,,ii ,calendar ,no4 #dgc #aaeth ,,congress #b;d ,session ,s4 #bece ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ab1 #bjah,mr4 ,durbin 7for himself1 ,mr4 ,kennedy1 ,mr4 ,grassley1 and ,mrs4 ,feinstein7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,june #ai1 #bjah,reported by ,mr4 ,grassley1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,controlled ,substances ,act to strengthen ,drug ,enforcement ,administration discretion in setting opioid quotas4 #a4 ,short title ,this ,act may be cited as the ,opioid ,quota ,reform ,act4 #b4 ,strengthening considerations for ,,dea opioid quotas ,section #cjf of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbf7 is amended-- 7#a7 in the last sentence of subsection 7a71 by striking and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance2 and 7#b7 by adding at the end the following3 7i7 7#a7 ,in fixing and adjusting production and manufacturing quotas under this section for fentanyl1 oxycodone1 hydrocodone1 oxymorphone1 and hydromorphone1 the ,attorney ,general shall consider the impact of the production and manufacturing quotas on overall public health and rates of diversion1 abuse1 and overdose deaths related to these controlled substances in the ,united ,states4 ,any of the considerations in this subsection or in subsection 7a7 may be used to determine changes to levels of such production and manufacturing quotas in a given year4 7#b7 7,a7 ,for any year in which the approved production quota for fentanyl1 oxycodone1 hydrocodone1 oxymorphone1 or hydromorphone is higher than the approved production quota for the substance in the previous year1 the ,attorney ,general shall include in its final order an explanation of why the public health benefits of increasing such quota outweigh the consequences of having an increased volume of such substance available for sale1 and potential diversion1 in the ,united ,states4 7,b7 ,not later than #a year after the date of enactment of this subsection and every year thereafter1 the ,attorney ,general shall provide to the ,caucus on ,international ,narcotics ,control1 ,committee on the ,judiciary1 ,committee on ,health1 ,education1 ,labor1 and ,pensions1 and ,committee on ,appropriations of the ,senate and the ,committee on the ,judiciary1 ,committee on ,energy and ,commerce1 and ,committee on ,appropriations of the ,house of ,representatives1 the following information with regard to each of the substances described in subparagraph 7,a73 7i7 ,an anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for that substance4 7ii7 ,a count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for that substance in the previous year4 7#c7 ,not later than #ahj days after the date of enactment of this subsection1 the ,attorney ,general shall submit to ,congress a report on how the ,attorney ,general will ensure that the annual process of fixing and adjusting production and manufacturing quotas under this section takes into consideration-- 7,a7 efforts to reduce the costs1 injuries1 and deaths associated with the diversion and abuse of prescription opioids and heroin1 including changes in the accepted medical use of certain controlled substances2 and 7,b7 data collection and evaluation of the volume of controlled substances that are diverted and collected from approved drug collection receptacles1 mail-back programs1 and take-back events4 4 #a4 ,short title ,this ,act may be cited as the ,opioid ,quota ,reform ,act4 #b4 ,strengthening considerations for ,,dea opioid quotas 7a7 ,in general ,section #cjf of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbf7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by inserting 7#a7 after 7a72 7,b7 in the second sentence1 by striking ,production and inserting ,except as provided in paragraph 7#b71 production2 and 7,c7 by adding at the end the following3 7#b7 ,the ,attorney ,general may1 if the ,attorney ,general determines it will assist in avoiding the overproduction1 shortages1 or diversion of a controlled substance1 establish an aggregate or individual production quota under this subsection1 or a procurement quota established by the ,attorney ,general by regulation1 in terms of pharmaceutical dosage forms prepared from or containing the controlled substance4 2 7#b7 in subsection 7b71 in the first sentence1 by striking production and inserting manufacturing2 7#c7 in subsection 7c71 by striking ,october and inserting ,december2 and 7#d7 by adding at the end the following3 7i7 7#a7 7,a7 ,in establishing any quota under this section1 or any procurement quota established by the ,attorney ,general by regulation1 for fentanyl1 oxycodone1 hydrocodone1 oxymorphone1 or hydromorphone 7in this subsection referred to as a covered controlled substance71 the ,attorney ,general shall estimate the amount of diversion of the covered controlled substance that occurs in the ,united ,states4 7,b7 ,in estimating diversion under this paragraph1 the ,attorney ,general-- 7i7 shall consider information the ,attorney ,general1 in consultation with the ,secretary of ,health and ,human ,services1 determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the ,united ,states2 and 7ii7 may take into consideration whatever other sources of information the ,attorney ,general determines reliable4 7,c7 ,after estimating the amount of diversion of a covered controlled substance1 the ,attorney ,general shall make appropriate quota reductions1 as determined by the ,attorney ,general1 from the quota the ,attorney ,general would have otherwise established had such diversion not been considered4 7#b7 7,a7 ,for any year for which the approved aggregate production quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year1 the ,attorney ,general shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered controlled substance available for sale1 and potential diversion1 in the ,united ,states4 7,b7 ,not later than #a year after the date of enactment of this subsection1 and every year thereafter1 the ,attorney ,general shall submit to the ,caucus on ,international ,narcotics ,control1 the ,committee on the ,judiciary1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions1 and the ,committee on ,appropriations of the ,senate and the ,committee on the ,judiciary1 the ,committee on ,energy and ,commerce1 and the ,committee on ,appropriations of the ,house of ,representatives the following information with regard to each covered controlled substance3 7i7 ,an anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance4 7ii7 ,an anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year4 7#c7 ,not later than #a year after the date of enactment of this subsection1 the ,attorney ,general shall submit to ,congress a report on how the ,attorney ,general1 when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances1 will-- 7,a7 take into consideration changes in the accepted medical use of the covered controlled substances2 and 7,b7 work with the ,secretary of ,health and ,human ,services on methods to appropriately and anonymously survey opioid patients in order to estimate and evaluate the type and amount of covered controlled substances that patients are submitting for collection from approved drug collection receptacles1 mail-back programs1 and take-back events4 4 7b7 ,conforming change ,the ,law ,revision ,counsel is directed to amend the heading for subsection 7b7 of section #hbf of title #ba1 ,united ,states ,code1 by striking production and inserting manufacturing4 ,june #ai1 #bjah,reported with an amendment