Title: HALT Fentanyl Act
Policy area: Crime and Law Enforcement

Summary:
Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act
This bill places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act.
Additionally, the bill establishes a new, alternative registration process for schedule I research that is funded by the Department of Health and Human Services or the Department of Veterans Affairs or that is conducted under an investigative new drug exemption from the Food and Drug Administration.
The bill also makes several other changes to registration requirements for conducting research with controlled substances, including

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3336 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 3336

 To amend the Controlled Substances Act with respect to the scheduling 
        of fentanyl-related substances, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            December 8, 2021

 Mr. Cassidy (for himself and Mr. Burr) introduced the following bill; 
  which was read twice and referred to the Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
 To amend the Controlled Substances Act with respect to the scheduling 
        of fentanyl-related 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 ``Halt All Lethal Trafficking of 
Fentanyl Act'' or the ``HALT Fentanyl Act''.

SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUBSTANCES.

    Section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) 
is amended 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 a fentanyl-related substance, or which 
contains the salts, isomers, and salts of isomers of a fentanyl-related 
substance whenever the existence of such salts, isomers, and salts of 
isomers is possible within the specific chemical designation.
    ``(2) For purposes of paragraph (1), except as provided in 
paragraph (3), the term `fentanyl-related substance' means any 
substance that is structurally related to fentanyl by 1 or more of the 
following modifications:
            ``(A) By replacement of the phenyl portion of the phenethyl 
        group by any monocycle, whether or not further substituted in 
        or on the monocycle.
            ``(B) By substitution in or on the phenethyl group with 
        alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or 
        nitro groups.
            ``(C) By substitution in or on the piperidine ring with 
        alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, 
        haloalkyl, amino, or nitro groups.
            ``(D) By replacement of the aniline ring with any aromatic 
        monocycle whether or not further substituted in or on the 
        aromatic monocycle.
            ``(E) By replacement of the N-propionyl group with another 
        acyl group.
    ``(3) A substance that satisfies the definition of the term 
`fentanyl-related substance' in paragraph (2) shall nonetheless not be 
treated as a fentanyl-related substance subject to this schedule if the 
substance--
            ``(A) is controlled by action of the Attorney General under 
        section 201; or
            ``(B) is otherwise expressly listed in a schedule other 
        than this schedule.
    ``(4)(A) The Attorney General may by order publish in the Federal 
Register a list of substances that satisfy the definition of the term 
`fentanyl-related substance' in paragraph (2).
    ``(B) The absence of a substance from a list published under 
subparagraph (A) does not negate the control status of the substance 
under this schedule if the substance satisfies the definition of the 
term `fentanyl-related substance' in paragraph (2).''.

SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RESEARCH.

    (a) Alternative Registration Process for Schedule I Research.--
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended 
by adding at the end the following:
    ``(l) Special Provisions for Practitioners Conducting Certain 
Research With Schedule I Controlled Substances.--
            ``(1) In general.--Notwithstanding subsection (f), a 
        practitioner may conduct research described in paragraph (2) of 
        this subsection with 1 or more schedule I substances in 
        accordance with subparagraph (A) or (B) of paragraph (3) of 
        this subsection.
            ``(2) Research subject to expedited procedures.--Research 
        described in this paragraph is research that--
                    ``(A) is with respect to a drug that is the subject 
                of an investigational use exemption under section 
                505(i) of the Federal Food, Drug, and Cosmetic Act; or
                    ``(B) is--
                            ``(i) conducted by the Department of Health 
                        and Human Services or the Department of 
                        Veterans Affairs; or
                            ``(ii) funded partly or entirely by a 
                        grant, contract, cooperative agreement, or 
                        other transaction from the Department of Health 
                        and Human Services or the Department of 
                        Veterans Affairs.
            ``(3) Expedited procedures.--
                    ``(A) Researcher with a current schedule i or ii 
                research registration.--
                            ``(i) In general.--If a practitioner is 
                        registered to conduct research with a 
                        controlled substance in schedule I or II, the 
                        practitioner may conduct research under this 
                        subsection on and after the date that is 30 
                        days after the date on which the practitioner 
                        sends a notice to the Attorney General 
                        containing the following information, with 
                        respect to each substance with which the 
                        practitioner will conduct the research:
                                    ``(I) The chemical name of the 
                                substance.
                                    ``(II) The quantity of the 
                                substance to be used in the research.
                                    ``(III) Demonstration that the 
                                research is in the category described 
                                in paragraph (2), which demonstration 
                                may be satisfied--
                                            ``(aa) in the case of a 
                                        grant, contract, cooperative 
                                        agreement, or other 
                                        transaction, or intramural 
                                        research project, by 
                                        identifying the sponsoring 
                                        agency and supplying the number 
                                        of the grant, contract, 
                                        cooperative agreement, other 
                                        transaction, or project; or
                                            ``(bb) in the case of an 
                                        application under section 
                                        505(i) of the Federal Food, 
                                        Drug, and Cosmetic Act, by 
                                        supplying the application 
                                        number and the sponsor of 
                                        record on the application.
                                    ``(IV) Demonstration that the 
                                researcher is authorized to conduct 
                                research with respect to the substance 
                                under the laws of the State in which 
                                the research will take place.
                            ``(ii) Verification of information by hhs 
                        or va.--Upon request from the Attorney General, 
                        the Secretary of Health and Human Services or 
                        the Secretary of Veterans Affairs, as 
                        appropriate, shall verify information submitted 
                        by an applicant under clause (i)(III).
                    ``(B) Researcher without a current schedule i or ii 
                research registration.--
                            ``(i) In general.--If a practitioner is not 
                        registered to conduct research with a 
                        controlled substance in schedule I or II, the 
                        practitioner may send a notice to the Attorney 
                        General containing the information listed in 
                        subparagraph (A)(i), with respect to each 
                        substance with which the practitioner will 
                        conduct the research.
                            ``(ii) Attorney general action.--The 
                        Attorney General shall--
                                    ``(I) treat notice received under 
                                clause (i) as a sufficient application 
                                for a research registration; and
                                    ``(II) not later than 45 days of 
                                receiving such a notice that contains 
                                all information required under 
                                subparagraph (A)(i)--
                                            ``(aa) register the 
                                        applicant; or
                                            ``(bb) serve an order to 
                                        show cause upon the applicant 
                                        in accordance with section 
                                        304(c).
            ``(4) Electronic submissions.--The Attorney General shall 
        provide a means to permit a practitioner to submit a 
        notification under paragraph (3) electronically.
            ``(5) Limitation on amounts.--A practitioner conducting 
        research with a schedule I substance under this subsection may 
        only possess the amounts of schedule I substance identified 
        in--
                    ``(A) the notification to the Attorney General 
                under paragraph (3); or
                    ``(B) a supplemental notification that the 
                practitioner may send if the practitioner needs 
                additional amounts for the research, which supplemental 
                notification shall include--
                            ``(i) the name of the practitioner;
                            ``(ii) the additional quantity needed of 
                        the substance; and
                            ``(iii) an attestation that the research to 
                        be conducted with the substance is consistent 
                        with the scope of the research that was the 
                        subject of the notification under paragraph 
                        (3).
            ``(6) Importation and exportation requirements not 
        affected.--Nothing in this subsection alters the requirements 
        of part A of title III, regarding the importation and 
        exportation of controlled substances.''.
    (b) Separate Registrations Not Required for Additional Researcher 
in Same Institution.--Section 302(c) of the Controlled Substances Act 
(21 U.S.C. 822(c)) is amended by adding at the end the following:
            ``(4) An agent or employee of a research institution that 
        is conducting research with a controlled substance if--
                    ``(A) the agent or employee is acting within the 
                scope of the professional practice of the agent or 
                employee;
                    ``(B) another agent or employee of the institution 
                is registered to conduct research with a controlled 
                substance in the same schedule;
                    ``(C) the researcher who is so registered--
                            ``(i) informs the Attorney General of the 
                        name, position title, and employing institution 
                        of the agent or employee who is not separately 
                        registered;
                            ``(ii) authorizes that agent or employee to 
                        perform research under the registration of the 
                        registered researcher; and
                            ``(iii) affirms that any act taken by that 
                        agent or employee involving a controlled 
                        substance shall be attributable to the 
                        registered researcher, as if the researcher had 
                        directly committed the act, for purposes of any 
                        proceeding under section 304(a) to suspend or 
                        revoke the registration of the registered 
                        researcher; and
                    ``(D) the Attorney General does not, within 30 days 
                of receiving the information, authorization, and 
                affirmation described in subparagraph (C), refuse, for 
                a reason listed in section 304(a), to allow the agent 
                or employee to possess the substance without a separate 
                registration.''.
    (c) Single Registration for Related 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:
    ``(3)(A) Notwithstanding paragraph (1), a person registered to 
conduct research with a controlled substance under section 303(f) may 
conduct the research under a single registration if--
            ``(i) the research occurs exclusively on sites all of which 
        are--
                    ``(I) within the same city or county; and
                    ``(II) under the control of the same institution, 
                organization, or agency; and
            ``(ii) before commencing the research, the researcher 
        notifies the Attorney General of each site where--
                    ``(I) the research will be conducted; or
                    ``(II) the controlled substance will be stored or 
                administered.
    ``(B) A site described in subparagraph (A) shall be included in a 
registration described in that subparagraph only if the researcher has 
notified the Attorney General of the site--
            ``(i) in the application for the registration; or
            ``(ii) before the research is conducted, or before the 
        controlled substance is stored or administered, at the site.
    ``(C) The Attorney General may, in consultation with the Secretary, 
issue regulations addressing, with respect to research sites described 
in subparagraph (A)--
            ``(i) the manner in which controlled substances may be 
        delivered to the research sites;
            ``(ii) the storage and security of controlled substances at 
        the research sites;
            ``(iii) the maintenance of records for the research sites; 
        and
            ``(iv) any other matters necessary to ensure effective 
        controls against diversion at the research sites.''.
    (d) New Inspection Not Required in Certain Situations.--Section 
302(f) of the Controlled Substances Act (21 U.S.C. 822(f)) is amended--
            (1) by striking ``(f) The'' and inserting ``(f)(1) The''; 
        and
            (2) by adding at the end the following:
    ``(2)(A) If a person is registered to conduct research with a 
controlled substance and applies for a registration, or for a 
modification of a registration, to conduct research with a second 
controlled substance that is in the same schedule as the first 
controlled substance, or is in a schedule with a higher numerical 
designation than the schedule of the first controlled substance, a new 
inspection by the Attorney General of the registered location is not 
required.
    ``(B) Nothing in subparagraph (A) shall prohibit the Attorney 
General from conducting an inspection that the Attorney General 
determines necessary to ensure that a registrant maintains effective 
controls against diversion.''.
    (e) Continuation of Research on Substances Newly Added to Schedule 
I.--Section 302 of the Controlled Substances Act (21 U.S.C. 822) is 
amended by adding at the end the following:
    ``(h) Continuation of Research on Substances Newly Added to 
Schedule I.--If a person is conducting research on a substance when the 
substance is added to schedule I, and the person is already registered 
to conduct research with a controlled substance in schedule I--
            ``(1) not later than 90 days after the scheduling of the 
        newly scheduled substance, the person shall submit a completed 
        application for registration or modification of existing 
        registration, to conduct research on the substance, in 
        accordance with regulations issued by the Attorney General for 
        purposes of this paragraph;
            ``(2) the person may, notwithstanding subsections (a) and 
        (b), continue to conduct the research on the substance until--
                    ``(A) the person withdraws the application 
                described in paragraph (1) of this subsection; or
                    ``(B) the Attorney General serves on the person an 
                order to show cause proposing the denial of the 
                application under section 304(c);
            ``(3) if the Attorney General serves an order to show cause 
        as described in paragraph (2)(B) and the person requests a 
        hearing, the 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 
        person; and
            ``(4) if the person sends a copy of the application 
        described in paragraph (1) to a manufacturer or distributor of 
        the substance, receipt of the copy by the manufacturer or 
        distributor shall constitute sufficient evidence that the 
        person is authorized to receive the substance.''.
    (f) Treatment of Certain Manufacturing Activities as Coincident to 
Research.--Section 302 of the Controlled Substances Act (21 U.S.C. 
822), as amended by subsection (e), is amended by adding at the end the 
following:
    ``(i) Treatment of Certain Manufacturing Activities as Coincident 
to Research.--
            ``(1) In general.--Except as provided in paragraph (3), a 
        person who is registered to perform research on a controlled 
        substance may perform manufacturing activities with small 
        quantities of that substance, including activities described in 
        paragraph (2), without being required to obtain a manufacturing 
        registration, if--
                    ``(A) the activities are performed for the purpose 
                of the research; and
                    ``(B) the activities and the quantities of the 
                substance involved in the activities are stated in--
                            ``(i) a notification submitted to the 
                        Attorney General under section 303(l);
                            ``(ii) a research protocol filed with an 
                        application for registration approval under 
                        section 303(f); or
                            ``(iii) a notification to the Attorney 
                        General that includes--
                                    ``(I) the name of the registrant; 
                                and
                                    ``(II) an attestation that the 
                                research to be conducted with the small 
                                quantities of manufactured substance is 
                                consistent with the scope of the 
                                research that is the basis for the 
                                registration.
            ``(2) Activities included.--Activities permitted under 
        paragraph (1) include--
                    ``(A) processing the substance to create extracts, 
                tinctures, oils, solutions, derivatives, or other forms 
                of the substance consistent with--
                            ``(i) the information provided as part of a 
                        notification submitted to the Attorney General 
                        under section 303(l); or
                            ``(ii) a research protocol filed with an 
                        application for registration approval under 
                        section 303(f); and
                    ``(B) dosage form development studies performed for 
                the purpose of requesting an investigational new drug 
                exemption under section 505(i) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 355(i)).
            ``(3) Exception regarding marihuana.--The authority under 
        paragraph (1) to manufacture substances does not include the 
        authority to grow marihuana.''.
    (g) Transparency Regarding Special Procedures.--Section 303 of the 
Controlled Substances Act (21 U.S.C. 823), as amended by subsection 
(a), is amended by adding at the end the following:
    ``(m) Transparency Regarding Special Procedures.--
            ``(1) In general.--If the Attorney General determines, with 
        respect to a controlled substance, that an application by a 
        practitioner to conduct research with the substance should be 
        considered under a process, or subject to criteria, different 
        from the process or criteria applicable to applications to 
        conduct research with other controlled substances in the same 
        schedule, the Attorney General shall make public, including by 
        posting on the website of the Drug Enforcement Administration--
                    ``(A) the identities of all substances for which 
                such determinations have been made;
                    ``(B) the process and criteria that shall be 
                applied to applications to conduct research with those 
                substances; and
                    ``(C) how the process and criteria described in 
                subparagraph (B) differ from the process and criteria 
                applicable to applications to conduct research with 
                other controlled substances in the same schedule.
            ``(2) Timing of posting.--The Attorney General shall make 
        information described in paragraph (1) public upon making a 
        determination described in that paragraph, regardless of 
        whether a practitioner has submitted such an application at 
        that time.''.

SEC. 4. RULEMAKING.

    (a) Interim Final Rules.--The Attorney General--
            (1) shall, not later than 1 year of the date of enactment 
        of this Act, issue rules to implement this Act and the 
        amendments made by this Act; and
            (2) may issue the rules under paragraph (1) as interim 
        final rules.
    (b) Procedure for Final Rule.--
            (1) Effectiveness of interim final rules.--A rule issued by 
        the Attorney General as an interim final rule under subsection 
        (a) shall become immediately effective as an interim final rule 
        without requiring the Attorney General to demonstrate good 
        cause therefor, notwithstanding subparagraph (B) of section 
        553(b) of title 5, United States Code.
            (2) Opportunity for comment and hearing.--An interim final 
        rule issued under subsection (a) shall give interested persons 
        the opportunity to comment and to request a hearing.
            (3) Final rule.--After the conclusion of such proceedings, 
        the Attorney General shall issue a final rule to implement this 
        Act and the amendments made by this Act in accordance with 
        section 553 of title 5, United States Code.
                                 <all>