Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 70997 

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 revising the 

entry for ‘‘Schering-Plough Animal 

Health Corp.’’; and in the table in 

paragraph (c)(2) by revising the entry for 

‘‘000061’’ 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 

* * * * * 

Schering-Plough Animal 

Health Corp., 556 Morris 

Ave., Summit, NJ 07901.

000061 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

000061 Schering-Plough Animal 

Health Corp., 556 Morris 

Ave., Summit, NJ 07901 

* * * * * 

Dated: November 15, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–23296 Filed 11–23–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 510 

New Animal Drugs; Change of 

Sponsor’s Name 

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 name from Phoenix 

Scientific, Inc., to IVX Animal Health, 

Inc. In order to improve the accuracy of 

the regulations, erroneous entries for 

Phoenix Pharmaceutical, Inc., are also 

being removed at this time. 

DATES: This rule is effective November 

25, 2005. 

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.gov. 

SUPPLEMENTARY INFORMATION: Phoenix 

Scientific, Inc., 3915 South 48th Street 

Ter., St. Joseph, MO 64503, has 

informed FDA that it has changed its 

name to IVX Animal Health, Inc. 

Accordingly, the agency is amending 

the regulations in § 510.600 (21 CFR 

510.600) to reflect the change. 

In addition, FDA has noticed that 

Phoenix Pharmaceutical, Inc., is no 

longer a sponsor of an approved new 

animal drug application. At this time, 

§ 510.600 is amended to remove entries 

for this sponsor. This action is being 

taken to improve the accuracy of the 

regulations. 

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 entries for ‘‘Phoenix Pharmaceutical, 

Inc.’’ and ‘‘Phoenix Scientific, Inc.’’, and 

by alphabetically adding a new entry for 

‘‘IVX Animal Health, Inc.’’; and in the 

table in paragraph (c)(2) by removing 

the entry for ‘‘057319’’ and by revising 

the entry for ‘‘059130’’ 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 

* * * * * 

IVX Animal Health, Inc., 

3915 South 48th Street 

Ter., St. Joseph, MO 

64503.

059130 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

059130 IVX Animal Health, Inc., 

3915 South 48th Street 

Ter., St. Joseph, MO 

64503 

* * * * * 

Dated: November 15, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–23297 Filed 11–23–05; 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; Boldenone 

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 supplemental new animal 

drug application (NADA) filed by Fort 

Dodge Animal Health. The 

supplemental NADA provides for 

70998 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 

revised labeling for the veterinary 

prescription use of injectable boldenone 

solution in horses. 

DATES: This rule is effective November 

25, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7543, email: melanie.berson@fda.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, A Division of 

Wyeth Holdings Corp., P.O. Box 1339, 

Fort Dodge, IA 50501, filed a 

supplement to NADA 34–705 that 

provides for veterinary prescription use 

of EQUIPOISE (boldenone 

undecylenate) by injection in horses. 

The supplemental NADA provides for a 

revised indication and food safety 

warning on labeling. The supplemental 

NADA is approved as of October 7, 

2005, and the regulations are amended 

in 21 CFR 522.204 to reflect the 

approval and a current format. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data. Therefore, a 

freedom of information summary is not 

required. 

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 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. Section 522.204 is revised to read 

as follows: 

§ 522.204 Boldenone. 

(a) Specifications. Each milliliter of 

solution contains 25 or 50 milligrams 

(mg) boldenone undecylenate. 

(b) Sponsor. See No. 053501 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in horses—(1) 

Amount. 0.5 mg per pound body weight 

by intramuscular injection. Treatment 

may be repeated at 3-week intervals. 

(2) Indications for use. As an aid for 

treating debilitated horses when an 

improvement in weight, hair coat, or 

general physical condition is desired. 

(3) Limitations. Do not administer to 

horses intended for human 

consumption. Federal law restricts this 

drug to use by or on the order of a 

licensed veterinarian. 

Dated: November 15, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–23295 Filed 11–23–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 522 and 556 

New Animal Drugs; Flunixin 

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 supplemental new animal 

drug application (NADA) filed by 

Schering-Plough Animal Health Corp. 

The supplemental NADA provides for 

the veterinary prescription use of 

flunixin meglumine solution by 

intramuscular injection for the control 

of pyrexia associated with swine 

respiratory disease. 

DATES: This rule is effective November 

25, 2005. 

FOR FURTHER INFORMATION CONTACT: Joan 

C. Gotthardt, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov. 

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095 

Morris Ave., Union, NJ 07083, filed a 

supplement to NADA 101–479 that 

provides for the veterinary prescription 

use of BANAMINE-S (flunixin 

meglumine) Injectable Solution by 

intramuscular injection for the control 

of pyrexia associated with swine 

respiratory disease. The supplemental 

NADA is approved as of November 1, 

2005, and the regulations are amended 

in 21 CFR 522.970 and 556.286 to reflect 

the approval. The basis of approval is 

discussed in the freedom of information 

summary. 

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)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360b(c)(2)(F)(iii)), 

this supplemental approval qualifies for 

3 years of marketing exclusivity 

beginning November 1, 2005. 

FDA has determined under 

§ 25.33(d)(5) 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 

21 CFR Part 522 

Animal drugs. 

21 CFR Part 556 

Animal drugs, Foods. 

■ 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 parts 522 and 556 are amended as 

follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. Section 522.970 is amended by 

adding paragraph (e)(3) to read as 

follows: 

§ 522.970 Flunixin. 

* * * * *