27732 Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations 

TABLE 1.—APPLICABILITY—Continued 

EMBRAER model— As identified in—

EMB–135BJ airplanes .............................................................................. EMBRAER Service Bulletin 145LEG–28–0030, dated April 19, 2006. 

Unsafe Condition 

(d) This AD results from a report of the 

failure of a fitting clamp of an electrical 

bonding cable for the fuel tubing. We are 

issuing this AD to prevent loss of bonding 

protection in the interior of the fuel tanks or 

adjacent areas, and a consequent potential 

source of ignition in a fuel tank and possible 

fire or explosion. 

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. 

Electrical Bonding Clamp Replacement 

(f) At the time specified in paragraph (f)(1) 

or (f)(2) of this AD, as applicable: Replace the 

electrical bonding clamps having part 

numbers AN735D6 and AN735D4 inside the 

forward fuel tank or the ventral, wing stub, 

and wing fuel tanks, and adjacent areas, as 

applicable; by accomplishing all actions 

specified in the Accomplishment 

Instructions of the applicable service bulletin 

identified in Table 2 of this AD. 

TABLE 2.—APPLICABLE SERVICE INFORMATION

For EMBRAER model— Use—

EMB–145LR, –145XR, –145MP, and –135LR airplanes ......................... EMBRAER Service Bulletin 145–28–0028, dated November 7, 2005 

EMB–135BJ airplanes .............................................................................. EMBRAER Service Bulletin 145LEG–28–0030, dated April 19, 2006. 

(1) For Model EMB–145LR, –145XR, and 

–145MP airplanes; and Model EMB–135LR 

airplanes: Within 5,000 flight hours after the 

effective date of this AD. 

(2) For Model EMB–135BJ airplanes: 

Within 4,000 flight hours or 48 calendar 

months after the effective date of this AD, 

whichever occurs first. 

Alternative Methods of Compliance 

(AMOCs) 

(g)(1) The Manager, International Branch 

ANM–116, Transport Airplane Directorate, 

FAA, has the authority to approve AMOCs 

for this AD, if requested in accordance with 

the procedures found in 14 CFR 39.19. 

(2) Before using any AMOC approved in 

accordance with § 39.19 on any airplane to 

which the AMOC applies, notify the 

appropriate principal inspector in the FAA 

Flight Standards Certificate Holding District 

Office. 

Related Information 

(h) Brazilian airworthiness directive 2006–

02–03R2, effective October 8, 2006, also 

addresses the subject of this AD. 

Material Incorporated by Reference 

(i) You must use EMBRAER Service 

Bulletin 145–28–0028, dated November 7, 

2005; or EMBRAER Service Bulletin 

145LEG–28–0030, dated April 19, 2006; as 

applicable; to perform the actions that are 

required by this AD, unless the AD specifies 

otherwise. The Director of the Federal 

Register approved the incorporation by 

reference of these documents in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. 

Contact Empresa Brasileira de Aeronautica 

S.A. (EMBRAER), P.O. Box 343—CEP 12.225, 

Sao Jose dos Campos—SP, Brazil, for a copy 

of this service information. You may review 

copies at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington; or 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 Renton, Washington, on May 7, 

2007. 

Stephen P. Boyd, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. E7–9401 Filed 5–16–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Parts 401, 415, 431, 435, 440 

and 460 

[Docket No. FAA–2005–23449] 

Human Space Flight Requirements for 

Crew and Space Flight Participants 

AGENCY: Federal Aviation 

Administration, DOT. 

ACTION: Notice of Office of Management 

and Budget Approval for Information 

Collection. 

SUMMARY: This notice announces the 

Office of Management and Budget’s 

(OMB) approval of the information 

collection requirement in the final rule 

published on December 15, 2006. The 

sections of the final rule pending 

approval of this information collection 

request are effective upon publication of 

this notice. 

DATES: On April 16, 2007, the FAA 

received OMB approval for the 

information collection requirement in 

the final rule published at 71 FR 75616 

(December 15, 2006). The compliance 

date for information collection 

requirements in §§ 460.5, 460.7, 460.9, 

460.19, 460.45, and 460.49 is May 17, 

2007. 

FOR FURTHER INFORMATION CONTACT: For 

technical information, contact Kenneth 

Wong, Deputy Manager, Licensing and 

Safety Division, Commercial Space 

Transportation, AST–200, Federal 

Aviation Administration, 800 

Independence Avenue, SW., 

Washington, DC 20591; telephone (202) 

267–8465; facsimile (202) 267–3686; 

e-mail ken.wong@faa.gov. For legal 

information, contact Laura Montgomery, 

Senior Attorney, Office of the Chief 

Counsel, Federal Aviation 

Administration, 800 Independence 

Avenue, SW., Washington, DC 20591; 

telephone (202) 267–3150; facsimile 

(202) 267–7971, e-mail 

laura.montgomery@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

On December 15, 2006, the FAA 

published the final rule, Human Space 

Flight Requirements for Crew and Space 

Flight Participants, in the Federal 

Register. The rule established 

requirements for human space flight as 

required by the Commercial Space 

Launch Amendments Act of 2004. In the 

DATES section of the final rule, we noted 

that affected parties did not need to 

comply with the information collection 

requirements in specified sections of the 

rule until the Office of Management and 

Budget (OMB) approved the FAA’s 

request to collect the information. 

According to the Paperwork 

Reduction Act, OMB approved the 

FAA’s request for new information 

collection on April 16, 2007, and 

assigned the information collection 

OMB Control Number 2120–0720. The 


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Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations 27733 

control number was not available when 

the final rule was published, thus 

necessitating publication of this notice. 

The FAA request was approved by OMB 

without change and expires on April 30, 

2010. 

Title 49 U.S.C. 106(g), 40113, 40119, 

41706, 44101, 44701–44702, 44705, 

44709–44711, 44713, 44716–44717, 

44722, 46105, grants authority to the 

Administrator to publish this notice. 

The final rule (71 FR 75616) became 

effective on February 13, 2007 and the 

compliance date for information 

collection requirements in §§ 460.5, 

460.7, 460.9, 460.19, 460.45, and 460.49 

is May 17, 2007. 

Issued in Washington, DC on May 8, 2007. 

Pamela Hamilton-Powell, 

Director, Office of Rulemaking Aviation 

Safety. 

[FR Doc. E7–9480 Filed 5–16–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Pimobendan 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a new animal drug 

application (NADA) filed by Boehringer 

Ingelheim Vetmedica, Inc. The NADA 

provides for the veterinary prescription 

use of pimobendan chewable tablets in 

dogs for the management of the signs of 

congestive heart failure. 

DATES: This rule is effective May 17, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Boehringer Ingelheim Vetmedica, Inc., 

2621 N. Belt Hwy., St. Joseph, MO 

64506–2002, filed NADA 141–273 that 

provides for the veterinary prescription 

use of VETMEDIN (pimobendan) 

Chewable Tablets in dogs for the 

management of the signs of mild, 

moderate, or severe (modified New York 

Heart Association Class II, III, or IV) 

congestive heart failure due to 

atrioventricular valvular insufficiency 

or dilated cardiomyopathy; for use with 

concurrent therapy for congestive heart 

failure as appropriate on a case-by-case 

basis. The NADA is approved as of 

April 30, 2007, and the regulations in 21 

CFR part 520 are amended by adding 

§ 520.1780 to reflect the approval. 

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 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. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(i)), this 

approval qualifies for 5 years of 

marketing exclusivity beginning on the 

date of the approval. 

The agency has determined under 21 

CFR 25.33(d)(1) 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 520 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

■ 2. Add § 520.1780 to read as follows: 

§ 520.1780 Pimobendan. 

(a) Specifications. Each chewable 

tablet contains 1.25, 2.5, or 5 milligrams 

(mg) pimobendan. 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Administer orally at a total 

daily dose of 0.23 mg per pound (0.5 mg 

per kilogram) body weight, using a 

suitable combination of whole or half 

tablets. The total daily dose should be 

divided into two portions administered 

approximately 12 hours apart. 

(2) Indications for use. For the 

management of the signs of mild, 

moderate, or severe (modified New York 

Heart Association Class II, III, or IV) 

congestive heart failure due to 

atrioventricular valvular insufficiency 

or dilated cardiomyopathy; for use with 

concurrent therapy for congestive heart 

failure as appropriate on a case-by-case 

basis. 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: May 7, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–9516 Filed 5–16–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Implantation or Injectable Dosage 

Form New Animal Drugs; Ivermectin 

and Clorsulon 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an abbreviated new animal 

drug application (ANADA) filed by 

Norbrook Laboratories, Ltd. The 

ANADA provides for the use of an 

ivermectin and clorsulon solution by 

subcutaneous injection in cattle for 

control of various internal and external 

parasites. 

DATES: This rule is effective May 17, 

2007. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Norbrook 

Laboratories, Ltd., Station Works, 

Newry BT35 6JP, Northern Ireland, filed 

ANADA 200–436 that provides for use 

of NOROMECTIN Plus (ivermectin and 

clorsulon) Injection for Cattle by 

subcutaneous injection in cattle for 

control of various internal and external 

parasites. Norbrook Laboratories, Ltd.’s 

NOROMECTIN Plus Injection for Cattle 


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