Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6323 

4700 River Road, Unit 43, Riverdale, 

MD 20737–1231; (301) 734–6954. 

SUPPLEMENTARY INFORMATION: On 

December 27, 2010, we published in the 

Federal Register (75 FR 81090–81096, 

Docket No. APHIS–2009–0083) an 

interim rule that amended the 

brucellosis regulations to reduce the 

amount of testing required to maintain 

Class Free status for States that have 

been Class Free for 5 or more years and 

that also have no Brucella abortus in 

wildlife. The interim rule also removed 

the provision for automatic 

reclassification of any Class Free State 

or area to a lower status if two or more 

herds are found to have brucellosis 

within a 2-year period or if a single 

brucellosis-affected herd is not 

depopulated within 60 days. Further, 

the interim rule reduced the age at 

which cattle are included in herd blood 

tests. The interim rule also added a 

requirement that any Class Free State or 

area with Brucella abortus in wildlife 

must develop and implement a 

brucellosis management plan approved 

by the Administrator in order to 

maintain Class Free status. Finally, the 

interim rule provided an alternative 

testing protocol for maintaining the 

certified brucellosis-free status of dairy 

herds, which will give producers more 

flexibility for the herd certification 

process. 

Comments on the interim rule were 

currently required to be received on or 

before February 25, 2011. We are 

extending the comment period on 

Docket No. APHIS–2009–0083 for an 

additional 14 days. This action will 

allow interested persons additional time 

to prepare and submit comments. 

Authority: 7 U.S.C. 8301–8317; 7 CFR 

2.22, 2.80, and 371.4. 

Done in Washington, DC, this 31st day of 

January 2011. 

Gregory L. Parham, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2011–2507 Filed 2–3–11; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2010–0068; Directorate 

Identifier 2010–NE–05–AD; Amendment 39– 

16580; AD 2011–02–07] 

RIN 2120–AA64 

Airworthiness Directives; General 

Electric Company CF6–45 and CF6–50 

Series Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are superseding an 

existing airworthiness directive (AD) for 

General Electric Company (GE) CF6–45 

and CF6–50 series turbofan engines 

with certain low-pressure turbine (LPT) 

rotor stage 3 disks installed. That AD 

currently requires initial and repetitive 

borescope inspections of the highpressure turbine (HPT) rotor stage 1 and 

stage 2 blades for wear and damage, 

including excessive airfoil material loss. 

That AD also requires fluorescentpenetrant inspection (FPI) of the LPT 

rotor stage 3 disk under certain 

conditions and removal of the disk from 

service before further flight if found 

cracked. That AD also requires 

repetitive exhaust gas temperature 

(EGT) system checks (inspections). This 

AD requires HPT rotor stage 1 and stage 

2 blade inspections and EGT system 

inspections. This AD also requires FPI 

of the LPT rotor stage 3 disk under 

certain conditions, removal of the disk 

from service before further flight if 

found cracked, and an ultrasonic 

inspection (UI) of the LPT rotor stage 3 

disk forward spacer arm. This AD also 

requires initial and repetitive engine 

core vibration surveys and reporting to 

the FAA any crack findings, disks that 

fail the UI, and engines that fail the 

engine core vibration survey. 

This AD was prompted by reports 

received of additional causes of HPT 

rotor imbalance not addressed in AD 

2010–12–10, and two additional LPT 

rotor stage 3 disk events. We are issuing 

this AD to prevent critical life-limited 

rotating engine part failure, which could 

result in an uncontained engine failure 

and damage to the airplane. 

DATES: This AD is effective February 22, 

2011. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in the AD 

as of February 22, 2011. 

We must receive any comments on 

this AD by March 21, 2011. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Management Facility 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 Office (phone: 800–647– 

5527) is in the ADDRESSES section. 

Comments will be available in the AD 

docket shortly after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Tomasz Rakowski, Aerospace Engineer, 

Engine Certification Office, FAA, Engine 

& Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

phone: 781–238–7735; fax: 781–238– 

7199; e-mail: tomasz.rakowski@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Discussion 

On June 4, 2010, we issued AD 2010– 

12–10, Amendment 39–16331 (75 FR 

32649, June 9, 2010), for CF6–45 and 

CF6–50 series turbofan engines with 

certain LPT rotor stage 3 disks installed. 

That AD requires initial and repetitive 

borescope inspections of the HPT rotor 

stage 1 and stage 2 blades for wear and 

damage, including excessive airfoil 

material loss. That AD also requires FPI 

of the LPT rotor stage 3 disk under 

certain conditions, removal of the disk 

from service before further flight if 

found cracked, and repetitive EGT 

system checks (inspections). That AD 

resulted from reports received of two 

additional LPT rotor stage 3 disk events 

since the original AD 2010–06–15, 

Amendment 39–16240 (75 FR 12661, 

March 17, 2010) was issued. We issued 

those ADs to prevent critical life-limited 

rotating engine part failure, which could 

result in an uncontained engine failure 

and damage to the airplane. 


jdjones on DSK8KYBLC1PROD with RULES
6324 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

Actions Since AD was Issued 

Since we issued AD 2010–12–10, 

investigations have revealed additional 

causes for HPT rotor imbalance not 

addressed in that AD, and two 

additional LPT rotor stage 3 disk events 

have occurred. 

FAA’s Determination 

We are issuing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

AD Requirements 

This AD requires: 

• HPT rotor stage 1 and stage 2 blade 

inspections and EGT system 

inspections; and 

• FPI of the LPT rotor stage 3 disk 

under certain conditions and removal of 

the disk from service before further 

flight if found cracked; and 

• A UI of the LPT rotor stage 3 disk 

forward spacer arm; and 

• Initial and repetitive engine core 

vibration surveys; and 

• Reporting to the FAA any crack 

findings, disks that fail the UI, and 

engines that fail the engine core 

vibration survey. 

FAA’s Justification and Determination 

of the Effective Date 

An unsafe condition exists that 

requires the immediate adoption of this 

AD. The FAA has found that the risk to 

the flying public justifies waiving notice 

and comment prior to adoption of this 

rule because we require near immediate 

corrective action to address the unsafe 

condition. Therefore, we find that notice 

and opportunity for prior public 

comment are impracticable, and that 

good cause exists for making this 

amendment effective in less than 30 

days. 

Comments Invited 

This AD is a final rule that involves 

requirements affecting flight safety, and 

we did not provide you with notice and 

an opportunity to provide your 

comments before it becomes effective. 

However, we invite you to send any 

written data, views, or arguments about 

this AD. Send your comments to an 

address listed under the ADDRESSES

section. Include the docket number 

FAA–2010–0068 and directorate 

identifier 2010–NE–05–AD at the 

beginning of your comments. We 

specifically invite comments on the 

overall regulatory, economic, 

environmental, and energy aspects of 

this AD. We will consider all comments 

received by the closing date and may 

amend this AD because of those 

comments. 

We will post all comments we 

receive, without change, to http:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this AD. 

Costs of Compliance 

We estimate that this AD will affect 

387 CF6–45 and CF6–50 series turbofan 

engines installed on airplanes of U.S. 

registry. We also estimate that it will 

take, about 8 hours to perform the HPT 

blade inspection, 6 hours to perform a 

vibration survey, 4 hours to perform an 

ultrasonic inspection, 2 hours to 

perform an EGT resistance check, and 

1 hour to perform an EGT thermocouple 

inspection for each engine. The average 

labor rate is $85 per work-hour. We 

anticipate no required parts cost. Based 

on these figures, we estimate the total 

cost of the AD to U.S. operators to be 

$690,795. 

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 

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), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) 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. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA 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. The FAA amends § 39.13 by 

removing airworthiness directive (AD) 

2010–12–10, Amendment 39–16331 (75 

FR 32649, June 9, 2010) and adding the 

following new AD: 

2011–02–07 General Electric Company: 

Amendment 39–16580; Docket No. 

FAA–2010–0068; Directorate Identifier 

2010–NE–05–AD. 

Effective Date 

(a) This AD is effective February 22, 2011. 

Affected ADs 

(b) This AD supersedes AD 2010–12–10, 

Amendment 39–16331. 

Applicability 

(c) This AD applies to the following 

engines with any of the low-pressure turbine 

(LPT) rotor stage 3 disk part numbers listed 

in Table 1 of this AD installed in: 

(1) General Electric Company (GE) CF6– 

45A, CF6–45A2, CF6–50A, CF6–50C, CF6– 

50CA, CF6–50C1, CF6–50C2, CF6–50C2B, 

CF6–50C2D, CF6–50E, CF6–50E1, and CF6– 

50E2 turbofan engines, including engines 

marked on the engine data plate as CF6– 

50C2–F and CF6–50C2–R. 

(2) These engines are installed on, but not 

limited to, Airbus A300 series, Boeing 747 

series, McDonnell Douglas DC–10 series, and 

DC–10–30F (KDC–10) airplanes. 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6325 

TABLE 1—APPLICABLE LPT ROTOR STAGE 3 DISK PART NUMBERS

9061M23P06 9061M23P07 9061M23P08 9061M23P09 9224M75P01 

9061M23P10 1473M90P01 1473M90P02 1473M90P03 1473M90P04 

9061M23P12 9061M23P14 9061M23P15 9061M23P16 1479M75P01 

1479M75P02 1479M75P03 1479M75P04 1479M75P05 1479M75P06 

1479M75P07 1479M75P08 1479M75P09 1479M75P11 1479M75P13 

1479M75P14 N/A N/A N/A N/A 

Unsafe Condition 

(d) This AD results from reports received 

of additional causes of high-pressure turbine 

(HPT) rotor imbalance not addressed in AD 

2010–12–10, and two additional LPT rotor 

stage 3 disk events. We are issuing this AD 

to prevent critical life-limited rotating engine 

part failure, which could result in an 

uncontained engine failure and damage to 

the airplane. 

Compliance 

(e) Comply with this AD within the 

compliance times specified, unless already 

done. 

Borescope Inspections of HPT Rotor Stage 1 

and Stage 2 Blades 

(f) For the borescope inspections required 

by paragraphs (f)(1), (f)(2), and (f)(3) of this 

AD, inspect the blades from the forward and 

aft directions. Inspect all areas of the blade 

airfoil: Your inspection must include blade 

leading and trailing edges, and their convex 

and concave airfoil surfaces. Inspect for signs 

of impact, cracking, burning, damage, or 

distress. 

(1) Perform an initial borescope inspection 

of the HPT rotor stage 1 and stage 2 blades, 

within 10 cycles after the effective date of 

this AD. 

(2) Thereafter, repeat the borescope 

inspection of the HPT rotor stage 1 and stage 

2 blades within every 75 cycles-since-lastinspection (CSLI). 

(3) Borescope-inspect the HPT rotor stage 

1 and stage 2 blades within the cycle limits 

after the engine has experienced any of the 

events specified in Table 2 of this AD. 

(4) Remove any engine from service before 

further flight if the engine fails any of the 

borescope inspections required by this AD. 

TABLE 2—CONDITIONAL BORESCOPE INSPECTION CRITERIA

If the engine has experienced: Then Borescope-Inspect: 

(i) An exhaust gas temperature (EGT) above redline .................................................................................................... Within 10 cycles. 

(ii) A shift in the smoothed EGT trending data that exceeds 18 °F (10 °C), but is less than or equal to 36 °F (20 

°C).

Within 10 cycles. 

(iii) A shift in the smoothed EGT trending data that exceeds 36 °F (20 °C) ................................................................. Before further flight. 

(iv) Two consecutive raw EGT trend data points that exceed 18 °F (10 °C) above the smoothed average, but is 

less than or equal to 36 °F (20 °C).

Within 10 cycles. 

(v) Two consecutive raw EGT trend data points that exceed 36 °F (20 °C) above the smoothed average ................ Before further flight. 

Actions Required for Engines With Damaged 

HPT Rotor Blades 

(g) For those engines that fail any 

borescope inspection requirements of this 

AD, before returning the engine to service, 

fluorescent-penetrant inspect the inner 

diameter surface forward cone body (forward 

spacer arm) of the LPT rotor stage 3 disk. If 

a crack is found or if a circumferential band 

of fluorescence appears, remove the disk 

from service. 

EGT Thermocouple Probe Inspections 

(h) Inspect the EGT thermocouple probe for 

damage within 50 cycles after the effective 

date of this AD or before accumulating 750 

CSLI, whichever occurs later. 

(i) Thereafter, re-inspect the EGT 

thermocouple probe for damage within every 

750 CSLI. 

(j) If any EGT thermocouple probe shows 

wear through the thermocouple guide sleeve, 

remove and replace the EGT thermocouple 

probe before further flight, and ensure the 

turbine mid-frame liner does not contact the 

EGT thermocouple probe. 

EGT System Resistance Check Inspections 

(k) Perform an EGT system resistance 

check within 50 cycles from the effective 

date of this AD or before accumulating 750 

cycles-since-the-last-resistance check on the 

EGT system, whichever occurs later. 

(l) Thereafter, repeat the EGT system 

resistance check within every 750 cyclessince-the-last-resistance check. 

(m) Remove and replace, or repair any EGT 

system component that fails the resistance 

system check before further flight. 

Ultrasonic Inspection (UI) of the LPT Rotor 

Stage 3 Disk Forward Spacer Arm 

(n) Within 75 cycles after the effective date 

of this AD, perform a UI of the forward cone 

body (forward spacer arm) of the LPT rotor 

stage 3 disk. Use paragraphs E. through K. of 

Appendix A of GE Service Bulletin (SB) No. 

CF6–50–SB 72–1312, Revision 1, dated 

October 18, 2010, to do the UI. 

Engine Core Vibration Survey 

(o) Within 75 cycles after the effective date 

of this AD, perform an initial engine core 

vibration survey. 

(1) Use approximately a one-minute 

acceleration and a one-minute deceleration of 

the engine between ground idle and 84% N2 

(about 8,250 rpm) to perform the engine core 

vibration survey. 

(2) Use a spectral/trim balance analyzer or 

equivalent, to determine the N2 rotor 

vibration. 

(p) Thereafter, within every 350 cyclessince-the-last-engine core vibration survey, 

perform the engine core vibration survey as 

required in paragraphs (o)(1) through (o)(2) of 

this AD. 

(q) If the vibration level is above 5 mils 

Double Amplitude then before further flight, 

remove the engine from service. 

(r) For those engines that fail any engine 

core vibration survey requirements of this 

AD, before returning the engine to service, 

fluorescent-penetrant inspect the inner 

diameter surface forward cone body (forward 

spacer arm) of the LPT rotor stage 3 disk. If 

a crack is found or if a circumferential band 

of fluorescence appears, remove the disk 

from service. 

(s) If the engine has experienced any 

vibration reported by maintenance or flight 

crew that is suspected to be caused by the 

HPT rotor (N2), perform the engine core 

vibration survey as required in paragraphs 

(o)(1) through (o)(2) of this AD within 10 

cycles after the report. 

(t) You can find further guidance about 

performing the engine core vibration survey 

in GE SB No. CF6–50–SB 72–1313, Revision 

1, dated October 18, 2010. 

Reporting Requirements 

(u) Report to the FAA within 10 days after 

any of the following: 

(1) Any crack findings; and 

(2) Any disks that failed a UI performed as 

specified in paragraph (n) of this AD; and 

(3) Any engines that failed an engine core 

vibration survey as specified in paragraphs 

(o) and (p) of this AD. 

(4) Submit these findings to FAA, Engine 

& Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; eVerDate Mar<15>2010 14:40 Feb 03, 2011 Jkt 223001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\04FER1.SGM 04FER1

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6326 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

mail: tomasz.rakowski@faa.gov; phone: 781– 

238–7735; fax: 781–238–7199. 

Paperwork Reduction Act Burden Statement 

(5) A federal agency may not conduct or 

sponsor, and a person is not required to 

respond to, nor shall a person be subject to 

a penalty for failure to comply with a 

collection of information subject to the 

requirements of the Paperwork Reduction 

Act unless that collection of information 

displays a current valid OMB Control 

Number. The OMB Control Number for this 

information collection is 2120–0056. Public 

reporting for this collection of information is 

estimated to be approximately 5 minutes per 

response, including the time for reviewing 

instructions, completing and reviewing the 

collection of information. All responses to 

this collection of information are mandatory. 

Comments concerning the accuracy of this 

burden and suggestions for reducing the 

burden should be directed to the FAA at: 800 

Independence Ave., SW., Washington, DC 

20591, Attn: Information Collection 

Clearance Officer, AES–200. 

Definitions 

(v) For the purposes of this AD, an EGT 

above redline is a confirmed overtemperature indication that is not a result of 

EGT system error. 

(w) For the purposes of this AD, a shift in 

the smoothed EGT trending data is a shift in 

a rolling average of EGT that can be 

confirmed by a corresponding shift in the 

trending of fuel flow or fan speed/core speed 

(N1/N2) relationship. You can find further 

guidance about evaluating EGT trend data in 

GE Company Service Rep Tip 373 

‘‘Guidelines For Parameter Trend 

Monitoring.’’ 

Previous Credit 

(x) A borescope inspection performed 

before the effective date of this AD using AD 

2010–06–15, Amendment 39–16240 (75 FR 

12661, March 17, 2010) or AD 2010–12–10, 

Amendment 39–16331 (75 FR 32649, June 9, 

2010) within the last 75 cycles, satisfies the 

initial borescope inspection requirement in 

paragraph (f)(1) of this AD. 

(y) A UI performed before the effective date 

of this AD using GE SB No. CF6–50–SB 72– 

1312, dated August 9, 2010 or GE SB No. 

CF6–50–SB 72–1312 Revision 1, dated 

October 18, 2010, satisfies the inspection 

requirement in paragraph (n) of this AD. 

(z) An engine core vibration survey 

performed before the effective date of this AD 

using GE SB No. CF6–50–SB 72–1313, dated 

August 9, 2010 or GE SB No. CF6–50–SB 72– 

1313 Revision 1, dated October 18, 2010, 

within the last 350 cycles, satisfies the initial 

survey requirement in paragraph (o) of this 

AD. 

Alternative Methods of Compliance 

(AMOCs) 

(aa) AMOCs previously approved for AD 

2010–06–15, Amendment 39–16240 (75 FR 

12661, March 17, 2010) are not approved for 

this AD. However, AMOCs previously 

approved for AD 2010–12–10, Amendment 

39–16331 (75 FR 32649, June 9, 2010) are 

approved for this AD. 

(bb) 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. 

Related Information 

(cc) Contact Tomasz Rakowski, Aerospace 

Engineer, Engine Certification Office, FAA, 

Engine & Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; phone: 781–238–7735; fax: 781–238– 

7199; e-mail: tomasz.rakowski@faa.gov, for 

more information about this AD. 

Material Incorporated by Reference 

(dd) You must use GE Service Bulletin No. 

CF6–50–SB 72–1312, Revision 1, dated 

October 18, 2010, to do the ultrasonic 

inspections required by this AD. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service bulletin in accordance with 5 

U.S.C. 552(a) and 1 CFR part 51. 

(2) Contact General Electric Company, GE– 

Aviation, Room 285, 1 Neumann Way, 

Cincinnati, OH 45215, telephone (513) 552– 

3272; fax (513) 552–3329; e-mail: 

geae.aoc@ge.com for a copy of this service 

information. 

(3) You may review copies at the FAA, 

New England Region, 12 New England 

Executive Park, Burlington, MA. For 

information on the availability of this 

material at the FAA, call 781–238–7125. 

(4) You may also review copies of the 

service information that is incorporated by 

reference at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, or go 

to: http://www.archives.gov/federal-register/

cfr/ibr-locations.html. 

Issued in Burlington, Massachusetts, on 

January 14, 2011. 

Peter A. White, 

Acting Manager, Engine & Propeller 

Directorate, Aircraft Certification Service. 

[FR Doc. 2011–2387 Filed 2–3–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 516 

[Docket No. FDA–2011–N–0003] 

New Animal Drugs; Masitinib 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

conditional approval of an application 

for a new animal drug intended for a 

minor use filed by AB Science. The 

application for conditional approval 

provides for the veterinary prescription 

use of masitinib mesylate tablets in 

dogs. 

DATES: This rule is effective February 4, 

2011. 

FOR FURTHER INFORMATION CONTACT: Lisa 

M. Troutman, Center for Veterinary 

Medicine (HFV–116), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8322, 

e-mail: lisa.troutman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: AB 

Science, 3 Avenue George V, 75008 

Paris, France, filed an application for 

conditional approval (141–308) that 

provides for veterinary prescription use 

of KINAVET–CA1 (masitinib mesylate) 

Tablets for the treatment of recurrent 

(post-surgery) or nonresectable Grade II 

or III cutaneous mast cell tumors in dogs 

that have not previously received 

radiotherapy and/or chemotherapy 

except corticosteroids. In accordance 

with the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), as 

amended by the Minor Use and Minor 

Species Animal Health Act of 2004 

(MUMS Act), this drug is conditionally 

approved as of December 15, 2010, and 

the regulations in part 516 (21 CFR part 

516) are amended by adding new 

§ 516.1318. 

In addition, AB Science has not been 

previously listed in the animal drug 

regulations as a sponsor of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to add 

entries for this firm. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support conditional approval of this 

application may be seen in the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852, between 9 a.m. and 4 p.m., 

Monday through Friday. 

The Agency has determined under 21 

CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

KINAVET–CA1 (masitinib mesylate) 

Tablets for the intended uses 

conditionally approved by FDA under 

application number 141–308 qualifies 

for 7 years of exclusive marketing rights 

beginning on the date of conditional 

approval. This new animal drug 

qualifies for exclusive marketing rights 

under section 573(c) of the FD&C Act 

(21 U.S.C. 360ccc–2(c)) because it has 


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