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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
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component associated with a DEAregistered NTP to be considered a coincident activity permitted under the NTPs registration. Based on these revisions, NTP registrants that operate or wish to operate mobile components in the State in which the registrant is registered to dispense narcotic drugs in schedules IIV at remote locations for the purpose of maintenance or detoxification treatment do not need a separate registration for such mobile component. This final rule waives the requirement of a separate registration at each principal place of business or professional practice where controlled substances are dispensed for those NTPs with mobile components that fully comply with the requirements of this rule. These revisions to the regulations are intended to make maintenance or detoxification treatments more widely available, while ensuring that safeguards are in place to reduce the likelihood of diversion.
DATES: This final rule is effective July 28, 2021.
FOR FURTHER INFORMATION CONTACT:
Scott A. Brinks, Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, Diversion Control Division; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: 571 7762265.
SUPPLEMENTARY INFORMATION:
Legal Authority and Background The Controlled Substances Act CSA
generally provides, with certain exceptions, that all persons who are required to register under the Act must obtain a separate registration at each principal place of business or professional practice where such persons manufacture, distribute, or dispense a controlled substance. 21
U.S.C. 822e1. However, the CSA
authorizes the Attorney General to issue regulations waiving the requirement of registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety. 21 U.S.C. 822d. The Attorney General has delegated this authority to the Administrator of the Drug Enforcement Administration Administrator of DEA or Administrator. Pursuant to this authority, DEA is hereby finalizing a regulation that would waive the requirement of a separate registration for narcotic treatment programs NTPs that utilize mobile components under certain conditions. Specifically, under this final rule, an NTP is permitted to dispense narcotic drugs in schedules II
V from a mobile component at locations remote from, but within the
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same State as, the NTPs registered location, for the purpose of maintenance or detoxification treatment. Under this final rule, the NTP does not need to obtain a separate DEA registration for dispensing from the mobile component at a separate location as long as it complies with the requirements of the final rule. Such remote dispensing from an NTPs mobile component is deemed under the final rule to be a coincident activity permitted under the NTPs registration. In the interest of helping to alleviate the ongoing opioid epidemic in the United States, the Acting Administrator of DEA Acting Administrator finds that this waiver of registration is consistent with the public health and safety.
The final rule also contains additional requirements specified in the proposed rule to reduce the likelihood of diversion. Certain aspects of these additional requirements, which were raised by the commenters, are addressed below in the discussion of the comments. In addition, a section-bysection analysis of the final rule is provided following the discussion of the comments.
Notice of Proposed Rulemaking On February 26, 2020, DEA published a notice of proposed rulemaking NPRM in the Federal Register, which provided an opportunity for comment on the proposed rule. 85 FR 11008. The comment period closed on April 27, 2020. Through this final rule, DEA is responding to these comments and finalizing the proposed rule with certain modifications discussed below.
Discussion of Comments DEA received a total of 114 comments on the NPRM, copies of which are available online at www.regulations.gov.
The commenters included: Researchers, practitioners, universities, non-profit organizations, addiction treatment programs, State and city boards of behavioral health and human services, associations, manufacturers, a law enforcement office, and other individual or anonymous commenters. DEA thanks all commenters for their thoughtful questions and suggestions, and appreciates their input during the rulemaking process.
One comment was a general statement of support for the rule, with no discussion of the proposed regulatory changes. Some commenters sought clarification of certain provisions in the proposed rule or recommended additional changes. The majority of commenters expressed support for various provisions in the proposed rule.
That said, some commenters offered
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only partial support for the rule, agreeing with its general purpose but disagreeing with particular provisions;
some of these commenters offered suggestions and proposed amendments to the rule that they thought would help DEA achieve its purpose. Three comments were outside of the scope of the rule. One commenta general complaint about the governments COVID19 response, unrelated to DEAwas outside the scope of the rulemaking and will therefore not be addressed. Another commenter suggested lengthening the five-year term for nurse anesthetists to treat patients with substance use disorder, which is a matter beyond the scope of this rule and will not be addressed. A third commenter suggested future rule changes DEA should consider to reduce patient access burdens, including:
Reducing adherence requirements for take-home dosing, allowing community pharmacies to dispense methadone treatment, and allowing physicians outside of NTPs to prescribe methadone treatment for patients with opioid use disorders OUDs. These issues are outside the scope of the rule and will not be addressed.
After a review of the comments, DEA
noted that there were thirteen main issues that commenters raised, and many commenters raised multiple issues in their comments. Each issue is summarized below, along with DEAs responses. DEA has also summarized the remainder of the comments that did not fit into one of the thirteen main issues.
Expanding the Rules Scope Beyond Mobile NTPs Comment: One commenter recommended that the scope of the proposed rule be expanded to allow mobile components to carry controlled substances used for sedation general anesthesia. The commenter stated that many specialty doctors such as oral surgeons work in multiple locations each week and are required to obtain separate permits i.e., separate DEA
registrations for each office in which they operate, and as such, cannot fill in for another doctor in the case of an emergency.
DEA Response: DEA understands that many specialty doctors such as oral surgeons may work in multiple locations each week and are therefore required under 21 U.S.C. 822e1 and 21 CFR 1301.12a to obtain separate registrations for each office in which they operate, and as such are unable to fill in for another doctor in the case of an emergency.

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