17770 Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Rules and Regulations 

factors which, individually or in 

combination, indicate that a decline in 

value of an equity security classified as 

available-for-sale is other than 

temporary and that a write-down of the 

carrying value is required: 

a. The length of the time and the 

extent to which the market value has 

been less than cost; 

b. The financial condition and nearterm prospects of the issuer, including 

any specific events which may 

influence the operations of the issuer 

such as changes in technology that may 

impair the earnings potential of the 

investment or the discontinuance of a 

segment of the business that may affect 

the future earnings potential; or 

c. The intent and ability of the holder 

to retain its investment in the issuer for 

a period of time sufficient to allow for 

any anticipated recovery in market 

value. 

Unless evidence exists to support a 

realizable value equal to or greater than 

the carrying value of the investment in 

equity securities classified as availablefor-sale, a write-down to fair value 

accounted for as a realized loss should 

be recorded. Such loss should be 

recognized in the determination of net 

income of the period in which it occurs 

and the written down value of the 

investment in the company becomes the 

new cost basis of the investment. 

[FR Doc. E9–8801 Filed 4–16–09; 8:45 am] 

BILLING CODE 0000–00–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2009–N–0665] 

Oral Dosage Form New Animal Drugs; 

Fenbendazole Suspension 

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 a revised human food 

safety warning for use of fenbendazole 

suspension in horses. 

DATES: This rule is effective April 17, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, 

e-mail: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Intervet, 

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

Millsboro, DE 19966, filed a supplement 

to NADA 104–494 that provides for use 

of PANACUR (fenbendazole) 

Suspension 10% in horses for the 

control of various internal parasites. The 

supplemental NADA provides for a 

revised human food safety warning on 

product labeling. The supplemental 

NADA is approved as of March 25, 

2009, and the regulations are amended 

in 21 CFR 520.905a 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(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 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 § 520.905a as follows: 

■ a. Revise paragraph (a); 

■ b. Remove paragraph (e); 

■ c. Redesignate paragraph (d) as 

paragraph (e); 

■ d. Add new paragraph (d); and 

■ e. Revise newly redesignated 

paragraphs (e)(1)(i), (e)(1)(iii), (e)(2)(i), 

(e)(2)(iii), (e)(3)(i), (e)(3)(ii) , and 

(e)(4)(i). 

The revisions and addition are to read 

as follows: 

§ 520.905a Fenbendazole suspension. 

(a) Specifications. Each milliliter of 

suspension contains 100 milligrams 

(mg) fenbendazole. 

* * * * * 

(d) Special considerations—(1) See 

§ 500.25 of this chapter. 

(2) Fenbendazole suspension 10 

percent and approved forms of 

trichlorfon, when used concomitantly 

for treating the indications provided in 

paragraph (e) of this section and for 

treating infections of stomach bot as 

provided in § 520.2520, have been 

shown to be compatible and not to 

interfere with one another. 

(e) * * * 

(1) * * * 

(i) Amount. Administer orally 5 mg 

per kilogram (/kg) (2.3 mg per pound (/ 

lb)) for the control of large strongyles, 

small strongyles, and pinworms; 10 mg/ 

kg for the control of ascarids. 

* * * * * 

(iii) Limitations. Administer by dose 

syringe or suitable plastic syringe. Do 

not use in horses intended for human 

consumption. 

(2) * * * 

(i) Amount. Administer orally 5 mg/ 

kg of body weight (2.3 mg/lb). 

* * * * * 

(iii) Limitations. Retreatment may be 

needed after 4 to 6 weeks. Cattle must 

not be slaughtered within 8 days 

following last treatment. 

(3) * * * 

(i) Amount. Administer orally 10 mg/ 

kg of body weight. 

(ii) Indications for use. For the 

removal and control of stomach worm 

(4th stage inhibited larvae/type II 

ostertagiasis), Ostertagia ostertagi, and 

tapeworm, Moniezia benedeni. 

* * * * * 

(4) * * * 

(i) Amount. Administer orally 5 mg/ 

kg of body weight (2.3 mg/lb). 

* * * * * 

Dated: April 9, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–8822 Filed 4–16–09; 8:45 am] 

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