[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 5167 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 5167

     To extend the temporary order for fentanyl-related substances.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            December 1, 2022

  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 2022'' or the ``TEST Act of 
2022''.

SEC. 2. 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. 3. EXTENSION OF TEMPORARY ORDER FOR FENTANYL-RELATED SUBSTANCES.

    Section 2 of the Temporary Reauthorization and Study of the 
Emergency Scheduling of Fentanyl Analogues Act (Public Law 116-114; 134 
Stat. 103) is amended by striking ``December 31, 2022'' and inserting 
``2 years after the date of enactment of the Temporary Emergency 
Scheduling and Testing of Fentanyl Analogues Act of 2022''.

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

    (a) Synthetic Compound.--Not later than 1 year after the date of 
enactment of this Act, for each fentanyl-related substance that the 
Attorney General has encountered before the date of enactment of this 
Act, but not yet conducted an evaluation, the Attorney General shall 
create a synthetic compound of that substance and submit the compound 
to the Secretary of Health and Human Services in order to solicit a 
scientific and medical evaluation of that compound from the Secretary.
    (b) Deadline.--
            (1) In general.--Except as provided in paragraph (2), the 
        Secretary of Health and Human Services shall complete the 
        requested scientific and medical evaluation under subsection 
        (a) not later than 1 year after receiving the solicitation from 
        the Attorney General.
            (2) Extension.--If the Attorney General is unable to create 
        a synthetic compound before the expiration of the 1-year period 
        described in paragraph (1)--
                    (A) the Attorney General shall--
                            (i) 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
                            (ii) complete the requirements under 
                        subsection (a) not later than 180 days after 
                        the expiration of the 1-year period.

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 are any of 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) Previously Analyzed Fentanyl-Related Substances.--To the 
extent that the Drug Enforcement Administration or the Department of 
Health and Human Services has conducted any evaluation or analysis 
(even if such analysis is not an evaluation under this section) of any 
fentanyl-related substance before the date of the enactment of this 
subsection, the Attorney General shall publish the results and any 
other information related to the evaluation or analysis on a public 
website not later than 90 days after the date of enactment of this 
subsection.
    ``(m) Fentanyl-Related Substances Research Capacity.--The Drug 
Enforcement Administration and Department of Health and Human Services 
shall hire, employ, or retain the staff, researchers, and other 
qualified individuals necessary to carry out the requirements of 
paragraphs (1) and (2) of subsection (k), including, if appropriate to 
fulfill those requirements, establishing a consortium of chemists and 
researchers who may be readily hired, employed, or retrained without a 
request for proposals.
    ``(n) Evaluations or Studies.--The Secretary may enter into 
contracts or other agreements to conduct or support evaluations or 
studies of fentanyl-related substances.
    ``(o) Registration Requirements for Research Applications.--
Registration requirements for the research of fentanyl-related 
substances shall be those applicable to schedule II substances pursuant 
to section 1301.13 of title 21, Code of Federal Regulations.
    ``(p) Publication.--The Secretary shall publish on a public 
website--
            ``(1) each evaluation conducted pursuant to an Attorney 
        General solicitation 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
            ``(2) the results and any other information related to 
        previously evaluated fentanyl-related services pursuant to 
        subsection (l).
    ``(q) 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 section 3 of the Temporary Emergency 
Scheduling and Testing of Fentanyl Analogues Act of 2022.''.

SEC. 6. NOTIFICATION.

    The Attorney General shall notify each individual who is the 
subject of a pending prosecution for, or has been convicted or 
sentenced for, an offense involving a fentanyl-related substance that 
is subsequently removed or rescheduled under paragraphs (1) and (2) of 
section 201(k) of the Controlled Substances Act, as added by section 5 
of this Act, about the change in schedule designation not later than 90 
days after the change, and provide information about the effect of the 
change on their prosecution, conviction, or sentence.
                                 <all>