,,ii #aagth ,,congress #b;d ,session ,s4 #eafg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #a1 #bjbb ,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 #bjbb or the ,,test ,act of #bjbb4 #b4 ,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 #c4 ,extension of temporary order for fentanyl-related substances ,section #b of the ,temporary ,reauthorization and ,study of the ,emergency ,scheduling of ,fentanyl ,analogues ,act 7,public ,law #aaf-aad2 #acd ,stat4 #ajc7 is amended by striking ,december #ca1 #bjbb and inserting #b years after the date of enactment of the ,temporary ,emergency ,scheduling and ,testing of ,fentanyl ,analogues ,act of #bjbb4 #d4 ,evaluation of encountered fentanyl-related substances 7a7 ,synthetic compound ,not later than #a year after the date of enactment of this ,act1 for each fentanyl-related substance that the ,attorney ,general has encountered before the date of enactment of this ,act1 but not yet conducted an evaluation1 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 ,secretary4 7b7 ,deadline 7#a7 ,in general ,except as provided in paragraph 7#b71 the ,secretary of ,health and ,human ,services shall complete the requested scientific and medical evaluation under subsection 7a7 not later than #a year after receiving the solicitation from the ,attorney ,general4 7#b7 ,extension ,if the ,attorney ,general is unable to create a synthetic compound before the expiration of the #a-year period described in paragraph 7#a7-- 7,a7 the ,attorney ,general shall-- 7i7 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 7ii7 complete the requirements under subsection 7a7 not later than #ahj days after the expiration of the #a-year period4 #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 ,,iv 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 are any of 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 ,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 7even if such analysis is not an evaluation under this section7 of any fentanyl-related substance before the date of the enactment of this subsection1 the ,attorney ,general shall publish the results and any other information related to the evaluation or analysis on a public website not later than #ij days after the date of enactment of this subsection4 7m7 ,fentanyl-,related substances research capacity ,the ,drug ,enforcement ,administration and ,department of ,health and ,human ,services shall hire1 employ1 or retain the staff1 researchers1 and other qualified individuals necessary to carry out the requirements of paragraphs 7#a7 and 7#b7 of subsection 7k71 including1 if appropriate to fulfill those requirements1 establishing a consortium of chemists and researchers who may be readily hired1 employed1 or retrained without a request for proposals4 7n7 ,evaluations or studies ,the ,secretary may enter into contracts or other agreements to conduct or support evaluations or studies of fentanyl-related substances4 7o7 ,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 #acja4ac of title #ba1 ,code of ,federal ,regulations4 7p7 ,publication ,the ,secretary shall publish on a public website-- 7#a7 each evaluation conducted pursuant to an ,attorney ,general solicitation 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 7q7 ,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 section #c of the ,temporary ,emergency ,scheduling and ,testing of ,fentanyl ,analogues ,act of #bjbb4 4 #f4 ,notification ,the ,attorney ,general shall notify each individual who is the subject of a pending prosecution for1 or has been convicted or sentenced for1 an offense involving a fentanyl-related substance that is subsequently removed or rescheduled under paragraphs 7#a7 and 7#b7 of section #bja7k7 of the ,controlled ,substances ,act1 as added by section #e of this ,act1 about the change in schedule designation not later than #ij days after the change1 and provide information about the effect of the change on their prosecution1 conviction1 or sentence4