Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations 28735 

1Because the Secretary of the Department of 

Health and Human Services (HHS) 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.’’ As set forth in a 

memorandum of understanding entered into by 

HHS, the Food and Drug Administration (FDA), and 

the National Institute on Drug Abuse (NIDA), FDA 

acts as the lead agency within HHS in carrying out 

the Secretary’s scheduling responsibilities under 

the Controlled Substance Act (CSA), with the 

concurrence of NIDA. 50 FR 9518. 

§ 880.6305 Ingestible event marker. 

(a) Identification. An ingestible event 

marker is a prescription device used to 

record time-stamped, patient-logged 

events. The ingestible component links 

wirelessly through intrabody 

communication to an external recorder 

which records the date and time of 

ingestion as well as the unique serial 

number of the ingestible device. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The device must be demonstrated 

to be biocompatible and non-toxic; 

(2) Nonclinical, animal, and clinical 

testing must provide a reasonable 

assurance of safety and effectiveness, 

including device performance, 

durability, compatibility, usability 

(human factors testing), event recording, 

and proper excretion of the device; 

(3) Appropriate analysis and 

nonclinical testing must validate 

electromagnetic compatibility 

performance, wireless performance, and 

electrical safety; and 

(4) Labeling must include a detailed 

summary of the nonclinical and clinical 

testing pertinent to use of the device 

and the maximum number of daily 

device ingestions. 

Dated: May 10, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–11628 Filed 5–15–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–373] 

Schedules of Controlled Substances: 

Temporary Placement of Three 

Synthetic Cannabinoids Into 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: The Deputy Administrator of 

the Drug Enforcement Administration 

(DEA) is issuing this final order to 

temporarily schedule three synthetic 

cannabinoids under the Controlled 

Substances Act (CSA) pursuant to the 

temporary scheduling provisions of 21 

U.S.C. 811(h). The substances are (1- 

pentyl-1H-indol-3-yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone (UR144), [1-(5-fluoro-pentyl)-1H-indol-3- 

yl](2,2,3,3- 

tetramethylcyclopropyl)methanone (5- 

fluoro-UR-144, XLR11) and N-(1- 

adamantyl)-1-pentyl-1H-indazole-3- 

carboxamide (APINACA, AKB48). This 

action is based on a finding by the 

Deputy Administrator that the 

placement of these synthetic 

cannabinoids and their salts, isomers 

and salts of isomers into Schedule I of 

the CSA is necessary to avoid an 

imminent hazard to the public safety. 

As a result of this order, the full effect 

of the CSA and the Controlled 

Substances Import and Export Act 

(CSIEA) and their 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 cannabinoids. 

DATES: Effective Date: This Final Order 

is effective on May 16, 2013. 

FOR FURTHER INFORMATION CONTACT: John 

W. Partridge, Executive Assistant, Office 

of Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; telephone (202) 307–7165. 

SUPPLEMENTARY INFORMATION: 

Background 

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 he 

finds that such action is necessary to 

avoid imminent hazard to the public 

safety. 21 U.S.C. 811(h). 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 up to one year. 

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 under 

section 505 of the Federal Food, Drug 

and Cosmetic Act (FD&C Act) (21 U.S.C. 

355) for the substance (21 U.S.C. 811 

(h)(1)). The Attorney General has 

delegated his authority under 21 U.S.C. 

811 to the Administrator of DEA, who 

in turn has delegated her authority to 

the Deputy Administrator of DEA. 28 

CFR 0.100, Appendix to Subpart R. 

Section 201(h)(4) of the CSA (21 

U.S.C. 811(h)(4)) requires the Deputy 

Administrator to notify the Secretary of 

the Department of Health and Human 

Services (HHS) of his intention to 

temporarily place a substance into 

Schedule I of the CSA.1 The Deputy 

Administrator has transmitted notice of 

his intent to place UR-144, XLR11 and 

AKB48 in Schedule I on a temporary 

basis to the Assistant Secretary by letter 

dated February 14, 2013. The Assistant 

Secretary responded to this notice by 

letter dated March 14, 2013 (received by 

DEA on March 21, 2013), and advised 

that based on review by the Food and 

Drug Administration (FDA), there are 

currently no investigational new drug 

applications or approved new drug 

applications for UR-144, XLR11 or 

AKB48. The Assistant Secretary also 

stated that HHS has no objection to the 

temporary placement of UR-144, XLR11 

or AKB48 into Schedule I of the CSA. 

DEA has taken into consideration the 

Assistant Secretary’s comments (21 

U.S.C. 811(h)(4)). As UR-144, XLR11 

and AKB48 are not currently listed in 

any schedule under the CSA, and as no 

exemptions or approvals are in effect for 

UR-144, XLR11 and AKB48 under 

Section 505 of the FD&C Act (21 U.S.C. 

355), DEA believes that the conditions 

of 21 U.S.C. 811(h)(1) have been 

satisfied. On April 12, 2013, a Notice of 

Intent to temporarily schedule these 

three synthetic cannabinoids was 

published in the Federal Register (78 

FR 21858). 

To make a finding that placing a 

substance temporarily into Schedule I of 

the CSA is necessary to avoid an 

imminent hazard to the public safety, 

the Deputy Administrator is required to 

consider three of the eight factors set 

forth in section 201(c) of the CSA (21 

U.S.C. 811(h)(3)). These factors are as 

follows: the substance’s history and 

current pattern of abuse; the scope, 

duration and significance of abuse, and 

what, if any, risk there is to the public 

health. 21 U.S.C. 811(c)(4)–(6). 

Consideration of these factors includes 

actual abuse, diversion from legitimate 

channels and clandestine importation, 

manufacture or distribution. 21 U.S.C. 

811(h)(3). 

A substance meeting the statutory 

requirements for temporary scheduling 

(21 U.S.C. 811(h)) may only be placed 

in Schedule I. Substances in Schedule I 

are those that have a high potential for 


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28736 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations 

2National Forensic Laboratory Information 

System (NFLIS) is a program sponsored by the Drug 

Enforcement Administration’s (DEA), Office of 

Diversion Control which compiles information on 

exhibits analyzed in State and local law 

enforcement forensic laboratories. System to 

Retrieve Information from Drug Evidence (STRIDE) 

is a DEA database which compiles information on 

exhibits analyzed in DEA laboratories. 

3Subtitle D of Title XI of the Food and Drug 

Administration Safety and Innovation Act 

(FDASIA), which includes Sections 1151–1153 of 

Pub. L. 112–144, is also known as the ‘‘Synthetic 

Drug Abuse Prevention Act of 2012,’’ or ‘‘SDAPA.’’ 

4American Association of Poison Control Centers 

(AAPCC) is a non-profit, national organization that 

represents the poison centers of the United States. 

abuse, no currently accepted medical 

use in treatment in the United States 

(U.S.), and a lack of accepted safety for 

use under medical supervision. 21 

U.S.C. 812(b)(1). Available data and 

information for UR-144, XLR11 and 

AKB48 indicate that these three 

synthetic cannabinoids have a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

U.S., and a lack of accepted safety for 

use under medical supervision. 

Synthetic Cannabinoids 

While synthetic cannabinoids have 

been developed over the last 30 years 

for research purposes to investigate the 

cannabinoid system, no scientific 

literature referring to UR-144, XLR11 or 

AKB48 was available prior to these 

drugs’ identification in the illicit 

market. In addition, no legitimate nonresearch uses have been identified for 

these synthetic cannabinoids nor have 

they been approved by FDA for human 

consumption. Synthetic cannabinoids, 

of which (1-pentyl-1H-indol-3- 

yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone (UR144), [1-(5-fluoro-pentyl)-1H-indol-3- 

yl](2,2,3,3- 

tetramethylcyclopropyl)methanone (5- 

fluoro-UR-144, XLR11), and N-(1- 

adamantyl)-1-pentyl-1H-indazole-3- 

carboxamide (APINACA, AKB48) are 

representative, are so-termed for their 

D9-tetrahydrocannabinol (THC)-like 

pharmacological properties. Numerous 

herbal products have been analyzed, 

and UR-144, XLR11 and AKB48 have 

been identified, in varying mixture 

profiles and amounts, spiked on plant 

material. 

As of April 3, 2013, according to the 

System to Retrieve Information from 

Drug Evidence (STRIDE) data, there are 

1,510 reports involving 179 total cases 

for UR-144, 1,194 reports involving 186 

total cases for XLR11 and 112 reports 

involving 40 total cases for AKB48. 

From January 2010 to March 2013, the 

National Forensic Laboratory 

Information System (NFLIS) registered 

14,831 reports containing these 

synthetic cannabinoids (UR-144—5,465 

reports; XLR11—8,837 reports; 

AKB48—529 reports) from at least 32 

states. No instances regarding UR-144, 

XLR11 or AKB48 were reported in 

NFLIS prior to March of 2010. For the 

period January 2010 through March 

2013, NFLIS and STRIDE reports 2 for 

the three synthetic cannabinoids UR144, XLR11 and AKB48 (16,014 total 

reports) exceeded the number of reports 

for the five synthetic cannabinoids 

JWH–018, JWH–073, JWH–200, CP– 

47,497 and CP–47,497 C8 (7,555 total 

reports). JWH–018, JWH–200, JWH–073, 

CP–47,497 and CP–47,497 C8 

homologue were temporarily scheduled 

on March 1, 2011, and later placed in 

Schedule I by Section 1152 of Food and 

Drug Administration Safety and 

Innovation Act (FDASIA), Pub. L. 112– 

144, on July 9, 2012. Section 1152 of the 

FDASIA 3 amended the CSA by placing 

cannabimimetic agents and 26 specific 

substances (including 15 synthetic 

cannabinoids, 2 synthetic cathinones, 

and 9 phenethylamines of the 2C-series) 

in Schedule I. UR-144, XLR11 and 

AKB48 were not included among the 15 

specific named synthetic cannabinoids, 

and do not fall under the definition of 

cannabimimetic agents, under FDASIA. 

Factor 4. History and Current Pattern of 

Abuse 

Synthetic cannabinoids (JWH–018) 

laced on plant material were first 

reported in the U.S. in December 2008, 

when a shipment of ‘‘Spice’’ was seized 

and analyzed by U.S. Customs and 

Border Patrol in Dayton, Ohio. Also in 

December 2008, JWH–018 and 

cannabicyclohexanol were identified by 

German forensic laboratories. 

Since the initial identification of 

JWH–018 (December 2008), many 

additional synthetic cannabinoids with 

purported psychotropic effects have 

been found laced on plant material or 

related products. The popularity of 

these synthetic cannabinoids and their 

associated products appears to have 

increased since January 2010 in the U.S. 

based on seizure exhibits and media 

reports. This trend appears to mirror 

that experienced in Europe since 2008. 

Synthetic cannabinoids are being 

encountered in several regions of the 

U.S. with the substances primarily 

found as adulterants on plant material 

products as self-reported on internet 

discussion boards. Since then, 

numerous other synthetic cannabinoids 

including UR-144, XLR11 and AKB48 

have been identified as product 

adulterants. 

Data gathered from published studies, 

supplemented by discussions on 

Internet Web sites and personal 

communications with toxicological 

testing laboratories, demonstrate that 

products laced with UR-144, XLR11 

and/or AKB48 are being abused mainly 

by smoking for their psychoactive 

properties. The adulterated products are 

marketed as ‘legal’ alternatives to 

marijuana. This characterization, along 

with their reputation as potent herbal 

intoxicants, has increased their 

popularity. Several synthetic 

cannabinoids, including UR-144, XLR11 

and AKB48, have been shown to display 

higher potency in scientific studies 

when compared to THC. Smoking 

mixtures of these substances for the 

purpose of achieving intoxication has 

been identified as a reason for numerous 

emergency room visits and calls to 

poison control centers. Abuse of these 

synthetic cannabinoids and their 

products has been characterized with 

both acute and long term public health 

and safety issues. In addition, numerous 

states, local jurisdictions, and the 

international community have 

controlled these substances. 

Factor 5. Scope, Duration and 

Significance of Abuse 

According to forensic laboratory 

reports, the first appearance of synthetic 

cannabinoids in the U.S. occurred in 

December 2008, when U.S. Customs and 

Border Protection analyzed ‘‘Spice’’ 

products. NFLIS has reported 14,831 

exhibits (January 2010 to March 2013) 

related to UR-144, XLR11 and AKB48 

from various states including Alaska, 

Alabama, Arkansas, California, 

Colorado, Florida, Georgia, Iowa, 

Indiana, Illinois, Kansas, Kentucky, 

Louisiana, Maryland, Minnesota, 

Missouri, New Hampshire, New Jersey, 

New Mexico, North Dakota, Nebraska, 

Nevada, Ohio, Oklahoma, Pennsylvania, 

South Carolina, Tennessee, Texas, Utah, 

Virginia, Wisconsin and Wyoming. 

STRIDE has reported 2,816 records 

involving UR-144, XLR11 and/or AKB48 

from January 2010 through April 3, 

2013. From January 1 through December 

31, 2012, the American Association of 

Poison Control Centers 4 has reported 

receiving in excess of 5,200 calls 

relating to products purportedly laced 

with synthetic cannabinoids. Although 

the center does not identify specific 

cannabinoid substances, the data does 

indicate the magnitude of adverse 

exposure to synthetic cannabinoids. 

Factor 6. What, If Any, Risk There Is 

to the Public Health 

UR-144, XLR11 and AKB48 are 

pharmacologically similar to Schedule I 


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Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations 28737 

substances THC and JWH–018, as well 

as other synthetic cannabinoids. By 

sharing pharmacological similarities 

with the Schedule I substances (THC 

and JWH–018), synthetic cannabinoids 

pose a risk to the abuser. In addition, 

the chronic abuse of products laced 

with synthetic cannabinoids has also 

been linked to addiction and 

withdrawal. Law enforcement, military 

and public health officials have reported 

exposure incidents that demonstrate the 

dangers associated with abuse of 

synthetic cannabinoids to both the 

individual abusers and other affected 

individuals since these substances were 

never intended for human use. 

Warnings regarding the dangers 

associated with abuse of synthetic 

cannabinoids and their products have 

been issued by numerous state public 

health departments, poison control 

centers and private organizations. In a 

2012 report, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) reported 11,406 emergency 

department visits involving a synthetic 

cannabinoid product during 2010. In a 

2013 report, SAMHSA reported the 

number of emergency department visits 

in 2011 involving a synthetic 

cannabinoid product had increased 2.5 

times to 28,531. 

Detailed product analyses have 

detected variations in the amount and 

type of synthetic cannabinoid laced on 

plant material even within samplings of 

the same product. Since abusers obtain 

these drugs through unknown sources, 

purity of these drugs is uncertain, thus 

posing significant adverse health risk to 

these users. Submissions to DEA 

laboratories from January 2012 through 

February 11, 2013, have documented 

over 142 distinct packaging examples 

containing a mixture of UR-144, XLR11 

and/or AKB48. These unknown factors 

present a significant risk of danger to 

the abuser. Some of the adverse health 

effects reported in response to the abuse 

of synthetic cannabinoids include 

vomiting, anxiety, agitation, irritability, 

seizures, hallucinations, tachycardia, 

elevated blood pressure, and loss of 

consciousness. As mentioned above, 

there are reported instances of 

emergency department admissions in 

association with the abuse of these THClike substances. There are no recognized 

therapeutic uses of these substances in 

the U.S. 

In February 2013, the Centers for 

Disease Control and Prevention 

published a report by Murphy et al. 

describing unexplained cases of acute 

kidney injury in 16 patients, all of 

whom had reported recent smoking of 

synthetic cannabinoids. Upon further 

investigation, it was determined that of 

the 16 patients, 7 of the subjects had 

smoked substances that were positive 

for XLR11 or its metabolite. Cases were 

reported from Wyoming (4 cases), 

Rhode Island (1 case), New York (2 

cases), Oregon (6 cases), Kansas (1 case) 

and Oklahoma (2 cases). 

Finding of Necessity of Schedule I 

Scheduling To Avoid Imminent Hazard 

to Public Safety 

Based on the available data and 

information, the continued uncontrolled 

manufacture, distribution, importation, 

exportation and abuse of UR-144, 

XLR11 and AKB48 pose an imminent 

hazard to the public safety. DEA is not 

aware of any currently accepted medical 

uses for these synthetic cannabinoids in 

the U.S. A substance meeting the 

statutory requirements for temporary 

scheduling (21 U.S.C. 811(h)) may only 

be placed in Schedule I. Substances in 

Schedule I are those that have a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

U.S., and a lack of accepted safety for 

use under medical supervision. 

Available data and information for UR144, XLR11 and AKB48 indicate that 

these three synthetic cannabinoids have 

a high potential for abuse, no currently 

accepted medical use in treatment in the 

U.S., and a lack of accepted safety for 

use under medical supervision. 

Conclusion 

In accordance with the provisions of 

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

811(h)), the Deputy Administrator has 

considered available data and 

information and has set forth herein the 

grounds for his determination that it is 

necessary to temporarily schedule three 

synthetic cannabinoids, (1-pentyl-1Hindol-3-yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone (UR144), [1-(5-fluoro-pentyl)-1H-indol-3- 

yl](2,2,3,3- 

tetramethylcyclopropyl)methanone 

(5-fluoro-UR-144, XLR11) and N-(1- 

adamantyl)-1-pentyl-1H-indazole-3- 

carboxamide (APINACA, AKB48) in 

Schedule I of the CSA and finds that 

placement of these synthetic 

cannabinoids into Schedule I of the CSA 

is warranted in order to avoid an 

imminent hazard to the public safety. 

Because the Deputy Administrator 

hereby finds that it is necessary to 

temporarily place these synthetic 

cannabinoids into Schedule I to avoid 

an imminent hazard to the public safety, 

the final order temporarily scheduling 

these substances will be effective on the 

date of publication in the Federal 

Register, and will be in effect for a 

period of up to three years pending 

completion of the permanent or regular 

scheduling process. 

Regular scheduling actions in 

accordance with 21 U.S.C. 811(a) are 

subject to formal rulemaking procedures 

done ‘‘on the record after opportunity 

for a hearing’’ conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557. 

The CSA sets forth specific criteria for 

scheduling a drug or other substance. 

While temporary scheduling orders are 

not subject to judicial review (21 U.S.C. 

811(h)(6)), the regular scheduling 

process of formal rulemaking affords 

interested parties with appropriate 

process and the government with any 

additional relevant information needed 

to make a permanent scheduling 

determination. Final decisions which 

conclude the regular scheduling process 

of formal rulemaking are subject to 

judicial review. 21 U.S.C. 877. 

Regulatory Requirements 

With the issuance of this final order, 

UR-144, XLR11 and AKB48 become 

subject to the regulatory controls and 

administrative, civil and criminal 

sanctions applicable to the manufacture, 

distribution, possession, importation 

and exportation of a Schedule I 

controlled substance under the CSA and 

the CSIEA. 

1. Registration. Any person who 

manufactures, distributes, imports, 

exports, or possesses UR-144, XLR11 or 

AKB48, or who engages in research or 

conducts instructional activities with 

respect to UR-144, XLR11 or AKB48, or 

who proposes to engage in such 

activities, must be registered to conduct 

such activities in accordance with 21 

U.S.C. 822 and 957. Any person who is 

currently engaged in any of the above 

activities and is not registered with DEA 

must submit an application for 

registration and may not continue their 

activities until DEA has approved that 

application. Retail sales of Schedule I 

controlled substances to the general 

public are not allowed under the CSA. 

Possession of any of these substances in 

a manner not authorized by the CSA on 

or after May 16, 2013 is unlawful and 

may subject those in possession of any 

of these substances to prosecution 

pursuant to the Controlled Substances 

Act. 

2. Security. UR-144, XLR11 and 

AKB48 are subject to Schedule I 

security requirements. Accordingly, 

appropriately registered DEA registrants 

must manufacture, distribute and store 

these substances in accordance with 

1301.71; 1301.72(a), (c) and (d); 1301.73; 

1301.74; 1301.75(a) and (c); and 1301.76 

of Title 21 of the Code of Federal 

Regulations as of May 16, 2013. 


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28738 Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations 

3. Labeling and packaging. All 

labeling and packaging requirements for 

controlled substances set forth in Part 

1302 of Title 21 of the Code of Federal 

Regulations shall apply to commercial 

containers of UR-144, XLR11 and 

AKB48. Current DEA registrants 

authorized to handle UR-144, XLR11 

and AKB48 shall comply with Part 1302 

of Title 21 of the Code of Federal 

Regulations within thirty (30) calendar 

days of May 16, 2013. 

4. Quotas. Every manufacturer 

authorized to manufacture UR-144, 

XLR11 and AKB48 must apply for and 

be granted a quota to manufacture such 

substance(s) pursuant to Part 1303 of 

Title 21 of the Code of Federal 

Regulations. No authorized 

manufacturer may manufacture UR-144, 

XLR11 or AKB48 in excess of a quota 

assigned to him as of May 16, 2013. 

5. Inventory. Every DEA registrant 

authorized to possess any quantity of 

UR-144, XLR11 or AKB48 is required to 

keep inventory of all stocks of these 

substances on hand pursuant to 

1304.03, 1304.04 and 1304.11 of Title 21 

of the Code of Federal Regulations. 

Every authorized DEA registrant shall 

comply with all inventory requirements 

within thirty (30) calendar days of May 

16, 2013. 

6. Records. All registrants who are 

authorized to handle UR-144, XLR11 or 

AKB48 are required to keep records 

pursuant to 1304.03, 1304.04, 1304.21, 

1304.22 and 1304.23 of Title 21 of the 

Code of Federal Regulations. Current 

DEA registrants authorized to handle 

UR-144, XLR11 or AKB48 shall comply 

with all recordkeeping requirements 

within thirty (30) calendar days of May 

16, 2013. 

7. Reports. All registrants are required 

to submit reports in accordance with 

1304.33 of Title 21 of the Code of 

Federal Regulations. Registrants who 

manufacture or distribute UR-144, 

XLR11 or AKB48 are required to comply 

with these reporting requirements and 

shall do so as of May 16, 2013. 

8. Order Forms. All registrants 

involved in the distribution of UR-144, 

XLR11 or AKB48 must comply with 

order form requirements of Part 1305 of 

Title 21 of the Code of Federal 

Regulations as of May 16, 2013. 

9. Importation and Exportation. All 

importation and exportation of UR-144, 

XLR11 or AKB48 must be conducted by 

appropriately registered DEA registrants 

in compliance with Part 1312 of Title 21 

of the Code of Federal Regulations on or 

after May 16, 2013. 

10. Criminal Liability. The 

manufacture, distribution or possession 

with the intent to conduct these 

activities; as well as possession, 

importation or exportation of UR-144, 

XLR11 or AKB48 not authorized by, or 

in violation of the CSA or the Controlled 

Substances Import and Export Act 

occurring as of May 16, 2013 is 

unlawful. 

Regulatory Matters 

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 a 

proposed temporary scheduling order is 

transmitted to the Secretary of HHS. 21 

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

In as much 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, 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 final order. In the 

alternative, even assuming that this final 

order might be deemed to be subject to 

section 553 of the APA, the Deputy 

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 

issuance of temporary scheduling orders 

would be impracticable and contrary to 

the public interest in view of the 

manifest urgency of the temporary 

scheduling action to avoid an imminent 

hazard to the public safety. 

Further, DEA believes that this 

temporary scheduling action Final 

Order is not a ‘‘rule’’ as defined by 5 

U.S.C. 601(2), and, accordingly, not 

subject to the requirements of the 

Regulatory Flexibility Act. 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 agency 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. 

This action will not have substantial 

direct effects on the states, on the 

relationship between the national 

government and the states, or on 

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 the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Congressional Review Act) (5 

U.S.C. 801–808), DEA has submitted a 

copy of this Final Order 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. 

Under the authority vested in the 

Attorney General by section 201(h) of 

the CSA (21 U.S.C. 811(h)), and 

delegated to the Deputy Administrator 

of the DEA by Department of Justice 

regulations (28 CFR 0.100, Appendix to 

Subpart R), the Deputy Administrator 

hereby orders that 21 CFR part 1308 be 

amended 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. Section 1308.11 is amended by 

adding new paragraphs (h)(9), (10), and 

(11) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(9) (1-pentyl-1H-indol-3-yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone, its 

optical, positional, and geometric 

isomers, salts and salts of isomers— 

7144 (Other names: UR–144, 1-pentyl-3- 

(2,2,3,3-tetramethylcyclopropoyl)indole) 

(10) [1-(5-fluoro-pentyl)-1H-indol-3- 

yl](2,2,3,3- 

tetramethylcyclopropyl)methanone, its 

optical, positional, and geometric 

isomers, salts and salts of isomers— 

7011 (Other names: 5-fluoro-UR-144, 5- 

F-UR-144, XLR11, 1-(5-fluoro-pentyl)-3- 

(2,2,3,3-tetramethylcyclopropoyl)indole) 

(11) N-(1-adamantyl)-1-pentyl-1Hindazole-3-carboxamide, its optical, 

positional, and geometric isomers, salts 

and salts of isomers—7048 (Other 

names: APINACA, AKB48) 


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Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Rules and Regulations 28739 

Dated: May 10, 2013. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2013–11593 Filed 5–15–13; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Part 5 

[Docket No. TTB–2012–0001; T.D. TTB–113; 

Re: Notice No. 126] 

RIN 1513–AB91 

Standards of Identity for Pisco and 

Cognac 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Final rule; Treasury decision. 

SUMMARY: This final rule amends the 

Alcohol and Tobacco Tax and Trade 

Bureau regulations setting forth the 

standards of identity for distilled spirits 

to include Pisco as a type of brandy that 

must be manufactured in accordance 

with the laws and regulations of either 

Peru or Chile, as appropriate, governing 

the manufacture of those products. This 

final rule also removes ‘‘Pisco brandy’’ 

from the list of examples of geographical 

designations in the distilled spirits 

standards of identity, and it includes a 

technical correction to remove 

‘‘Cognac’’ from the same list of 

examples. These changes provide 

greater clarity in distilled spirits 

labeling. 

DATES: Effective Date: This final rule is 

effective July 15, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Karen Welch, Alcohol and Tobacco Tax 

and Trade Bureau, Regulations and 

Rulings Division; telephone 202–453– 

1039, ext. 046; email ITD@ttb.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

TTB Authority 

Section 105(e) of the Federal Alcohol 

Administration Act (FAA Act), codified 

in the United States Code at 27 U.S.C. 

205(e), authorizes the Secretary of the 

Treasury (Secretary) to prescribe 

regulations relating to the packaging, 

marking, branding, labeling, and size 

and fill of containers of alcohol 

beverages that will prohibit consumer 

deception and provide the consumer 

with adequate information as to the 

identity and quality of the product. 

Section 105(e) of the FAA Act also 

generally requires bottlers and importers 

of alcohol beverages to obtain 

certificates of label approval prior to 

bottling or importing alcohol beverages 

for sale in interstate commerce. 

Regulations implementing those 

provisions of section 105(e) as they 

relate to distilled spirits are set forth in 

part 5 of title 27 of the Code of Federal 

Regulations (27 CFR part 5). The 

Alcohol and Tobacco Tax and Trade 

Bureau (TTB) administers the FAA Act 

pursuant to section 1111(d) of the 

Homeland Security Act of 2002, 

codified at 6 U.S.C. 531(d). The 

Secretary has delegated various 

authorities through Treasury 

Department Order 120–01 (Revised), 

dated January 21, 2003, to the TTB 

Administrator to perform the functions 

and duties in the administration and 

enforcement of this law. 

Certificates of Label Approval 

TTB’s regulations prohibit the release 

of bottled distilled spirits from customs 

custody for consumption unless an 

approved Certificate of Label Approval 

(COLA) covering the product has been 

deposited with the appropriate Customs 

officer at the port of entry. See 27 CFR 

5.51. The TTB regulations also generally 

prohibit the bottling or removal from a 

plant of distilled spirits unless the 

proprietor possesses a COLA covering 

the labels on the bottle. See 27 CFR 

5.55. 

Classes and Types of Spirits 

The TTB labeling regulations require 

that the class and type of distilled 

spirits appear on the product’s brand 

label. See 27 CFR 5.32(a)(2) and 5.35. 

Those regulations provide that the class 

and type must be stated in conformity 

with § 5.22 of the TTB regulations (27 

CFR 5.22) if defined therein. Otherwise, 

the product must be designated in 

accordance with trade and consumer 

understanding thereof, or, if no such 

understanding exists, by a distinctive or 

fanciful name, and in either case (with 

limited exceptions), followed by a 

truthful and adequate statement of 

composition (see 27 CFR 5.35). 

Section 5.22 establishes standards of 

identity for distilled spirits products 

and categorizes these products 

according to various classes and types. 

As used in § 5.22, the term ‘‘class’’ refers 

to a general category of spirits, such as 

‘‘whisky’’ or ‘‘brandy.’’ Currently, there 

are 12 different classes of distilled 

spirits recognized in § 5.22, including 

whisky, rum, and brandy. The term 

‘‘type’’ refers to a subcategory within a 

class of spirits. For example, ‘‘Cognac’’ 

is a type of brandy, and ‘‘Canadian 

whisky’’ is a type of whisky. 

Brandy and Pisco 

Brandy is Class 4 in the standards of 

identity, where it is defined in § 5.22(d) 

as ‘‘an alcoholic distillate from the 

fermented juice, mash, or wine of fruit, 

or from the residue thereof, produced at 

less than 190° proof in such manner that 

the distillate possesses the taste, aroma, 

and characteristics generally attributed 

to the product, and bottled at not less 

than 80° proof.’’ ‘‘Pisco’’ is a term 

recognized by both the governments of 

Peru and Chile as a designation for a 

distilled spirits product made from 

grapes. Generally, Pisco is classified as 

brandy under the terms of TTB’s current 

labeling regulations. However, Pisco is 

not currently listed as a type of brandy 

in Class 4. Rather, ‘‘Pisco brandy’’ has 

been included in Class 11, at 

§ 5.22(k)(3), as an example of a 

geographical name that is not a name for 

a distinctive type of distilled spirits, and 

that has not become generic. 

International Agreements 

Pursuant to the United States-Peru 

Trade Promotion Agreement, the United 

States recognized Pisco Peru ́ as a 

distinctive product of Peru (Article 

2.12(2) of the Agreement). Accordingly, 

the United States agreed not to permit 

the sale of any product as Pisco Peru ́

unless it has been manufactured in Peru 

in accordance with the laws and 

regulations of Peru governing Pisco. 

In addition, pursuant to the United 

States-Chile Free Trade Agreement, the 

United States recognized Pisco Chileno 

(Chilean Pisco) as a distinctive product 

of Chile (Article 3.15(2) of the 

Agreement). Accordingly, the United 

States agreed not to permit the sale of 

any product as Pisco Chileno (Chilean 

Pisco) unless it has been manufactured 

in Chile in accordance with the laws 

and regulations of Chile governing the 

manufacture of Pisco. 

In like manner, Peru and Chile agreed, 

respectively, to recognize Bourbon 

Whiskey and Tennessee Whiskey 

(which is defined in both Agreements as 

a straight Bourbon Whiskey authorized 

to be produced only in the State of 

Tennessee), as distinctive products of 

the United States, and not to permit the 

sale of any product as Bourbon Whiskey 

or Tennessee Whiskey unless it has 

been manufactured in the United States 

in accordance with the laws and 

regulations of the United States 

governing the manufacture of Bourbon 

Whiskey and Tennessee Whiskey. (TTB 

notes that there are alternative spellings 

for the same term—‘‘whisky’’ in the TTB 

regulations in 27 CFR part 5 and 

‘‘whiskey’’ in the Agreements with Peru 

and Chile.) 


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