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contains regulatory documents having general

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are keyed to and codified in the Code of

Federal Regulations, which is published under

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Rules and Regulations Federal Register

9327 

Vol. 75, No. 40 

Tuesday, March 2, 2010 

1 ICAO Annex 16, Volume I, Part II. Chapter 1, 

Paragraph 1,1 states that: The provisions of 1.2 to 

1.6 shall apply to all aircraft included in the 

classifications defined for noise certification 

purposes in Chapters 2, 3, 4, 5, 6, 8, 10, 11 and 12 

of this part where such aircraft are engaged in 

international air navigation. 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 91 

[Docket No.: FAA–2008–1097; Amendment 

No. 91–312] 

RIN 2120–AJ31 

Aircraft Noise Certification Documents 

for International Operations 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This action amends the 

operating rules to require U.S. operators 

flying outside the United States to carry 

aircraft noise certification information 

on board the aircraft. This rule is 

intended to ensure that affected U.S. 

operators have the appropriate noise 

certification information on board when 

they fly outside the United States as 

required by the International Civil 

Aviation Organization (ICAO), and to 

ensure compliance between domestic 

U.S. regulations and ICAO Annex 16, 

Amendment 8. 

DATES: This amendment becomes 

effective May 3, 2010. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions concerning this final 

rule contact Laurette Fisher, Office of 

Environment and Energy, AEE–100, 

Federal Aviation Administration, 800 

Independence Avenue, SW., 

Washington, DC 20591; telephone (202) 

267–3561; facsimile (202) 267–5594, email Laurette.fisher@faa.gov. For legal 

questions concerning this final rule 

contact Karen Petronis, Senior Attorney 

for Regulations, Office of the Chief 

Counsel, AGC–200, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone 202–267–3073, e-mail 

Karen.petronis@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Authority for This Rulemaking 

The FAA’s authority to issue rules on 

aviation safety is found in Title 49 of the 

United States Code. Subtitle I, Section 

106 describes the authority of the FAA 

Administrator. Subtitle VII, Aviation 

Programs, describes in more detail the 

scope of the agency’s authority. 

This rulemaking is promulgated 

under the authority described in 

Subtitle VII, Part A, Subpart III, Section 

44715, Controlling aircraft noise and 

sonic boom. Under that section, the 

FAA is charged with prescribing 

regulations to measure and abate aircraft 

noise. This proposed regulation is 

within the scope of that authority since 

it would require certain operators to 

carry on board documentation listing 

the noise characteristics of the aircraft. 

These characteristics are already 

contained in the aircraft flight manual 

and approved as part of the aircraft’s 

airworthiness certification, and 

compliance with 14 CFR part 36. 

Background 

On October 23, 2008, the FAA 

published a notice of proposed 

rulemaking (NPRM) proposing to amend 

14 CFR part 91 to add a new paragraph 

in § 91.703 to require the carriage of 

noise certification documents on board 

aircraft that leave the United States (73 

FR 63098). A brief history of the FAA’s 

regulation of aircraft noise certification 

requirements (14 CFR part 36) was 

presented in the preamble of the NPRM. 

The FAA proposed requiring affected 

operators that fly outside the United 

States using aircraft subject to the 

International Civil Aviation 

Organization (ICAO) Annex 16 1 to carry 

aircraft noise certification information 

on board the aircraft. As stated in the 

NPRM, the ICAO adopted this 

requirement in Amendment 8 of Annex 

16, Volume 1 on February 23, 2005, and 

it became effective on November 24, 

2005. Paragraph 1.4 of Annex 16 now 

requires that ‘‘documents attesting noise 

certification shall be approved by the 

State of Registry and required by that 

State to be carried on the aircraft.’’ 

The current U.S. regulations in part 

36 (§§ 36.1581 and 36.1583) describe the 

specific noise certification data 

requirements that need to be included 

in an FAA-approved Airplane Flight 

Manual (AFM) or Rotorcraft Flight 

Manual (RFM) as part of an aircraft’s 

certification. However, there is no 

specific operating requirement for the 

entire FAA-approved AFM/RFM to be 

carried on board an aircraft, including 

the noise certification data. In the 

United States, we have relied on the fact 

that no airworthiness certificate will be 

issued unless an aircraft complies with 

the applicable noise requirements in 

part 36. Accordingly, we have never 

implemented a separate operating rule 

that requires the data be on board the 

aircraft. The addition of this 

requirement is meant to satisfy the 

ICAO standard since other countries 

may not recognize the underlying U.S. 

system. 

For U.S. air carriers operating under 

part 121, a carrier is allowed to create 

an Aircraft Operations Manual (AOM) 

or a Flight Crew Operating Manual 

(FCOM) as an alternative to the AFM to 

be carried on board the aircraft. That 

manual typically contains only the 

aircraft limitations and performance 

information from the FAA-approved 

AFM. The AOM or FCOM may or may 

not contain the noise characteristics 

pages from the FAA-approved AFM, 

depending on the operator’s needs and 

the manual’s organization. This rule 

requires all U.S. operators to carry the 

appropriate noise certification 

information on board when they fly 

outside the United States. 

The issue of noise documentation was 

undertaken by the Certificate Task 

Group (CTG) of the ICAO’s Committee 

on Aviation Environmental Protection 

Noise Technical Working Group. As a 

member State of ICAO, the United 

States participates in this task group. A 

more in-depth discussion of the task 

group’s activities may be found in the 

preamble to the NPRM for this rule. 

The CTG considered various options 

for standardization of documents to be 

carried by aircraft operators. The ICAO 

member States use a variety of 

administrative systems, with differing 

requirements for noise documentation at 

certification and for designating 

documents that must be carried on 

board. The CTG proposed three options 

designed to accommodate the varying 

certification practices and existing 

regulatory systems of its member States. 

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The three options were incorporated 

into a new Attachment G to Annex 16, 

Volume 1, Amendment 8. Attachment G 

describes the three options to satisfy the 

certification documentation 

requirements of Sections 1.4 and 1.5 as 

follows: 

1. A stand-alone State-issued noise 

certificate in which the mandatory 

information requirements of Annex 16, 

Volume 1, are contained in a single 

document. 

2. Two complementary documents, 

one of which may be the Airplane Flight 

Manual (AFM) or the Airline Operations 

Manual (AOM). 

3. Three complementary documents. 

As explained in the NPRM, Option 1 

is not available to U.S. operators. The 

FAA does not have the statutory 

authority required to issue stand-alone 

noise certificates. 

Option 2, which requires the carriage 

of two complementary documents, 

accommodates those ICAO member 

States, including the United States, that 

do not include all noise certification 

data on a single certificate. 

Option 3, which requires three 

documents, was designed for other 

member States and would be more 

burdensome than option 2. 

ICAO Option 2 Compliance 

For U.S. operators, the first document 

is the aircraft airworthiness certificate 

issued by the FAA. An aircraft must 

meet the noise certification 

requirements of part 36 in order to be 

issued an airworthiness certificate, and 

it is already required to be carried on 

board. 

The second document is one that 

contains the noise certification data that 

is already contained in the AFM/RFM, 

but not required under current U.S. 

regulation to be carried on board. 

Operators that currently carry the noise 

data on board in the AFM, RFM, AOM, 

or FCOM may already satisfy ICAO 

option 2 and this regulation. 

Operators that do not carry the noise 

certification data as part of one of those 

documents have several choices. One is 

to incorporate the approved data as part 

of on-board manuals. One of the limits 

of this option is that noise certification 

data is often contained in different parts 

of the original flight manuals, and could 

be burdensome to locate, incorporate, 

and access. 

Operators may choose to create and 

carry a separate document containing 

the noise certification data required by 

ICAO. Annex 16 does not specify the 

format for that information, and neither 

does this regulation. 

Before ICAO changed Annex 16 to 

make the carriage of noise data 

mandatory, the FAA had published a 

draft Advisory Circular (AC) (70 FR 

60127, October 14, 2005) that 

recommended that U.S. operators be 

prepared to produce noise certification 

data when operating outside of the 

United States. That draft AC also 

included a suggested format for the data. 

Before that AC was made final, ICAO 

made data carriage mandatory. In 

response, the FAA realized that a 

regulatory change was needed and that 

advisory material was no longer 

appropriate. The AC was never 

finalized. 

When we proposed this rule change 

in 2008, we included an almostidentical version of the form from the 

draft AC as an optional means of 

gathering the AFM/RFM noise data that 

would satisfy the ICAO requirements as 

the second document for Option 2. That 

suggested form is also included here as 

one method of ensuring that the already 

approved data is easily accessed. 

Operators are free to adopt other ways 

to carry the data as fits their operations. 

Comments to the NPRM 

The FAA received 8 comments in 

response to the NPRM. Comments were 

submitted by four operators, two 

individuals, one industry association 

and one aircraft manufacturer. All the 

commenters except one supported the 

proposed rule. 

The NPRM sought input on the form 

in which the information is to be carried 

and included the draft optional form 

that included the information already in 

the possession of operators and required 

by Annex 16. Five of the commenters 

suggested that operators be allowed to 

determine the format in which noise 

certification data is to be carried, and 

where on the aircraft it will be kept. 

Ameristar Air Cargo suggested it be 

made part of an operator’s operations 

specifications because an additional 

document would be burdensome. FedEx 

Express indicated it had developed its 

own form and has been using it 

successfully in several ICAO countries 

since the FAA issued the draft AC in 

2005. Continental Airlines indicated 

that it has chosen to maintain the 

information in graph form as it appears 

in its airplane flight manuals from the 

manufacturers. Gulfstream Aerospace 

also stated that it had developed its own 

certificate for its customer that it 

believes meets the intent of the 

proposed regulation. 

The FAA agrees that operators are free 

to use whatever format works best for 

them as long as the information required 

by Annex 16 is available to the flight 

crew. It can be a form developed by a 

manufacturer, or by the operator for its 

own use. Operators may choose to 

incorporate the applicable pages from 

an FAA-approved flight manual, or they 

may transfer that data to an optional 

form such as the one provided as an 

example in the rule. As long as the 

information required by Annex 16 

Sections 1.4 and 1.5 is included for 

individual aircraft and accessible to the 

flight crew, an operator will be in 

compliance with this regulation. 

We disagree that the operations 

specifications are an appropriate place 

for such information. Operations 

specifications are not designed to be 

aircraft specific. As illustrated by the 

optional form and indicated in the 

NPRM, discrete information for each 

airplane must be carried. Airplanes may 

not be grouped on a form, such as a list 

of serial numbers for all of the aircraft 

of one model. 

Note that we do not and will not refer 

to this information carried in any form 

as a ‘‘noise certificate’’ since it is not 

issued by the FAA and does not have 

the legal standing of a certificate issued 

by the FAA. As discussed previously, 

the FAA has no authority to issue such 

a certificate. Calling such items ‘‘noise 

certificates’’ could be confusing since 

there are countries that issue noise 

certificates. 

FedEx Express suggested several 

changes to the information as shown on 

the optional form, including changing 

the name to ‘‘Noise Certification 

Document,’’ removing certain 

information identifying the operator, 

deleting the references to the source of 

the noise data (such as the dated 

airplane flight manual with the revision 

number), and deleting the information 

at the end of the form indicating that the 

data were included in an FAA-approved 

document and that responsibility for its 

correct transfer is that of the operator. 

None of these changes is acceptable. 

The suggested change to reference part 

36 compliance in lieu of a reference to 

an approved manual is unacceptable 

since a statement of part 36 compliance, 

by itself, does not provide any 

information specific to the aircraft. 

While FedEx Express states that it could 

be burdensome to have to change the 

reference when an AFM is revised, the 

AFM remains the document that 

contains the FAA approval for the 

aircraft noise data, and is thus the 

source of the data regardless of the 

format in which an operator chooses to 

carry it. Further, allowing the operator 

the choice of format is a reason to 

clearly indicate that the data were 

formatted by the operator, not the FAA, 

and that the only FAA-approved source 

is the airplane flight manual. That 

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information is considered essential to 

Annex 16 compliance. 

One operator, Florida Air Transport, 

indicated that it operates several older 

airplanes between the United States and 

places in the Caribbean. None of its 

airplanes have ever been noise 

certificated since all pre-date the 

requirements for such testing and 

certification. Florida Air Transport 

asked if ICAO has an exemption for 

such aircraft. 

Annex 16 does not account for the 

existence of older airplanes that were 

never subject to noise certification 

requirements. The concept is well 

understood in other ICAO member 

States, however, and certain 

‘‘grandfathering’’ clauses have been 

adopted, some informally. 

The FAA will be publishing guidance 

in the form of an AC on what airplanes 

it has determined pre-date the noise 

certification requirements of part 36. In 

order to comply with this regulation, we 

suggest that some form be carried 

containing as much information as is 

available regarding the aircraft, but we 

will provide a recommended statement 

for inclusion that replaces certain noise 

levels that are not entered on the form. 

The FAA anticipates that the AC will be 

available at the time the final rule is 

published. 

The Regional Airline Association 

requested that the proposed rule be 

withdrawn since the FAA did not 

indicate in the NPRM how we 

concluded that a regulation was 

necessary. The RAA indicated that the 

‘‘only rationale’’ for the proposed 

regulation is that ‘‘it might ‘help’ U.S. air 

carriers who might possibly be cited by 

inspectors in other countries.’’ The RAA 

said that since ICAO standards ‘‘are 

directed at ‘‘States of Registry’’ not the 

individual airlines,’’ it is within the 

prerogative of a member State not to 

enforce, and suggests the FAA request a 

waiver, which the RAA characterizes as 

‘‘routine.’’ 

The RAA is mistaken in its 

characterization of Annex 16 and the 

actions required by ICAO member 

States. While it is possible to file a 

difference with ICAO standards, it is not 

a routine occurrence and carries more 

than moderate risk. It is not simply a 

matter of a member State choosing not 

to enforce one of the ICAO regulations. 

Aircraft operators that do not comply 

with ICAO standards may be denied 

entry to other ICAO countries. Filing a 

difference merely serves notice that the 

operators from a member State are not 

in compliance, it is not a free pass to 

ignore particular ICAO regulations. 

Before the carriage of noise 

documentation was a requirement in 

Annex 16, it was a note, which was 

advisory in nature and suggested that 

noise certification data be carried on an 

aircraft that left its member State. In 

2005, however, ICAO adopted it as a 

requirement in Annex 16 and the 

advisory nature of compliance 

disappeared. As stated in the NPRM, 

when a review of our regulations 

revealed that there was no requirement 

in U.S. regulations to carry noise data, 

we began the process of this rulemaking 

to comply with the Annex requirement. 

The FAA is not requiring any 

particular format for carriage of the 

information, but cautions operators that 

all of the information required by the 

Annex must be carried to comply with 

both Annex 16 and the new 

§ 91.703(a)(5). Annex 16 contains 

Attachment G, which is the ICAO’s 

suggested format for the document. The 

FAA developed the optional form 

included in this document from 

Attachment G, modifying it to indicate 

that the form is the responsibility of the 

operator and not an FAA-approved 

document. For an operator that does not 

have the resources to research and 

develop its own form, we strongly 

suggest that the optional FAA form be 

used to eliminate inconsistencies in the 

data carried. The FAA has received 

approval from the Office of Management 

and Budget (OMB #2120–0737) to 

maintain this as an official form. 

One commenter recommended that 

the FAA also issue an Advisory Circular 

(AC) or other guidance regarding means 

of compliance for this proposal. 

The FAA will be issuing guidance 

material at the time this final rule is 

published. We anticipate that the AC 

will contain the optional form, the 

instructions for completing the form 

that appear in this document, and 

guidance for aircraft that are not 

required to be noise certificated because 

of their age. 

Summary of Changes to the Final Rule 

No substantive changes are being 

made from the rule proposed in the 

NPRM. This final rule adds a new 

paragraph (a)(5) to § 91.703 that requires 

aircraft subject to ICAO Annex 16 to 

carry noise certification data on board 

when those aircraft leave the United 

States. 

Format of the data is at the operator’s 

discretion. Operators developing their 

own formats are advised to ensure that 

all of the information required by ICAO 

Annex 16 Sections 1.4 and 1.5 is 

included. Data carried on board must be 

specific to each aircraft. Lists of aircraft 

noise levels that apply to more than one 

serial number aircraft are not acceptable 

for compliance. The FAA encourages 

operators to use the optional form 

included in this publication as a means 

of ensuring that all of the required data 

are included. The data, in whatever 

chosen format, must be available to the 

flight crew. To the extent that operators 

have the approval to carry documents 

electronically, this information may be 

included. The FAA will not be signing 

or otherwise approving the forms 

carried by the operator. The FAA does 

not issue noise certificates and 

information carried to comply with this 

regulation may not be referred to as an 

official or approved noise certificate. 

Accurate data transfer from an FAAapproved data source is the 

responsibility of the operator. 

BILLING CODE 4910–13–P 

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BILLING CODE 4910–13–C 

The following describes the data to be 

entered on the form: 

1. United States of America (ICAOrequired name of member State). 

2. Title (Aircraft Noise Certification 

Information), plus the name of the 

operator and contact information. 

3. Document number (optional for 

operator’s use). 

4. The nationality or common mark 

and registration marks (in the United 

States, N-number). 

5. The aircraft manufacturer and 

manufacturer’s designation of the 

aircraft (model and series, as 

appropriate). 

6. The aircraft serial number. 

7. The type and model of the subject 

aircraft’s engine(s) (for identification 

and verification of the aircraft 

configuration). 


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2 In 1959, the directors of the national standards 

laboratories of the United States, Canada, the 

United Kingdom, Australia, New Zealand, and the 

Union of South Africa agreed on common 

definitions of the customary length and mass units. 

They define the pound avoirdupois as 4.53592 E– 

01 kg. The engineering practice of using lbm for 

pound mass is obsolete. 

8. For propeller-driven airplanes, the 

propeller type and model. 

9. The maximum takeoff mass and 

unit. The primary U.S. unit differs from 

the international unit: the appropriate 

conversion factor can be found in ICAO 

Annex 5. To avoid confusion, a U.S. 

operator may choose to record weight/ 

mass in both English and metric units. 

An example of a conversion change 

from pounds to kilograms is shown 

below: 

Aircraft weight (pounds) conversion 

to aircraft mass (kilograms) 2: 

To convert 

aircraft weight 

from 

to Multiply by 

pound (lb) ..... kilogram (kg) 4.53592 E– 

01. 

Example: For a Boeing 747–400F that 

weighs 875,000 lb, 875,000 (lb) × 

4.53592 E–01 (kg/lb) = 396,893 (kg) 

10. The maximum landing mass and 

unit. To avoid confusion, a U.S. 

operator may choose to record weight/ 

mass in both English and metric units. 

See conversion example above. 

11. The Part 36 noise stage of the 

certificated aircraft. The terminology of 

aircraft certification classification in the 

United States is ‘‘Stage’’ rather than 

‘‘Chapter’’ as used in Annex 16. The U.S. 

term is recognized by ICAO and is not 

considered a difference from Annex 16. 

Note that the term ‘‘Stage’’ is not 

applicable to airplanes certificated 

under 14 CFR part 36, Subpart F. 

12. Any modifications to the aircraft 

incorporated for compliance with 

applicable noise certification standards. 

This item should include any 

modifications to the basic aircraft 

described in items 7 and 8. 

13. The lateral/full-power noise level, 

as certificated. Operators of U.S.- 

registered aircraft must use the 14 CFR 

part 36 certificated noise levels, 

expressed as Effective Perceived Noise 

Level (EPNdB). Note: For 14 CFR part 

36, appendix B, certifications that 

predate Amendment 36–24 use the term 

‘‘sideline’’ instead of ‘‘lateral.’’ 

14. The approach noise level, as 

certificated. Operators of U.S.-registered 

aircraft must use the 14 CFR part 36, 

appendices B or H certificated noise 

levels, expressed as EPNdB. 

15. The flyover noise level, as 

certificated. Operators of U.S.-registered 

aircraft must use the 14 CFR part 36 

certificated noise levels, expressed as 

EPNdB. For rotorcraft, certificated under 

appendices H or J, noise levels are 

expressed as either EPNdB or Aweighted Sound Exposure Level (dBA 

SEL), respectively. Note: For 14 CFR 

part 36, appendix B certifications that 

predate Amendment 36–24 use the term 

‘‘takeoff’’ instead of ‘‘flyover.’’ 

16. The overflight noise level, as 

certificated. Operators of U.S.-registered 

aircraft must include the 14 CFR part 36 

certificated noise levels. For small 

airplanes, certificated under appendix 

F, noise levels are expressed as 

maximum A-weighted sound level 

(dBA). For rotorcraft, certificated under 

appendices H or J, noise levels are 

expressed as either EPNdB or Aweighted SEL (dBA SEL), respectively. 

Note: The terminology describing this 

noise level in 14 CFR part 36 is ‘‘flyover’’ 

rather than ‘‘overflight’’ as used in Annex 16. 

17. The takeoff noise level, as 

certificated. Operators of U.S.-registered 

aircraft must use the 14 CFR part 36, 

appendices G and H certificated noise 

levels as described in item 16. 

18. A statement that the individual 

aircraft complies with the applicable 

noise requirements of the U.S. 

regulations applicable to its type and 

size. 

19. The date on which the noise 

certification document was created by 

the operator. 

20. The signature of the official of the 

operator attesting to the accuracy of the 

information in the FAA Form. 

Listing multiple aircraft with similar 

characteristics on the same document 

will not be allowed. Only the data for 

the single aircraft listed in the serial 

number and registration sections is to be 

listed on this form. Failure to carry the 

correct information, regardless of form, 

is considered a violation of the 

regulation. 

Paperwork Reduction Act 

Information collection requirements 

associated with this final rule have been 

previously approved by the Office of 

Management and Budget (OMB) under 

the provisions of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)), and have been assigned OMB 

Control Number 2120–0737. 

International Compatibility 

In keeping with U.S. obligations 

under the Convention on International 

Civil Aviation, the FAA policy is to 

conform to International Civil Aviation 

Organization (ICAO) Standards and 

Recommended Practices to the 

maximum extent practicable. The FAA 

has reviewed the corresponding ICAO 

Standards and Recommended Practices 

and has determined this regulation is a 

means of compliance with Annex 16 

regarding noise documentation carried 

on board aircraft that leave the United 

States. 

Regulatory Evaluation 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 directs 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). 

The Department of Transportation 

Order DOT 2100.5 prescribes policies 

and procedures for simplification, 

analysis, and review of regulations. If 

the expected cost impact is so minimal 

that the proposal or final rule does not 

warrant a full evaluation, this order 

permits that a statement to that effect 

and the basis for it to be included in the 

preamble if a full regulatory evaluation 

of the cost and benefits is not prepared. 

Such a determination has been made for 

this final rule. The reasoning for this 

determination follows: 

This final rule will require operators 

of U.S. registered civil aircraft flying 

outside the United States subject to 

ICAO Annex 16, Volume 1, Amendment 

8, to carry aircraft noise certification 

data on board the aircraft. Operators 

may comply with the rule by 

transferring the data from the Airplane 

Flight Manual or Airline Operations 

Manual to a suggested form included in 

this rulemaking. Operators may also 

choose to carry the required information 

in a different format. The rule will 

require that this information be easily 

accessible to the flight crew and 

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3Tables 20 and 21, U.S. Mainline Air Carriers, 

Cargo Jet Aircraft, FAA Aerospace Forecast, FY 

2008–2025. 

4FAA, APO–310, N & O Rule Regulatory 

Evaluation. 

5Hourly wage derived by taking median salary of 

$133,916 for a chief pilot, dividing by 2,080 hours 

per year, and multiplying by the fringe benefit 

factor of 1.2345. Salary source: http:// 

swz.salary.com/salarywizard/layouthtmls/ 

swzl_compresult_national_TR20000019.html, last 

accessed June 30, 2008. 

presentable upon request to the 

appropriate officials. 

The FAA was unable to determine the 

exact number of U.S. registered aircraft 

that will be subject to this final rule. 

Also, the FAA received no comments 

about its methodology used to estimate 

the cost of this rule. Therefore, the FAA 

will continue to use (as an overestimate) 

the total number of passenger jet and 

cargo jet aircraft registered to U.S. 

mainline carriers in its cost 

computations. Based on the FAA 

Aerospace Forecast, there are a total of 

5,066 aircraft currently registered to 

U.S. mainline air carriers.3

For the purposes of this analysis, we 

assume that operators would choose to 

comply with the final rule by using the 

provided recommended form. This form 

would be completed one time for each 

aircraft. We estimate that completion of 

the form would require 15 minutes of a 

technical writer’s time and 10 minutes 

of a chief pilot’s or chief engineer’s 

time. The average wage rate for a 

technical writer is $29.95 per hour 4

after accounting for fringe benefits. The 

average wage rate for a chief pilot or 

chief engineer is estimated at $79.48 per 

hour 5 after accounting for fringe 

benefits. 

The cost of the final rule per affected 

airplane was derived by multiplying the 

technical writer’s wage rate of $29.95 

per hour by 0.25 hours required to 

complete the form, and adding to that 

the chief pilot’s wage rate of $79.48 per 

hour multiplied by 0.17 hours required 

to review and sign the form. Thus, 

compliance with this regulation will 

result in a per-airplane cost of $21. As 

a result, the initial cost of the final rule 

will be $21 per aircraft times 5,066 

aircraft, for a total of $106,386. 

Operators may subsequently decide to 

purchase or modify aircraft affected by 

the final rule. If they do so, operators 

will incur an extra cost of $21 per 

additional airplane to bring it into 

compliance with ICAO Annex 16, 

Volume 1, Amendment 8. 

This final rule will ensure that U.S. 

aircraft that fly outside the United States 

are in compliance with ICAO Annex 16, 

Amendment 8. Operators will benefit 

from the rule by having the proper 

documentation readily available for 

foreign authorities, avoiding delays and 

detainment when noise certification 

status is questioned. The FAA believes 

that the negligible cost of compliance 

with this rule is outweighed by the 

benefit of compliance with the 

international standard. 

Regulatory Flexibility Determination 

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, 

agencies are required 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. 

This rule will ensure that U.S. 

operators have consistent noise 

certification information on board when 

they fly outside the United States. This 

rule is needed to ensure compliance 

with the ICAO Annex 16 that requires 

certain noise information be carried on 

board. Under the final rule, each small 

entity will incur a one-time cost of $21 

per aircraft currently in its fleet. 

Operators may subsequently decide to 

purchase or modify aircraft affected by 

the final rule; if they do so, they will 

incur an extra cost of $21 per airplane 

to comply. The FAA does not consider 

this a significant cost. The FAA received 

no comments from the public regarding 

this finding. Therefore, as the 

Administrator of the FAA, I certify that 

this final rule will not have a significant 

impact on a substantial number of small 

entities. 

International Trade Impact Assessment 

The Trade Agreements Act of 1979 

(Pub. L. 96–39), as amended by the 

Uruguay Round Agreement Act (Pub. L. 

103–465), prohibits Federal agencies 

from establishing standards or engaging 

in related activities that create 

unnecessary obstacles to the foreign 

commerce of the United States. 

Legitimate domestic objectives, such as 

safety, are not considered unnecessary 

obstacles to the foreign commerce of the 

United States, so long as the standard 

has a legitimate domestic objective, 

such as the protection of safety, and 

does not operate in a manner that 

excludes imports that meet this 

objective. The statute also requires 

consideration of international standards 

and, where appropriate, that they be the 

basis for U.S. standards. The FAA has 

assessed the potential effect of this final 

rule and has determined that it will 

affect only those U.S. operators that 

conduct international operations. The 

expected outcome of this final rule will 

be a minimal impact on affected 

operators with the net benefits of ICAO 

compliance. 

Unfunded Mandates Assessment 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) 

requires each Federal agency to prepare 

a written statement assessing the effects 

of any Federal mandate in a proposed or 

final agency rule that may result in an 

expenditure of $100 million or more 

(adjusted annually for inflation with the 

base year 1995) in any one year by State, 

local, and tribal governments, in the 

aggregate, or by the private sector; such 

a mandate is deemed to be a ‘‘significant 

regulatory action.’’ The FAA currently 

uses an inflation-adjusted value of 

$136.1 million in lieu of $100 million. 

This final rule does not contain such 

a mandate. 

Executive Order 13132, Federalism 

The FAA has analyzed this NPRM 

under the principles and criteria of 

Executive Order 13132, Federalism. We 

determined that this action will not 

have a substantial direct effect on the 

States, or the relationship between the 

Federal Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, and, therefore, 

does not have federalism implications. 

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 

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Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Rules and Regulations 9333 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 312f and involves no 

extraordinary circumstances. 

Regulations That Significantly Affect 

Energy, Supply, Distribution, or Use 

The FAA has analyzed this NPRM 

under Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

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

have determined that it is not a 

‘‘significant energy action’’ under the 

executive order because it is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866, and it is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. 

Availability of Rulemaking Documents 

You can get an electronic copy of 

rulemaking documents using 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 Web page at http:// 

www.gpoaccess.gov/fr/index.html. 

You can also get a copy 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. Make sure to 

identify the amendment number or 

docket number of this rulemaking. 

You may search the electronic form of 

all comments received into any of our 

dockets by the name of the individual 

submitting the comment (or signing the 

comment, if submitted on behalf of an 

association, business, labor union, etc.). 

You may review DOT’s complete 

Privacy Act statement in the Federal 

Register published on April 11, 2000 

(Volume 65, Number 70; Pages 19477– 

78) or you may visit http:// 

DocketsInfo.dot.gov. 

Small Business Regulatory Enforcement 

Fairness Act 

The Small Business Regulatory 

Enforcement Fairness Act (SBREFA) of 

1996 requires FAA to comply with 

small entity requests for information or 

advice about compliance with statutes 

and regulations within its jurisdiction. If 

you are a small entity and you have a 

question regarding this document, you 

may contact your local FAA official, or 

the person listed under the FOR FURTHER

INFORMATION CONTACT heading at the 

beginning of the preamble. You can find 

out more about SBREFA on the Internet 

at http://www.faa.gov/ 

regulations_policies/rulemaking/ 

sbre_act/. 

List of Subjects in 14 CFR part 91 

Aircraft, Noise control, Reporting and 

recordkeeping requirements. 

The Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends Chapter 1 of Title 14, Code of 

Federal Regulations, as follows: 

PART 91—GENERAL OPERATING AND 

FLIGHT RULES 

■ 1. The authority citation for part 91 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 1155, 40103, 

40113, 40120, 44101, 44111, 44701, 44709, 

44711, 44712, 44715, 44716, 44717, 44722, 

46306, 46315, 46316, 46504, 46506, 46507, 

47122, 47508, 47528–47531, articles 12 and 

29 of the Convention on International Civil 

Aviation (61 stat 1180). 

■ 2. Amend § 91.703 by adding 

paragraph (a)(5) to read as follows: 

§ 91.703 Operations of civil aircraft of U.S. 

registry outside of the United States. 

(a) * * * 

(5) For aircraft subject to ICAO Annex 

16, carry on board the aircraft 

documents that summarize the noise 

operating characteristics and 

certifications of the aircraft that 

demonstrate compliance with this part 

and part 36 of this chapter. 

* * * * * 

Issued in Washington, DC, on February 18, 

2010. 

J. Randolph Babbitt, 

Administrator. 

[FR Doc. 2010–4316 Filed 3–1–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2010–N–0002] 

Implantation or Injectable Dosage 

Form New Animal Drugs; Tilmicosin 

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 supplemental new animal 

drug application (NADA) filed by 

Elanco Animal Health, A Division of Eli 

Lilly & Co. The supplemental NADA 

provides a dose range for use of an 

injectable solution of tilmicosin 

phosphate for treatment of respiratory 

disease in cattle and additional 

pathogens for which this therapy is 

effective. 

DATES: This rule is effective March 2, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, A Division of Eli Lilly 

& Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed a 

supplement to NADA 140–929 for 

MICOTIL 300 (tilmicosin injection, 

USP) Injection, available by veterinary 

prescription for use in the treatment and 

control of respiratory disease in cattle 

and the treatment of respiratory disease 

in sheep. The supplemental NADA 

establishes a dose range and adds 

pathogens for which this therapy is 

effective in the management of bovine 

respiratory disease. As a consequence of 

revising the dosage, the preslaughter 

withdrawal period has been 

recalculated. The supplemental NADA 

is approved as of December 30, 2009, 

and the regulations in 21 CFR 522.2471 

are amended 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)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

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

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

on the date of approval. 

The agency 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 

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