Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26289 

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: American 

Pharmaceuticals Partners, Inc., 2045 

North Cornell Ave., Melrose Park, IL 

60160, has informed FDA of a change of 

name and mailing address to Abraxis 

Pharmaceutical Products, a Div. of 

Abraxis Bioscience, 6133 River Rd., 

suite 500, Rosemont, Il 60018. 

Accordingly, the agency is amending 

the regulations in 21 CFR 510.600(c) to 

reflect these changes. 

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. Section 510.600 is amended in the 

table in paragraph (c)(1) by removing 

the entry for ‘‘American 

Pharmaceuticals Partners, Inc.’’ and 

alphabetically adding a new entry for 

‘‘Abraxis Pharmaceutical Products’’; and 

in the table in paragraph (c)(2) by 

revising the entry for ‘‘063323’’ 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 

* * * * * 

Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., 

suite 500, Rosemont, IL 

60018.

063323 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

063323 ....... Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., 

suite 500, Rosemont, IL 

60018 

* * * * * 

Dated: May 1, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–8870 Filed 5–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 529 

Certain Other Dosage Form New 

Animal Drugs; Oxytetracycline 

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 

Cross Vetpharm Group Ltd. The 

ANADA provides for use of 

oxytetracycline hydrochloride soluble 

powder for skeletal marking of finfish 

fry and fingerlings by immersion. 

DATES: This rule is effective May 9, 

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: Cross 

Vetpharm Group Ltd., Broomhill Rd., 

Tallaght, Dublin 24, Ireland, filed 

ANADA 200–460 that provides for use 

of TETROXY Aquatic (oxytetracycline 

hydrochloride) Soluble Powder for 

skeletal marking of finfish fry and 

fingerlings by immersion. The 

application is approved as of April 20, 

2007, and the regulations are amended 

in 21 CFR 529.1660 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. 

FDA has determined under 21 CFR 

25.33(a)(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 529 

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 529 is amended as follows: 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

■ 2. In § 529.1660, revise paragraph 

(b)(1) to read as follows: 

§ 529.1660 Oxytetracycline. 

* * * * * 

(b) * * * 

(1) Nos. 046573 and 061623 for use of 

product in paragraph (a)(1) of this 

section. 

* * * * * 

Dated: May 1, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–8869 Filed 5–8–07; 8:45 am] 

BILLING CODE 4160–01–S 


rmajette on PROD1PC67 with RULES