committees on Appropriations of the House of Representatives and the Senate on uses of funding for Operation Warp Speed, detailing current obligations by Department or Agency, or component thereof broken out by the coronavirus supplemental appropriations Act that provided the source of funds: <italic>Provided further</italic>, That the plan outlined in the previous proviso shall include funding by contract, grant, or other transaction in excess of $20,000,000 with a notation of which Department or Agency, and component thereof is managing the contract: <italic>Provided further</italic>, That such amount is designated by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985. </text></appropriations-small><appropriations-small id="HBCC254D2AE84418680C707C4AEC7ECC9"><text display-inline="no-display-inline">For an additional amount for <quote>Public Health and Social Services Emergency Fund</quote>, $16,000,000,000, to remain available until September 30, 2023, to prevent, prepare for, and respond to coronavirus, domestically or internationally, which shall be for necessary expenses for testing, contact tracing, surveillance, containment, and mitigation to monitor and suppress COVID–19, including tests for both active infection and prior exposure, including molecular, antigen, and serological tests, the manufacturing, procurement and distribution of tests, testing equipment and testing supplies, including personal protective equipment needed for administering tests, the development and validation of rapid, molecular point-of-care tests, and other tests, support for workforce, epidemiology, to scale up academic, commercial, public health, and hospital laboratories, to conduct surveillance and contact tracing, support development of COVID–19 testing plans, and other related activities related to COVID–19 testing: <italic>Provided</italic>, That of the amount appropriated under this paragraph in this title, not less than $15,000,000,000 shall be for States, localities, territories, Tribes, Tribal organizations, urban Indian health organizations, or health service providers to Tribes for necessary expenses for testing, contact tracing, surveillance, containment, and mitigation, including support for workforce, epidemiology, use by employers, elementary and secondary schools, child care facilities, institutions of higher education, long-term care facilities, or in other settings, scale up of testing by public health, academic, commercial, and hospital laboratories, and community-based testing sites, health care facilities, and other entities engaged in COVID–19 testing, and other related activities related to COVID–19 testing, contact tracing, surveillance, containment, and mitigation: <italic>Provided further</italic>, That the amount provided in the preceding proviso shall be made available within 30 days of the date of enactment of this title: <italic>Provided further</italic>, That the amount identified in the first proviso under this paragraph in this title shall be allocated to States, localities, and territories according to the formula that applied to the Public Health Emergency Preparedness cooperative agreement in fiscal year 2019: <italic>Provided further</italic>, That not less than $500,000,000 shall be allocated in coordination with the Director of the Indian Health Service, to Tribes, Tribal organizations, urban Indian health organizations, or health service providers to Tribes: <italic>Provided further</italic>, That the Secretary of Health and Human Services (referred to in this paragraph as the <quote>Secretary</quote>) may satisfy the funding thresholds outlined in the first and fourth provisos under this paragraph in this title by making awards through other grant or cooperative agreement mechanisms: <italic>Provided further</italic>, That the Governor or designee of each State, locality, territory, Tribe, or Tribal organization receiving funds pursuant to this title shall update their plans, as applicable, for COVID–19 testing and contact tracing submitted to the Secretary pursuant to the Paycheck Protection Program and Health Care Enhancement Act (<external-xref legal-doc="public-law" parsable-cite="pl/116/139">Public Law 116–139</external-xref>) and submit such updates to the Secretary not later than 60 days after funds appropriated in this paragraph in this title have been awarded to such recipient: <italic>Provided further</italic>, That not later than 60 days after the date of enactment, and every quarter thereafter until funds are expended, the Governor or designee of each State, locality, territory, Tribe, or Tribal organization receiving funds shall report to the Secretary on uses of funding, detailing current commitments and obligations broken out by the coronavirus supplemental appropriations Act that provided the source of funds: <italic>Provided further</italic>, That not later than 15 days after receipt of such reports, the Secretary shall summarize and report to the Committees on Appropriations of the House of Representatives and the Senate on States’ commitments and obligations of funding: <italic>Provided further</italic>, That funds an entity receives from amounts described in the first proviso in this paragraph may also be used for the rent, lease, purchase, acquisition, construction, alteration, renovation, or equipping of nonfederally owned facilities to improve coronavirus preparedness and response capability at the State and local level: <italic>Provided further</italic>, That such amount is designated by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985.</text></appropriations-small></subtitle> <subtitle id="HA7C53CB93C734C69B594AB43577B6C6D"><enum>B</enum><header>General provisions–This Title</header> <section id="H4A25C250AA5A4E508A154892B0BD1EB8"><enum>10101.</enum><text display-inline="yes-display-inline">Each amount appropriated or made available by this title is in addition to amounts otherwise appropriated for the fiscal year involved.</text></section> <section id="H0C6B3109AA424ADEB6163B41858E93D4"><enum>10102.</enum><text display-inline="yes-display-inline">No part of any appropriation contained in this title shall remain available for obligation beyond the current fiscal year unless expressly so provided herein.</text></section> <section id="H37F70F85F3EC40B6943B336EC6DDC05A"><enum>10103.</enum><text display-inline="yes-display-inline">Unless otherwise provided for by this title, the additional amounts appropriated by this title to appropriations accounts shall be available under the authorities and conditions applicable to such appropriations accounts for fiscal year 2020.</text></section> <section id="HA9D32F7356E9435EBEAF40678DC1F9B3"><enum>10104.</enum><text display-inline="yes-display-inline">In this title, the term <term>coronavirus</term> means SARS–CoV–2 or another coronavirus with pandemic potential.</text></section> <section id="HF01C5C2A833441E6B39627D981830656"><enum>10105.</enum><text display-inline="yes-display-inline">Each amount designated in this title by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985 shall be available (or rescinded or transferred, if applicable) only if the President subsequently so designates all such amounts and transmits such designations to the Congress.</text></section> <section id="H2CFA6F2141EA4079B642B4D20E61BFE6"><enum>10106.</enum><text display-inline="yes-display-inline">Any amount appropriated by this title, designated by the Congress as an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985 and subsequently so designated by the President, and transferred pursuant to transfer authorities provided by this title shall retain such designation.</text></section> <section id="H6A49E892E8C44D139DDA73727F6177AA"><enum>10107.</enum> <subsection commented="no" display-inline="yes-display-inline" id="H982F5406D34F4276970C30A0CAED9133"><enum>(a)</enum><header>Statutory paygo scorecards</header><text>The budgetary effects of this title shall not be entered on either PAYGO scorecard maintained pursuant to section 4(d) of the Statutory Pay As-You-Go Act of 2010.</text></subsection> <subsection id="H90290F9BFE854E939EBDF7DD35D01F4A"><enum>(b)</enum><header>Senate paygo scorecards</header><text>The budgetary effects of this title shall not be entered on any PAYGO scorecard maintained for purposes of section 4106 of H. Con. Res. 71 (115th Congress).</text></subsection> <subsection id="HA1AA182420C64FBCBEB685B8B9283753"><enum>(c)</enum><header>Classification of budgetary effects</header><text>Notwithstanding Rule 3 of the Budget Scorekeeping Guidelines set forth in the joint explanatory statement of the committee of conference accompanying Conference Report 105–217 and section 250(c)(7) and (c)(8) of the Balanced Budget and Emergency Deficit Control Act of 1985, the budgetary effects of this title shall be estimated for purposes of section 251 of such Act.</text></subsection> <subsection id="H979E71DC5E6C431B87284B3B3DA9261E"><enum>(d)</enum><header>Ensuring no within-Session sequestration</header><text>Solely for the purpose of calculating a breach within a category for fiscal year 2020 pursuant to section 251(a)(6) or section 254(g) of the Balanced Budget and Emergency Deficit Control Act of 1985, and notwithstanding any other provision of this title, the budgetary effects from this title shall be counted as amounts designated as being for an emergency requirement pursuant to section 251(b)(2)(A) of such Act.</text></subsection></section> <section id="H895A33FC1014426D91BEB9617E749821" section-type="undesignated-section"><text display-inline="yes-display-inline">This title may be cited as the <quote>Coronavirus Response Additional Supplemental Appropriations Act, 2020</quote>.</text></section></subtitle>