Removal from schedule I of fentanyl-related substances

Section 201 of the Controlled Substances Act (21 U.S.C. 811) is amended by adding at the end the following new subsection: (k) Removal from schedule I of fentanyl-Related substances (1) Determination resulting in removal 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. (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 suffice to 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. (4) Advance notice regarding evaluation and conclusion The Secretary shall give the Attorney General at least 30 days notice before sending the Attorney General an evaluation and determination under paragraph (1) or (2) with respect to a fentanyl-related substance. (5) Exception for treaty obligations If a fentanyl-related substance is a substance that the United States is obligated to control under international treaties, conventions, or protocols in effect on the date of enactment of the Save Americans from the Fentanyl Emergency Act, this subsection shall not require the Attorney General— (A) to remove such substance from control; or (B) to place such substance in a schedule less restrictive than that which the Attorney General determines is necessary to carry out such obligations. (6) Identification of fentanyl-related substances If the Attorney General or any official of the Department of Justice determines that a substance is a fentanyl-related substance, the Attorney General shall— (A) within 30 days of such determination, notify the Secretary; and (B) include in such notification the identity of the substance, its structure, and the basis for the determination. (7) Petitions for removing a fentanyl-related substance (A) In general If a person petitions the Attorney General to remove a fentanyl-related substance from schedule I(e) or to reschedule such a substance to another schedule, the Attorney General shall consider such a petition in accordance with the procedures and standards set forth in— (i) subsections (a) and (b) of this section; and (ii) section 1308.43 of title 21, Code of Federal Regulations (or any successor regulations). (B) Attorney General to inform Secretary Within 30 days of receiving such a petition, the Attorney General shall forward a copy of the petition to the Secretary. (C) Determination procedure not precluded by filing of petition The filing of a petition under this paragraph shall not preclude the Secretary from making a determination and sending an evaluation under paragraph (1) or (2). (8) Rule of construction Nothing in this subsection shall be construed to preclude the Attorney General from transferring a substance listed in schedule I to another schedule, or removing such substance entirely from the schedules, pursuant to other provisions of this section and section 202. (9) Subsequent controlling of removed substance A substance removed from schedule I pursuant to this subsection may, at any time, be controlled pursuant to the other provisions of this section and section 202 without regard to the removal pursuant to this subsection. (10) Evaluations or studies The Secretary may enter into contracts or other agreements to conduct or support evaluations or studies of fentanyl-related substances. (11) Definition In this subsection, the term fentanyl-related substance means a fentanyl-related substance as defined in schedule I(e) of section 202(c)..