Federal Register / Vol. 69, No. 30 / Friday, February 13, 2004 / Rules and Regulations 7113

or at the next ‘‘C’’ check, whichever occurs 

first. 

New Requirements of This AD 

Modification 

(b) For all airplanes: Within 36 months 

after the effective date of this AD; modify the 

electrical wires in the cable trough below the 

cabin floor at Sections X510.00 to X580.50 

(including a general visual inspection and 

any applicable repair) per Part III, paragraphs 

1 through 9 and 12 through 20, of the 

Accomplishment Instructions of Bombardier 

Service Bulletin 8–53–80, Revision ‘A’, dated 

July 25, 2000. Any applicable repair must be 

done before further flight. Accomplishment 

of these actions before the effective date of 

this AD per Bombardier Service Bulletin 8–

53–80, dated December 22, 1999, is 

considered acceptable for compliance with 

the actions required by this paragraph. 

Alternative Methods of Compliance 

(c) In accordance with 14 CFR 39.19, the 

Manager, New York Aircraft Certification 

Office, FAA is authorized to approve 

alternative methods of compliance for this 

AD. 

Incorporation by Reference 

(d) The actions shall be done in accordance 

with Bombardier Service Bulletin S.B. 8–53–

66, dated March 27, 1998; and Bombardier 

Service Bulletin 8–53–80, Revision ‘A’, dated 

July 25, 2000; as applicable. 

(1) The incorporation by reference of 

Bombardier Service Bulletin 8–53–80, 

Revision ‘A’, dated July 25, 2000; is approved 

by the Director of the Federal Register in 

accordance with 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) The incorporation by reference of 

Bombardier Service Bulletin S.B. 8–53–66, 

dated March 27, 1998; was approved 

previously by the Director of the Federal 

Register as of October 27, 1998 (63 FR 50501, 

September 22, 1998). 

(3) Copies may be obtained from 

Bombardier, Inc., Bombardier Regional 

Aircraft Division, 123 Garratt Boulevard, 

Downsview, Ontario M3K 1Y5, Canada. 

Copies may be inspected at the FAA, 

Transport Airplane Directorate, 1601 Lind 

Avenue, SW., Renton, Washington; or at the 

FAA, New York Aircraft Certification Office, 

1600 Stewart Avenue, Westbury, New York; 

or at the Office of the Federal Register, 800 

North Capitol Street, NW., suite 700, 

Washington, DC.

Note 2: The subject of this AD is addressed 

in Canadian airworthiness directive CF–

1998–08R2, dated July 10, 2000.

Effective Date 

(e) This amendment becomes effective on 

March 19, 2004.

Issued in Renton, Washington, on January 

29, 2004. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service.

[FR Doc. 04–2576 Filed 2–12–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. 2002–SW–45–AD; Amendment 

39–13471; AD 2004–03–27] 

RIN 2120–AA64 

Airworthiness Directives; Eurocopter 

France Model AS332C, L, and L1 

Helicopters

AGENCY: Federal Aviation 

Administration, DOT.

ACTION: Final rule.

SUMMARY: This amendment adopts a 

new airworthiness directive (AD) for the 

specified Eurocopter France 

(Eurocopter) model helicopters that 

requires inspecting the bevel gear for a 

crack using a borescope. This 

amendment is prompted by a crack that 

was detected on a bevel gear during a 

main gearbox teardown inspection. The 

actions specified by this AD are 

intended to prevent failure of the bevel 

gear, loss of torque to the main rotor 

system, and subsequent loss of control 

of the helicopter.

DATES: Effective March 19, 2004. 

The incorporation by reference of 

certain publications listed in the 

regulations is approved by the Director 

of the Federal Register as of March 19, 

2004.

ADDRESSES: The service information 

referenced in this AD may be obtained 

from American Eurocopter Corporation, 

2701 Forum Drive, Grand Prairie, Texas 

75053–4005, telephone (972) 641–3460, 

fax (972) 641–3527. This information 

may be examined at the FAA, Office of 

the Regional Counsel, Southwest 

Region, 2601 Meacham Blvd., Room 

663, Fort Worth, Texas; or at the Office 

of the Federal Register, 800 North 

Capitol Street, NW., suite 700, 

Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Uday Garadi, Aviation Safety Engineer, 

FAA, Rotorcraft Directorate, Safety 

Management Group, Fort Worth, Texas 

76193–0110, telephone (817) 222–5123, 

fax (817) 222–5961.

SUPPLEMENTARY INFORMATION: A 

proposal to amend part 39 of the Federal 

Aviation Regulations (14 CFR part 39) to 

include an AD that is applicable to 

Eurocopter Model AS332C, L, and L1 

helicopters was published in the 

Federal Register on December 31, 2002 

(67 FR 79893). That action proposed to 

require inspecting the bevel gear for 

cracks using a borescope within 50 

hours TIS, and thereafter at intervals not 

to exceed 150 hours TIS, for bevel gears 

with more than 6,600 hours TIS. If a 

crack was found in the bevel gear, it was 

proposed that replacing the bevel gear 

would be required. However, before the 

final rule was published, we discovered 

that certain part-numbered bevel gears 

were omitted from the applicability and 

one was incorrectly stated in that 

previous proposal. Also, the 

manufacturer revised the service 

information to introduce the new 

inspection interval of 1,000 cycles for 

helicopter operations involving a torque 

application frequency of more than 4 

cycles per hour for helicopters that 

conduct external load operations 

involving more frequent torque 

applications. Additionally, we 

inadvertently included Model AS332C1 

helicopters in the ‘‘Applicability’’

section of the proposal—those model 

helicopters are not on the U.S. Registry. 

Finally, the DGAC issued a revised AD 

for helicopters operated in France. 

Therefore, we reopened the comment 

period by publishing a supplemental 

notice of proposed rulemaking on 

September 18, 2003 (68 FR 54686). That 

action: 

• Corrected the basic bevel gear part 

number (P/N) stated in the 

‘‘Applicability’’ of the proposal to state 

‘‘332A32–2181–00’’; 

• Added bevel gear P/Ns 332A32–

2181–01 and –08 to the ‘‘Applicability’’; 

• Deleted the Model AS332C1 

helicopters from the ‘‘Applicability’’; 

• Incorporated the latest Eurocopter 

Alert Telex and referenced the latest 

DGAC AD; 

• Proposed requiring the repetitive 

inspection at intervals not to exceed 150 

hours TIS or 1,000 torque cycles, 

whichever occurs first; and 

• Excluded from the ‘‘Applicability’’

any main gearbox (regardless of the P/

N of the main reduction gear module or 

bevel gear) overhauled after December 

31, 2002, and any P/N inspected in 

accordance with AS332 letter to Repair 

Stations No. 183 or repaired in 

accordance with Repair Sheet (F.R.) 

332A32–2181–ZA or 331A32–3110–ZA.

The Direction Generale De L’Aviation 

Civile (DGAC), the airworthiness 

authority for France, notified the FAA 

that an unsafe condition may exist on 

Eurocopter Model AS332C, C1, L, and 

L1 helicopters. The DGAC advises that 

borescope inspections of the bevel gear 

are necessary to detect cracks. 

Eurocopter has issued Alert Telex No. 

05.00.58 R2, dated February 3, 2003, 

which indicates that as a result of metal 

particles found on the chip detector of 

the main gearbox sump on a helicopter, 

further investigation has revealed a 

longitudinal crack that grows 

lengthwise in the shaft, up to the

7114 Federal Register / Vol. 69, No. 30 / Friday, February 13, 2004 / Rules and Regulations 

combiner gear, in the bevel gear where 

the ring retains the pinion toe bearing. 

The alert telex specifies inspecting the 

bevel gear for cracks using a borescope, 

pending the result of the investigation 

into the cause of the fatigue crack 

initiation currently being conducted in 

France. The DGAC classified this alert 

telex as mandatory and issued AD 

2002–424–081(A) R2, dated March 19, 

2003, to ensure the continued 

airworthiness of these helicopters in 

France. 

Interested persons have been afforded 

an opportunity to participate in the 

making of this amendment. No 

comments were received on the 

proposal or the FAA’s determination of 

the cost to the public. The FAA has 

determined that air safety and the 

public interest require the adoption of 

the rule as proposed. 

The FAA estimates that this AD will 

affect 4 helicopters of U.S. registry, and 

the required actions will take 

approximately 4 work hours for the 

inspections and 16 work hours to 

replace the bevel gear, if necessary, at an 

average labor rate of $65 per work hour. 

Required parts will cost approximately 

$31,372. Based on these figures, we 

estimate the total cost impact of the AD 

on U.S. operators to be $130,688, 

assuming that upon the first inspection 

a crack is detected and the bevel gear 

will need to be replaced. 

The regulations adopted herein will 

not have a substantial direct effect on 

the States, on the relationship between 

the national Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. Therefore, it is 

determined that this final rule does not 

have federalism implications under 

Executive Order 13132. 

For the reasons discussed above, I 

certify that this action (1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under DOT 

Regulatory Policies and Procedures (44 

FR 11034, February 26, 1979); and (3) 

will not have a significant economic 

impact, positive or negative, on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. A final evaluation has 

been prepared for this action and it is 

contained in the Rules Docket. A copy 

of it may be obtained from the Rules 

Docket at the location provided under 

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety.

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, the Federal Aviation 

Administration amends part 39 of the 

Federal Aviation Regulations (14 CFR 

part 39) as follows:

PART 39—AIRWORTHINESS 

DIRECTIVES

■ 1. The authority citation for part 39 

continues to read as follows:

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

§ 39.13 [Amended]

■ 2. Section 39.13 is amended by adding 

a new airworthiness directive to read as 

follows:

2002–SW–45–AD Eurocopter France:

Amendment 39–13471. Docket No. 

2002–SW–45–AD.

Applicability: Model AS332C, L, and L1 

helicopters, with main gearbox bevel gear 

(bevel gear), part numbers (P/N) 332A32–

2027–00 or 332A32–2026–00, containing 

bevel gears, P/N 332A32–2181–00, –01, –02, 

–03, or –04, or 331A32–3110–07, –08, –09, or 

–19, installed, certificated in any category. 

This AD does not apply to: 

• Main gearboxes that were overhauled 

after December 31, 2002; 

• Parts inspected in accordance with 

AS332 letter to Repair Stations No. 183; or 

• Parts repaired in accordance with Repair 

Sheet (F.R.) 332A32–2181–ZA or 331A32–

3110–ZA. 

Compliance: Required as indicated, unless 

accomplished previously.

To detect a bevel gear crack and prevent 

failure of the bevel gear, loss of torque to the 

main rotor system, and subsequent loss of 

control of the helicopter, accomplish the 

following: 

(a) For bevel gears that have more than 

6,600 hours time-in-service (TIS), within 50 

hours TIS and thereafter at intervals not to 

exceed 150 hours TIS, or at intervals not to 

exceed 1,000 frequent torque variation 

cycles, whichever occurs first, inspect for a 

crack using a borescope in accordance with 

the Operational Procedure, paragraph 2.B.1. 

and 2.B.2. of Eurocopter Telex No. 05.00.58 

R2, dated February 3, 2003. A frequent torque 

variation cycle is each landing or external 

load operation beginning at the point when 

there are 4 or more landings, or 4 or more 

external load operations, or any combination 

of 4 or more landings and external load 

operations in any 60 minute time period, and 

ending when any combination of landings 

and external load operations is less than 4 in 

any 60 minute time period. 

(b) If a crack is found in the bevel gear, 

before further flight, replace the bevel gear 

with an airworthy bevel gear. 

(c) To request a different method of 

compliance or a different compliance time 

for this AD, follow the procedures in 14 CFR 

39.19. Contact the Safety Management Group, 

Rotorcraft Directorate, FAA, for information 

about previously approved alternative 

methods of compliance. 

(d) The inspection and replacement, if 

necessary, shall be done in accordance with 

Eurocopter Telex No. 05.00.58 R2, dated 

February 3, 2003. The Director of the Federal 

Register approved this incorporation by 

reference in accordance with 5 U.S.C. 552(a) 

and 1 CFR part 51. Copies may be obtained 

from American Eurocopter Corporation, 2701 

Forum Drive, Grand Prairie, Texas 75053–

4005, telephone (972) 641–3460, fax (972) 

641–3527. Copies may be inspected at the 

FAA, Office of the Regional Counsel, 

Southwest Region, 2601 Meacham Blvd., 

Room 663, Fort Worth, Texas; or at the Office 

of the Federal Register, 800 North Capitol 

Street, NW., Suite 700, Washington, DC. 

(e) This amendment becomes effective on 

March 19, 2004.

Note: The subject of this AD is addressed 

in Direction Generale De L’Aviation Civile 

(France) AD 2002–424–081(A) R2, dated 

March 19, 2003.

Issued in Fort Worth, Texas, on January 30, 

2004. 

David A. Downey, 

Manager, Rotorcraft Directorate, Aircraft 

Certification Service.

[FR Doc. 04–2782 Filed 2–12–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 610

[Docket No. 1980N–0208]

Biological Products; Bacterial 

Vaccines and Toxoids; Implementation 

of Efficacy Review; Correction

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule and final order; 

correction.

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

final rule and final order that appeared 

in the Federal Register of January 5, 

2004 (69 FR 255). The document 

amended the biologics regulations and 

categorized certain biological products 

licensed before July 1, 1972, based on 

their safety, effectiveness, and labeling. 

The document was published with some 

typographical errors in the reference 

section. This document corrects those 

errors.

DATES: Effective February 13, 2004.

FOR FURTHER INFORMATION CONTACT:

Astrid Szeto, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: In FR Doc. 

03–32255, appearing on page 255, in the