10596 Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by Fort 

Dodge Animal Health, Division of 

Wyeth. The supplemental NADA 

provides for over-the-counter (OTC) 

marketing status for oral use of 

oxfendazole suspension in cattle. 

DATES: This rule is effective March 9, 

2007. 

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.hhs.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, Division of 

Wyeth, 800 Fifth St. NW., Fort Dodge, 

IA 50501, filed a supplement to NADA 

140–854 for SYNANTHIC (oxfendazole) 

Bovine Dewormer Suspension, 

approved for oral use in cattle for the 

removal of various internal parasites. 

The supplemental NADA provides for 

OTC marketing status. The 

supplemental application is approved as 

of January 29, 2007, and the regulations 

are amended in 21 CFR 520.1630 to 

reflect the approval and a current 

format. 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. 

The agency 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 Parts 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. Amend § 520.1630 as follows: 

■ a. Redesignate paragraph (d) as 

paragraph (e); 

■ b. Add new paragraph (d); 

■ c. Revise the introductory text in 

newly redesignated paragraphs (e)(1) 

and (e)(2); and 

■ d. Revise paragraph (a) and newly 

redesignated paragraphs (e)(1)(i), 

(e)(1)(iii), (e)(2)(i), and (e)(2)(iii). 

The redesignation, addition, and 

revisions read as follows: 

§ 520.1630 Oxfendazole suspension. 

(a) Specifications. Each milliliter of 

suspension contains: 

(1) 90.6 milligrams (mg) oxfendazole 

(9.06 percent). 

(2) 225.0 mg oxfendazole (22.5 

percent). 

* * * * * 

(d) Special considerations. See 

§ 500.25 of this chapter. If labeled for 

administration by stomach tube: Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

(e) Conditions of use—(1) Horses. Use 

the product described in paragraph 

(a)(1) of this section as follows: 

(i) Amount. 10 mg per kilogram (/kg) 

of body weight by stomach tube or dose 

syringe. Horses maintained on premises 

where reinfection is likely to occur 

should be retreated in 6 to 8 weeks. 

* * * * * 

(iii) Limitations. Withholding feed or 

water prior to use is unnecessary. 

Administer drug with caution to sick or 

debilitated horses. Do not use in horses 

intended for human consumption. 

(2) Cattle. Use the products described 

in paragraphs (a)(1) and (a)(2) of this 

section as follows: 

(i) Amount. 4.5 mg/kg of body weight 

by dose syringe. Treatment may be 

repeated in 4 to 6 weeks. 

* * * * * 

(iii) Limitations. Cattle must not be 

slaughtered until 7 days after treatment. 

Do not use in lactating dairy cattle. 

Dated: February 21, 2007. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E7–4205 Filed 3–8–07; 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; Enrofloxacin 

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 Bayer 

HealthCare LLC. The supplemental 

NADA provides for changing scientific 

nomenclature for a bovine respiratory 

pathogen on labeling for enrofloxacin 

injectable solution. 

DATES: This rule is effective March 9, 

2007. 

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.hhs.gov. 

SUPPLEMENTARY INFORMATION: Bayer 

HealthCare LLC, Animal Health 

Division, P.O. Box 390, Shawnee 

Mission, KS 66201, filed a supplement 

to NADA 141 068 for BAYTRIL 100 

(enrofloxacin) Injectable Solution used 

for the treatment of bovine respiratory 

disease associated with several bacterial 

pathogens. The supplemental NADA 

provides for changing a pathogen name 

from Pasteurella haemolytica to 

Mannheimia haemolytica on product 

labeling. The supplemental NADA is 

approved as of February 15, 2007, and 

the regulations in 21 CFR 522.812 are 

amended to reflect the approval and a 

current format. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33 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. 


erjones on PRODPC74 with RULES
Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 10597 

List of Subjects in 21 CFR Part 522 

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 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. Revise § 522.812 to read as follows: 

§ 522.812 Enrofloxacin. 

(a) Specifications. Each milliliter (mL) 

of solution contains: 

(1) 22.7 milligrams (mg) enrofloxacin 

or 

(2) 100 mg enrofloxacin. 

(b) Sponsor. See No. 000859 in 

§ 510.600(c) of this chapter. 

(c) Related tolerance. See § 556.228 of 

this chapter. 

(d) Special considerations. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

Federal law prohibits the extra-label use 

of this drug in food-producing animals. 

(e) Conditions of use—(1) Dogs. Use 

the product described in paragraph 

(a)(1) of this section as follows: 

(i) Amount. 2.5 mg per kilogram (/kg) 

of body weight (1.13 mg per pound) as 

a single, intramuscular, initial dose 

followed by use of tablets twice daily for 

2 to 3 days beyond cessation of clinical 

signs to a maximum of 10 days. 

(ii) Indications for use. For the 

management of diseases associated with 

bacteria susceptible to enrofloxacin. 

(2) Cattle. Use the product described 

in paragraph (a)(2) of this section as 

follows: 

(i) Amount. Single-dose therapy: 7.5 

to 12.5 mg/kg of body weight (3.4 to 5.7 

mL per 100 pounds) by subcutaneous 

injection. Multiple-day therapy: 2.5 to 

5.0 mg/kg of body weight (1.1 to 2.3 mL 

per 100 pounds) by subcutaneous 

injection once daily for 3 to 5 days. 

(ii) Indications for use. For the 

treatment of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, and 

Haemophilus somnus. 

(iii) Limitations. Animals intended for 

human consumption must not be 

slaughtered within 28 days from the last 

treatment. Do not use in cattle intended 

for dairy production. A withdrawal 

period has not been establishedfor this 

product in pre-ruminating calves. Do 

not use in calves to be processed for 

veal. The effect of enrofloxacin on 

bovine reproductive performance, 

pregnancy, and lactation have not been 

determined. 

Dated: February 28, 2007. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E7–4206 Filed 3–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 524 

Ophthalmic and Topical Dosage Form 

New Animal Drugs; Imidacloprid and 

Moxidectin 

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 two new animal drug 

applications (NADAs) filed by Bayer 

HealthCare LLC. The NADAs provide 

for the topical use by veterinary 

prescription of topical solutions 

containing imidacloprid and two 

strengths of moxidectin, one for use on 

dogs and the other for use on cats, for 

the prevention of heartworm disease, 

the treatment of flea infestations, and 

the treatment and control of several 

internal parasites. 

DATES: This rule is effective March 9, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV-110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855; tel: 301–827–

7540; e-mail: 

melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Bayer 

HealthCare LLC, Animal Health 

Division, P.O. Box 390, Shawnee 

Mission, KS 66201, filed NADA 141–

251 that provides for veterinary 

prescription use of ADVANTAGE 

MULTI (imidacloprid 10% and 

moxidectin 2.5%) for Dogs, a topical 

solution used for the prevention of 

heartworm disease, the treatment of flea 

infestations, and the treatment and 

control of several internal parasites. 

Bayer HealthCare LLC also filed NADA 

141–254 that provides for veterinary 

prescription use of ADVANTAGE 

MULTI (imidacloprid 10% and 

moxidectin 1%) for Cats, a topical 

solution used for the prevention of 

heartworm disease, the treatment of flea 

infestations, and the treatment and 

control of ear mites and several internal 

parasites. NADA 141–251 is approved 

as of December 20, 2006, and NADA 

141–254 is approved as of January 19, 

2007. Accordingly, the regulations are 

amended in part 524 (21 CFR part 524) 

by adding § 524.1146 to reflect these 

approvals. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), 

summaries of safety and effectiveness 

data and information submitted to 

support approval of these applications 

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)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

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

approval under NADA 141–251 

qualifies for 3 years of marketing 

exclusivity beginning December 20, 

2006, and this approval under NADA 

141–254 qualifies for 3 years of 

marketing exclusivity beginning January 

19, 2007. 

The agency has determined under 21 

CFR 25.33(d)(1) that these actions are of 

a type that do 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 524 

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 524 is amended as follows: 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 2. Add § 524.1146 to read as follows: 


erjones on PRODPC74 with RULES