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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