[Congressional Record Volume 169, Number 120 (Thursday, July 13, 2023)]
[Senate]
[Pages S2800-S2802]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 696. Mr. CASSIDY submitted an amendment intended to be proposed by 
him to the bill S. 2226, to authorize appropriations for fiscal year 
2024 for military activities of the Department of Defense, for military 
construction, and for defense activities of the Department of Energy, 
to prescribe military personnel strengths for such fiscal year, and for 
other purposes; which was ordered to lie on the table; as follows:

       At the end of title X, add the following:

                     Subtitle H--HALT Fentanyl Act

     SEC. 1091. SHORT TITLE.

       This subtitle may be cited as the ``Halt All Lethal 
     Trafficking of Fentanyl Act'' or the ``HALT Fentanyl Act''.

     SEC. 1092. 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.

[[Page S2801]]

       ``(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. 1093. 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 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 (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 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:
       ``(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

[[Page S2802]]

     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 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.''.

     SEC. 1094. RULEMAKING.

       (a) Interim Final Rules.--The Attorney General--
       (1) shall, not later than 1 year after the date of 
     enactment of this Act, issue rules to implement this subtitle 
     and the amendments made by this subtitle; 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 subtitle and the amendments made by this subtitle in 
     accordance with section 553 of title 5, United States Code.
                                 ______