Federal Register / Vol. 84, No. 159 / Friday, August 16, 2019 / Rules and Regulations 41913

Dated: August 13, 2019. the plant species Papaver somniferum L. schedules. Listing noroxymorphone also Robert E. Perez, that is lawfully defined as ‘‘opium will not affect the aggregate production Deputy Commissioner, U.S. Customs and poppy’’ by 21 U.S.C. 802(19). It is not quota currently established. DEA- Border Protection. an isoquinoline alkaloid, which is registered manufacturers of Approved: categorically excluded from the noroxymorphone previously granted statutory definition of a ‘‘narcotic drug.’’ Timothy E. Skud, individual quotas for such purposes 21 U.S.C. 802(17)(A). Rather, may continue to apply for quota after Deputy Assistant Secretary of the Treasury. noroxymorphone is a phenanthrene this rule is finalized. [FR Doc. 2019–17743 Filed 8–14–19; 4:15 pm] alkaloid with a similar chemical BILLING CODE 9111–14–P structure to other opium and opiate Regulatory Analyses phenanthrene alkaloids listed in 21 CFR Administrative Procedure Act (APA) 1308.12(b)(1), such as hydrocodone, DEPARTMENT OF JUSTICE hydromorphone, dihydroetorphine, Under 5 U.S.C. 553(b)(3)(B), an ethylmorphine, etorphine agency may dispense with notice and Drug Enforcement Administration hydrochloride, metopon, thebaine, comment rulemaking when, for good morphine, codeine, oxycodone, and cause, it ‘‘finds . . . that notice and 21 CFR Part 1308 oxymorphone. Noroxymorphone meets public procedure thereon are [Docket No. DEA–332] the statutory definition of ‘‘opiate’’ as it impracticable, unnecessary, or contrary can be readily converted to other to the public interest.’’ DEA finds that Listing of Noroxymorphone in the morphine-like substances including notice and comment rulemaking is Code of Federal Regulations and oxymorphone, which has an addiction- unnecessary and that good cause exists Assignment of a Controlled forming or addiction-sustaining abuse to dispense with these procedures Substances Code Number liability similar to morphine. Based on because the inclusion of the similarity of the chemical structure noroxymorphone and its DEA AGENCY: Drug Enforcement of noroxymorphone to opium alkaloids Controlled Substances Code Number in Administration, Department of Justice. listed in 21 CFR 1308.12(b)(1), and the the list of schedule II substances in 21 ACTION: Final rule. fact that it is obtained by the chemical CFR 1308.12(b)(1) is ‘‘ ‘a minor or modification of these listed opium merely technical amendment in which SUMMARY: Noroxymorphone is a alkaloids, noroxymorphone is a the public is not particularly derivative of opium and opiates and, as derivative of opium and opiates and a interested.’ ’’ National Nutritional Foods such, is a schedule II controlled schedule II controlled substance as Ass’n v. Kennedy, 572 F.2d 377, 385 (2d substance. The Drug Enforcement defined by 21 U.S.C. 812(a)(1) Schedule Cir. 1978) (quoting S. Rep. No. 79–752, Administration (DEA) has established II and 21 CFR 1308.12(b)(1). at 200 (1945)). See also Utility Solid the use of the Drug Enforcement As provided in 21 CFR 1308.03, each Waste Activities Group v. E.P.A., 236 Administration Code Number 9668 for controlled substance or basic class F.3d 749, 755 (D.C. Cir. 2001) (the tracking noroxymorphone and for thereof is assigned a four digit Drug ‘‘unnecessary’’ prong ‘‘is confined to establishing aggregate production Enforcement Administration Controlled those situations in which the quotas. This rule amends the Code of Substances Code Number that is used to administrative rule is a routine Federal Regulations (CFR) to reflect the track quantities of the controlled determination, insignificant in nature current practice of using the Code substance imported and exported to and and impact, and inconsequential to the Number 9668 for noroxymorphone. This from the United States. Additionally, industry and public’’) (int. quotations rulemaking will list the schedule II DEA uses these Code Numbers in and citation omitted). This rule is a controlled substance noroxymorphone establishing aggregate production quotas ‘‘technical amendment’’ to 21 CFR as a basic class with the Code Number for basic classes of controlled 1308.12(b)(1) as it is ‘‘insignificant in 9668. This rule does not affect the substances listed in schedules I and II nature and impact, and inconsequential control of noroxymorphone as a as required by 21 U.S.C. 826. to the industry and public.’’ schedule II controlled substance. Since 1996, DEA has established an aggregate production quota for Similarly, the APA states that a rule DATES: Effective: August 16, 2019. noroxymorphone using the DEA cannot be made effective less than 30 FOR FURTHER INFORMATION CONTACT: Controlled Substances Code Number days after publication, unless the rule Lynnette Wingert, Diversion Control 9668. In this final rule, DEA is falls under one of three enumerated Division, Drug Enforcement amending the CFR to reflect the current exceptions. One of these exceptions is Administration; Mailing Address: 8701 practice of using the DEA Controlled when an agency provides good cause Morrissette Drive, Springfield, Virginia Substances Code Number 9668 for that compliance would be 22152; Telephone (202) 598–8837. noroxymorphone. Listing impracticable, unnecessary, or contrary SUPPLEMENTARY INFORMATION: noroxymorphone and its DEA to the public interest. 5 U.S.C. 553(d)(3). Noroxymorphone is a schedule II Controlled Substances Code Number in A delayed effective date for this rule is controlled substance defined in the 21 CFR 1308.12(b)(1) does not alter the unnecessary because this rule simply Controlled Substances Act (CSA) by 21 status of noroxymorphone as a Schedule lists the schedule II controlled U.S.C. 812(c), Schedule II (a)(1) and 21 II controlled substance. substance noroxymorphone in 21 CFR CFR 1308.12(b)(1), which control Noroxymorphone already is included as 1308.12(b)(1) as a basic class and ‘‘opium and opiate, and any salt, a Schedule II controlled substance assigns to it the DEA Controlled compound, derivative, or preparation of because 21 CFR 1308.12(b)(1) controls Substances Code Number 9668. This opium or opiate.’’ It meets the statutory any salt, compound, derivative, or rule merely amends the CFR to reflect definition of a ‘‘narcotic drug’’ as stated preparation of the listed substances. the current DEA business practice and in 21 U.S.C. 802(17) as it can be Accordingly, noroxymorphone has been better assist companies in complying obtained from the chemical controlled as a derivative of the listed with registration and quota modification of substances extracted substances and this rule will not result requirements. In addition, this rule does from vegetable origin, specifically from in adding any new substances into the not require those firms that handle

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noroxymorphone to alter their current Executive Order 13175, Consultation adding a new paragraph (b)(1)(x) to read practices with respect to their quota and Coordination With Indian Tribal as follows: applications and reporting obligations. Governments § 1308.12 Schedule II. For the reasons stated above, notice This rule does not have tribal * * * * * and comment procedures are implications warranting the application (b) * * * unnecessary and this rule may be made of Executive Order 13175. It does not (1) * * * effective upon publication. have substantial direct effects on one or more Indian tribes, on the relationship * * * * * Executive Order 12866, 13563, and between the Federal Government and (x) Noroxymorphone ...... 9668 13771, Regulatory Planning and Review, Indian tribes, or on the distribution of * * * * * Improving Regulation and Regulatory power and responsibilities between the Dated: August 5, 2019. Review, and Reducing Regulation and Federal Government and Indian tribes. Controlling Regulatory Costs Uttam Dhillon, Regulatory Flexibility Act Acting Administrator. This regulation has been drafted and The Regulatory Flexibility Act (RFA) [FR Doc. 2019–17623 Filed 8–15–19; 8:45 am] reviewed in accordance with the (5 U.S.C. 601–612) applies to rules that BILLING CODE 4410–09–P principles of Executive Orders 12866 are subject to notice and comment and 13563. This rule is not a significant under section 553(b) of the APA or other regulatory action under Executive Order laws. As explained above, the DEA ENVIRONMENTAL PROTECTION 12866. Noroxymorphone is a derivative determined that there was good cause to AGENCY of opium and opiates and, as such, is a exempt this final rule from notice and schedule II controlled substance. In this comment. Consequently, the RFA does 40 CFR Part 300 final rule, DEA is merely amending its not apply to this final rule. regulations to reflect the current [EPA–HQ–SFUND–1995–0005; FRL–9998– practice of using the DEA Controlled Unfunded Mandates Reform Act of 1995 43–Region 4] Substances Code Number 9668 for This final rule will not result in the National Oil and Hazardous noroxymorphone. Listing expenditure by state, local, and tribal Substances Pollution Contingency noroxymorphone and its DEA governments, in the aggregate, or by the Plan; National Priorities List: Deletion Controlled Substances Code Number private sector, of $100,000,000 or more of the Tennessee Products Superfund will not alter the status of (adjusted for inflation) in any one year, Site noroxymorphone as a Schedule II and will not significantly or uniquely controlled substance. Accordingly, this affect small governments. Therefore, no AGENCY: Environmental Protection rule has not been reviewed by the Office actions were deemed under the Agency (EPA). of Management and Budget. provisions of the Unfunded Mandates ACTION: Final rule. Because this final rule is not Reform Act of 1995, 2 U.S.C. 1532. SUMMARY: The Environmental Protection significant under Executive Order Paperwork Reduction Act of 1995 12866, it is not subject to the Agency (EPA) Region 4 announces the requirements of Executive Order This rule does not impose a collection deletion of the Tennessee Products Superfund Site (Site) located in 13771.1 of information requirement under the Paperwork Reduction Act of 1995. 44 Chattanooga, Tennessee, from the Executive Order 12988, Civil Justice U.S.C. 3501–3521. National Priorities List (NPL). The NPL, Reform promulgated pursuant to section 105 of Congressional Review Act the Comprehensive Environmental This regulation meets the applicable This rule is not a major rule as Response, Compensation, and Liability standards set forth in sections 3(a) and defined by section 804 of the Act (CERCLA) of 1980, as amended, is 3(b)(2) of Executive Order 12988 to Congressional Review Act (CRA), 5 an appendix of the National Oil and eliminate drafting errors and ambiguity, U.S.C. 804. Pursuant to the CRA, the Hazardous Substances Pollution minimize litigation, provide a clear legal DEA is submitting a copy of this final Contingency Plan (NCP). The EPA and standard for affected conduct, and rule to both Houses of Congress and to the State of Tennessee, through the promote simplification and burden the Comptroller General. Tennessee Department of Environment reduction. and Conservation, have determined that List of Subjects in 21 CFR Part 1308 Executive Order 13132, Federalism all appropriate response actions under Drug traffic control, Controlled CERCLA, other than Five Year Reviews, This rulemaking does not have Substances. have been completed. However, this federalism implications warranting the For the reasons set out above, 21 CFR deletion does not preclude future application of Executive Order 13132. part 1308 is amended as follows: actions under Superfund. The rule does not have substantial DATES: This action is effective August direct effects on the States, on the PART 1308—SCHEDULES OF 16, 2019. CONTROLLED SUBSTANCES relationship between the national ADDRESSES: Docket: EPA has established government and the States, or the ■ a docket for this action under Docket distribution of power and 1. The authority citation for part 1308 continues to read as follows: Identification No. EPA–HQ–SFUND– responsibilities among the various 1995–0005. All documents in the docket levels of government. Authority: 21 U.S.C. 811, 812, 871(b), are listed on the http:// unless otherwise noted. www.regulations.gov website. Although 1 Office of Mgmt. & Budget, Exec. Office of The ■ 2. Section 1308.12 is amended by listed in the index, some information is President, Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 Titled redesignating paragraphs (b)(1)(x) not publicly available, i.e., Confidential ‘‘Reducing Regulation and Controlling Regulatory through (xviii) as paragraphs (b)(1)(xi) Business Information or other Costs’’ (Feb. 2, 2017). through (xix), respectively, and by information whose disclosure is

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