TEST Act

II 118TH CONGRESS 1ST SESSION S. 1950 To extend the temporary order for fentanyl-related substances. IN THE SENATE OF THE UNITED STATES JUNE 13, 2023 Mr. BOOKER introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To extend the temporary order for fentanyl-related substances. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Temporary Emergency 4 Scheduling and Testing of Fentanyl Analogues Act of 5 2023’’ or the ‘‘TEST Act’’. 6 SEC. 2. FINDINGS. 7 Congress finds the following: 8 (1) Passed in 1970, the Controlled Substances 9 Act (21 U.S.C. 801 et seq.) created 5 schedules for 10 controlled substances. To schedule a substance, the 11 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1950 IS Drug Enforcement Administration must make a 1 finding of the potential for abuse and currently ac- 2 cepted medical use of the substance. 3 (2) Under section 201(b) of the Controlled Sub- 4 stances Act (21 U.S.C. 811(b)), the Attorney Gen- 5 eral must request a scheduling recommendation 6 from the Secretary of Health and Human Services 7 based on an 8-factor medical and scientific analysis. 8 (3) The Secretary is required to return a rec- 9 ommendation to the Attorney General within a rea- 10 sonable amount of time and the recommendation 11 shall be binding on the Attorney General as to sci- 12 entific and medical matters. 13 (4) The scientific and medical evaluation con- 14 ducted by the Secretary is necessary to understand 15 the characteristics of any substance, including 16 whether the substance may be harmful, harmless, or 17 have potential medical uses. 18 (5) Since October 2016, the Drug Enforcement 19 Administration has identified 36 fentanyl-related 20 substances to be scheduled pursuant to section 21 201(b) of the Controlled Substances Act (21 U.S.C. 22 811(b)). 23 (6) As of April 2023, of the 36 fentanyl-related 24 substances described in paragraph (5), 24 have been 25 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1950 IS subjected to scientific and medical analysis. There 1 remain 12 fentanyl-related substances for which the 2 Drug Enforcement Administration has yet to begin 3 or complete a scientific medical evaluation. 4 (7) In the midst of the fentanyl crisis that is 5 ravaging communities across the United States, it is 6 imperative that the Federal Government analyze and 7 study fentanyl-related substances expeditiously and 8 that the scientific community be able to research 9 these substances in order to develop life-saving anti- 10 dotes and treatments. The most promising life-sav- 11 ing antidotes and treatments for fentanyl addiction 12 and overdose are likely to share molecular properties 13 with fentanyl and its related substances. 14 SEC. 3. DEFINITIONS. 15 In this Act: 16 (1) EVALUATION.—The term ‘‘evaluation’’ 17 means a scientific and medical evaluation, as con- 18 ducted by the Secretary of Health and Human Serv- 19 ices at the request of the Attorney General, and the 20 recommendations as to whether such drug or other 21 substance should be so controlled or removed as a 22 controlled substance from the schedules pursuant to 23 section 201(b) of the Controlled Substances Act (21 24 U.S.C. 811(b)). 25 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 1950 IS (2) FENTANYL-RELATED SUBSTANCE.—The 1 term ‘‘fentanyl-related substance’’ has the meaning 2 given the term in section 1308.11 of title 21, Code 3 of Federal Regulations. 4 SEC. 4. EVALUATION OF ENCOUNTERED FENTANYL-RE- 5 LATED SUBSTANCES. 6 (a) IDENTIFIED SUBSTANCES.— 7 (1) IN GENERAL.—The Attorney General shall 8 complete the proceedings to schedule or transfer be- 9 tween schedules, or remove any fentanyl-related sub- 10 stances from the schedules pursuant to subsection 11 (k) of section 201 of the Controlled Substances Act 12 (21 U.S.C. 811), as added by section 5 of this Act— 13 (A) not later than 1 year after the date of 14 enactment of this Act for each fentanyl-related 15 substance that— 16 (i) the Drug Enforcement Administra- 17 tion has identified, as of the date of enact- 18 ment of this Act; and 19 (ii) is not permanently scheduled; and 20 (B) not later than 3 years after the date 21 on which a fentanyl-related substance is identi- 22 fied if the fentanyl-related substance— 23 (i) is identified after the date of en- 24 actment of this Act; and 25 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 1950 IS (ii) is not permanently scheduled. 1 (2) EXTENSION.—If the Attorney General is 2 unable to complete the proceedings described in 3 paragraph (1) within the required time period the 4 Attorney General shall— 5 (A) notify the Committee on the Judiciary 6 of the Senate and the Committee on the Judici- 7 ary of the House of Representatives of the 8 delay and publish the notification on a public 9 website; and 10 (B) complete the proceedings described in 11 paragraph (1) not later than 1 year after the 12 notification required under subparagraph (A) of 13 this paragraph. 14 (b) TEMPORARY SCHEDULING.—Notwithstanding 15 any other provision of law, the Attorney General may 16 schedule a fentanyl-related substance identified after the 17 date of enactment of this Act in schedule I of section 18 202(c) of the Controlled Substances Act (21 U.S.C. 19 812(c)) in accordance with section 201(h) of that Act (21 20 U.S.C. 811(h)) for not longer than 3 years after the date 21 on which the order scheduling the fentanyl-related sub- 22 stance is issued. 23 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 1950 IS SEC. 5. REMOVAL FROM SCHEDULE I OF FENTANYL-RE- 1 LATED SUBSTANCES. 2 Section 201 of the Controlled Substances Act (21 3 U.S.C. 811) is amended by adding at the end the following 4 new subsection: 5 ‘‘(k) DETERMINATION RESULTING IN REMOVAL.— 6 ‘‘(1) IN GENERAL.—If the Secretary deter- 7 mines, taking into consideration factors as set forth 8 in paragraph (3), that a fentanyl-related substance 9 has a potential for abuse that is less than the drugs 10 or other substances in schedule V— 11 ‘‘(A) the Secretary shall submit to the At- 12 torney General a scientific and medical evalua- 13 tion of that fentanyl-related substance sup- 14 porting that determination; 15 ‘‘(B) the Secretary shall submit any such 16 evaluation and determination in writing and in- 17 clude the bases therefor; 18 ‘‘(C) the scientific and medical determina- 19 tion of the Secretary contained in such evalua- 20 tion shall be binding on the Attorney General; 21 and 22 ‘‘(D) not later than 90 days after receiving 23 such evaluation and determination, the Attor- 24 ney General shall issue an order removing such 25 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 1950 IS fentanyl-related substance from the schedules 1 under section 202. 2 ‘‘(2) DETERMINATION RESULTING IN RESCHED- 3 ULING.—If the Secretary determines, taking into 4 consideration factors as set forth in paragraph (3), 5 that a fentanyl-related substance has a potential for 6 abuse that is less than the drugs or other substances 7 in schedules I and II— 8 ‘‘(A) the Secretary shall submit to the At- 9 torney General a scientific and medical evalua- 10 tion of that fentanyl-related substance sup- 11 porting that determination; 12 ‘‘(B) the Secretary shall submit any such 13 evaluation and determination in writing and in- 14 clude the bases therefor; 15 ‘‘(C) the scientific and medical determina- 16 tion of the Secretary contained in such evalua- 17 tion shall be binding on the Attorney General; 18 and 19 ‘‘(D) not later than 90 days after receiving 20 such evaluation, the Attorney General shall 21 issue an order removing such fentanyl-related 22 substance from schedule I and controlling such 23 substance under schedule III, IV, or V. 24 ‘‘(3) EVALUATION FACTORS.— 25 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •S 1950 IS ‘‘(A) IN GENERAL.—In making a deter- 1 mination under paragraph (1) or (2), the Sec- 2 retary— 3 ‘‘(i) shall consider— 4 ‘‘(I) the factor listed in para- 5 graph (2) of subsection (c); 6 ‘‘(II) the factors listed in para- 7 graphs (1), (3), and (6) of such sub- 8 section to the extent evidence exists 9 with respect to such factors; and 10 ‘‘(III) any information submitted 11 to the Secretary by the Attorney Gen- 12 eral for purposes of such determina- 13 tion; and 14 ‘‘(ii) may consider the factors listed in 15 paragraphs (4), (5), and (7) of subsection 16 (c) if the Secretary finds that evidence ex- 17 ists with respect to such factors. 18 ‘‘(B) CONSIDERATION OF SCIENTIFIC EVI- 19 DENCE OF PHARMACOLOGICAL EFFECT.— 20 ‘‘(i) IN GENERAL.—For the purposes 21 of subparagraph (A)(i)(I), consideration by 22 the Secretary of the results of an assess- 23 ment consisting of the studies described in 24 clause (ii) shall constitute consideration of 25 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •S 1950 IS the factor listed in paragraph (2) of sub- 1 section (c) if— 2 ‘‘(I) each such study is per- 3 formed according to scientific methods 4 and protocols commonly accepted in 5 the scientific community; and 6 ‘‘(II) the Secretary determines 7 that such assessment is adequate for 8 such purposes. 9 ‘‘(ii) DESCRIBED STUDIES.—The 10 studies described in this clause include the 11 following: 12 ‘‘(I) A receptor binding study 13 that can demonstrate whether the 14 substance has affinity for the human 15 mu opioid receptor. 16 ‘‘(II) An in vitro functional assay 17 that can demonstrate whether the 18 substance has agonist activity at the 19 human mu opioid receptor. 20 ‘‘(III) One or more in vivo ani- 21 mal behavioral studies that can dem- 22 onstrate whether the substance has 23 abuse-related drug effects consistent 24 with mu opioid agonist activity, such 25 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •S 1950 IS as demonstrating similarity to the ef- 1 fects of morphine. 2 ‘‘(l) PUBLICATION.— 3 ‘‘(1) IN GENERAL.—The Secretary shall publish 4 on a public website— 5 ‘‘(A) information related to each evaluation 6 conducted pursuant to subsection (k)(3) within 7 60 days of the completion of the scientific and 8 medical evaluation, even if such evaluation did 9 not result in a descheduling or rescheduling de- 10 termination; and 11 ‘‘(B) the results and any other information 12 related to previously evaluated fentanyl-related 13 services pursuant to subsection (l). 14 ‘‘(2) APPLICABILITY.—Paragraph (1) shall not 15 apply to an evaluation conducted for an application 16 for a new drug under section 505 of the Federal 17 Food, Drug, and Cosmetic Act (21 U.S.C. 355). 18 ‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—There 19 is authorized to be appropriated to the Secretary 20 $50,000,000 for fiscal years 2023 and 2024, to remain 21 available until expended, for the evaluation fentanyl-re- 22 lated substances pursuant to this section.’’. 23 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •S 1950 IS SEC. 6. REGISTRATION REQUIREMENTS RELATED TO RE- 1 SEARCH. 2 (a) ALTERNATIVE REGISTRATION PROCESS FOR 3 SCHEDULE I RESEARCH.—Section 303 of the Controlled 4 Substances Act (21 U.S.C. 823) is amended— 5 (1) by redesignating the second subsection (l) 6 (relating to required training for prescribers) as sub- 7 section (m); and 8 (2) by adding at the end the following: 9 ‘‘(n) SPECIAL PROVISIONS FOR PRACTITIONERS 10 CONDUCTING CERTAIN RESEARCH WITH SCHEDULE I 11 CONTROLLED SUBSTANCES.— 12 ‘‘(1) IN GENERAL.—Notwithstanding subsection 13 (f), a practitioner may conduct research described in 14 paragraph (2) of this subsection with 1 or more 15 schedule I substances in accordance with subpara- 16 graph (A) or (B) of paragraph (3) of this sub- 17 section. 18 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO- 19 CEDURES.—Research described in this paragraph is 20 research that— 21 ‘‘(A) is with respect to a drug that is the 22 subject of an investigational use exemption 23 under section 505(i) of the Federal Food, Drug, 24 and Cosmetic Act (21 U.S.C. 355(i)); or 25 ‘‘(B) is— 26 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 12 •S 1950 IS ‘‘(i) conducted by the Department of 1 Health and Human Services, the Depart- 2 ment of Defense, or the Department of 3 Veterans Affairs; or 4 ‘‘(ii) funded partly or entirely by a 5 grant, contract, cooperative agreement, or 6 other transaction from the Department of 7 Health and Human Services, the Depart- 8 ment of Defense, or the Department of 9 Veterans Affairs. 10 ‘‘(3) EXPEDITED PROCEDURES.— 11 ‘‘(A) RESEARCHER WITH A CURRENT 12 SCHEDULE I OR II RESEARCH REGISTRATION.— 13 ‘‘(i) IN GENERAL.—If a practitioner is 14 registered to conduct research with a con- 15 trolled substance in schedule I or II, the 16 practitioner may conduct research under 17 this subsection on and after the date that 18 is 30 days after the date on which the 19 practitioner sends a notice to the Attorney 20 General containing the following informa- 21 tion, with respect to each substance with 22 which the practitioner will conduct the re- 23 search: 24 VerDate Sep 11 2014 23:08 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1950.IS S1950 pbinns on DSKJLVW7X2PROD with $$_JOB 13 •S 1950 IS ‘‘(I) The chemical name of the 1 substance. 2 ‘‘(II) The quantity of the sub- 3 stance to be used in the research. 4 ‘‘(III) Demonstration that the re- 5 search is in the category described in 6 paragraph (2), which demonstration 7 may be satisfied— 8 ‘‘(aa) in the case of a grant, 9 contract, cooperative agreement, 10 or other transaction, or intra- 11 mural research [Text truncated for display. 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