I 

117TH CONGRESS 

1ST SESSION H. R. 2405 

To amend the Controlled Substances Act to improve the process for conducting scientific research on schedule I controlled substances, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 8, 2021 

Mr. GRIFFITH (for himself and Mr. CRENSHAW) 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 to improve the 

process for conducting scientific research on schedule 

I controlled 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 ‘‘Streamlining Research 

5 on Controlled Substances Act of 2021’’. 


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1 SEC. 2. CLARIFICATION OF CERTAIN REGISTRATION RE2 QUIREMENTS RELATED TO RESEARCH. 

3 (a) EXCEPTION FOR AGENTS OR EMPLOYEES OF

4 REGISTERED RESEARCHERS.—Section 302(c) of the Con5 trolled Substances Act (21 U.S.C. 822(c)) is amended in 

6 paragraph (1) by striking ‘‘or dispenser’’ and inserting 

7 ‘‘dispenser, or researcher’’. 

8 (b) CONFORMING AMENDMENT.—Section 102(3) of 

9 the Controlled Substances Act (21 U.S.C. 802(3)) is 

10 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis11 penser, or researcher’’. 

12 (c) SINGLE REGISTRATION FOR CONTIGUOUS RE13 SEARCH SITES.—Section 302(e) of the Controlled Sub14 stances Act (21 U.S.C. 822(e)) is amended by adding at 

15 the end the following new paragraph: 

16 ‘‘(3) Notwithstanding paragraph (1), a person reg17 istered to conduct research with a controlled substance 

18 under section 303(f) may conduct such research under a 

19 single registration if such research occurs exclusively on 

20 a single, contiguous campus and the registrant notifies the 

21 Attorney General in writing of all sites on the campus 

22 where the research will be conducted or where the con23 trolled substance will be stored or administered. The reg24 istrant must so notify the Attorney General prior to con25 ducting research at such additional sites.’’. 


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1 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

2 SITUATIONS.—Section 303(f) of the Controlled Sub3 stances Act (21 U.S.C. 823(f)) is amended— 

4 (1) by redesignating paragraphs (1) through 

5 (5) as subparagraphs (A) through (E), respectively, 

6 and by moving the margins of such subparagraphs 

7 two ems to the right; 

8 (2) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 

9 The’’; and 

10 (3) by adding at the end, after the matter fol11 lowing subparagraph (E), as so redesignated, the 

12 following new paragraph: 

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

14 with a controlled substance and applies for a registration, 

15 or a modification of a registration to conduct research 

16 with a second controlled substance that is in the same 

17 schedule or in a schedule with a higher numerical designa18 tion, a new inspection by the Attorney General of the reg19 istered location is not required. 

20 ‘‘(B) Nothing in this paragraph shall prohibit the At21 torney General from conducting any inspection if the At22 torney General deems it necessary.’’. 

23 (e) CONTINUATION OF RESEARCH ON SUBSTANCES

24 NEWLY ADDED TO SCHEDULE I; AUTHORITY TO CON25 DUCT RESEARCH WITH OTHER SUBSTANCES IN SCHEDVerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405

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1 ULE I.—Section 302 of the Controlled Substances Act (21 

2 U.S.C. 822) is amended by adding at the end the following 

3 new subsection: 

4 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES

5 NEWLY ADDED TO SCHEDULE I; AUTHORITY TO CON6 DUCT RESEARCH WITH OTHER SUBSTANCES IN SCHED7 ULE I.— 

8 ‘‘(1) If a person is conducting research on a 

9 substance at the time the substance is added to 

10 schedule I, and such person is already registered to 

11 conduct research with a controlled substance in 

12 schedule I or II then— 

13 ‘‘(A) the person shall, within 30 days of 

14 the scheduling of the newly scheduled sub15 stance, submit a completed application for reg16 istration or modification of existing registration, 

17 to conduct research on such substance, in ac18 cordance with the regulations issued by the At19 torney General; 

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

23 referred to in subparagraph (A) is withdrawn 

24 by the applicant or until the Attorney General 

25 serves on the applicant an order to show cause 


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1 proposing the denial of the application pursuant 

2 to section 304(c); and 

3 ‘‘(C) if the Attorney General serves such 

4 an order to show cause and the applicant re5 quests a hearing, such hearing shall be held on 

6 an expedited basis and not later than 45 days 

7 after the request is made, except that the hear8 ing may be held at a later time if so requested 

9 by the applicant. 

10 ‘‘(2)(A) A person who is registered to conduct 

11 research with a controlled substance in schedule I 

12 may, notwithstanding subsections (a) and (b), con13 duct research with another controlled substance in 

14 schedule I, provided the following conditions are 

15 met: 

16 ‘‘(i) The person has applied for a modifica17 tion of the person’s registration to authorize re18 search with such other controlled substance in 

19 accordance with the regulations issued by the 

20 Attorney General. 

21 ‘‘(ii) The Attorney General has obtained 

22 verification from the Secretary that the re23 search protocol submitted with the application 

24 is meritorious. 


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1 ‘‘(iii) The Attorney General has deter2 mined that such activity is consistent with 

3 United States obligations under the Single Con4 vention on Narcotic Drugs, 1961. The Attorney 

5 General shall make such determination not 

6 later than 30 days after receiving the applica7 tion referred to in clause (i). 

8 ‘‘(B) Nothing in this section shall be construed 

9 to alter the authority of the Attorney General to ini10 tiate proceedings to deny, suspend, or revoke any 

11 registration in accordance with sections 303 and 

12 304.’’. 

13 (f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI14 DENT TO RESEARCH.—Section 302 of the Controlled Sub15 stances Act (21 U.S.C. 822), as amended by subsection 

16 (d), is further amended by adding at the end the following 

17 new subsection: 

18 ‘‘(i) TREATMENT OF CERTAIN ACTIVITIES AS COIN19 CIDENT TO RESEARCH.— 

20 ‘‘(1) IN GENERAL.—Except as specified in 

21 paragraph (2), a person who is registered to perform 

22 research with a controlled substance may perform 

23 the following activities with small quantities of that 

24 substance, as set forth in the relevant statement or 

25 protocol filed with the application for registration 


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1 approved by the Attorney General without being re2 quired to obtain a manufacturing registration: 

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

5 other forms of the substance consistent with the 

6 approved research protocol. 

7 ‘‘(B) Dosage form development for the 

8 purpose of satisfying regulatory requirements 

9 implemented by the Food and Drug Adminis10 tration for submitting an investigational new 

11 drug application. 

12 ‘‘(2) EXCEPTION REGARDING MARIHUANA.— 

13 The authority under paragraph (1) does not include 

14 authority to grow marihuana.’’. 

15 SEC. 3. REVIEW OF RESEARCH REGISTRATION PROCESS. 

16 (a) REVIEW.—Not later than one year after the date 

17 of the enactment of this section, the Attorney General and 

18 the Secretary of Health and Human Services shall conduct 

19 a review of the processes used to obtain or modify Federal 

20 authorization to conduct research with controlled sub21 stances, including— 

22 (1) an evaluation of the impacts of the amend23 ments made by section 2 on the risk of the diversion 

24 of controlled substances used in research and related 

25 public safety considerations; and 


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1 (2) identification of opportunities to reduce any 

2 unnecessary burden on persons seeking registration, 

3 potential redundancies, and inefficiencies in the 

4 process to obtain or modify Federal authorization to 

5 conduct research with controlled substances, includ6 ing the process for obtaining a registration under 

7 section 303 of the Controlled Substances Act (21 

8 U.S.C. 823) and the process by which the Secretary 

9 of Health and Human Services reviews research pro10 tocols. 

11 (b) GUIDANCE.—Following the review described in 

12 subsection (a), the Attorney General and the Secretary of 

13 Health and Human Services shall, as appropriate, jointly 

14 issue guidance to registrants and potential registrants 

15 clarifying the process for registration under section 303 

16 of the Controlled Substances Act (21 U.S.C. 823). 

Æ 


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