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] 


dwashington3 on PRODPC61 with RULES
58874 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 

(iii) Free-choice feeds—(A) Amount. 5 

mg/kg body weight (2.27 mg/lb), 

including the following formulations: 

Ingredient1 Percent International Feed No. 

(1) Free-choice, dry Type C feed: 

Salt (sodium chloride) 59.00 6–04–152 

Monosodium phosphate 31.16 6–04–288 

Dried cane molasses 3.12 4–04–695 

Zinc sulfate 0.76 6–05–556 

Copper sulfate 0.45 6–01–720 

Fenbendazole 20% Type A article 5.51 n/a 

(2) Free-choice, dry Type C feed: 

Salt (sodium chloride) 35.93 6–04–152 

Dicalcium phosphate (18.5% P) 32.44 6–00–080 

Calcium carbonate (38% Ca) 15.93 6–01–069 

Magnesium oxide (56% Mg) 10.14 6–02–756 

Zinc sulfate 1.47 6–05–556 

Mineral oil 1.00 8–03–123 

Dried cane molasses (46% sugars) 0.98 4–04–695 

Potassium iodide 0.01 6–03–759 

Fenbendazole 20% Type A article 2.10 n/a 

(3) Free-choice, liquid Type C feed: 

Cane molasses2 80.902 4–13–251 

Water 9.36 n/a 

Urea solution, 55% 7.05 5–05–707 

Phosphoric acid 75% (feed grade) 2.00 6–03–707 

Xantham gum 0.20 8–15–818 

Trace minerals 0.20 n/a 

Vitamin premix 0.01 n/a 

Fenbendazole 20% Type A article 0.278 n/a 

1The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer 

for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the freechoice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published 

regulations (see 21 CFR 573.920). 2The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to 

the industry standard of 79.5 brix. 

(B) Indications for use. As in 

paragraph (e)(3)(i) of this section. 

(C) Limitations. Feed a total of 5 mg 

of fenbendazole per kg (2.27 mg/lb) of 

body weight to cattle over a 3- to 6-day 

period. 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 preruminating calves. Do not use in calves 

to be processed for veal. 

* * * * * 

Dated: September 29, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–23845 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 801 

[Docket No. FDA–2008–N–0148] 

Medical Devices; Hearing Aids; 

Technical Data Amendments; 

Confirmation of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation 

of effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of October 15, 2008, for 

the final rule that appeared in the 

Federal Register of June 2, 2008 (73 FR 

31358). The direct final rule amends the 

hearing aid labeling to reference the 

most recent version of the consensus 

standard used to determine the 

technical data to be included in labeling 

for hearing aids. This document 

confirms the effective date of the direct 

final rule. 

DATES: Effective date confirmed: 

October 15, 2008. 

FOR FURTHER INFORMATION CONTACT: Eric 

A. Mann, Center for Devices and 

Radiological Health (HFZ–460), Food 

and Drug Administration,9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4242. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 2, 2008 (73 FR 

31358), FDA solicited comments 

concerning the direct final rule for a 75- 

day period ending August 18, 2008. 

FDA stated that the effective date of the 

direct final rule would be on October 

15, 2008, 60 days after the end of the 

comment period, unless any significant 

adverse comment was submitted to FDA 

during the comment period. FDA 

received one letter of comment on the 

direct final rule. However, this comment 

does not constitute a significant adverse 

comment. Therefore, FDA is confirming 

the effective date of the direct final rule. 

The comment received and FDA’s 

response to the comment are discussed 

as follows: 

The only comment on the direct final 

rule requested clarification regarding 

the applicability of the proposed change 

in the standard of the American 

National Standards Institute to hearing 

aid models that were tested and 

characterized prior to the effective date 


dwashington3 on PRODPC61 with RULES