58872 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 

of bovine foot rot (interdigital 

necrobacillosis). 

DATES: This rule is effective October 8, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Donald A. Prater, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pharmacia 

& Upjohn Co., a Division of Pfizer, Inc., 

235 East 42d St., New York, NY 10017, 

filed a supplement to NADA 141–209 

for EXCEDE (ceftiofur crystalline free 

acid) Sterile Suspension. The 

supplemental NADA provides for 

veterinarian prescription use of ceftiofur 

crystalline free acid injectable 

suspension for the treatment of bovine 

foot rot (interdigital necrobacillosis) in 

beef, non-lactating dairy, and lactating 

dairy cattle. The application is approved 

as of August 15, 2008, and the 

regulations are amended in 21 CFR 

522.313a 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), 

summaries of the 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)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

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

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

on the date of approval. The 3 years of 

marketing exclusivity apply only to the 

bovine foot rot indication for which this 

supplement is approved. 

The agency has determined under 21 

CFR 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 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. In § 522.313a, amend paragraph 

(e)(2)(ii) by adding a third sentence to 

read as follows: 

§ 522.313a Ceftiofur crystalline free acid. 

* * * * * 

(e) * * * 

(2) * * * 

(ii) * * * For the treatment of bovine 

foot rot (interdigital necrobacillosis) 

associated with Fusobacterium 

necrophorum and Porphyromonas levii 

in beef, non-lactating dairy, and 

lactating dairy cattle. 

* * * * * 

Dated: September 29, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–23830 Filed 10–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2008–N–0039] 

Implantation or Injectable Dosage 

Form New Animal Drugs; 

Tulathromycin 

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 Pfizer, 

Inc. The supplemental NADA provides 

for veterinarian prescription use of 

tulathromycin injectable solution for the 

treatment of bovine foot rot (interdigital 

necrobacillosis) in beef and nonlactating dairy cattle. 

DATES: This rule is effective October 8, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Donald A. Prater, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pfizer, 

Inc., 235 East 42d St., New York, NY 

10017, filed a supplement to NADA 

141–244 for DRAXXIN (tulathromycin) 

Injectable Solution. The supplemental 

NADA provides for treatment of bovine 

foot rot (interdigital necrobacillosis) 

associated with Fusobacterium 

necrophorum and Porphyromonas levii 

in beef and non-lactating dairy cattle. 

The application is approved as of 

August 28, 2008, and the regulations are 

amended in 21 CFR 522.2630 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)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

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

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

on the date of approval. The 3 years of 

marketing exclusivity apply only to the 

bovine foot rot indication for which this 

supplement is approved. 

The agency has determined under 21 

CFR 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 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. In § 522.2630, revise paragraph 

(d)(1)(ii) to read as follows: 


dwashington3 on PRODPC61 with RULES
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 58873 

§ 522.2630 Tulathromycin. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) Indications for use. For the 

treatment of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, 

Histophilus somni, and Mycoplasma 

bovis. For the control of respiratory 

disease in cattle at high risk of 

developing BRD associated with M. 

haemolytica, P. multocida, H. somni, 

and M. bovis. For the treatment of 

infectious bovine keratoconjunctivitis 

(IBK) associated with Moraxella bovis. 

For the treatment of bovine foot rot 

(interdigital necrobacillosis) associated 

with Fusobacterium necrophorum and 

Porphyromonas levii. 

* * * * * 

Dated: September 29, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–23832 Filed 10–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2008–N–0039] 

New Animal Drugs for Use in Animal 

Feeds; Fenbendazole 

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 

Intervet Inc. The supplemental NADA 

provides for use of a fenbendazole free 

choice, liquid Type C medicated feed in 

dairy and beef cattle for the removal and 

control of various internal parasites. 

DATES: This rule is effective October 8, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Donald A. Prater, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Intervet 

Inc., P.O. Box 318, 29160 Intervet Lane, 

Millsboro, DE 19966, filed a supplement 

to NADA 131–675 for SAFE-GUARD 

(fenbendazole) 20% Type A medicated 

article. The supplemental NADA 

provides for manufacture of a 

fenbendazole free choice, liquid Type C 

medicated feed for use in dairy and beef 

cattle for the removal and control of 

various internal parasites. The 

supplemental NADA is approved as of 

September 5, 2008, and the regulations 

are amended in 21 CFR 558.258 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)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

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

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

on the date of approval. The 3 years of 

exclusivity apply only to the use of 

fenbendazole liquid Type C medicated 

feed for the removal and control of 

lungworms (Dictyocaulus viviparus), 

one of the parasite species for which the 

supplement is approved. 

FDA has determined under 21 CFR 

25.33(a) 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 558 

Animal drugs, Animal feeds. 

■ 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 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 2. In § 558.258, in the table in 

paragraph (e)(1), in the ‘‘Indications for 

use’’ column, remove ‘‘round worms’’ 

and in its place add ‘‘roundworms’’; and 

revise paragraph (e)(3) to read as 

follows: 

§ 558.258 Fenbendazole. 

* * * * * 

(e) * * * 

(3) Cattle. 

Amount fenbendazole Indications for use Limitations Sponsor 

(i) 5 mg/kg body weight (2.27 mg/ 

lb) 

Dairy and beef cattle: For the removal and control of: Lungworms 

(Dictyocaulus viviparus); Stomach 

worms: barberpole worms 

(Haemonchus contortus), brown 

stomach worms (Ostertagia 

ostertagi), small stomach worms 

(Trichostrongylus axei); Intestinal 

worms: hookworms (Bunostomum 

phlebotomum), thread-necked intestinal worms (Nematodirus 

helvetianus), small intestinal 

worms (Cooperia oncophora and 

C. punctata); Bankrupt worms 

(Trichostrongylus colubriformis); 

and Nodular worms 

(Oesophagostomum radiatum). 

Feed as the sole ration or as a 

top dress for one day. Retreatment may be needed after 4 to 6 

weeks. Cattle must not be slaughtered within 13 days following last 

treatment. For dairy cattle the milk 

discard time is zero hours. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in 

calves to be processed for veal. 

057926 

(ii) [Reserved] 


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