Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations 12559 

R–2203A Eagle River, AK [Amended] 

By removing the existing Using Agency 

information and substituting the following: 

Using agency. U.S. Army, AK (USARAK), 

Commanding General, Fort Richardson, AK. 

R–2203B Eagle River, AK [Amended] 

By removing the existing Using Agency 

information and substituting the following: 

Using agency. U.S. Army, AK (USARAK), 

Commanding General, Fort Richardson, AK. 

R–2203C Eagle River, AK [Amended] 

By removing the existing Using Agency 

information and substituting the following: 

Using agency. U.S. Army, AK (USARAK), 

Commanding General, Fort Richardson, AK. 

* * * * * 

R–2205 Stuart Creek, AK [Amended] 

By removing the existing Using Agency 

information and substituting the following: 

Using agency. U.S. Army, AK (USARAK), 

Commanding General, Fort Richardson, AK. 

Issued in Washington, DC, on March 2, 

2011. 

Rodger A. Dean, 

Acting Manager, Airspace, Regulations and 

ATC Procedures Group. 

[FR Doc. 2011–5246 Filed 3–7–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 121 

[Docket No.: FAA–2002–11301; Amendment 

No. 121–315A] 

RIN 2120–AH14 

Antidrug and Alcohol Misuse 

Prevention Programs for Personnel 

Engaged in Specified Aviation 

Activities; Supplemental Regulatory 

Flexibility Determination 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; supplemental 

regulatory flexibility determination. 

SUMMARY: This document announces the 

completion and availability of a 

supplemental regulatory flexibility 

determination for a previously 

published final rule. That final rule 

amended the FAA regulations governing 

drug and alcohol testing to clarify that 

each person who performs a safetysensitive function for a regulated 

employer by contract, including 

bysubcontract at any tier, is subject to 

testing. 

DATES: Submit comments on or before 

May 9, 2011. 

ADDRESSES: Send comments identified 

by docket number 2002–11301 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: The FAA will post all 

comments it receives, without change, 

to http://www.regulations.gov, including 

any personal information the 

commenter provides. Using the search 

function of the docket Web site, anyone 

can find and read the electronic form of 

all comments received into any FAA 

dockets, including the name of the 

individual sending the comment (or 

signing the comment for an association, 

business, labor union, etc.). DOT’s 

complete Privacy Act Statement can be 

found in the Federal Register published 

on April 11, 2000 (65 FR 19477–19478), 

as well as at 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 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: 

Nicole Nance, Office of Aviation Policy 

and Plans, APO–300, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone (202) 267–3311; e-mail 

nicole.nance@faa.gov. For legal 

questions concerning this document, 

contact Anne Bechdolt, Regulations 

Division, AGC–220, Office of the Chief 

Counsel, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone (202) 267–7230; e-mail 

anne.bechdolt@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On February 28, 2002, the FAA issued 

a notice of proposed rulemaking seeking 

to revise the drug and alcohol testing 

regulations by amending the definition 

of employee (67 FR. 9366, 9377, Feb. 28, 

2002). The FAA action addressed those 

individuals performing safety-sensitive 

functions under contract who may not 

have been subject to testing under the 

drug and alcohol testing regulations 

established in 1988 and 1994, 

respectively. Upon review of comments, 

the FAA, in 2004, issued a 

supplemental notice of proposed 

rulemaking to seek comment regarding 

how small entities would be impacted 

by this rule (69 FR 27980, May 17, 

2004). From the comments received the 

FAA believed that the rule would not 

have a significant impact on a 

substantial number of small entities. 

On January 10, 2006, the FAA issued 

the final rule (71 FR 1666). This rule 

requires that each person who performs 

a safety-sensitive aviation function 

directly for an employer is subject to 

testing and that each person who 

performs a safety-sensitive function at 

any tier of a contract for that employer 

is also subject to testing. This 

requirement includes contractors and 

subcontractors. Contracting companies 

have two testing options: Option one is 

for the contracting company to obtain 

and implement its own FAA drug and 

alcohol (D&A) testing programs. Under 

this option, the company would subject 

the individuals to testing. The other 

option is for the regulated employer to 

maintain its own testing programs and 

subject the individual to testing under 

these programs. To establish a D&A 

program a company would need to 

develop and maintain testing, training, 

and annual reporting requirements. 

To comply with the Regulatory 

Flexibility Analysis (RFA), and to 

evaluate the impact on small businesses, 

the FAA described and estimated the 

number of affected businesses and 

estimated the economic impact. In the 

final regulatory flexibility analysis the 

FAA estimated that the costs were 

minimal, and that contractors would 

absorb some of these costs. In order to 

estimate the maximum impact of this 

regulation on regulated entities the FAA 

assumed that all of the additional cost 

would be passed along to regulated 

employers. Since costs were minimal, 

the FAA again certified that the rule 

would not have a significant economic 

impact on a substantial number of small 

entities. 71 FR 1666, 1674 (Jan. 10, 

2006) 

The Aeronautical Repair Station 

Association, Inc., (ARSA) and other 

affected businesses challenged the final 

rule on several grounds, including the 

FAA’s compliance with the Regulatory 

Flexibility Act. The entities argued that 

contractors and subcontractors were 

directly affected by the final rule, and in 

failing to consider them in the final 


emcdonald on DSK2BSOYB1PROD with RULES
12560 Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations 

1Aircraft Repair Station Security (49 CFR part 

1520 and 1554). Regulatory and Economic Analysis: 

Transportation Security Administration Department 

of Homeland Security, October 15, 2009. 

regulatory flexibility analysis, the FAA 

failed to comply with the RFA. Upon 

review, the U.S. Court of Appeals for the 

District of Columbia upheld ‘‘the 

substance of the 2006 final rule’’ and 

remanded ‘‘for the limited purpose of 

conducting the analysis required under 

the RFA, treating the contractors and 

subcontractors as regulated entities.’’ 

The Court found that contractors and 

subcontractors were directly affected by 

the final rule and that the FAA failed to 

comply with the RFA by not 

considering them in the analysis. To 

comply with the Court’s ruling, the FAA 

has extended the regulatory flexibility 

analysis to include contractors and 

subcontractors as discussed below. 

The Regulatory Flexibility Act of 1980 

(Pub. L. 96–354) (RFA) establishes ‘‘as a 

principle of regulatory issuance that 

agencies shall endeavor, consistent with 

the objectives 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 this principle, 

the RFA requires agencies to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ The RFA 

covers a wide-range of small entities, 

including small businesses, not-forprofit organizations and small 

governmental jurisdictions. 

Agencies must perform a review to 

determine whether a 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 

RFA. However, if an agency determines 

that a rule is not expected to have a 

significant economic impact on a 

substantial number of small entities, 

section 605(b) of the 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. 

Discussion 

The Small Business Administration 

(SBA) has established small business 

size standards pursuant to the Small 

Business Act (Act) (Pub. L. 85–236, as 

amended) and related legislative 

guidelines. Using the NAICS (North 

American Industrial Classification 

System) classifications, the SBA 

classifies ‘‘small’’ businesses based on 

their employment or annual revenue. 

For this rule, part 145 certificated repair 

stations and their subcontractors are 

considered small businesses as defined 

by this definition. Repair stations are 

classified as ‘‘Other Support Activities 

for Air Transport’’ (488190) with small 

businesses defined as businesses with 

annual revenues of $7 million or less. 

Subcontractors, conversely, overlap 

several industries and have multiple 

NAICS codes. The SBA and ARSA 

provided a list of 21 NAICS codes for 

suppliers, parts fabricators and metal 

finishers, among others that may 

perform safety sensitive repairs and 

therefore would be considered a 

subcontractor under the rule. For these 

NAICS codes the definition of a small 

business ranges from 500 to 1,000 

employees or annual revenues of $7 

million or less. 

Based upon data compiled by the 

Transportation Security Administration 

(TSA) for an aircraft repair station 

security rule, in the RFA the FAA 

estimated the number of small business 

repair stations. TSA used revenue and 

employment records from Dun & 

Bradstreet for approximately 2,276 

domestic repair stations.1 From this 

total they identified 2,123 that reflect 

small businesses as defined by the SBA. 

Their analysis indicates that most repair 

stations are small businesses. Accepting 

the TSA percentage of small entities for 

domestic repair stations and our 

internal data, the FAA has estimated 

that out of 4,105 domestic U.S. 

certificated repair stations 3,829 are 

small businesses with revenues of $7 

million or less. 

After estimating the number of small 

entity repair stations, we now focus on 

describing subcontractors impacted by 

this rule. In order to provide a 

description of subcontractors, the FAA 

examined the submitted list of 21 

NAICS codes provided by the SBA and 

ARSA. There was some duplication in 

the codes, reducing the actual number 

of codes to be examined. 

During the comment period ARSA not 

only provided a list of NAICS codes, but 

they also conducted and provided 

information on a Non-Certificated 

Maintenance Subcontractor (NCMS) 

Survey. Some of the information from 

the survey proved to be useful in 

determining the small business impact 

on subcontractors, particularly the 

responses to questions 1 (number of 

employees), 2 (annual revenue), 3 (an 

existing contract with a U.S. air carrier 

to perform maintenance), 4 (type of 

work). These responses are used, in this 

analysis, to determine the 

characteristics of these companies. 

The FAA finds it appropriate to start 

with the responses to question 4, which 

deals with the work-related functions of 

the respondents, as a snapshot of some 

of the types of companies that need to 

be included in this analysis. The FAA 

grouped the responses to question 4 into 

the NAICS codes that both ARSA and 

the SBA provided and the FAA was able 

to correlate 98 of the 134 survey 

respondents with these codes; these 98 

are shown in Table 1 below. While there 

are discrepancies with regard to the 

count, we can validate 98 of the 134 

responses. This shows the wide 

spectrum of businesses providing 

contracting support. 

TABLE 1—SURVEY RESULTS—NAICS CODES AND WORK FUNCTIONS

Number of 

NCMS 

NAICS 

Code Work functions Require D&A program? 

1 .................. 313311 Fireproofing of fabrics ........................................................................................................................... Y 

14 ................ 313320 Metallizing (including plating) ............................................................................................................... S 

9 .................. 332322 Manufacturing airframe parts (mostly sheet metal) ............................................................................. N 

Manufacturing per approved drawing or data ...................................................................................... N 

Manufacturing small parts; some of which are used by part 121 operators ....................................... N 

23 ................ 332710 Chemical milling (reduction of weight) ................................................................................................. S 

Machining ............................................................................................................................................. S 

Machining and welding of ground support parts for planes ................................................................. N 

Machining of turbine engine components ............................................................................................ S 

Machining; chrome plating; anodize; metal finishing; shot peening .................................................... S 

3 .................. 332722 Manufacturer of miniature turned parts. Screws and like .................................................................... N 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations 12561 

TABLE 1—SURVEY RESULTS—NAICS CODES AND WORK FUNCTIONS—Continued 

Number of 

NCMS 

NAICS 

Code Work functions Require D&A program? 

2 .................. 332811 Heat treating ......................................................................................................................................... Y 

1 .................. 332812 Painting ................................................................................................................................................. Y 

8 .................. 332813 Chrome plating; nickel plating (metal finishing) ................................................................................... S 

Machining; chrome plating; anodize; metal finishing; shot peening .................................................... S 

Metal finishing (grinding) (zinc plating) ................................................................................................ S 

Plating; precision grinding; non-destructive testing .............................................................................. S 

3 .................. 332999 Die-cut parts—shims; washers; gaskets; etc. ...................................................................................... N 

1 .................. 334511 Rebuild electro-mechanical switches for aviation use ......................................................................... N 

1 .................. 336412 Overhauling of engine blocker doors ................................................................................................... Y 

22 ................ 488190 Minor maintenance ............................................................................................................................... Y 

Maintenance on 135 charter aircraft line ............................................................................................. Y 

Overhauling of engine blocker doors ................................................................................................... Y 

5 .................. 541380 Calibration and repair of test and measuring equipment ..................................................................... N 

Hydrostatic testing ................................................................................................................................ N 

Inspection ............................................................................................................................................. N 

Machining & fabrication of test fixtures & equipment used in repair processes ................................. N 

Non-destructive testing ......................................................................................................................... N 

1 .................. 561740 Cleaning seat covers ............................................................................................................................ N 

4 .................. 811310 Machining and welding of ground support parts for planes ................................................................. N 

Manufacturing & precision grinding and testing of various fuel & hydraulic/pneumatic valve assemblies.N 

Table 1 also indicates whether a 

specific function would require a D&A 

program. The last column is either 

marked with ‘‘Y’’ meaning yes, ‘‘N’’ 

meaning no, and ‘‘S’’ meaning some in 

this grouping might need such a 

program, as this work function 

conceivably could mandate such a 

program. Companies that have work that 

is strictly manufacturing will not be 

required to comply with the D&A testing 

rules. Several companies mentioned in 

their survey responses that they do not 

perform maintenance, and would not be 

included among companies required to 

set up and implement D&A testing. For 

example, the 14 companies 

characterized as 313320, which involves 

metal finishing including plating, may 

need to conduct D&A testing if some of 

the work they perform is considered 

maintenance under 14 CFR part 43. 

The responses to questions 1 and 2 

address the number of employees and 

the annual revenue reported by the 

surveyed companies. These responses 

are helpful in establishing the type of 

impact that this program will have on 

these companies. Question 1 asked 

‘‘How many employees does your 

company have?’’ Table 2 summarizes the 

responses provided by the ARSA 

survey. All but two of the responses are 

in the category of 750 or below. The two 

responses for ‘‘1501+’’ are outliers and, 

for computational purposes, can be 

ignored. Approximately 75% of the 

respondents stated that they employed 

between 1 and 50 employees, indicating 

that the majority of subcontracting 

companies are small entities. 

TABLE 2—SURVEY RESULTS— 

EMPLOYEES BY COMPANY

Response Count Percent 

1 to 10 .......................... 43 32.09 

11 to 50 ........................ 58 43.28 

51 to 100 ...................... 10 7.46 

101 to 500 .................... 18 13.43 

501 to 750 .................... 3 2.24 

751 to 1000 .................. 0 0.00 

1001 to 1500 ................ 0 0.00 

1501+ ............................ 2 1.49 

Total ....................... 134 100.00 

Question 2 of the survey asked about 

the company’s annual revenues; Table 3 

summarizes the survey responses: 

TABLE 3—SURVEY RESULTS—ANNUAL

REVENUE BY COMPANY

Response Count Percent 

Under $750,000 ............ 43 32.09 

$750,000 to $1 million .. 14 10.45 

$1 million to $2 million .. 20 14.93 

$2 million to $6 million .. 24 17.91 

$6 million to $10.5 million ............................. 8 5.97 

$10.5 million to $21.5 

million ........................ 7 5.22 

$21.5 million to $25 million ............................. 1 0.75 

$25 million to $30 million ............................. 4 2.99 

More than $30 million ... 13 9.70 

Total .......................... 134 100.00 

Most of these companies reported 

average annual revenue of $7 million or 

less. 

As noted above, ARSA did a survey 

and 134 members responded; the FAA 

believes that this is only a fraction of the 

total number of NCMS. As mentioned 

above, a small business is defined as 

having either 1,000 employees or less, 

or having revenue of $7 million or less, 

depending on the NAICS code. The 

majority of the companies in the ARSA 

survey are small entities which leads 

the FAA to believe that a substantial 

number of subcontractors will be small 

entities impacted by this rule. 

The next step is to estimate the 

economic impact. The FAA rule 

requires small businesses to administer 

random drug tests to those employees 

who perform safety-sensitive functions. 

For a high cost estimate, the FAA based 

costs on subcontractors initiating and 

then implementing their own programs. 

It is important to note that these costs 

are much higher than when repair 

stations or contractors at higher tiers 

absorb some of the cost of D&A testing 

for the smaller firms. Moreover, most 

repair stations have drug and alcohol 

programs and therefore would not 

experience a cost burden based on the 

amendments to this rule. However, to 

estimate the maximum impact of this 

regulation on regulated employers, the 

FAA assumes that all of the additional 

cost for D&A testing is absorbed by each 

NCMS. The costs include: (1) Testing, 

(2) training and education, (3) program 

development and maintenance, and 

(4) annual documentation. The 

assumptions and calculations are 

described below: 


emcdonald on DSK2BSOYB1PROD with RULES
12562 Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations 

2Two of the costs described below, testing costs 

and employee training costs, involve all employees, 

both supervisors and non-supervisors. For these 

two sets of calculations, the FAA uses a weighted 

wage rate from the maintenance supervisor and 

maintenance employee salary that is applicable to 

all employees. 

General Cost and Salary Assumptions 

Maintenance supervisor salary—$39.68/ 

hour 

Maintenance employee salary—$33.07/ 

hour 

Blended Wage 2—$33.84 

Instructor salary—$36.37/hour 

1 Supervisor for every 8 employees 

1 Instructor for every 20 employees 

Testing Cost 

Drug and alcohol tests are required 

periodically for all employees 

performing safety sensitive functions. 

The test costs approximately $45 or $35, 

respectively. The test includes specimen 

collection, laboratory processing, and 

MRO (medical review officer) 

verification. Testing takes place during 

an employee’s shift. This is time not 

worked but still paid by the company 

and is included as part of the testing 

cost. Previously, the FAA estimated that 

the testing process would take 45 

minutes, but because of industry 

comments the FAA has adopted a 2 

hour testing window for this analysis. 

The total cost of testing is calculated by 

adding the 2 hour blended wage paid to 

the employee to the cost of the test. The 

total cost of testing sums to $113 per 

employee for a drug test and $102 per 

employee for an alcohol test. 

Training and Education 

Training costs are a combination of 

supervisor and employee training costs, 

plus the cost to establish and maintain 

a training program. For both the 

antidrug and alcohol misuse prevention 

programs, the employer will train 

supervisors to make reasonable cause/ 

suspicion determinations. In addition, 

supervisors and employees will receive 

training 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. For 

supervisors, this training is initially 

estimated to take an hour and a half, 

followed by a recommended annual 

hourly refresher course. Employee 

training will also be given annually for 

approximately an hour. Training costs 

include the cost of the instructor at $84 

per supervisor and $70 per employee. 

Companies must also establish an 

education program that includes 

informational material, videos, etc. Per 

employee, these costs average $65 per 

person. Summing all of these together 

gives an estimated total education and 

training cost of either $149 per 

supervisor or $135 per employee per 

year. 

Program Development and Maintenance 

Each subcontractor will have to 

devote resources to developing an 

antidrug and alcohol misuse prevention 

testing program. In addition, each of 

these subcontractors will have to spend 

time to produce information required 

for their registration and submit it to the 

FAA. At the FAA, this information will 

have to be processed, and entered into 

the appropriate database. The FAA 

estimates that development and 

maintenance of a drug and alcohol 

program would each require a minimum 

of 16 administrative hours per program 

at $21 per hour for a total of $336 per 

company per year. 

Annual Documentation 

Each subcontractor has to periodically 

submit documentation. They will be 

required to report or submit the 

following documents; Training records, 

reasonable suspicion cases of drug and 

alcohol misuse, a positive drug or 

alcohol test, an employee’s refusal to 

submit to a drug or alcohol test, postaccident alcohol tests, and, if a postaccident alcohol test is not promptly 

administered, documentation stating the 

reasoning behind the delay. The FAA 

estimates that it will cost $1.29 to report 

each training record, to document each 

reasonable suspicious case, or to submit 

every rationale behind tests not being 

promptly administered. Notification of a 

positive drug or alcohol test or an 

employee’s refusal to be tested is 

estimated to take .25 administrative 

hours at an hourly rate of $21 at roughly 

$5 per notification. The FAA projects 

that these documents will be submitted 

annually, but each company on average 

only submits a certain number of 

reports. Using this average, 

documentation cost is estimated at $50 

per company for the first year and $4.50 

per company for subsequent years. 

We estimate that the typical 

subcontracting company has 25 

employees. This number comes from 

Table 2 above, where 75% of the 

respondents have fewer than 50 

employees. Several of the costs are 

variable costs and are dependent on the 

number of employees; testing costs, 

supervisor training, and employee 

training. For testing and training costs, 

the FAA multiplied the cost per 

employee by the average number of 

employees. For a small subcontracting 

company with 25 employees we 

estimate $2,825 for drug tests, $2,550 for 

alcohol tests, and $3,417 for training. 

Adding these numbers to per company 

cost of program development and 

maintenance and annual documentation 

costs gives the average cost percompany of $6,628 or $6,353 for drug 

testing and alcohol testing, respectively. 

Detailed calculations are done below. 

This value can be compared to annual 

revenues to determine the impact on 

companies with 25 employees. Using 

the survey results from Table 2 and 3 

above, we believe that a subcontracting 

company with 25 employees will have 

annual revenues of $750,000 to $2 

million. For a company with $750,000 

to $2 million in annual revenue 

estimated costs of $12,981 is less than 

2% of their annual revenue. From this 

example we conclude that even for 

firms with revenues less than $750,000 

per year, if we underestimated the 

compliance cost by more than 10%, the 

compliance cost is still less than 2% of 

their annual revenue. Since most of the 

costs are employee driven the 

compliance cost will be less than 2% of 

annual revenue for all companies. 

From this the FAA asserts that 

although there are a substantial number 

of small businesses the economic 

impact is minimal. 

Cost for Firms With 25 Employees and 

Annual Revenue of $750,000 to $2 

Million 

Cost of Drug Testing Program 

$113 Testing Cost × 25 Employees = 

$2,825 

$149 Supervisor Training × 3 

Supervisors = $447 

$135 Employee Training × 22 

Employees = $2,970 

$336 Program Development per 

Company 

+$50 for Annual Documentation per 

Company 

lllllllllllllllllll

Total Cost = $6,628 per Company 

Cost of Alcohol Testing Program 

$102 Testing Cost × 25 Employees = 

$2,550 

$149 Supervisor Training × 3 

Supervisors = $447 

$135 Employee Training × 22 

Employees = $2970 

$336 Program Development per 

Company = $336 

+$50 for Annual Documentation per 

Company 

lllllllllllllllllll

Total Cost = $6,353 per Company 

The FAA is aware that a substantial 

number of small entities must comply 

with this rule; however, the percentage 

of cost to revenue is less that 1 percent, 

therefore we believe that this rule does 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Rules and Regulations 12563 

not have a significant economic impact. 

Therefore the FAA preliminarily 

certifies that this rule will not have a 

significant economic impact on a 

substantial number of small entities. 

The FAA solicits comments regarding 

this determination on this supplemental 

regulatory flexibility analysis. Please 

provide detailed economic analysis to 

support the position of higher cost. The 

FAA also invites comments regarding 

other small entity concerns with respect 

to the final rule. 

Nan Shellabarger, 

Director, Office of Aviation Policy and Plans. 

[FR Doc. 2011–5257 Filed 3–7–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 14, and 17 

[Docket No. FDA–2010–N–0560] 

RIN 0910–AG55 

Amendments to General Regulations 

of the Food and Drug Administration; 

Confirmation of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of April 14, 2011, for the 

final rule that appeared in the Federal 

Register of November 30, 2010 (75 FR 

73951). The direct final rule amends 

certain general regulations of FDA to 

include tobacco products, where 

appropriate, in light of FDA’s authority 

to regulate these products under the 

Family Smoking Prevention and 

Tobacco Control Act, by revising the 

Agency’s regulations to require tobacco 

products to be subject to the same 

general requirements that apply to other 

FDA-regulated products. This document 

confirms the effective date of the direct 

final rule. 

DATES: Effective date confirmed: April 

14, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Gerie A. Voss, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

rm. 204G, Rockville, MD 20850, 1–877– 

CTP–1373. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 30, 2010 

(75 FR 73951), FDA solicited comments 

concerning the direct final rule for a 75- 

day period ending February 14, 2011. 

FDA stated that the effective date of the 

direct final rule would be on April 14, 

2011, 60 days after the end of the 

comment period, unless any significant 

adverse comment was submitted to FDA 

during the comment period. FDA did 

not receive any significant adverse 

comments. 

Authority: Therefore, under the Federal 

Food, Drug, and Cosmetic Act and under 

authority delegated to the Commissioner of 

Food and Drugs, 21 CFR parts 1, 14, and 17 

are amended. Accordingly, the amendments 

issued thereby are effective. 

Dated: March 2, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5147 Filed 3–7–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2011–N–0003] 

Oral Dosage Form New Animal Drugs; 

Spinosad and Milbemycin Oxime 

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 of a new animal drug 

application (NADA) filed by Elanco 

Animal Health. The NADA provides for 

veterinary prescription use of chewable 

tablets containing spinosad and 

milbemycin oxime in dogs for the 

treatment and prevention of flea 

infestations and for the prevention and 

control of various internal parasites. 

DATES: This rule is effective March 8, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Angela Clarke, Center for Veterinary 

Medicine (HFV–112), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8318, email: angela.clarke@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, A Division of Eli Lilly 

& Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed NADA 

141–321 that provides for veterinary 

prescription use of TRIFEXIS (spinosad 

and milbemycin oxime) Chewable 

Tablets in dogs for the treatment and 

prevention of flea infestations and for 

the prevention and control of various 

internal parasites. The NADA is 

approved as of January 4, 2011, and the 

regulations in part 520 (21 CFR part 

520) are amended by adding § 520.2134 

to reflect the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

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. 

Under section 512(c)(2)(F)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(ii)), this 

approval qualifies for 3 years of 

marketing exclusivity beginning on the 

date of approval. 

FDA has determined under 21 CFR 

25.33 that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

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. 

List of Subjects in 21 CFR Part 520 

Animal drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Add § 520.2134 to read as follows: 

§ 520.2134 Spinosad and milbemycin. 

(a) Specifications. Each chewable 

tablet contains 140 milligrams (mg) 

spinosad and 2.3 mg milbemycin oxime, 

270 mg spinosad and 4.5 mg 

milbemycin oxime, 560 mg spinosad 

and 9.3 mg milbemycin oxime, 810 mg 

spinosad and 13.5 mg milbemycin 

oxime, or 1,620 mg spinosad and 27 mg 

milbemycin oxime. 

(b) Sponsor. See No. 000986 in 

§ 510.600 of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer once a month at a 


emcdonald on DSK2BSOYB1PROD with RULES