Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Rules and Regulations 27919 

Actions and Compliance 

(f) Unless already done, do the following 

actions within the next 20 hours time-inservice after July 17, 2009 (the effective date 

of this AD) or within the next 30 days after 

July 17, 2009 (the effective date of this AD), 

whichever occurs first, following AEROMOT 

Alert Service Bulletin No. 200–71–106, Rev. 

B, dated December 20, 2006; ROTAX Aircraft 

Engines Mandatory Service Bulletin SB–912– 

043 R2/SB–914–029 R2, dated November 10, 

2006; and ROTAX Aircraft Engines Service 

Instruction SI–912–016/SI–914–019, dated 

August 28, 2006: 

(1) Replace the EVANS NPG + cooling 

liquid with a conventional, FAA-approved 

coolant for the ROTAX 912 and 914 series 

engines. 

(2) Apply a new red line marking on the 

engine cylinder head temperature gauge at 

120 degrees C/248 degrees F. 

(3) Replace the radiator cap part number 

(P/N) 922075 from the affected engines with 

a new radiator cap P/N 922070. 

(4) Insert into the AFM Limitations section 

an amendment to include the new operation 

limit of the cylinder head temperature to 120 

degrees C/248 degrees F by inserting a copy 

of AEROMOT Alert Service Bulletin No. 

200–71–106, Rev. B, dated December 20, 

2006, into the AFM, Limitations section, 

Section 2 on item 2.4, power plant, fuel and 

oil limitations and item 2.5, power plant 

instrument markings. 

FAA AD Differences 

Note: This AD differs from the MCAI and/ 

or service information as follows: No 

differences. 

Other FAA AD Provisions 

(g) The following provisions also apply to 

this AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Standards Office, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. Send information to 

ATTN: Greg Davison, Glider Program 

Manager, FAA, Small Airplane Directorate, 

901 Locust, Room 301, Kansas City, Missouri 

64106; telephone: (816) 329–4130; fax: (816) 

329–4090. Before using any approved AMOC 

on any airplane to which the AMOC applies, 

notify your appropriate principal inspector 

(PI) in the FAA Flight Standards District 

Office (FSDO), or lacking a PI, your local 

FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, under the 

provisions of the Paperwork Reduction Act 

(44 U.S.C. 3501 et seq.), the Office of 

Management and Budget (OMB) has 

approved the information collection 

requirements and has assigned OMB Control 

Number 2120–0056. 

Related Information 

(h) Refer to MCAI ANAC Brazilian 

Airworthiness Directive AD No. 2007–01–01, 

dated January 29, 2007; AEROMOT Alert 

Service Bulletin No. 200–71–106, Rev. B, 

dated December 20, 2006; ROTAX Aircraft 

Engines Mandatory Service Bulletin SB–912– 

043 R2/SB–914–029 R2, dated November 10, 

2006; and ROTAX Aircraft Engines Service 

Instruction SI–912–016/SI–914–019, dated 

August 28, 2006, for related information. 

Material Incorporated by Reference 

(i) You must use AEROMOT Alert Service 

Bulletin No. 200–71–106, Rev. B, dated 

December 20, 2006; ROTAX Aircraft Engines 

Mandatory Service Bulletin SB–912–043 R2/ 

SB–914–029 R2, dated November 10, 2006; 

and ROTAX Aircraft Engines Service 

Instruction SI–912–016/SI–914–019, dated 

August 28, 2006, to do the actions required 

by this AD, unless the AD specifies 

otherwise. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service information under 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) For service information identified in 

this AD, contact Aeromot-Industria Mecanico 

Metalurgica ltda., Av. das Industrias, 1210– 

Bairro Anchieta, Caixa Postal 8031, 90 200– 

290–Porto Alegre-RS–Brazil; telephone: +55 

51 3357 8550; fax: +55 51 3371 1655; 

Internet: http://www.aeromot.com.br. 

(3) You may review copies of the service 

information incorporated by reference for 

this AD at the FAA, Central Region, Office of 

the Regional Counsel, 901 Locust, Kansas 

City, Missouri 64106. For information on the 

availability of this material at the Central 

Region, call (816) 329–3768. 

(4) You may also review copies of the 

service information incorporated by reference 

for this AD 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/

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Kansas City, Missouri, on June 4, 

2009. 

Kim Smith, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. E9–13575 Filed 6–11–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs for Use in Animal 

Feeds; Chlortetracycline 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by 

Alpharma Inc. The supplemental NADA 

provides for revised Blue Bird labeling 

for chlortetracycline Type A medicated 

articles used to formulate Type B and 

Type C medicated feeds in various 

classes of livestock and poultry. 

DATES: This rule is effective June 12, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Timothy Schell, Center for Veterinary 

Medicine (HFV–128), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8116, email: timothy.schell@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Alpharma 

Inc., 440 Rte. 22, Bridgewater, NJ 08807, 

filed a supplement to NADA 46–699 

that provides revised Blue Bird labeling 

for CHLORMAX (chlortetracycline) 

Type A medicated articles used to 

formulate Type B and Type C medicated 

feeds in various classes of livestock and 

poultry. The supplemental NADA is 

approved as of May 22, 2009, and the 

regulations are amended in § 558.128 

(21 CFR 558.128) to reflect the approval. 

In addition, § 558.128 is amended to 

differentiate certain withdrawal times in 

cattle for two chlortetracycline Type A 

medicated articles sponsored by 

Alpharma Inc. under separate NADAs 

and to correct the spelling of a turkey 

pathogen. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

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. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 558 

Animal drugs, Animal feeds. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

27920 Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Rules and Regulations 

the Center for Veterinary Medicine, 21 

CFR part 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 2. In § 558.128, in the table in 

paragraph (e)(2)(iii), in the ‘‘Indications 

for use’’ column, remove ‘‘meleagrides’’ 

and in its place add ‘‘meleagridis’’; and 

revise paragraphs (e)(4)(iv), (e)(4)(v), 

and (e)(4)(ix) to read as follows: 

§ 558.128 Chlortetracycline. 

* * * * * 

(e) * * * 

(4) * * * 

Chlortetracycline amount Indications for use Limitations Sponsor 

* * * * * * * 

(iv) 10 mg/lb of body weight daily ............. 1. Calves, beef and nonlactating dairy 

cattle; treatment of bacterial enteritis 

caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline. 

Feed approximately 400 g/ton, varying 

with body weight and feed consumption 

to provide 10 mg/lb per day. Treat for 

not more than 5 d; in feed including 

milk replacers; withdraw 10 d prior to 

slaughter. To sponsor No. 048164: 

zero withdrawal time. See paragraph 

(d)(1) of this section. 

012286, 

048164, 

066104. 

2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E. 

coli susceptible to chlortetracycline. 

See paragraph (d)(1) of this section. 012286, 

046573, 

048164, 

066104. 

(v) 500 to 4,000 g/ton ............................... Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis 

caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline. 

Feed continuously for not more than 5 

days to provide 10 mg/lb body weight 

per day. To sponsor No. 046573 under 

NADA 046–699: 24-h withdrawal time. 

To sponsor No. 046573 under NADA 

048–761: zero withdrawal time. 

046573. 

* * * * * * * 

(ix) 350 mg/head/day ................................ 1. Beef cattle: For control of bacterial 

pneumonia associated with shipping 

fever complex caused by Pasteurella 

spp. susceptible to chlortetracycline. 

Withdraw 48 h prior to slaughter. To 

sponsor No. 046573 under NADA 046– 

699: 48-h withdrawal time. To sponsor 

No. 046573 under NADA 048–761 and 

No. 048164: zero withdrawal time. 

012286, 

046573, 

048164, 

066104. 

2. Beef cattle (under 700 lb): For control 

of active infection of anaplasmosis 

caused by A. marginale susceptible to 

chlortetracycline. 

Withdraw 48 h prior to slaughter. To 

sponsor No. 046573 under NADA 046– 

699: 48-h withdrawal time. To sponsor 

No. 046573 under NADA 048–761 and 

No. 048164: zero withdrawal time. 

012286, 

046573, 

048164, 

066104. 

* * * * * 

Dated: June 8, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–13849 Filed 6–11–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9453] 

RIN 1545–BI81 

Guidance Under Section 7874 

Regarding Surrogate Foreign 

Corporations 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final and temporary 

regulations. 

SUMMARY: This document contains final 

and temporary regulations under section 

7874 of the Internal Revenue Code 

(Code) concerning the determination of 

whether a foreign corporation shall be 

treated as a surrogate foreign 

corporation. The temporary regulations 

primarily affect domestic corporations 

or partnerships (and certain parties 

related thereto), and certain foreign 

corporations that acquire substantially 

all of the properties of such domestic 

corporations or partnerships. The text of 

these temporary regulations serves as 

the text of the proposed regulations set 

forth in the notice of proposed 

rulemaking on this subject also 

published in this issue of the Federal 

Register. 

DATES: Effective Dates: The regulations 

are effective on June 12, 2009. 

Applicability Date: For dates of 

applicability, see §§ 1.7874–1T(g) and 

1.7874–2T(o).