Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 14719 

scheduled check test for each assay that 

it performs. 

(b) Trained technicians. The testing 

procedures at the laboratory must be run 

or overseen by a laboratory technician 

who has attended and satisfactorily 

completed Service-approved laboratory 

workshops for Plan-specific diseases 

within the past 3 years. 

(c) Laboratory protocol. Official Plan 

assays must be performed and reported 

as described in this part. 

(d) State site visit. The Official State 

Agency will conduct a site visit and 

recordkeeping audit annually. 

(e) Service review. Authorized 

laboratories will be reviewed by the 

Service (NPIP staff) every 3 years. The 

Service’s review may include, but will 

not necessarily be limited to, checking 

records, laboratory protocol, check-test 

proficiency, technician training, and 

peer review. 

(f) Reporting. (1) A memorandum of 

understanding or other means shall be 

used to establish testing and reporting 

criteria to the Official State Agency, 

including criteria that provide for 

reporting H5 and H7 low pathogenic 

avian influenza directly to the Service. 

(2) Salmonella pullorum and 

Mycoplasma Plan disease reactors must 

be reported to the Official State Agency 

within 48 hours. 

(g) Verification. Random samples may 

also be required to be submitted for 

verification as specified by the Official 

State Agency. 

§ 147.52 Approved tests. 

(a) The procedures for the 

bacteriological examination of poultry 

and poultry environments described in 

this part are approved tests for use in 

the NPIP. In addition, all tests that use 

veterinary biologics (e.g., antiserum and 

other products of biological origin) that 

are licensed or produced by the Service 

and used as described in this part are 

approved for use in the NPIP. 

(b) Diagnostic test kits that are not 

licensed by the Service (e.g., 

bacteriological culturing kits) may be 

approved through the following 

procedure: 

(1) The sensitivity of the kit will be 

estimated in at least three authorized 

laboratories selected by the Service by 

testing known positive samples, as 

determined by the official NPIP 

procedures found in Subparts A, B, C, 

and D of this part. If certain conditions 

or interfering substances are known to 

affect the performance of the kit, 

appropriate samples will be included so 

that the magnitude and significance of 

the effect(s) can be evaluated. 

(2) The specificity of the kit will be 

estimated in at least three authorized 

laboratories selected by the Service by 

testing known negative samples, as 

determined by the official NPIP 

procedures found in this part. If certain 

conditions or interfering substances are 

known to affect the performance of the 

kit, appropriate samples will be 

included so that the magnitude and 

significance of the effect(s) can be 

evaluated. 

(3) The kit will be provided to the 

cooperating laboratories in its final form 

and include the instructions for use. 

The cooperating laboratories must 

perform the assay exactly as stated in 

the supplied instructions. Each 

laboratory must test a panel of at least 

25 known positive clinical samples 

supplied by the manufacturer of the test 

kit. In addition, each laboratory will be 

asked to test 50 known negative clinical 

samples obtained from several sources, 

to provide a representative sampling of 

the general population. The identity of 

the samples must be coded so that the 

cooperating laboratories are blinded to 

identity and classification. Each sample 

must be provided in duplicate or 

triplicate, so that error and repeatability 

data may be generated. 

(4) Cooperating laboratories will 

submit to the kit manufacturer all raw 

data regarding the assay response. Each 

sample tested will be reported as 

positive or negative, and the official 

NPIP procedure used to classify the 

sample must be submitted in addition to 

the assay response value. 

(5) The findings of the cooperating 

laboratories will be evaluated by the 

NPIP technical committee, and the 

technical committee will make a 

recommendation regarding whether to 

approve the test kit to the General 

Conference Committee. If the technical 

committee recommends approval, the 

final approval will be granted in 

accordance with the procedures 

described in §§ 147.46 and 147.47. 

Done in Washington, DC, this 26th day of 

March 2009. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. E9–7240 Filed 3–31–09; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2008–1206; Directorate 

Identifier 2008–NE–19–AD; Amendment 39– 

15869; AD 2009–07–10] 

RIN 2120–AA64 

Airworthiness Directives; General 

Electric Company CF6–80A Series 

Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: The FAA is adopting a new 

airworthiness directive (AD) for General 

Electric Company (GE) CF6–80A series 

turbofan engines with a high-pressure 

turbine rotor (HPTR) stage 1 disk, part 

number (P/N) 9367M45G06, installed. 

This AD requires removing any HPTR 

stage 1 disk, P/N 9367M45G06, before 

exceeding 2,075 cycles-since-new 

(CSN). This AD results from an error by 

GE that incorrectly cited a cyclic life of 

12,600 CSN for the HPTR stage 1 disk, 

P/N 9367M45G06. We are issuing this 

AD to prevent the HPTR stage 1 disk 

from exceeding its part life, which could 

cause fatigue cracks to start and grow. 

These cracks could result in a possible 

uncontained disk failure and damage to 

the airplane. 

DATES: This AD becomes effective May 

6, 2009. 

ADDRESSES: The Docket Operations 

office is located at the Docket 

Management Facility, U.S. Department 

of Transportation, 1200 New Jersey 

Avenue, SE., West Building Ground 

Floor, Room W12–140, Washington, DC 

20590–0001. 

FOR FURTHER INFORMATION CONTACT: 

Robert Green, Aerospace Engineer, 

Engine Certification Office, FAA, Engine 

& Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

e-mail: robert.green@faa.gov; telephone 

(781) 238–7754; fax (781) 238–7199. 

SUPPLEMENTARY INFORMATION: The FAA 

proposed to amend 14 CFR part 39 with 

a proposed AD. The proposed AD 

applies to GE CF6–80A series turbofan 

engines with a HPTR stage 1 disk, P/N 

9367M45G06, installed. We published 

the proposed AD in the Federal Register 

on November 14, 2008 (73 FR 67433). 

That action proposed to require 

removing any HPTR stage 1 disk, P/N 

9367M45G06, before exceeding 2,075 

CSN. 

14720 Federal Register / Vol. 74, No. 61 / Wednesday, April 1, 2009 / Rules and Regulations 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Operations office between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this AD, the regulatory 

evaluation, any comments received, and 

other information. The street address for 

the Docket Operations office (telephone 

(800) 647–5527) is provided in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

Comments 

We provided the public the 

opportunity to participate in the 

development of this AD. We have 

considered the comment received. The 

commenter supports the proposal. 

Conclusion 

We have carefully reviewed the 

available data, including the comment 

received, and determined that air safety 

and the public interest require adopting 

the AD as proposed. 

Costs of Compliance 

We estimate that this AD will affect 

10 engines installed on airplanes of U.S. 

registry. We also estimate that it will 

take about 110 work-hours per engine to 

perform the actions, and that the 

average labor rate is $80 per work-hour. 

Required parts will cost about $437,000 

per engine. Based on these figures, we 

estimate the total cost of the AD to U.S. 

operators to be $4,458,000. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

Section 106, describes the authority of 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in Subtitle VII, 

Part A, Subpart III, Section 44701, 

‘‘General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We have determined that this AD will 

not have federalism implications under 

Executive Order 13132. This AD 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. 

For the reasons discussed above, I 

certify that this AD: 

(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. 

We prepared a summary of the costs 

to comply with this AD and placed it in 

the AD Docket. You may get a copy of 

this summary at the address listed 

under ADDRESSES. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety. 

Adoption of the Amendment 

■ Accordingly, under the authority 

delegated to me by the Administrator, 

the Federal Aviation Administration 

amends 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. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive: 

2009–07–10 General Electric Company: 

Amendment 39–15869. Docket No. 

FAA–2008–1206; Directorate Identifier 

2008–NE–19–AD. 

Effective Date 

(a) This airworthiness directive (AD) 

becomes effective May 6, 2009. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to General Electric Co. 

(GE) CF6–80A, CF6–80A1, CF6–80A2, and 

CF6–80A3 turbofan engines with a highpressure turbine rotor (HPTR) stage 1 disk, 

part number (P/N) 9367M45G06, installed. 

These engines are installed on, but not 

limited to, Airbus A310 series and Boeing 

767 series airplanes. 

Unsafe Condition 

(d) This AD results from an error by GE 

that incorrectly cited a cyclic life of 12,600 

CSN in the Airworthiness Limitations 

Section (ALS) of the Instructions for 

Continued Airworthiness (ICA) for the HPTR 

stage 1 disk, P/N 9367M45G06. We are 

issuing this AD to prevent the HPTR stage 1 

disk from exceeding its part life, which could 

cause fatigue cracks to start and grow. These 

cracks could result in a possible uncontained 

disk failure and damage to the airplane. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified unless the 

actions have already been done. 

New Reduced Life Limit for HPTR Stage 1 

Disks, P/N 9367M45G06 

(f) After the effective date of this AD, 

remove HPTR stage 1 disks, P/N 

9367M45G06, from service before exceeding 

the new, reduced life limit of 2,075 cyclessince-new. 

Alternative Methods of Compliance 

(g) The Manager, Engine Certification 

Office, has the authority to approve 

alternative methods of compliance for this 

AD if requested using the procedures found 

in 14 CFR 39.19. 

Special Flight Permits 

(h) Under 14 CFR part 39.23, we are 

prohibiting any special flight permits. 

Related Information 

(i) Contact Robert Green, Aerospace 

Engineer, Engine Certification Office, FAA, 

Engine & Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; e-mail: robert.green@faa.gov; 

telephone (781) 238–7754; fax (781) 238– 

7199, for more information about this AD. 

Material Incorporated by Reference 

(j) None. 

Issued in Burlington, Massachusetts, on 

March 25, 2009. 

Peter A. White, 

Assistant Manager, Engine and Propeller 

Directorate, Aircraft Certification Service. 

[FR Doc. E9–7280 Filed 3–31–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 5 

[Docket No. FDA–2009–N–0144] 

Revision of Organization and 

Conforming Changes to Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule.