This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

41999 

Vol. 78, No. 135 

Monday, July 15, 2013 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 120 

[Docket No.: FAA–2012–0688; Amdt. No. 

120–1] 

RIN 2120–AK01 

Combined Drug and Alcohol Testing 

Programs 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This rulemaking allows air 

carrier operators and commuter or ondemand operators that also conduct 

commercial air tour operations to 

combine the drug and alcohol testing 

required for each operation into one 

testing program. The current rule 

requires those operators to conduct 

separate testing programs for their 

commercial air tour operations. This 

results in an unnecessary duplication of 

effort. The intended effect of this 

rulemaking is to decrease operating 

costs by eliminating the requirement for 

duplicate programs while maintaining 

the level of safety intended by existing 

rules. This final rule also clarifies 

existing instructions within the rule, 

corrects a typographical error, and 

removes language describing a practice 

that has been discontinued. 

DATES: Effective September 13, 2013. 

Any currently held exemptions allowing 

part 121 or part 135 operators to 

combine their drug and alcohol testing 

programs with the testing programs for 

their commercial air tour operations 

will expire on the effective date of this 

rule. 

ADDRESSES: For information on where to 

obtain copies of rulemaking documents 

and other information related to this 

final rule, see ‘‘How To Obtain 

Additional Information’’ in the 

SUPPLEMENTARY INFORMATION section of 

this document. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions concerning this 

action, contact Rafael Ramos, Office of 

Aerospace Medicine, Drug Abatement 

Division, AAM–800, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone (202) 267–8442; facsimile 

(202) 267–5200; email: 

drugabatement@faa.gov. 

For legal questions concerning this 

action, contact Neal O’Hara, Attorney, 

Office of the Chief Counsel— 

International Law, Legislation, and 

Regulations Division, AGC–200, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–5348; email: neal.o’hara@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Authority for This Rulemaking 

The FAA’s authority to issue rules on 

aviation safety is found in Title 49 of the 

United States Code. Subtitle I, Section 

106 describes the authority of the FAA 

Administrator. Subtitle VII, Aviation 

Programs, describes in more detail the 

scope of the Agency’s authority. 

This rulemaking is promulgated 

under the authority described in 

Subtitle VII, Part A, Chapter 451, 

Section 45102—Alcohol and Controlled 

Substances Testing. Under that section, 

the FAA is charged with prescribing 

regulations for operators to establish 

and to conduct pre-employment, 

reasonable suspicion, random, and postaccident drug and alcohol testing. Parts 

of this rule, for example those sections 

dealing with contract air traffic 

controllers, were promulgated under the 

FAA’s general rulemaking authority in 

49 U.S.C. 44701(a)(5). This regulation is 

within the scope of that authority. 

I. Overview of Final Rule 

Some part 121 air carriers and part 

135 commuter and on-demand operators 

also conduct commercial air tours. Part 

121 and part 135 each contain 

requirements for drug and alcohol 

testing. Until 2007, an operator’s drug 

and alcohol testing program covered its 

commercial air tour operations. 

In 2007, the National Air Tour Safety 

Standards rule (72 FR 6884, February 

13, 2007) established a separate subpart 

in part 91 to govern commercial air tour 

operators. That rule required drug and 

alcohol testing for commercial air tour 

operations that was separate from, and 

in addition to, the testing required by 

part 121 and part 135. This final rule 

gives part 121 and part 135 operators 

with commercial air tour operations the 

option of administering one drug and 

alcohol testing program that will cover 

both operations. The intent of this 

action is to lessen the administrative 

burden on such operators. 

This rule also includes four other 

actions— 

1. It makes clear that operators 

obtaining a Letter of Authorization from 

the local Flight Standards District Office 

(FSDO) to conduct commercial air tour 

operations are considered to have 

registered their drug and alcohol testing 

program by submitting certain 

information to the FSDO. 

2. It corrects the omission of a 

reference reiterating that on-duty use of 

alcohol is grounds for permanent 

disqualification from service. That 

reference was inadvertently left out of 

the May 14, 2009, final rule titled ‘‘Drug 

and Alcohol Testing Program’’ (74 FR 

22653). 

3. It reorganizes existing rule text to 

alleviate any confusion about the 

requirement that training of supervisors, 

as well as training of employees, must 

be documented as part of each 

employer’s employee assistance 

program. 

4. It makes clear that the Agency’s 

practice of approving the employer’s 

drug and alcohol testing program has 

been discontinued. 

II. Background 

As noted above, in May 2009, the 

FAA published the Drug and Alcohol 

Testing Program rule. That rule moved 

the drug and alcohol testing regulations 

into a new part 120. 

Part 120 of Title 14 of the Code of 

Federal Regulations (CFR) requires the 

establishment of a drug and alcohol 

testing program designed to prevent 

accidents and injuries that result from 

the use of prohibited drugs and the 

misuse of alcohol. Specifically, the rule 

requires three groups of operators to 

implement a drug and alcohol testing 

program: 

• Part 119 certificate holders 

authorized to conduct part 121 

operations. 

• Part 119 certificate holders 

authorized to conduct part 135 

operations. 

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42000 Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations 

• Commercial air tour operators as 

defined in § 91.147. 

These requirements are meant to 

ensure that any person who performs 

safety-sensitive functions for these 

operators, either directly or by contract 

(including subcontractor at any tier), is 

subject to drug and alcohol testing. 

Under the current rules, operators 

who are conducting a part 121 or part 

135 operation and commercial air tour 

operations must administer separate 

drug and alcohol testing programs. 

Numerous operators have petitioned the 

FAA for an exemption from the 

requirement to maintain two separate 

drug and alcohol testing programs 

because having two programs often 

requires testing the same employees 

twice. This duplication adds 

administrative and financial burdens for 

the operator but it does not increase 

safety. 

Since 2008, the FAA has granted 

approximately 135 exemptions allowing 

operators to implement a single testing 

program. Given the large number of 

exemptions that the Agency has granted, 

and the need to renew them every two 

years, the FAA believes it is appropriate 

to simply amend the existing rule. This 

approach relieves operators from 

seeking an operator-specific exemption. 

In granting these exemptions, the FAA 

has recognized that, in most cases, the 

same employees and equipment are 

used interchangeably between the part 

121 or part 135 operation and its 

commercial air tour operation. 

Therefore, the FAA has found that when 

a part 119 certificate holder operates 

both a part 121 or a part 135 operation 

and a § 91.147 commercial air tour 

operation, combining the two testing 

programs maintains a level of safety 

equivalent to that provided by the 

current regulations. Under one testing 

program, employees are still subject to 

drug and alcohol testing in accordance 

with part 120. Any existing exemptions 

for combined testing programs held by 

part 121 or part 135 operators that also 

conduct § 91.147 operations will expire 

on the effective date of this rule. Those 

certificate holders with current 

exemptions need not take any action to 

comply with the requirements outlined 

in this rule. 

III. Discussion of Public Comments 

On July 2, 2012, the FAA published 

a Notice of Proposed Rulemaking 

(NPRM) (77 FR 39194), entitled 

‘‘Combined Drug and Alcohol Testing 

Programs.’’ The comment period for the 

NPRM closed on August 31, 2012. The 

FAA received four comments to the 

NPRM. The National Air Transportation 

Association expressed its support for 

the proposed rule, noting that the rule 

would reduce costs and ease 

administrative burdens without 

compromising safety. 

One individual suggested that 

combining the two testing programs 

should be a requirement rather than an 

option. The FAA believes that most 

operators will take advantage of the 

option to reduce the amount of work 

and cost involved in administering 

duplicate testing. Regardless of how 

many operators take advantage of this 

option, however, it would not be 

appropriate to require it. While 

combining programs may have financial 

and administrative benefits, it has no 

safety benefit. 

The Drug and Alcohol Testing 

Industry Association (DATIA) 

commented in support of this rule and 

requested that the FAA address how 

operators can make the transition from 

two programs to one and how 

Management Information System (MIS) 

information should be reported after 

combining the programs. The FAA will 

post instructional information in a 

separate document on its Drug 

Abatement Web site (http:// 

www.faa.gov/go/drugabatement) for part 

119 certificate holders operating part 

121 or part 135 operations and § 91.147 

operations to describe what must be 

done when first seeking to combine 

programs. The first step is for the part 

121 or part 135 operator to advise the 

Principal Operations Inspector (POI) 

that one program will be implemented 

for both the part 121 or part 135 

operation and the § 91.147 operation. 

The POI will annotate the § 91.147 

operator’s records (Letter of 

Authorization (LOA)) with an ‘‘A3’’ and 

the part 121 or part 135 certificate 

number to indicate that the programs 

are combined. The operator must then 

give the same notification to the FAA’s 

Drug Abatement Division. Once a single 

testing program is established, the part 

121 or part 135 operation must submit 

a single MIS report. The FAA wishes to 

emphasize that an operator currently 

holding an exemption to conduct one 

combined drug and alcohol testing 

program is not required to take any 

action to continue administering its 

combined testing program. 

Another comment was received from 

the Aircraft Owners and Pilots 

Association (AOPA) regarding the 

proposal that, under a combined testing 

program, the FAA would take 

enforcement action for noncompliance 

against the part 121 or part 135 

operation, even if the pilot whose 

testing is in question is only used for 

§ 91.147 commercial air tour operations. 

The AOPA maintains that the FAA 

should be able to discern which 

operation was responsible for the 

infraction and adjust the enforcement 

action accordingly. The FAA, however, 

assesses penalties against the employer, 

not the type of operation. Under this 

rule, once the two programs have been 

combined, they become one program. 

So, for example, when a part 121 

operator fails to give a pre-employment 

drug test to a pilot who conducts part 

121 and air tour flights, the part 121 

operator has responsibility for the error. 

Therefore, any civil penalties for 

regulatory violations are assessed at the 

part 121 or part 135 operator level. This 

is consistent with existing exemptions 

allowing part 119 certificate holders to 

combine their part 121 or part 135 

operation’s testing program with their 

§ 91.147 commercial air tour operation’s 

testing program. 

Additionally, AOPA commented that 

the proposed language for clarifying the 

consequence of on-duty alcohol use was 

still not completely clear and suggested 

alternate language. The FAA agrees with 

AOPA’s comment and has adopted its 

suggested language for § 120.221(b). 

IV. Discussion of Other Provisions in 

the Final Rule 

The NPRM proposed provisions 

identical to those codified here with the 

exception that the wording of a few 

sections have been revised to make their 

meaning clearer. The headings of 

§§ 120.117(e) and 120.225(e) have been 

changed along with the regulatory 

language to clarify that the procedure 

for registering a drug and alcohol testing 

program for a § 91.147 commercial air 

tour operator is similar to the procedure 

used to obtain a drug and alcohol testing 

program operations specification for a 

part 121 or part 135 operator. 

Specifically, the revised rule requires 

the commercial air tour operator to 

submit certain information to the local 

FSDO instead of the Drug Abatement 

Division. In addition, paragraph (f) of 

both §§ 120.117 and 120.225 have been 

changed slightly to clarify that the 

paragraphs apply to employers who are 

not certificated air carriers or 

commercial air tour operators. Also, the 

wording of § 120.221 has been revised. 

The meaning and intent of § 120.221 

have not changed from what was 

originally proposed. 

This rule amends §§ 120.117 and 

120.225 to give a part 121 or part 135 

operator the option of including its 

commercial air tour operation 

employees under § 91.147 in a 

combined drug and alcohol testing 

program. 

This rule also clarifies the 

requirement for registering a drug and 

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Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations 42001 

alcohol program for a § 91.147 

commercial air tour operator by aligning 

that requirement with the requirements 

for obtaining a drug and alcohol 

program operations specification for a 

part 121 or part 135 operator. Currently, 

§ 91.147 specifies that operators 

intending to begin commercial air tour 

operations must obtain a Letter of 

Authorization which includes an 

‘‘Antidrug and Alcohol Misuse 

Prevention Program registration.’’ The 

current §§ 120.117 and 120.225, which 

contain the drug and alcohol testing 

requirements that apply to commercial 

air tour operations, refer to a need for 

operators intending to begin commercial 

air tours to ‘‘register with the FAA.’’ 

This rule changes §§ 120.117(e) and 

120.225(e) to clarify that operators 

obtaining a Letter of Authorization from 

their local FSDO are considered to have 

registered their drug and alcohol testing 

program by submitting certain 

information to the local FSDO. In 

addition, the language of §§ 120.117(f) 

and 120.225(f) was changed slightly to 

indicate that it applies to contractors 

and repair stations, but not to 

certificated air carriers or commercial 

air tour operators. Also, the FAA has 

removed language in § 120.117(e) and (f) 

and § 120.225(e) and (f) that referred to 

submitting information to the FSDO in 

duplicate. The FAA does not need the 

information to be submitted in 

duplicate. 

Other errors in the Agency’s 2009 

Drug and Alcohol Testing Program final 

rule were also brought to the FAA’s 

attention. In § 120.221(b), references to 

§§ 120.19(c) and 120.37(c) were 

inadvertently omitted. The omitted 

references point the reader to existing 

§§ 120.19(c) and 120.37(c), which 

indicate that one occurrence of on-duty 

alcohol use carries the consequence of 

permanent disqualification from service. 

The FAA has corrected that error and 

has reorganized that paragraph for 

clarity. 

Additionally, when the FAA 

combined part 121 appendices I and J to 

form part 120, the FAA renumbered the 

requirements. This reorganization 

created some confusion in § 120.115, 

which contains the requirement that 

employers must include documentation 

of the training given to both supervisors 

and employees in their employee 

assistance programs. When moving 

these requirements from appendix I to 

the subpart in part 120, not only did the 

FAA need to assign new section 

numbers to the requirements but the 

FAA also needed to list the details of 

those requirements under separate line 

numbers. Requirements that had been 

previously stated in one paragraph were 

now broken into separate lines. For 

§ 120.115, the requirements were 

ultimately numbered in such a way that 

it appeared that employers needed only 

to retain employee training records. The 

FAA is reordering the wording to make 

it clear that supervisory training must be 

documented as well. It was never the 

FAA’s intention to change this 

requirement. 

Finally, in 2004, the FAA 

discontinued the practice of approving 

drug and alcohol testing programs. That 

language was never removed from the 

Code of Federal Regulations. This rule 

amends § 120.115 to remove ‘‘submitted 

to the FAA for approval.’’ 

V. Regulatory Notices and Analyses 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 and 

Executive Order 13563 direct that each 

Federal agency shall propose or adopt a 

regulation only upon a reasoned 

determination that the benefits of the 

intended regulation justify its costs. 

Second, the Regulatory Flexibility Act 

of 1980 (Pub. L. 96–354) requires 

agencies to analyze the economic 

impact of regulatory changes on small 

entities. Third, the Trade Agreements 

Act (Pub. L. 96–39) prohibits agencies 

from setting standards that create 

unnecessary obstacles to the foreign 

commerce of the United States. In 

developing U.S. standards, this Trade 

Act requires agencies to consider 

international standards and, where 

appropriate, that they be the basis of 

U.S. standards. Fourth, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4) requires agencies to prepare a 

written assessment of the costs, benefits, 

and other effects of proposed or final 

rules that include a Federal mandate 

likely to result in the expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more annually (adjusted 

for inflation with base year of 1995). 

This portion of the preamble 

summarizes the FAA’s analysis of the 

economic impacts of this final rule. 

Department of Transportation Order 

DOT 2100.5 prescribes policies and 

procedures for simplification, analysis, 

and review of regulations. If the 

expected cost impact is so minimal that 

a proposed or final rule does not 

warrant a full evaluation, this order 

permits that a statement to that effect 

and the basis for it be included in the 

preamble if a full regulatory evaluation 

of the cost and benefits is not prepared. 

Such a determination has been made for 

this final rule. The reasoning for this 

determination follows: 

(1) The final rule is voluntary. The 

final rule does not impose new 

regulatory requirements or additional 

costs. 

(2) The final rule is not a ‘‘significant 

regulatory action’’ as defined in section 

3(f) of Executive Order 12866; 

(3) The final rule will not have a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act; 

(4) The final rule will not have a 

significant effect on international trade; 

and 

(5) The final rule will not impose an 

unfunded mandate on State, local, or 

tribal governments, or on the private 

sector, by exceeding the monetary 

threshold identified. 

(6) No comments were received on the 

economic portions of the NPRM during 

the public comment period. 

These analyses are summarized below. 

Currently, part 121 operators or part 

135 operators who also conduct air tour 

operations must have separate drug and 

alcohol testing programs for the air tour 

operations and their other (part 121 or 

part 135) operations. The intended 

effect of this rulemaking is to decrease 

this duplicative drug and alcohol testing 

by eliminating the requirement for two 

testing programs while maintaining the 

level of safety required by the current 

drug and alcohol testing regulations. 

This may reduce operators’ costs by 

allowing them to eliminate one testing 

program and its associated costs. This 

final rule will also reduce the FAA’s 

costs by reducing the number of drug 

and alcohol testing programs that the 

FAA will have to inspect. 

In addition, this rulemaking allows 

the agency to clarify that air tour 

operators obtaining a Letter of 

Authorization from the local FSDO to 

conduct air tour operations are 

considered to have registered their drug 

and alcohol testing program by 

submitting certain information to the 

FSDO. This may reduce costs to the 

operators and the FAA by reducing the 

amount of time spent attempting to 

clarify requirements. 

Based on the above analyses, this final 

rule is considered to be a cost-relieving 

rule. For this reason, and because the 

FAA made a similar determination for 

the proposed rule and received no 

comment on this point, the FAA 

believes that the final rule will reduce 

costs with no loss of benefits. Thus this 

final rule is cost beneficial. 

Regulatory Flexibility Determination 

The Regulatory Flexibility Act of 1980 

(RFA) establishes ‘‘as a principle of 

regulatory issuance that agencies shall 

endeavor, consistent with the objective 

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42002 Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations 

of the rule and of applicable statutes, to 

fit regulatory and informational 

requirements to the scale of the 

businesses, organizations, and 

governmental jurisdictions subject to 

regulation.’’ To achieve that principle, 

the RFA requires agencies to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions. The RFA covers a wide range of 

small entities, including small 

businesses, not-for-profit organizations 

and small governmental jurisdictions. 

Agencies must perform a review to 

determine whether a proposed or final 

rule will have a significant economic 

impact on a substantial number of small 

entities. If the agency determines that it 

will, the agency must prepare a 

regulatory flexibility analysis as 

described in the Act. 

However, if an agency determines that 

a proposed or final rule is not expected 

to have a significant economic impact 

on a substantial number of small 

entities, section 605(b) of the 1980 RFA 

provides that the head of the agency 

may so certify and a regulatory 

flexibility analysis is not required. The 

certification must include a statement 

providing the factual basis for this 

determination, and the reasoning should 

be clear. 

Size Standards 

Size standards for small entities are 

published by the Small Business 

Administration (SBA) on their Web site 

at http://www.sba.gov/size. The size 

standards used herein are from ‘‘SBA 

U.S. Small Business Administration, 

Table of Small Business Size Standards, 

Matched to North American Industry 

Classification System Codes.’’ The Table 

is effective November 5, 2010, and uses 

the 2007 NAICS codes. Scheduled 

Passenger Air Transportation is listed in 

Sector 48–49–Transportation and 

Warehousing; Subsector 481–Air 

Transportation; NAICS Code 48111. 

Non-Scheduled Chartered Passenger Air 

Transportation is listed under the same 

Sector and Subsector with NAICS code 

481211. In both cases the small entity 

size standard is 1,500 employees. 

It is estimated that most of the air 

carriers involved in this type of activity 

are small entities. Therefore, the final 

rule affects a large number of small 

entities. 

However, the final rule imposes no 

costs and may result in a cost reduction 

for an entity that should choose to use 

the final rule. No comments were 

received on the Regulatory Flexibility 

Section of the NPRM. Therefore, the 

FAA Administrator certifies that this 

final rule will not have a significant 

economic impact on a substantial 

number of small part 119 certificate 

holders that conduct part 121 operations 

or part 135 operations and commercial 

air tour operations under § 91.147. 

International Trade Impact Assessment 

The Trade Agreements Act of 1979 

(Pub. L. 96–39), as amended by the 

Uruguay Round Agreements Act (Pub. 

L. 103–465), prohibits Federal agencies 

from establishing standards or engaging 

in related activities that create 

unnecessary obstacles to the foreign 

commerce of the United States. 

Pursuant to these Acts, the 

establishment of standards is not 

considered an unnecessary obstacle to 

the foreign commerce of the United 

States, so long as the standard has a 

legitimate domestic objective, such as 

the protection of safety, and does not 

operate in a manner that excludes 

imports that meet this objective. The 

statute also requires consideration of 

international standards and, where 

appropriate, that they be the basis for 

U.S. standards. No comments were 

received on this section in the NPRM 

during the public comment period. The 

FAA has assessed the potential effect of 

this final rule and has determined that 

it will have little or no effect on 

international trade. 

Unfunded Mandates Assessment 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) 

requires each Federal agency to prepare 

a written statement assessing the effects 

of any Federal mandate in a proposed or 

final agency rule that may result in an 

expenditure of $100 million or more 

(adjusted annually for inflation) in any 

one year by State, local, and tribal 

governments, in the aggregate, or by the 

private sector; such a mandate is 

deemed to be a ‘‘significant regulatory 

action.’’ The FAA currently uses an 

inflation-adjusted value of $143.1 

million in lieu of $100 million. No 

comments on this section in the NPRM 

were received during the public 

comment period. This final rule does 

not contain such a mandate; therefore, 

the requirements of Title II do not 

apply. 

Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)) requires that the 

FAA consider the impact of paperwork 

and other information collection 

burdens imposed on the public. The 

FAA has determined that there is no 

new information collection associated 

with allowing operators to combine 

drug and alcohol testing programs. 

International Compatibility and 

Cooperation 

In keeping with U.S. obligations 

under the Convention on International 

Civil Aviation, it is FAA policy to 

conform to International Civil Aviation 

Organization (ICAO) Standards and 

Recommended Practices to the 

maximum extent practicable. The FAA 

has reviewed the corresponding ICAO 

Standards and Recommended Practices 

and has identified no differences with 

these regulations. 

Executive Order 13609, Promoting 

International Regulatory Cooperation 

Executive Order 13609, Promoting 

International Regulatory Cooperation, 

(77 FR 26413, May 4, 2012) promotes 

international regulatory cooperation to 

meet shared challenges involving 

health, safety, labor, security, 

environmental, and other issues and to 

reduce, eliminate, or prevent 

unnecessary differences in regulatory 

requirements. The FAA has analyzed 

this action under the policies and 

agency responsibilities of Executive 

Order 13609, and has determined that 

this action would have no effect on 

international regulatory cooperation. 

Environmental Analysis 

FAA Order 1050.1E identifies FAA 

actions that are categorically excluded 

from preparation of an environmental 

assessment or environmental impact 

statement under the National 

Environmental Policy Act in the 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 312d and involves no 

extraordinary circumstances. 

VI. Executive Order Determinations 

A. Executive Order 13132, Federalism 

The FAA has analyzed this final rule 

under the principles and criteria of 

Executive Order 13132, Federalism. The 

agency determined that this action will 

not have a substantial direct effect on 

the States, or the relationship between 

the Federal Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, and, therefore, 

does not have Federalism implications. 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

The FAA analyzed this final rule 

under Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (May 18, 2001). The 

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Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations 42003 

agency has determined that it is not a 

‘‘significant energy action’’ under the 

executive order and it is not likely to 

have a significant adverse effect on the 

supply, distribution, or use of energy. 

VII. How To Obtain Additional 

Information 

A. Rulemaking Documents 

An electronic copy of a rulemaking 

document may be obtained by using the 

Internet— 

1. Search the Federal eRulemaking 

Portal at http://www.regulations.gov; 

2. Visit the FAA’s Regulations and 

Policies Web page at http:// 

www.faa.gov/regulations_policies/ or 

3. Access the Government Printing 

Office’s Federal Digital System Web 

page at http://www.gpo.gov/fdsys/. 

Copies may also be obtained by 

sending a request (identified by notice, 

amendment, or docket number of this 

rulemaking) to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. 

B. Comments Submitted to the Docket 

Comments received may be viewed by 

going to http://www.regulations.gov and 

following the online instructions to 

search the docket number for this 

action. Anyone is able to search the 

electronic form of all comments 

received into any of the FAA’s dockets 

by the name of the individual 

submitting the comment (or signing the 

comment, if submitted on behalf of an 

association, business, labor union, etc.). 

C. Small Business Regulatory 

Enforcement Fairness Act 

The Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996 requires FAA to comply with 

small entity requests for information or 

advice about compliance with statutes 

and regulations within its jurisdiction. 

A small entity with questions regarding 

this document may contact its local 

FAA official, or the person listed under 

the FOR FURTHER INFORMATION CONTACT

heading at the beginning of the 

preamble. To find out more about 

SBREFA on the Internet, visit http:// 

www.faa.gov/regulations_policies/ 

rulemaking/sbre_act/. 

List of Subjects in 14 CFR Part 120 

Alcoholism, Air carriers, Air traffic 

control, Airmen, Alcohol abuse, Alcohol 

testing, Aviation safety, Charter flights, 

Commercial air tour operators, Contract 

air traffic controllers, Drug abuse, Drug 

testing, Operators, Reporting and 

recordkeeping requirements, Safety, 

Safety-sensitive, Transportation. 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends chapter I of title 14, Code of 

Federal Regulations as follows: 

PART 120—DRUG AND ALCOHOL 

TESTING PROGRAM 

■ 1. The authority citation for part 120 

is revised to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40101– 

40103, 40113, 40120, 41706, 41721, 44106, 

44701, 44702, 44703, 44709, 44710, 44711, 

45101–45105, 46105, 46306. 

■ 2. Amend § 120.115 as follows: 

■ a. Redesignate paragraphs (c)(1)(iii) 

and (c)(5) as paragraphs (c)(5) and (c)(6) 

respectively. 

■ b. Revise newly redesignated 

paragraphs (c)(5) and (c)(6). 

The revisions read as follows: 

§ 120.115 Employee Assistance Program 

(EAP). 

* * * * * 

(c) * * * 

(5) Documentation of all training 

given to employees and supervisory 

personnel must be included in the 

training program. 

(6) The employer shall identify the 

employee and supervisor EAP training 

in the employer’s drug testing program. 

■ 3. Amend § 120.117 as follows: 

■ a. Revise paragraphs (a) and (b); 

■ b. Redesignate paragraph (e) as 

paragraph (f); 

■ c. Add new paragraph (e); 

■ d. Revise newly redesignated 

paragraph (f). 

The additions and revisions read as 

follows: 

§ 120.117 Implementing a drug testing 

program. 

(a) Each company must meet the 

requirements of this subpart. Use the 

following chart to determine whether 

your company must obtain an Antidrug 

and Alcohol Misuse Prevention Program 

Operations Specification, Letter of 

Authorization, or Drug and Alcohol 

Testing Program Registration from the 

FAA: 

If you are . . . You must . . . 

(1) A part 119 certificate holder with authority to operate under parts 

121 or 135.

Obtain an Antidrug and Alcohol Misuse Prevention Program Operations 

Specification by contacting your FAA Principal Operations Inspector. 

(2) An operator as defined in § 91.147 of this chapter ............................ Obtain a Letter of Authorization by contacting the Flight Standards District Office nearest to your principal place of business. 

(3) A part 119 certificate holder with authority to operate under parts 

121 or 135 and an operator as defined in § 91.147 of this chapter.

Complete the requirements in paragraphs 1 and 2 of this chart and advise the Flight Standards District Office and the Drug Abatement Division that the § 91.147 operation will be included under the part 119 

testing program. Contact the Drug Abatement Division at FAA, Office 

of Aerospace Medicine, Drug Abatement Division (AAM–800), 800 

Independence Avenue SW., Washington, DC 20591. 

(4) An air traffic control facility not operated by the FAA or by or under 

contract to the U.S. Military.

Register with the FAA, Office of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence Avenue SW., Washington, 

DC 20591. 

(5) A part 145 certificate holder who has your own drug testing program.Obtain an Antidrug and Alcohol Misuse Prevention Program Operations 

Specification by contacting your Principal Maintenance Inspector or 

register with the FAA, Office of Aerospace Medicine, Drug Abatement Division (AAM–800), 800 Independence Avenue SW., Washington, DC 20591, if you opt to conduct your own drug testing program. 

(6) A contractor who has your own drug testing program ....................... Register with the FAA, Office of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence Avenue SW., Washington, 

DC 20591, if you opt to conduct your own drug testing program. 

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42004 Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations 

(b) Use the following chart for 

implementing a drug testing program if 

you are applying for a part 119 

certificate with authority to operate 

under parts 121 or 135 of this chapter, 

if you intend to begin operations as 

defined in § 91.147 of this chapter, or if 

you intend to begin air traffic control 

operations (not operated by the FAA or 

by or under contract to the U.S. 

Military). Use it to determine whether 

you need to have an Antidrug and 

Alcohol Misuse Prevention Program 

Operations Specification, Letter of 

Authorization, or Drug and Alcohol 

Testing Program Registration from the 

FAA. Your employees who perform 

safety-sensitive functions must be tested 

in accordance with this subpart. The 

chart follows: 

If you . . . You must . . . 

(1) Apply for a part 119 certificate with authority to operate under parts 

121 or 135.

(i) Have an Antidrug and Alcohol Misuse Prevention Program Operations Specification, 

(ii) Implement an FAA drug testing program no later than the date you 

start operations, and 

(iii) Meet the requirements of this subpart. 

(2) Intend to begin operations as defined in § 91.147 of this chapter ..... (i) Have a Letter of Authorization, 

(ii) Implement an FAA drug testing program no later than the date you 

start operations, and 

(iii) Meet the requirements of this subpart. 

(3) Apply for a part 119 certificate with authority to operate under parts 

121 or 135 and intend to begin operations as defined in § 91.147 of 

this chapter.

(i) Have an Antidrug and Alcohol Misuse Prevention Program Operations Specification and a Letter of Authorization, 

(ii) Implement your combined FAA drug testing program no later than 

the date you start operations, and 

(iii) Meet the requirements of this subpart. 

(4) Intend to begin air traffic control operations (at an air traffic control 

facility not operated by the FAA or by or under contract to the U.S. 

military).

(i) Register with the FAA, Office of Aerospace Medicine, Drug Abatement Division (AAM–800), 800 Independence Avenue SW., Washington, DC 20591, prior to starting operations, 

(ii) Implement an FAA drug testing program no later than the date you 

start operations, and 

(iii) Meet the requirements of this subpart. 

* * * * * 

(e) Register your Drug and Alcohol 

Testing Program by obtaining a Letter of 

Authorization from the FAA in 

accordance with § 91.147. (1) A drug 

and alcohol testing program is 

considered registered when the 

following information is submitted to 

the Flight Standards District Office 

nearest your principal place of business: 

(i) Company name. 

(ii) Telephone number. 

(iii) Address where your drug and 

alcohol testing program records are 

kept. 

(iv) Type of safety-sensitive functions 

you or your employees perform (such as 

flight instruction duties, aircraft 

dispatcher duties, maintenance or 

preventive maintenance duties, ground 

security coordinator duties, aviation 

screening duties, air traffic control 

duties). 

(v) Whether you have 50 or more 

covered employees, or 49 or fewer 

covered employees. 

(vi) A signed statement indicating that 

your company will comply with this 

part and 49 CFR part 40. 

(2) This Letter of Authorization will 

satisfy the requirements for both your 

drug testing program under this subpart 

and your alcohol testing program under 

subpart F of this part. 

(3) Update the Letter of Authorization 

information as changes occur. Send the 

updates to the Flight Standards District 

Office nearest your principal place of 

business. 

(4) If you are a part 119 certificate 

holder with authority to operate under 

parts 121 or 135 and intend to begin 

operations as defined in § 91.147 of this 

chapter, you must also advise the 

Federal Aviation Administration, Office 

of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence 

Avenue SW., Washington, DC 20591. 

(f) Obtaining a Drug and Alcohol 

Testing Program Registration from the 

FAA. (1) Except as provided in 

paragraphs (d) and (e) of this section, to 

obtain a Drug and Alcohol Testing 

Program Registration from the FAA, you 

must submit the following information 

to the Office of Aerospace Medicine, 

Drug Abatement Division: 

(i) Company name. 

(ii) Telephone number. 

(iii) Address where your drug and 

alcohol testing program records are 

kept. 

(iv) Type of safety-sensitive functions 

you or your employees perform (such as 

flight instruction duties, aircraft 

dispatcher duties, maintenance or 

preventive maintenance duties, ground 

security coordinator duties, aviation 

screening duties, air traffic control 

duties). 

(v) Whether you have 50 or more 

covered employees, or 49 or fewer 

covered employees. 

(vi) A signed statement indicating 

that: your company will comply with 

this part and 49 CFR part 40; and you 

intend to provide safety-sensitive 

functions by contract (including 

subcontract at any tier) to a part 119 

certificate holder with authority to 

operate under part 121 or part 135 of 

this chapter, an operator as defined in 

§ 91.147 of this chapter, or an air traffic 

control facility not operated by the FAA 

or by or under contract to the U.S. 

military. 

(2) Send this information to the 

Federal Aviation Administration, Office 

of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence 

Avenue SW., Washington, DC 20591. 

(3) This Drug and Alcohol Testing 

Program Registration will satisfy the 

registration requirements for both your 

drug testing program under this subpart 

and your alcohol testing program under 

subpart F of this part. 

(4) Update the registration 

information as changes occur. Send the 

updates to the address specified in 

paragraph (f)(2) of this section. 

■ 4. Amend § 120.221 by revising 

paragraph (b) to read as follows: 

§ 120.221 Consequences for employees 

engaging in alcohol-related conduct. 

* * * * * 

(b) Permanent disqualification from 

service. (1) An employee who violates 

§§ 120.19(c) or 120.37(c) is permanently 

precluded from performing for an 

employer the safety-sensitive duties the 

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Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations 42005 

employee performed before such 

violation. 

(2) An employee who engages in 

alcohol use that violates another alcohol 

misuse provision of §§ 120.19 or 120.37, 

and who had previously engaged in 

alcohol use that violated the provisions 

of §§ 120.19 or 120.37 after becoming 

subject to such prohibitions, is 

permanently precluded from performing 

for an employer the safety-sensitive 

duties the employee performed before 

such violation. 

* * * * * 

■ 5. Amend § 120.225 as follows: 

■ a. Revise paragraphs (a) and (b); 

■ b. Redesignate paragraph (e) as 

paragraph (f); 

■ c. Add new paragraph (e); 

■ d. Revise newly redesignated 

paragraph (f). 

The additions and revisions read as 

follows: 

§ 120.225 Implementing an alcohol testing 

program. 

(a) Each company must meet the 

requirements of this subpart. Use the 

following chart to determine whether 

your company must obtain an Antidrug 

and Alcohol Misuse Prevention Program 

Operations Specification, Letter of 

Authorization, or Drug and Alcohol 

Testing Program Registration from the 

FAA: 

If you are . . . You must . . . 

(1) A part 119 certificate holder with authority to operate under part 121 

or 135.

Obtain an Antidrug and Alcohol Misuse Prevention Program Operations 

Specification by contacting your FAA Principal Operations Inspector. 

(2) An operator as defined in § 91.147 of this chapter ............................ Obtain a Letter of Authorization by contacting the Flight Standards District Office nearest to your principal place of business. 

(3) A part 119 certificate holder with authority to operate under part 121 

or part 135 and an operator as defined in § 91.147 of this chapter.

Complete the requirements in paragraphs 1 and 2 of this chart and advise the Flight Standards District Office and Drug Abatement Division 

that the § 91.147 operation will be included under the part 119 testing program. Contact Drug Abatement Division at FAA, Office of 

Aerospace Medicine, Drug Abatement Division (AAM–800), 800 

Independence Avenue SW., Washington, DC 20591. 

(4) An air traffic control facility not operated by the FAA or by or under 

contract to the U.S. Military.

Register with the FAA, Office of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence Avenue SW., Washington, 

DC 20591. 

(5) A part 145 certificate holder who has your own alcohol testing program.Obtain an Antidrug and Alcohol Misuse Prevention Program Operations 

Specification by contacting your Principal Maintenance Inspector or 

register with the FAA Office of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence Avenue SW., Washington, 

DC 20591, if you opt to conduct your own alcohol testing program. 

(6) A contractor who has your own alcohol testing program ................... Register with the FAA, Office of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence Avenue SW., Washington, 

DC 20591, if you opt to conduct your own alcohol testing program. 

(b) Use the following chart for 

implementing an alcohol testing 

program if you are applying for a part 

119 certificate with authority to operate 

under part 121 or part 135 of this 

chapter, if you intend to begin 

operations as defined in § 91.147 of this 

chapter, or if you intend to begin air 

traffic control operations (not operated 

by the FAA or by or under contract to 

the U.S. Military). Use it to determine 

whether you need to have an Antidrug 

and Alcohol Misuse Prevention Program 

Operations Specification, Letter of 

Authorization, or Drug and Alcohol 

Testing Program Registration from the 

FAA. Your employees who perform 

safety-sensitive duties must be tested in 

accordance with this subpart. The chart 

follows: 

If you . . . You must . . . 

(1) Apply for a part 119 certificate with authority to operate under parts 

121 or 135.

(i) Have an Antidrug and Alcohol Misuse Prevention Program Operations Specification, 

(ii) Implement an FAA alcohol testing program no later than the date 

you start operations, and 

(iii) Meet the requirements of this subpart. 

(2) Intend to begin operations as defined in § 91.147 of this chapter ..... (i) Have a Letter of Authorization, 

(ii) Implement an FAA alcohol testing program no later than the date 

you start operations, and 

(iii) Meet the requirements of this subpart. 

(3) Apply for a part 119 certificate with authority to operate under parts 

121 or 135 and intend to begin operations as defined in § 91.147 of 

this chapter.

(i) Have an Antidrug and Alcohol Misuse Prevention Program Operations Specification and a Letter of Authorization, 

(ii) Implement your combined FAA alcohol testing program no later 

than the date you start operations, and 

(iii) Meet the requirements of this subpart. 

(4) Intend to begin air traffic control operations (at an air traffic control 

facility not operated by the FAA or by or under contract to the U.S. 

military).

(i) Register with the FAA, Office of Aerospace Medicine, Drug Abatement Division (AAM–800), 800 Independence Avenue SW., Washington, DC 20591, prior to starting operations, 

(ii) Implement an FAA alcohol testing program no later than the date 

you start operations, and 

(iii) Meet the requirements of this subpart. 

* * * * * (e) Register your Drug and Alcohol 

Testing Program by obtaining a Letter of 

Authorization from the FAA in 

accordance with § 91.147. (1) A drug 

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42006 Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Rules and Regulations 

and alcohol testing program is 

considered registered when the 

following information is submitted to 

the Flight Standards District Office 

nearest your principal place of business: 

(i) Company name. 

(ii) Telephone number. 

(iii) Address where your drug and 

alcohol testing program records are 

kept. 

(iv) Type of safety-sensitive functions 

you or your employees perform (such as 

flight instruction duties, aircraft 

dispatcher duties, maintenance or 

preventive maintenance duties, ground 

security coordinator duties, aviation 

screening duties, air traffic control 

duties). 

(v) Whether you have 50 or more 

covered employees, or 49 or fewer 

covered employees. 

(vi) A signed statement indicating that 

your company will comply with this 

part and 49 CFR part 40. 

(2) This Letter of Authorization will 

satisfy the requirements for both your 

drug testing program under subpart E of 

this part and your alcohol testing 

program under this subpart. 

(3) Update the Letter of Authorization 

information as changes occur. Send the 

updates to the Flight Standards District 

Office nearest your principal place of 

business. 

(4) If you are a part 119 certificate 

holder with authority to operate under 

part 121 or part 135 and intend to begin 

operations as defined in § 91.147 of this 

chapter, you must also advise the 

Federal Aviation Administration, Office 

of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence 

Avenue SW., Washington, DC 20591. 

(f) Obtaining a Drug and Alcohol 

Testing Program Registration from the 

FAA. (1) Except as provided in 

paragraphs (d) and (e) of this section, to 

obtain a Drug and Alcohol Testing 

Program Registration from the FAA you 

must submit the following information 

to the Office of Aerospace Medicine, 

Drug Abatement Division: 

(i) Company name. 

(ii) Telephone number. 

(iii) Address where your drug and 

alcohol testing program records are 

kept. 

(iv) Type of safety-sensitive functions 

you or your employees perform (such as 

flight instruction duties, aircraft 

dispatcher duties, maintenance or 

preventive maintenance duties, ground 

security coordinator duties, aviation 

screening duties, air traffic control 

duties). 

(v) Whether you have 50 or more 

covered employees, or 49 or fewer 

covered employees. 

(vi) A signed statement indicating 

that: your company will comply with 

this part and 49 CFR part 40; and you 

intend to provide safety-sensitive 

functions by contract (including 

subcontract at any tier) to a part 119 

certificate holder with authority to 

operate under part 121 or part 135 of 

this chapter, an operator as defined in 

§ 91.147 of this chapter, or an air traffic 

control facility not operated by the FAA 

or by or under contract to the U.S. 

military. 

(2) Send this information to the 

Federal Aviation Administration, Office 

of Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence 

Avenue SW., Washington, DC 20591. 

(3) This Drug and Alcohol Testing 

Program Registration will satisfy the 

registration requirements for both your 

drug testing program under subpart E of 

this part and your alcohol testing 

program under this subpart. 

(4) Update the registration 

information as changes occur. Send the 

updates to the address specified in 

paragraph (f)(2) of this section. 

Issued under authority provided by 49 

U.S.C. 106(f) and 45102 in Washington, DC, 

on July 1, 2013. 

Michael P. Huerta, 

Administrator. 

[FR Doc. 2013–16852 Filed 7–12–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520 and 558 

[Docket No. FDA–2013–N–0002] 

Oral Dosage Form New Animal Drugs; 

Nicarbazin; Oclacitinib; Zilpaterol 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval actions for new animal drug 

applications (NADAs) and abbreviated 

new animal drug applications 

(ANADAs) during May 2013. FDA is 

also informing the public of the 

availability of summaries the basis of 

approval and of environmental review 

documents, where applicable. 

DATES: This rule is effective July 15, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9019, 

ghaibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

amending the animal drug regulations to 

reflect approval actions for NADAs and 

ANADAs during May 2013, as listed in 

table 1. In addition, FDA is informing 

the public of the availability, where 

applicable, of documentation of 

environmental review required under 

the National Environmental Policy Act 

(NEPA) and, for actions requiring 

review of safety or effectiveness data, 

summaries of the basis of approval (FOI 

Summaries) under the Freedom of 

Information Act (FOIA). These public 

documents may be seen in the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, between 9 a.m. and 4 p.m., 

Monday through Friday. Persons with 

access to the Internet may obtain these 

documents at the CVM FOIA Electronic 

Reading Room: http://www.fda.gov/ 

AboutFDA/CentersOffices/ 

OfficeofFoods/CVM/ 

CVMFOIAElectronicReadingRoom/ 

default.htm. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY 2013 

NADA/ 

ANADA Sponsor New animal drug product name Action 21 CFR section 

FOIA 

summary 

NEPA 

review 

141–279 .... Zoetis Inc., 333 Portage St., 

Kalamazoo, MI 49007.

NICARB 25% (nicarbazin) 

and BMD (bacitracin methylene disalicylate) Type A 

medicated articles.

Supplement revising 

nicarbazin dosage to a 

range consistent with dosage approved for use in 

combination feeds.

558.366 No .......... CE1

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