One Hundred Sixteenth Congress of the United States of America 2d Session Begun and held at the City of Washington on Friday, the third day of January, two thousand and twenty S. 3201 IN THE SENATE OF THE UNITED STATES AN ACT To extend the temporary scheduling order for fentanyl-related substances, and for other purposes.

1. Short title This Act may be cited as the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act . 2. Extension of temporary order for fentanyl-related substances Notwithstanding any other provision of law, section 1308.11(h)(30) of title 21, Code of Federal Regulations, shall remain in effect until May 6, 2021. 3. Study and report on impacts of classwide scheduling (a) Definition In this section, the term fentanyl-related substance has the meaning given the term in section 1308.11(h)(30)(i) of title 21, Code of Federal Regulations. (b) GAO report The Comptroller General of the United States shall— (1) conduct a study of the classification of fentanyl-related substances as schedule I controlled substances under the Controlled Substances Act ( 21 U.S.C. 801 et seq.), research on fentanyl-related substances, and the importation of fentanyl-related substances into the United States; and (2) not later than 1 year after the date of enactment of this Act, submit a report on the results of the study conducted under paragraph (1) to— (A) the Committee on the Judiciary of the Senate; (B) the Committee on Health, Education, Labor, and Pensions of the Senate; (C) the Caucus on International Narcotics Control of the Senate; (D) the Committee on the Judiciary of the House of Representatives; and (E) the Committee on Energy and Commerce of the House of Representatives. (c) Requirements The Comptroller General, in conducting the study and developing the report required under subsection (b), shall— (1) evaluate class control of fentanyl-related substances, including— (A) the definition of the class of fentanyl-related substances in section 1308.11(h)(30)(i) of title 21, Code of Federal Regulations, including the process by which the definition was formulated; (B) the potential for classifying fentanyl-related substances with no, or low, abuse potential, or potential accepted medical use, as schedule I controlled substances when scheduled as a class; and (C) any known classification of fentanyl-related substances with no, or low, abuse potential, or potential accepted medical use, as schedule I controlled substances that has resulted from the scheduling action of the Drug Enforcement Administration that added paragraph (h)(30) to section 1308.11 of title 21, Code of Federal Regulations; (2) review the impact or potential impact of controls on fentanyl-related substances on public health and safety, including on— (A) diversion risks, overdose deaths, and law enforcement encounters with fentanyl-related substances; and (B) Federal law enforcement investigations and prosecutions of offenses relating to fentanyl-related substances; (3) review the impact of international regulatory controls on fentanyl-related substances on the supply of such substances to the United States, including by the Government of the People’s Republic of China; (4) review the impact or potential impact of screening and other interdiction efforts at points of entry into the United States on the importation of fentanyl-related substances into the United States; (5) recommend best practices for accurate, swift, and permanent control of fentanyl-related substances, including— (A) how to quickly remove from the schedules under the Controlled Substances Act substances that are determined, upon discovery, to have no abuse potential; and (B) how to reschedule substances that are determined, upon discovery, to have a low abuse potential or potential accepted medical use; (6) review the impact or potential impact of fentanyl-related controls by class on scientific and biomedical research; and (7) evaluate the processes used to obtain or modify Federal authorization to conduct research with fentanyl-related substances, including by— (A) identifying opportunities to reduce unnecessary burdens on persons seeking to research fentanyl-related substances; (B) identifying opportunities to reduce any redundancies in the responsibilities of Federal agencies; (C) identifying opportunities to reduce any inefficiencies related to the processes used to obtain or modify Federal authorization to conduct research with fentanyl-related substances; (D) identifying opportunities to improve the protocol review and approval process conducted by Federal agencies; and (E) evaluating the degree, if any, to which establishing processes to obtain or modify a Federal authorization to conduct research with a fentanyl-related substance that are separate from the applicable processes for other schedule I controlled substances could exacerbate burdens or lead to confusion among persons seeking to research fentanyl-related substances or other schedule I controlled substances. (d) Input from certain Federal agencies In conducting the study and developing the report under subsection (b), the Comptroller General shall consider the views of the Department of Health and Human Services and the Department of Justice. (e) Information from Federal agencies Each Federal department or agency shall, in accordance with applicable procedures for the appropriate handling of classified information, promptly provide reasonable access to documents, statistical data, and any other information that the Comptroller General determines is necessary to conduct the study and develop the report required under subsection (b). (f) Input from certain non-Federal entities In conducting the study and developing the report under subsection (b), the Comptroller General shall consider the views of experts from certain non-Federal entities, including experts from— (1) the scientific and medical research community; (2) the State and local law enforcement community; and (3) the civil rights and criminal justice reform communities.

Speaker of the House of Representatives Vice President of the United States and President of the Senate