Sec. 5. Removal from schedule I of fentanyl-related substances
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/bill/117/s/5167/is/section-5·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 201 of the Controlled Substances Act ( 21 U.S.C. 811 ) is amended by adding at the end the following new subsection: 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— the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination; the Secretary shall submit any such evaluation and determination in writing and include the bases therefor; the scientific and medical determination of the Secretary contained in such evaluation shall be binding on the Attorney General; and 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.
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— the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination; the Secretary shall submit any such evaluation and determination in writing and include the bases therefor; the scientific and medical determination of the Secretary contained in such evaluation shall be binding on the Attorney General; and 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.
In making a determination under paragraph
(1)or (2), the Secretary— shall consider— the factor listed in paragraph
(2)of subsection (c); the factors listed in paragraphs (1), (3), and
(6)of such subsection to the extent evidence exists with respect to such factors; and any information submitted to the Secretary by the Attorney General for purposes of such determination; and 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. 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— each such study is performed according to scientific methods and protocols commonly accepted in the scientific community; and the Secretary determines that such assessment is adequate for such purposes. The studies described in this clause are any of the following: A receptor binding study that can demonstrate whether the substance has affinity for the human mu opioid receptor. An in vitro functional assay that can demonstrate whether the substance has agonist activity at the human mu opioid receptor. 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. 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. 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. The Secretary may enter into contracts or other agreements to conduct or support evaluations or studies of fentanyl-related substances. 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. The Secretary shall publish on a public website— 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 the results and any other information related to previously evaluated fentanyl-related services pursuant to subsection (l). 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 . .
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Sec. 5
Removal from schedule I of fentanyl-related substances
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