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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices overprescribing of controlled substances.
DEA Response: DEA has reviewed the conclusions of these studies and believes they are insufficient to support a reduction in the APQs because the studies examined a limited set of medical procedures that could not be generalized to all prescriptions dispensed in the United States. The studies have found, with respect to certain medical procedures, that physicians prescribe more controlled substances for post-operative pain than patients utilize. While the referenced studies are concerning, DEA believes they are insufficient to impact DEAs APQ determination.

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Percentage of Prescription Opioids Being Diverted Issue: Multiple commenters said that the APQs should not be reduced from calendar year 2021 APQ levels, given that less than 1 percent of prescription controlled substances are diverted. One commenter cited DEAs statements in the 2020 Proposed APQ to support this statistic.
DEA Response: DEAs regulations require it to consider numerous relevant factors in its determination of the APQ.
One factor is the extent of diversion of controlled substances. Diversion is defined as all distribution, dispensing, or other use of controlled substances for other than legitimate medical purposes.
The commenter is correct that in the Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020 84 FR
48170, DEA determined that the quantity of FDA-approved drug products containing controlled substances that were diverted in 2018
represented less than one percent of the total quantity of controlled substances distributed to retail purchasers.
However, DEA also considers other relevant factors, as required by regulation, when determining the APQ.
21 U.S.C. 826a, 21 CFR 1303.11b.
DEAs consideration of all of these relevant factors resulted in the proposed 2022 APQ as published.
Relevant Information From FDA
Issue: Comments raised questions regarding the data provided by FDA, including the methodology it used to determine domestic medical need.
DEA Response: The information DEA
received from FDA included the observed and projected domestic usage of schedule II controlled substances, new drug application and abbreviated
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new drug application approvals, manufacturers discontinuing production, product shortages, and clinical trials for schedule I and II
controlled substances. FDA utilizes a variety of data sources in developing its estimates, and also describes certain caveats regarding the forecasts it provides. The data provided by FDA
contributed to DEAs estimate of declining legitimate domestic medical need for opioids.
FDA provides an important portion of the data that DEA analyzes in developing the annual APQs, but DEA
also utilizes other data sources to meet its statutory and regulatory requirements. For instance, DEA
utilized information provided by quota applicants and research protocols submitted directly to DEA to derive the estimates of scientific, research, and industrial needs; lawful export requirements; and current reserve stocks. No single data element is adequate to address all of the legal factors.
Issue: The State Attorneys General raised a concern that the proposed APQ
for the five covered controlled substances defined in 21 U.S.C.
826i1A as fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone are not aligned with the decline in medical need for schedule II
opioids as projected by FDA.
DEA Response: DEA notes that the decline of 18.88 percent was an average for certain schedule II opioids including but not limited to the five covered controlled substances predicted between 2021 and 2022. This estimated decline was for the domestic medical need only, which is one of several factors that DEA must consider when establishing APQ estimates for the entire calendar year.
Estimates of Diversion Mandated by the SUPPORT Act Issue: The State Attorneys General inquired about DEAs method of assessing diversion of the five covered controlled substances, as compared with the other basic classes of controlled substances subject to quotas.
DEA Response: Pursuant to 21 CFR
1303.11b5, DEA considered the extent of diversion of the basic class as a factor in setting each APQ for each respective basic class, as well as the extent of diversion for all other schedule I and II controlled substances in proposing the estimated APQ. As the State Attorneys General note, the Substance-Use Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act SUPPORT Act, Pub. L. 115271

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requires that DEA provide the diversion estimate only for the five covered controlled substances. In compliance with the SUPPORT Act, DEA published the estimated diversion for the five covered controlled substances in its October 18, 2021 notice, and provides revised estimates in Tables 2 and 3
below.
Issue: DEA received comments that raised questions regarding DEAs use of law enforcement data, including seizure data and theft and loss reporting, in its estimation of diversion for the five covered controlled substances.
DEA Response: DEA considered the reliability of all reported law enforcement data for the purpose of calculating estimates of diversion for the APQs of the five covered controlled substances. DEA did not include seizure data in its estimate of diversion because DEA could not conclusively determine that the collected data did not overlap with other data sources used to calculate relevant diversion estimates, nor could DEA determine from the reported data whether the seized substances contained illicitly manufactured fentanyl.
Issue: Commenters questioned the inclusion of losses due to disasters.
DEA Response: DEA registrants are required to report thefts and significant losses to DEA. These reports are often submitted before the registrant has had the opportunity to fully investigate the reason for the loss. Loss reports may include incidents of employee pilferage that may not be reported initially as theft to DEA. A loss in transit is nominally a loss but may in fact represent diversion by employees or other individuals. Generally, loss is considered diversion because it involves controlled substances falling outside the closed system of distribution. However, DEA agrees that reported losses due to disaster fire, weather, etc. should be distinguished from diversion for APQ
purposes. DEA therefore has adjusted its estimate of diversion of covered controlled substances in the supply chain by excluding those losses due to disaster, fire, weather, etc., as shown in Table 1.

TABLE 1SUPPLY CHAIN LOSS DUE
TO DISASTER
Fire, etc Controlled substance Fentanyl
Hydrocodone
Hydromorphone
Oxycodone
Oxymorphone

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g 1
123
5 214
4