[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5421 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 5421

    To amend the Controlled Substances Act to list fentanyl-related 
            substances as schedule I controlled substances.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 12, 2019

   Mr. Luetkemeyer (for himself, Mrs. Wagner, Mr. Clay, Mr. Smith of 
Missouri, Mr. Long, Mr. Graves of Missouri, and Mr. Cleaver) 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 list fentanyl-related 
            substances as schedule I controlled substances.

    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 ``Stopping Illicit Trafficking Act of 
2019'' or the ``SIFT Act of 2019''.

SEC. 2. FENTANYL-RELATED SUBSTANCES.

    Section 202(c) of the Controlled Substances Act (21 U.S.C. 812) is 
amended--
            (1) by adding at the end of subsection (b) of Schedule I 
        the following:
            ``(23) Isobutyryl fentanyl.
            ``(24) Para-Methoxybutyrylfentanyl.
            ``(25) Valeryl fentanyl.
            ``(26) Cyclopentyl fentanyl.
            ``(27) Para-Chloroisobutyryl fentanyl.''; and
            (2) by adding at the end of Schedule I the following:
    ``(e)(1) Unless specifically exempted or unless listed in another 
schedule, any material, compound, mixture, or preparation which 
contains any quantity of fentanyl-related substances, or which contains 
their salts, isomers, and salts of isomers whenever the existence of 
such salts, isomers, and salts of isomers is possible within the 
specific chemical designation.
    ``(2) In paragraph (1), the term `fentanyl-related substances' 
includes the following:
            ``(A) Any substance that is structurally related to 
        fentanyl by one or more of the following modifications:
                    ``(i) By replacement of the phenyl portion of the 
                phenethyl group by any monocycle, whether or not 
                further substituted in or on the monocycle.
                    ``(ii) By substitution in or on the phenethyl group 
                with alkyl, alkenyl, alkoxy, hydroxy, halo, haloalkyl, 
                amino or nitro groups.
                    ``(iii) By substitution in or on the piperidine 
                ring with alkyl, alkenyl, alkoxy, ester, ether, 
                hydroxy, halo, haloalkyl, amino or nitro groups.
                    ``(iv) By replacement of the aniline ring with any 
                aromatic monocycle whether or not further substituted 
                in or on the aromatic monocycle.
                    ``(v) By replacement of the N-propionyl group by 
                another acyl group.
            ``(B) 4'-Methyl acetyl fentanyl.
            ``(C) Crotonyl fentanyl.
            ``(D) 2'-Fluoro ortho-fluorofentanyl.
            ``(E) Ortho-Methyl acetylfentanyl.
            ``(F) Thiofuranyl fentanyl.
            ``(G) Ortho-Fluorobutyryl fentanyl.
            ``(H) Ortho-Fluoroacryl fentanyl.
            ``(I) Beta-Methyl fentanyl.
            ``(J) Phenyl fentanyl.
            ``(K) Para-Methylfentanyl.
            ``(L) Beta'-Phenyl fentanyl.
            ``(M) Benzodioxole fentanyl.''.

SEC. 3. REMOVAL FROM SCHEDULE I(E) OF FENTANYL-RELATED SUBSTANCES.

    Section 201 of the Controlled Substances Act (21 U.S.C. 811) is 
amended by adding at the end the following new subsection:
    ``(k)(1) If the Secretary finds, based on the factors specified in 
paragraph (4), that a substance listed in schedule I(e) has no 
potential for abuse, the Secretary shall--
            ``(A) notify the Attorney General at least 90 days prior to 
        submitting an evaluation scientific and medical evaluation of 
        that substance supporting that conclusion; and
            ``(B) submit to the Attorney General such evaluation and 
        conclusion that--
                    ``(i) is in writing; and
                    ``(ii) includes the bases for such conclusion.
    ``(2) Not later than 90 days after the receipt of such evaluation 
and conclusion, the Attorney General shall issue an order removing such 
substance from the schedule.
    ``(3)(A) If the Secretary finds, based on the factors specified in 
paragraph (4), that a substance listed in schedule I(e) does not meet 
the requirements for inclusion in that schedule, and that the substance 
has a low potential for abuse, the Secretary shall submit to the 
Attorney General a scientific and medical evaluation of that substance 
supporting those conclusions that is in writing and that includes the 
bases for that conclusion.
    ``(B) Within 180 days of receipt of such evaluation and conclusion, 
the Attorney General shall--
            ``(i) issue an order removing such substance from 
        scheduling for research purposes only, or
            ``(ii) notify the Secretary in writing that the Attorney 
        General declines to issue such an order.
    ``(4) In making the evaluation and conclusion described in 
paragraph (1) or (3), the Secretary--
            ``(A) shall consider the factors specified in paragraphs 
        (1), (2), (3), and (6) of subsection (c) and any information 
        submitted to the Attorney General under paragraph (1) of this 
        subsection; and
            ``(B) may also consider factors specified in paragraphs 
        (4), (5), and (7) of subsection (c) if the Secretary finds that 
        reliable evidence exists with respect to such factors.
    ``(5) Nothing in this subsection shall preclude the Attorney 
General from transferring a substance listed in schedule I to another 
schedule, or removing such substance entirely from the schedules, 
pursuant to other provisions of this section or section 202.
    ``(6) A substance removed from schedule I(e) pursuant to paragraph 
(1) or (3) may, at any time, be controlled pursuant to the other 
provisions of this section or section 202 without regard to that 
removal.''.

SEC. 4. CLARIFICATION OF CERTAIN REGISTRATION REQUIREMENTS RELATED TO 
              RESEARCH.

    (a) Exception for Agents or Employees of Registered Researchers.--
Section 302(c)(1) of the Controlled Substances Act (21 U.S.C. 
822(c)(1)) is amended 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. 
        If the registrant seeks to conduct such research at additional 
        sites, the registrant shall submit a new notification before 
        conducting such research at any 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 striking ``(f) The'' and inserting ``(f)(1) The''; 
        and
            (2) by adding a new paragraph, as follows:
    ``(2)(A) If a person is registered to conduct research with a 
controlled substance and applies to be registered, or to modify 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 determines such 
an inspection is necessary.''.
    (e) Continuation of Research on Newly Added Substances; Authority 
To Conduct Research With Other Substances.--Section 302 of the 
Controlled Substances Act (21 U.S.C. 822), as amended by subsections 
(a) and (c), is further amended by adding at the end the following new 
subsection:
    ``(h)(1) In the case of a person who is conducting research on a 
substance at the time the substance is added to schedule I and who is 
already registered to conduct research with another controlled 
substance in schedule I or II, the person--
            ``(A) within 30 days of the scheduling of such substance, 
        shall submit a completed application for registration or 
        modification of the existing registration of such person, to 
        conduct research on such substance, in accordance with the 
        regulations issued by the Attorney General; and
            ``(B) notwithstanding subsections (a) and (b), may continue 
        to conduct the research on such substance until the date on 
        which--
                    ``(i) the application referred to in subparagraph 
                (A) is withdrawn by the applicant; or
                    ``(ii) the Attorney General serves on the applicant 
                an order to show cause proposing the denial of the 
                application pursuant to section 304(c).
    ``(2) If the Attorney General serves an order to show cause under 
paragraph (1)(B) and the applicant requests a hearing, such hearing 
shall be held--
            ``(A) on an expedited basis; and
            ``(B) not later than 45 days after the request is made, or 
        such a later time as requested by the applicant.
    ``(3)(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, if each of 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 under 
        subparagraph (B) that the conduct of such research is 
        consistent with United States obligations under the Single 
        Convention on Narcotic Drugs, 1961.
    ``(B) Not later than 30 days after receiving an application under 
clause (i), the Attorney General shall determine whether the conduct of 
research that is the subject of the application is consistent with 
United States obligations under the Single Convention on Narcotic 
Drugs, 1961.
    ``(C) 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 subsections (a), (c), and (e), is further amended by adding 
at the end the following new subsection:
    ``(i) A person who is registered to perform research with a 
controlled substance (other than marihuana) under this title may, 
without being required to registered to manufacture such substance, 
using small quantities of such substance, perform the following 
activities:
            ``(1) Processing the substance to create extracts, 
        tinctures, oils, solutions, derivatives, or other forms of the 
        substance consistent with the approved research protocol.
            ``(2) Dosage form development for the purpose of satisfying 
        requirements with respect to the submission of an 
        investigational new drug application under section 505(i) of 
        the Federal Food, Drug, and Cosmetic Act.''.

SEC. 5. 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 jointly conduct a review of the 
processes used to register or modify a registration to conduct research 
with controlled substances under the Controlled Substances Act (21 
U.S.C. 801 et seq.), including--
            (1) an evaluation of the impacts of the amendments made by 
        this Act on the risk of the diversion of controlled substances 
        used in research and related public safety considerations; and
            (2) an identification of opportunities to reduce any 
        unnecessary burden on persons seeking registration, potential 
        redundancies, and inefficiencies in such processes, including--
                    (A) the process for obtaining a registration under 
                section 303 of the Controlled Substances Act (21 U.S.C. 
                823); and
                    (B) the process by which the Secretary reviews 
                research protocols submitted with respect to such 
                registration.
    (b) Guidance.--Not later than 60 days after concluding the review 
described in subsection (a), the Attorney General and the Secretary 
shall, as appropriate, jointly issue guidance to registrants and 
potential registrants clarifying the process for registration.
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