15036 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

or any other applicable laws or 

regulations or the need to comply with 

applicable food and sanitary regulations 

of city, county, State or Federal 

agencies. 

Dated: March 26, 2007. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. 07–1557 Filed 3–27–07; 10:50 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 23 

[Docket No. CE255; Special Conditions No. 

23–195A–SC] 

Special Conditions: Aviation 

Technology Group (ATG), Inc., Javelin 

Model 100 Series Airplane; Flight 

Performance, Flight Characteristics, 

and Operating Limitations 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Amended final special 

conditions. 

SUMMARY: These amended special 

conditions are issued for the Aviation 

Technology Group (ATG), Inc., Javelin 

Model 100 Series airplane. This is an 

amendment to special condition 23–

195–SC, which was published on 

February 1, 2007 (72 FR 4618), for 

certain novel or unusual design features 

associated with engine location, certain 

performance, flight characteristics and 

operating limitations. The original final 

special conditions were more generic 

and contained requirement language 

that was not necessary for jet airplanes. 

This amendment also corrects several 

references to part 23 sections to be 

consistent with these special conditions. 

This airplane will have a novel or 

unusual design feature(s) associated 

with engine location, certain 

performance, flight characteristics and 

operating limitations necessary for this 

type of 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 airworthiness 

standards applicable to these airplanes. 

DATES: The effective date of these 

special conditions is March 23, 2007. 

FOR FURTHER INFORMATION CONTACT: J. 

Lowell Foster, Federal Aviation 

Administration, Aircraft Certification 

Service, Small Airplane Directorate, 

ACE–111, 901 Locust, Room 301, 

Kansas City, Missouri, 816–329–4125, 

fax 816–329–4090. 

SUPPLEMENTARY INFORMATION: The final 

special conditions with a request for 

comments were published on February 

1, 2007 (72 FR 4618). No comments 

were received. These amended final 

special conditions remove requirement 

language that is not necessary for jet 

airplanes. 

Background 

On February 15, 2005, Aviation 

Technology Group (ATG); 8001 South 

InterPort Boulevard, Suite 310; 

Englewood, Colorado 80112–5951, 

applied for a type certificate for their 

new Model 100 Javelin airplane in 

accordance with the airworthiness 

standards in 14 CFR, part 23. The 

Javelin is a two-place, twin engine, 

turbofan-powered light jet airplane with 

a planned maximum operating altitude 

of 45,000 feet. Part 23 regulations in 

effect on the date of ATG’s application 

do not contain adequate or appropriate 

safety standards for a small, high 

performance jet airplane such as the 

Javelin. In accordance with Small 

Airplane Directorate policy, the safety 

standards for flight performance, flight 

characteristics and operational 

limitations that the Federal Aviation 

Administration (FAA) finds necessary to 

establish an acceptable level of safety 

for this type of airplane are presented in 

this special condition. 

Final special conditions with request 

for comments were issued on January 

24, 2007, and were published on 

February 1, 2007. The comment period 

closed March 5, 2007, and no comments 

were received. However, the original 

issue contained requirement language 

that is not necessary for jet airplanes, 

and this amendment removes that 

language. 

Type Certification Basis 

Under the provisions of 14 CFR, part 

21, § 21.17, ATG must show that the 

Model 100 meets the applicable 

provisions of part 23, as amended by 

Amendment 23–1 through 23–55 

thereto. If the Administrator finds that 

the applicable airworthiness regulations 

(i.e., 14 CFR, part 23) do not contain 

adequate or appropriate safety standards 

for the ATG Model 100 series because 

of a novel or unusual design feature, 

special conditions are prescribed under 

the provisions of § 21.16. 

Special conditions, as appropriate, as 

defined in § 11.19, are issued in 

accordance with § 11.38, and become 

part of the type certification basis in 

accordance with § 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 novel or unusual 

design feature, the special conditions 

would also apply to the other model 

under the provisions of § 21.101(a)(1). 

In addition to the applicable 

airworthiness regulations and special 

conditions, the Model 100 must comply 

with the part 23 fuel vent and exhaust 

emission requirements of 14 CFR, part 

34 and the part 23 noise certification 

requirements of 14 CFR, part 36; and the 

FAA must issue a finding of regulatory 

adequacy pursuant to § 611 of Public 

Law 92–574, the ‘‘Noise Control Act of 

1972.’’

Novel or Unusual Design Features 

ATG intends to certificate the Javelin 

in both utility and acrobatic categories. 

The ATG Javelin Model 100 will 

incorporate the following novel or 

unusual design features: 

• Two-place, tandem configuration. 

• Maximum takeoff weight of 

approximately 6,900 pounds. 

• Design cruise speed of 500 knots 

calibrated airspeed. 

• Two Williams FJ33–4A–18M 

turbofan engines with dual channel 

FADEC controls. 

• Major airframe components 

constructed of carbon fiber composite 

materials. 

• Hydraulically boosted flight control 

system with floor-mounted control 

sticks. 

• Integrated avionics including 

Avidyne displays, autopilot, and flight 

management system. 

Novel features on the ATG Model 100 

include rear mounted turbine engines 

embedded in the fuselage, boosted 

controls, and high-speed, high-altitude 

acrobatic capability. 

Applicability 

As discussed above, these special 

conditions are applicable to the ATG 

Model 100 series. Should ATG apply at 

a later date for a change to the type 

certificate to include another model 

incorporating the same novel or unusual 

design feature, the special conditions 

would apply to that model as well 

under the provisions of § 21.101(a)(1). 

Conclusion 

This action affects only certain novel 

or unusual design features on ATG 

Model 100 series airplanes. It is not a 

rule of general applicability and affects 

only the applicant who applied to the 

FAA for approval of these features on 

the airplane. 


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Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15037 

The substance of these special 

conditions has been subjected to the 

notice and comment period in several 

prior instances and has been derived 

without substantive change from those 

previously issued. It is unlikely that 

prior public comment would result in a 

significant change from the substance 

contained herein. For this reason, the 

FAA has determined that prior public 

notice and comment are unnecessary 

and impracticable, and good cause 

exists for adopting these special 

conditions upon issuance. The FAA is 

requesting comments to allow interested 

persons to submit views that may not 

have been submitted in response to the 

prior opportunities for comment 

described above. 

List of Subjects in 14 CFR Part 23 

Aircraft, Aviation safety, Signs and 

symbols. 

Citation 

The authority citation for these 

special conditions is as follows: 

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

44701; 14 CFR 21.16 and 14 CFR 11.38 and 

11.19. 

The Special Conditions 

Several 14 CFR, part 23 paragraphs 

have been replaced by or supplemented 

with special conditions. These special 

conditions have been numbered to 

match the 14 CFR, part 23 paragraphs 

they replace or supplement. 

Additionally, many of the other 

applicable part 23 paragraphs crossreference paragraphs that are replaced 

by or supplemented with special 

conditions. It is implied that the special 

conditions associated with these 

paragraphs must be applied. This 

principal applies to all part 23 

paragraphs that cross-reference 

paragraphs associated with 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 ATG Model 

100 series airplanes. 

1. SC 23.45 General 

Instead of compliance with § 23.45, 

the following apply: 

(a) Unless otherwise prescribed, the 

performance requirements of this part 

must be met for—

(1) Still air and standard atmosphere; 

and 

(2) Ambient atmospheric conditions. 

(b) Performance data must be 

determined over not less than the 

following ranges of conditions—

(1) Airport altitudes from sea level to 

10,000 feet; and 

(2) Temperature from standard to 30° 

C above standard, or the maximum 

ambient atmospheric temperature at 

which compliance with the cooling 

provisions of § 23.1041 to § 23.1047 is 

shown, if lower. 

(c) Performance data must be 

determined with the cowl flaps or other 

means for controlling the engine cooling 

air supply in the position used in the 

cooling tests required by § 23.1041 to 

§ 23.1047. 

(d) The available propulsive thrust 

must correspond to engine power, not 

exceeding the approved power, less—

(1) Installation losses; and 

(2) The power absorbed by the 

accessories and services appropriate to 

the particular ambient atmospheric 

conditions and the particular flight 

condition. 

(e) The performance, as affected by 

engine power or thrust, must be based 

on a relative humidity: 

(1) Of 80 percent at and below 

standard temperature; and 

(2) From 80 percent, at the standard 

temperature, varying linearly down to 

34 percent at the standard temperature 

plus 50 °F. 

(f) Unless otherwise prescribed, in 

determining the takeoff and landing 

distances, changes in the airplane’s 

configuration, speed, and power must 

be made in accordance with procedures 

established by the applicant for 

operation in service. These procedures 

must be able to be executed consistently 

by pilots of average skill in atmospheric 

conditions reasonably expected to be 

encountered in service. 

(g) The following, as applicable, must 

be determined on a smooth, dry, hardsurfaced runway—

(1) Not applicable; 

(2) Accelerate-stop distance of SC 

23.55; 

(3) Takeoff distance and takeoff run of 

SC 23.59; and 

(4) Landing distance of SC 23.75. 

Note: The effect on these distances of 

operation on other types of surfaces (for 

example, grass, gravel) when dry, may be 

determined or derived and these surfaces 

listed in the Airplane Flight Manual in 

accordance with SC 23.1583(p). 

(h) The following also apply: 

(1) Unless otherwise prescribed, the 

applicant must select the takeoff, 

enroute, approach, and landing 

configurations for the airplane. 

(2) The airplane configuration may 

vary with weight, altitude, and 

temperature, to the extent that they are 

compatible with the operating 

procedures required by paragraph (h)(3) 

of this section. 

(3) Unless otherwise prescribed, in 

determining the critical-engineinoperative takeoff performance, takeoff 

flight path, and accelerate-stop distance, 

changes in the airplane’s configuration, 

speed, and power must be made in 

accordance with procedures established 

by the applicant for operation in service. 

(4) Procedures for the execution of 

discontinued approaches and balked 

landings associated with the conditions 

prescribed in SC 23.67(c)(4) and SC 

23.77(c) must be established. 

(5) The procedures established under 

paragraphs (h)(3) and (h)(4) of this 

section must—

(i) Be able to be consistently executed 

by a crew of average skill in 

atmospheric conditions reasonably 

expected to be encountered in service; 

(ii) Use methods or devices that are 

safe and reliable; and 

(iii) Include allowance for any 

reasonably expected time delays in the 

execution of the procedures. 

2. SC 23.51 Takeoff Speeds 

Instead of compliance with § 23.51, 

the following apply: 

(a) Not applicable. 

(b) Not applicable. 

(c) The following apply: 

(l) V1 must be established in relation 

to VEF as follows: 

(i) VEF is the calibrated airspeed at 

which the critical engine is assumed to 

fail. VEF must be selected by the 

applicant but must not be less than 1.05 

VMC determined under § 23.149(b) or, at 

the option of the applicant, not less than 

VMCG determined under § 23.149(f). 

(ii) The takeoff decision speed, V1, is 

the calibrated airspeed on the ground at 

which, as a result of engine failure or 

other reasons, the pilot is assumed to 

have made a decision to continue or 

discontinue the takeoff. The takeoff 

decision speed, V1, must be selected by 

the applicant but must not be less than 

VEF plus the speed gained with the 

critical engine inoperative during the 

time interval between the instant at 

which the critical engine is failed and 

the instant at which the pilot recognizes 

and reacts to the engine failure, as 

indicated by the pilot’s application of 

the first retarding means during the 

accelerate-stop determination of SC 

23.55. 

(2) The rotation speed, VR, in terms of 

calibrated airspeed, must be selected by 

the applicant and must not be less than 

the greatest of the following: 

(i) V1; 

(ii) 1.05 VMC determined under 

§ 23.149(b); 

(iii) 1.10 VS1; or 

(iv) The speed that allows attaining 

the initial climb-out speed, V2, before 


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15038 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 

reaching a height of 35 feet above the 

takeoff surface in accordance with SC 

23.57(c)(2). 

(3) For any given set of conditions, 

such as weight, altitude, temperature, 

and configuration, a single value of VR

must be used to show compliance with 

both the one-engine-inoperative takeoff 

and all-engines-operating takeoff 

requirements. 

(4) The takeoff safety speed, V2, in 

terms of calibrated airspeed, must be 

selected by the applicant so as to allow 

the gradient of climb required in SC 

23.67(c)(1) and (c)(2) but must not be 

less than 1.10 VMC or less than 1.20 VS1. 

(5) The one-engine-inoperative takeoff 

distance, using a normal rotation rate at 

a speed 5 knots less than VR, established 

in accordance with paragraph (c)(2) of 

this section, must be shown not to 

exceed the corresponding one-engineinoperative takeoff distance, determined 

in accordance with SC 23.57 and SC 

23.59(a)(1), using the established VR. 

The takeoff, otherwise performed in 

accordance with SC 23.57, must be 

continued safely from the point at 

which the airplane is 35 feet above the 

takeoff surface and at a speed not less 

than the established V2 minus 5 knots. 

(6) The applicant must show, with all 

engines operating, that marked increases 

in the scheduled takeoff distances, 

determined in accordance with SC 

23.59(a)(2), do not result from overrotation of the airplane or out-of-trim 

conditions. 

3. SC 23.53 Takeoff Performance 

Instead of compliance with § 23.53, 

the following apply: 

(a) Not applicable. 

(b) Not applicable. 

(c) Takeoff performance, as required 

by SC 23.55 through SC 23.59, must be 

determined with the operating engine(s) 

within approved operating limitations. 

4. SC 23.55 Accelerate-Stop Distance 

Instead of compliance with § 23.55, 

the following apply: 

The accelerate-stop distance must be 

determined as follows: 

(a) The accelerate-stop distance is the 

sum of the distances necessary to—

(1) Accelerate the airplane from a 

standing start to VEF with all engines 

operating; 

(2) Accelerate the airplane from VEF to 

V1, assuming the critical engine fails at 

VEF; and 

(3) Come to a full stop from the point 

at which V1 is reached. 

(b) Means other than wheel brakes 

may be used to determine the 

accelerate-stop distances if that means—

(1) Is safe and reliable; 

(2) Is used so that consistent results 

can be expected under normal operating 

conditions; and 

(3) Is such that exceptional skill is not 

required to control the airplane. 

5. SC 23.57 Takeoff Path 

Instead of compliance with § 23.57, 

the following apply: 

The takeoff path is as follows: 

(a) The takeoff path extends from a 

standing start to a point in the takeoff 

at which the airplane is 1,500 feet above 

the takeoff surface at or below which 

height the transition from the takeoff to 

the enroute configuration must be 

completed; and 

(1) The takeoff path must be based on 

the procedures prescribed in SC 23.45; 

(2) The airplane must be accelerated 

on the ground to VEF at which point the 

critical engine must be made 

inoperative and remain inoperative for 

the rest of the takeoff; and 

(3) After reaching VEF, the airplane 

must be accelerated to V2. 

(b) During the acceleration to speed 

V2, the nose gear may be raised off the 

ground at a speed not less than VR. 

However, landing gear retraction must 

not be initiated until the airplane is 

airborne. 

(c) During the takeoff path 

determination, in accordance with 

paragraphs (a) and (b) of this section—

(1) The slope of the airborne part of 

the takeoff path must not be negative at 

any point; 

(2) The airplane must reach V2 before 

it is 35 feet above the takeoff surface, 

and must continue at a speed as close 

as practical to, but not less than V2, 

until it is 400 feet above the takeoff 

surface; 

(3) At each point along the takeoff 

path, starting at the point at which the 

airplane reaches 400 feet above the 

takeoff surface, the available gradient of 

climb must not be less than 1.2 percent 

for two-engine airplanes; and 

(4) Except for gear retraction and 

automatic propeller feathering, the 

airplane configuration must not be 

changed, and no change in power that 

requires action by the pilot may be 

made, until the airplane is 400 feet 

above the takeoff surface. 

(d) The takeoff path to 35 feet above 

the takeoff surface must be determined 

by a continuous demonstrated takeoff. 

(e) The takeoff path from 35 feet above 

the takeoff surface must be determined 

by synthesis from segments; and 

(1) The segments must be clearly 

defined and must be related to distinct 

changes in configuration, power, and 

speed; 

(2) The weight of the airplane, the 

configuration, and the power must be 

assumed constant throughout each 

segment and must correspond to the 

most critical condition prevailing in the 

segment; and 

(3) The takeoff flight path must be 

based on the airplane’s performance 

without utilizing ground effect. 

6. SC 23.59 Takeoff Distance and 

Takeoff Run 

Instead of compliance with § 23.59, 

the following apply: 

The takeoff distance and, at the option 

of the applicant, the takeoff run, must be 

determined. 

(a) Takeoff distance is the greater of—

(1) The horizontal distance along the 

takeoff path from the start of the takeoff 

to the point at which the airplane is 35 

feet above the takeoff surface as 

determined under SC 23.57; or 

(2) With all engines operating, 115 

percent of the horizontal distance from 

the start of the takeoff to the point at 

which the airplane is 35 feet above the 

takeoff surface, determined by a 

procedure consistent with SC 23.57. 

(b) If the takeoff distance includes a 

clearway, the takeoff run is the greater 

of—

(1) The horizontal distance along the 

takeoff path from the start of the takeoff 

to a point equidistant between the liftoff 

point and the point at which the 

airplane is 35 feet above the takeoff 

surface as determined under SC 23.57; 

or 

(2) With all engines operating, 115 

percent of the horizontal distance from 

the start of the takeoff to a point 

equidistant between the liftoff point and 

the point at which the airplane is 35 feet 

above the takeoff surface, determined by 

a procedure consistent with SC 23.57. 

7. SC 23.61 Takeoff Flight Path 

Instead of compliance with § 23.61, 

the following apply: 

The takeoff flight path must be 

determined as follows: 

(a) The takeoff flight path begins 35 

feet above the takeoff surface at the end 

of the takeoff distance determined in 

accordance with SC 23.59. 

(b) The net takeoff flight path data 

must be determined so that they 

represent the actual takeoff flight paths, 

as determined in accordance with SC 

23.57 and with paragraph (a) of this 

section, reduced at each point by a 

gradient of climb equal to 0.8 percent 

for two-engine airplanes. 

(c) The prescribed reduction in climb 

gradient may be applied as an 

equivalent reduction in acceleration 

along that part of the takeoff flight path 

at which the airplane is accelerated in 

level flight. 


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Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations 15039 

8. SC 23.63 Climb: General 

Instead of compliance with § 23.63, 

the following apply: 

(a) Compliance with the requirements 

of §§ 23.65, SC 23.67, 23.69, and SC 

23.77 must be shown—

(1) Out of ground effect; and 

(2) At speeds that are not less than 

those at which compliance with the 

powerplant cooling requirements of 

§§ 23.1041 to 23.1047 has been 

demonstrated; and 

(3) Unless otherwise specified, with 

one engine inoperative, at a bank angle 

not exceeding 5 degrees. 

(b) Not applicable. 

(c) Not applicable. 

(d) Compliance must be shown at 

weights as a function of airport altitude 

and ambient temperature within the 

operational limits established for takeoff 

and landing, respectively, with—

(1) SC 23.67(c)(1), SC 23.67(c)(2), and 

SC 23.67(c)(3) for takeoff; and 

(2) SC 23.67(c)(3), SC 23.67(c)(4), and 

SC 23.77(c) for landing. 

9. SC 23.66 Takeoff Climb: OneEngine Inoperative 

Instead of compliance with § 23.66, 

see SC 23.67. 

10. SC 23.67 Climb: One Engine 

Inoperative 

Instead of compliance with § 23.67, 

the following apply: 

(a) Not applicable. 

(b) Not applicable. 

(c) The following apply: 

(1) Takeoff; landing gear extended. 

The steady gradient of climb at the 

altitude of the takeoff surface must be 

measurably positive for two-engine 

airplanes with—

(i) The critical engine inoperative; 

(ii) The remaining engine(s) at takeoff 

power; 

(iii) The landing gear extended, and 

all landing gear doors open; 

(iv) The wing flaps in the takeoff 

position(s); 

(v) The wings level; and 

(vi) A climb speed equal to V2. 

(2) Takeoff; landing gear retracted. 

The steady gradient of climb at an 

altitude of 400 feet above the takeoff 

surface must be not less than 2.0 percent 

of two-engine airplanes with—

(i) The critical engine inoperative; 

(ii) The remaining engine(s) at takeoff 

power; 

(iii) The landing gear retracted; 

(iv) The wing flaps in the takeoff 

position(s); 

(v) A climb speed equal to V2. 

(3) Enroute. The steady gradient of 

climb at an altitude of 1,500 feet above 

the takeoff or landing surface, as 

appropriate, must be not less than 1.2 

percent for two-engine airplanes with—

(i) The critical engine inoperative; 

(ii) The remaining engine(s) at not 

more than maximum continuous power; 

(iii) The landing gear retracted; 

(iv) The wing flaps retracted; and 

(v) A climb speed not less than 1.2 

VS1. 

(4) Discontinued approach. The 

steady gradient of climb at an altitude 

of 400 feet above the landing surface 

must be not less than 2.1 percent for 

two-engine airplanes with—

(i) The critical engine inoperative; 

(ii) The remaining engine(s) at takeoff 

power; 

(iii) Landing gear retracted; 

(iv) Wing flaps in the approach 

position(s) in which VS1 for these 

position(s) does not exceed 110 percent 

of the VS1 for the related all-enginesoperating landing position(s); and 

(v) A climb speed established in 

connection with normal landing 

procedures but not exceeding 1.5 VS1. 

11. SC 23.73 Reference Landing 

Approach Speed 

Instead of compliance with § 23.73, 

the following apply: 

(a) Not applicable. 

(b) Not applicable. 

(c) The reference landing approach 

speed, VREF, must not be less than the 

greater of 1.05 VMC, determined in 

§ 23.149(c), and 1.3 VSO. 

12. SC 23.77 Balked Landing 

Instead of compliance with § 23.77, 

the following apply: 

(a) Not applicable. 

(b) Not applicable. 

(c) Each airplane must be able to 

maintain a steady gradient of climb of 

at least 3.2 percent with—

(1) Not more than the power that is 

available on each engine eight seconds 

after initiation of movement of the 

power controls from the minimum flight 

idle position; 

(2) Landing gear extended; 

(3) Wing flaps in the landing position; 

and 

(4) A climb speed equal to VREF, as 

defined in SC 23.73(c). 

13. SC 23.177 Static Directional and 

Lateral Stability 

Instead of compliance with § 23.177, 

the following apply: 

(a) The static directional stability, as 

shown by the tendency to recover from 

a wings-level sideslip with the rudder 

free, must be positive for any landing 

gear and flap position appropriate to the 

takeoff, climb, cruise, approach, and 

landing configurations. This must be 

shown with symmetrical power up to 

maximum continuous power, and at 

speeds from 1.2 VS1 up to VFE, VLE, or 

VFC/MFC (as appropriate). The angle of 

sideslip for these tests must be 

appropriate to the type of airplane. At 

larger angles of sideslip, up to that at 

which full rudder is used or a control 

force limit in § 23.143 is reached, 

whichever occurs first, and at speeds 

from 1.2 VS1 to VO, the rudder pedal 

force must not reverse. 

(b) The static lateral stability, as 

shown by the tendency to raise the low 

wing in a sideslip, must be positive for 

all landing gear and flap positions. This 

must be shown with symmetrical power 

up to 75 percent of maximum 

continuous power at speeds above 1.2 

VS1 in the takeoff configuration(s) and at 

speeds above 1.3 VS1 in other 

configurations, up to VFE, VLE, or VFC/ 

MFC (as appropriate) for the 

configuration being investigated, in the 

takeoff, climb, cruise, and approach 

configurations. For the landing 

configuration, the power must be that 

necessary to maintain a 3 degree angle 

of descent in coordinated flight. The 

static lateral stability must not be 

negative at 1.2 VS1 in the takeoff 

configuration, or at 1.3 VS1 in other 

configurations. The angle of sideslip for 

these tests must be appropriate to the 

type of airplane, but in no case may the 

constant heading sideslip angle be less 

than that obtainable with a 10 degree 

bank or, if less, the maximum bank 

angle obtainable with full rudder 

deflection or 150 pound rudder force. 

(c) Paragraph (b) of this section does 

not apply to acrobatic category airplanes 

certificated for inverted flight. 

(d) In straight, steady slips at 1.2 VS1

for any landing gear and flap positions, 

and for any symmetrical power 

conditions up to 50 percent of 

maximum continuous power, the 

aileron and rudder control movements 

and forces must increase steadily, but 

not necessarily in constant proportion, 

as the angle of sideslip is increased up 

to the maximum appropriate to the type 

of airplane. At larger slip angles, up to 

the angle at which the full rudder or 

aileron control is used or a control force 

limit contained in § 23.143 is reached, 

the aileron and rudder control 

movements and forces must not reverse 

as the angle of sideslip is increased. 

Rapid entry into, and recovery from, a 

maximum sideslip considered 

appropriate for the airplane must not 

result in uncontrollable flight 

characteristics. 

14. SC 23.201(e) Wings Level Stall 

Instead of compliance with 

§ 23.201(e), the following apply: 


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(e) Compliance with the requirements 

of this section must be shown under the 

following conditions: 

(1) The flaps, landing gear, and 

speedbrakes in any likely combination 

of positions and altitudes appropriate 

for the various positions. 

(2) Thrust—

(i) Idle; and 

(ii) The thrust necessary to maintain 

level flight at 1.6 VS1 (where VS1

corresponds to the stalling speed with 

flaps in the approach position, the 

landing gear retracted, and maximum 

landing weight). 

(3) Trim at 1.4 VS1 or the minimum 

trim speed, whichever is higher. 

15. SC 23.203(c) Turning Flight and 

Accelerated Turning Stalls 

Instead of compliance with 

§ 23.203(c), the following apply: 

(c) Compliance with the requirements 

of this section must be shown under the 

following conditions: 

(1) The flaps, landing gear, and 

speedbrakes in any likely combination 

of positions and altitudes appropriate 

for the various positions. 

(2) Thrust—

(i) Idle; and 

(ii) The thrust necessary to maintain 

level flight at 1.6 VS1 (where VS1

corresponds to the stalling speed with 

flaps in the approach position, the 

landing gear retracted, and maximum 

landing weight). 

(3) Trim at 1.4 VS1 or the minimum 

trim speed, whichever is higher. 

16. SC 23.251 Vibration and Buffeting 

Instead of compliance with § 23.251, 

the following apply: 

(a) The airplane must be 

demonstrated in flight to be free from 

any vibration and buffeting that would 

prevent continued safe flight in any 

likely operating condition. 

(b) Each part of the airplane must be 

shown in flight to be free from excessive 

vibration under any appropriate speed 

and thrust conditions up to VDF/MDF. 

The maximum speeds shown must be 

used in establishing the operating 

limitations of the airplane in accordance 

with special condition SC 23.1505. 

(c) Except as provided in paragraph 

(d) of this special condition, there may 

be no buffeting condition, in normal 

flight, including configuration changes 

during cruise, severe enough to interfere 

with the control of the airplane, to cause 

excessive fatigue to the crew, or to cause 

structural damage. Stall warning 

buffeting within these limits is 

allowable. 

(d) There may be no perceptible 

buffeting condition in the cruise 

configuration in straight flight at any 

speed up to VMO/MMO, except that stall 

warning buffeting is allowable. 

(e) With the airplane in the cruise 

configuration, the positive maneuvering 

load factors at which the onset of 

perceptible buffeting occurs must be 

determined for the ranges of airspeed or 

Mach number, weight, and altitude for 

which the airplane is to be certified. The 

envelopes of load factor, speed, altitude, 

and weight must provide a sufficient 

range of speeds and load factors for 

normal operations. Probable inadvertent 

excursions beyond the boundaries of the 

buffet onset envelopes may not result in 

unsafe conditions. 

17. SC 23.253 High Speed 

Characteristics 

Instead of compliance with § 23.253, 

the following apply: 

(a) Speed increase and recovery 

characteristics. The following speed 

increase and recovery characteristics 

must be met: 

(1) Operating conditions and 

characteristics likely to cause 

inadvertent speed increases (including 

upsets in pitch and roll) must be 

simulated with the airplane trimmed at 

any likely cruise speed up to VMO/MMO. 

These conditions and characteristics 

include gust upsets, inadvertent control 

movements, low stick force gradient in 

relation to control friction, passenger 

movement, leveling off from climb, and 

descent from Mach to airspeed limit 

altitudes. 

(2) Allowing for pilot reaction time 

after effective inherent or artificial 

speed warning occurs, it must be shown 

that the airplane can be recovered to a 

normal altitude and its speed reduced to 

VMO/MMO, without: 

(i) Exceptional piloting strength or 

skill; 

(ii) Exceeding VD/MD, VDF/MDF, or the 

structural limitations; and 

(iii) Buffeting that would impair the 

pilot’s ability to read the instruments or 

control the airplane for recovery. 

(3) There may be no control reversal 

about any axis at any speed up to VDF/ 

MDF. Any reversal of elevator control 

force or tendency of the airplane to 

pitch, roll, or yaw must be mild and 

readily controllable, using normal 

piloting techniques. 

(b) Maximum speed for stability 

characteristics, VFC/MFC. VFC/MFC is the 

maximum speed at which the 

requirements of § 23.175(b)(1), special 

condition SC 23.177, and 23.181 must 

be met with flaps and landing gear 

retracted. It may not be less than a speed 

midway between VMO/MMO and VDF/ 

MDF except that, for altitudes where 

Mach number is the limiting factor, MFC

need not exceed the Mach number at 

which effective speed warning occurs. 

18. SC 23.255 Out of Trim 

Characteristics 

In the absence of specific 

requirements for out-of-trim 

characteristics, apply the following: 

(a) From an initial condition with the 

airplane trimmed at cruise speeds up to 

VMO/MMO, the airplane must have 

satisfactory maneuvering stability and 

controllability with the degree of out-oftrim in both the airplane nose-up and 

nose-down directions, which results 

from the greater of the following: 

(1) A three-second movement of the 

longitudinal trim system at its normal 

rate for the particular flight condition 

with no aerodynamic load (or an 

equivalent degree of trim for airplanes 

that do not have a power-operated trim 

system), except as limited by stops in 

the trim system, including those 

required by § 23.655(b) for adjustable 

stabilizers; or 

(2) The maximum mis-trim that can 

be sustained by the autopilot while 

maintaining level flight in the high 

speed cruising condition. 

(b) In the out-of-trim condition 

specified in paragraph (a) of this special 

condition, when the normal acceleration 

is varied from +1 g to the positive and 

negative values specified in paragraph 

(c) of this special condition, the 

following apply: 

(1) The stick force versus g curve must 

have a positive slope at any speed up to 

and including VFC/MFC; and 

(2) At speeds between VFC/MFC and 

VDF/MDF, the direction of the primary 

longitudinal control force may not 

reverse. 

(c) Except as provided in paragraph 

(d) and (e) of this special condition, 

compliance with the provisions of 

paragraph (a) of this special condition 

must be demonstrated in flight over the 

acceleration range as follows: 

(1) ¥1 g to +2.5 g; or 

(2) 0 g to 2.0 g, and extrapolating by 

an acceptable method to ¥1 g and +2.5 

g. 

(d) If the procedure set forth in 

paragraph (c)(2) of this special condition 

is used to demonstrate compliance and 

marginal conditions exist during flight 

test with regard to reversal of primary 

longitudinal control force, flight tests 

must be accomplished from the normal 

acceleration at which a marginal 

condition is found to exist to the 

applicable limit specified in paragraph 

(b)(1) of this special condition. 

(e) During flight tests required by 

paragraph (a) of this special condition, 

the limit maneuvering load factors, 

prescribed in §§ 23.333(b) and 23.337, 


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need not be exceeded. Also, the 

maneuvering load factors associated 

with probable inadvertent excursions 

beyond the boundaries of the buffet 

onset envelopes determined under SC 

23.251(e), need not be exceeded. In 

addition, the entry speeds for flight test 

demonstrations at normal acceleration 

values less than 1 g must be limited to 

the extent necessary to accomplish a 

recovery without exceeding VDF/MDF. 

(f) In the out-of-trim condition 

specified in paragraph (a) of this special 

condition, it must be possible from an 

overspeed condition at VDF/MDF to 

produce at least 1.5 g for recovery by 

applying not more than 125 pounds of 

longitudinal control force using either 

the primary longitudinal control alone 

or the primary longitudinal control and 

the longitudinal trim system. If the 

longitudinal trim is used to assist in 

producing the required load factor, it 

must be shown at VDF/MDF that the 

longitudinal trim can be actuated in the 

airplane nose-up direction with the 

primary surface loaded to correspond to 

the least of the following airplane noseup control forces: 

(1) The maximum control forces 

expected in service, as specified in 

§§ 23.301 and 23.397. 

(2) The control force required to 

produce 1.5 g. 

(3) The control force corresponding to 

buffeting or other phenomena of such 

intensity that is a strong deterrent to 

further application of primary 

longitudinal control force. 

19. SC 23.703 Takeoff Warning 

System 

Unless it can be shown that a lift or 

longitudinal trim device that affects the 

takeoff performance of the aircraft 

would not give an unsafe takeoff 

configuration when selected out of an 

approved takeoff position, a takeoff 

warning system must be installed and 

meet the following requirements: 

(a) The system must provide to the 

pilots an aural warning that is 

automatically activated during the 

initial portion of the takeoff roll if the 

airplane is in a configuration that would 

not allow a safe takeoff. The warning 

must continue until—

(1) The configuration is changed to 

allow safe takeoff, or 

(2) Action is taken by the pilot to 

abandon the takeoff roll. 

(b) The means used to activate the 

system must function properly for all 

authorized takeoff power settings and 

procedures and throughout the ranges of 

takeoff weights, altitudes, and 

temperatures for which certification is 

requested. 

20. SC 23.735 Brakes 

In addition to paragraphs (a), (b), (c), 

and (d), the following apply: 

(e) The rejected takeoff brake kinetic 

energy capacity rating of each main 

wheel brake assembly must not be less 

than the kinetic energy absorption 

requirements determined under either 

of the following methods—

(1) The brake kinetic energy 

absorption requirements must be based 

on a conservative rational analysis of 

the sequence of events expected during 

a rejected takeoff at the design takeoff 

weight. 

(2) Instead of a rational analysis, the 

kinetic energy absorption requirements 

for each main wheel brake assembly 

may be derived from the following 

formula—

Where: 

KE=Kinetic energy per wheel (ft.-lbs.); 

W=Design takeoff weight (lbs.); 

V=Ground speed, in knots, associated with 

the maximum value of V1 selected in 

accordance with SC 23.51(c)(1); 

N=Number of main wheels with brakes. 

21. SC 23.1323 Airspeed Indicating 

System 

In addition to paragraphs (a), (b), (c), 

and (d), the following apply: 

(e) In addition, the airspeed indicating 

system must be calibrated to determine 

the system error during the acceleratetakeoff ground run. The ground run 

calibration must be obtained between 

0.8 of the minimum value of V1, and 1.2 

times the maximum value of V1

considering the approved ranges of 

altitude and weight. The ground run 

calibration must be determined 

assuming an engine failure at the 

minimum value of V1. 

(f) Where duplicate airspeed 

indicators are required, their respective 

pitot tubes must be far enough apart to 

avoid damage to both tubes in a 

collision with a bird. 

22. SC 23.1505 Airspeed limitations 

Instead of compliance with 

§ 23.1505(a), the following apply: 

(a) The maximum operating limit 

speed (VMO/MMO-airspeed or Mach 

number, whichever is critical at a 

particular altitude) is a speed that may 

not be deliberately exceeded in any 

regime of flight (climb, cruise, or 

descent), unless a higher speed is 

authorized for flight test or pilot training 

operations. VMO/MMO must be 

established so that it is not greater than 

the design cruising speed VC/MC and so 

that it is sufficiently below VD/MD or 

VDF/MDF, to make it highly improbable 

that the latter speeds will be 

inadvertently exceeded in operations. 

The speed margin between VMO/MMO

and VD/MD or VDF/MDF may not be less 

than that determined under § 23.335(b) 

or found necessary in the flight test 

conducted under SC 23.253. 

23. SC 23.1583 Operating Limitations 

Instead of compliance with § 23.1583, 

the following apply: 

The Airplane Flight Manual must 

contain operating limitations 

determined under this part 23, 

including the following—

(a) Airspeed limitations. The 

following information must be 

furnished: 

(1) Information necessary for the 

marking of the airspeed limits on the 

indicator as required in § 23.1545, and 

the significance of each of those limits 

and of the color coding used on the 

indicator. 

(2) The speeds VMC, VO, VLE, and VLO, 

if established, and their significance. 

(3) In addition, for turbine powered 

airplanes—

(i) The maximum operating limit 

speed, VMO/MMO and a statement that 

this speed must not be deliberately 

exceeded in any regime of flight (climb, 

cruise or descent) unless a higher speed 

is authorized for flight test or pilot 

training; 

(ii) If an airspeed limitation is based 

upon compressibility effects, a 

statement to this effect and information 

as to any symptoms, the probable 

behavior of the airplane, and the 

recommended recovery procedures; and 

(iii) The airspeed limits must be 

shown in terms of VMO/MMO instead of 

VNO and VNE. 

(b) Powerplant limitations. The 

following information must be 

furnished: 

(1) Limitations required by § 23.1521. 

(2) Explanation of the limitations, 

when appropriate. 

(3) Information necessary for marking 

the instruments required by § 23.1549 

through § 23.1553. 

(c) Weight. The airplane flight manual 

must include—

(1) The maximum weight; and 

(2) The maximum landing weight, if 

the design landing weight selected by 

the applicant is less than the maximum 

weight. 

(3) Not applicable. 

(4) The maximum takeoff weight for 

each airport altitude and ambient 

temperature within the range selected 

by the applicant at which—

(i) The airplane complies with the 

climb requirements of SC 23.63(d)(1); 

and 


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(ii) The accelerate-stop distance 

determined under SC 23.55 is equal to 

the available runway length plus the 

length of any stopway, if utilized; and 

either: 

(iii) The takeoff distance determined 

under SC 23.59(a) is equal to the 

available runway length; or 

(iv) At the option of the applicant, the 

takeoff distance determined under SC 

23.59(a) is equal to the available runway 

length plus the length of any clearway 

and the takeoff run determined under 

SC 23.59(b) is equal to the available 

runway length. 

(5) The maximum landing weight for 

each airport altitude within the range 

selected by the applicant at which—

(i) The airplane complies with the 

climb requirements of § 23.63(d)(2) for 

ambient temperatures within the range 

selected by the applicant; and 

(ii) The landing distance determined 

under § 23.75 for standard temperatures 

is equal to the available runway length. 

(6) The maximum zero wing fuel 

weight, where relevant, as established in 

accordance with § 23.343. 

(d) Center of gravity. The established 

center of gravity limits. 

(e) Maneuvers. The following 

authorized maneuvers, appropriate 

airspeed limitations, and unauthorized 

maneuvers, as prescribed in this section. 

(1) Not applicable. 

(2) Not applicable. 

(3) Acrobatic category airplanes. A 

list of approved flight maneuvers 

demonstrated in type flight tests, 

together with recommended entry 

speeds and any other associated 

limitations. 

(4) Not applicable. 

(5) Not applicable. 

(f) Maneuver load factor. The positive 

limit load factors in g’s, and, in 

addition, the negative limit load factor 

for acrobatic category airplanes. 

(g) Minimum flight crew. The number 

and functions of the minimum flight 

crew determined under § 23.1523. 

(h) Kinds of operation. A list of the 

kinds of operation to which the airplane 

is limited or from which it is prohibited 

under § 23.1525, and also a list of 

installed equipment that affects any 

operating limitation and identification 

as to the equipment’s required 

operational status for the kinds of 

operation for which approval has been 

given. 

(i) Maximum operating altitude. The 

maximum altitude established under 

§ 23.1527. 

(j) Maximum passenger seating 

configuration. The maximum passenger 

seating configuration. 

(k) Allowable lateral fuel loading. The 

maximum allowable lateral fuel loading 

differential, if less than the maximum 

possible. 

(l) Baggage and cargo loading. The 

following information for each baggage 

and cargo compartment or zone—

(1) The maximum allowable load; and 

(2) The maximum intensity of 

loading. 

(m) Systems. Any limitations on the 

use of airplane systems and equipment. 

(n) Ambient temperatures. Where 

appropriate, maximum and minimum 

ambient air temperatures for operation. 

(o) Smoking. Any restrictions on 

smoking in the airplane. 

(p) Types of surface. A statement of 

the types of surface on which operations 

may be conducted. (See SC 23.45(g) and 

SC 23.1587(a)(4) and (d)(4)). 

24. SC 23.1585 Operating Procedures 

Instead of compliance with § 23.1585, 

the following apply: 

(a) For all airplanes, information 

concerning normal, abnormal (if 

applicable), and emergency procedures 

and other pertinent information 

necessary for safe operation and the 

achievement of the scheduled 

performance must be furnished, 

including—

(1) An explanation of significant or 

unusual flight or ground handling 

characteristics; 

(2) The maximum demonstrated 

values of crosswind for takeoff and 

landing, and procedures and 

information pertinent to operations in 

crosswinds; 

(3) A recommended speed for flight in 

rough air. This speed must be chosen to 

protect against the occurrence, as a 

result of gusts, of structural damage to 

the airplane and loss of control (for 

example, stalling); 

(4) Procedures for restarting any 

turbine engine in flight, including the 

effects of altitude; and 

(5) Procedures, speeds, and 

configuration(s) for making a normal 

approach and landing, in accordance 

with SC 23.73 and § 23.75, and a 

transition to the balked landing 

condition. 

(6) Not applicable. 

(b) Not applicable. 

(c) In addition to paragraph (a) of this 

section, for all multiengine airplanes, 

the following information must be 

furnished: 

(1) Procedures, speeds, and 

configuration(s) for making an approach 

and landing with one engine 

inoperative; 

(2) Procedures, speeds, and 

configuration(s) for making a balked 

landing with one engine inoperative and 

the conditions under which a balked 

landing can be performed safely, or a 

warning against attempting a balked 

landing; 

(3) The VSSE determined in § 23.149; 

and 

(4) Procedures for restarting any 

engine in flight including the effects of 

altitude. 

(d) Not applicable. 

(e) Not applicable. 

(f) In addition to paragraphs (a) and 

(c) of this section, the information must 

include the following: 

(1) Procedures, speeds, and 

configuration(s) for making a normal 

takeoff. 

(2) Procedures and speeds for carrying 

out an accelerate-stop in accordance 

with SC 23.55. 

(3) Procedures and speeds for 

continuing a takeoff following engine 

failure in accordance with SC 

23.59(a)(1) and for following the flight 

path determined under SC 23.57 and SC 

23.61(a). 

(g) Information identifying each 

operating condition in which the fuel 

system independence prescribed in 

§ 23.953 is necessary for safety must be 

furnished, together with instructions for 

placing the fuel system in a 

configuration used to show compliance 

with that section. 

(h) For each airplane showing 

compliance with § 23.1353(g)(2) or 

(g)(3), the operating procedures for 

disconnecting the battery from its 

charging source must be furnished. 

(i) Information on the total quantity of 

usable fuel for each fuel tank, and the 

effect on the usable fuel quantity, as a 

result of a failure of any pump, must be 

furnished. 

(j) Procedures for the safe operation of 

the airplane’s systems and equipment, 

both in normal use and in the event of 

malfunction, must be furnished. 

25. SC 23.1587 Performance 

Information 

Instead of compliance with § 23.1587, 

the following apply: 

Unless otherwise prescribed, 

performance information must be 

provided over the altitude and 

temperature ranges required by SC 

23.45(b). 

(a) For all airplanes, the following 

information must be furnished—

(1) The stalling speeds VSO and VS1

with the landing gear and wing flaps 

retracted, determined at maximum 

weight under § 23.49, and the effect on 

these stalling speeds of angles of bank 

up to 60 degrees; 

(2) The steady rate and gradient of 

climb with all engines operating, 

determined under § 23.69(a); 

(3) The landing distance, determined 

under § 23.75 for each airport altitude 


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and standard temperature, and the type 

of surface for which it is valid; 

(4) The effect on landing distances of 

operation on other than smooth hard 

surfaces, when dry, determined under 

SC 23.45(g); and 

(5) The effect on landing distances of 

runway slope and 50 percent of the 

headwind component and 150 percent 

of the tailwind component. 

(b) Not applicable. 

(c) Not applicable. 

(d) In addition to paragraph (a) of this 

section the following information must 

be furnished—

(1) The accelerate-stop distance 

determined under SC 23.55; 

(2) The takeoff distance determined 

under SC 23.59(a); 

(3) At the option of the applicant, the 

takeoff run determined under SC 

23.59(b); 

(4) The effect on accelerate-stop 

distance, takeoff distance and, if 

determined, takeoff run, of operation on 

other than smooth hard surfaces, when 

dry, determined under SC 23.45(g); 

(5) The effect on accelerate-stop 

distance, takeoff distance, and if 

determined, takeoff run, of runway 

slope and 50 percent of the headwind 

component and 150 percent of the 

tailwind component; 

(6) The net takeoff flight path 

determined under SC 23.61(b); 

(7) The enroute gradient of climb/ 

descent with one engine inoperative, 

determined under § 23.69(b); 

(8) The effect, on the net takeoff flight 

path and on the enroute gradient of 

climb/descent with one engine 

inoperative, of 50 percent of the 

headwind component and 150 percent 

of the tailwind component; 

(9) Overweight landing performance 

information (determined by 

extrapolation and computed for the 

range of weights between the maximum 

landing and maximum takeoff weights) 

as follows—

(i) The maximum weight for each 

airport altitude and ambient 

temperature at which the airplane 

complies with the climb requirements of 

SC 23.63(d)(2); and 

(ii) The landing distance determined 

under § 23.75 for each airport altitude 

and standard temperature. 

(10) The relationship between IAS 

and CAS determined in accordance with 

§ 23.1323 (b) and (c). 

(11) The altimeter system calibration 

required by § 23.1325(e). 

Issued in Kansas City, Missouri on March 

23, 2007. 

Kim Smith, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. E7–5951 Filed 3–29–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 310 

[Docket No. 2007N–0099] 

New Drugs Exempted From 

Prescription-Dispensing 

Requirements; Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: Amendments to the Federal 

Food, Drug, and Cosmetic Act (the act) 

necessitate several changes to the 

citations used in Food and Drug 

Administration (FDA) regulations 

regarding the prescription-exemption 

procedure and the list of new drugs that 

are exempted from the prescriptiondispensing requirements. These changes 

are editorial, pertaining only to 

citations, and do not constitute a change 

in FDA regulation. 

DATES: This rule is effective March 30, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Gerald M. Rachanow, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5496, 

Silver Spring, MD 20993, 301–796–

2090. 

SUPPLEMENTARY INFORMATION: Section 

126 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended section 503(b)(1) of the act (21 

U.S.C. 353(b)(1)). Specifically, the 

previous paragraph (b)(1)(A) of the act 

was stricken from the act and 

paragraphs (b)(1)(B) and (b)(1)(C) were 

redesignated as paragraphs (b)(1)(A) and 

(b)(1)(B), respectively. This amendment 

to the act necessitates that FDA revise 

the corresponding citations in its 

regulations. FDA is making this change 

in 21 CFR part 310 (§§ 310.200 and 

310.201). These changes are editorial, 

pertaining only to citations, and do not 

constitute a change in FDA regulation. 

Publication of this document 

constitutes final action on this change 

under the Administrative Procedure Act 

(5 U.S.C. 553). Notice and public 

procedures are unnecessary because 

FDA is merely implementing a change 

in citation to a section of the act as a 

result of amendment of the act. 

List of Subjects in 21 CFR Part 310 

Administrative practice and 

procedure, Drugs, Labeling, Medical 

devices, Reporting and recordkeeping 

requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 310 is 

amended as follows: 

PART 310—NEW DRUGS 

■ 1. The authority citation for 21 CFR 

part 310 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360b–360f, 360j, 361(a), 371, 374, 

375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 

263b–263n. 

§ 310.200 [Amended] 

■ 2. In § 310.200(a), (b), and (e) remove 

‘‘503(b)(1)(C)’’ wherever it appears and 

add in its place ‘‘503(b)(1)(B)’’. 

§ 310.201 [Amended] 

■ 3. In § 310.201(a) remove 

‘‘503(b)(1)(C)’’ and add in its place 

‘‘503(b)(1)(B)’’. 

Dated: March 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5895 Filed 3–29–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9320] 

RIN 1545-BF67 

United States Dollar Approximate 

Separate Transactions Method 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulation. 

SUMMARY: This document contains final 

regulations which provide the 

translation rates that must be used when 

translating into dollars certain items and 

amounts transferred by a qualified 

business unit (QBU) to its home office 

or parent corporation for purposes of 

computing dollar approximate separate 

transactions method (DASTM) gain or 

loss. This regulation is necessary to 

provide guidance under section 985 


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