,,ii #aahth ,,congress #ast ,session ,s4 #aiej ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #ac1 #bjbc,mr4 ,booker introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to extend the temporary order for fentanyl-related substances4 #a4 ,short title ,this ,act may be cited as the ,temporary ,emergency ,scheduling and ,testing of ,fentanyl ,analogues ,act of #bjbc or the ,,test ,act4 #b4 ,findings ,congress finds the following3 7#a7 ,passed in #aigj1 the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 created #e schedules for controlled substances4 ,to schedule a substance1 the ,drug ,enforcement ,administration must make a finding of the potential for abuse and currently accepted medical use of the substance4 7#b7 ,under section #bja7;b7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7;b771 the ,attorney ,general must request a scheduling recommendation from the ,secretary of ,health and ,human ,services based on an #h-;factor medical and scientific analysis4 7#c7 ,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 matters4 7#d7 ,the scientific and medical evaluation conducted by the ,secretary is necessary to understand the characteristics of any substance1 including whether the substance may be harmful1 harmless1 or have potential medical uses4 7#e7 ,since ,october #bjaf1 the ,drug ,enforcement ,administration has identified #cf fentanyl-related substances to be scheduled pursuant to section #bja7;b7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7;b774 7#f7 ,as of ,april #bjbc1 of the #cf fentanyl-related substances described in paragraph 7#e71 #bd have been subjected to scientific and medical analysis4 ,there remain #ab fentanyl-related substances for which the ,drug ,enforcement ,administration has yet to begin or complete a scientific medical evaluation4 7#g7 ,in the midst of the fentanyl crisis that is ravaging communities across the ,united ,states1 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 treatments4 ,the most promising life-saving antidotes and treatments for fentanyl addiction and overdose are likely to share molecular properties with fentanyl and its related substances4 #c4 ,definitions ,in this ,act3 7#a7 ,evaluation ,the term evaluation means a scientific and medical evaluation1 as conducted by the ,secretary of ,health and ,human ,services at the request of the ,attorney ,general1 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 #bja7;b7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7;b774 7#b7 ,fentanyl-related substance ,the term fentanyl-related substance has the meaning given the term in section #acjh4aa of title #ba1 ,code of ,federal ,regulations4 #d4 ,evaluation of encountered fentanyl-related substances 7a7 ,identified substances 7#a7 ,in general ,the ,attorney ,general shall complete the proceedings to schedule or transfer between schedules1 or remove any fentanyl-related substances from the schedules pursuant to subsection 7k7 of section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa71 as added by section #e of this ,act-- 7,a7 not later than #a year after the date of enactment of this ,act for each fentanyl-related substance that-- 7i7 the ,drug ,enforcement ,administration has identified1 as of the date of enactment of this ,act2 and 7ii7 is not permanently scheduled2 and 7,b7 not later than #c years after the date on which a fentanyl-related substance is identified if the fentanyl-related substance-- 7i7 is identified after the date of enactment of this ,act2 and 7ii7 is not permanently scheduled4 7#b7 ,extension ,if the ,attorney ,general is unable to complete the proceedings described in paragraph 7#a7 within the required time period the ,attorney ,general shall-- 7,a7 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 website2 and 7,b7 complete the proceedings described in paragraph 7#a7 not later than #a year after the notification required under subparagraph 7,a7 of this paragraph4 7b7 ,temporary scheduling ,notwithstanding any other provision of law1 the ,attorney ,general may schedule a fentanyl-related substance identified after the date of enactment of this ,act in schedule ,i of section #bjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7;c77 in accordance with section #bja7;h7 of that ,act 7#ba ,u4,s4,c4 #haa7;h77 for not longer than #c years after the date on which the order scheduling the fentanyl-related substance is issued4 #e4 ,removal from schedule ,i of fentanyl-related substances ,section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 is amended by adding at the end the following new subsection3 7k7 ,determination resulting in removal 7#a7 ,in general ,if the ,secretary determines1 taking into consideration factors as set forth in paragraph 7#c71 that a fentanyl-related substance has a potential for abuse that is less than the drugs or other substances in schedule ,v-- 7,a7 the ,secretary shall submit to the ,attorney ,general a scientific and medical evaluation of that fentanyl-related substance supporting that determination2 7,b7 the ,secretary shall submit any such evaluation and determination in writing and include the bases therefor2 7,c7 the scientific and medical determination of the ,secretary contained in such evaluation shall be binding on the ,attorney ,general2 and 7,d7 not later than #ij days after receiving such evaluation and determination1 the ,attorney ,general shall issue an order removing such fentanyl-related substance from the schedules under section #bjb4 7#b7 ,determination resulting in rescheduling ,if the ,secretary determines1 taking into consideration factors as set forth in paragraph 7#c71 that a fentanyl-related substance has a potential for abuse that is less than the drugs or other substances in schedules ,i and ,,ii-- 7,a7 the ,secretary shall submit to the ,attorney ,general a scientific and medical evaluation of that fentanyl-related substance supporting that determination2 7,b7 the ,secretary shall submit any such evaluation and determination in writing and include the bases therefor2 7,c7 the scientific and medical determination of the ,secretary contained in such evaluation shall be binding on the ,attorney ,general2 and 7,d7 not later than #ij days after receiving such evaluation1 the ,attorney ,general shall issue an order removing such fentanyl-related substance from schedule ,i and controlling such substance under schedule ,,iii1 ,,iv1 or ,v4 7#c7 ,evaluation factors 7,a7 ,in general ,in making a determination under paragraph 7#a7 or 7#b71 the ,secretary-- 7i7 shall consider-- 7,i7 the factor listed in paragraph 7#b7 of subsection 7c72 7,,ii7 the factors listed in paragraphs 7#a71 7#c71 and 7#f7 of such subsection to the extent evidence exists with respect to such factors2 and 7,,iii7 any information submitted to the ,secretary by the ,attorney ,general for purposes of such determination2 and 7ii7 may consider the factors listed in paragraphs 7#d71 7#e71 and 7#g7 of subsection 7c7 if the ,secretary finds that evidence exists with respect to such factors4 7,b7 ,consideration of scientific evidence of pharmacological effect 7i7 ,in general ,for the purposes of subparagraph 7,a77i77,i71 consideration by the ,secretary of the results of an assessment consisting of the studies described in clause 7ii7 shall constitute consideration of the factor listed in paragraph 7#b7 of subsection 7c7 if-- 7,i7 each such study is performed according to scientific methods and protocols commonly accepted in the scientific community2 and 7,,ii7 the ,secretary determines that such assessment is adequate for such purposes4 7ii7 ,described studies ,the studies described in this clause include the following3 7,i7 ,a receptor binding study that can demonstrate whether the substance has affinity for the human mu opioid receptor4 7,,ii7 ,an in vitro functional assay that can demonstrate whether the substance has agonist activity at the human mu opioid receptor4 7,,iii7 ,one or more in vivo animal behavioral studies that can demonstrate whether the substance has abuse-related drug effects consistent with mu opioid agonist activity1 such as demonstrating similarity to the effects of morphine4 7l7 ,publication 7#a7 ,in general ,the ,secretary shall publish on a public website-- 7,a7 information related to each evaluation conducted pursuant to subsection 7k77#c7 within #fj days of the completion of the scientific and medical evaluation1 even if such evaluation did not result in a descheduling or rescheduling determination2 and 7,b7 the results and any other information related to previously evaluated fentanyl-related services pursuant to subsection 7l74 7#b7 ,applicability ,paragraph 7#a7 shall not apply to an evaluation conducted for an application for a new drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7m7 ,authorization of appropriations ,there is authorized to be appropriated to the ,secretary #ej1jjj1jjj for fiscal years #bjbc and #bjbd1 to remain available until expended1 for the evaluation fentanyl-related substances pursuant to this section4 4 #f4 ,registration requirements related to research 7a7 ,alternative registration process for schedule i research ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended-- 7#a7 by redesignating the second subsection 7l7 7relating to required training for prescribers7 as subsection 7m72 and 7#b7 by adding at the end the following3 7n7 ,special provisions for practitioners conducting certain research with schedule ,i controlled substances 7#a7 ,in general ,notwithstanding subsection 7f71 a practitioner may conduct research described in paragraph 7#b7 of this subsection with #a or more schedule ,i substances in accordance with subparagraph 7,a7 or 7,b7 of paragraph 7#c7 of this subsection4 7#b7 ,research subject to expedited procedures ,research described in this paragraph is research that-- 7,a7 is with respect to a drug that is the subject of an investigational use exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i772 or 7,b7 is-- 7i7 conducted by the ,department of ,health and ,human ,services1 the ,department of ,defense1 or the ,department of ,veterans ,affairs2 or 7ii7 funded partly or entirely by a grant1 contract1 cooperative agreement1 or other transaction from the ,department of ,health and ,human ,services1 the ,department of ,defense1 or the ,department of ,veterans ,affairs4 7#c7 ,expedited procedures 7,a7 ,researcher with a current schedule i or ii research registration 7i7 ,in general ,if a practitioner is registered to conduct research with a controlled substance in schedule ,i or ,,ii1 the practitioner may conduct research under this subsection on and after the date that is #cj days after the date on which the practitioner sends a notice to the ,attorney ,general containing the following information1 with respect to each substance with which the practitioner will conduct the research3 7,i7 ,the chemical name of the substance4 7,,ii7 ,the quantity of the substance to be used in the research4 7,,iii7 ,demonstration that the research is in the category described in paragraph 7#b71 which demonstration may be satisfied-- 7aa7 in the case of a grant1 contract1 cooperative agreement1 or other transaction1 or intramural research project1 by identifying the sponsoring agency and supplying the number of the grant1 contract1 cooperative agreement1 other transaction1 or project2 or 7bb7 in the case of an application under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771 by supplying the application number and the sponsor of record on the application4 7,,iv7 ,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 place4 7ii7 ,verification of information by hhs or va ,upon request from the ,attorney ,general1 the ,secretary of ,health and ,human ,services1 the ,secretary of ,defense1 or the ,secretary of ,veterans ,affairs1 as appropriate1 shall verify information submitted by an applicant under clause 7i77,,iii74 7,b7 ,researcher without a current schedule i or ii research registration 7i7 ,in general ,if a practitioner is not registered to conduct research with a controlled substance in schedule ,i or ,,ii1 the practitioner may send a notice to the ,attorney ,general containing the information listed in subparagraph 7,a77i71 with respect to each substance with which the practitioner will conduct the research4 7ii7 ,attorney ,general action ,the ,attorney ,general shall-- 7,i7 treat notice received under clause 7i7 as a sufficient application for a research registration2 and 7,,ii7 not later than #de days of receiving such a notice that contains all information required under subparagraph 7,a77i7-- 7aa7 register the applicant2 or 7bb7 serve an order to show cause upon the applicant in accordance with section #cjd7;c74 7#d7 ,electronic submissions ,the ,attorney ,general shall provide a means to permit a practitioner to submit a notification under paragraph 7#c7 electronically4 7#e7 ,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-- 7,a7 the notification to the ,attorney ,general under paragraph 7#c72 or 7,b7 a supplemental notification that the practitioner may send if the practitioner needs additional amounts for the research1 which supplemental notification shall include-- 7i7 the name of the practitioner2 7ii7 the additional quantity needed of the substance2 and 7iii7 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 7#c74 7#f7 ,importation and exportation requirements not affected ,nothing in this subsection alters the requirements of part ,a of title ,,iii1 regarding the importation and exportation of controlled substances4 7#g7 ,inspector ,general report ,not later than #a year after the date of enactment of this ,act1 the ,inspector ,general of the ,department of ,justice shall complete a study1 and submit to ,congress a report thereon1 about research described in paragraph 7#b7 of this subsection with fentanyl4 4 7b7 ,separate registrations not required for additional researcher in same institution ,section #cjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7;c77 is amended by adding at the end the following3 7#d7 ,an agent or employee of a research institution that is conducting research with a controlled substance if-- 7,a7 the agent or employee is acting within the scope of the professional practice of the agent or employee2 7,b7 another agent or employee of the institution is registered to conduct research with a controlled substance in the same schedule2 7,c7 the researcher who is so registered-- 7i7 informs the ,attorney ,general of the name1 position title1 and employing institution of the agent or employee who is not separately registered2 7ii7 authorizes that agent or employee to perform research under the registration of the registered researcher2 and 7iii7 affirms that any act taken by that agent or employee involving a controlled substance shall be attributable to the registered researcher1 as if the researcher had directly committed the act1 for purposes of any proceeding under section #cjd7;a7 to suspend or revoke the registration of the registered researcher2 and 7,d7 the ,attorney ,general does not1 within #cj days of receiving the information1 authorization1 and affirmation described in subparagraph 7,c71 refuse1 for a reason listed in section #cjd7;a71 to allow the agent or employee to possess the substance without a separate registration4 4 7c7 ,single registration for related research sites ,section #cjb7;e7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7;e77 is amended by adding at the end the following3 7#d7 7,a7 ,notwithstanding paragraph 7#a71 a person registered to conduct research with a controlled substance under section #cjc7;f7 may conduct the research under a single registration if-- 7i7 the research occurs exclusively on sites all of which are-- 7,i7 within the same city or county2 and 7,,ii7 under the control of the same institution1 organization1 or agency2 and 7ii7 before commencing the research1 the researcher notifies the ,attorney ,general of each site where-- 7,i7 the research will be conducted2 or 7,,ii7 the controlled substance will be stored or administered4 7,b7 ,a site described in subparagraph 7,a7 shall be included in a registration described in that subparagraph only if the researcher has notified the ,attorney ,general of the site-- 7i7 in the application for the registration2 or 7ii7 before the research is conducted1 or before the controlled substance is stored or administered1 at the site4 7,c7 ,the ,attorney ,general may1 in consultation with the ,secretary1 issue regulations addressing1 with respect to research sites described in subparagraph 7,a7-- 7i7 the manner in which controlled substances may be delivered to the research sites2 7ii7 the storage and security of controlled substances at the research sites2 7iii7 the maintenance of records for the research sites2 and 7iv7 any other matters necessary to ensure effective controls against diversion at the research sites4 4 7d7 ,new inspection not required in certain situations ,section #cjb7;f7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7;f77 is amended-- 7#a7 by striking 7f7 ,the and inserting 7f77#a7 ,the2 and 7#b7 by adding at the end the following3 7#b7 7,a7 ,if a person is registered to conduct research with a controlled substance and applies for a registration1 or for a modification of a registration1 to conduct research with a second controlled substance that is in the same schedule as the first controlled substance1 or is in a schedule with a higher numerical designation than the schedule of the first controlled substance1 a new inspection by the ,attorney ,general of the registered location is not required4 7,b7 ,nothing in subparagraph 7,a7 shall prohibit the ,attorney ,general from conducting an inspection that the ,attorney ,general determines necessary to ensure that a registrant maintains effective controls against diversion4 4 7e7 ,continuation of research on substances newly added to schedule i ,section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7 is amended by adding at the end the following3 7h7 ,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 ,i1 and the person is already registered to conduct research with a controlled substance in schedule ,i-- 7#a7 not later than #ij days after the scheduling of the newly scheduled substance1 the person shall submit a completed application for registration or modification of existing registration1 to conduct research on the substance1 in accordance with regulations issued by the ,attorney ,general for purposes of this paragraph2 7#b7 the person may1 notwithstanding subsections 7a7 and 7b71 continue to conduct the research on the substance until-- 7,a7 the person withdraws the application described in paragraph 7#a7 of this subsection2 or 7,b7 the ,attorney ,general serves on the person an order to show cause proposing the denial of the application under section #cjd7;c72 7#c7 if the ,attorney ,general serves an order to show cause as described in paragraph 7#b77;,b7 and the person requests a hearing1 the hearing shall be held on an expedited basis and not later than #de days after the request is made1 except that the hearing may be held at a later time if so requested by the person2 and 7#d7 if the person sends a copy of the application described in paragraph 7#a7 to a manufacturer or distributor of the substance1 receipt of the copy by the manufacturer or distributor shall constitute sufficient evidence that the person is authorized to receive the substance4 4 7f7 ,treatment of certain manufacturing activities as coincident to research ,section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb71 as amended by subsection 7e71 is amended by adding at the end the following3 7i7 ,treatment of certain manufacturing activities as coincident to research 7#a7 ,in general ,except as provided in paragraph 7#c71 a person who is registered to perform research on a controlled substance may perform manufacturing activities with small quantities of that substance1 including activities described in paragraph 7#b71 without being required to obtain a manufacturing registration1 if-- 7,a7 the activities are performed for the purpose of the research2 and 7,b7 the activities and the quantities of the substance involved in the activities are stated in-- 7i7 a notification submitted to the ,attorney ,general under section #cjc7n72 7ii7 a research protocol filed with an application for registration approval under section #cjc7;f72 or 7iii7 a notification to the ,attorney ,general that includes-- 7,i7 the name of the registrant2 and 7,,ii7 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 registration4 7#b7 ,activities included ,activities permitted under paragraph 7#a7 include-- 7,a7 processing the substance to create extracts1 tinctures1 oils1 solutions1 derivatives1 or other forms of the substance consistent with-- 7i7 the information provided as part of a notification submitted to the ,attorney ,general under section #cjc7n72 or 7ii7 a research protocol filed with an application for registration approval under section #cjc7;f72 and 7,b7 dosage form development studies performed for the purpose of requesting an investigational new drug exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i774 7#c7 ,exception regarding marijuana ,the authority under paragraph 7#a7 to manufacture substances does not include the authority to grow marijuana4 4 7g7 ,transparency regarding special procedures ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc71 as amended by subsection 7a71 is amended by adding at the end the following3 7o7 ,transparency regarding special procedures 7#a7 ,in general ,if the ,attorney ,general determines1 with respect to a controlled substance1 that an application by a practitioner to conduct research with the substance should be considered under a process1 or subject to criteria1 different from the process or criteria applicable to applications to conduct research with other controlled substances in the same schedule1 the ,attorney ,general shall make public1 including by posting on the website of the ,drug ,enforcement ,administration-- 7,a7 the identities of all substances for which such determinations have been made2 7,b7 the process and criteria that shall be applied to applications to conduct research with those substances2 and 7,c7 how the process and criteria described in subparagraph 7,b7 differ from the process and criteria applicable to applications to conduct research with other controlled substances in the same schedule4 7#b7 ,timing of posting ,the ,attorney ,general shall make information described in paragraph 7#a7 public upon making a determination described in that paragraph1 regardless of whether a practitioner has submitted such an application at that time4 4