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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
U.S. Treaty Obligations Issue: DEA received several comments requesting that the United States become a signatory to the Nagoya Protocol and Convention on Biological Diversity.
DEA Response: DEA does not have the authority to enter into or sign treaty agreements on behalf of the United States. This request is outside the scope of this notice.
Request for Public Hearing Issue: One commenter requested a public hearing on the data and methodology used by DEA for this 2022
proposed APQ determination. The commenter also raised issues relating to the 2018 and 2019 APQs.
DEA Response: The decision whether to grant a hearing on the issues raised by the commenter lies solely within the discretion of the Administrator. 21 CFR
1303.11c. This commenter is not a state. This request does not present any evidence that would lead to the conclusion that a hearing is necessary or warranted. The 2018 and 2019 APQs also fall outside of the scope of this order.
Stakeholder Forum Issue: One commenter requested DEA
schedule a public hearing or engage in an organized public process to allow interested parties to express their views and concerns about quota issues at least six months in advance of the proposed APQ.
DEA Response: DEA invites all interested persons to participate by commenting on proposed APQs. 21 CFR
1303.11c. The Federal Register comment period provides an opportunity for all stakeholders to make their issues known to DEA.

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Out of Scope Comments DEA received comments that are outside the scope of this order. The comments were general in nature and raised issues of specific medical illnesses, medical treatments, and medication costs. These comments do not impact the analysis involved in establishing the 2022 APQ.
IV. Determination of 2022 Aggregate Production Quotas and Assessment of Annual Needs In determining the established 2022
aggregate production quotas and assessment of annual needs, DEA has considered the above comments along with the factors set forth in 21 CFR
1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826a. These factors include, but are not limited to, the 2021 manufacturing quotas, current
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2021 sales and inventories, anticipated 2022 export requirements, industrial use, additional applications for 2022
quotas, and information on research and product development requirements.
Based on all of the above, the Administrator establishes the 2022 APQ
for 5-MEO-DMT, DMT, lisdexamfetamine, MDMA, phenylacetone, psilocybin, and psilocin at higher levels than was proposed.
DEA has determined that the proposed APQs for D-amphetamine for conversion, dexmethylphenidate for sale, methadone, methadone intermediate, methylphenidate for sale, noroxymorphone for conversion, and remifentanil are sufficient to provide for the 2022 estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these APQ at the same amounts as proposed.
Estimates of Diversion Pursuant to the SUPPORT Act As specified in the proposal, and as required by 21 U.S.C. 826i, DEA
calculated a national diversion estimate for each of the covered controlled substances.
DEA solicited PDMP data through NASCSA from state PDMP
Administrators. Based on the data received, DEA considered the number of individuals who received a prescription for a covered controlled substance that met any of the three diversion metrics red flags mentioned in the October 18, 2021, notice for each of calendar years 201820. That number was then compared to the corresponding population for the states responding to DEAs request in order to estimate a percentage of the population issued a prescription meeting one of the red flag metrics. Using this estimated percentage for 201820, DEA analyzed trends in the data to predict the estimated percentage of patients who would be expected to meet these diversion metrics for 2022.
DEA also reviewed aggregate sales data for each of the covered controlled substances, which it extracted from IQVIAs National Sales Perspective.3
DEA multiplied the forecasted percentage of patients who received a prescription for a covered controlled substance that met any of the three diversion-related metrics for 2022 by the forecasted sales data from IQVIA for 2022 to estimate diversion for each of 3 DEA has purchased this data from IQVIA for decades and routinely uses this information to administer several regulatory functions, including the administration of DEAs quota program.

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the covered controlled substances. This data, which remains unchanged, was published 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 2022, and contributed to the final diversion estimates for covered controlled substances, as set forth in Table 3.
Registrant Reported Legitimate Distribution Chain Diversion DEA extracted data from its Drug Theft and Loss database and categorized it by basic class. The quantity of active pharmaceutical ingredient API in each dosage form was determined, and then the quantity of API of each covered controlled substance was aggregated by metric weight where the data was available. DEA calculated the estimated amount of diversion by multiplying the strength of the API listed for each finished dosage form by the total amount of units reported to estimate the metric weight in grams of the controlled substance being diverted. The estimate of diversion for each of the covered controlled substances, which does not contain any loss reported due to fire, weather, or other disaster, is displayed in Table 2. This data contributed to the final diversion estimates for covered controlled substances, as set forth in Table 3.

TABLE 2DIVERSION ESTIMATES
BASED ON SUPPLY CHAIN DIVERSION DATA FOR COVERED CONTROLLED SUBSTANCES
Controlled substance Fentanyl
Hydrocodone
Hydromorphone
Oxycodone
Oxymorphone

g 76
19,325
896
45,368
524

DEAs estimate of diversion for the five covered controlled substances was calculated by combining the diversion estimates from the state PDMP data and the supply chain diversion data. DEA
reduced the aggregate production quotas for each covered controlled substance by the resulting quantities listed in Table 3.

TABLE 3TOTAL ESTIMATES OF DIVERSION
FOR
COVERED CONTROLLED SUBSTANCES
Controlled substance Fentanyl
Hydrocodone

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g 92
154,916