Federal Register / Vol. 72, No. 96 / Friday, May 18, 2007 / Rules and Regulations 27955 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4138; 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 Civil Aviation Authority 

AD No. G–2004–0024, Issue Date: September 

22, 2004, EASA approved on September 16, 

2004, under approval number 2004–9648, for 

related information. 

Issued in Kansas City, Missouri, on May 9, 

2007. 

Charles L. Smalley, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 07–2472 Filed 5–17–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 510 

New Animal Drugs; Change of 

Sponsor’s Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor’s address for Modern 

Veterinary Therapeutics, LLC. 

DATES: This rule is effective May 18, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Modern 

Veterinary Therapeutics, LLC, 18301 

SW. 86th Ave., Miami, FL 33157, has 

informed FDA of a change of address to 

1550 Madruga Ave., suite 329, Coral 

Gables, FL 33146. Accordingly, the 

agency is amending the regulations in 

21 CFR 510.600(c) to reflect the change. 

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 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

■ 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 510 is amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) revise the entry for 

‘‘Modern Veterinary Therapeutics, 

LLC’’; and in the table in paragraph 

(c)(2) revise the entry for ‘‘015914’’ to 

read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Modern Veterinary Therapeutics, LLC, 1550 

Madruga Ave., suite 329, 

Coral Gables, FL 33146 015914 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

015914 Modern Veterinary Therapeutics, LLC, 1550 

Madruga Ave., suite 329, 

Coral Gables, FL 33146 

* * * * * 

Dated: May 7, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–9555 Filed 5–17–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 520 

Oral Dosage Form New Animal Drugs; 

Phenylbutazone Powder 

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 

Superior Equine Pharmaceuticals, Inc. 

The ANADA provides for the veterinary 

prescription use of phenylbutazone 

powder administered to horses in feed 

for the relief of inflammatory conditions 

associated with the musculoskeletal 

system. 

DATES: This rule is effective May 18, 

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: Superior 

Equine Pharmaceuticals, Inc., Pleasant 

Grove, UT 84062, filed ANADA 200–

333 that provides for the veterinary 

prescription use of SUPERIORBUTE 

(phenylbutazone) Powder administered 

to horses in feed for the relief of 

inflammatory conditions associated 

with the musculoskeletal system. 

Superior Equine Pharmaceuticals, Inc.’s 

SUPERIORBUTE Powder is approved as 

a generic copy of IVX Animal Health, 

Inc.’s Phenylbutazone Tablets, USP, 

approved under NADA 91–818. The 

ANADA is approved as of April 20, 

2007, and the regulations are amended 

in 21 CFR 520.1720e to reflect the 

approval. The basis of approval is 

discussed in the freedom of information 

summary. 

In addition, Superior Equine 

Pharmaceuticals, Inc., has not been 

previously listed in the animal drug 

regulations as a sponsor of an approved 

application. At this time, 21 CFR 

510.600(c) is being amended to add 

entries for the firm. 


cprice-sewell on PRODPC61 with RULES