Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules 14621 

1Except when quoting the text of section 308 of 

the Act, the FAA uses the term ‘‘drug’’ rather than 

‘‘controlled substance’’ in this ANPRM, because an 

illegal substance in the United States may be legal 

to use in the country in which a covered 

maintenance provider is located. 

Dated: March 6, 2014. 

Marianne O. Markowitz, 

Acting Administrator. 

[FR Doc. 2014–05549 Filed 3–14–14; 8:45 am] 

BILLING CODE 8025–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 120 

[Docket No.: FAA–2012–1058; Notice No. 

14–02] 

RIN 2120–AK09 

Drug and Alcohol Testing of Certain 

Maintenance Provider Employees 

Located Outside of the United States 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Advance notice of proposed 

rulemaking (ANPRM). 

SUMMARY: The FAA is considering 

amending its drug and alcohol testing 

regulations to require drug and alcohol 

testing of certain maintenance personnel 

outside the United States. Specifically, 

the FAA is considering requiring certain 

air carriers to ensure that all employees 

of certificated repair stations, and 

certain other maintenance organizations 

that are located outside the United 

States, who perform safety-sensitive 

maintenance functions on aircraft 

operated by that air carrier are subject 

to a drug and alcohol testing program 

that has been determined acceptable by 

the FAA Administrator and is consistent 

with the applicable laws of the country 

in which the repair station is located. 

Safety-sensitive maintenance functions 

include aircraft maintenance and 

preventive maintenance duties. This 

action is necessary to address a statutory 

mandate. The FAA has determined that 

it needs additional information to 

develop a proposed rule and assess its 

likely economic impact. This notice 

invites comments on a variety of issues 

related to proposing drug and alcohol 

testing requirements for the relevant 

employees of covered maintenance 

providers. 

DATES: Send comments on or before 

May 16, 2014. 

ADDRESSES: Send comments identified 

by docket number FAA–2012–1058 

using any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for sending your 

comments electronically. 

• Mail: Send comments to Docket 

Operations, M–30; U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

• Hand Delivery or Courier: Take 

comments to Docket Operations in 

Room W12–140 of the West Building 

Ground Floor at 1200 New Jersey 

Avenue SE., Washington, DC, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

• Fax: Fax comments to Docket 

Operations at (202) 493–2251. 

Privacy: In accordance with 5 USC 

553(c), DOT solicits comments from the 

public to better inform its rulemaking 

process. DOT posts these comments, 

without edit, including any personal 

information the commenter provides, to 

www.regulations.gov, as described in 

the system of records notice (DOT/ALL– 

14 FDMS), which can be reviewed at 

www.dot.gov/privacy. http://

DocketsInfo.dot.gov. 

Docket: Background documents or 

comments received may be read at 

http://www.regulations.gov at any time. 

Follow the online instructions for 

accessing the docket or go to the Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

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, 

Regulations Division, AGC–240, Federal 

Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267–5348. 

For cost and benefit questions 

concerning this action, contact Nicole 

Nance, Office of Aviation Policy and 

Plans, APO–300, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone (202) 267–3311. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

See the ‘‘Additional Information’’ 

section for information on how to 

comment on this ANPRM and how the 

FAA will handle comments received. 

The ‘‘Additional Information’’ section 

also contains related information about 

the docket, privacy, and the handling of 

proprietary or confidential business 

information. In addition, there is 

information on obtaining copies of 

related rulemaking documents. 

Authority for This Rulemaking 

The FAA’s authority to issue rules on 

aviation safety is found in title 49 of the 

United States Code (U.S.C.). 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. In carrying out part A (Air 

Commerce and Safety) of subtitle VII, 

the Administrator is directed to act 

consistently with obligations of the 

United States Government under an 

international agreement and to consider 

applicable laws and requirements of a 

foreign country. See 49 U.S.C. 

40105(b)(1)-(2). Additionally, section 

308(d)(2) of the FAA Modernization and 

Reform Act of 2012 (the Act), 49 U.S.C. 

44733 requires that: 

Not later than 1 year after the date of 

enactment of this section, the [FAA] 

Administrator shall promulgate a proposed 

rule requiring that all part 145 repair station 

employees responsible for safety-sensitive 

maintenance functions on part 121 air carrier 

aircraft are subject to an alcohol and 

controlled substances testing program 

determined acceptable by the Administrator 

and consistent with the applicable laws of 

the country in which the repair station is 

located.1

In 49 U.S.C. 44733(d)(2) Congress did 

not address employees of maintenance 

providers located outside the United 

States that are not certificated by the 

FAA. However, authorized persons 

performing safety-sensitive maintenance 

functions on aircraft operated by part 

121 air carriers in accordance with 14 

CFR 43.17 are substantially similar to 

those employees of part 145 repair 

stations located outside the United 

States for whom the FAA has been 

directed to propose drug and alcohol 

testing. Because of their substantial 

similarity, under the authority of 49 

U.S.C. 44701(a)(5), which requires the 

Administrator to promote the safe flight 

of civil aircraft in air commerce by 

prescribing regulations and minimum 

standards for practices, methods, and 

procedures that the Administrator finds 

necessary for safety in air commerce and 

national security, we request comment 

on the application of these requirements 

to this group/category of authorized 

persons. 


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14622 Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules 

2Alcohol and drug testing of employees of part 

145 repair stations located in the United States who 

perform safety-sensitive maintenance functions on 

aircraft operated by part 121 air carriers is already 

required under 14 CFR part 120. The FAA does not 

anticipate making any changes as part of this 

rulemaking to its drug and alcohol testing 

requirements that apply to safety-sensitive 

personnel within the United States. 

I. Overview of Advance Notice of 

Proposed Rulemaking (ANPRM) 

The Act requires the FAA to propose 

alcohol and drug testing requirements 

for employees of part 145 repair stations 

located outside the United States who 

perform safety-sensitive maintenance 

functions on aircraft operated by part 

121 air carriers, as the FAA currently 

does not require drug or alcohol testing 

for such personnel. Currently, as 

required under 14 CFR part 120, 

employees performing aircraft 

maintenance and preventive 

maintenance duties on part 121, 135 or 

91.147 certificated air craft within the 

U.S. are required to be subject to drug 

and alcohol testing. The FAA believes 

Congress intended that preventive 

maintenance is a safety-sensitive 

maintenance function as currently 

described under 14 CFR part 120, 

therefore safety-sensitive maintenance 

functions include both aircraft 

maintenance and preventive 

maintenance duties.2

While Congress did not address 

maintenance providers that are not 

certificated by the FAA in 49 U.S.C. 

44733(d)(2), authorized persons 

performing safety-sensitive maintenance 

functions on aircraft operated by part 

121 air carriers in accordance with 14 

CFR 43.17, are substantially similar to 

the employees of part 145 repair stations 

in other countries for whom the FAA 

must propose drug and alcohol testing. 

Therefore, the FAA is also considering 

whether to require each part 121 air 

carrier to ensure that authorized persons 

performing safety-sensitive maintenance 

functions on aircraft operated by that 

part 121 air carrier in accordance with 

14 CFR 43.17, and is not also a 

certificated part 145 repair station, are 

subject to drug and alcohol testing 

programs that meet the same or similar 

requirements as programs for their 

counterparts at part 145 repair stations 

located outside the United States. 

Currently, there are approximately 

120 part 145 repair stations located 

outside the United States whose 

employees perform safety-sensitive 

maintenance functions on aircraft 

operated by part 121 air carriers. There 

are also organizations in one other 

country outside the United States that 

are not part 145 repair stations, but 

whose employees perform safetysensitive maintenance functions on 

aircraft operated by part 121 air carriers 

in accordance with 14 CFR 43.17. 

II. Background 

A. Statement of the Issue 

The FAA’s drug and alcohol testing 

regulations, contained in 14 CFR part 

120, do not extend to companies or 

individuals who perform safetysensitive functions, including, but not 

limited to, aircraft maintenance and 

preventive maintenance, outside of the 

United States. They currently apply to 

all air carriers and operators authorized 

to conduct operations under part 121 or 

part 135; all air traffic control facilities 

not operated by the FAA or by or under 

contract to the U.S. military; all air tour 

operators as defined in 14 CFR 91.147; 

and all part 145 certificate holders and 

contractors who employ individuals 

who perform, either directly or by 

contract, including subcontract at any 

tier, any of the following safety-sensitive 

functions: Flight crewmember duties, 

flight attendant duties, flight instruction 

duties, aircraft dispatcher duties, 

aircraft maintenance and preventive 

maintenance duties, ground security 

coordinator duties, aviation screening 

duties, air traffic control duties. 

Additionally, the regulations do not 

permit any part of the testing process, 

including specimen collection, to be 

conducted outside the United States. As 

described above, the Act requires that 

the FAA propose extending drug and 

alcohol testing to employees of part 145 

repair stations located outside the 

United States who perform safetysensitive maintenance functions on part 

121 air carrier aircraft in a manner 

consistent with local laws. 

B. International Civil Aviation 

Organization (ICAO) Standards and 

Recommended Practices 

International Civil Aviation 

Organization (ICAO) standards do not 

presently require ICAO Member States 

to establish (or direct industry to 

establish) testing programs to deter or 

detect inappropriate drug and alcohol 

use by aviation personnel with safetysensitive responsibilities. However, a 

number of ICAO standards and 

recommended practices address misuse 

of drugs and alcohol by aviation 

personnel and recognize the potential 

hazard that such misuse may pose to 

aviation safety. For example, the 

recommended practice in paragraph 

1.2.7.3 of Annex 1 (Personnel Licensing) 

to the Convention on International Civil 

Aviation (the ‘‘Chicago Convention’’), 

states that ICAO Member States ‘‘. . . 

should ensure, as far as practicable, that 

all licen[s]e holders who engage in any 

kind of problematic use of substances 

are identified and removed from their 

safety-critical functions.’’ ICAO further 

recommends that ‘‘[r]eturn to the safetycritical functions may be considered 

after successful treatment or, in cases 

where no treatment is necessary, after 

cessation of the problematic use of 

substances and upon determination that 

the person’s continued performance of 

the function is unlikely to jeopardize 

safety.’’ In addition, the standard in 

paragraph 2.5 of Annex 2 (Rules of the 

Air) to the Chicago Convention states 

that ‘‘[n]o person whose function is 

critical to the safety of aviation (safetysensitive personnel) shall undertake that 

function while under the influence of 

any psychoactive substance, by reason 

of which human performance is 

impaired. No such person shall engage 

in any kind of problematic use of 

substances.’’ See also paragraphs 1.2.6, 

1.2.7, 6.3.2.2, 6.4.2.2, and 6.5.2.2 of 

Annex 1 to the Chicago Convention. 

C. History 

The FAA’s original drug testing rule, 

published in 1988 (53 FR 47024), 

required drug testing of certain aviation 

personnel, including some that 

performed safety-sensitive functions 

outside the United States. However, the 

effective date of the rule with respect to 

testing outside the territory of the 

United States was deferred on a number 

of occasions to permit related 

negotiations with governments and 

international organizations to continue 

in an orderly and effective fashion. In 

1994, the FAA published two final rules 

related to drug and alcohol testing. 

Alcohol Misuse Prevention Program for 

Personnel Engaged in Specified 

Aviation Activities (59 FR 7380) 

established the FAA’s alcohol testing 

requirements. The alcohol testing rule 

was not extended to employees located 

outside the territory of the United States 

due to significant logistical issues and 

possible conflicts with local laws. AntiDrug Program for Personnel Engaged in 

Specified Aviation Activities (59 FR 

42922) amended certain provisions of 

the existing FAA drug testing rules to 

comply with the requirements of the 

Omnibus Transportation Employee 

Testing Act of 1991. The drug testing 

requirements were not extended to 

employees located outside of United 

States territory due to significant 

practical and legal concerns. Rather, the 

rule specifically stated that no employee 

located outside of the United States 

would be tested for drugs. Additionally, 

in 1994, the FAA published a Notice of 

Proposed Rulemaking (NPRM), 

Antidrug Program and Alcohol Misuse 


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3For example, suitable laboratory facilities for 

analyzing specimens would need to be available. 

4Based on the waiver provision in the Office of 

the Secretary of Transportation’s nondiscrimination on the basis of disability in air travel 

regulations described in 14 CFR § 382.9. 

Prevention Program for Employees of 

Foreign Air Carriers Engaged in 

Specified Aviation Activities, to address 

requirements in the Omnibus 

Transportation Employee Testing Act of 

1991. This NPRM required foreign air 

carriers operating into the U.S. to 

implement testing programs like those 

required of U.S. air carriers unless 

‘‘multilateral action was taken to 

support an international aviation 

environment free of substance abuse’’. 

However, in 2000, the FAA withdrew 

the NPRM stating, ‘‘For the foregoing 

reasons, the FAA is withdrawing the 

rulemaking proposed on February 15, 

1994, and is leaving within the purview 

of each government the method chosen 

to respond to the ICAO initiatives. We 

will continue to view a multilateral 

response as the best approach to 

evolving issues in the substance abuse 

arena. Should the FAA subsequently 

determine, however, that the scope of 

the threat of substance abuse is not 

being adequately addressed by the 

international community, the FAA will 

take appropriate action, including the 

possible re-initiation of this 

rulemaking.’’ 

D. Related Actions 

Under 49 U.S.C. 44733(d)(1), Congress 

mandated that the Secretary of State and 

the Secretary of Transportation, acting 

jointly, request the governments of 

countries that are members of ICAO to 

establish international standards for 

alcohol and drug testing of persons that 

perform safety-sensitive maintenance 

functions on commercial air carrier 

aircraft. The FAA strongly supports the 

development of such international 

standards and believes that they would 

help deter and detect drug and alcohol 

use that could compromise aviation 

safety. 

III. Discussion of Proposals Under 

Consideration 

Although ICAO standards and many 

countries’ aviation regulations prohibit 

the use of drugs and alcohol by certain 

aviation personnel in circumstances in 

which such use may threaten aviation 

safety, many countries either do not 

require testing of such personnel to 

verify compliance or do not extend such 

testing to maintenance personnel. 

Congress, however, has now enacted 

legislation that requires the FAA to 

propose a rule requiring that all Part 145 

repair station employees responsible for 

safety-sensitive maintenance functions 

on part 121 air carrier aircraft, not just 

those in the United States, be subject to 

a drug and alcohol testing program that 

is acceptable to the Administrator and 

consistent with the applicable laws of 

the country in which the repair station 

is located. 

The FAA is aware, however, that 

establishing drug and alcohol testing 

requirements for such personnel 

presents complex practical and legal 

issues and could impose potentially 

significant costs on industry. Therefore, 

the FAA is issuing this ANPRM, rather 

than an NPRM, to seek comments from 

the public, as well as interested 

governments, to help inform the 

development of a proposed rule and the 

analysis of its economic impact. 

The FAA expects to propose to allow 

the testing process to take place outside 

the United States.3 Any part of the 

testing process conducted outside the 

United States would need to be both 

acceptable to the Administrator and 

permitted under the applicable laws and 

regulations of the relevant foreign 

country or countries. The FAA believes 

that it would be less expensive and 

logistically simpler to conduct testing 

for the relevant employees of covered 

maintenance providers in the country 

where the covered maintenance 

provider is located or possibly in a 

nearby country. 

The FAA understands that other 

countries may have a wide variety of 

laws and regulations concerning the use 

of and testing for alcohol and drugs. The 

FAA further understands that other 

countries’ laws and regulations 

concerning other matters, such as 

personal privacy and employment, may 

affect whether and under what 

circumstances drug and alcohol testing 

may be conducted in those countries. 

Some countries might need to pass 

authorizing legislation before they could 

permit testing within their borders. The 

FAA also recognizes the diversity of 

policy, moral, and religious views that 

exist internationally regarding drug and 

alcohol use and testing. 

The FAA seeks input from the public 

and interested governments to help 

inform the development of a proposed 

rule and the analysis of its economic 

impact. In responding to the requests for 

comment below, the FAA asks that 

commenters distinguish between 

responses relating to alcohol testing and 

those relating to drug testing, if the same 

comment does not apply to both. 

A. Foreign Countries Laws and 

Regulations 

To help the FAA expand its 

understanding of the laws and 

regulations of other countries that bear 

on drug and alcohol testing, the FAA 

requests the information described 

below regarding countries in which 

covered maintenance providers are 

located. It would be particularly helpful 

to receive the requested information 

regarding the countries’ laws and 

regulations from the responsible 

government authorities of the relevant 

country, although private parties are 

also encouraged to provide information. 

A 1. Is drug and alcohol testing of any 

aviation personnel required in that 

country, and, if so, for what categories 

of aviation personnel (e.g., pilots, flight 

attendants, maintenance personnel, 

flight dispatchers, others (please 

specify))? 

A 2. Please provide an explanation of 

laws and regulations on other subjects, 

such as personal privacy or 

employment, which may affect the 

permissibility of drug and alcohol 

testing in the country, the circumstances 

under which such testing may be 

conducted, or the manner in which it 

may be conducted. Please include 

information on which categories of 

aviation personnel are subject to these 

requirements (e.g., pilots, flight 

attendants, maintenance personnel, 

flight dispatchers, others (please 

specify)). English language copies of the 

applicable laws and regulations would 

be greatly appreciated. 

A 3. What types of testing are (a) 

permitted and (b) required under the 

laws and regulations of the country? 

Please address the following testing by 

type: 

a. Pre-employment testing; 

b. Random testing during 

employment; 

c. Periodic testing during 

employment; 

d. Testing based on a reasonable 

cause/suspicion that an employee is 

under the influence of alcohol or drugs 

while performing a safety-sensitive 

function or within a certain period of 

time before or after performing such a 

function; 

e. Post-accident testing; 

f. Return-to-duty and follow-up 

testing of individuals who have 

previously tested positive for alcohol or 

drugs; 

g. Any other drug or alcohol testing 

(please specify)? 

A 4. Should an FAA regulation 

include a provision to allow regulated 

parties to apply for a waiver 4 if any 

provision conflicts with a foreign law or 

regulation? Please state the rationale for 


tkelley on DSK3SPTVN1PROD with PROPOSALS
14624 Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules 

why such a waiver provision should or 

should not be included. 

B. Program Elements of Acceptable Drug 

and Alcohol Testing 

The FAA is considering addressing 

the program elements listed below in 

establishing the criteria for determining 

whether a drug and alcohol testing 

program is acceptable to the 

Administrator. Questions associated 

with each program element are listed 

below. 

1. A defined set of circumstances 

under which testing is conducted for 

alcohol and the most pervasive drugs of 

abuse in the relevant country. Under the 

FAA’s current domestic drug and 

alcohol testing regulations for persons 

performing flight crewmember duties, 

flight attendant duties, flight instruction 

duties, aircraft dispatcher duties, 

aircraft maintenance and preventive 

maintenance duties, ground security 

coordinator duties, aviation screening 

duties, air traffic control duties testing 

is required in the following 

circumstances: 

• Pre-employment (for drugs only); 

• Randomly during employment; 

• After an accident; 

• If there is reasonable cause/

suspicion to believe that an individual 

is under the influence of alcohol or 

drugs while performing safety-sensitive 

functions or within a certain period of 

time before or after performing such 

functions; 

• Return-to-duty testing and followup testing before and after returning an 

employee to duty who previously tested 

positive for alcohol or drugs or refused 

to submit to testing. 

B1. For a program to be found 

acceptable to the Administrator, should 

the FAA require that testing be 

conducted under all of the above 

circumstances for which it is required in 

the U.S.? If not, under what 

circumstances should testing be 

required? 

2. Types of substances tested. 49 

U.S.C. 44733(d)(2) requires that the 

proposed rule include ‘‘alcohol and 

controlled substances testing’’. The 

substances that are tested in the United 

States include alcohol, marijuana, 

cocaine, opiates, phencyclidine (PCP), 

and amphetamines. The FAA recognizes 

that the drugs of concern in other 

countries may vary depending upon 

conditions in those countries. Therefore, 

the FAA poses the following questions: 

B2a. Should an acceptable program 

require testing for, at a minimum, the 

drugs for which the FAA requires 

testing in the United States? If not, 

please provide information on which 

drugs should be tested for, at a 

minimum, to constitute an acceptable 

program. 

B2b. At what concentrations should a 

test for alcohol, drugs, or their 

metabolites be considered positive? 

Should an acceptable program identify 

set ceiling concentrations above which 

tests must be considered positive? If so, 

what should those levels be? 

3. A mechanism that is an effective 

deterrent to drug and alcohol misuse. 

The FAA views random testing as an 

effective deterrent because there is an 

element of surprise. Employees subject 

to random testing receive little notice 

before they must report for testing. 

Other countries or industry may have 

developed other effective methods of 

deterrence and some countries may 

prohibit or significantly restrict the use 

of random testing. The FAA poses the 

following questions with respect to this 

potential program element: 

B3a. Does the country allow or require 

random drug and/or alcohol testing? If 

so, please describe the process. 

B3b. If the country does not allow or 

require random drug and/or alcohol 

testing, are there laws to prohibit 

random testing? 

B3c. If random testing is not allowed 

in a given country, what other methods 

could be used to successfully deter 

employees from misusing drugs or 

alcohol while performing safetysensitive duties or within a certain 

period of time before performing such 

duties? How would such misuse be 

detected? 

4. Procedures that ensure the 

integrity, identity, and proper analysis 

of the collected specimen to ensure 

accuracy of the test result. In the United 

States, the U.S. Department of 

Transportation has adopted a chain-ofcustody process developed by the U.S. 

Department of Health and Human 

Services (HHS) to document the 

handling and storage of a specimen from 

the time it is collected until the time it 

is released to the testing facility. This 

process, coupled with the FAA’s 

requirement that testing programs in the 

United States use a laboratory certified 

by HHS, helps ensure the accuracy of 

testing results. The FAA poses the 

following questions with respect to this 

potential program element: 

B4a. What testing methods, if any, in 

addition to those currently permitted 

under part 120, should be permitted in 

programs outside the United States? 

B4b. What standards should 

personnel and laboratories or other 

facilities in foreign countries be 

required to meet? Please address the 

following matters: 

• Personnel qualifications; 

• Measures to prevent adulteration, 

substitution, or mistaken identification 

of specimens; 

• Measures to ensure drug and 

alcohol testing information is only 

released to authorized persons; 

• Measures to determine whether 

there is a legitimate medical explanation 

for a positive test result; 

• Other relevant considerations 

(please specify). 

B4c. HHS-certified laboratories are 

not available outside the United States; 

therefore, should a program be 

acceptable if it allows the use of other 

laboratories that have been certified by 

DOT, another regulatory authority, or 

international organization as meeting 

equivalent or more stringent 

international standards? 

5. A means of ensuring that an 

employee who returns to work [after 

violating the law] is no longer misusing 

alcohol or drugs. If an employee who 

violated the drug or alcohol regulations 

is permitted to return to work, it is 

important to have a means for ensuring 

that the employee is no longer misusing 

alcohol or drugs and a means of 

detecting such misuse if it recurs after 

the employee returns to safety-sensitive 

duties. The return-to-duty process in the 

United States is described in the 

Department of Transportation’s 

regulations at 49 CFR part 40, subpart O. 

The FAA poses the following questions 

with respect to this potential program 

element: 

B5a. What are the minimum standards 

that employees who have violated drug 

and alcohol regulations should meet 

before they return to performing safetysensitive maintenance functions? 

B5b. If follow-up testing is not 

permitted, what other methods would 

ensure that an employee who has 

previously tested positive for alcohol or 

drugs does not misuse them again after 

returning to safety-sensitive duties? 

C. Existing Drug and Alcohol Testing 

Programs in Other Countries 

The FAA recognizes that existing drug 

and alcohol testing programs in other 

countries may take various forms and 

must comply with the applicable laws 

and regulations of those countries. In 

some countries, drug and alcohol testing 

programs may be established by 

industry in accordance with regulations 

promulgated by a government agency, as 

is the case in the United States. In 

others, a government agency may 

administer a national drug and alcohol 

testing program. In yet others, industry 

participants may have voluntarily 

established drug and alcohol testing 

programs as a good business practice or 

for competitive advantage in the 


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Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules 14625 

marketplace without being required to 

do so. In addition to the information 

provided in part B above, the FAA 

requests the information described 

below about existing drug and alcohol 

testing programs in other countries, 

whether legally mandated or voluntarily 

established. The FAA is interested in 

both nationwide information for other 

countries and information pertaining to 

the testing programs of specific 

companies or the members of an 

association: 

C 1. Which drugs are most pervasively 

misused in the country? Please provide 

data to support this answer. 

C 2. Are testing programs in the 

country: 

a. Administered by a national 

regulatory authority; 

b. Required to be established by 

industry participants under that 

country’s laws and regulations; 

c. Voluntarily established by industry 

participants; 

d. Other (please specify)? 

C 3. Please describe the process that 

is followed after an employee’s drug test 

is confirmed positive or alcohol 

concentration is confirmed to be above 

the permitted limit, including at what 

point an individual would be removed 

from safety-sensitive duty. 

C 4. If the country allows drug or 

alcohol testing, what protections does 

the country’s legal system provide for 

the employee? 

C 5. What are the potential 

consequences in that country, 

including, but not limited to, 

enforcement action by the relevant 

government authority, when an 

individual who performs safetysensitive aviation duties tests positive 

for alcohol or drugs? 

D. Miscellaneous 

D 1. Should the FAA include within 

the scope of a proposed rule all 

authorized persons performing safetysensitive maintenance functions on 

aircraft operated by part 121 air carriers 

in accordance with 14 CFR 43.17 ? 

Please include the rationale for why 

such personnel should or should not be 

subject to testing in any comment. 

IV. Regulatory Notices and Analyses 

A. Regulatory Evaluation 

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 questions about 

the economic impacts of a future 

proposed rule. 

Congress mandated that the FAA 

propose a rule requiring that all 

employees of part 145 repair stations 

who perform safety-sensitive 

maintenance functions on part 121 air 

carriers’ aircraft be subject to an alcohol 

and drug testing program that has been 

determined acceptable by the 

Administrator and is consistent with the 

applicable laws of the country in which 

the repair station is located. This 

mandate requires the FAA to propose 

drug and alcohol testing for employees 

of part 145 repair stations located 

outside the United States who perform 

safety-sensitive maintenance functions 

on aircraft operated by part 121 air 

carriers. The FAA understands that the 

implementation of such a regulation 

would impose costs on industry, the 

FAA, and perhaps other parties. 

The FAA might also extend this 

testing requirement to include all 

authorized persons performing safetysensitive maintenance functions on 

aircraft operated by part 121 air carriers 

in accordance with 14 CFR § 43.17. It is 

very difficult, however, for the FAA to 

reliably estimate such costs at this time, 

given the limited information about 

other countries’ relevant laws and 

regulations, existing drug and alcohol 

testing programs in other countries, the 

actual and potential costs associated 

with conducting drug and alcohol 

testing in other countries (which is 

expected to vary), the cost of 

establishing testing programs in 

countries where they do not currently 

exist, and other relevant information. To 

help gauge the economic impact of a 

proposed rule, the FAA is requesting 

information from industry, as well as 

from the government of countries as 

described below. For all cost questions 

in this ‘‘Regulatory Notices and 

Analyses’’ section, please note who 

bears or would bear the costs (e.g., the 

employee; the air carrier for whom work 

is performed; the covered maintenance 

provider, a regulatory authority, other 

(please specify)) in any response 

provided. 

In January 2006, the FAA issued a 

final rule entitled Antidrug and Alcohol 

Misuse Prevention Programs for 

Personnel Engaged in Specified 

Aviation Activities (71 FR 1666). That 

rule amended the FAA’s regulations 

governing drug and alcohol testing in 

the United States to clarify that each 

person who performs a safety-sensitive 

function for a regulated employer by 

contract, including by subcontract at 

any tier, is subject to testing. 

Consequently, the regulatory evaluation 

for that final rule (hereinafter referred to 

as the ‘‘2005 Regulatory Evaluation’’), 

which was published in Docket No.: 

FAA–2002–11301, addresses costs 

associated with drug and alcohol testing 

in the United States. 

The FAA is providing information 

from the 2005 Regulatory Evaluation to 

provide the public with an 

understanding of the types and level of 

detail of information needed to 

accurately estimate the economic 

impact of a rule for drug and alcohol 

testing of employees of covered 

maintenance providers who perform 

safety-sensitive maintenance functions 

on aircraft operated by part 121 air 

carriers. The FAA understands that the 

costs associated with drug and alcohol 

testing are likely to be different outside 

the United States and may vary from 

country to country. The FAA also 

understands that the specific details of 

drug and alcohol testing programs likely 

vary from country to country; however, 

the FAA expects that, for any drug and 

alcohol testing program, there will be 

costs associated with the testing 

process, training and education, 

developing and maintaining a testing 

program, and keeping (and possibly 

submitting) any documentation that 

may be required by national regulatory 

authorities or as part of a voluntary 

program’s policies. The FAA requests 

that commenters also provide 

information about any other costs that 

may be relevant. The FAA is interested 

in data at the national level, from the 

members of associations, and from 

specific companies’ programs. There 

were a number of basic assumptions 

that the FAA made in the 2005 

Regulatory Evaluation. The FAA 

assumed the following: 


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• Maintenance providers affected by 

that rule would develop and implement 

their own programs, instead of being 

covered under another company’s 

program or using a service agent with 

already-established procedures. 

• An additional 2.5% of maintenance 

workers would be subject to the 

antidrug and alcohol misuse prevention 

programs under that rule. 

• The number of employees in the 

maintenance sector grows at 1.5% per 

year. 

• There would be two supervisors per 

contractor and that the attrition rate for 

mechanics was approximately 10% per 

year. 

The FAA requests comments on these 

assumptions. 

The FAA also assumed the following 

values: 

• Price of a drug test—$45; 

• Price of an alcohol test—$34; 

• Time for a drug test (hours)—0.75; 

• Time for an alcohol test (hours)— 

0.75; 

• One instructor for every 20 

supervisors and/or employees to be 

trained 

• Maintenance employee salary— 

$33.07/hour; 

• Maintenance supervisor salary— 

$39.68/hour; 

• Instructor—$36.37/hour; 

• Clerical—$18.62/hour; 

The FAA requests comments on these 

assumptions. 

Testing Costs 

All employees who are subject to drug 

and alcohol testing under FAA 

regulations in the United States are 

subject to the following types of tests: 

pre-employment (for drugs only), 

random, post-accident, reasonable 

cause/suspicion, return-to-duty, and 

follow-up. The 2005 Regulatory 

Evaluation considered the cost of testing 

to include the actual cost of the test, as 

well as the cost of the employee’s time. 

Please answer the following questions. 

RE 1. For each year of the last 10 

years, please provide the number of (a) 

drug and (b) alcohol tests conducted on 

aviation personnel who perform safetysensitive functions and the number of 

positive tests, regardless of whether 

maintenance personnel are currently 

tested under the particular program 

described. If maintenance personnel are 

currently tested, please provide the 

number of (a) drug and (b) alcohol tests 

conducted on maintenance personnel 

that perform safety-sensitive functions 

and the number of positive tests for 

such personnel separately. For an 

example of the type of data that the FAA 

seeks, see the table below from the 2005 

Regulatory Evaluation. 

RE 2. What types of testing are 

required for (a) drugs and (b) alcohol 

(e.g., pre-employment, post-accident, 

reasonable cause/suspicion, random, 

return-to-duty, follow-up, other (please 

specify))? 

RE 3. What types of personnel are 

subject to (a) drug and (b) alcohol 

testing in the relevant country, 

company, or among the members of the 

association (e.g., pilots, flight 

attendants, air traffic controllers, flight 

dispatchers, maintenance personnel, 

other (please specify))? 

RE 4. Is drug and alcohol testing 

currently conducted in the relevant 

country? If not, how would a 

requirement to drug and alcohol test be 

met (i.e. travel to a different country, 

implement a testing program within the 

relevant country, or other (please 

specify))? If traveling to another 

country, what is the distance from the 

relevant country? How much time will 

be spent traveling? 

RE 5. What is the cost of (a) the drug 

test and (b) the alcohol test per person? 

Do or would the costs differ for different 

categories of tests (i.e., pre-employment, 

post-accident, reasonable cause/

suspicion, random, periodic, return-toduty, follow-up, or other (please 

specify))? How long does it take for an 

employee to complete each of these 

tests? If screening tests for (a) drugs or 

(b) alcohol are or would be conducted, 

followed by confirmatory testing when 

the screening test is positive, what are 

or would be the costs associated with 

conducting (a) the screening test and (b) 

the confirmatory test? 

RE 6. How many maintenance 

personnel in the relevant country or in 

a particular company or group of 

companies perform safety-sensitive 

maintenance functions? How many of 

them perform safety-sensitive 

maintenance functions on aircraft 

operated by part 121 air carriers (and are 

not directly employed by such air 

carriers)? How many are subject to drug 

and alcohol testing? 

RE 7. How many new employees are 

hired to perform safety-sensitive 

maintenance functions per year? How 

many maintenance employees who 

perform safety-sensitive functions leave 

per year? The FAA will need to be able 

to estimate testing costs in future years. 

See the table below for an example from 

the 2005 Regulatory Evaluation. 


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RE 7. What is or would be the annual 

cost per person of each category of staff 

required to conduct testing (collection 

personnel, laboratory personnel, other 

(please specify))? 

Training and Education Costs 

In the United States, for each drug 

and alcohol testing program, the 

employer must train employees and 

supervisors on the effects and 

consequences of drug use on personal 

health, safety, and work environment, as 

well as the manifestations and 

behavioral cues that may indicate drug 

use and abuse. The regulations do not 

specify the amount of time associated 

with this training; in the 2005 

Regulatory Evaluation, the FAA 

assumed 30 minutes. 

Under current regulations, 

supervisors who will make reasonable 

cause/suspicion determinations must 

receive at least 60 minutes for each 

program (for a total of 120 minutes). 

Supervisors must also receive recurrent 

training under the FAA’s drug testing 

rules. The rules do not say when the 

recurrent training must occur or how 

long it must be; however, the FAA 

recommends recurrent training every 12 

to 18 months and that it include an 

element on alcohol testing. For the 2005 

Regulatory Evaluation, the FAA 

assumed that the recurrent training 

occurs every 12 months and takes 60 

minutes. 

Please answer the following questions. 

RE 8. What are or would be the initial 

and recurrent training and education 

costs, on a per person basis? For: 

a. Employees subject to testing, 

b. Supervisors, 

c. Persons authorized to determine 

whether there is reasonable cause/

suspicion to believe that an employee 

may be under the influence of alcohol 

or drugs while performing, or within a 

certain amount of time before or after 

performing, a safety-sensitive function 

and that the employee should be tested 

on that basis, 

d. Specimen collectors, 

e. Persons responsible for analyzing 

specimens for alcohol, drugs, or their 

metabolites, 

f. Persons involved in determining or 

recommending the appropriate course of 

treatment and/or education for an 

employee who has tested positive for 

drugs or alcohol, 

g. Other personnel involved in the 

drug or alcohol testing program (please 

specify)? 

RE 9. How many personnel in 

category (g) of question RE8 receive or 

would receive (1) initial and (2) 

recurrent training and/or education 

annually? 

RE 10. What was or would be the cost 

of developing any necessary training 

program initially, including materials, 

and what is or would be the annual cost, 

including materials, of maintaining it? 

What types of training materials are or 

would be required? 

RE 11. What are or would be the 

annual costs of the staff required to 

conduct training? How many staff 

would be required to conduct training? 


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5That analysis was limited to maintenance 

workers because that was the population affected by 

that rulemaking. 

RE 12. How often is/must/would 

recurrent training be conducted? 

Program Development and Maintenance 

Costs 

Under the rule for which the 2005 

Regulatory Evaluation was conducted, it 

was assumed that each affected 

maintenance provider would have to 

devote resources to developing drug and 

alcohol testing programs. In addition, 

each affected maintenance provider 

would have to spend time to produce 

information required to either obtain an 

operations specification for its part 145 

certificate or register its drug and 

alcohol program with the FAA. At the 

FAA, the submitted information would 

have to be processed and entered into 

the appropriate database. 

In calculating program development 

costs in the 2005 Regulatory Evaluation, 

the FAA assumed 16 hours for start-up 

program development. The FAA 

estimated that, for affected maintenance 

providers that chose to register with the 

FAA, it would take each one 20 minutes 

at $21 per hour to gather the required 

information and submit it to the FAA. 

At the FAA, the submitted information 

has to be processed. In the 2005 

Regulatory Evaluation, the FAA 

estimated that an administrative 

assistant, an FG–7 being paid at about 

$25.00 per hour, would enter this 

information into a database. The FAA 

assumed that administrative assistants 

would need 10 minutes to input the 

information. 

Please answer the following questions. 

RE 13. How much would it cost 

(besides training costs already 

addressed above or cost to do the actual 

testing) to develop a drug and alcohol 

testing program? What would be the 

annual program maintenance costs 

(besides training costs already 

addressed above)? What items are 

included in both of these types of costs? 

RE 14. Is the drug and alcohol testing 

program regulated by an agency of a 

government? If so, how much time per 

year is required to prepare and maintain 

required documentation and submit 

information to the responsible 

regulatory authority? What information 

items must be submitted? How long 

does it take for the company to gather 

this information? How long does it take 

for the responsible regulatory authority 

to process the submission? Who at the 

responsible regulatory authority 

processes these submissions? 

RE 15. How many submissions must 

be made per year? 

RE 16. What are or would be the costs 

of staff required to evaluate employees 

who have tested positive for drugs or 

alcohol and to provide any needed 

education and/or treatment? What 

would the cost of treatment be, in terms 

of employees time and opportunity 

cost? How many such staff would be 

needed? What are or would be the other 

costs associated with any program of 

treatment and/or education? 

RE 17. What are or would be the costs 

for a laboratory in the relevant country 

to obtain HHS, its equivalent, or more 

stringent certification, including both 

fees and the costs of any actions that 

would need to be taken to meet the 

applicable certification standards? 

Please specify the certification 

standards being used as a point of 

reference in any comments. 

RE 18. Is shipping specimens to an 

existing HHS-certified or DOT approved 

laboratory a reasonable alternative? 

What would be the costs associated with 

packaging and shipping specimens to 

one of the existing HHS-certified 

laboratories for testing? 

Annual Documentation Costs 

The FAA’s drug testing regulations 

require each company to document both 

the initial and recurrent training for 

supervisory personnel who make 

reasonable cause determinations. In the 

2005 Regulatory Evaluation, the FAA 

assumed that the cost of this 

documentation is about $1.30 per 

record, which included record creation, 

filing, and storage. The same sort of 

documentation is needed for the 

supervisors who determine whether 

reasonable suspicion exists concerning 

probable alcohol misuse. The FAA 

assumed the cost of this documentation 

is also about $1.30 per record. The 

FAA’s existing regulations require 

documentation of such things as: 

• Training of employees in the 

requirements of the antidrug program; 

• All reasonable cause/suspicion 

cases; 

• If a post-accident alcohol test is not 

administered within 2 hours following 

the accident, the reasons the test was 

not promptly administered; 

• If a post-accident alcohol test is not 

administered within 8 hours following 

the accident, the reasons the test was 

not promptly administered; 

• Refusal to submit to a required drug 

or alcohol test (the company must also 

notify the FAA); and 

• Medical Review Officer (MRO) 

reports of verified positive drug test 

results for employees holding airman 

medical certificates issued by the FAA 

under 14 CFR part 67. (Both the MRO 

and the company must also notify the 

FAA.) 

Please answer the following questions. 

RE 19. What are or would be the 

annual recordkeeping or other 

documentation costs associated with the 

drug and/or alcohol testing program? 

RE 20. Who maintains or would 

maintain any required documentation 

(e.g., employer, government agency, 

other (please specify))? 

RE 21. What documentation is or 

would be required to be maintained by 

and/or submitted to the responsible 

regulatory agency? How much time 

would be needed to prepare and/or 

submit the documentation? 

RE 22. What is the format for 

recordkeeping? 

Accident Prevention Benefits 

The FAA indicated in the 2005 

Regulatory Evaluation that it believed it 

was possible that illegal drug use or 

alcohol misuse by members of the 

aviation community may have 

contributed to additional accidents or 

incidents. The FAA acknowledged the 

fact that there had not been any aviation 

accidents directly attributed to a 

maintenance worker misusing or 

abusing drugs or alcohol.5 However, as 

the table below shows, maintenance 

employees had among the highest 

positive rates on alcohol and drug tests 

among aviation-related employees, so 

the connection between illegal drug use 

and alcohol misuse and maintenancerelated accidents certainly could exist. 

The FAA stated that it was important to 

note that not only are maintenance 

workers rarely tested after an accident 

(only 0.05% and 0.09% of maintenance 

workers are administered post-accident 

alcohol and drug tests, respectively), but 

it would be difficult to directly tie poor 

maintenance work, due to inappropriate 

drug use or alcohol misuse, to an 

accident that may occur weeks or 

months later, particularly with the 

widespread use of contract workers at 

many different tiers. 


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Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules 14629 

The 2005 Regulatory Evaluation 

indicated that, while there had been no 

documented aviation accidents in the 

United States in the time period 

analyzed that were directly attributed to 

misuse or abuse of drugs or alcohol by 

maintenance personnel, the FAA 

believed it was possible that such 

misuse or abuse may have contributed 

to aviation-related accidents. The FAA 

believed it was prudent to base the 

estimated benefits of the final rule on 

avoiding one part 135 accidents over the 

next 10 years, thus avoiding a total of 

5 fatalities and a destroyed or damaged 

airplane. The FAA estimated the 

benefits of avoided fatalities at $15 

million. This number of accidents, 

fatalities, and destroyed airplanes was 

less than 1% of all maintenance-related 

accidents that had occurred; the FAA 

considered these benefits to be 

reasonable. The total benefits in the 

2005 regulatory evaluation were 

calculated by assuming an equally likely 

chance of avoiding these accidents in 

each of the next 10 years. Total benefits 

summed to $15.07 million ($10.59 

million, discounted). 

Please answer the following questions. 

RE 22. What benefits has the relevant 

country/company seen from drug and 

alcohol testing? 

RE 23. Are you aware of any accidents 

in which drug or alcohol misuse by 

safety-sensitive aviation personnel (e.g. 

pilots, flight attendants, maintenance 

personnel, air traffic controllers, flight 

dispatchers, other (please specify)) may 

have caused or contributed to the 

accident? Please describe the 

circumstances and identify the type of 

safety-sensitive personnel whose drug 

or alcohol misuse may have caused or 

contributed to the accident. Were there 

any fatalities, injuries, or damage to 

aircraft? If so, please describe. How 

many confirmed positive drug and 

alcohol tests occur annually in the 

country/company? 

RE 24. Have industry participants 

experienced a savings in insurance 

premiums as a result of drug and 

alcohol testing? 

B. International Compatibility 

In keeping with the United States’ 

obligations under the Chicago 

Convention, it is FAA policy to conform 

to ICAO Standards and Recommended 

Practices to the maximum extent 

practicable. The FAA has determined 

that there are no ICAO Standards and 

Recommended Practices that exactly 

correspond to the regulations being 

considered for proposal, as ICAO 

neither requires nor recommends that 

Member States implement testing of 

aviation personnel with safety-sensitive 

responsibilities for alcohol or drugs. As 

discussed in the Background section of 

this preamble, however, there are a 

number of ICAO standards and 

recommended practices that address the 

misuse of drugs and alcohol by such 

personnel and recognize the potential 

hazard that such substance misuse may 

pose to aviation safety. 

C. 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 ANPRM 

qualifies for the categorical exclusion 

identified in paragraph 312d and 

involves no extraordinary 

circumstances. 

V. Executive Order Determinations 

A. Executive Order 12866, Regulatory 

Planning and Review, Executive Order 

13563, Improving Regulation and 

Regulatory Review and DOT Regulatory 

Policies and Procedures 

The FAA is soliciting comments on 

the potential costs and benefits of the 

initiatives in the ANPRM. This ANPRM 

has been drafted and reviewed in 

accordance with Executive Order 12866 

and Executive Order 13563. This 

ANPRM has been reviewed by the 

Office of Management and Budget and 

is considered ‘‘significant’’ under the 

Department of Transportation’s 

Regulatory Policies and Procedures. 

B. Executive Order 13132, Federalism 

The FAA has analyzed this ANPRM 

under the principles and criteria of 

Executive Order 13132, Federalism. The 

agency has determined that this action 

would 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, would not have Federalism 

implications. 

C. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

The FAA analyzed this ANPRM under 

Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

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

agency has determined that it would not 

be a ‘‘significant energy action’’ under 

the executive order and likely would 

not have a significant adverse effect on 

the supply, distribution, or use of 

energy. 

VI. Additional Information 

A. Comments Invited 

The FAA invites interested persons to 

participate in this rulemaking by 

submitting written comments, data, or 

views. The Agency also invites 

comments relating to the economic, 

environmental, energy, or federalism 

impacts that might result from adopting 

the proposals in this document. The 

most helpful comments reference a 

specific portion of the proposal, or a 


tkelley on DSK3SPTVN1PROD with PROPOSALSEP17MR14.006</GPH>
14630 Federal Register / Vol. 79, No. 51 / Monday, March 17, 2014 / Proposed Rules 

specific question posed by the FAA, and 

fully explain the rationale for any 

comment, include supporting data, if 

applicable. To ensure the docket does 

not contain duplicate comments, 

commenters should send only one copy 

of written comments, or if comments are 

filed electronically, commenters should 

submit only one time. The FAA requests 

that all comments be submitted in 

English. 

The FAA will file in the docket all 

comments it receives, as well as a report 

summarizing each substantive public 

contact with FAA personnel concerning 

this ANPRM. Before acting on this 

ANPRM, the FAA will consider all 

comments it receives on or before the 

closing date for comments. The FAA 

will consider comments filed after the 

comment period has closed if it is 

possible to do so without incurring 

expense or delay. The Agency may 

change its potential proposals in light of 

the comments it receives. 

Proprietary or Confidential Business 

Information: Do not file proprietary or 

confidential business information in the 

docket. Such information must be sent 

or delivered directly to any of the 

persons identified in the FOR FURTHER

INFORMATION CONTACT section of this 

document, and marked as proprietary or 

confidential. If submitting information 

on a disk or CD ROM, mark the outside 

of the disk or CD ROM, and identify 

electronically within the disk or CD 

ROM the specific information that is 

proprietary or confidential. 

Under 14 CFR 11.35(b), if the FAA is 

aware of proprietary information filed 

with a comment, the Agency does not 

place it in the docket. It is held in a 

separate file to which the public does 

not have access, and the FAA places a 

note in the docket that it has received 

it. If the FAA receives a request to 

examine or copy this information, it 

treats it as any other request under the 

Freedom of Information Act (5 U.S.C. 

552). The FAA processes such a request 

under Department of Transportation 

procedures found in 49 CFR part 7. 

B. Availability of Rulemaking 

Documents 

Electronic copies of rulemaking 

documents may be obtained from the 

Internet by— 

1. Searching the Federal eRulemaking 

Portal (http://www.regulations.gov); 

2. Visiting the FAA’s Regulations and 

Policies Web page at http://

www.faa.gov/regulations_policies or 

3. Accessing the Government Printing 

Office’s Federal Digital System at 

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

Copies may also be obtained by 

sending a request to the Federal 

Aviation Administration, Office of 

Rulemaking, ARM–1, 800 Independence 

Avenue SW., Washington, DC 20591, or 

by calling (202) 267–9680. Commenters 

must identify the docket or notice 

number of this rulemaking. 

All documents the FAA considered in 

developing this ANPRM, including 

economic analyses and technical 

reports, may be accessed from the 

Internet through the Federal 

eRulemaking Portal referenced in item 

(1) above. 

Issued in Washington, DC, under the 

authority set forth in 49 U.S.C. 44733 on: 

March 5, 2014. 

James R. Fraser, 

Federal Air Surgeon. 

[FR Doc. 2014–05653 Filed 3–14–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 514 

[Docket No. FDA–2014–N–0108] 

New Animal Drug Applications; 

Confidentiality of Data and Information 

in a New Animal Drug Application File 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

proposing to amend its regulation 

regarding the confidentiality of data and 

information in and about new animal 

drug application files to change when 

certain approval-related information 

would be disclosed by the Agency. This 

change would ensure that the Agency is 

able to update its list of approved new 

animal drug products within the 

statutory timeframe. It would also 

permit more timely public disclosure of 

approval-related information, increasing 

the transparency of FDA decision 

making in the approval of new animal 

drugs. 

DATES: Submit either electronic or 

written comments by June 2, 2014. If 

FDA receives any significant adverse 

comments, the Agency will publish a 

document in the Federal Register 

withdrawing the direct final rule within 

30 days after the comment period ends. 

FDA will then proceed to respond to 

comments under this proposed rule 

using the usual notice and comment 

procedures. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2014–N– 

0108, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand Delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2014–N–0108 for this 

rulemaking. All comments received may 

be posted without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Scott Fontana, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0656. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 512(i) (21 U.S.C. 360b(i)) was 

added to the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by the 

Animal Drug Amendments of 1968 

(Pub. L. 90–399). Section 512(i) requires 

the conditions and indications of use of 

a new animal drug to be published in 

the Federal Register upon approval of a 

new animal drug application (NADA) 

filed under section 512(b) of the FD&C 

Act. 

In 1974, FDA revised its regulations 

regarding the confidentiality of 

information in applications in § 135.33a 

(21 CFR 135.33a) to include provisions 

of the Freedom of Information Act (Pub. 

L. 89–487). That revision established 

that public disclosure by the Agency of 

certain data and information in an 

NADA file could not occur before the 

Federal Register notice of approval 


tkelley on DSK3SPTVN1PROD with PROPOSALS