The Power and Security Systems (“PASS”) Act, Public Law 115-78 (November 2, 2017) and the EPS Improvement Act of 2017 (Pub. L. 115-115) both amended certain aspects of the Energy Policy and Conservation Act, as amended (“EPCA”), Public Law 94-163. These recent amendments modified, among other things, the applicability of certain compliance deadlines related to external power supplies (“EPSs”) used in certain applications and aspects of the definition for external power supplies. Pursuant to the PASS Act, DOE is modifying its regulations regarding the non-application of no-load mode requirements by amending the text to explicitly state that the no-load requirements do not apply to certain external power supplies manufactured prior to the effective date of any amendment from a final rule published by DOE under 42 U.S.C. 6295(u)(3)(D)(ii). That provision requires DOE to publish a final rule by July 1, 2021, that determines whether the standards in effect should be amended. If DOE amends those standards, the amended standards would apply to products manufactured starting on July 1, 2023. With respect to the EPS Improvement Act, DOE is amending its external power supply definition by excluding certain categories of products—namely, those power supply circuits, drivers, or devices that are “designed exclusively to be connected to, and power” light-emitting diodes (“LEDs”) providing illumination, organic light-emitting diodes (“OLEDs”) providing illumination; or ceiling fans using direct current motors. See 42 U.S.C. 6291(36)(A)(ii) (as amended by the EPS Improvement Act).

This document codifies in the Code of Federal Regulations (“CFR”) these revisions to EPCA. Additionally, to ensure consistency throughout its regulatory framework, DOE is also correcting a cross-reference in the certification requirements for external power supplies that appear in the CFR and making a correction regarding the description of the standards currently in place for Class A external power supplies. See 10 CFR 429.37(b)(2)(iv) and 10 CFR 430.32(w)(1)(i). The rule corrects the internal cross-reference in 10 CFR 429.37(b)(2)(iv) to refer to § 430.32(w)(5), which relates to certification requirements involving external power supplies that are exempt from the no-load mode requirements. The Class A external power supply-related correction addresses missing text describing the maximum energy consumption limit for Class A external power supplies with a nameplate output of not more than 250 watts by including (as already provided in the statute) a separate internal header denoting the “No-Load Mode” required for these types of external power supplies and adding internal column headers for the specified “Nameplate Output” and “Maximum Consumption” level. (EPCA does not have an efficiency requirement for Class A external power supplies with a no-load nameplate output exceeding 250 watts.) Without including this statutorily-prescribed explanatory text, the current value of 0.5 watts included in the current table listing the active mode energy efficiency/energy usage requirements may be unclear. This clarifying change would comport with the active mode requirements with the requirements already found in 42 U.S.C. 6295(u)(3)(A).

DOE is placing the amendments described in the previous section ( i.e., definitional changes, modified dates, and clarification) into 10 CFR part 430 (“Energy Conservation Program for Certain Consumer Products”). In addition, DOE is prescribing modifications to 10 CFR part 429 (“Certification, Compliance, and Enforcement for Consumer Products and Commercial and Industrial Equipment”). As a result of these provisions, power supply circuits, drivers, and devices designed exclusively to be connected to and power three key categories of products—(1) light-emitting diodes providing illumination; (2) organic light-emitting diodes providing illumination; or (3) ceiling fans using direct current motors—are excluded from the external power supply definition. Additionally, the no-load mode standards will not apply to certain external power supplies certified to DOE as being designed to be connected to a security or life safety alarm and surveillance system component until the effective date of any amended standards that DOE publishes through a final rule in July 2021 regarding whether to amend the external power supply standards in place. Finally, DOE's current table listing the active mode standards for Class A external power supplies will match the statutory text.

DOE has determined, pursuant to 5 U.S.C. 553(b)(B), that prior notice and an opportunity for public comment on this final rule are unnecessary. This rule inserts into the CFR, for the benefit of the public, the revised definitional provisions and timelines related to external power supplies prescribed by the PASS Act and EPS Improvement Act, corrects an internal cross-reference in DOE's certification regulations, and makes a clarification to bring the current regulatory text into conformity with the relevant statutory provision. DOE, therefore, finds that good cause exists to waive prior notice and an opportunity to comment for this rulemaking. For the same reasons, DOE, pursuant to 5 U.S.C. 553(d)(3), finds that good cause exists for making this final rule effective upon publication in the Federal Register .

DOE has determined that the PASS Act and the EPS Improvement Act of 2017 would result in costs savings to manufacturers of EPSs, LEDs, and ceiling fans. Consistent with OMB Circular A-4 and E.O. 13771, these changes would yield annualized cost savings of approximately $2.14 and $2.62 million (2016$), discounted at 3 and 7 percent, respectively.

As described in section II, the PASS Act delays by six years a requirement that DOE determine whether to amend the standards in effect ( i.e., from 2015 to 2021) and that the compliance date for any amended standards that DOE may decide to set be delayed from 2017 to 2023. Prior to the PASS Act, DOE was required to complete energy conservation standards for EPSs in 2015 that would have become effective in 2017. Due to the PASS Act, DOE is now required to complete energy conservation standards for EPSs by 2021 that will become effective in 2023. This change, assuming that DOE decided to amend the current standards, would result in cost savings for EPS manufacturers. DOE estimated anticipated conversion costs for EPS manufacturers to comply with future amended EPS energy conservation standards and calculated the cost savings of delaying those estimated conversion costs by six years ( i.e., from occurring in the years leading up to 2023 as opposed to in the years leading up to 2017).

DOE published estimated conversion costs for the adopted EPS energy conservation standards and for efficiency levels higher than the adopted standards in the February 2014 Energy Conservation Standards (“ECS”) Final Rule for EPSs. 79 FR 7846, 7901-7904 (February 10, 2014). As part of the February 2014 ECS Final Rule for EPSs, DOE adopted energy conservation standards at TSL 2 and estimated that EPS manufacturers would have to spend approximately $43.4 million (2012$) in conversion costs to comply with standards set at TSL 2, or $46.0 million in 2016$. Additionally, DOE estimated conversion costs of more stringent standards. As part of that rulemaking DOE estimated that conversion costs at TSL 3, one TSL higher than the adopted standards, would be approximately $45.2 million (2012$), or $47.9 million in 2016$.

Based on these costs, DOE estimates conversion costs of future amended EPS energy conservation standards could be approximately $1.9 million in 2016$. This delay of conversion costs by six years is calculated as cost savings to EPS manufacturers. DOE then calculated the net present value of delaying approximately $1.9 million in conversion costs by six years (leading up to 2023 instead of leading up to 2017).

As described in section II, the EPS Improvement Act of 2017 excludes certain devices that would otherwise be considered as EPSs from the EPS definition when they are used in LEDs providing illumination, OLEDs providing illumination, and ceiling fans using direct current motors from the EPS energy conservation standards. This change results in cost savings for LED, OLED, ceiling fan, and EPS manufacturers since these devices will no longer be required to meet the current energy conservation standards for EPSs. As a result, manufacturers of these devices will no longer need to redesign any existing EPS models that may have failed to meet the current EPS standards. Manufacturers also are not required to test and certify any products exempt from the EPS definition when introducing them into the market in the future.

DOE estimated the number of LED, OLED, and ceiling fan models that would be affected by this statutory change because manufacturers would no longer need to redesign them to accommodate the EPS standards. DOE also used data from the February 2014 ECS Final Rule for EPSs and data from DOE's Compliance Certification Database to estimate the average EPS revenue per model to be approximately $126,000 in 2016$. 1 DOE then estimated the per model capital conversion costs and per model product conversion costs to be approximately $10,600 and $9,600 respectively. 2 DOE then calculated the estimated percentage of EPS models that need to be converted to meet the February 2014 ECS Final Rule for EPSs for the product class based on the 18W AC-DC, Basic Voltage representative unit to be 90.2 percent. 3 Lastly, DOE estimated that there would be approximately 752 LED and OLED models and 131 ceiling fans models using these EPSs. 4 Therefore, DOE estimated that manufacturers would have had to spend approximately $13.7 million in conversion costs for EPSs used in LEDs and OLEDs  5 and an additional $2.4 million in conversion costs for EPSs used in ceiling fans with direct current motors. 6

In addition to conversion costs avoided, manufacturers will not incur ongoing testing and certification costs when new models falling within the scope of the statutory definitional changes are introduced into the market. DOE used the estimated testing time per EPS model published in the August 2015 TP Final Rule for EPSs 80 FR 51424 (August 25, 2015) and an average wage rate based on data from the Bureau of Labor Statistics and U.S. Census Bureau's Annual Survey of Manufacturers  7 to calculate total testing costs absent the adoption of the EPS Improvement Act of 2017. Based on these estimates, DOE estimated a per model cost of approximately $154 for manufacturers to conduct testing to comply with the current EPS test procedure.

DOE also estimated the production design cycle of EPSs used in LEDs and OLEDs and of EPSs used in ceiling fans. DOE used these estimates and the per model testing costs to calculate the average annual testing cost of EPSs used in LEDs and OLEDs, estimated at approximately $58,000, and the average annual testing cost of EPSs used in ceiling fans with direct current motors, estimated at approximately $5,700, absent the adoption of the EPS Improvement Act of 2017.

In addition to testing costs avoided, DOE calculated annual certification costs avoided by not having to certify the energy efficiency performance of those devices that are no longer considered as EPSs when used in LEDs, OLEDs, and ceiling fans with direct current motors using the DOE's EPS test procedure. DOE estimated the number of LED, OLED, and ceiling fan manufacturers producing products using these now excluded devices. DOE also estimated the annual certification burden of these manufacturers to introduce new models every year. DOE estimated annual certification costs of approximately $700,000 for these devices when used in LEDs or OLEDs, and annual certification costs of approximately $945,000 for these devices when used in ceiling fans with direct current motors absent the adoption of the EPS Improvement Act of 2017.

This final rule is a “significant regulatory action” under the criteria set out in section 3(f) of Executive Order 12866, “Regulatory Planning and Review.” 58 FR 51735 (October 4, 1993). Accordingly, this action was subject to review by the Office of Information and Regulatory Affairs (“OIRA”) in the Office of Management and Budget (“OMB”).

On January 30, 2017, the President issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.” That Order stated the policy of the executive branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources. The Order stated it is essential to manage the costs associated with the governmental imposition of private expenditures required to comply with Federal regulations. This final rule is expected to be an E.O. 13771 deregulatory action.

Additionally, on February 24, 2017, the President issued Executive Order 13777, “Enforcing the Regulatory Reform Agenda.” The Order required the head of each agency designate an agency official as its Regulatory Reform Officer (RRO). Each RRO oversees the implementation of regulatory reform initiatives and policies to ensure that agencies effectively carry out regulatory reforms, consistent with applicable law. Further, E.O. 13777 requires the establishment of a regulatory task force at each agency. The regulatory task force is required to make recommendations to the agency head regarding the repeal, replacement, or modification of existing regulations, consistent with applicable law. At a minimum, each regulatory reform task force must attempt to identify regulations that:

(i) Eliminate jobs, or inhibit job creation;

(ii) Are outdated, unnecessary, or ineffective;

(iii) Impose costs that exceed benefits;

(iv) Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;

(v) Are inconsistent with the requirements of Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or

(vi) Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.

The PASS Act and the EPS Improvement Act of 2017 delay DOE consideration of standards and exclude certain power supplies from the regulations for EPSs. This rule incorporates the provisions of these acts into the CFR. The resulting cost savings are due to ongoing avoided testing costs and certification costs for excluded power supplies; the interest on upfront conversion costs delayed by the PASS Act from 2017 to 2023; and one-time avoided conversion costs for excluded power supplies. Excluded power supplies include EPSs used in LEDs, OLEDs, and ceiling fans with direct current motors.

DOE concludes that this final rule is consistent with the directives set forth in these executive orders. Assuming a 7 percent discount rate, the final rule yields annualized cost savings of approximately $2.62 million (2016$). Therefore, this final rule is an Executive Order 13771 deregulatory action.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process. 68 FR 7990. The Department has made its procedures and policies available on the Office of General Counsel's website: http://energy.gov/gc/office-general-counsel. This rule revises the Code of Federal Regulations to incorporate, without substantive change, statutorily-imposed definitional changes affecting coverage under current energy conservation standards, applicable timelines related to certain rulemaking requirements, and related provisions prescribed by Public Law 115-78 and Public Law 115-115, along with a separate correction to reflect the current language found in the statute. Because this is a technical amendment for which a general notice of proposed rulemaking is not required, the Regulatory Flexibility Act does not apply to this rulemaking.

This rulemaking imposes no new information or record keeping requirements. Accordingly, Office of Management and Budget clearance is not required under the Paperwork Reduction Act. (44 U.S.C. 3501 et seq. )

In this rule, DOE is incorporating requirements prescribed by the PASS Act and EPS Improvement Act and preexisting statutory language. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ) and DOE's implementing regulations at 10 CFR part 1021. Specifically, this rule is strictly procedural and, therefore, would not result in any environmental impacts. Thus, this rulemaking is covered by Categorical Exclusion A6 under 10 CFR part 1021, subpart D, which applies to procedural rulemakings. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this final rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297) No further action is required by Executive Order 13132.

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. (Pub. L. 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA (62 FR 12820) (also available at http://www.gc.doe.gov). This final rule contains neither an intergovernmental mandate nor a mandate that may result in the expenditure of $100 million or more in any year, so these requirements under the Unfunded Mandates Reform Act do not apply.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This final rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

The Department has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 18, 1988), that this rule would not result in any takings which might require compensation under the Fifth Amendment to the United States Constitution.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed this final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. This final rule, which incorporates recently-enacted statutory provisions into DOE's regulations and makes specific corrections in conformity with the current statutory text, would not have a significant adverse effect on the supply, distribution, or use of energy and, therefore, is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The Secretary of Energy has approved publication of this final rule.

For the reasons set forth in the preamble, DOE hereby amends chapter II, subchapter D, of title 10 of the Code of Federal Regulations as set forth below:

As published, Airworthiness Directive 2019-01-01, Amendment 39-19540 (84 FR 129, January 18, 2019) (“AD 2019-01-01”), requires revising the airplane flight manual (AFM) to limit extended operations (ETOPS) for The Boeing Company Model 787-8 airplanes powered by RR Trent 1000-A (including -A/01 and -A/01A), Trent 1000-AE (including -AE/01A), Trent 1000-C (including -C/01 and -C/01A), Trent 1000-CE (including -CE/01A), Trent 1000-D (including -D/01 and -D/01A), Trent 1000-E (including -E/01 and -E/01A), Trent 1000-G (including -G/01 and -G/01A), and Trent 1000-H (including -H/01 and H/01A) turbofan engines.

As published, a document specified in the regulatory text is incorrect. Specifically, a service bulletin that is referenced in figure 1 to paragraph (g) of AD 2019-01-01 was incorrectly identified as Rolls Royce Non Modification Service Bulletin Trent 1000 “72-AK132.” The correct number is “72-K132.” Service bulletin “72-AK132” does not exist, and therefore, operators cannot directly comply with the AD requirement that refers to that service bulletin.

The error appeared in figure 1 to paragraph (g) of AD 2019-01-01. Although no other part of the preamble or regulatory information has been corrected, we are publishing the entire rule in the Federal Register .

The effective date of this AD remains February 4, 2019.

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

Legal Authority

Under the Controlled Substances Act (CSA), each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of scheduled substances is published at 21 CFR part 1308.

Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed. . . . ” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA (Administrator). 28 CFR 0.100.

The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS);  1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated on the Attorney General's own motion, as delegated to the Administrator, and is supported by, inter alia, a recommendation from the Acting Assistant Secretary for Health of the HHS (Acting Assistant Secretary) and an evaluation of all relevant data by the DEA. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle MAB-CHMINACA.

On February 5, 2016, the DEA published a final order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place the synthetic cannabinoid N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA) in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 81 FR 6171. That final order was effective on the date of publication, and was based on findings by the Acting Administrator of the DEA (Acting Administrator) that the temporary scheduling of this synthetic cannabinoid was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Section 201(h)(2) of the CSA, 21 U.S.C. 811(h)(2), requires that the temporary control of this substance expire two years from the issuance date of the scheduling order, on or before February 4, 2018. However, the CSA also provides that during the pendency of proceedings under 21 U.S.C. 811(a)(1), with respect to the substance, the temporary scheduling of that substance could be extended for up to one year. Accordingly, on January 30, 2018, the DEA extended the temporary scheduling of MAB-CHMINACA by one year, or until February 5, 2019. 83 FR 4411. Also, on January 30, 2018, the DEA published a notice of proposed rulemaking (NPRM) to permanently control MAB-CHMINACA in schedule I of the CSA. 83 FR 4406. Specifically, the DEA proposed to add this synthetic cannabinoid to the hallucinogenic substances list under 21 CFR 1308.11(d).

On January 19, 2018, the HHS provided the DEA with a scientific and medical evaluation document prepared by the Food and Drug Administration (FDA) entitled “Basis for the Recommendation to Place N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (MAB-CHMINACA; ADB-CHMINACA), and its salts, in Schedule I of the Controlled Substances Act.” After considering the eight factors in 21 U.S.C. 811(c), each substance's abuse potential, lack of legitimate medical use in the United States, and lack of accepted safety for use under medical supervision pursuant to 21 U.S.C. 812(b), the Acting Assistant Secretary recommended that MAB-CHMINACA be controlled in schedule I of the CSA. In response, the DEA conducted its own eightfactor analysis of MAB-CHMINACA. The DEA and HHS analyses are available in their entirety in the public docket for this rule (Docket Number DEA-421/DEA-2018-0001) at http://www.regulations.gov under “Supporting Documents.”

After a review of the available data, including the scientific and medical evaluation, and the scheduling recommendations from the HHS, the DEA published an NPRM entitled “Schedules of Controlled Substances: Placement of MAB-CHMINACA into Schedule I.” This NPRM proposed to control MAB-CHMINACA, and its salts, isomers, and salts of isomers in schedule I of the CSA. 83 FR 4406, January 30, 2018. The proposed rule provided an opportunity for interested persons to file a request for hearing in accordance with the DEA regulations on or before March 1, 2018. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposed rule on or before March 1, 2018.

The DEA received six comments on the proposed rule to control MAB-CHMINACA in schedule I of the CSA.

Not related to rulemaking: Four commenters submitted responses that did not pertain to the rulemaking and were not considered.

DEA's Future Diversion Efforts: One commenter quoted various statements from the proposed rule pertaining to the risk of MAB-CHMINACA to the public health ( i.e., information about clusters of overdoses, deaths, and adverse health effects associated with these incidents) and questioned the DEA's future response to stay ahead of synthetic cannabinoid manufacturers who alter the chemical formulation of substances to circumvent current controls.

DEA Response: The DEA continues to monitor various synthetic cannabinoids and has taken additional control actions against new substances as they are encountered. The DEA is continuing to use all available resources to address the issue of trafficking and abuse of novel psychoactive substances to safeguard the public from hazards associated with these substances.

Dissent for rulemaking: One commenter acknowledged that MAB-CHMINACA has no currently accepted medical use in treatment and there is a lack of accepted safety for its use under medical supervision. However, the commenter believes this does not represent the danger or high abuse potential of the substance, attributed to it by DEA. Rather, the commenter believes MAB-CHMINACA is so similar to tetrahydrocannabinol (THC) that its use is “a symptom of” the schedule I controls placed on THC, and questions the reliability of the data that DEA provided—as reported by state public health entities over a two-month period in 2015—to support Factor 4 (Its History and Current Pattern of Abuse). The commenter predicted that use of this drug has likely dropped since 2015 due to “medicinal THC use” becoming more acceptable by the general public nationwide, and therefore does not reflect the current abuse potential. Additionally, this commenter expressed concern that placing MAB-CHMINACA in schedule I would prevent medical research.

DEA Response: The DEA does not agree. Both the DEA and HHS analyses documented serious adverse effects including the deaths of individuals following the ingestion of MAB-CHMINACA. Pharmacology studies, overdose reports, law enforcement seizures, and other data collectively demonstrated the hazard to public safety and the dangers associated with this substance. With regard to the commenter's prediction that abuse of MAB-CHMINACA will become secondary due to the notion that THC is becoming more widely accepted, it is important to note that the extent of trafficking and abuse of a given substance at a given time is not typically determined by a sole factor. Complex factors related to the substance's abuse potential, market dynamics such as availability of similar other novel substances, and drug use trends in the drug abuser community are also considered when scheduling a substance. In fact, following temporary control of MAB-CHMINACA, several pharmacologically similar new substances appeared on the illicit market and the DEA has taken control actions on these substances. While MAB-CHMINACA continues to be abused in the United States, law enforcement encounters have decreased, as normally occur following the control of synthetic cannabinoids, including MAB-CHMINACA. As with other dangerous substances, the placement of a drug in schedule I does require additional regulatory controls. The Diversion Control Division's mission is to prevent, detect and investigate the diversion of controlled substances while ensuring an adequate and uninterrupted supply of these substances to meet legitimate medical, commercial and scientific needs. The DEA ensures that adequate security measures and background investigations are conducted for researchers who have legitimate need to conduct research and development with schedule I controlled synthetic drug substances.

After consideration of the relevant matter presented as a result of public comments, the scientific and medical evaluations and accompanying recommendation of HHS, and after its own eight-factor evaluation, the DEA finds that these facts and all other relevant data constitute substantial evidence of potential for abuse of MAB-CHMINACA. As such, the DEA is permanently scheduling MAB-CHMINACA as a controlled substance under the CSA.

The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analyses and recommendations of the Assistant Secretary and review of all other available data, the Acting Administrator, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds that:

(1) N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (MAB-CHMINACA; ADB-CHMINACA) has a high potential for abuse that is comparable to other schedule I substances such as delta-9-tetrahydrocannabinol (Δ 9 -THC) and JWH-018;

(2) N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (MAB-CHMINACA; ADB-CHMINACA) has no currently accepted medical use in treatment in the United States; and

(3) There is a lack of accepted safety for use of N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (MAB-CHMINACA; ADB-CHMINACA) under medical supervision.

Based on these findings, the Acting Administrator concludes that N -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H -indazole-3-carboxamide (MAB-CHMINACA; ADB-CHMINACA), including its salts, isomers and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, warrants control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

MAB-CHMINACA will continue  2 to be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, research, and conduct of instructional activities, including the following:

1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, MAB-CHMINACA must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.

2. Security. MAB-CHMINACA is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b) and in accordance with 21 CFR 1301.71-1301.93.

3. Labeling and Packaging. All labels and labeling for commercial containers of MAB-CHMINACA must be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.

4. Quota. Only registered manufacturers are permitted to manufacture MAB-CHMINACA in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

5. Inventory. Every DEA registrant who possesses any quantity of MAB-CHMINACA on the effective date of this final rule, must take an inventory of all stocks of these substances on hand as of January 29, 2019, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11 (a) and (d). Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements.

After the initial inventory, every DEA registrant must take a new inventory of all controlled substances (including MAB-CHMINACA) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records and Reports. Every DEA registrant must maintain records and submit reports with respect to MAB-CHMINACA pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312.

7. Order Forms. Every DEA registrant who distributes MAB-CHMINACA must continue to comply with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305.

8. Importation and Exportation. All importation and exportation of MAB-CHMINACA must continue to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

9. Liability. Any activity involving MAB-CHMINACA not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.

This final rule does not meet the definition of an Executive Order 13771 regulatory action. OMB has previously determined that formal rulemaking actions concerning the scheduling of controlled substances, such as this rule, are not significant regulatory actions under Section 3(f) of Executive Order 12866.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications warranting the application of Executive Order 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.

The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-602, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On February 6, 2016, the DEA published a final order to temporarily place this substance in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The DEA estimates that all entities handling or planning to handle these substances have already established and implemented the systems and processes required to handle MAB-CHMINACA. As of January 2018, there were 16 registrations authorized to handle MAB-CHMINACA specifically, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. These 16 registrations represent 14 entities, of which 8 are small entities. Therefore, the DEA estimates eight small entities are affected by this rule.

A review of the 16 registrations indicates that all entities that currently handle MAB-CHMINACA also handle other schedule I controlled substances, and have established and implemented (or maintain) the systems and processes required to handle MAB-CHMINACA. Therefore, the DEA anticipates that this rule will impose minimal or no economic impact on any affected entities; and thus, will not have a significant economic impact on any of the eight affected small entities. Therefore, the DEA has concluded that this rule will not have a significant effect on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This rule will not result in: “an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.” However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, 21 CFR part 1308 is amended as follows: