Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations 6175 

with 21 U.S.C. 952, 953, 957, 958, and 

in accordance with 21 CFR part 1312 as 

of February 5, 2016. 

11. Liability. Any activity involving 

MAB-CHMINACA not authorized by, or 

in violation of the CSA, occurring as of 

February 5, 2016, is unlawful, and may 

subject the person to administrative, 

civil, and/or criminal sanctions. 

Regulatory Analyses 

Section 201(h) of the CSA, 21 U.S.C. 

811(h), provides for an expedited 

temporary scheduling action where 

such action is necessary to avoid an 

imminent hazard to the public safety. 

As provided in this subsection, the 

Attorney General may, by order, 

schedule a substance in schedule I on a 

temporary basis. Such an order may not 

be issued before the expiration of 30 

days from (1) the publication of a notice 

in the Federal Register of the intention 

to issue such order and the grounds 

upon which such order is to be issued, 

and (2) the date that notice of the 

proposed temporary scheduling order is 

transmitted to the Assistant Secretary. 

21 U.S.C. 811(h)(1). 

Inasmuch as section 201(h) of the 

CSA directs that temporary scheduling 

actions be issued by order and sets forth 

the procedures by which such orders are 

to be issued, the DEA believes that the 

notice and comment requirements of the 

Administrative Procedure Act (APA) at 

5 U.S.C. 553, do not apply to this 

temporary scheduling action. In the 

alternative, even assuming that this 

action might be subject to 5 U.S.C. 553, 

the Administrator finds that there is 

good cause to forgo the notice and 

comment requirements of 5 U.S.C. 553, 

as any further delays in the process for 

issuance of temporary scheduling orders 

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 

temporary scheduling action final order 

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 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. 

As noted above, this action is an 

order, not a rule. Accordingly, the 

Congressional Review Act (CRA) is 

inapplicable, as it applies only to rules. 

5 U.S.C. 808(2). It is in the public 

interest to schedule this substance 

immediately because it poses a public 

health risk. This temporary scheduling 

action is 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. For the same 

reasons that underlie 21 U.S.C. 811(h), 

that is, the need to move quickly to 

place this substance into schedule I 

because it poses an imminent hazard to 

public safety, it would be contrary to the 

public interest to delay implementation 

of the temporary scheduling order. 

Therefore, this order shall take effect 

immediately upon its publication. 

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, the DEA 

amends 21 CFR part 1308 as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for part 1308 

continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

■ 2. Amend § 1308.11 by adding 

paragraph (h)(25) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(25) N-(1-amino-3,3-dimethyl-1- 

oxobutan-2-yl)-1-(cyclohexylmethyl)- 

1H-indazole-3-carboxamide, its optical, 

positional, and geometric isomers, salts 

and salts of isomers (Other names: 

MAB-CHMINACA; ADB-CHMINACA) 

(7032) 

Dated: February 2, 2016. 

Chuck Rosenberg, 

Acting Administrator. 

[FR Doc. 2016–02302 Filed 2–4–16; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–385E] 

Schedules of Controlled Substances: 

Extension of Temporary Placement of 

PB-22, 5F-PB-22, AB-FUBINACA and 

ADB-PINACA in Schedule I of the 

Controlled Substances Act 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration is issuing 

this final order to extend the temporary 

schedule I status of four synthetic 

cannabinoids pursuant to the temporary 

scheduling provisions of the Controlled 

Substances Act. The substances are: 

quinolin-8-yl 1-pentyl-1H-indole-3- 

carboxylate (PB-22; QUPIC); quinolin-8- 

yl 1-(5-fluoropentyl)-1H-indole-3- 

carboxylate (5-fluoro-PB-22; 5F-PB-22); 

N-(1-amino-3-methyl-1-oxobutan-2-yl)- 

1-(4-fluorobenzyl)-1H-indazole-3- 

carboxamide (AB-FUBINACA); and N- 

(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 

1-pentyl-1H-indazole-3-carboxamide 

(ADB-PINACA), including their optical, 

positional and geometric isomers, salts, 

and salts of isomers. The current final 

order temporarily placing PB-22, 5F-PB22, AB-FUBINACA, and ADB-PINACA 

into schedule I is in effect through 

February 9, 2016. This final order will 

extend the temporary scheduling of PB22, 5F-PB-22, AB-FUBINACA, and ADBPINACA for one year, or until the 

permanent scheduling action for these 

four substances is completed, whichever 

occurs first. 

DATES: This final order is effective 

February 5, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Barbara J. Boockholdt, 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 


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6176 Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations 

1Because 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.’’ 

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 February 10, 2014, the DEA 

published a final order in the Federal 

Register amending 21 CFR 1308.11(h) to 

temporarily place the four synthetic 

cannabinoids quinolin-8-yl 1-pentyl-1Hindole-3-carboxylate (PB-22; QUPIC); 

quinolin-8-yl 1-(5-fluoropentyl)-1Hindole-3-carboxylate (5-fluoro-PB-22; 

5F-PB-22); N-(1-amino-3-methyl-1- 

oxobutan-2-yl)-1-(4-fluorobenzyl)-1Hindazole-3-carboxamide (ABFUBINACA); and N-(1-amino-3,3- 

dimethyl-1-oxobutan-2-yl)-1-pentyl-1Hindazole-3-carboxamide (ADBPINACA), into schedule I of the CSA 

pursuant to the temporary scheduling 

provisions of 21 U.S.C. 811(h). 79 FR 

7577. 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 four 

synthetic cannabinoids 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, which was February 

10, 2014. 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. 

Proceedings for the 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. 

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 PB-22, 5F-PB-22, ABFUBINACA, and ADB-PINACA. The 

DEA has gathered and reviewed the 

available information regarding the 

pharmacology, chemistry, trafficking, 

actual abuse, pattern of abuse, and the 

relative potential for abuse for these four 

synthetic cannabinoids. On December 

30, 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 PB-22, 5F-PB-22, 

AB-FUBINACA, and ADB-PINACA, and 

in accordance with 21 U.S.C. 811 (b) 

and (c). Upon evaluating the scientific 

and medical evidence, on January 19, 

2016, the HHS submitted to the 

Administrator of the DEA its four 

scientific and medical evaluations for 

these substances. 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 PB-22, 5F-PB22, AB-FUBINACA, and ADB-PINACA 

in accordance with 21 U.S.C. 811(c). 

The DEA published a notice of proposed 

rulemaking for the placement of PB-22, 

5F-PB-22, AB-FUBINACA, and ADBPINACA 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 PB-22, 5FPB-22, AB-FUBINACA and ADBPINACA, including their optical, 

positional and geometric isomers, salts, 

and salts of isomers, be extended for one 

year, or until the permanent scheduling 

proceeding is completed, whichever 

occurs first. 

In accordance with this final order, 

the schedule I requirements for 

handling PB-22, 5F-PB-22, ABFUBINACA and ADB-PINACA, 

including their optical, positional and 

geometric isomers, salts, and salts of 

isomers, 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 


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Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Rules and Regulations 6177 

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. 

As noted above, this action is an 

order, not a rule. Accordingly, the 

Congressional Review Act (CRA) is 

inapplicable, as it applies only to rules. 

5 U.S.C. 808(2). It is in the public 

interest to maintain the temporary 

placement of PB-22, 5F-PB-22, ABFUBINACA and ADB-PINACA 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: February 2, 2016. 

Chuck Rosenberg, 

Acting Administrator. 

[FR Doc. 2016–02308 Filed 2–4–16; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

29 CFR Part 1952 

[Docket No. OSHA–2015–0003] 

RIN 1218–AC97 

Maine State Plan for State and Local 

Government Employers 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Department of 

Labor. 

ACTION: Final rule. 

SUMMARY: This document announces the 

publication of the regulatory provisions 

which formalize the initial approval of 

the Maine State and Local Government 

Only State Plan. 

DATES: Effective February 5, 2016. Initial 

approval of the Maine State Plan was 

granted on August 5, 2015. 

FOR FURTHER INFORMATION CONTACT:

For press inquiries: Contact Francis 

Meilinger, Office of Communications, 

Room N–3647, OSHA, U.S. Department 

of Labor, 200 Constitution Avenue NW., 

Washington, DC 20210; telephone (202) 

693–1999; email meilinger.francis2@

dol.gov. 

For general and technical 

information: Contact Douglas J. 

Kalinowski, Director, OSHA Directorate 

of Cooperative and State Programs, 

Room N–3700, U.S. Department of 

Labor, 200 Constitution Avenue NW., 

Washington, DC 20210; telephone (202) 

693–2200; email: kalinowski.doug@

dol.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

On May 20, 2015, OSHA published a 

notice in the Federal Register (80 FR 

28890) concerning the submission of the 

Maine State and Local Government 

Only State Plan, announcing that initial 

Federal approval of the Plan was at 

issue, and offering interested parties an 

opportunity to review the Plan and 

submit data, views, arguments or 

requests for a hearing concerning the 

Plan. No comments were received. 

OSHA, after carefully reviewing the 

Maine State Plan for the development 

and enforcement of state standards 

applicable to state and local government 

employers and the record developed 

during the above described proceedings, 

determined that the requirements and 

criteria for initial approval of a 

developmental State Plan were met. The 

Plan was approved as a developmental 

State Plan for State and Local 

Government Only under Section 18 of 

the OSH Act on August 5, 2015. (80 FR 

46487). 

B. Notice of Publication of the 

Regulatory Description of the Maine 

State Plan 

In light of the reorganization of the 

State Plan regulations through the 

streamlining of 29 CFR part 1952 and 29 

CFR part 1956, OSHA deferred any 

change to those regulatory provisions 

relating to the Maine State Plan until the 

streamlining changes took effect. (80 FR 

46487, 46492). These streamlining 

changes took effect October 19, 2015. 

(80 FR 49897, Aug. 18, 2015). Therefore 

OSHA is now amending 29 CFR part 

1952 to incorporate the description of 

the Maine State Plan. 

C. Regulatory Flexibility Act 

OSHA certifies pursuant to the 

Regulatory Flexibility Act of 1980 (5 

U.S.C. 601 et seq.) that the initial 

approval of the Maine State Plan will 

not have a significant economic impact 

on a substantial number of small 

entities. By its own terms, the Plan will 

have no effect on private sector 

employment, but is limited to the state 

and its political subdivisions. Moreover, 

Title 26, Labor and Industry, of the 

Maine Revised Statutes was enacted in 

1971. This legislation established the 

Board, whose purpose is to formulate 

rules that shall, at a minimum, conform 

with Federal standards of occupational 


Lhorne on DSK5TPTVN1PROD with RULES