Quiero saber acerca de...

khammond on DSKJM1Z7X2PROD with RULES

33880

Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health, and safety effects; distributive impacts; and equity. E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review established in E.O. 12866. DEA
expects that this final rule will not have an annual effect on the economy of $100
million or more in at least one year and therefore is not an economically significant regulatory action. DEA
examined each of the provisions of the final rule to estimate its economic impact, comparing the costs and/or costsavings of a no action baseline regulatory environment with the costs and/or cost-savings of the regulatory environment that will result from this final rule. This final rule is an enabling rule designed to expand the supply of MAT providers, and DEA currently has only authorized mobile NTPs on an ad hoc basis, with a present moratorium on further such authorizations. Thus, DEA
compared the costs of delivering MAT
services in a baseline regulatory environment in which no new mobile NTPs are authorized, to the costs of delivering an equivalent level of MAT
services in the final rules regulatory environment in which a registered NTP
may begin to operate a mobile component as a coincident activity, subject to the provisions of this final rule. DEAs analysis, summarized in the preceding section, finds that this final rule will result in a net cost-savings between $3,509,759 and $3,953,059, and is therefore below the $100 million threshold.
For a number of years, DEA has allowed registered NTPs to utilize mobile components as part of their programs through special arrangements with local DEA field offices. The use of these mobile components was in response to the opioid epidemic that is currently affecting the nation. With the number of deaths attributed to overdoses increasing, the demand for access to medication-assisted treatment increased. In many areas, this has resulted in long wait lists and high service fees for services provided by NTPs. Alternative guidelines and methods were sought to increase accessibility to treatment for people with substance use disorder, including OUD, especially in rural areas or areas where NTPs are not accessible, or to allow those who have health conditions that prevent them from traveling long distances to receive maintenance or
VerDate Sep<11>2014

15:59 Jun 25, 2021

Jkt 253001

detoxification treatment. Mobile components associated with the registered NTP were seen as an alternative because they increased accessibility to treatment in the areas that needed it.
This final rule builds on the existing experience and provides additional flexibility for NTPs in operating mobile components, subject to regulatory restrictions put into place to prevent the diversion of controlled substances. DEA
is revising 21 CFR 1301.13 to make operating a mobile component of an NTP a coincident activity of an existing NTP registration, and this provision will reduce the regulatory burden on NTPs by waiving the separate DEA
registration requirement. These mobile NTPs are required to maintain effective security to guard against theft and diversion of controlled substances in accordance with 21 CFR 1301.72. The mobile NTPs are also subject to the recordkeeping requirements in 21 CFR
1304.04 and 1304.24. Many of the current mobile NTPs are already following these regulatory requirements.
This final rule ensures that these regulatory requirements can be enforced consistently over any current or future NTP wishing to operate a mobile NTP.
Thus, this final rule will enable any NTP registered with DEA to engage in an activity that was previously authorized through special arrangements with DEA field offices.
Furthermore, DEAs purpose for allowing registered NTPs to operate a mobile component as a coincident activity is to expand the availability of MAT in accordance with the priorities outlined in the Presidents Commission on Combating Drug Addiction and The Opioid Crisis, published on November 1, 2017.
While the findings of the regulatory impact analysis of this final rule support the conclusion that this rulemaking is not economically significant, the Office of Information and Regulatory Affairs OIRA has nonetheless determined that the final rule is a significant regulatory action under E.O. 12866, section 3f.
Accordingly, this rule has been reviewed by OIRA.
Executive Order 12988, Civil Justice Reform This final rule meets the applicable standards set forth in sections 3a and 3b2 of E.O. 12988, Civil Justice Reform, to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
Executive Order 13132, Federalism This final rule does not have federalism implications warranting the
PO 00000

Frm 00028

Fmt 4700

Sfmt 4700

application of E.O. 13132. The final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This final rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
Regulatory Flexibility Act In accordance with the Regulatory Flexibility Act RFA, DEA evaluated the impact of this final rule on small entities. DEAs evaluation of economic impact by size category indicates that the final rule will not have a significant economic impact on a substantial number of these small entities.
The RFA requires agencies to analyze options for regulatory relief of small entities unless it can certify that the rule will not have a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. DEA evaluated the impact of this rule on small entities and discussions of its findings are below.
Description and Estimate of the Number of Small Entities To determine the final rules effect on small entities, DEA must first calculate the total number of affected entities. To do this, DEA must determine the total number of NTP entities in the United States, as those are the entities that are able to take advantage of this enabling rule.
DEA begins with the number of relevant DEA registrationsthat is, NTP
registrations. The number of NTP
entities differs from the number of NTP
registrations, however, because NTP
entities often hold more than one DEA
registration, such as where a registrant handles controlled substances at multiple locations, requiring the entity to hold registrations for each of these locations. DEA does not, in the general course of business, collect or otherwise maintain information regarding associated or parent organizations holding multiple registrations.
Therefore, to derive the total number of NTP entities from the number of NTP

E:FRFM28JNR1.SGM

28JNR1