TEST Act of 2022

To extend the temporary order for fentanyl-related substances. 1. Short title This Act may be cited as the Temporary Emergency Scheduling and Testing of Fentanyl Analogues Act of 2022 TEST Act of 2022 2. Definitions In this Act: (1) Evaluation The term evaluation 21 U.S.C. 811(b) (2) Fentanyl-related substance The term fentanyl-related substance 3. Extension of temporary order for fentanyl-related substances Section 2 of the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act ( Public Law 116–114 December 31, 2022 2 years after the date of enactment of the Temporary Emergency Scheduling and Testing of Fentanyl Analogues Act of 2022 4. Evaluation of encountered fentanyl-related substances (a) Synthetic compound Not later than 1 year after the date of enactment of this Act, for each fentanyl-related substance that the Attorney General has encountered before the date of enactment of this Act, but not yet conducted an evaluation, the Attorney General shall create a synthetic compound of that substance and submit the compound to the Secretary of Health and Human Services in order to solicit a scientific and medical evaluation of that compound from the Secretary. (b) Deadline (1) In general Except as provided in paragraph (2), the Secretary of Health and Human Services shall complete the requested scientific and medical evaluation under subsection (a) not later than 1 year after receiving the solicitation from the Attorney General. (2) Extension If the Attorney General is unable to create a synthetic compound before the expiration of the 1-year period described in paragraph (1)— (A) the Attorney General shall— (i) notify the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives of the delay and publish the notification on a public website; and (ii) complete the requirements under subsection (a) not later than 180 days after the expiration of the 1-year period. 5. Removal from schedule I of fentanyl-related substances Section 201 of the Controlled Substances Act ( 21 U.S.C. 811 (k) Determination resulting in removal (1) In general If the Secretary determines, taking into consideration factors as set forth in paragraph (3), that a fentanyl-related substance has a potential for abuse that is less than the drugs or other substances in schedule V— (A) the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination; (B) the Secretary shall submit any such evaluation and determination in writing and include the bases therefor; (C) the scientific and medical determination of the Secretary contained in such evaluation shall be binding on the Attorney General; and (D) not later than 90 days after receiving such evaluation and determination, the Attorney General shall issue an order removing such fentanyl-related substance from the schedules under section 202. (2) Determination resulting in rescheduling If the Secretary determines, taking into consideration factors as set forth in paragraph (3), that a fentanyl-related substance has a potential for abuse that is less than the drugs or other substances in schedules I and II— (A) the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination; (B) the Secretary shall submit any such evaluation and determination in writing and include the bases therefor; (C) the scientific and medical determination of the Secretary contained in such evaluation shall be binding on the Attorney General; and (D) not later than 90 days after receiving such evaluation, the Attorney General shall issue an order removing such fentanyl-related substance from schedule I and controlling such substance under schedule III, IV or V. (3) Evaluation factors (A) In general In making a determination under paragraph (1) or (2), the Secretary— (i) shall consider— (I) the factor listed in paragraph (2) of subsection (c); (II) the factors listed in paragraphs (1), (3), and (6) of such subsection to the extent evidence exists with respect to such factors; and (III) any information submitted to the Secretary by the Attorney General for purposes of such determination; and (ii) may consider the factors listed in paragraphs (4), (5), and (7) of subsection (c) if the Secretary finds that evidence exists with respect to such factors. (B) Consideration of scientific evidence of pharmacological effect (i) In general For the purposes of subparagraph (A)(i)(I), consideration by the Secretary of the results of an assessment consisting of the studies described in clause (ii) shall constitute consideration of the factor listed in paragraph (2) of subsection (c) if— (I) each such study is performed according to scientific methods and protocols commonly accepted in the scientific community; and (II) the Secretary determines that such assessment is adequate for such purposes. (ii) Described studies The studies described in this clause are any of the following: (I) A receptor binding study that can demonstrate whether the substance has affinity for the human mu opioid receptor. (II) An in vitro functional assay that can demonstrate whether the substance has agonist activity at the human mu opioid receptor. (III) One or more in vivo animal behavioral studies that can demonstrate whether the substance has abuse-related drug effects consistent with mu opioid agonist activity, such as demonstrating similarity to the effects of morphine. (l) Previously analyzed fentanyl-Related substances To the extent that the Drug Enforcement Administration or the Department of Health and Human Services has conducted any evaluation or analysis (even if such analysis is not an evaluation under this section) of any fentanyl-related substance before the date of the enactment of this subsection, the Attorney General shall publish the results and any other information related to the evaluation or analysis on a public website not later than 90 days after the date of enactment of this subsection. (m) Fentanyl-Related substances research capacity The Drug Enforcement Administration and Department of Health and Human Services shall hire, employ, or retain the staff, researchers, and other qualified individuals necessary to carry out the requirements of paragraphs (1) and (2) of subsection (k), including, if appropriate to fulfill those requirements, establishing a consortium of chemists and researchers who may be readily hired, employed, or retrained without a request for proposals. (n) Evaluations or studies The Secretary may enter into contracts or other agreements to conduct or support evaluations or studies of fentanyl-related substances. (o) Registration requirements for research applications Registration requirements for the research of fentanyl-related substances shall be those applicable to schedule II substances pursuant to section 1301.13 of title 21, Code of Federal Regulations. (p) Publication The Secretary shall publish on a public website— (1) each evaluation conducted pursuant to an Attorney General solicitation within 60 days of the completion of the scientific and medical evaluation, even if such evaluation did not result in a descheduling or rescheduling determination; and (2) the results and any other information related to previously evaluated fentanyl-related services pursuant to subsection (l). (q) Authorization of appropriations There is authorized to be appropriated to the Secretary $50,000,000 for fiscal years 2023 and 2024, to remain available until expended, for the evaluation fentanyl-related substances pursuant to section 3 of the Temporary Emergency Scheduling and Testing of Fentanyl Analogues Act of 2022 . 6. Notification The Attorney General shall notify each individual who is the subject of a pending prosecution for, or has been convicted or sentenced for, an offense involving a fentanyl-related substance that is subsequently removed or rescheduled under paragraphs (1) and (2) of section 201(k) of the Controlled Substances Act, as added by section 5 of this Act, about the change in schedule designation not later than 90 days after the change, and provide information about the effect of the change on their prosecution, conviction, or sentence.

Summary: Temporary Emergency Scheduling and Testing of Fentanyl Analogues Act of 2022 or the TEST Act of 2022 This bill (1) extends the temporary scheduling of fentanyl-related substances in schedule I of the Controlled Substances Act for two years; (2) requires the Drug Enforcement Administration to submit synthetic compounds of fentanyl-related substances it has encountered thus far to the Food and Drug Administration for scientific and medical evaluations, if they have not yet been evaluated; and (3) provides for the removal and rescheduling of fentanyl-related substances from schedule I if certain criteria are met, as well as notifications about any such scheduling changes to individuals who were or are being prosecuted for offenses related to such substances.