[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2405 Introduced in House (IH)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Streamlining Research on Controlled 
Substances Act of 2021''.

SEC. 2. CLARIFICATION OF CERTAIN REGISTRATION REQUIREMENTS RELATED TO 
              RESEARCH.

    (a) Exception for Agents or Employees of Registered Researchers.--
Section 302(c) of the Controlled Substances Act (21 U.S.C. 822(c)) is 
amended in paragraph (1) by striking ``or dispenser'' and inserting 
``dispenser, or researcher''.
    (b) Conforming Amendment.--Section 102(3) of the Controlled 
Substances Act (21 U.S.C. 802(3)) is amended by striking ``or 
dispenser'' and inserting ``dispenser, or researcher''.
    (c) Single Registration for Contiguous Research Sites.--Section 
302(e) of the Controlled Substances Act (21 U.S.C. 822(e)) is amended 
by adding at the end the following new paragraph:
    ``(3) Notwithstanding paragraph (1), a person registered to conduct 
research with a controlled substance under section 303(f) may conduct 
such research under a single registration if such research occurs 
exclusively on a single, contiguous campus and the registrant notifies 
the Attorney General in writing of all sites on the campus where the 
research will be conducted or where the controlled substance will be 
stored or administered. The registrant must so notify the Attorney 
General prior to conducting research at such additional sites.''.
    (d) New Inspection Not Required in Certain Situations.--Section 
303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) is amended--
            (1) by redesignating paragraphs (1) through (5) as 
        subparagraphs (A) through (E), respectively, and by moving the 
        margins of such subparagraphs two ems to the right;
            (2) by striking ``(f) The'' and inserting ``(f)(1) The''; 
        and
            (3) by adding at the end, after the matter following 
        subparagraph (E), as so redesignated, the following new 
        paragraph:
    ``(2)(A) If a person is registered to conduct research with a 
controlled substance and applies for a registration, or a modification 
of a registration to conduct research with a second controlled 
substance that is in the same schedule or in a schedule with a higher 
numerical designation, a new inspection by the Attorney General of the 
registered location is not required.
    ``(B) Nothing in this paragraph shall prohibit the Attorney General 
from conducting any inspection if the Attorney General deems it 
necessary.''.
    (e) Continuation of Research on Substances Newly Added to Schedule 
I; Authority To Conduct Research With Other Substances in Schedule I.--
Section 302 of the Controlled Substances Act (21 U.S.C. 822) is amended 
by adding at the end the following new subsection:
    ``(h) Continuation of Research on Substances Newly Added to 
Schedule I; Authority To Conduct Research With Other Substances in 
Schedule I.--
            ``(1) If a person is conducting research on a substance at 
        the time the substance is added to schedule I, and such person 
        is already registered to conduct research with a controlled 
        substance in schedule I or II then--
                    ``(A) the person shall, within 30 days of the 
                scheduling of the newly scheduled substance, submit a 
                completed application for registration or modification 
                of existing registration, to conduct research on such 
                substance, in accordance with the regulations issued by 
                the Attorney General;
                    ``(B) the person may, notwithstanding subsections 
                (a) and (b), continue to conduct the research on such 
                substance until the application referred to in 
                subparagraph (A) is withdrawn by the applicant or until 
                the Attorney General serves on the applicant an order 
                to show cause proposing the denial of the application 
                pursuant to section 304(c); and
                    ``(C) if the Attorney General serves such an order 
                to show cause and the applicant requests a hearing, 
                such hearing shall be held on an expedited basis and 
                not later than 45 days after the request is made, 
                except that the hearing may be held at a later time if 
                so requested by the applicant.
            ``(2)(A) A person who is registered to conduct research 
        with a controlled substance in schedule I may, notwithstanding 
        subsections (a) and (b), conduct research with another 
        controlled substance in schedule I, provided the following 
        conditions are met:
                    ``(i) The person has applied for a modification of 
                the person's registration to authorize research with 
                such other controlled substance in accordance with the 
                regulations issued by the Attorney General.
                    ``(ii) The Attorney General has obtained 
                verification from the Secretary that the research 
                protocol submitted with the application is meritorious.
                    ``(iii) The Attorney General has determined that 
                such activity is consistent with United States 
                obligations under the Single Convention on Narcotic 
                Drugs, 1961. The Attorney General shall make such 
                determination not later than 30 days after receiving 
                the application referred to in clause (i).
            ``(B) Nothing in this section shall be construed to alter 
        the authority of the Attorney General to initiate proceedings 
        to deny, suspend, or revoke any registration in accordance with 
        sections 303 and 304.''.
    (f) Treatment of Certain Activities as Coincident to Research.--
Section 302 of the Controlled Substances Act (21 U.S.C. 822), as 
amended by subsection (d), is further amended by adding at the end the 
following new subsection:
    ``(i) Treatment of Certain Activities as Coincident to Research.--
            ``(1) In general.--Except as specified in paragraph (2), a 
        person who is registered to perform research with a controlled 
        substance may perform the following activities with small 
        quantities of that substance, as set forth in the relevant 
        statement or protocol filed with the application for 
        registration approved by the Attorney General without being 
        required to obtain a manufacturing registration:
                    ``(A) Processing the substance to create extracts, 
                tinctures, oils, solutions, derivatives, or other forms 
                of the substance consistent with the approved research 
                protocol.
                    ``(B) Dosage form development for the purpose of 
                satisfying regulatory requirements implemented by the 
                Food and Drug Administration for submitting an 
                investigational new drug application.
            ``(2) Exception regarding marihuana.--The authority under 
        paragraph (1) does not include authority to grow marihuana.''.

SEC. 3. REVIEW OF RESEARCH REGISTRATION PROCESS.

    (a) Review.--Not later than one year after the date of the 
enactment of this section, the Attorney General and the Secretary of 
Health and Human Services shall conduct a review of the processes used 
to obtain or modify Federal authorization to conduct research with 
controlled substances, including--
            (1) an evaluation of the impacts of the amendments made by 
        section 2 on the risk of the diversion of controlled substances 
        used in research and related public safety considerations; and
            (2) identification of opportunities to reduce any 
        unnecessary burden on persons seeking registration, potential 
        redundancies, and inefficiencies in the process to obtain or 
        modify Federal authorization to conduct research with 
        controlled substances, including the process for obtaining a 
        registration under section 303 of the Controlled Substances Act 
        (21 U.S.C. 823) and the process by which the Secretary of 
        Health and Human Services reviews research protocols.
    (b) Guidance.--Following the review described in subsection (a), 
the Attorney General and the Secretary of Health and Human Services 
shall, as appropriate, jointly issue guidance to registrants and 
potential registrants clarifying the process for registration under 
section 303 of the Controlled Substances Act (21 U.S.C. 823).
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