21858 Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Proposed Rules 

1Because the Secretary of the Department of 

Health and Human Services (HHS) has delegated to 

the Assistant Secretary for Health the Department 

of Health and Human Services the authority to 

make domestic drug scheduling recommendations, 

for purposes of this Notice of Intent, 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. 

Issued in Washington, DC, on April 4, 

2013. 

Gary A. Norek, 

Manager, Airspace Policy and ATC 

Procedures Group. 

[FR Doc. 2013–08546 Filed 4–11–13; 8:45 am] 

BILLING CODE 4910–13–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: Notice of Intent. 

SUMMARY: The Deputy Administrator of 

the Drug Enforcement Administration 

(DEA) is issuing this notice of intent to 

temporarily schedule three synthetic 

cannabinoids into 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 

(UR–144), 1-(5-fluoro-pentyl)-1H-indol3-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 into Schedule I of the CSA 

is necessary to avoid an imminent 

hazard to the public safety. Any final 

order will be published in the Federal 

Register and may not be issued prior to 

May 13, 2013. Any final order will 

impose the administrative, civil, and 

criminal sanctions and regulatory 

controls of Schedule I substances under 

the CSA on the manufacture, 

distribution, possession, importation, 

and exportation of these synthetic 

cannabinoids. 

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. 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. 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. Any 

additional comments submitted by the 

Assistant Secretary in response to this 

notification shall also be taken into 

consideration before a final order is 

published. 21 U.S.C. 811(h)(4). 

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(c)). 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)(1)) 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 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 non-research 

uses have been identified for these 

synthetic cannabinoids nor have they 

been approved by FDA for human 

consumption. These synthetic 

cannabinoids, of which 1-pentyl-1Hindol-3-yl)(2,2,3,3- 

tetramethylcyclopropyl)methanone 

(UR–144), 1-(5-fluoro-pentyl)-1H-indol3-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 

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Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Proposed Rules 21859 

2National Forensic Laboratory Information 

System (NFLIS) is a program sponsored by Drug 

Enforcement Administration’s (DEA) Office of 

Diversion Control which compiles information on 

exhibits analyzed in State and local law 

enforcement 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. 

5Substance Abuse and Mental Health Services 

Administration (SAMHSA) is a branch of the U.S. 

Department of Health and Human Services (HHS). 

It is charged with improving the quality and 

availability of prevention, treatment, and 

rehabilitative services in order to reduce illness, 

death, disability, and cost to society resulting from 

substance abuse and mental illnesses. 

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. 

From January 2009 through January 

24, 2013, according to the System to 

Retrieve Information from Drug 

Evidence (STRIDE) data, there are 1,074 

reports involving 137 cases for UR–144, 

773 reports involving 134 cases for 

XLR11, and 66 reports involving 25 

cases for AKB48. From March 2010 to 

January 29, 2013, the National Forensic 

Laboratory Information System (NFLIS) 

registered 9,346 reports containing these 

synthetic cannabinoids (UR–144—4,387 

reports; XLR11—4,516 reports; 

AKB48—443 reports) across 32 states. 

No instances regarding UR–144, XLR11 

or AKB48 were reported in NFLIS prior 

to March of 2010. Collectively, reports 

from NFLIS and (STRIDE) 2 (11,259 

reports total through January 29, 2013) 

for UR–144, XLR11 and AKB48 have 

exceeded the number of reports for the 

five synthetic cannabinoid substances 

(JWH–018, JWH–200, JWH–073, CP– 

47,497 and CP–47,497 C8 homologue 

[cannabicyclohexanol]) (7,340 total 

reports through December 31, 2012). 

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 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 discussion 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 have been 

shown to display higher potency in 

vitro 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 

November 2008, when U.S. Customs 

and Border Protection analyzed ‘‘Spice’’ 

products. NFLIS has reported 9,346 

exhibits (March 2010 to January 29, 

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 1,913 records 

involving UR–144, XLR11 and AKB48 

from January 2009 through January 24, 

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 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 

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 and poison control 

centers and private organizations. In a 

2012 report, the Substance Abuse and 

Mental Health Services Administration 5

reported 11,406 emergency department 

visits involving a synthetic cannabinoid 

product during 2010. 

Detailed product analyses have 

detected variations in the amount and 

type of synthetic cannabinoid laced on 

plant material even within samplings of 

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21860 Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Proposed Rules 

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 above 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)(1)) 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 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. As 

required by section 201(h)(4) of the CSA 

(21 U.S.C. 811(h)), the Deputy 

Administrator through a letter dated 

February 14, 2013, notified the Assistant 

Secretary of Health of the intention to 

temporarily place these three synthetic 

cannabinoids in Schedule I. 

Conclusion 

This notice of intent initiates 

expedited temporary scheduling action 

and provides the 30-day notice pursuant 

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

811(h)). 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-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) 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, 

any subsequent 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. It is the 

intention of the Deputy Administrator to 

issue such a final order as soon as 

possible after the expiration of 30 days 

from the date of publication of this 

notice. UR–144, XLR11, and AKB48 will 

then be subject to the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to the 

manufacture, distribution, possession, 

importing and exporting of a Schedule 

I controlled substance under the CSA. 

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 determination. Final 

decisions which conclude the regular 

scheduling process of formal 

rulemaking are subject to judicial 

review. 21 U.S.C. 877. 

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). 

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, 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 notice of intent. In the 

alternative, even assuming that this 

notice of intent 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. 

Although this notice of intent to issue 

a temporary scheduling order is not 

subject to the notice and comment 

requirements of section 553 of the APA, 

DEA notes that in accordance with 21 

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

Administrator will be taking into 

consideration any comments submitted 

by the Secretary of HHS with regard to 

the proposed temporary scheduling 

order. Further, DEA believes that this 

temporary scheduling action 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 

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Federal Register / Vol. 78, No. 71 / Friday, April 12, 2013 / Proposed Rules 21861 

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. 

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 intends to order 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) 

Dated: April 5, 2013. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2013–08671 Filed 4–11–13; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

25 CFR Part 170 

[BY–/AM65P0002.99900/] 

Tribal Consultation on the Draft 

Regulations Governing the Tribal 

Transportation Program 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Notice of Tribal Consultations 

and Informational Meetings. 

SUMMARY: The Bureau of Indian Affairs 

is announcing tribal consultations to 

discuss draft revisions of the regulations 

governing the Tribal Transportation 

Program. The consultations will also 

cover requirements for proposed roads 

and access roads to be included in the 

National Tribal Transportation Facility 

Inventory and will include an update 

regarding the ongoing quality assurance 

review of the facility inventory. 

DATES: Comments on the draft rule are 

due by June 14, 2013. The consultation 

sessions will be held on the following 

dates, at the following locations: 

Meeting date Location Time 

May 14, 2013 .................................................. Anchorage, AK ........................................................................................... 9 a.m.–4:30 p.m. 

May 16, 2013 .................................................. Phoenix, AZ ............................................................................................... 9 a.m.–4:30 p.m. 

May 21, 2013 .................................................. Minneapolis, MN ........................................................................................ 9 a.m.–4:30 p.m. 

ADDRESSES: 

• Send comments to: LeRoy M. Gishi, 

Chief, Division of Transportation, 

Bureau of Indian Affairs, 1849 C Street, 

NW., MS–4513, Washington, DC 20240, 

telephone (202) 513–7711, email: 

leroy.gishi@bia.gov; or Robert W. 

Sparrow, Jr., Director, Tribal 

Transportation Program, Federal 

Highway Administration, 1200 New 

Jersey Ave, SE., Room E61–311, 

Washington, DC 20159, telephone (202) 

366–9483, email: 

robert.sparrow@dot.gov. 

• Addresses of the venues at which 

each meeting will be held, a copy of the 

draft regulation, and background 

information are posted at the following 

Web site (the address is case-sensitive, 

please use capitals where indicated): 

http://www.bia.gov/WhoWeAre/BIA/ 

OIS/Transportation. 

FOR FURTHER INFORMATION CONTACT: 

LeRoy M. Gishi, telephone (202) 513– 

7711; email: leroy.gishi@bia.gov; or 

Robert W. Sparrow, Jr., telephone (202) 

366–9483; email: 

robert.sparrow@dot.gov. 

SUPPLEMENTARY INFORMATION: Federally 

recognized tribes are invited to attend 

one or more of the consultation and 

informational sessions regarding the 

following topics: 

• On July 6, 2012, Moving Ahead for 

Progress in the 21st Century Act (MAP– 

21), Public Law 112–141, a two-year 

reauthorization of the transportation act, 

was signed into law by President Obama 

and became effective on October 1, 

2012. 

• Section 1119 of MAP–21 struck the 

existing laws governing the Indian 

Reservation Roads Program from 23 

U.S.C. 201–204, and renumbered many 

of those sections under 23 U.S.C. 201 

and 202 and changed the name from 

‘‘Indian Reservation Roads Program’’ to 

‘‘Tribal Transportation Program (TTP).’’ 

MAP–21 also changed the name of the 

‘‘Indian Reservation Roads Inventory’’ 

to the ‘‘National Tribal Transportation 

Program Facility Inventory (NTTFI).’’ 

See 23 U.S.C. 202(b)(1). Section 1103 of 

MAP–21 amended the name of an 

‘‘Indian Reservation Road’’ to a ‘‘Tribal 

Transportation Facility.’’ 

• Section 1119 of MAP–21 created a 

new formula for distribution of TTP 

funds among tribes, which had the 

effect of overriding the existing Relative 

Need Distribution Formula (RNDF) that 

was published in 2004 at 25 CFR part 

170, Subpart C. See 23 U.S.C. 202(b)(3). 

Although the RNDF is no longer 

applicable under the new TTP formula, 

certain historical aspects of the former 

mstockstill on DSK6TPTVN1PROD with PROPOSALS