Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Rules and Regulations 6453 

1Levmetamfetamine is controlled in schedule II 

of the CSA because it is an isomer of 

methamphetamine. 

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 United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

Accordingly, for the reasons stated 

above, the interim final rule that was 

published in the Federal Register on 

October 27, 2015 (80 FR 65635), is 

adopted as final with the following 

change: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

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

unless otherwise noted. 

■ 2. Amend § 1308.22, in the table, by 

removing the company name, ‘‘Proctor 

& Gamble Co., The’’ and adding in its 

place ‘‘Procter & Gamble Co., The’’. 

Dated: February 2, 2016. 

Louis J. Milione, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. 2016–02403 Filed 2–5–16; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–409] 

RIN 1117–ZA30 

Schedules of Controlled Substances: 

Table of Excluded Nonnarcotic 

Products: Nasal Decongestant Inhaler/ 

Vapor Inhaler 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: This final rule adopts, 

without change, the interim final rule 

that was published in the Federal 

Register on October 27, 2015. The Drug 

Enforcement Administration is 

amending the table of Excluded 

Nonnarcotic Products to update the 

company name for the drug product 

Nasal Decongestant Inhaler/Vapor 

Inhaler (containing 50 milligrams 

levmetamfetamine) to Aphena Pharma 

Solutions—New York, LLC. This overthe-counter, nonnarcotic drug product is 

excluded from the provisions of the 

Controlled Substances Act. 

DATES: This final rule is effective on 

February 8, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Barbara J. Boockholdt, Office of 

Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The Drug Enforcement 

Administration (DEA) implements and 

enforces titles II and III of the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970, as amended. 21 

U.S.C. 801–971. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 

Substances Import and Export Act,’’ 

respectively, and they are collectively 

referred to as the ‘‘Controlled 

Substances Act’’ or the ‘‘CSA’’ for the 

purpose of this action. The DEA 

publishes the implementing regulations 

for these statutes in title 21 of the Code 

of Federal Regulations (CFR), chapter II. 

The CSA and its implementing 

regulations are designed to prevent, 

detect, and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

ensuring an adequate supply is available 

for the legitimate medical, scientific, 

research, and industrial needs of the 

United States. Controlled substances 

have the potential for abuse and 

dependence and are controlled to 

protect the public health and safety. 

Under the CSA, each controlled 

substance is classified into one of five 

schedules based upon its potential for 

abuse, its currently accepted medical 

use in treatment in the United States, 

and the degree of dependence the drug 

or other substance may cause. 21 U.S.C. 

812. The initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c) and the 

current list of all scheduled substances 

is published at 21 CFR part 1308. 

The CSA states that the Attorney 

General shall by regulation exclude any 

nonnarcotic drug which contains a 

controlled substance from the 

application of the CSA, if such drug 

may, under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), 21 U.S.C. 301 

et seq., be lawfully sold over-thecounter without a prescription. 21 

U.S.C. 811(g)(1). Such exclusions apply 

only to specific nonnarcotic drugs 

following suitable application to the 

DEA in accordance with 21 CFR 

1308.21. The current table of Excluded 

Nonnarcotic Products is found in 21 

CFR 1308.22. The authority to exclude 

such substances has been delegated to 

the Administrator of the DEA, 28 CFR 

0.100, and redelegated to the Deputy 

Assistant Administrator of the Office of 

Diversion Control, section 7 of 28 CFR 

part 0, appendix to subpart R. 

Background 

This final rule adopts, without 

change, the interim final rule, 

‘‘Schedules of Controlled Substances: 

Table of Excluded Nonnarcotic 

Products: Nasal Decongestant Inhaler/

Vapor Inhaler’’ that was published in 

the Federal Register on October 27, 

2015. 80 FR 65632. 

On December 10, 2013, pursuant to 

the application process of § 1308.21, the 

DEA received correspondence from 

Aphena Pharma Solutions—New York, 

LLC (Aphena Pharma) stating that it had 

acquired Classic Pharmaceuticals LLC 

and requesting that the current 

exclusion for the drug product Nasal 

Decongestant Inhaler/Vapor Inhaler be 

transferred to Aphena Pharma. Aphena 

Pharma also stated that the 

manufacturing process (i.e., facility) and 

the formulation for the drug product 

Nasal Decongestant Inhaler/Vapor 

Inhaler had not changed. 

Based on the application and other 

information received, the DEA 

determined that this product may, 

under the FD&C Act, be lawfully sold 

over-the-counter without a prescription. 

21 U.S.C. 811(g)(1). In addition, the 

Deputy Assistant Administrator of the 

Office of Diversion Control found that 

the active ingredient in this drug 

product (levmetamfetamine) is a 

schedule II controlled substance 1 and is 

not a narcotic drug as defined by 21 

U.S.C. 802(17). The Deputy Assistant 

Administrator of the Office of Diversion 

Control therefore found and concluded 

that this drug product continues to meet 

the criteria for exclusion from the CSA 

pursuant to 21 U.S.C. 811(g)(1). 

The interim final rule provided an 

opportunity for interested persons to 


asabaliauskas on DSK5VPTVN1PROD with RULES
6454 Federal Register / Vol. 81, No. 25 / Monday, February 8, 2016 / Rules and Regulations 

submit written comments on the rule on 

or before December 28, 2015. The DEA 

received one comment in response to 

the publication of the interim final rule 

voicing support for the action. The DEA 

appreciates the support for the rule. 

This exclusion only applies to the 

finished drug product in the form of an 

inhaler (in the exact formulation 

detailed in the application for 

exclusion), which is lawfully sold under 

the FD&C Act over-the-counter without 

a prescription. The extraction or 

removal of the active ingredient 

(levmetamfetamine) from the inhaler 

shall negate this exclusion and result in 

the possession of a schedule II 

controlled substance. 

Regulatory Analyses 

Executive Orders 12866 and 13563 

This regulation has been developed in 

accordance with the Executive Orders 

12866, ‘‘Regulatory Planning and 

Review,’’ section 1(b) and Executive 

Order 13563, ‘‘Improving Regulation 

and Regulatory Review.’’ The DEA has 

determined that this rule is not a 

significant regulatory action, and 

accordingly this rule has not been 

reviewed by the Office of Management 

and Budget. As discussed above, this 

product was previously exempted under 

a different company name. As discussed 

in the interim final rule, this action will 

not have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local or tribal governments or 

communities; create a serious 

inconsistency or otherwise interfere 

with an action taken or planned by 

another agency; materially alter the 

budgetary impact of entitlements, 

grants, user fees, or loan programs or the 

rights and obligations of recipients 

thereof; or raise novel legal or policy 

issues arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in Executive Order 12866. 

Regulatory Flexibility Analysis 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) applies to rules that 

are subject to notice and comment. The 

DEA determined, as explained in the 

interim final rule, that public notice and 

comment were impracticable and 

contrary to the public interest. 

Consequently, the RFA does not apply. 

Although the RFA does not apply to this 

rulemaking, the DEA has reviewed the 

potential impacts of this final rule and 

determined that it will not have a 

significant economic impact on a 

substantial number of small entities. As 

discussed above and in the interim final 

rule, this product was previously 

exempted under a different company 

name. The Deputy Assistant 

Administrator, in accordance with the 

RFA, has reviewed this regulation and 

by approving it certifies that this 

regulation will not have a significant 

economic impact on a substantial 

number of small entities. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988, ‘‘Civil 

Justice Reform,’’ 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 Federal 

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. This rule 

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. 

Unfunded Mandates Reform Act of 1995 

The DEA has determined and certifies 

pursuant to the Unfunded Mandates 

Reform Act of 1995 (UMRA), 2 U.S.C. 

1501 et seq., 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 provisions of the UMRA. 

Paperwork Reduction Act 

This rule does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act, 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 United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

Accordingly, for the reasons stated 

above, the interim final rule that was 

published in the Federal Register on 

October 27, 2015 (80 FR 65632), is 

adopted as a final rule without change. 

Dated: February 2, 2016. 

Louis J. Milione, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. 2016–02404 Filed 2–5–16; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

[Docket No. NHTSA–2014–0073] 

RIN 2127–AL27 

Federal Motor Vehicle Safety 

Standards; Lamps, Reflective Devices, 

and Associated Equipment 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: NHTSA is amending the side 

marker requirements contained in the 


asabaliauskas on DSK5VPTVN1PROD with RULES