II 

117TH CONGRESS 

2D SESSION S. 5167 

To extend the temporary order for fentanyl-related substances. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 1, 2022 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Temporary Emergency 

5 Scheduling and Testing of Fentanyl Analogues Act of 

6 2022’’ or the ‘‘TEST Act of 2022’’. 

7 SEC. 2. DEFINITIONS. 

8 In this Act: 

9 (1) EVALUATION.—The term ‘‘evaluation’’ 

10 means a scientific and medical evaluation, as con11 ducted by the Secretary of Health and Human ServVerDate Sep 11 2014 22:18 Dec 06, 2022 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S5167.IS S5167

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1 ices at the request of the Attorney General, and the 

2 recommendations as to whether such drug or other 

3 substance should be so controlled or removed as a 

4 controlled substance from the schedules pursuant to 

5 section 201(b) of the Controlled Substances Act (21 

6 U.S.C. 811(b)). 

7 (2) FENTANYL-RELATED SUBSTANCE.—The 

8 term ‘‘fentanyl-related substance’’ has the meaning 

9 given the term in section 1308.11 of title 21, Code 

10 of Federal Regulations. 

11 SEC. 3. EXTENSION OF TEMPORARY ORDER FOR 

12 FENTANYL-RELATED SUBSTANCES. 

13 Section 2 of the Temporary Reauthorization and 

14 Study of the Emergency Scheduling of Fentanyl Ana15 logues Act (Public Law 116–114; 134 Stat. 103) is 

16 amended by striking ‘‘December 31, 2022’’ and inserting 

17 ‘‘2 years after the date of enactment of the Temporary 

18 Emergency Scheduling and Testing of Fentanyl Analogues 

19 Act of 2022’’. 

20 SEC. 4. EVALUATION OF ENCOUNTERED FENTANYL-RE21 LATED SUBSTANCES. 

22 (a) SYNTHETIC COMPOUND.—Not later than 1 year 

23 after the date of enactment of this Act, for each fentanyl24 related substance that the Attorney General has encoun25 tered before the date of enactment of this Act, but not 


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1 yet conducted an evaluation, the Attorney General shall 

2 create a synthetic compound of that substance and submit 

3 the compound to the Secretary of Health and Human 

4 Services in order to solicit a scientific and medical evalua5 tion of that compound from the Secretary. 

6 (b) DEADLINE.— 

7 (1) IN GENERAL.—Except as provided in para8 graph (2), the Secretary of Health and Human 

9 Services shall complete the requested scientific and 

10 medical evaluation under subsection (a) not later 

11 than 1 year after receiving the solicitation from the 

12 Attorney General. 

13 (2) EXTENSION.—If the Attorney General is 

14 unable to create a synthetic compound before the ex15 piration of the 1-year period described in paragraph 

16 (1)— 

17 (A) the Attorney General shall— 

18 (i) notify the Committee on the Judi19 ciary of the Senate and the Committee on 

20 the Judiciary of the House of Representa21 tives of the delay and publish the notifica22 tion on a public website; and 

23 (ii) complete the requirements under 

24 subsection (a) not later than 180 days 

25 after the expiration of the 1-year period. 


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1 SEC. 5. REMOVAL FROM SCHEDULE I OF FENTANYL-RE2 LATED SUBSTANCES. 

3 Section 201 of the Controlled Substances Act (21 

4 U.S.C. 811) is amended by adding at the end the following 

5 new subsection: 

6 ‘‘(k) DETERMINATION RESULTING IN REMOVAL.— 

7 ‘‘(1) IN GENERAL.—If the Secretary deter8 mines, taking into consideration factors as set forth 

9 in paragraph (3), that a fentanyl-related substance 

10 has a potential for abuse that is less than the drugs 

11 or other substances in schedule V— 

12 ‘‘(A) the Secretary shall submit to the At13 torney General a scientific and medical evalua14 tion of that fentanyl-related substance sup15 porting that determination; 

16 ‘‘(B) the Secretary shall submit any such 

17 evaluation and determination in writing and in18 clude the bases therefor; 

19 ‘‘(C) the scientific and medical determina20 tion of the Secretary contained in such evalua21 tion shall be binding on the Attorney General; 

22 and 

23 ‘‘(D) not later than 90 days after receiving 

24 such evaluation and determination, the Attor25 ney General shall issue an order removing such 


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1 fentanyl-related substance from the schedules 

2 under section 202. 

3 ‘‘(2) DETERMINATION RESULTING IN RESCHED4 ULING.—If the Secretary determines, taking into 

5 consideration factors as set forth in paragraph (3), 

6 that a fentanyl-related substance has a potential for 

7 abuse that is less than the drugs or other substances 

8 in schedules I and II— 

9 ‘‘(A) the Secretary shall submit to the At10 torney General a scientific and medical evalua11 tion of that fentanyl-related substance sup12 porting that determination; 

13 ‘‘(B) the Secretary shall submit any such 

14 evaluation and determination in writing and in15 clude the bases therefor; 

16 ‘‘(C) the scientific and medical determina17 tion of the Secretary contained in such evalua18 tion shall be binding on the Attorney General; 

19 and 

20 ‘‘(D) not later than 90 days after receiving 

21 such evaluation, the Attorney General shall 

22 issue an order removing such fentanyl-related 

23 substance from schedule I and controlling such 

24 substance under schedule III, IV or V. 

25 ‘‘(3) EVALUATION FACTORS.— 


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1 ‘‘(A) IN GENERAL.—In making a deter2 mination under paragraph (1) or (2), the Sec3 retary— 

4 ‘‘(i) shall consider— 

5 ‘‘(I) the factor listed in para6 graph (2) of subsection (c); 

7 ‘‘(II) the factors listed in para8 graphs (1), (3), and (6) of such sub9 section to the extent evidence exists 

10 with respect to such factors; and 

11 ‘‘(III) any information submitted 

12 to the Secretary by the Attorney Gen13 eral for purposes of such determina14 tion; and 

15 ‘‘(ii) may consider the factors listed in 

16 paragraphs (4), (5), and (7) of subsection 

17 (c) if the Secretary finds that evidence ex18 ists with respect to such factors. 

19 ‘‘(B) CONSIDERATION OF SCIENTIFIC EVI20 DENCE OF PHARMACOLOGICAL EFFECT.— 

21 ‘‘(i) IN GENERAL.—For the purposes 

22 of subparagraph (A)(i)(I), consideration by 

23 the Secretary of the results of an assess24 ment consisting of the studies described in 

25 clause (ii) shall constitute consideration of 


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1 the factor listed in paragraph (2) of sub2 section (c) if— 

3 ‘‘(I) each such study is per4 formed according to scientific methods 

5 and protocols commonly accepted in 

6 the scientific community; and 

7 ‘‘(II) the Secretary determines 

8 that such assessment is adequate for 

9 such purposes. 

10 ‘‘(ii) DESCRIBED STUDIES.—The 

11 studies described in this clause are any of 

12 the following: 

13 ‘‘(I) A receptor binding study 

14 that can demonstrate whether the 

15 substance has affinity for the human 

16 mu opioid receptor. 

17 ‘‘(II) An in vitro functional assay 

18 that can demonstrate whether the 

19 substance has agonist activity at the 

20 human mu opioid receptor. 

21 ‘‘(III) One or more in vivo ani22 mal behavioral studies that can dem23 onstrate whether the substance has 

24 abuse-related drug effects consistent 

25 with mu opioid agonist activity, such 


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1 as demonstrating similarity to the ef2 fects of morphine. 

3 ‘‘(l) PREVIOUSLY ANALYZED FENTANYL-RELATED

4 SUBSTANCES.—To the extent that the Drug Enforcement 

5 Administration or the Department of Health and Human 

6 Services has conducted any evaluation or analysis (even 

7 if such analysis is not an evaluation under this section) 

8 of any fentanyl-related substance before the date of the 

9 enactment of this subsection, the Attorney General shall 

10 publish the results and any other information related to 

11 the evaluation or analysis on a public website not later 

12 than 90 days after the date of enactment of this sub13 section. 

14 ‘‘(m) FENTANYL-RELATED SUBSTANCES RESEARCH

15 CAPACITY.—The Drug Enforcement Administration and 

16 Department of Health and Human Services shall hire, em17 ploy, or retain the staff, researchers, and other qualified 

18 individuals necessary to carry out the requirements of 

19 paragraphs (1) and (2) of subsection (k), including, if ap20 propriate to fulfill those requirements, establishing a con21 sortium of chemists and researchers who may be readily 

22 hired, employed, or retrained without a request for pro23 posals. 

24 ‘‘(n) EVALUATIONS OR STUDIES.—The Secretary 

25 may enter into contracts or other agreements to conduct 


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1 or support evaluations or studies of fentanyl-related sub2 stances. 

3 ‘‘(o) REGISTRATION REQUIREMENTS FOR RESEARCH

4 APPLICATIONS.—Registration requirements for the re5 search of fentanyl-related substances shall be those appli6 cable to schedule II substances pursuant to section 

7 1301.13 of title 21, Code of Federal Regulations. 

8 ‘‘(p) PUBLICATION.—The Secretary shall publish on 

9 a public website— 

10 ‘‘(1) each evaluation conducted pursuant to an 

11 Attorney General solicitation within 60 days of the 

12 completion of the scientific and medical evaluation, 

13 even if such evaluation did not result in a 

14 descheduling or rescheduling determination; and 

15 ‘‘(2) the results and any other information re16 lated to previously evaluated fentanyl-related serv17 ices pursuant to subsection (l). 

18 ‘‘(q) 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-re22 lated substances pursuant to section 3 of the Temporary 

23 Emergency Scheduling and Testing of Fentanyl Analogues 

24 Act of 2022.’’. 


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1 SEC. 6. NOTIFICATION. 

2 The Attorney General shall notify each individual 

3 who is the subject of a pending prosecution for, or has 

4 been convicted or sentenced for, an offense involving a 

5 fentanyl-related substance that is subsequently removed or 

6 rescheduled under paragraphs (1) and (2) of section 

7 201(k) of the Controlled Substances Act, as added by sec8 tion 5 of this Act, about the change in schedule designa9 tion not later than 90 days after the change, and provide 

10 information about the effect of the change on their pros11 ecution, conviction, or sentence. 

Æ 


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