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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations the government to clarify treatment standards specific to the mobile components of NTPs, they should contact the government entities that establish and enforce those standards.
Comment: One commenter stated that in the final rule DEA should consider clarifying that the ability of mobile vans to convey injectable and implantable buprenorphine products that are administered to patients will not be restricted. The commenter also requested that DEA consider clarifying in the final rules preamble section the role of Hospital/Clinic as nonpractitioner registrants to provide buprenorphine products for the treatment of OUD in accordance with 21 CFR 1301.28.
DEA Response: The purpose of this rule is to waive the requirement of a separate registration for NTPs that utilize mobile components and to allow an NTP to dispense narcotic drugs in schedules IIV at locations remote from, but within the same State as, the NTPs registered location, for the purpose of maintenance or detoxification treatment. The registered NTP, not DEA, should decide which narcotic drugs should be dispensed to its patients, both at the registered location and on the mobile component, in accordance with each individual patients medical needs as determined by a medical professional authorized to make such a determination. Nothing in this final rule prevents a mobile NTP
from providing the same treatment as would be available at the registered NTP
location, as long as the mobile NTPs follow all applicable Federal, State, local, and tribal laws.
DEA regulations in 21 CFR 1301.28
include provisions for exemption from separate registration requirements for individual practitioners dispensing or prescribing schedule IIIV narcotic controlled drugs approved by FDA for maintenance or detoxification treatment provided they meet certain conditions, including being a qualifying physician or qualifying other practitioner, as defined in 21 U.S.C.
823g2Gii or g2Giv, respectively. Thus, the request to clarify the role of Hospital/Clinic in accordance with 21 CFR 1301.28 is beyond the scope of this final rule.
Comment: Another commenter noted that the proposed rule does not include guidance on parking guidelines for the mobile component, and suggested that the NTP should be required to establish a standard operating procedure or obtain linkage agreements with organizations e.g., hospitals or programs operating needle exchange programs where the vehicle will be
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parked. The commenter stated the linkage agreements must include the mobile components days/date and hours of operation, and that without these agreements, there may be complaints and issues for local law enforcement agencies or community leaders.
DEA Response: Regarding the commenters parking concerns for the mobile NTP, DEA appreciates the potential issues; however, DEA will not provide any guidance in this final rule.
The NTP is responsible for establishing a protocol for parking, and to determine the appropriate organizations that might assist with parking. What constitutes an appropriate parking location for a mobile NTP will vary significantly from area to area based on local conditions and laws. Dictating what must be included in any agreements is thus outside the scope of this rulemaking and will not be addressed. DEA would like to remind NTP registrants of their obligations under any applicable Federal, State, or local laws when it comes to operating these mobile components.
Comment: One commenter suggested that DEA not require NTPs to get preapproval from the local DEA field office before operating a mobile component;
rather, DEA should only require registered NTPs to notify the local DEA
field office that they will begin operating a mobile component. The commenter stated that this will prevent a situation where a registered NTP
seeking to expand access with a mobile component will be required to wait for approval, missing out on critical days and weeks that could be spent providing access to patients. The commenter argued that other conditions in the proposed rule, combined with DEAs regular inspections, are sufficient to ensure diversion is not occurring at mobile components, especially since the NTPs that are already registered will be familiar with DEA diversion regulations and capable of complying with the conditions for mobile components. The commenter also suggested that in the preamble to the final rule, DEA should commit to conducting a retrospective review and collecting data to assess the impact of the rule on treatment accessibility and the risk of diversion.
The commenter stated that if this final rule succeeds at expanding treatment for opioid use disorder to patients while simultaneously minimizing diversion risks, DEA should further expand the program.
DEA Response: DEA will not change the requirement that NTPs obtain preapproval from the local DEA field office before operating a mobile component.

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DEA appreciates the commenters concern about how possible delays in the approval process could have negative effects on those individuals who need access to treatment. Preapproval from the local DEA field office is part of the registration process for the mobile component; without it, the NTP
will not be permitted to operate the mobile component under the requirements set forth by this final rule.
DEA continually reviews the programs that fall under its regulatory authority; if it determines that adjustments are required to ensure compliance or to ensure that the rules effect is more successful, the appropriate action will be taken.
Section-by-Section Analysis of the Final Rule DEA is finalizing the proposed rule with certain modifications to 21 CFR
1300.01, 1301.13, and 1301.72. In brief, this rule slightly revises the mobile NTP
definition at 1300.01b from that proposed. The definition is revised to clarify that it is the operation of the mobile NTP i.e., administering maintenance and/or detoxification treatment from the mobile component that is the coincident activity, not the vehicle itself. The application fee in 1301.13e1vii, in the table, is revised to reflect the new registration fee schedule that became effective on October 1, 2020.12
Also, this rule revises the proposed new 1301.13e4 by adding a third subparagraph iii to clarify that a mobile NTP may operate at a location or locations, including correctional facilities, away from, but within the same State as, the NTPs registered location. Previously, the proposed rule was silent as to correctional facilities.
Relatedly, in several places, references in the proposed rule to the remote location where the mobile NTP
operates are replaced with references to the mobile NTPs location or locations to clarify that a mobile NTP
can operate at more than one remote location under appropriate circumstances.
This rule revises the proposed new 1301.72e to allow the mobile component to be parked at the registered location or any secure, fenced-in area when the mobile component is not in use. Prior to parking the conveyance at a secure, fenced-in location, all controlled substances must be removed from the conveyance and returned to the registered location and, the local DEA
office must be notified of the location of 12 85

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FR 44710 July 24, 2020.

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