81 FR 66181 - Schedules of Controlled Substances: Placement of Three Synthetic Phenethylamines Into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 187 (September 27, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 187 (September 27, 2016)
| Page Range | 66181-66184 | |
| FR Document | 2016-23185 |
[Federal Register Volume 81, Number 187 (Tuesday, September 27, 2016)] [Rules and Regulations] [Pages 66181-66184] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23185] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-423] Schedules of Controlled Substances: Placement of Three Synthetic Phenethylamines Into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: With the issuance of this final rule, the Administrator of the Drug Enforcement Administration places three synthetic phenethylamines: 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I- NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-chloro-2,5-dimethoxyphenyl)-N- (2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B- NBOMe; 2C-B-NBOMe; 25B; Cimbi-36), including their optical, positional, and geometric isomers, salts and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action continues the application of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe. DATES: Effective: October 27, 2016. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598- 6812. SUPPLEMENTARY INFORMATION: Legal Authority The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the ``Controlled Substances Act'' and the ``Controlled Substances Import and Export Act,'' respectively, and are collectively referred to as the ``Controlled Substances Act'' or the ``CSA'' for the purposes of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, 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 all 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 * * * finds that such drug or other substance has a potential for abuse, and * * * 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, 28 CFR 0.100, who in turn has redelegated that authority to the Deputy Administrator of the DEA. 28 CFR part 0, appendix to subpart R. 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 [[Page 66182]] Attorney General (1) on her 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 Drug Enforcement Administration, and is supported by, inter alia, a recommendation from the Assistant Secretary for Health of the HHS \2\ and an evaluation of all relevant data by the DEA. This action continues the application of the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles, or proposes to handle, 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe. --------------------------------------------------------------------------- \1\ As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the Department of Health and Human Services (HHS) in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. --------------------------------------------------------------------------- Background On October 10, 2013, the DEA published a notice of intent to temporarily place 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2- methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4- chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2- methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) into schedule I pursuant to the temporary scheduling provisions of the CSA. 78 FR 61991. On November 15, 2013, the DEA published a final order amending 21 CFR 1308.11(h) to temporarily place these three synthetic phenethylamines into schedule I of the CSA. 78 FR 68716. That final order was effective on the date of publication, and was based on findings by the Deputy Administrator of the DEA that the temporary scheduling of these three synthetic phenethylamine substances was necessary to avoid an imminent hazard to public safety pursuant to 21 U.S.C. 811(h)(1). Section 201(h)(2) of the CSA requires that the temporary scheduling of a substance expire two years from the effective date of the scheduling order, or on or before November 14, 2015. 21 U.S.C. 811(h)(2). However, the CSA also provides that the temporary scheduling may be extended for up to one year during the pendency of proceedings under 21 U.S.C. 811(a)(1). Id. Accordingly, on November 13, 2015, the DEA published a notice of proposed rulemaking (NPRM) to permanently control 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in schedule I of the CSA. 80 FR 70649. Specifically, the DEA proposed to add these substances to 21 CFR 1308.11(d), hallucinogenic substances. Also, on November 13, 2015, the DEA extended the temporary scheduling of 25I- NBOMe, 25C-NBOMe, and 25B-NBOMe by one year, until November 13, 2016. 80 FR 70658. DEA and HHS Eight Factor Analyses On August 12, 2015, the HHS provided the DEA with three scientific and medical evaluation documents prepared by the FDA entitled ``Basis for the Recommendation to Place 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2- methoxybenzyl)ethanamine (25I-NBOMe) and its Salts in Schedule I of the Controlled Substances Act (CSA);'' ``Basis for the Recommendation to Place 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe) and its Salts in Schedule I of the Controlled Substances Act (CSA);'' and ``Basis for the Recommendation to Place 2-(4-bromo- 2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe) and its Salts in Schedule I of the Controlled Substances Act (CSA).'' After considering the eight factors in 21 U.S.C. 811(c), including consideration of each substance's abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary of the HHS recommended that 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe be controlled in schedule I of the CSA. In response, the DEA conducted its own eightfactor analysis of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe. Both the DEA and HHS analyses are available in their entirety under the tab ``Supporting Documents'' of the public docket of this action at http://www.regulations.gov under FDMS Docket ID: DEA-2015-0019 (Docket Number DEA-423). Determination to Schedule 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe After a review of the available data, including the scientific and medical evaluations and the scheduling recommendations from the HHS, the DEA published an NPRM entitled ``Schedules of Controlled Substances: Placement of Three Synthetic Phenethylamines into Schedule I,'' proposing to control 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in schedule I of the CSA. 80 FR 70649, November 13, 2015. The proposed rule provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations on or before December 14, 2015. 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 proposal on or before December 14, 2015. Comments Received The DEA received no comments on the proposed rule to schedule 25I- NBOMe, 25C-NBOMe, and 25B-NBOMe. Scheduling Conclusion After consideration of the scientific and medical evaluations and accompanying recommendations of the HHS, and the DEA's consideration of its own eight-factor analyses, the DEA finds that these facts and all other relevant data constitute substantial evidence of potential for abuse of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe. As such, the DEA is permanently scheduling 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe as controlled substances under the CSA. Determination of Appropriate Schedule 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 analysis and recommendation of the Assistant Secretary for HHS and review of all other available data, the Administrator of the DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that: (1) 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have a high potential for abuse that is comparable to other schedule I substances such as 2C-I, 2C-C, 2C-B, LSD and DOM; (2) 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe have no currently accepted medical use in treatment in the United States; and (3) There is a lack of accepted safety for use of 25I-NBOMe, 25C- NBOMe, or 25B-NBOMe under medical supervision. Based on these findings, the Administrator of the DEA concludes that 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I- NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-(4-chloro-2,5-dimethoxyphenyl)-N- (2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), and 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B- NBOMe; 2C-B-NBOMe; 25B; Cimbi-36), including their optical, positional, and geometric isomers, salts and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is [[Page 66183]] possible, warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1). Requirements for Handling 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe are currently scheduled on a temporary basis in schedule I \2\ and are therefore currently subject to the CSA regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, conduct of instructional activities or chemical analysis, and possession of schedule I controlled substances, including those listed below. These controls will continue on a permanent basis: --------------------------------------------------------------------------- \2\ 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe are currently subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 80 FR 70658, Nov. 13, 2015. --------------------------------------------------------------------------- 1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) 25I- NBOMe, 25C-NBOMe, or 25B-NBOMe, or who desires to handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe 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. Disposal of Stocks. 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe must be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws. 3. Security. 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe continue to be subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, and 871(b), and in accordance with 21 CFR 1301.71-1301.93. 4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302. 5. Quota. Only registered manufacturers are permitted to manufacture 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303. 6. Inventory. Every DEA registrant required to keep records and who possesses any quantity of 25I-NBOMe, 25C-NBOMe, and/or 25B-NBOMe is required to maintain an inventory of all stocks of NBOMes on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 7. Records and Reports. Every DEA registrant must maintain records and submit reports with respect to 25I-NBOMe, 25C-NBOMe, and/or 25B- NBOMe pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304 and 1317. Manufacturers and distributors must submit reports regarding 25I-NBOMe, 25C-NBOMe, and/or 25B-NBOMe to the Automation of Reports and Consolidated Order System (ARCOS) pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.33. 8. Order Forms. Every DEA registrant who distributes 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must continue to comply with the order form requirements, pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305. 9. Importation and Exportation. All importation and exportation of 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and be in accordance with 21 CFR part 1312. 10. Liability. Any activity involving 25I-NBOMe, 25C-NBOMe, or 25B- NBOMe not authorized by, or in violation of, the CSA or its implementing regulations continues to be unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Analyses Executive Orders 12866 and 13563, Regulatory Planning and Review, and 13563, Improving Regulation and Regulatory Review 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. Executive Order 12988, Civil Justice Reform 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. Executive Order 13132, Federalism 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. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments 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. Regulatory Flexibility Act The Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this rule and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. On November 15, 2013, the DEA published a final order to temporarily place these three synthetic phenethylamines into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 78 FR 68716. On November 13, 2015, the DEA published a final order extending the temporary placement of these substances in schedule I of the CSA for up to one year pursuant to 21 U.S.C. 811(h)(2). 80 FR 70658. The DEA estimates that all entities handling or planning to handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe are currently registered to handle these substances. There are currently 18 registrations authorized to handle 25I-NBOMe, 25C- NBOMe, or 25B-NBOMe, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. These 18 registrations represent 13 entities, of which 6 are small entities Therefore, the DEA estimates six small entities are affected by this rule. A review of the 18 registrations indicates that all entities that currently handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe handle other schedule I controlled substances, and have established and implemented (or currently maintain) the systems and processes required to handle 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe. [[Page 66184]] 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 six affected small entities. Therefore, the DEA has concluded that this rule will not have a significant effect on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 On the basis of information contained in the ``Regulatory Flexibility Act'' section above, the DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., 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 provisions of the UMRA of 1995. Paperwork Reduction Act 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. Congressional Review Act This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). 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 U.S.-based companies to compete with foreign based companies 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. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR part 1308 is amended to read as follows: PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 0 2. Amend Sec. 1308.11 by: 0 a. Adding paragraphs (d)(55) through (57); and 0 b. Removing paragraphs (h)(1) through (3) and redesignating paragraphs (h)(4) through (20) as (h)(1) through (17), respectively. The additions read as follows: Sec. 1308.11 Schedule I. * * * * * (d) * * * (55) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe, 2C-I-NBOMe) (7538) (56) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe, 2C-C-NBOMe) (7537) (57) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe, 2C-B-NBOMe) (7536) * * * * * Dated: September 15, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-23185 Filed 9-26-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 187 / Tuesday, September 27, 2016 / Rules and Regulations 66181
promulgated, does not have a significant Paragraph 6009(d)—Blue Federal airways. Control, Drug Enforcement
economic impact on a substantial * * * * * Administration; Mailing Address: 8701
number of small entities under the Morrissette Drive, Springfield, Virginia
B–1 [Removed]
criteria of the Regulatory Flexibility Act. 22152; Telephone: (202) 598–6812.
B–12 [New] SUPPLEMENTARY INFORMATION:
Environmental Review
From Woody Island, AK, NDB to Iliamna,
The FAA has determined that this AK, NDB. Legal Authority
action qualifies for categorical exclusion Issued in Washington, DC, on September The Drug Enforcement
under the National Environmental 19, 2016. Administration (DEA) implements and
Policy Act, and its agency implementing Leslie M. Swann, enforces titles II and III of the
regulations in FAA Order 1050.1F, Comprehensive Drug Abuse Prevention
Acting Manager, Airspace Policy Group.
‘‘Environmental Impacts: Policies and and Control Act of 1970, as amended. 21
[FR Doc. 2016–23116 Filed 9–26–16; 8:45 am]
Procedures’’ regarding categorical U.S.C. 801–971. Titles II and III are
BILLING CODE 4910–13–P referred to as the ‘‘Controlled
exclusions for procedural actions at
paragraph 5–6.5k, which categorically Substances Act’’ and the ‘‘Controlled
excludes from full environmental Substances Import and Export Act,’’
impact review actions that include, DEPARTMENT OF JUSTICE respectively, and are collectively
‘‘Publication of existing air traffic referred to as the ‘‘Controlled
control procedures that do not Drug Enforcement Administration Substances Act’’ or the ‘‘CSA’’ for the
essentially change existing tracks, create purposes of this action. The DEA
new tracks, change altitude, or change 21 CFR Part 1308 publishes the implementing regulations
concentration of aircraft on these [Docket No. DEA–423] for these statutes in title 21 of the Code
tracks.’’ Since this procedural action of Federal Regulations (CFR), chapter II.
consists only of a name change from Schedules of Controlled Substances: The CSA and its implementing
Blue Federal airway B–1 in Alaska to B– Placement of Three Synthetic regulations are designed to prevent,
12 to de-conflict with an identically Phenethylamines Into Schedule I detect, and eliminate the diversion of
named airway in Taiwan, this name controlled substances and listed
AGENCY: Drug Enforcement chemicals into the illicit market while
change action is not expected to cause Administration, Department of Justice.
any potentially significant ensuring an adequate supply is available
ACTION: Final rule. for the legitimate medical, scientific,
environmental impacts. In accordance
with FAAO 1050.1F, paragraph 5–2 SUMMARY: With the issuance of this final research, and industrial needs of the
regarding Extraordinary Circumstances, rule, the Administrator of the Drug United States. Controlled substances
this action has been reviewed for factors Enforcement Administration places have the potential for abuse and
and circumstances in which a normally three synthetic phenethylamines: 2-(4- dependence and are controlled to
categorically excluded action may have iodo-2,5-dimethoxyphenyl)-N-(2- protect the public health and safety.
a significant environmental impact Under the CSA, each controlled
methoxybenzyl)ethanamine (25I-
requiring further analysis, and it is substance is classified into one of five
NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2-
determined that no extraordinary schedules based upon its potential for
(4-chloro-2,5-dimethoxyphenyl)-N-(2-
circumstances exist that warrant abuse, its currently accepted medical
methoxybenzyl)ethanamine (25C-
preparation of an environmental use in treatment in the United States,
NBOMe; 2C-C-NBOMe; 25C; Cimbi-82),
assessment. and the degree of dependence the
and 2-(4-bromo-2,5-dimethoxyphenyl)-
substance may cause. 21 U.S.C. 812. The
List of Subjects in 14 CFR Part 71 N-(2-methoxybenzyl)ethanamine (25B- initial schedules of controlled
NBOMe; 2C-B-NBOMe; 25B; Cimbi-36), substances established by Congress are
Airspace, Incorporation by reference, including their optical, positional, and
Navigation (air). found at 21 U.S.C. 812(c), and the
geometric isomers, salts and salts of current list of all scheduled substances
Adoption of the Amendment isomers, whenever the existence of such is published at 21 CFR part 1308.
salts, isomers, and salts of isomers is Pursuant to 21 U.S.C. 811(a)(1), the
In consideration of the foregoing, the possible, into schedule I of the
Federal Aviation Administration Attorney General may, by rule, ‘‘add to
Controlled Substances Act. This such a schedule or transfer between
amends 14 CFR part 71 as follows: scheduling action is pursuant to the such schedules any drug or other
PART 71—DESIGNATION OF CLASS A, Controlled Substances Act which substance if he * * * finds that such
B, C, D, AND E AIRSPACE AREAS; AIR requires that such actions be made on drug or other substance has a potential
TRAFFIC SERVICE ROUTES; AND the record after opportunity for a for abuse, and * * * makes with respect
REPORTING POINTS hearing through formal rulemaking. to such drug or other substance the
This action continues the application of findings prescribed by subsection (b) of
■ 1. The authority citation for part 71 the regulatory controls and section 812 of this title for the schedule
continues to read as follows: administrative, civil, and criminal in which such drug is to be placed
sanctions applicable to schedule I * * *.’’ The Attorney General has
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, controlled substances on persons who delegated scheduling authority under 21
1959–1963 Comp., p. 389. handle (manufacture, distribute, reverse U.S.C. 811 to the Administrator of the
asabaliauskas on DSK3SPTVN1PROD with RULES
distribute, import, export, engage in DEA, 28 CFR 0.100, who in turn has
§ 71.1 [Amended] research, conduct instructional redelegated that authority to the Deputy
■ 2. The incorporation by reference in activities or chemical analysis, or Administrator of the DEA. 28 CFR part
14 CFR 71.1 of FAA Order 7400.11A possess), or propose to handle 25I- 0, appendix to subpart R.
Airspace Designations and Reporting NBOMe, 25C-NBOMe, or 25B-NBOMe. The CSA provides that proceedings
Points, dated August 3, 2016 and DATES: Effective: October 27, 2016. for the issuance, amendment, or repeal
effective September 15, 2016, is FOR FURTHER INFORMATION CONTACT: of the scheduling of any drug or other
amended as follows: Michael J. Lewis, Office of Diversion substance may be initiated by the
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Therefore, the DEA anticipates that this Reporting and recordkeeping FOR FURTHER INFORMATION CONTACT:
rule will impose minimal or no requirements. Stephanie Traub, Office of Legal Affairs,
economic impact on any affected For the reasons set out above, 21 CFR Passport Services, (202) 485–6500.
entities; and thus, will not have a part 1308 is amended to read as follows: Hearing- or speech-impaired persons
significant economic impact on any of may use the Telecommunications
the six affected small entities. Therefore, PART 1308—SCHEDULES OF Devices for the Deaf (TDD) by contacting
the DEA has concluded that this rule CONTROLLED SUBSTANCES the Federal Information Relay Service at
will not have a significant effect on a 1–800–877–8339.
substantial number of small entities. ■ 1. The authority citation for part 1308 SUPPLEMENTARY INFORMATION: The
continues to read as follows: Department of State published a final
Unfunded Mandates Reform Act of 1995
Authority: 21 U.S.C. 811, 812, 871(b), rule on September 2, 2016 (81 FR
On the basis of information contained unless otherwise noted. 60608). This document corrects the final
in the ‘‘Regulatory Flexibility Act’’ ■ 2. Amend § 1308.11 by: rule by changing ‘‘42 U.S.C. 16935a’’ to
section above, the DEA has determined ■ a. Adding paragraphs (d)(55) through ‘‘22 U.S.C. 212b(c)(1)’’, wherever it
and certifies pursuant to the Unfunded (57); and occurs; and by adding a paragraph to the
Mandates Reform Act (UMRA) of 1995, ■ b. Removing paragraphs (h)(1) through SUPPLEMENTARY INFORMATION, regarding
2 U.S.C. 1501 et seq., that this action (3) and redesignating paragraphs (h)(4) implementation of the rule.
would not result in any Federal through (20) as (h)(1) through (17),
mandate that may result in the Correction
respectively.
expenditure by State, local, and tribal The additions read as follows: In the FR Doc 2016–21087, appearing
governments, in the aggregate, or by the on page 60608, in the Federal Register
private sector, of $100,000,000 or more § 1308.11 Schedule I. of September 2, 2016 (81 FR 60608) the
(adjusted for inflation) in any one year. * * * * * following corrections are made:
Therefore, neither a Small Government (d) * * * 1. Remove ‘‘42 U.S.C. 16935a’’ and
Agency Plan nor any other action is (55) 2-(4-iodo-2,5-dimethoxyphenyl)- add in its place ‘‘22 U.S.C. 212b(c)(1)’’
required under provisions of the UMRA N-(2-methoxybenzyl)ethanamine (25I- in the following places:
of 1995. NBOMe, 2C-I-NBOMe) (7538) a. On page 60608, in the second
(56) 2-(4-chloro-2,5- column, first paragraph, of the
Paperwork Reduction Act of 1995 SUPPLEMENTARY INFORMATION; and
dimethoxyphenyl)-N-(2-
This action does not impose a new methoxybenzyl)ethanamine (25C- b. On page 60608, in the third
collection of information under the NBOMe, 2C-C-NBOMe) (7537) column, first full paragraph.
(57) 2-(4-bromo-2,5- 2. Add the following paragraph on
Paperwork Reduction Act of 1995. 44
dimethoxyphenyl)-N-(2- page 60608, third column, after the first
U.S.C. 3501–3521. This action would
methoxybenzyl)ethanamine (25B- full paragraph and prior to ‘‘Regulatory
not impose recordkeeping or reporting
NBOMe, 2C-B-NBOMe) (7536) Findings’’:
requirements on State or local Pursuant to 22 U.S.C. 212b(f),
governments, individuals, businesses, or * * * * * § 51.60(a)(4) and (g) shall not be applied
organizations. An agency may not Dated: September 15, 2016. until the Secretary of State, the
conduct or sponsor, and a person is not Secretary of Homeland Security, and the
Chuck Rosenberg,
required to respond to, a collection of Attorney General certify to Congress
information unless it displays a Acting Administrator.
[FR Doc. 2016–23185 Filed 9–26–16; 8:45 am] that the process they developed and
currently valid OMB control number. reported to Congress has been
BILLING CODE 4410–09–P
Congressional Review Act successfully implemented. Updates
regarding the implementation of these
This rule is not a major rule as sections as well as § 51.60(a)(3) will be
defined by section 804 of the Small DEPARTMENT OF STATE
posted on http://travel.state.gov.
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional 22 CFR Part 51 List of Subjects in 22 CFR Part 51
Review Act (CRA)). This rule will not [Public Notice: 9715] Passports.
result in: An annual effect on the Accordingly, for the reasons set forth
RIN 1400–AD97
economy of $100,000,000 or more; a in the preamble, 22 CFR part 51 is
major increase in costs or prices for Passports; Correction corrected by making the following
consumers, individual industries, correcting amendments:
federal, state, or local government AGENCY:Department of State.
agencies, or geographic regions; or Final rule; correction; correcting
ACTION: PART 51—PASSPORTS
significant adverse effects on amendments.
competition, employment, investment, ■ 1. The authority citation for part 51
productivity, innovation, or on the SUMMARY: The Department of State continues to read as follows:
ability of U.S.-based companies to published a final rule in the Federal Authority: 8 U.S.C. 1504; 18 U.S.C. 1621;
compete with foreign based companies Register on September 2, 2016 (81 FR 22 U.S.C. 211a, 212, 212b, 213, 213n (Pub. L.
in domestic and export markets. 60608), amending the passport rules for 106–113 Div. B, Sec. 1000(a)(7) [Div. A, Title
asabaliauskas on DSK3SPTVN1PROD with RULES
However, pursuant to the CRA, the DEA the Department of State (the II, Sec. 236], 113 Stat. 1536, 1501A–430);
has submitted a copy of this final rule Department). The document requires 214, 214a, 217a, 218, 2651a, 2671(d)(3), 2705,
to both Houses of Congress and to the certain corrections: A correction to a 2714, 2714a, 2721, & 3926; 26 U.S.C. 6039E;
statutory citation; and adds a paragraph 31 U.S.C. 9701; 42 U.S.C. 652(k) [Div. B, Title
Comptroller General.
V of Pub. L. 103–317, 108 Stat. 1760]; E.O.
to the SUPPLEMENTARY INFORMATION
List of Subjects in 21 CFR Part 1308 11295, Aug. 6, 1966, FR 10603, 3 CFR, 1966–
relating to implementation of the rule. 1970 Comp., p. 570; Pub. L. 114–119, 130
Administrative practice and DATES: This rule is effective on Stat. 15; Sec. 1 of Pub. L. 109–210, 120 Stat.
procedure, Drug traffic control, September 27, 2016. 319; Sec. 2 of Pub. L. 109–167, 119 Stat.
VerDate Sep<11>2014 16:16 Sep 26, 2016 Jkt 238001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\27SER1.SGM 27SER1](https://thefederalregister.org/doc/81_FR_66368/page/4.svg)
Document Created: 2016-09-27 01:18:54
Document Modified: 2016-09-27 01:18:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | Effective: October 27, 2016. | |
| Contact | Michael J. Lewis, Office of Diversion | |
| FR Citation | 81 FR 66181 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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