Streamlining Research on Controlled Substances Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 2405 To amend the Controlled Substances Act to improve the process for con- ducting 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 subse- quently 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. 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 ‘‘Streamlining Research 4 on Controlled Substances Act of 2021’’. 5 VerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 2405 IH SEC. 2. CLARIFICATION OF CERTAIN REGISTRATION RE- 1 QUIREMENTS RELATED TO RESEARCH. 2 (a) EXCEPTION FOR AGENTS OR EMPLOYEES OF 3 REGISTERED RESEARCHERS.—Section 302(c) of the Con- 4 trolled Substances Act (21 U.S.C. 822(c)) is amended in 5 paragraph (1) by striking ‘‘or dispenser’’ and inserting 6 ‘‘dispenser, or researcher’’. 7 (b) CONFORMING AMENDMENT.—Section 102(3) of 8 the Controlled Substances Act (21 U.S.C. 802(3)) is 9 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis- 10 penser, or researcher’’. 11 (c) SINGLE REGISTRATION FOR CONTIGUOUS RE- 12 SEARCH SITES.—Section 302(e) of the Controlled Sub- 13 stances Act (21 U.S.C. 822(e)) is amended by adding at 14 the end the following new paragraph: 15 ‘‘(3) Notwithstanding paragraph (1), a person reg- 16 istered to conduct research with a controlled substance 17 under section 303(f) may conduct such research under a 18 single registration if such research occurs exclusively on 19 a single, contiguous campus and the registrant notifies the 20 Attorney General in writing of all sites on the campus 21 where the research will be conducted or where the con- 22 trolled substance will be stored or administered. The reg- 23 istrant must so notify the Attorney General prior to con- 24 ducting research at such additional sites.’’. 25 VerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 2405 IH (d) NEW INSPECTION NOT REQUIRED IN CERTAIN 1 SITUATIONS.—Section 303(f) of the Controlled Sub- 2 stances Act (21 U.S.C. 823(f)) is amended— 3 (1) by redesignating paragraphs (1) through 4 (5) as subparagraphs (A) through (E), respectively, 5 and by moving the margins of such subparagraphs 6 two ems to the right; 7 (2) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 8 The’’; and 9 (3) by adding at the end, after the matter fol- 10 lowing subparagraph (E), as so redesignated, the 11 following new paragraph: 12 ‘‘(2)(A) If a person is registered to conduct research 13 with a controlled substance and applies for a registration, 14 or a modification of a registration to conduct research 15 with a second controlled substance that is in the same 16 schedule or in a schedule with a higher numerical designa- 17 tion, a new inspection by the Attorney General of the reg- 18 istered location is not required. 19 ‘‘(B) Nothing in this paragraph shall prohibit the At- 20 torney General from conducting any inspection if the At- 21 torney General deems it necessary.’’. 22 (e) CONTINUATION OF RESEARCH ON SUBSTANCES 23 NEWLY ADDED TO SCHEDULE I; AUTHORITY TO CON- 24 DUCT RESEARCH WITH OTHER SUBSTANCES IN SCHED- 25 VerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 2405 IH ULE I.—Section 302 of the Controlled Substances Act (21 1 U.S.C. 822) is amended by adding at the end the following 2 new subsection: 3 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES 4 NEWLY ADDED TO SCHEDULE I; AUTHORITY TO CON- 5 DUCT RESEARCH WITH OTHER SUBSTANCES IN SCHED- 6 ULE I.— 7 ‘‘(1) If a person is conducting research on a 8 substance at the time the substance is added to 9 schedule I, and such person is already registered to 10 conduct research with a controlled substance in 11 schedule I or II then— 12 ‘‘(A) the person shall, within 30 days of 13 the scheduling of the newly scheduled sub- 14 stance, submit a completed application for reg- 15 istration or modification of existing registration, 16 to conduct research on such substance, in ac- 17 cordance with the regulations issued by the At- 18 torney General; 19 ‘‘(B) the person may, notwithstanding sub- 20 sections (a) and (b), continue to conduct the re- 21 search on such substance until the application 22 referred to in subparagraph (A) is withdrawn 23 by the applicant or until the Attorney General 24 serves on the applicant an order to show cause 25 VerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 2405 IH proposing the denial of the application pursuant 1 to section 304(c); and 2 ‘‘(C) if the Attorney General serves such 3 an order to show cause and the applicant re- 4 quests a hearing, such hearing shall be held on 5 an expedited basis and not later than 45 days 6 after the request is made, except that the hear- 7 ing may be held at a later time if so requested 8 by the applicant. 9 ‘‘(2)(A) A person who is registered to conduct 10 research with a controlled substance in schedule I 11 may, notwithstanding subsections (a) and (b), con- 12 duct research with another controlled substance in 13 schedule I, provided the following conditions are 14 met: 15 ‘‘(i) The person has applied for a modifica- 16 tion of the person’s registration to authorize re- 17 search with such other controlled substance in 18 accordance with the regulations issued by the 19 Attorney General. 20 ‘‘(ii) The Attorney General has obtained 21 verification from the Secretary that the re- 22 search protocol submitted with the application 23 is meritorious. 24 VerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 2405 IH ‘‘(iii) The Attorney General has deter- 1 mined that such activity is consistent with 2 United States obligations under the Single Con- 3 vention on Narcotic Drugs, 1961. The Attorney 4 General shall make such determination not 5 later than 30 days after receiving the applica- 6 tion referred to in clause (i). 7 ‘‘(B) Nothing in this section shall be construed 8 to alter the authority of the Attorney General to ini- 9 tiate proceedings to deny, suspend, or revoke any 10 registration in accordance with sections 303 and 11 304.’’. 12 (f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI- 13 DENT TO RESEARCH.—Section 302 of the Controlled Sub- 14 stances Act (21 U.S.C. 822), as amended by subsection 15 (d), is further amended by adding at the end the following 16 new subsection: 17 ‘‘(i) TREATMENT OF CERTAIN ACTIVITIES AS COIN- 18 CIDENT TO RESEARCH.— 19 ‘‘(1) IN GENERAL.—Except as specified in 20 paragraph (2), a person who is registered to perform 21 research with a controlled substance may perform 22 the following activities with small quantities of that 23 substance, as set forth in the relevant statement or 24 protocol filed with the application for registration 25 VerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 2405 IH approved by the Attorney General without being re- 1 quired to obtain a manufacturing registration: 2 ‘‘(A) Processing the substance to create ex- 3 tracts, tinctures, oils, solutions, derivatives, or 4 other forms of the substance consistent with the 5 approved research protocol. 6 ‘‘(B) Dosage form development for the 7 purpose of satisfying regulatory requirements 8 implemented by the Food and Drug Adminis- 9 tration for submitting an investigational new 10 drug application. 11 ‘‘(2) EXCEPTION REGARDING MARIHUANA.— 12 The authority under paragraph (1) does not include 13 authority to grow marihuana.’’. 14 SEC. 3. REVIEW OF RESEARCH REGISTRATION PROCESS. 15 (a) REVIEW.—Not later than one year after the date 16 of the enactment of this section, the Attorney General and 17 the Secretary of Health and Human Services shall conduct 18 a review of the processes used to obtain or modify Federal 19 authorization to conduct research with controlled sub- 20 stances, including— 21 (1) an evaluation of the impacts of the amend- 22 ments made by section 2 on the risk of the diversion 23 of controlled substances used in research and related 24 public safety considerations; and 25 VerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 2405 IH (2) identification of opportunities to reduce any 1 unnecessary burden on persons seeking registration, 2 potential redundancies, and inefficiencies in the 3 process to obtain or modify Federal authorization to 4 conduct research with controlled substances, includ- 5 ing the process for obtaining a registration under 6 section 303 of the Controlled Substances Act (21 7 U.S.C. 823) and the process by which the Secretary 8 of Health and Human Services reviews research pro- 9 tocols. 10 (b) GUIDANCE.—Following the review described in 11 subsection (a), the Attorney General and the Secretary of 12 Health and Human Services shall, as appropriate, jointly 13 issue guidance to registrants and potential registrants 14 clarifying the process for registration under section 303 15 of the Controlled Substances Act (21 U.S.C. 823). 16 Æ VerDate Sep 11 2014 22:15 May 27, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H2405.IH H2405 kjohnson on DSK79L0C42PROD with BILLS