,,ii #aagth ,,congress #ast ,session ,s4 #cccf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #h1 #bjba,mr4 ,cassidy 7for himself and ,mr4 ,burr7 introduced the following bill2 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 substances1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,halt ,all ,lethal ,trafficking of ,fentanyl ,act or the ,,halt ,fentanyl ,act4 #b4 ,class scheduling of fentanyl-related substances ,section #bjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7;c77 is amended by adding at the end of schedule ,i the following3 7e7 7#a7 ,unless specifically exempted or unless listed in another schedule1 any material1 compound1 mixture1 or preparation which contains any quantity of a fentanyl-related substance1 or which contains the salts1 isomers1 and salts of isomers of a fentanyl-related substance whenever the existence of such salts1 isomers1 and salts of isomers is possible within the specific chemical designation4 7#b7 ,for purposes of paragraph 7#a71 except as provided in paragraph 7#c71 the term fentanyl-related substance means any substance that is structurally related to fentanyl by #a or more of the following modifications3 7,a7 ,by replacement of the phenyl portion of the phenethyl group by any monocycle1 whether or not further substituted in or on the monocycle4 7,b7 ,by substitution in or on the phenethyl group with alkyl1 alkenyl1 alkoxyl1 hydroxyl1 halo1 haloalkyl1 amino1 or nitro groups4 7,c7 ,by substitution in or on the piperidine ring with alkyl1 alkenyl1 alkoxyl1 ester1 ether1 hydroxyl1 halo1 haloalkyl1 amino1 or nitro groups4 7,d7 ,by replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle4 7,e7 ,by replacement of the ,n-propionyl group with another acyl group4 7#c7 ,a substance that satisfies the definition of the term fentanyl-related substance in paragraph 7#b7 shall nonetheless not be treated as a fentanyl-related substance subject to this schedule if the substance-- 7,a7 is controlled by action of the ,attorney ,general under section #bja2 or 7,b7 is otherwise expressly listed in a schedule other than this schedule4 7#d7 7,a7 ,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 7#b74 7,b7 ,the absence of a substance from a list published under subparagraph 7,a7 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 7#b74 4 #c4 ,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 by adding at the end the following3 7l7 ,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 ,act2 or 7,b7 is-- 7i7 conducted by the ,department of ,health and ,human ,services 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 ,services 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 ,act1 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 ,services 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 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#c7 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 #cjc7l72 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 #cjc7l72 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 marihuana ,the authority under paragraph 7#a7 to manufacture substances does not include the authority to grow marihuana4 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 7m7 ,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 #d4 ,rulemaking 7a7 ,interim final rules ,the ,attorney ,general-- 7#a7 shall1 not later than #a year of the date of enactment of this ,act1 issue rules to implement this ,act and the amendments made by this ,act2 and 7#b7 may issue the rules under paragraph 7#a7 as interim final rules4 7b7 ,procedure for final rule 7#a7 ,effectiveness of interim final rules ,a rule issued by the ,attorney ,general as an interim final rule under subsection 7a7 shall become immediately effective as an interim final rule without requiring the ,attorney ,general to demonstrate good cause therefor1 notwithstanding subparagraph 7,b7 of section #eec7;b7 of title #e1 ,united ,states ,code4 7#b7 ,opportunity for comment and hearing ,an interim final rule issued under subsection 7a7 shall give interested persons the opportunity to comment and to request a hearing4 7#c7 ,final rule ,after the conclusion of such proceedings1 the ,attorney ,general shall issue a final rule to implement this ,act and the amendments made by this ,act in accordance with section #eec of title #e1 ,united ,states ,code4