44278 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations 

(iv) Repayment of the Federal share of 

a cost-shared activity under Section 988 

of the Energy Policy Act of 2005 shall 

not be a condition of the award. 

§ 600.31 [Amended] 

■ 26. Section 600.31 is amended as 

follows: 

■ a. In paragraph (c), the phrase 

‘‘Contracting Officer’’ is capitalized in 

all occurrences. 

■ b. In paragraph (d), the phrase 

‘‘Contracting Officer’’ is capitalized. 

■ c. In paragraph (f)(5), the phrase 

‘‘Contracting Officer’’ is capitalized. 

■ 27. Section 600.112 is revised to read 

as follows: 

§ 600.112 Forms for applying for Federal 

assistance. 

(a) General. An application for an 

award shall be on the form or in the 

format specified in a program rule or in 

the funding opportunity announcement. 

When a version of the Standard Form 

424 is not used, DOE shall indicate 

whether the application is subject to 

review by the State under Executive 

Order 12372. 

(b) Budgetary information. DOE may 

request and the applicant shall submit 

the minimum budgetary information 

necessary to evaluate the costs of the 

proposed project. 

(c) DOE may, subsequent to receipt of 

an application, request additional 

information from an applicant when 

necessary for clarification or to make 

informed preaward determinations. 

(d) Continuation and renewal 

applications. DOE may require that an 

application for a continuation or 

renewal award be made in the format or 

on the forms authorized by paragraphs 

(a) and (b) of this section. 

§ 600.113 [Amended] 

■ 28. Section 600.113 is amended by 

removing ‘‘10 CFR part 1036’’ and 

adding ‘‘2 CFR 180 and 901’’ in its 

place. 

§ 600.117 [Removed and Reserved] 

■ 29. Section 600.117 is removed and 

reserved. 

§ 600.305 [Amended] 

■ 30. Section 600.305 is amended by 

removing ‘‘10 CFR part 1036’’ and 

adding ‘‘2 CFR 180 and 901’’ in its 

place. 

PART 1024—[REMOVED] 

■ 31. Under the authority of 42 U.S.C. 

7254, part 1024 is removed. 

[FR Doc. E9–20299 Filed 8–27–09; 8:45 am] 

BILLING CODE 6450–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 25 

[Docket No. NM398; Special Conditions No. 

25–390–SC] 

Special Conditions: Alenia Aeronautica 

Model C–27J Airplane; Interaction of 

Systems and Structures 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final special conditions. 

SUMMARY: These special conditions are 

issued for the Alenia Model C–27J 

airplane. This airplane will have novel 

or unusual design features when 

compared to the state of technology 

described in the airworthiness standards 

for transport-category airplanes. These 

special conditions pertain to the effects 

of novel or unusual design features such 

as effects on the structural performance 

of the airplane. 

The applicable airworthiness 

regulations do not contain adequate or 

appropriate safety standards for this 

design feature. These special conditions 

contain the additional safety standards 

that the Administrator considers 

necessary to establish a level of safety 

equivalent to that established by the 

existing airworthiness standards. 

DATES: Effective Date: September 28, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Holly Thorson, FAA, International 

Branch, ANM–116, Transport Airplane 

Directorate, Aircraft Certification 

Service, 1601 Lind Avenue, SW., 

Renton, Washington 98057–3356; 

telephone (425) 227–1357, facsimile 

(425) 227–1149. 

SUPPLEMENTARY INFORMATION: 

Background 

On March 27, 2006, the European 

Aviation Safety Agency (EASA) 

forwarded to the FAA an application 

from Alenia Aeronautica of Torino, 

Italy, for U.S. type certification of a 

twin-engine commercial transport 

designated as the Alenia model C–27J. 

The Alenia model C–27J is a twinturbopropeller, cargo-transport aircraft 

with a maximum takeoff weight of 

67,240 pounds. 

Type Certification Basis 

Under the provisions of Title 14, Code 

of Federal Regulations (14 CFR) 21.17 

and the bilateral agreement between the 

U.S. and Italy, Alenia Aeronautica must 

show that the Alenia model C–27J meets 

the applicable provisions of 14 CFR part 

25, as amended by Amendments 25–1 

through 25–87. Alenia also elects to 

comply with Amendment 25–122, 

effective September 5, 2007, for 

§ 25.1317. 

If the Administrator finds that 

existing airworthiness regulations do 

not adequately or appropriately address 

safety standards for the Alenia model 

C–27J due to a novel or unusual design 

feature, we prescribe special conditions 

under provisions of § 21.16. 

In addition to the applicable 

airworthiness regulations and special 

conditions, the Alenia model C–27J 

must comply with the fuel-vent and 

exhaust-emission requirements of 14 

CFR part 34 and the noise-certification 

requirements of 14 CFR part 36. In 

addition, the FAA must issue a finding 

of regulatory adequacy pursuant to § 611 

of Public Law 92–574, the ‘‘Noise 

Control Act of 1972.’’ 

The FAA issues special conditions, as 

defined in 14 CFR 11.19, in accordance 

with § 11.38, and they become part of 

the type-certification basis under 

§ 21.17(a)(2). 

Special conditions are initially 

applicable to the model for which they 

are issued. Should the type certificate 

for that model be amended later to 

include any other model that 

incorporates the same or similar novel 

or unusual design feature, the special 

conditions also apply to the other model 

under § 21.101. 

Novel or Unusual Design Features 

The Alenia model C–27J incorporates 

several novel or unusual design 

features. Because of rapid improvements 

in airplane technology, the existing 

airworthiness regulations do not 

adequately or appropriately address 

safety standards for these design 

features. These special conditions for 

the Alenia model C–27J contain the 

additional safety standards that the 

Administrator considers necessary to 

establish a level of safety equivalent to 

that established by the existing 

airworthiness standards. 

These special conditions were derived 

initially from standardized requirements 

developed by the Aviation Rulemaking 

Advisory Committee (ARAC), 

comprised of representatives of the 

FAA, Europe’s Joint Aviation 

Authorities (JAA), now replaced by the 

European Aviation Safety Agency 

(EASA), and industry. From the initial 

proposal, the JAA proposed these 

special conditions in Notice of Proposed 

Amendment (NPA) 25C–199. When 

Ente Nazionale per l’Aviazione Civile 

(ENAC) certified the Alenia model 

C–27J they applied NPA 25C–199, 

issued July 3, 1997. 


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Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations 44279 

Discussion 

The Alenia model C–27J is equipped 

with systems that affect the airplane’s 

structural performance, either directly 

or as a result of failure or malfunction. 

That is, the airplane’s systems affect 

how it responds in maneuver and gust 

conditions, and thereby affect its 

structural capability. These systems may 

also affect the aeroelastic stability of the 

airplane. Such systems represent a 

novel and unusual feature when 

compared to the technology described 

in the current airworthiness standards. 

Special conditions are needed to require 

consideration of the effects of systems 

on the structural capability and 

aeroelastic stability of the airplane, in 

both the normal and the failed states. 

These special conditions require that 

the airplane meet the structural 

requirements of subparts C and D of part 

25 when the airplane systems are fully 

operative. These special conditions also 

require that the airplane meet these 

requirements taking into consideration 

failure conditions. In some cases, 

reduced margins are allowed for failure 

conditions based on system reliability. 

Discussion of Comments 

Notice of proposed special conditions 

no. 25–09–01–SC for the Alenia model 

C–27J airplane was published in the 

Federal Register on May 4, 2009. No 

comments were received, and the 

special conditions are adopted as 

proposed. 

Applicability 

As discussed above, these special 

conditions are applicable to the Alenia 

model C–27J. Should Alenia apply at a 

later date for a change to the type 

certificate to include another model 

incorporating the same novel or unusual 

design features, these special conditions 

apply to that model as well. 

Conclusion 

This action affects only certain novel 

or unusual design features of the Alenia 

model C–27J. It is not a rule of general 

applicability, and it affects only the 

applicant that applied to the FAA for 

approval of these features on the 

airplane. 

List of Subjects in 14 CFR Part 25 

Aircraft, Aviation safety, Reporting 

and recordkeeping requirements. 

■ The authority citation for these 

special conditions is as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701, 

44702, 44704. 

The Special Conditions 

■ Accordingly, pursuant to the authority 

delegated to me by the Administrator, 

the following special conditions are 

issued as part of the type-certification 

basis for the Alenia model C–27J. 

1. General 

(a) The Alenia model C–27J is 

equipped with systems that affect the 

airplane’s structural performance either 

directly or as a result of failure or 

malfunction. The influence of these 

systems and their failure conditions 

must be taken into account when 

showing compliance with requirements 

of subparts C and D of Title 14 of the 

Code of Federal Regulations (14 CFR), 

part 25. The following criteria must be 

used for showing compliance with these 

special conditions for airplanes 

equipped with flight control systems, 

autopilots, stability-augmentation 

systems, load-alleviation systems, 

flutter-control systems, fuelmanagement systems, and other systems 

that either directly, or as a result of 

failure or malfunction, affect structural 

performance. If these special conditions 

are used for other systems, it may be 

necessary to adapt the criteria to the 

specific system. 

(b) The criteria defined here address 

only the direct structural consequences 

of the system responses and 

performances, and cannot be considered 

in isolation, but should be included in 

the overall safety evaluation of the 

airplane. These criteria may, in some 

instances, duplicate standards already 

established for this evaluation. These 

criteria are only applicable to structure 

the failure of which could prevent 

continued safe flight and landing. 

Specific criteria that define acceptable 

limits on handling characteristics or 

stability requirements, when operating 

in the system-degraded or inoperative 

mode, are not provided in these special 

conditions. 

(c) Depending upon the specific 

characteristics of the airplane, 

additional studies may be required, that 

go beyond the criteria provided in these 

special conditions, to demonstrate the 

capability of the airplane to meet other 

realistic conditions, such as alternative 

gust or maneuver descriptions, for an 

airplane equipped with a loadalleviation system. 

(d) The following definitions are 

applicable to these special conditions. 

Structural Performance 

Capability of the airplane to meet the 

structural requirements of part 25. 

Flight Limitations 

Limitations that can be applied to the 

airplane flight conditions following an 

in-flight occurrence, and that are 

included in the flight manual (e.g., 

speed limitations, avoidance of severe 

weather conditions, etc.). 

Operational Limitations 

Limitations, including flight 

limitations, that can be applied to the 

airplane operating conditions before 

dispatch (e.g., fuel, payload, and Master 

Minimum Equipment List limitations). 

Probabilistic Terms 

The probabilistic terms (probable, 

improbable, extremely improbable) used 

in these special conditions are the same 

as those used in § 25.1309. 

Failure Condition 

The term ‘‘failure condition’’ here is 

the same as that used in § 25.1309. 

However, these special conditions apply 

only to system-failure conditions that 

affect the structural performance of the 

airplane (e.g., system-failure conditions 

that induce loads, change the response 

of the airplane to variables such as gusts 

or pilot actions, or reduce flutter 

margins). 

2. Effects of Systems on Structures 

(a) General. The following criteria 

determine the influence of a system and 

its failure conditions on the airplane 

structure. 

(b) System fully operative. With the 

system fully operative, the following 

apply: 

(1) Limit loads must be derived in all 

normal operating configurations of the 

system from all the limit conditions 

specified in Subpart C, taking into 

account any special behavior of such a 

system or associated functions, or any 

effect on the structural performance of 

the airplane that may occur up to the 

limit loads. In particular, any significant 

nonlinearity (rate of displacement of 

control surface, thresholds, or any other 

system nonlinearities) must be 

accounted for in a realistic or 

conservative way when deriving limit 

loads from limit conditions. 

(2) The airplane must meet the 

strength requirements of part 25 (static 

strength, residual strength) using the 

specified factors to derive ultimate loads 

from the limit loads defined above. The 

effect of nonlinearities must be 

investigated beyond limit conditions to 

ensure the behavior of the system 

presents no anomaly compared to the 

behavior below limit conditions. 

However, conditions beyond limit 

conditions need not be considered when 

it can be shown that the airplane has 

design features that will not allow it to 

exceed those limit conditions. 

(3) The airplane must meet the 

aeroelastic-stability requirements of 

§ 25.629. 


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44280 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations 

(c) System in the failure condition. 

For any system-failure condition not 

shown to be extremely improbable, the 

following apply: 

(1) At the time of occurrence. Starting 

from 1-g level-flight conditions, a 

realistic scenario, including pilot 

corrective actions, must be established 

to determine the loads occurring at the 

time of failure and immediately after 

failure. 

(i) For static-strength substantiation, 

these loads, multiplied by an 

appropriate factor of safety that is 

related to the probability of occurrence 

of the failure, are ultimate loads to be 

considered for design. The factor of 

safety (F.S.) is defined in Figure 1. 

(ii) For residual-strength 

substantiation, the airplane must be able 

to withstand two-thirds of the ultimate 

loads defined in subparagraph (c)(1)(i). 

(iii) Freedom from aeroelastic 

instability must be shown up to the 

speeds defined in § 25.629(b)(2). For 

failure conditions that result in speed 

increases beyond VC/MC, freedom from 

aeroelastic instability must be shown at 

increased speeds, so that the margins 

intended by § 25.629(b)(2) are 

maintained. 

(iv) Failures of the system that result 

in forced structural vibrations 

(oscillatory failures) must not produce 

loads that could result in detrimental 

deformation of primary structure. 

(2) For the continuation of the flight. 

For the airplane in the system-failed 

state, and considering any appropriate 

reconfiguration and flight limitations, 

the following apply: 

(i) The loads derived from the 

following conditions at speeds up to VC/ 

MC, or the speed limitation prescribed 

for the remainder of the flight, must be 

determined: 

(A) The limit-symmetricalmaneuvering conditions specified in 

§ 25.331 and in § 25.345. 

(B) The limit-gust-and-turbulence 

conditions specified in § 25.341 and in 

§ 25.345. 

(C) The limit-rolling conditions 

specified in § 25.349, and the limitunsymmetrical conditions specified in 

§ 25.367 and § 25.427(b) and (c). 

(D) The limit-yaw-maneuvering 

conditions specified in § 25.351. 

(E) The limit-ground-loading 

conditions specified in § 25.473 and 

§ 25.491. 

(ii) For static-strength substantiation, 

each part of the structure must be able 

to withstand the loads in subparagraph 

(2)(i) of this paragraph, multiplied by a 

factor of safety depending on the 

probability of being in this failure state. 

The factor of safety is defined in Figure 

2. 


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Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations 44281 

Qj = (Tj)(Pj) 

Where: 

Tj = Average time spent in failure condition 

j (in hours). 

Pj = Probability of occurrence of failure mode 

j (per hour). 

Note: If Pj is greater than 10¥3 per flight 

hour, then a 1.5 factor of safety must be 

applied to all limit-load conditions specified 

in Subpart C. 

(iii) For residual-strength 

substantiation, the airplane must be able 

to withstand two-thirds of the ultimate 

loads defined in subparagraph (c)(2)(ii). 

(iv) If the loads induced by the failure 

condition have a significant effect on 

fatigue or damage tolerance, then their 

effects must be taken into account. 

(v) Freedom from aeroelastic 

instability must be shown up to a speed 

determined from Figure 3. Flutterclearance speeds V′ and V′′ may be 

based on the speed limitation specified 

for the remainder of the flight using the 

margins defined by § 25.629(b). 

V′ = Clearance speed as defined by 

§ 25.629(b)(2). 

V′′ = Clearance speed as defined by 

§ 25.629(b)(1). 

Qj = (Tj)(Pj) 

Where: 

Tj = Average time spent in failure condition 

j (in hours). 

Pj = Probability of occurrence of failure mode 

j (per hour). 

Note: If Pj is greater than 10¥3 per flight 

hour, then the flutter clearance speed must 

not be less than V’’. 

(vi) Freedom from aeroelastic 

instability must also be shown, up to V′ 

in Figure 3 above, for any probable 

system-failure condition combined with 

any damage required or selected for 

investigation by § 25.571(b). 

(3) Consideration of certain failure 

conditions may be required by other 

subparts of part 25 regardless of 

calculated system reliability. Where 

analysis shows the probability of these 

failure conditions to be less than 10¥9, 

criteria other than those specified in this 

paragraph may be used for structural 

substantiation to show continued safe 

flight and landing. 

(d) Failure indications. For systemfailure detection and indication, the 

following apply: 

(1) The system must be checked for 

failure conditions, not extremely 

improbable, that degrade the structural 

capability below the level required by 

part 25, or that significantly reduce the 

reliability of the remaining system. To 

the extent practicable, these failures 

must be detected and annunciated to the 

flight crew before flight. Certain 

elements of the control system, such as 

mechanical and hydraulic components, 

may use special periodic inspections, 

and electronic components may use 

daily checks, in lieu of warning systems, 

to achieve the objective of this 

requirement. These certificationmaintenance requirements must be 

limited to components that are not 

readily detectable by normal warning 

systems, and where service history 

shows that inspections provide an 

adequate level of safety. 

(2) The existence of any failure 

condition, not extremely improbable, 

during flight, that could significantly 

affect the structural capability of the 

airplane and for which the associated 

reduction in airworthiness can be 

minimized by suitable flight limitations, 

must be signaled to the flight crew. 

Failure conditions that result in a factor 

of safety between the airplane strength 

and the loads of Subpart C below 1.25, 

or flutter margins below V′′, must be 

signaled to the crew during flight. 

(e) Dispatch with known failure 

conditions. If the airplane is to be 

dispatched in a known system-failure 

condition that affects structural 

performance, or affects the reliability of 

the remaining system to maintain 

structural performance, then the 

provisions of § 25.302 must be met for 

the dispatched condition and for 

subsequent failures. Flight limitations 

and expected operational limitations 

may be taken into account in 

establishing Qj as the combined 

probability of being in the dispatched 

failure condition and the subsequent 

failure condition for the safety margins 

in Figures 2 and 3. These limitations 

must be such that the probability of 

being in this combined failure state, and 

then subsequently encountering limitload conditions, is extremely 

improbable. No reduction in these safety 

margins is allowed if the subsequent 

system-failure rate is greater than 10¥3

per hour. 

Issued in Renton, Washington, on August 

20, 2009. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E9–20697 Filed 8–27–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–329I] 

RIN 1117–AB23 

Schedules of Controlled Substances; 

Table of Excluded Nonnarcotic 

Products: Nasal Decongestant Inhalers 

Manufactured by Classic 

Pharmaceuticals LLC 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Interim rule with request for 

comments. 

SUMMARY: Under this Interim Rule, the 

Drug Enforcement Administration 

(DEA) is updating the Table of Excluded 


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