[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1950 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  1st Session
                                S. 1950

     To extend the temporary order for fentanyl-related substances.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 13, 2023

  Mr. Booker introduced the following bill; which was read twice and 
               referred to the Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
     To extend the temporary order for fentanyl-related 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 ``Temporary Emergency Scheduling and 
Testing of Fentanyl Analogues Act of 2023'' or the ``TEST Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Passed in 1970, the Controlled Substances Act (21 
        U.S.C. 801 et seq.) created 5 schedules for controlled 
        substances. To schedule a substance, the Drug Enforcement 
        Administration must make a finding of the potential for abuse 
        and currently accepted medical use of the substance.
            (2) Under section 201(b) of the Controlled Substances Act 
        (21 U.S.C. 811(b)), the Attorney General must request a 
        scheduling recommendation from the Secretary of Health and 
        Human Services based on an 8-factor medical and scientific 
        analysis.
            (3) The Secretary is required to return a recommendation to 
        the Attorney General within a reasonable amount of time and the 
        recommendation shall be binding on the Attorney General as to 
        scientific and medical matters.
            (4) The scientific and medical evaluation conducted by the 
        Secretary is necessary to understand the characteristics of any 
        substance, including whether the substance may be harmful, 
        harmless, or have potential medical uses.
            (5) Since October 2016, the Drug Enforcement Administration 
        has identified 36 fentanyl-related substances to be scheduled 
        pursuant to section 201(b) of the Controlled Substances Act (21 
        U.S.C. 811(b)).
            (6) As of April 2023, of the 36 fentanyl-related substances 
        described in paragraph (5), 24 have been subjected to 
        scientific and medical analysis. There remain 12 fentanyl-
        related substances for which the Drug Enforcement 
        Administration has yet to begin or complete a scientific 
        medical evaluation.
            (7) In the midst of the fentanyl crisis that is ravaging 
        communities across the United States, it is imperative that the 
        Federal Government analyze and study fentanyl-related 
        substances expeditiously and that the scientific community be 
        able to research these substances in order to develop life-
        saving antidotes and treatments. The most promising life-saving 
        antidotes and treatments for fentanyl addiction and overdose 
        are likely to share molecular properties with fentanyl and its 
        related substances.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Evaluation.--The term ``evaluation'' means a scientific 
        and medical evaluation, as conducted by the Secretary of Health 
        and Human Services at the request of the Attorney General, and 
        the recommendations as to whether such drug or other substance 
        should be so controlled or removed as a controlled substance 
        from the schedules pursuant to section 201(b) of the Controlled 
        Substances Act (21 U.S.C. 811(b)).
            (2) Fentanyl-related substance.--The term ``fentanyl-
        related substance'' has the meaning given the term in section 
        1308.11 of title 21, Code of Federal Regulations.

SEC. 4. EVALUATION OF ENCOUNTERED FENTANYL-RELATED SUBSTANCES.

    (a) Identified Substances.--
            (1) In general.--The Attorney General shall complete the 
        proceedings to schedule or transfer between schedules, or 
        remove any fentanyl-related substances from the schedules 
        pursuant to subsection (k) of section 201 of the Controlled 
        Substances Act (21 U.S.C. 811), as added by section 5 of this 
        Act--
                    (A) not later than 1 year after the date of 
                enactment of this Act for each fentanyl-related 
                substance that--
                            (i) the Drug Enforcement Administration has 
                        identified, as of the date of enactment of this 
                        Act; and
                            (ii) is not permanently scheduled; and
                    (B) not later than 3 years after the date on which 
                a fentanyl-related substance is identified if the 
                fentanyl-related substance--
                            (i) is identified after the date of 
                        enactment of this Act; and
                            (ii) is not permanently scheduled.
            (2) Extension.--If the Attorney General is unable to 
        complete the proceedings described in paragraph (1) within the 
        required time period the Attorney General shall--
                    (A) notify the Committee on the Judiciary of the 
                Senate and the Committee on the Judiciary of the House 
                of Representatives of the delay and publish the 
                notification on a public website; and
                    (B) complete the proceedings described in paragraph 
                (1) not later than 1 year after the notification 
                required under subparagraph (A) of this paragraph.
    (b) Temporary Scheduling.--Notwithstanding any other provision of 
law, the Attorney General may schedule a fentanyl-related substance 
identified after the date of enactment of this Act in schedule I of 
section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) in 
accordance with section 201(h) of that Act (21 U.S.C. 811(h)) for not 
longer than 3 years after the date on which the order scheduling the 
fentanyl-related substance is issued.

SEC. 5. REMOVAL FROM SCHEDULE I 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) Determination Resulting in Removal.--
            ``(1) In general.--If the Secretary determines, taking into 
        consideration factors as set forth in paragraph (3), that a 
        fentanyl-related substance has a potential for abuse that is 
        less than the drugs or other substances in schedule V--
                    ``(A) the Secretary shall submit to the Attorney 
                General a scientific and medical evaluation of that 
                fentanyl-related substance supporting that 
                determination;
                    ``(B) the Secretary shall submit any such 
                evaluation and determination in writing and include the 
                bases therefor;
                    ``(C) the scientific and medical determination of 
                the Secretary contained in such evaluation shall be 
                binding on the Attorney General; and
                    ``(D) not later than 90 days after receiving such 
                evaluation and determination, the Attorney General 
                shall issue an order removing such fentanyl-related 
                substance from the schedules under section 202.
            ``(2) Determination resulting in rescheduling.--If the 
        Secretary determines, taking into consideration factors as set 
        forth in paragraph (3), that a fentanyl-related substance has a 
        potential for abuse that is less than the drugs or other 
        substances in schedules I and II--
                    ``(A) the Secretary shall submit to the Attorney 
                General a scientific and medical evaluation of that 
                fentanyl-related substance supporting that 
                determination;
                    ``(B) the Secretary shall submit any such 
                evaluation and determination in writing and include the 
                bases therefor;
                    ``(C) the scientific and medical determination of 
                the Secretary contained in such evaluation shall be 
                binding on the Attorney General; and
                    ``(D) not later than 90 days after receiving such 
                evaluation, the Attorney General shall issue an order 
                removing such fentanyl-related substance from schedule 
                I and controlling such substance under schedule III, 
                IV, or V.
            ``(3) Evaluation factors.--
                    ``(A) In general.--In making a determination under 
                paragraph (1) or (2), the Secretary--
                            ``(i) shall consider--
                                    ``(I) the factor listed in 
                                paragraph (2) of subsection (c);
                                    ``(II) the factors listed in 
                                paragraphs (1), (3), and (6) of such 
                                subsection to the extent evidence 
                                exists with respect to such factors; 
                                and
                                    ``(III) any information submitted 
                                to the Secretary by the Attorney 
                                General for purposes of such 
                                determination; and
                            ``(ii) may consider the factors listed in 
                        paragraphs (4), (5), and (7) of subsection (c) 
                        if the Secretary finds that evidence exists 
                        with respect to such factors.
                    ``(B) Consideration of scientific evidence of 
                pharmacological effect.--
                            ``(i) In general.--For the purposes of 
                        subparagraph (A)(i)(I), consideration by the 
                        Secretary of the results of an assessment 
                        consisting of the studies described in clause 
                        (ii) shall constitute consideration of the 
                        factor listed in paragraph (2) of subsection 
                        (c) if--
                                    ``(I) each such study is performed 
                                according to scientific methods and 
                                protocols commonly accepted in the 
                                scientific community; and
                                    ``(II) the Secretary determines 
                                that such assessment is adequate for 
                                such purposes.
                            ``(ii) Described studies.--The studies 
                        described in this clause include the following:
                                    ``(I) A receptor binding study that 
                                can demonstrate whether the substance 
                                has affinity for the human mu opioid 
                                receptor.
                                    ``(II) An in vitro functional assay 
                                that can demonstrate whether the 
                                substance has agonist activity at the 
                                human mu opioid receptor.
                                    ``(III) One or more in vivo animal 
                                behavioral studies that can demonstrate 
                                whether the substance has abuse-related 
                                drug effects consistent with mu opioid 
                                agonist activity, such as demonstrating 
                                similarity to the effects of morphine.
    ``(l) Publication.--
            ``(1) In general.--The Secretary shall publish on a public 
        website--
                    ``(A) information related to each evaluation 
                conducted pursuant to subsection (k)(3) within 60 days 
                of the completion of the scientific and medical 
                evaluation, even if such evaluation did not result in a 
                descheduling or rescheduling determination; and
                    ``(B) the results and any other information related 
                to previously evaluated fentanyl-related services 
                pursuant to subsection (l).
            ``(2) Applicability.--Paragraph (1) shall not apply to an 
        evaluation conducted for an application for a new drug under 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355).
    ``(m) Authorization of Appropriations.--There is authorized to be 
appropriated to the Secretary $50,000,000 for fiscal years 2023 and 
2024, to remain available until expended, for the evaluation fentanyl-
related substances pursuant to this section.''.

SEC. 6. 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--
            (1) by redesignating the second subsection (l) (relating to 
        required training for prescribers) as subsection (m); and
            (2) by adding at the end the following:
    ``(n) 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 (21 
                U.S.C. 355(i)); or
                    ``(B) is--
                            ``(i) conducted by the Department of Health 
                        and Human Services, the Department of Defense, 
                        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, the Department of Defense, 
                        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 (21 
                                        U.S.C. 355(i)), 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, the 
                        Secretary of Defense, 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.
            ``(7) Inspector general report.--Not later than 1 year 
        after the date of enactment of this Act, the Inspector General 
        of the Department of Justice shall complete a study, and submit 
        to Congress a report thereon, about research described in 
        paragraph (2) of this subsection with fentanyl.''.
    (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:
    ``(4)(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(n);
                            ``(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(n); 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 marijuana.--The authority under 
        paragraph (1) to manufacture substances does not include the 
        authority to grow marijuana.''.
    (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:
    ``(o) 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.''.
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