II 117th CONGRESS 2d Session S. 4782 IN THE SENATE OF THE UNITED STATES August 4, 2022 Mr. Scott of Florida introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To combat the fentanyl crisis.

1. Short title This Act may be cited as the Streamlining Text for Official Policy by Formulating Effective Needed Tools to Address Narcotics, Yearly Loss of life and Protect Americans from Chemical Killers and Against Gangs Effectively Act or the STOP FENTANYL PACKAGE . 2. Liability protections for opioid overdose reversal drugs (a) Definitions In this section: (1) First responder The term first responder means— (A) a first responder as defined in section 3025 of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10705 ); or (B) a special agent or task force officer of the Drug Enforcement Administration. (2) Health care provider The term health care provider has the meaning given such term in section 101 of the Family and Medical Leave Act of 1993 ( 29 U.S.C. 2611 ). (3) Lay administrator The term lay administrator — (A) means— (i) an individual at risk of undergoing an opioid-related overdose; (ii) an individual in a position to assist an individual at risk of undergoing an opioid-related overdose, including a family member or friend of such an individual at risk; or (iii) an employee or volunteer of a community-based organization; and (B) excludes a first responder as defined in paragraph (1). (4) Opioid overdose reversal drug The term opioid overdose reversal drug means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) that is designed to rapidly reverse the effects of an opioid-related overdose. (b) Health care providers (1) Authority (A) In general A health care provider, engaged in or affecting interstate or foreign commerce, may, subject to subparagraphs (B) and (C), prescribe, dispense, or distribute an opioid overdose reversal drug to— (i) an individual at risk of undergoing an opioid-related overdose; or (ii) an individual who is in a position to assist an individual at such risk, including a family member or friend of such an individual at risk. (B) Education and training requirements Upon prescribing, dispensing, or distributing an opioid overdose reversal drug to any individual as described in subparagraph (A), a health care provider (or designated staff of such provider) shall provide to that individual (or, with respect an individual described in subparagraph (A)(i), a family member or caregiver of such individual as the health care provider determines appropriate) education and training that includes information on— (i) the importance of seeking medical care for the individual undergoing the opioid-related overdose immediately after the drug is administered; (ii) how to access substance use disorder treatment services; (iii) how the opioid overdose reversal drug operates to stop an opioid-related overdose; (iv) when the administration of the opioid overdose reversal drug is medically indicated; (v) how to properly administer the opioid overdose reversal drug and circumstances under which administration of the opioid overdose reversal drug is contraindicated; (vi) precautions, warnings, and potential reactions with respect to the opioid overdose reversal drug; (vii) techniques on how to recognize symptoms of an opioid-related overdose; (viii) standards and procedures for the storage of the drug; (ix) proper disposal of expired opioid overdose reversal drugs; and (x) emergency follow-up procedures. (C) Records A health care provider shall maintain a record of each individual to whom the health care provider (or designated staff) has provided the education and training under subparagraph (B). Each such record shall be maintained for a period of 2 years beginning on the date on which the health care provider (or designated staff) provides the education and training. (2) Liability (A) In general A health care provider, engaged in or affecting interstate or foreign commerce, shall be immune from civil liability, criminal prosecution, or disciplinary or other adverse action under any professional licensing statute for any outcomes resulting from— (i) an action taken by the provider that is authorized under paragraph (1); or (ii) the administration by a person other than the health care provider of the opioid overdose reversal drug to an individual regardless of whether that individual is the person to whom the provider prescribed the drug. (B) Exception Subparagraph (A) shall not apply in the case that personal injury results from the gross negligence or willful or wanton misconduct of the health care provider. (c) First responders (1) Authority (A) In general A first responder, engaged in or affecting interstate or foreign commerce, may, subject to subparagraphs (B) and (C), receive a prescription or supply allocation for an opioid overdose reversal drug (including through a standing order), maintain the drug in the possession of the first responder, administer the drug to any individual who is undergoing or whom the responder believes is undergoing an opioid-related overdose, or distribute the drug to an individual described in clause (i) or (ii) of subsection (b)(1)(A). (B) Education and training requirements (i) In general Prior to receiving a prescription or supply allocation for an opioid overdose reversal drug as described in subparagraph (A), a first responder shall— (I) complete the education and training provided by a health care provider (or designated staff) under subsection (b)(1)(B); or (II) review the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration (or a successor publication), or a substantially similar publication from the applicable State public health agency. (ii) Renewals The requirement under clause (i) to complete the education and training or review the toolkit described in such clause shall be completed not less than once every 2 years. (C) Records A first responder shall maintain— (i) a record of each instance in which the first responder administers or distributes an opioid overdose reversal drug in accordance with subparagraph (A) for a period of 2 years beginning on the date on which the first responder administers or distributes the drug; and (ii) verification that the first responder has complied with the requirements under subparagraph (B) for a period of 2 years following each completion or review described in such subparagraph. (2) Liability (A) In general A first responder who takes any action authorized under paragraph (1) shall be immune from civil liability, criminal prosecution, or disciplinary or other adverse action under any professional licensing statute for any outcomes resulting from such action. (B) Exception Subparagraph (A) shall not apply in the case that personal injury results from the gross negligence or willful or wanton misconduct of the first responder. (d) Lay administrators (1) Authority (A) In general A lay administrator, engaged in or affecting interstate or foreign commerce, may, subject to subparagraphs (B) and (C), receive a prescription for an opioid overdose reversal drug (including through a standing order), maintain the drug in the possession of the lay administrator, and administer the drug to— (i) in the case of a lay administrator described in subsection (a)(3)(A)(i), the lay administrator; (ii) in the case of a lay administrator described in subsection (a)(3)(A)(ii), the individual at risk described in such subsection; or (iii) in the case of a lay administrator described in subsection (a)(3)(A)(iii), any individual who is undergoing, or who is believed to be undergoing an opioid-related overdose, and is being served through the organization described in such subsection. (B) Education and training requirements (i) In general Prior to receiving a prescription for an opioid overdose reversal drug as described in subparagraph (A), a lay administrator shall— (I) complete the education and training provided by a health care provider (or designated staff) under subsection (b)(1)(B); or (II) review the Opioid Overdose Prevention Toolkit published by the Substance Abuse and Mental Health Services Administration (or a successor publication), or a substantially similar publication from the applicable State public health agency. (ii) Renewals The requirement under clause (i) to complete the education and training or review the toolkit described in such clause shall be completed not less than once every 2 years. (C) Records A lay administrator shall maintain verification that the lay administrator has complied with the requirements under subparagraph (B) for a period of 2 years following each completion or review described in such subparagraph. (2) Liability (A) In general A lay administrator who takes any action authorized under paragraph (1) shall be immune from civil liability, criminal prosecution, or disciplinary or other adverse action under any professional licensing statute (including any penalties for the unauthorized practice of medicine) for any outcomes resulting from such action. (B) Exception Subparagraph (A) shall not apply in the case that personal injury results from the gross negligence or willful or wanton misconduct of the lay administrator. (3) Sense of Congress It is the sense of Congress that a lay administrator should— (A) call 9–1–1 immediately following administering an opioid overdose reversal drug to an individual as described in paragraph (1)(A); and (B) report to a first responder— (i) the name, address, and phone number of any individual for whom the opioid overdose reversal drug was administered as described in such paragraph; and (ii) the status as an injection or spray of the opioid overdose reversal drug used in such administration. (e) Preemption This section shall preempt any State law that conflicts with the authorities and protections provided under this section, except in the case of a State law that provides greater protection from liability than the protection provided under this section. (f) Sunset This section shall cease to have any force or effect on the date that is 90 days after the last day of the public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ) with respect to the opioid crisis, including any renewal of such emergency. 3. Accurate data on opioid-related overdoses The Secretary of Health and Human Services and the Attorney General may award grants to States, territories, and localities to support improved data and surveillance on opioid-related overdoses, including for activities to improve postmortem toxicology testing, data linkage across data systems throughout the United States, electronic death reporting, or the comprehensiveness of data on fatal and nonfatal opioid-related overdoses. 4. Law enforcement grants (a) In general The Attorney General shall make grants to local law enforcement agencies and forensic laboratories in communities with high rates of drug overdoses for the purpose of— (1) training to help officers identify overdoses; (2) upgrading essential systems for tracing drugs and processing samples in forensic laboratories to provide timely, accurate, and standard data reporting to the National Forensic Laboratory Information System; or (3) training to better trace criminals through the darknet. (b) Mandatory reporting None of the funds made under subsection (a) may be used by grantees that do not submit to the National Forensic Laboratory Information System reports on overdose data. (c) Federal Law Enforcement Training Centers Federal Law Enforcement Training Centers shall provide training to State and local law enforcement agencies on how to best coordinate with State and Federal partners for tracking drug-related activity. (d) COPS grants Section 1701(b) of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10381 ) is amended— (1) in paragraph (22), by striking and at the end; (2) in paragraph (23), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (24) to provide training and resources for containment devices to prevent secondary exposure to fentanyl and other substances for first responders. . 5. Office of National Drug Control Policy reform (a) Senses of Congress It is the sense of Congress that— (1) the Director of the Office of National Drug Control Policy shall be a Cabinet-level position; and (2) nothing in this section shall affect the reporting structure of agencies with drug enforcement responsibilities. (b) Requirements The Office of National Drug Control Policy shall— (1) document strategies for ensuring prevention of duplicating services and grant funding within National Drug Control Program agencies; (2) collaborate with the National Center for Health Statistics and the National Forensic Laboratory Information System, including by working with the Department of Justice to create national standards for submission data to ensure uniformity across the United States, including data from cases where the defendant pleads guilty; and (3) issue guidance that States and localities should record overdose deaths as homicides if there is sufficient evidence that the overdose was not self-induced and intentional. (c) Drug Enforcement Administration (1) In general The Drug Enforcement Administration shall develop uniform reporting standards for inputting data into the National Forensic Laboratory Information System for purity, formulation, and weight to allow for better comparison across jurisdictions and between agencies and the sharing of data. (2) Clarification Nothing in paragraph (1) may be construed to require the creation of new or increased obligations or reporting requirements on State or local laboratories. (d) Interagency Coordinating Council The Office of National Drug Control Policy, the Department of Justice, the Department of Health and Human Services, and other National Drug Control Program agencies coordinate across agencies to limit duplication and ensure uniform reporting standards and improve relationships between the agencies. (e) Congressional Review Act If the Office of National Drug Control Policy does not certify that a final rule made by a National Drug Control Program participant is consistent with the National Drug Control Policy, the rule shall be deemed to be submitted under section 801(a)(1) of title 5, United States Code. (f) Reprogramming and transfer requests Section 704(c)(4)(A) of the National Drug Control Policy Reauthorization Act of 1998 ( 21 U.S.C. 1703(c)(4)(A) ) is amended by striking approved and inserting denied . 6. DEA testing The Drug Enforcement Administration shall submit to Congress, as part of the annual budget process, a specific line item for the level of funding necessary for the Fentanyl Profiling Program. 7. State Opioid Response Grants The Assistant Secretary for Mental Health and Substance Use shall, to the extent practicable— (1) include in the annual report to Congress on the State Opioid Response Grants, authorized under the Consolidated Appropriations Act, 2022 ( Public Law 117–103 ), an assessment of challenges of recipients of such grants, accounting for variations in implementation; and (2) provide to recipients of such grants best practices on how to address opioid-related overdoses.