80 FR 70658 - Schedules of Controlled Substances: Extension of Temporary Placement of Three Synthetic Phenethylamines in Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 219 (November 13, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 219 (November 13, 2015)
| Page Range | 70658-70659 | |
| FR Document | 2015-29028 |
[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)] [Rules and Regulations] [Pages 70658-70659] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29028] [[Page 70657]] Vol. 80 Friday, No. 219 November 13, 2015 Part V Department of Justice ----------------------------------------------------------------------- Drug Enforcement Administration ----------------------------------------------------------------------- 21 CFR Part 1308 Schedules of Controlled Substances: Extension of Temporary Placement of Three Synthetic Phenethylamines in Schedule I; Final Order Federal Register / Vol. 80 , No. 219 / Friday, November 13, 2015 / Rules and Regulations [[Page 70658]] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-424] Schedules of Controlled Substances: Extension of Temporary Placement of Three Synthetic Phenethylamines in Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this final order extending the temporary schedule I status for three synthetic phenethylamines into the Controlled Substances Act pursuant to the temporary scheduling provisions of the Act. The substances are: 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) [hereinafter 25I-NBOMe, 2C-NBOMe, and 25-NBOMe, respectively]. The initial temporary scheduling was based on a finding by the Deputy Administrator that the placement of these synthetic phenethylamines and their optical, positional, and geometric isomers, salts, and salts of isomers into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. The current final order temporarily placing 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in schedule I is due to expire on November 14, 2015. This final order will extend the temporary scheduling of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe for one year, or until the permanent scheduling action for these three substances is completed, whichever occurs first. As a result of this order, the full effect of the Controlled Substances Act and its implementing regulations, including criminal, civil and administrative penalties, sanctions, and regulatory controls of schedule I substances will be imposed on the manufacture, distribution, possession, importation, and exportation of these synthetic phenethylamines. DATES: This final order is effective November 13, 2015. FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, 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. 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 purpose of this action. 21 U.S.C. 801-971. The DEA published 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, every 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 drug or other 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. Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2). Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated her scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100. Background On November 15, 2013, the DEA published a final order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place the 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) into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 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 phenethylamines 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 these substances expire two years from the effective date of the scheduling order, or on or before November 14, 2015. 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). 21 U.S.C. 811(h)(2). Proceedings for the permanent scheduling of a substance under 21 U.S.C. 811(a) may be initiated by the Attorney General (delegated to the Administrator of the DEA pursuant to 28 CFR 0.100) on his or her own motion, at the request of the Secretary of Health and Human Services,\1\ or on the petition of any interested party. --------------------------------------------------------------------------- \1\ Because the Secretary of the Department of Health and Human Services has delegated to the Assistant Secretary for Health of the Department of Health and Human Services the authority to make domestic drug scheduling recommendations, for purposes of this final order, all subsequent references to ``Secretary'' have been replaced with ``Assistant Secretary.'' --------------------------------------------------------------------------- The Administrator of the DEA, on his own motion pursuant to 21 U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to permanently schedule 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe. The DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of [[Page 70659]] abuse, and the relative potential for abuse for these three synthetic phenethylamines. On July 23, 2014, the DEA submitted a request to the HHS to provide the DEA with a scientific and medical evaluation of available information and a scheduling recommendation for 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe, in accordance with 21 U.S.C. 811 (b) and (c). Upon evaluating the scientific and medical evidence, on August 12, 2015, the HHS submitted to the Administrator of the DEA its three scientific and medical evaluations 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).'' Upon receipt of the scientific and medical evaluation and scheduling recommendations from the HHS, the DEA reviewed the documents and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe in accordance with 21 U.S.C. 811(c). The DEA published a notice of proposed rulemaking for the placement of 25I-NBOMe, 25C-NBOMe, and 25B-NBOMe into schedule I elsewhere in this issue of the Federal Register. Pursuant to 21 U.S.C. 811(h)(2), the Administrator of the DEA orders that the temporary scheduling of 25I-NBOMe, 25C-NBOMe, and 25B- NBOMe, 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, be extended for one year, or until the proceedings to permanently schedule these three substances is completed, whichever occurs first. In accordance with this final order, the schedule I requirements for handling 25I-NBOMe, 25C-NBOMe, or 25B-NBOMe, 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, will remain in effect for one year, or until the permanent scheduling proceeding is completed, whichever occurs first. Regulatory Matters The CSA provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h). The Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Id. 21 U.S.C. 811(h) also provides that the temporary scheduling of a substance shall expire at the end of two years from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings to permanently schedule the substance, extend the temporary scheduling for up to one year. To the extent that 21 U.S.C. 811(h) directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued and extended, the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this extension of the temporary scheduling action. In the alternative, even assuming that this action might be subject to section 553 of the APA, the Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for extending the temporary scheduling order would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety. Further, the DEA believes that this final order extending the temporary scheduling action is not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking. Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Pursuant to section 808(2) of the Congressional Review Act (CRA), ``any rule for which an agency for good cause finds * * * that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the Federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the public interest to maintain the temporary placement of 25I- NBOMe, 25C-NBOMe, and 25B-NBOMe in schedule I because they pose a public health risk. The temporary scheduling action was taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. Under 21 U.S.C. 811(h), temporary scheduling orders are not subject to notice and comment rulemaking procedures. The DEA understands that the CSA frames temporary scheduling actions as orders rather than rules to ensure that the process moves swiftly, and this extension of the temporary scheduling order continues to serve that purpose. For the same reasons that underlie 21 U.S.C. 811(h), that is, the need to place these substances in schedule I because they pose an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of this extension of the temporary scheduling order. Therefore, in accordance with section 808(2) of the CRA, this final order extending the temporary scheduling order shall take effect immediately upon its publication. The DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule. Dated: November 10, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015-29028 Filed 11-12-15; 8:45 am] BILLING CODE 4410-09-P
![70658 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Rules and Regulations
DEPARTMENT OF JUSTICE Control, Drug Enforcement (FDCA), 21 U.S.C. 355. 21 U.S.C.
Administration; Mailing Address: 8701 811(h)(1). The Attorney General has
Drug Enforcement Administration Morrissette Drive, Springfield, Virginia delegated her scheduling authority
22152; Telephone: (202) 598–6812. under 21 U.S.C. 811 to the
21 CFR Part 1308 SUPPLEMENTARY INFORMATION: Administrator of the DEA. 28 CFR
[Docket No. DEA–424] 0.100.
Legal Authority
Background
Schedules of Controlled Substances: The Drug Enforcement
Extension of Temporary Placement of Administration (DEA) implements and On November 15, 2013, the DEA
Three Synthetic Phenethylamines in enforces titles II and III of the published a final order in the Federal
Schedule I Comprehensive Drug Abuse Prevention Register amending 21 CFR 1308.11(h) to
and Control Act of 1970, as amended. temporarily place the three synthetic
AGENCY: Drug Enforcement Titles II and III are referred to as the phenethylamines 2-(4-iodo-2,5-
Administration, Department of Justice. ‘‘Controlled Substances Act’’ and the dimethoxyphenyl)-N-(2-
ACTION: Final order. ‘‘Controlled Substances Import and methoxybenzyl)ethanamine (25I-
Export Act,’’ respectively, and are NBOMe, 2C-I-NBOMe, 25I, Cimbi-5); 2-
SUMMARY: The Administrator of the Drug collectively referred to as the (4-chloro-2,5-dimethoxyphenyl)-N-(2-
Enforcement Administration is issuing ‘‘Controlled Substances Act’’ or the methoxybenzyl)ethanamine (25C-
this final order extending the temporary ‘‘CSA’’ for purpose of this action. 21 NBOMe, 2C-C-NBOMe, 25C, Cimbi-82);
schedule I status for three synthetic U.S.C. 801–971. The DEA published the and 2-(4-bromo-2,5-dimethoxyphenyl)-
phenethylamines into the Controlled implementing regulations for these N-(2-methoxybenzyl)ethanamine (25B-
Substances Act pursuant to the statutes in title 21 of the Code of Federal NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
temporary scheduling provisions of the Regulations (CFR), chapter II. into schedule I of the CSA pursuant to
Act. The substances are: 2-(4-iodo-2,5- The CSA and its implementing the temporary scheduling provisions of
dimethoxyphenyl)-N-(2- regulations are designed to prevent, 21 U.S.C. 811(h). 78 FR 68716. That
methoxybenzyl)ethanamine (25I- detect, and eliminate the diversion of final order was effective on the date of
NBOMe; 2C-I-NBOMe; 25I; Cimbi-5), 2- controlled substances and listed publication, and was based on findings
(4-chloro-2,5-dimethoxyphenyl)-N-(2- chemicals into the illicit market while by the Deputy Administrator of the DEA
methoxybenzyl)ethanamine (25C- ensuring an adequate supply is available that the temporary scheduling of these
NBOMe; 2C-C-NBOMe; 25C; Cimbi-82), for the legitimate medical, scientific, three synthetic phenethylamines was
and 2-(4-bromo-2,5-dimethoxyphenyl)- research, and industrial needs of the necessary to avoid an imminent hazard
N-(2-methoxybenzyl)ethanamine (25B- United States. Controlled substances to the public safety pursuant to 21
NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) have the potential for abuse and U.S.C. 811(h)(1). Section 201(h)(2) of the
[hereinafter 25I-NBOMe, 2C-NBOMe, dependence and are controlled to CSA, 21 U.S.C. 811(h)(2), requires that
and 25-NBOMe, respectively]. The protect the public health and safety. the temporary control of these
initial temporary scheduling was based Under the CSA, every controlled substances expire two years from the
on a finding by the Deputy substance is classified into one of five effective date of the scheduling order, or
Administrator that the placement of schedules based upon its potential for on or before November 14, 2015.
these synthetic phenethylamines and abuse, its currently accepted medical However, the CSA also provides that the
their optical, positional, and geometric use in treatment in the United States, temporary scheduling may be extended
isomers, salts, and salts of isomers into and the degree of dependence the drug for up to one year, during the pendency
schedule I of the Controlled Substances or other substance may cause. 21 U.S.C. of proceedings under 21 U.S.C.
Act is necessary to avoid an imminent 812. The initial schedules of controlled 811(a)(1). 21 U.S.C. 811(h)(2).
hazard to the public safety. The current substances established by Congress are Proceedings for the permanent
final order temporarily placing 25I- found at 21 U.S.C. 812(c), and the scheduling of a substance under 21
NBOMe, 25C-NBOMe, and 25B-NBOMe current list of all scheduled substances U.S.C. 811(a) may be initiated by the
in schedule I is due to expire on is published at 21 CFR part 1308. Attorney General (delegated to the
November 14, 2015. This final order Section 201 of the CSA, 21 U.S.C. 811, Administrator of the DEA pursuant to
will extend the temporary scheduling of provides the Attorney General with the 28 CFR 0.100) on his or her own motion,
25I-NBOMe, 25C-NBOMe, and 25B- authority to temporarily place a at the request of the Secretary of Health
NBOMe for one year, or until the substance into schedule I of the CSA for and Human Services,1 or on the petition
permanent scheduling action for these two years without regard to the
of any interested party.
three substances is completed, requirements of 21 U.S.C. 811(b) if she The Administrator of the DEA, on his
whichever occurs first. As a result of finds that such action is necessary to own motion pursuant to 21 U.S.C.
this order, the full effect of the avoid an imminent hazard to the public 811(a), has initiated proceedings under
Controlled Substances Act and its safety. 21 U.S.C. 811(h)(1). In addition, 21 U.S.C. 811(a)(1) to permanently
implementing regulations, including if proceedings to control a substance are schedule 25I-NBOMe, 25C-NBOMe, and
criminal, civil and administrative initiated under 21 U.S.C. 811(a)(1), the 25B-NBOMe. The DEA has gathered and
penalties, sanctions, and regulatory Attorney General may extend the reviewed the available information
controls of schedule I substances will be temporary scheduling for up to one regarding the pharmacology, chemistry,
imposed on the manufacture, year. 21 U.S.C. 811(h)(2). trafficking, actual abuse, pattern of
distribution, possession, importation, Where the necessary findings are
made, a substance may be temporarily
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and exportation of these synthetic 1 Because the Secretary of the Department of
phenethylamines. scheduled if it is not listed in any other Health and Human Services has delegated to the
schedule under section 202 of the CSA, Assistant Secretary for Health of the Department of
This final order is effective
DATES: 21 U.S.C. 812, or if there is no Health and Human Services the authority to make
November 13, 2015. domestic drug scheduling recommendations, for
exemption or approval in effect for the purposes of this final order, all subsequent
FOR FURTHER INFORMATION CONTACT: John substance under section 505 of the references to ‘‘Secretary’’ have been replaced with
R. Scherbenske, Office of Diversion Federal Food, Drug, and Cosmetic Act ‘‘Assistant Secretary.’’
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![Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Rules and Regulations 70659
abuse, and the relative potential for permanent scheduling proceeding is relationship between the national
abuse for these three synthetic completed, whichever occurs first. government and the States, or on the
phenethylamines. On July 23, 2014, the distribution of power and
Regulatory Matters
DEA submitted a request to the HHS to responsibilities among the various
provide the DEA with a scientific and The CSA provides for an expedited levels of government. Therefore, in
medical evaluation of available temporary scheduling action where accordance with Executive Order 13132
information and a scheduling such action is necessary to avoid an (Federalism) it is determined that this
recommendation for 25I-NBOMe, 25C- imminent hazard to the public safety. 21 action does not have sufficient
NBOMe, and 25B-NBOMe, in U.S.C. 811(h). The Attorney General federalism implications to warrant the
accordance with 21 U.S.C. 811 (b) and may, by order, schedule a substance in preparation of a Federalism Assessment.
(c). Upon evaluating the scientific and schedule I on a temporary basis. Id. 21
U.S.C. 811(h) also provides that the Pursuant to section 808(2) of the
medical evidence, on August 12, 2015, Congressional Review Act (CRA), ‘‘any
the HHS submitted to the Administrator temporary scheduling of a substance
shall expire at the end of two years from rule for which an agency for good cause
of the DEA its three scientific and finds * * * that notice and public
medical evaluations entitled, ‘‘Basis for the date of the issuance of the order
scheduling such substance, except that procedure thereon are impracticable,
the Recommendation to Place 2-(4-iodo- unnecessary, or contrary to the public
2,5-dimethoxyphenyl)-N-(2- the Attorney General may, during the
pendency of proceedings to interest, shall take effect at such time as
methoxybenzyl)ethanamine (25I- the Federal agency promulgating the
NBOMe) and its Salts in Schedule I of permanently schedule the substance,
extend the temporary scheduling for up rule determines.’’ 5 U.S.C. 808(2). It is
the Controlled Substances Act (CSA),’’ in the public interest to maintain the
‘‘Basis for the Recommendation to Place to one year.
To the extent that 21 U.S.C. 811(h) temporary placement of 25I-NBOMe,
2-(4-chloro-2,5-dimethoxyphenyl)-N-(2- 25C-NBOMe, and 25B-NBOMe in
directs that temporary scheduling
methoxybenzyl)ethanamine (25C- schedule I because they pose a public
actions be issued by order and sets forth
NBOMe) and its Salts in Schedule I of health risk. The temporary scheduling
the procedures by which such orders are
the Controlled Substances Act (CSA),’’ action was taken pursuant to 21 U.S.C.
to be issued and extended, the DEA
and ‘‘Basis for the Recommendation to 811(h), which is specifically designed to
believes that the notice and comment
Place 2-(4-bromo-2,5-dimethoxyphenyl)- enable the DEA to act in an expeditious
requirements of section 553 of the
N-(2-methoxybenzyl)ethanamine (25B- manner to avoid an imminent hazard to
Administrative Procedure Act (APA), 5
NBOMe) and its Salts in Schedule I of the public safety. Under 21 U.S.C.
U.S.C. 553, do not apply to this
the Controlled Substances Act (CSA).’’ 811(h), temporary scheduling orders are
extension of the temporary scheduling
Upon receipt of the scientific and action. In the alternative, even assuming not subject to notice and comment
medical evaluation and scheduling that this action might be subject to rulemaking procedures. The DEA
recommendations from the HHS, the section 553 of the APA, the understands that the CSA frames
DEA reviewed the documents and all Administrator finds that there is good temporary scheduling actions as orders
other relevant data, and conducted its cause to forgo the notice and comment rather than rules to ensure that the
own eight-factor analysis of the abuse requirements of section 553, as any process moves swiftly, and this
potential of 25I-NBOMe, 25C-NBOMe, further delays in the process for extension of the temporary scheduling
and 25B-NBOMe in accordance with 21 extending the temporary scheduling order continues to serve that purpose.
U.S.C. 811(c). The DEA published a order would be impracticable and For the same reasons that underlie 21
notice of proposed rulemaking for the contrary to the public interest in view U.S.C. 811(h), that is, the need to place
placement of 25I-NBOMe, 25C-NBOMe, of the manifest urgency to avoid an these substances in schedule I because
and 25B-NBOMe into schedule I imminent hazard to the public safety. they pose an imminent hazard to public
elsewhere in this issue of the Federal Further, the DEA believes that this final safety, it would be contrary to the public
Register. order extending the temporary interest to delay implementation of this
Pursuant to 21 U.S.C. 811(h)(2), the scheduling action is not a ‘‘rule’’ as extension of the temporary scheduling
Administrator of the DEA orders that defined by 5 U.S.C. 601(2), and, order. Therefore, in accordance with
the temporary scheduling of 25I- accordingly, is not subject to the section 808(2) of the CRA, this final
NBOMe, 25C-NBOMe, and 25B-NBOMe, requirements of the Regulatory order extending the temporary
including their optical, positional, and Flexibility Act (RFA). The requirements scheduling order shall take effect
geometric isomers, salts, and salts of for the preparation of an initial immediately upon its publication. The
isomers whenever the existence of such regulatory flexibility analysis in 5 U.S.C. DEA has submitted a copy of this final
salts, isomers, and salts of isomers is 603(a) are not applicable where, as here, order to both Houses of Congress and to
possible, be extended for one year, or the DEA is not required by section 553 the Comptroller General, although such
until the proceedings to permanently of the APA or any other law to publish filing is not required under the Small
schedule these three substances is a general notice of proposed Business Regulatory Enforcement
completed, whichever occurs first. rulemaking. Fairness Act of 1996 (Congressional
In accordance with this final order, Additionally, this action is not a Review Act), 5 U.S.C. 801–808 because,
the schedule I requirements for significant regulatory action as defined as noted above, this action is an order,
handling 25I-NBOMe, 25C-NBOMe, or by Executive Order 12866 (Regulatory not a rule.
25B-NBOMe, including their optical, Planning and Review), section 3(f), and,
positional, and geometric isomers, salts, Dated: November 10, 2015.
accordingly, this action has not been
and salts of isomers whenever the reviewed by the Office of Management Chuck Rosenberg,
tkelley on DSK3SPTVN1PROD with RULES3
existence of such salts, isomers, and and Budget (OMB). Acting Administrator.
salts of isomers is possible, will remain This action will not have substantial [FR Doc. 2015–29028 Filed 11–12–15; 8:45 am]
in effect for one year, or until the direct effects on the States, on the BILLING CODE 4410–09–P
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Document Created: 2018-03-01 11:22:54
Document Modified: 2018-03-01 11:22:54
| 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 order. | |
| Dates | This final order is effective November 13, 2015. | |
| Contact | John R. Scherbenske, Office of | |
| FR Citation | 80 FR 70658 |
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