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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
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included specific classes of prescribers or pharmacies.
Issue: The State Attorneys General suggested that DEA consider PDMP data about inconsistent or early refills of prescription opioids in estimating potential diversion.
DEA Response: Prescriptions for schedule II controlled substances cannot be refilled. 21 U.S.C. 829a. All of the substances for which DEA requested PDMP data were schedule II controlled substances.
Schedule I Controlled Substances Issue: Several commenters requested that DEA consider increasing production quotas for certain schedule I
controlled substances, including:
Bufotenine, 5-methoxy-N,Ndimethyltryptamine 5-MEO-DMT, ibogaine, psilocybin, mescaline, 3,4methylenedioxymethamphetamine MDMA, and dimethyltryptamine DMT for research activities and clinical trials in Canada and the United States.
DEA Response: The APQs established today reflect DEAs estimates of the medical, scientific, research, and industrial needs of the United States for 2022, as well as lawful export requirements and establishment and maintenance of reserve stocks. DEA can adjust the established APQs if these needs change. For instance, if DEA
receives additional research protocols from DEA-registered researchers, or additional quota applications from DEAregistered manufacturers, DEA will consider revising the APQ.
DEA did receive additional quota applications from DEA-registered manufacturers for 5-MEO-DMT, psilocybin, and MDMA. DEA
considered those applications accordingly, as discussed below. DEA
has not received quota applications from DEA-registered manufacturers to support the requested changes in the APQ for the other controlled substances mentioned.
Issue: DEA received a comment from a biotech company suggesting that DEA
discuss involving representatives from indigenous communities in determining APQ for controlled substances that are potentially derived from plants traditionally used by indigenous groups in the Americas and beyond.
Response: In accordance with 21 CFR
1303.11c, DEA invites all interested persons to participate by commenting on proposed APQs. The CSA requires DEA to establish APQ to provide for the estimated medical, scientific, research, and industrial needs of the U.S., for lawful export requirements, and for the establishment and maintenance of
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reserve stocks. The APQs and the individual manufacturing quotas are informed in part by the quota requests submitted by DEA-registered manufacturers of these substances.
Issue: The Native American Church of North America commented on the proposal to set the APQ for mescaline at 100 grams. They commented that their peyote ceremonies are contingent on the continued availability of peyote in the wild for sacramental use, and that the non-Native use of mescaline in research and clinical studies will have a direct impact upon the churchs ability to use, purchase, transport, and possess peyote pursuant to the American Indian Religious Freedom Act AIRFA, as it will lead to commercialization and exploitation of peyote across its natural range and potential reclassification of its scheduling status.
DEA Response: Mescaline is the schedule I controlled substance naturally occurring in peyote. The 2022
APQ for mescaline will only be used for the production of synthetic mescaline which is utilized to produce analytical reference standards. Thus, the 2022
APQ for mescaline does not have any material effect on the use of peyote by members of the Native American Church.
Schedule II Controlled Substances Issue: One commenter asked why DEA does not consider significantly reducing the hydrocodone quota to come in line with the rest of the world.
The commenter also asked why DEA
does not consider global use data in establishing APQ.
DEA Response: DEA is bound by the language of 21 U.S.C. 826 to consider the needs of the United States. After considering the factors defined in 21
CFR 1303.11b, this APQ represents DEAs best estimate of domestic needs, as well as quantities needed for lawful export and for the establishment and maintenance of reserve stocks.
Issue: DEA received a comment suggesting that DEA evaluate adjustments for the APQ of oral solid and injectable dosage forms of medicines separately. The commenter specifically highlighted differences between dosage forms of certain opioids.
DEA Response: DEA sets APQ in a manner to include dispensings for legitimate medical purposes and, in turn, the APQ takes into consideration both injectable opioids and solid oral opioids to meet the estimated medical needs of the United States. The SUPPORT Act allows, but does not require, DEA to grant individual quotas to DEA-registered manufacturers in
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terms of dosage forms if the Agency determines that doing so will assist in avoiding the overproduction, shortage, or diversion of controlled substances.
By issuing a single APQ covering all dosage forms of the basic class, rather than estimating APQ for each dosage form, DEA retains the flexibility to alleviate potential shortages and to react to unforeseen emergencies by adjusting the individual quotas granted to manufacturers under that APQ.
Assessment of Annual Needs for List I
Chemicals Issue: DEA received comments expressing concerns that the AAN limits the amount of pseudoephedrine for sale, a chemical found in the allergy medication SUDAFED.
DEA Response: The CSA requires DEA to establish the AAN for ephedrine, pseudoephedrine, and phenylpropanolamine to provide for the estimated legitimate medical, scientific, research, and industrial needs of the United States, lawful exports, and reserve stocks. 21 U.S.C. 826a. Control of the chemical pseudoephedrine in this manner over the past 15 years has not been shown to limit the availability of over-the-counter products such as Sudafed for legitimate needs. In anticipation of increased need due to the COVID19 public health emergency, the AAN for pseudoephedrine for sale was increased in 2020; however, the expected need did not materialize.
Therefore, DEA has reduced the AAN
for pseudoephedrine for sale back to the 2019 level.
Comments From DEA-Registered Manufacturers Issue: DEA received comments from three DEA-registered manufacturers regarding 13 different schedule I and II
controlled substances, requesting that the proposed APQ for 5-MEO-DMT, damphetamine for conversion, dexmethylphenidate for sale, DMT, lisdexamfetamine, methadone, methadone intermediate, methylphenidate for sale, noroxymorphone for conversion, phenylacetone, psilocybin, psilocin, and remifentanil be established to sufficient levels to allow for manufacturers to meet medical and scientific needs.
DEA Response: DEA considered the comments for specific controlled substances and made adjustments as needed, which are described below in the section titled Determination of 2022
Aggregate Production Quotas and Assessment of Annual Needs.

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