Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47971 

final order. The necessary special 

controls appear in the regulation 

codified by this order. This device is 

subject to premarket notification 

requirements under section 510(k). 

At the time of classification, enzyme 

packed cartridges are for prescription 

use only. Prescription devices are 

exempt from the requirement for 

adequate directions for use for the 

layperson under section 502(f)(1) of the 

FD&C Act (21 U.S.C. 352(f)(1)) and 21 

CFR 801.5, as long as the conditions of 

21 CFR 801.109 are met. 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Paperwork Reduction Act of 1995 

This final administrative order 

establishes special controls that refer to 

previously approved collections of 

information found in other FDA 

regulations. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in part 807, 

subpart E, regarding premarket 

notification submissions have been 

approved under OMB control number 

0910–0120, and the collections of 

information in 21 CFR part 801, 

regarding labeling, have been approved 

under OMB control number 0910–0485. 

List of Subjects in 21 CFR Part 876 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGYUROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 876.5985 to subpart F to read 

as follows: 

§ 876.5985 Enzyme packed cartridge. 

(a) Identification. An enzyme packed 

cartridge is an ex vivo prescription 

device that is used in enzymatic 

hydrolysis of macronutrients into their 

essential nutrient forms at the time of 

delivery. The device consists of an outer 

casing containing an inert polymer with 

a covalently bound enzyme through 

which nutritional formula is directed. 

The device fits in line with enteral 

feeding systems. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The patient contacting 

components of the device must be 

demonstrated to be biocompatible. 

(2) In vivo testing must be performed 

and must demonstrate that the device 

causes neither an adverse tissue 

response nor adverse performance. 

(3) Non-clinical testing must 

demonstrate that the device performs as 

intended under anticipated conditions 

of use. The following performance 

characteristics must be demonstrated: 

(i) Mechanical testing to demonstrate 

that the device can withstand clinical 

forces; 

(ii) Flow rate and leakage testing to 

demonstrate that the device does not 

impede the flow of enteral formula; 

(iii) Demonstration of enzymatic effect 

on intended macronutrient; 

(iv) The amount of enzyme that exits 

the cartridge must be characterized; 

(v) Validation that the device does not 

adversely impact the nutritional 

composition of enteral formula; and 

(vi) Validation that the device does 

not impede flow alarms on enteral 

feeding pumps. 

(4) Human factors testing must be 

performed to characterize use error 

risks. 

(5) Performance data must support 

shelf life by demonstrating package 

integrity and device functionality over 

the identified shelf life. 

(6) Labeling must include the 

following: 

(i) A detailed summary of in vivo 

testing pertinent to use of the device, 

including device-related adverse events; 

(ii) A detailed summary of compatible 

formulas that is supported by nonclinical testing, including the expected 

enzymatic conversion as a percentage; 

(iii) Detailed instructions on how to 

place the device into an enteral feeding 

circuit; 

(iv) A warning regarding the 

possibility for misconnections; and 

(v) Expiration date or shelf life. 

(7) Patient labeling must be provided 

and must include: 

(i) Relevant warnings, precautions, 

adverse effects, and complications; 

(ii) A description of the device and 

how it operates; 

(iii) Instructions on how to correctly 

use the device; and 

(iv) The benefits and risks associated 

with the use of the device. 

Dated: October 10, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22286 Filed 10–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–402] 

Schedules of Controlled Substances: 

Placement of AB-CHMINACA, ABPINACA and THJ-2201 Into Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Drug Enforcement 

Administration places N-(1-amino-3- 

methyl-1-oxobutan-2-yl)-1- 

(cyclohexylmethyl)-1H-indazole-3- 

carboxamide (AB-CHMINACA), N-(1- 

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

pentyl-1H-indazole-3-carboxamide (ABPINACA), and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1- 

yl)methanone (THJ-2201), including 

their salts, isomers, and salts of isomers 

whenever the existence of such salts, 

isomers, and salts of isomers is possible, 

into schedule I of the Controlled 

Substances Act. This scheduling action 

is pursuant to the Controlled Substances 

Act which requires that such actions be 

made on the record after opportunity for 

a hearing through formal rulemaking. 

This rule continues the imposition of 

the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to schedule I 

controlled substances on persons who 

handle (manufacture, distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis, or possess), or propose to 

handle AB-CHMINACA, AB-PINACA 

and THJ-2201. 

DATES: Effective October 16, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Lewis, Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

Under the Controlled Substances Act 

(CSA), each controlled substance is 

classified into one of five schedules 

based upon its potential for abuse, its 


jstallworth on DSKBBY8HB2PROD with RULES
47972 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 

1As set forth in a memorandum of understanding 

entered into by the Food and Drug Administration 

(FDA) and the National Institute on Drug Abuse 

(NIDA), the FDA acts as the lead agency within the 

Department of Health and Human Services (HHS) 

in carrying out the Secretary’s scheduling 

responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. 

The Secretary of the HHS has delegated to the 

Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations. 58 FR 35460, July 1, 1993. 

currently accepted medical use, and the 

degree of dependence the substance 

may cause. 21 U.S.C. 812. The initial 

schedules of controlled substances 

established by Congress are found at 21 

U.S.C. 812(c), and the current list of 

scheduled substances is published at 21 

CFR part 1308. 

Pursuant to 21 U.S.C. 811(a)(1), the 

Attorney General may, by rule, ‘‘add to 

such a schedule or transfer between 

such schedules any drug or other 

substance if he (A) finds that such drug 

or other substance has a potential for 

abuse, and (B) makes with respect to 

such drug or other substance the 

findings prescribed by subsection (b) of 

section 812 of this title for the schedule 

in which such drug is to be 

placed. . . .’’ The Attorney General has 

delegated scheduling authority under 21 

U.S.C. 811 to the Administrator of the 

DEA. 28 CFR 0.100. 

The CSA provides that proceedings 

for the issuance, amendment, or repeal 

of the scheduling of any drug or other 

substance may be initiated by the 

Attorney General (1) on his own motion; 

(2) at the request of the Secretary of the 

Department of Health and Human 

Services (HHS); 1 or (3) on the petition 

of any interested party. 21 U.S.C. 811(a). 

This action was initiated on the 

Attorney General’s own motion, as 

delegated to the Administrator of the 

DEA, and is supported by, inter alia, a 

recommendation from the Assistant 

Secretary for Health of the HHS and an 

evaluation of all relevant data by the 

DEA. This action continues the 

imposition of the regulatory controls 

and administrative, civil, and criminal 

sanctions of schedule I controlled 

substances on any person who handles 

or proposes to handle AB-CHMINACA, 

AB-PINACA and THJ-2201. 

Background 

On January 30, 2015, the DEA 

published a final order in the Federal 

Register amending 21 CFR 1308.11(h) to 

temporarily place the three synthetic 

cannabinoids N-(1-amino-3-methyl-1- 

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

1H-indazole-3-carboxamide (ABCHMINACA), N-(1-amino-3-methyl-1- 

oxobutan-2-yl)-1-pentyl-1H-indazole-3- 

carboxamide (AB-PINACA), and[1-(5- 

Fluoropentyl)-1H-indazol-3- 

yl](naphthalen-1-yl) methanone (THJ2201) into schedule I of the CSA 

pursuant to the temporary scheduling 

provisions of 21 U.S.C. 811(h). 80 FR 

5042. That final order was effective on 

the date of publication, and was based 

on findings by the Administrator of the 

DEA that the temporary scheduling of 

these three 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 

issuance date of the scheduling order, 

on or before January 29, 2017. 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. Accordingly, on January 27, 

2017, the DEA extended the temporary 

scheduling of AB-CHMINACA, ABPINACA and THJ-2201 by one year, or 

until January 29, 2018. 82 FR 8590. 

Also, on January 27, 2017, the DEA 

published a notice of proposed 

rulemaking (NPRM) to permanently 

control AB-CHMINACA, AB-PINACA 

and THJ-2201 in schedule I of the CSA. 

82 FR 8593. Specifically, DEA proposed 

to add these three synthetic 

cannabinoids to 21 CFR 1308.11(d), 

hallucinogenic substances. 

DEA and HHS Eight Factor Analyses 

On November 14, 2016, the HHS 

provided the DEA with a scientific and 

medical evaluation document prepared 

by the FDA entitled ‘‘Basis for the 

Recommendation to Place [1-(5- 

Fluoropentyl)-1H-Indazol-3-yl] 

(Naphthalen-1-yl) Methanone (THJ2201), N-[(2S)-1-Amino-3-Methyl-1- 

Oxo-2-Butanyl]-1-Pentyl-1H-Indazole-3- 

Carboxamide (AB-PINACA), and N- 

[(2S)-1-Amino-3-Methyl-1-Oxo-2- 

Butanyl]-1-(Cyclohexylmethyl)-1HIndazole-3-Carboxamide (ABCHMINACA) and their Salts in 

Schedule I of the Controlled Substances 

Act.’’ After considering the eight factors 

in 21 U.S.C. 811(c), and also considering 

each substance’s abuse potential, lack of 

legitimate medical use in the United 

States, and lack of accepted safety for 

use under medical supervision pursuant 

to 21 U.S.C. 812(b), the Assistant 

Secretary of the HHS recommended that 

AB-CHMINACA, AB-PINACA and THJ2201 be controlled in schedule I of the 

CSA. In response, the DEA conducted 

its own eightfactor analysis of ABCHMINACA, AB-PINACA and THJ2201. The DEA and HHS analyses are 

available in their entirety in the public 

docket for this rule (Docket Number 

DEA–402/DEA–2017–0001) at http://

www.regulations.gov under ‘‘Supporting 

Documents.’’ 

Determination to Schedule ABCHMINACA, AB-PINACA and THJ2201 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendations from the HHS, the 

DEA published an NPRM entitled 

‘‘Schedules of Controlled Substances: 

Placement of AB-CHMINACA, ABPINACA and THJ-2201 into Schedule I,’’ 

proposing to control AB-CHMINACA, 

AB-PINACA and THJ-2201, and their 

salts, isomers, and salts of isomers in 

schedule I of the CSA. 82 FR 8593, 

January 27, 2017. The proposed rule 

provided an opportunity for interested 

persons to file a request for hearing in 

accordance with the DEA regulations on 

or before February 27, 2017. No requests 

for such a hearing were received by the 

DEA. The NPRM also provided an 

opportunity for interested persons to 

submit written comments on the 

proposal on or before February 27, 2017. 

Comments Received 

The DEA received five comments on 

the proposed rule to control ABCHMINACA, AB-PINACA and THJ-2201 

in schedule I of the CSA. 

Support for rulemaking: Five 

commenters gave support for the 

rulemaking stating in unison that these 

substances have no medical use and are 

a danger to the community. 

DEA Response: The DEA appreciates 

the comments in support of this 

rulemaking. 

Scheduling Conclusion 

After consideration of the relevant 

matter presented as a result of public 

comments, the scientific and medical 

evaluations and accompanying 

recommendation of the HHS, and after 

its own eight-factor evaluation, the DEA 

finds that these facts and all other 

relevant data constitute substantial 

evidence of potential for abuse of ABCHMINACA, AB-PINACA and THJ2201. As such, the DEA is permanently 

scheduling AB-CHMINACA, ABPINACA and THJ-2201 as controlled 

substances under the CSA. 

Determination of Appropriate Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

also outlines the findings required to 

place a drug or other substance in any 

particular schedule. 21 U.S.C. 812(b). 

After consideration of the analyses and 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 47973 

2AB-CHMINACA, AB-PINACA or THJ-2201 are 

currently subject to schedule I controls on a 

temporary basis, pursuant to 21 U.S.C. 811(h). 80 

FR 5042, Jan. 30, 2015. 

recommendations of the Assistant 

Secretary for HHS and review of all 

other available data, the Administrator 

of the DEA, pursuant to 21 U.S.C. 811(a) 

and 21 U.S.C. 812(b)(1), finds that: 

(1) N-(1-amino-3-methyl-1-oxobutan2-yl)-1-(cyclohexylmethyl)-1H-indazole3-carboxamide (AB-CHMINACA), N-(1- 

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

pentyl-1H-indazole-3-carboxamide (ABPINACA) and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1- 

yl)methanone (THJ-2201) have a high 

potential for abuse that is comparable to 

other schedule I substances such as 

delta-9-tetrahydrocannabinol (D9-THC) 

and JWH-018; 

(2) N-(1-amino-3-methyl-1-oxobutan2-yl)-1-(cyclohexylmethyl)-1H-indazole3-carboxamide (AB-CHMINACA), N-(1- 

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

pentyl-1H-indazole-3-carboxamide (ABPINACA) and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1- 

yl)methanone (THJ-2201) have no 

currently accepted medical use in 

treatment in the United States; and 

(3) There is a lack of accepted safety 

for use of N-(1-amino-3-methyl-1- 

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

1H-indazole-3-carboxamide (ABCHMINACA), N-(1-amino-3-methyl-1- 

oxobutan-2-yl)-1-pentyl-1H-indazole-3- 

carboxamide (AB-PINACA) and [1-(5- 

fluoropentyl)-1H-indazol-3- 

yl](naphthalen-1-yl)methanone (THJ2201) under medical supervision. 

Based on these findings, the 

Administrator of the DEA concludes 

that N-(1-amino-3-methyl-1-oxobutan-2- 

yl)-1-(cyclohexylmethyl)-1H-indazole-3- 

carboxamide (AB-CHMINACA), N-(1- 

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

pentyl-1H-indazole-3-carboxamide (ABPINACA) and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1- 

yl)methanone (THJ-2201) including 

their salts, isomers and salts of isomers, 

whenever the existence of such salts, 

isomers, and salts of isomers is possible, 

warrant control in schedule I of the 

CSA. 21 U.S.C. 812(b)(1). 

Requirements for Handling ABCHMINACA, AB-PINACA and THJ2201 

AB-CHMINACA, AB-PINACA and 

THJ-2201 will continue 2 to be subject to 

the CSA’s schedule I regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, dispensing, importing, 

exporting, research, and conduct of 

instructional activities, including the 

following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

imports, exports, engages in research, or 

conducts instructional activities or 

chemical analysis with, or possesses), or 

who desires to handle AB-CHMINACA, 

AB-PINACA or THJ-2201, must be 

registered with the DEA to conduct such 

activities pursuant to 21 U.S.C. 822, 

823, 957, and 958 and in accordance 

with 21 CFR parts 1301 and 1312. 

2. Security. AB-CHMINACA, ABPINACA or THJ-2201are subject to 

schedule I security requirements and 

must be handled and stored pursuant to 

21 U.S.C. 821, 823, 871(b) and in 

accordance with 21 CFR 1301.71 

through 1301.93. 

3. Labeling and Packaging. All labels 

and labeling for commercial containers 

of AB-CHMINACA, AB-PINACA or THJ2201 must be in compliance with 21 

U.S.C. 825 and 958(e), and be in 

accordance with 21 CFR part 1302. 

4. Quota. Only registered 

manufacturers are permitted to 

manufacture AB-CHMINACA, ABPINACA or THJ-2201 in accordance 

with a quota assigned pursuant to 21 

U.S.C. 826 and in accordance with 21 

CFR part 1303. 

5. Inventory. Every DEA registrant 

who possesses any quantity of ABCHMINACA, AB-PINACA and THJ-2201 

on the effective date of this final rule, 

must take an inventory of all stocks of 

these substances on hand as of October 

16, 2017, pursuant to 21 U.S.C. 827 and 

958 and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11 (a) and 

(d). Current DEA registrants shall have 

30 calendar days from the effective date 

of this order to be in compliance with 

all inventory requirements. 

After the initial inventory, every DEA 

registrant must take a new inventory of 

all controlled substances (including ABCHMINACA, AB-PINACA and THJ2201) on hand on a biennial basis, 

pursuant to 21 U.S.C. 827 and 958, and 

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

6. Records and Reports. Every DEA 

registrant must maintain records and 

submit reports with respect to ABCHMINACA, AB-PINACA and/or THJ2201 pursuant to 21 U.S.C. 827 and 

958(e), and in accordance with 21 CFR 

parts 1304 and 1312. 

7. Order Forms. Every DEA registrant 

who distributes AB-CHMINACA, ABPINACA or THJ-2201 must continue to 

comply with the order form 

requirements, pursuant to 21 U.S.C. 828, 

and 21 CFR part 1305. 

8. Importation and Exportation. All 

importation and exportation of ABCHMINACA, AB-PINACA or THJ-2201 

must continue to be in compliance with 

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

in accordance with 21 CFR part 1312. 

9. Liability. Any activity involving 

AB-CHMINACA, AB-PINACA or THJ2201 not authorized by, or in violation 

of, the CSA or its implementing 

regulations is unlawful, and may subject 

the person to administrative, civil, and/ 

or criminal sanctions. 

Regulatory Analyses 

Executive Orders 12866 and 13563 

In accordance with 21 U.S.C. 811(a), 

this final scheduling action is subject to 

formal rulemaking procedures 

performed ‘‘on the record after 

opportunity for a hearing,’’ which are 

conducted pursuant to the provisions of 

5 U.S.C. 556 and 557. The CSA sets 

forth the criteria for scheduling a drug 

or other substance. Such actions are 

exempt from review by the Office of 

Management and Budget (OMB) 

pursuant to section 3(d)(1) of Executive 

Order 12866 and the principles 

reaffirmed in Executive Order 13563. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988 to 

eliminate drafting errors and ambiguity, 

minimize litigation, provide a clear legal 

standard for affected conduct, and 

promote simplification and burden 

reduction. 

Executive Order 13132 

This rulemaking does not have 

federalism implications warranting the 

application of Executive Order 13132. 

The rule does not have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175 

This rule does not have tribal 

implications warranting the application 

of Executive Order 13175. It does not 

have substantial direct effects on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act 

(RFA), 5 U.S.C. 601–602, has reviewed 

this final rule and by approving it 

certifies that it will not have a 

significant economic impact on a 


jstallworth on DSKBBY8HB2PROD with RULES
47974 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 

substantial number of small entities. On 

January 30, 2015, the DEA published a 

final order to temporarily place these 

three substances into schedule I of the 

CSA pursuant to the temporary 

scheduling provisions of 21 U.S.C. 

811(h). The DEA estimates that all 

entities handling or planning to handle 

these substances have already 

established and implemented the 

systems and processes required to 

handle AB-CHMINACA, AB-PINACA or 

THJ-2201. There are currently 25 

registrations authorized to handle ABCHMINACA, AB-PINACA and/or THJ2201 specifically, as well as a number 

of registered analytical labs that are 

authorized to handle schedule I 

controlled substances generally. These 

25 registrations represent 18 entities, of 

which 8 are small entities. Therefore, 

the DEA estimates eight small entities 

are affected by this rule. 

A review of the 25 registrations 

indicates that all entities that currently 

handle AB-CHMINACA, AB-PINACA or 

THJ-2201 also handle other schedule I 

controlled substances, and have 

established and implemented (or 

maintain) the systems and processes 

required to handle AB-CHMINACA, ABPINACA or THJ-2201. Therefore, the 

DEA anticipates that this rule will 

impose minimal or no economic impact 

on any affected entities; and thus, will 

not have a significant economic impact 

on any of the eight affected small 

entities. Therefore, the DEA has 

concluded that this rule will not have a 

significant effect on a substantial 

number of small entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., the DEA has 

determined and certifies that this action 

would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted for inflation) in any one 

year. . . .’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under UMRA of 1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information under the 

Paperwork Reduction Act of 1995. 44 

U.S.C. 3501–3521. This action would 

not impose recordkeeping or reporting 

requirements on State or local 

governments, individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act (CRA)). This rule will not 

result in: ‘‘an annual effect on the 

economy of $100,000,000 or more; a 

major increase in costs or prices for 

consumers, individual industries, 

Federal, State, or local government 

agencies, or geographic regions; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of U.S.-based companies to 

compete with foreign based companies 

in domestic and export markets.’’ 

However, pursuant to the CRA, the DEA 

has submitted a copy of this final rule 

to both Houses of Congress and to the 

Comptroller General. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, 21 CFR 

part 1308 is amended 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. In § 1308.11, 

■ a. Add paragraphs (d)(69) through 

(71); 

■ b. Remove paragraphs (h)(1) through 

(3); and 

■ c. Redesignate paragraphs (h)(4) 

through (17) as (h)(1) through (14). 

The additions to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(69) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA) .................... (7031) 

(70) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) ................................................ (7023) 

(71) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) ........................................................................ (7024) 

* * * * * 

Dated: October 6, 2017. 

Robert Patterson, 

Acting Administrator. 

[FR Doc. 2017–22325 Filed 10–13–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2017–0966] 

Drawbridge Operation Regulation; 

Cerritos Channel, Long Beach, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the operating 

schedule that governs the Henry Ford 

Avenue railroad bridge across the 

Cerritos Channel, mile 4.8, at Long 

Beach, CA. The deviation is necessary to 

allow the bridge owner to install 

necessary electrical equipment inside 

the bridge machinery room and operator 

house. This deviation allows the bridge 

to remain in the closed-to-navigation 

position during the deviation period. 

DATES: This deviation is effective from 

8 a.m. through noon on October 20, 

2017. 

ADDRESSES: The docket for this 

deviation, USCG–2017–0966, is 

available at http://www.regulations.gov. 

Type the docket number in the 

‘‘SEARCH’’ box and click ‘‘SEARCH.’’ 

Click on Open Docket Folder on the line 

associated with this deviation. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

deviation, call or email Carl T. Hausner, 

Chief, Bridge Section, Eleventh Coast 

Guard District; telephone 510–437– 

3516; email Carl.T.Hausner@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Port 

of Los Angeles has requested a 

temporary change to the operation of the 

Henry Ford Avenue railroad bridge, 

mile 4.8, over the Cerritos Channel, at 

Long Beach, CA. The drawbridge 

navigation span provides a vertical 

clearance of 6 feet above Mean High 

Water in the closed-to-navigation 

position. The draw operates as required 

by 33 CFR 117.147(b). Navigation on the 

waterway is commercial, search and 


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