Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 10595 

generally for congressional review of 

agency rules. A reporting requirement is 

triggered in instances where NCUA 

issues a final rule as defined by Section 

551 of the APA. 5 U.S.C. 551. NCUA has 

requested a SBREFA determination from 

the Office of Management and Budget, 

which is pending. As required by 

SBREFA, NCUA will file the 

appropriate reports with Congress and 

the General Accounting Office so that 

the final rule may be reviewed. 

List of Subjects 

12 CFR Part 745 

Credit unions, Share insurance. 

12 CFR Part 747 

Administrative practice and 

procedure, Bank deposit insurance, 

Claims, Credit unions, Equal access to 

justice, Investigations, Lawyers, 

Penalties. 

■ Accordingly, NCUA adopts as final 

the interim rule amending 12 CFR parts 

745 and 747. 

By the National Credit Union 

Administration Board on March 1, 2007. 

Mary F. Rupp, 

Secretary of the Board. 

[FR Doc. E7–4225 Filed 3–8–07; 8:45 am] 

BILLING CODE 7535–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Fenbendazole Paste 

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 supplemental new 

animal drug applications (NADAs) filed 

by Intervet, Inc. The supplemental 

NADAs provide for a revised human 

food safety warning for fenbendazole 

paste, used for the control of various 

internal parasites in horses and cattle. 

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, 301 827 7540, email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Intervet, 

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

Millsboro, DE 19966, filed a supplement 

to NADA 120–648 that provides for use 

of PANACUR (fenbendazole) Paste in 

horses for the control of various internal 

parasites, and to NADA 132–872 that 

provides for use of SAFE-GUARD 

(fenbendazole) Paste in cattle for the 

control of various internal parasites. The 

supplemental NADAs provide for a 

revised human food safety warning on 

product labeling. The supplemental 

NADAs are approved as of February 8, 

2007, and the regulations are amended 

in 21 CFR 520.905c to reflect the 

approval and a current format. 

Approval of these supplemental 

NADAs did not require review of 

additional safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

FDA 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. 

List of Subjects in 21 CFR Part 520 

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 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 § 520.905c as follows: 

■ a. Revise paragraph (a); 

■ b. Redesignate paragraph (d) as 

paragraph (e); 

■ c. Add new paragraph (d); and 

■ d. Revise newly redesignated 

paragraph (e). 

The revisions, redesignation, and 

addition read as follows: 

§ 520.905c Fenbendazole paste. 

(a) Specifications. Each gram of paste 

contains 100 milligrams (mg) 

fenbendazole (10 percent). 

* * * * * 

(d) Special considerations. See 

§ 500.25 of this chapter. 

(e) Conditions of use—(1) Horses—(i) 

Indications for use and amounts—(A) 

For control of large strongyles 

(Strongylus edentatus, S. equinus, S. 

vulgaris), small strongyles, pinworms 

(Oxyuris equi), and ascarids (Parascaris 

equorum): 2.3 mg per pound (/lb) of 

body weight, or for foals and weanlings 

(less than 18 months of age), 4.6 mg/lb 

of body weight. Retreatment at intervals 

of 6 to 8 weeks may be required. 

(B) For control of arteritis caused by 

the fourth-stage larvae of S. vulgaris: 4.6 

mg/lb of body weight daily for 5 days. 

Treatment should be initiated in the 

spring and repeated in 6 months. 

(C) For treatment of encysted mucosal 

cyathostome (small strongyle) larvae 

including early third-stage (hypobiotic), 

late third-stage, and fourth-stage larvae: 

4.6 mg/lb of body weight daily for 5 

consecutive days. 

(D) Fenbendazole paste 10 percent 

may be used concomitantly with 

approved forms of trichlorfon for the 

indications provided in paragraph 

(e)(1)(i)(A) of this section and for 

treating infections of stomach bots as 

provided in § 520.2520. 

(ii) Limitations. Do not use in horses 

intended for human consumption. 

(2) Cattle—(i) Amount. 2.3 mg/lb of 

body weight. Re-treatment may be 

needed after 4 to 6 weeks. 

(ii) Indications for use. For the 

removal and control of lungworms 

(Dictyocaulus viviparus), stomach 

worms (Haemonchus contortus, 

Ostertagia ostertagi, Trichostrongylus 

axei), and intestinal worms 

(Bunostomum phlebotomum, 

Nematodirus helvetianus, Cooperia 

punctata, C. oncophora, 

Trichostrongylus colubriformis, and 

Oesophagostomum radiatum). 

(iii) Limitations. Cattle must not be 

slaughtered within 8 days following last 

treatment. 

Dated: February 28, 2007. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E7–4204 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 520 

Oral Dosage Form New Animal Drugs; 

Oxfendazole Suspension 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 


erjones on PRODPC74 with RULES