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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations coordination with State opioid treatment authorities as well as SAMHSA and DEA, once the proposed rule had been finalized.
Several commenters also pointed out the advantages of allowing practitioners to dispense controlled substances at multiple locations, as the rule would facilitate. One commenter provided her personal experiences that she currently can only treat patients with opioid addiction at the DEA-registered location, where the injectable buprenorphine is delivered. The commenter believed that allowing providers to have more than one location is essential for good health care, because this would greatly increase access and treatment options for those suffering from opioid addiction.
Finally, several commenters mentioned how the current COVID19
public health emergency would have negative effects on individuals who were suffering from OUD, because of State-mandated stay-at-home orders, social distancing requirements, and severe limitations on some of the transportation options on which these individuals rely. Commenters further noted that these negative consequences of the public health emergency could cause increases in isolation and an inability to reach treatment clinics, which could result in an increase in overdoses or even deaths. These commenters said that the use of mobile components would ensure that these individuals would be able to continue treatment.
DEA Response: As stated in the NPRM, DEA concluded that waiving the requirement for separate registration for mobile NTPs is consistent with the public health and safety, as it will increase access to treatment for those suffering from OUD in rural and underserved communities. See NPRM, 85 FR 11008, 11011. DEA re-affirms that position in the final rule. Specifically, DEA will waive the requirement of separate registration only for an NTP
operating a mobile component at locations remote from, but within the same State as, the NTPs registered location for the purpose of maintenance or detoxification treatment.
The intent of the rule is to ensure that there is greater access to treatment for those who are suffering from OUD, and who are unable to access treatment because of rural or geographic limitations, mobility issues, etc.
Furthermore, DEA has no objection to NTPs seeking grants or funding from government programs, or partnering with other organizations in order to defray the costs of purchasing and
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outfitting a mobile component.
Regarding the COVID19 public health emergency, this is an unprecedented event that has resulted in many agencies and organizations changing the way they operate. As a result of the public health emergency, DEA has worked closely with SAMHSA to provide guidance and support to opioid treatment programs to ensure that any individual who relies on MAT is able to continue treatment without disruption.
It is DEAs hope that these mobile NTPs will be able to ensure greater access in in the future, especially when public health emergencies like this arise.
The Mobile Component Returning to Its Registered Location on a Daily Basis Comments: Multiple commenters expressed concern regarding the requirement in proposed 21 CFR
1301.72e to return the mobile component and the controlled substances on board to the NTPs registered location daily. One commenter asserted that the daily return trip to prevent diversion is unnecessary since the mobile NTPs would be required to keep a record of all controlled substances removed from the safe on any given day. Several other commenters were concerned that the proposal would reduce the effectiveness of the mobile NTPs. Two commenters specifically stated this requirement would significantly limit the geographical reach of the mobile component. Multiple commenters argued that travel times could negatively affect the amount of time the component could operate, as many of the communities being served by mobile NTPs were far from the nearest DEAregistered NTP location. In fact, some commenters contended that many of these communities were hundreds of miles, with some specifying 100 to 200
miles and some simply stating over one hundred miles, from the NTPs registered location. One commenter further stated that the time required to travel such large distances could deter NTPs from offering regular services in the most remote areas. The commenter indicated that there are communities with significant rates of OUD located as far as 195 miles from the nearest NTP, which would require the mobile component to travel six hours round trip daily to reach these communities.
The commenter recommended that DEA
allow NTPs to enter into DEA-approved agreements with local or State law enforcement entities closer to the remote service area to secure the controlled substances in their facility while the mobile NTP is not in operation. The commenter stated that
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DEA already requires controlled substances in the possession of law enforcement be stored in a manner consistent with DEAs standard procedures for storing illicit controlled substances, and referenced DEAs disposal final rule regulation at 21 CFR
1317.35c Collection by law enforcement.1 Accordingly, the commenter pointed out that, if a law enforcement entity in closer proximity to the mobile components service area than the NTPs registered location has secure storage procedures that meet DEA standards, the medications could be stored at this location for easier dayto-day access.
Another commenter expressed concerns that the security requirements DEA proposed were administratively burdensome, and specifically mentioned the requirement that the mobile component return to the NTPs registered location on a daily basis. The commenter stated that this requirement would increase the amount of time spent traveling, which would result in additional wear and tear on the vehicles and less time to work with patients who need care and rely on the mobile component. The commenter thus indicated that this requirement would detract from the increased access to treatment and reduced costs of expanded access that this regulation aims to achieve.
Likewise, a number of commenters also noted that requiring the mobile components to return to the NTPs registered location every day would be costly when factoring in staff time, travel costs, and the wear and tear on the vehicles. Several commenters postulated that these expenses could easily rival the cost of opening a new brick-and-mortar NTP. Two commenters estimated the cost for a mobile NTP, with at least one nurse and one medical assistant, traveling 100 miles round trip, six times per week for a year, as approaching $62,000. Both commenters stated this this amount could be more expensive than renting space for a new registered NTP location in some areas.
Several commenters suggested that this requirement might hinder the effectiveness of the rule, particularly in rural areas, due to the extra costs and travel time associated with traveling back and forth daily. One commenter further stated that although DEA
asserted that the proposed rule would benefit rural areas, this assertion was incorrect due to the scarcity of registered NTP locations near rural areas, and the costs that would be incurred if a mobile NTP attempted to 1 79

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