I 

117TH CONGRESS 

1ST SESSION H. R. 6184 

To amend the Controlled Substances Act with respect to the scheduling 

of fentanyl-related substances, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 8, 2021 

Mr. GRIFFITH (for himself, Mr. LATTA, Mr. BILIRAKIS, Mr. BURGESS, Mr. 

CARTER of Georgia, Mr. CLINE, Mr. CURTIS, Mr. FITZPATRICK, Mr. 

GUTHRIE, Mr. HARRIS, Mr. HUDSON, Mr. JACKSON, Mr. JOYCE of Pennsylvania, Mr. KELLER, Mrs. LESKO, Mr. LONG, Mr. MCKINLEY, Mrs. 

RODGERS of Washington, Mrs. MILLER of West Virginia, Mrs. MILLERMEEKS, Mr. MULLIN, Mr. ARMSTRONG, Mr. MURPHY of North Carolina, 

Mr. PALAZZO, Mr. AUSTIN SCOTT of Georgia, Mr. UPTON, Mr. 

WALBERG, and Ms. HERRELL) introduced the following bill; which was 

referred to the Committee on Energy and Commerce, and in addition to 

the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions 

as fall within the jurisdiction of the committee concerned 

A BILL 

To amend the Controlled Substances Act with respect to 

the scheduling of fentanyl-related substances, and for 

other purposes. 

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 ‘‘Halt All Lethal Traf5 ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 


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1 SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB2 STANCES. 

3 Section 202(c) of the Controlled Substances Act (21 

4 U.S.C. 812(c)) is amended by adding at the end of sched5 ule I the following: 

6 ‘‘(e)(1) Unless specifically exempted or unless listed 

7 in another schedule, any material, compound, mixture, or 

8 preparation which contains any quantity of a fentanyl-re9 lated substance, or which contains the salts, isomers, and 

10 salts of isomers of a fentanyl-related substance whenever 

11 the existence of such salts, isomers, and salts of isomers 

12 is possible within the specific chemical designation. 

13 ‘‘(2) For purposes of paragraph (1), except as pro14 vided in paragraph (3), the term ‘fentanyl-related sub15 stance’ means any substance that is structurally related 

16 to fentanyl by 1 or more of the following modifications: 

17 ‘‘(A) By replacement of the phenyl portion of 

18 the phenethyl group by any monocycle, whether or 

19 not further substituted in or on the monocycle. 

20 ‘‘(B) By substitution in or on the phenethyl 

21 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 

22 haloalkyl, amino, or nitro groups. 

23 ‘‘(C) By substitution in or on the piperidine 

24 ring with alkyl, alkenyl, alkoxyl, ester, ether, 

25 hydroxyl, halo, haloalkyl, amino, or nitro groups. 


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1 ‘‘(D) By replacement of the aniline ring with 

2 any aromatic monocycle whether or not further sub3 stituted in or on the aromatic monocycle. 

4 ‘‘(E) By replacement of the N–propionyl group 

5 with another acyl group. 

6 ‘‘(3) A substance that satisfies the definition of the 

7 term ‘fentanyl-related substance’ in paragraph (2) shall 

8 nonetheless not be treated as a fentanyl-related substance 

9 subject to this schedule if the substance— 

10 ‘‘(A) is controlled by action of the Attorney 

11 General under section 201; or 

12 ‘‘(B) is otherwise expressly listed in a schedule 

13 other than this schedule. 

14 ‘‘(4)(A) The Attorney General may by order publish 

15 in the Federal Register a list of substances that satisfy 

16 the definition of the term ‘fentanyl-related substance’ in 

17 paragraph (2). 

18 ‘‘(B) The absence of a substance from a list published 

19 under subparagraph (A) does not negate the control status 

20 of the substance under this schedule if the substance satis21 fies the definition of the term ‘fentanyl-related substance’ 

22 in paragraph (2).’’. 


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1 SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE2 SEARCH. 

3 (a) ALTERNATIVE REGISTRATION PROCESS FOR

4 SCHEDULE I RESEARCH.—Section 303 of the Controlled 

5 Substances Act (21 U.S.C. 823) is amended by adding at 

6 the end the following: 

7 ‘‘(l) SPECIAL PROVISIONS FOR PRACTITIONERS CON8 DUCTING CERTAIN RESEARCH WITH SCHEDULE I CON9 TROLLED SUBSTANCES.— 

10 ‘‘(1) IN GENERAL.—Notwithstanding subsection 

11 (f), a practitioner may conduct research described in 

12 paragraph (2) of this subsection with 1 or more 

13 schedule I substances in accordance with subpara14 graph (A) or (B) of paragraph (3) of this sub15 section. 

16 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO17 CEDURES.—Research described in this paragraph is 

18 research that— 

19 ‘‘(A) is with respect to a drug that is the 

20 subject of an investigational use exemption 

21 under section 505(i) of the Federal Food, Drug, 

22 and Cosmetic Act; or 

23 ‘‘(B) is— 

24 ‘‘(i) conducted by the Department of 

25 Health and Human Services or the De26 partment of Veterans Affairs; or 


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1 ‘‘(ii) funded partly or entirely by a 

2 grant, contract, cooperative agreement, or 

3 other transaction from the Department of 

4 Health and Human Services or the De5 partment of Veterans Affairs. 

6 ‘‘(3) EXPEDITED PROCEDURES.— 

7 ‘‘(A) RESEARCHER WITH A CURRENT

8 SCHEDULE I OR II RESEARCH REGISTRATION.— 

9 ‘‘(i) IN GENERAL.—If a practitioner is 

10 registered to conduct research with a con11 trolled substance in schedule I or II, the 

12 practitioner may conduct research under 

13 this subsection on and after the date that 

14 is 30 days after the date on which the 

15 practitioner sends a notice to the Attorney 

16 General containing the following informa17 tion, with respect to each substance with 

18 which the practitioner will conduct the re19 search: 

20 ‘‘(I) The chemical name of the 

21 substance. 

22 ‘‘(II) The quantity of the sub23 stance to be used in the research. 

24 ‘‘(III) Demonstration that the re25 search is in the category described in 


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1 paragraph (2), which demonstration 

2 may be satisfied— 

3 ‘‘(aa) in the case of a grant, 

4 contract, cooperative agreement, 

5 or other transaction, or intra6 mural research project, by identi7 fying the sponsoring agency and 

8 supplying the number of the 

9 grant, contract, cooperative 

10 agreement, other transaction, or 

11 project; or 

12 ‘‘(bb) in the case of an ap13 plication under section 505(i) of 

14 the Federal Food, Drug, and 

15 Cosmetic Act, by supplying the 

16 application number and the spon17 sor of record on the application. 

18 ‘‘(IV) Demonstration that the re19 searcher is authorized to conduct re20 search with respect to the substance 

21 under the laws of the State in which 

22 the research will take place. 

23 ‘‘(ii) VERIFICATION OF INFORMATION

24 BY HHS OR VA.—Upon request from the 

25 Attorney General, the Secretary of Health 


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1 and Human Services or the Secretary of 

2 Veterans Affairs, as appropriate, shall 

3 verify information submitted by an appli4 cant under clause (i)(III). 

5 ‘‘(B) RESEARCHER WITHOUT A CURRENT

6 SCHEDULE I OR II RESEARCH REGISTRATION.— 

7 ‘‘(i) IN GENERAL.—If a practitioner is 

8 not registered to conduct research with a 

9 controlled substance in schedule I or II, 

10 the practitioner may send a notice to the 

11 Attorney General containing the informa12 tion listed in subparagraph (A)(i), with re13 spect to each substance with which the 

14 practitioner will conduct the research. 

15 ‘‘(ii) ATTORNEY GENERAL ACTION.— 

16 The Attorney General shall— 

17 ‘‘(I) treat notice received under 

18 clause (i) as a sufficient application 

19 for a research registration; and 

20 ‘‘(II) not later than 45 days of 

21 receiving such a notice that contains 

22 all information required under sub23 paragraph (A)(i)— 

24 ‘‘(aa) register the applicant; 

25 or 


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1 ‘‘(bb) serve an order to show 

2 cause upon the applicant in ac3 cordance with section 304(c). 

4 ‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney 

5 General shall provide a means to permit a practi6 tioner to submit a notification under paragraph (3) 

7 electronically. 

8 ‘‘(5) LIMITATION ON AMOUNTS.—A practitioner 

9 conducting research with a schedule I substance 

10 under this subsection may only possess the amounts 

11 of schedule I substance identified in— 

12 ‘‘(A) the notification to the Attorney Gen13 eral under paragraph (3); or 

14 ‘‘(B) a supplemental notification that the 

15 practitioner may send if the practitioner needs 

16 additional amounts for the research, which sup17 plemental notification shall include— 

18 ‘‘(i) the name of the practitioner; 

19 ‘‘(ii) the additional quantity needed of 

20 the substance; and 

21 ‘‘(iii) an attestation that the research 

22 to be conducted with the substance is con23 sistent with the scope of the research that 

24 was the subject of the notification under 

25 paragraph (3). 


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1 ‘‘(6) IMPORTATION AND EXPORTATION RE2 QUIREMENTS NOT AFFECTED.—Nothing in this sub3 section alters the requirements of part A of title III, 

4 regarding the importation and exportation of con5 trolled substances.’’. 

6 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR

7 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec8 tion 302(c) of the Controlled Substances Act (21 U.S.C. 

9 822(c)) is amended by adding at the end the following: 

10 ‘‘(4) An agent or employee of a research insti11 tution that is conducting research with a controlled 

12 substance if— 

13 ‘‘(A) the agent or employee is acting with14 in the scope of the professional practice of the 

15 agent or employee; 

16 ‘‘(B) another agent or employee of the in17 stitution is registered to conduct research with 

18 a controlled substance in the same schedule; 

19 ‘‘(C) the researcher who is so registered— 

20 ‘‘(i) informs the Attorney General of 

21 the name, position title, and employing in22 stitution of the agent or employee who is 

23 not separately registered; 


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1 ‘‘(ii) authorizes that agent or em2 ployee to perform research under the reg3 istration of the registered researcher; and 

4 ‘‘(iii) affirms that any act taken by 

5 that agent or employee involving a con6 trolled substance shall be attributable to 

7 the registered researcher, as if the re8 searcher had directly committed the act, 

9 for purposes of any proceeding under sec10 tion 304(a) to suspend or revoke the reg11 istration of the registered researcher; and 

12 ‘‘(D) the Attorney General does not, within 

13 30 days of receiving the information, authoriza14 tion, and affirmation described in subparagraph 

15 (C), refuse, for a reason listed in section 

16 304(a), to allow the agent or employee to pos17 sess the substance without a separate registra18 tion.’’. 

19 (c) SINGLE REGISTRATION FOR RELATED RESEARCH

20 SITES.—Section 302(e) of the Controlled Substances Act 

21 (21 U.S.C. 822(e)) is amended by adding at the end the 

22 following: 

23 ‘‘(3)(A) Notwithstanding paragraph (1), a person 

24 registered to conduct research with a controlled substance 


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1 under section 303(f) may conduct the research under a 

2 single registration if— 

3 ‘‘(i) the research occurs exclusively on sites all 

4 of which are— 

5 ‘‘(I) within the same city or county; and 

6 ‘‘(II) under the control of the same institu7 tion, organization, or agency; and 

8 ‘‘(ii) before commencing the research, the re9 searcher notifies the Attorney General of each site 

10 where— 

11 ‘‘(I) the research will be conducted; or 

12 ‘‘(II) the controlled substance will be 

13 stored or administered. 

14 ‘‘(B) A site described in subparagraph (A) shall be 

15 included in a registration described in that subparagraph 

16 only if the researcher has notified the Attorney General 

17 of the site— 

18 ‘‘(i) in the application for the registration; or 

19 ‘‘(ii) before the research is conducted, or before 

20 the controlled substance is stored or administered, at 

21 the site. 

22 ‘‘(C) The Attorney General may, in consultation with 

23 the Secretary, issue regulations addressing, with respect 

24 to research sites described in subparagraph (A)— 


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1 ‘‘(i) the manner in which controlled substances 

2 may be delivered to the research sites; 

3 ‘‘(ii) the storage and security of controlled sub4 stances at the research sites; 

5 ‘‘(iii) the maintenance of records for the re6 search sites; and 

7 ‘‘(iv) any other matters necessary to ensure ef8 fective controls against diversion at the research 

9 sites.’’. 

10 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

11 SITUATIONS.—Section 302(f) of the Controlled Sub12 stances Act (21 U.S.C. 822(f)) is amended— 

13 (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 

14 The’’; and 

15 (2) by adding at the end the following: 

16 ‘‘(2)(A) If a person is registered to conduct research 

17 with a controlled substance and applies for a registration, 

18 or for a modification of a registration, to conduct research 

19 with a second controlled substance that is in the same 

20 schedule as the first controlled substance, or is in a sched21 ule with a higher numerical designation than the schedule 

22 of the first controlled substance, a new inspection by the 

23 Attorney General of the registered location is not required. 

24 ‘‘(B) Nothing in subparagraph (A) shall prohibit the 

25 Attorney General from conducting an inspection that the 


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1 Attorney General determines necessary to ensure that a 

2 registrant maintains effective controls against diversion.’’. 

3 (e) CONTINUATION OF RESEARCH ON SUBSTANCES

4 NEWLY ADDED TO SCHEDULE I.—Section 302 of the 

5 Controlled Substances Act (21 U.S.C. 822) is amended 

6 by adding at the end the following: 

7 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES

8 NEWLY ADDED TO SCHEDULE I.—If a person is con9 ducting research on a substance when the substance is 

10 added to schedule I, and the person is already registered 

11 to conduct research with a controlled substance in sched12 ule I— 

13 ‘‘(1) not later than 90 days after the scheduling 

14 of the newly scheduled substance, the person shall 

15 submit a completed application for registration or 

16 modification of existing registration, to conduct re17 search on the substance, in accordance with regula18 tions issued by the Attorney General for purposes of 

19 this paragraph; 

20 ‘‘(2) the person may, notwithstanding sub21 sections (a) and (b), continue to conduct the re22 search on the substance until— 

23 ‘‘(A) the person withdraws the application 

24 described in paragraph (1) of this subsection; 

25 or 


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1 ‘‘(B) the Attorney General serves on the 

2 person an order to show cause proposing the 

3 denial of the application under section 304(c); 

4 ‘‘(3) if the Attorney General serves an order to 

5 show cause as described in paragraph (2)(B) and 

6 the person requests a hearing, the hearing shall be 

7 held on an expedited basis and not later than 45 

8 days after the request is made, except that the hear9 ing may be held at a later time if so requested by 

10 the person; and 

11 ‘‘(4) if the person sends a copy of the applica12 tion described in paragraph (1) to a manufacturer or 

13 distributor of the substance, receipt of the copy by 

14 the manufacturer or distributor shall constitute suf15 ficient evidence that the person is authorized to re16 ceive the substance.’’. 

17 (f) TREATMENT OF CERTAIN MANUFACTURING AC18 TIVITIES AS COINCIDENT TO RESEARCH.—Section 302 of 

19 the Controlled Substances Act (21 U.S.C. 822), as amend20 ed by subsection (e), is amended by adding at the end 

21 the following: 

22 ‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC23 TIVITIES AS COINCIDENT TO RESEARCH.— 

24 ‘‘(1) IN GENERAL.—Except as provided in para25 graph (3), a person who is registered to perform reVerDate Sep 11 2014 08:15 Dec 15, 2021 Jkt 029200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H6184.IH H6184

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1 search on a controlled substance may perform manu2 facturing activities with small quantities of that sub3 stance, including activities described in paragraph 

4 (2), without being required to obtain a manufac5 turing registration, if— 

6 ‘‘(A) the activities are performed for the 

7 purpose of the research; and 

8 ‘‘(B) the activities and the quantities of 

9 the substance involved in the activities are stat10 ed in— 

11 ‘‘(i) a notification submitted to the 

12 Attorney General under section 303(l); 

13 ‘‘(ii) a research protocol filed with an 

14 application for registration approval under 

15 section 303(f); or 

16 ‘‘(iii) a notification to the Attorney 

17 General that includes— 

18 ‘‘(I) the name of the registrant; 

19 and 

20 ‘‘(II) an attestation that the re21 search to be conducted with the small 

22 quantities of manufactured substance 

23 is consistent with the scope of the re24 search that is the basis for the reg25 istration. 


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1 ‘‘(2) ACTIVITIES INCLUDED.—Activities per2 mitted under paragraph (1) include— 

3 ‘‘(A) processing the substance to create ex4 tracts, tinctures, oils, solutions, derivatives, or 

5 other forms of the substance consistent with— 

6 ‘‘(i) the information provided as part 

7 of a notification submitted to the Attorney 

8 General under section 303(l); or 

9 ‘‘(ii) a research protocol filed with an 

10 application for registration approval under 

11 section 303(f); and 

12 ‘‘(B) dosage form development studies per13 formed for the purpose of requesting an inves14 tigational new drug exemption under section 

15 505(i) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 355(i)). 

17 ‘‘(3) EXCEPTION REGARDING MARIHUANA.— 

18 The authority under paragraph (1) to manufacture 

19 substances does not include the authority to grow 

20 marihuana.’’. 

21 (g) TRANSPARENCY REGARDING SPECIAL PROCE22 DURES.—Section 303 of the Controlled Substances Act 

23 (21 U.S.C. 823), as amended by subsection (a), is amend24 ed by adding at the end the following: 


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1 ‘‘(m) TRANSPARENCY REGARDING SPECIAL PROCE2 DURES.— 

3 ‘‘(1) IN GENERAL.—If the Attorney General de4 termines, with respect to a controlled substance, that 

5 an application by a practitioner to conduct research 

6 with the substance should be considered under a 

7 process, or subject to criteria, different from the 

8 process or criteria applicable to applications to con9 duct research with other controlled substances in the 

10 same schedule, the Attorney General shall make 

11 public, including by posting on the website of the 

12 Drug Enforcement Administration— 

13 ‘‘(A) the identities of all substances for 

14 which such determinations have been made; 

15 ‘‘(B) the process and criteria that shall be 

16 applied to applications to conduct research with 

17 those substances; and 

18 ‘‘(C) how the process and criteria described 

19 in subparagraph (B) differ from the process 

20 and criteria applicable to applications to con21 duct research with other controlled substances 

22 in the same schedule. 

23 ‘‘(2) TIMING OF POSTING.—The Attorney Gen24 eral shall make information described in paragraph 

25 (1) public upon making a determination described in 


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1 that paragraph, regardless of whether a practitioner 

2 has submitted such an application at that time.’’. 

3 SEC. 4. RULEMAKING. 

4 (a) INTERIM FINAL RULES.—The Attorney Gen5 eral— 

6 (1) shall, not later than 1 year of the date of 

7 enactment of this Act, issue rules to implement this 

8 Act and the amendments made by this Act; and 

9 (2) may issue the rules under paragraph (1) as 

10 interim final rules. 

11 (b) PROCEDURE FOR FINAL RULE.— 

12 (1) EFFECTIVENESS OF INTERIM FINAL

13 RULES.—A rule issued by the Attorney General as 

14 an interim final rule under subsection (a) shall be15 come immediately effective as an interim final rule 

16 without requiring the Attorney General to dem17 onstrate good cause therefor, notwithstanding sub18 paragraph (B) of section 553(b) of title 5, United 

19 States Code. 

20 (2) OPPORTUNITY FOR COMMENT AND HEAR21 ING.—An interim final rule issued under subsection 

22 (a) shall give interested persons the opportunity to 

23 comment and to request a hearing. 

24 (3) FINAL RULE.—After the conclusion of such 

25 proceedings, the Attorney General shall issue a final 


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1 rule to implement this Act and the amendments 

2 made by this Act in accordance with section 553 of 

3 title 5, United States Code. 

Æ 


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