41588 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

524.1005(b)(1), (c)(2)(iii), and (c)(3) to

reflect the approval.

The regulations in § 524.1005(b)(1)

(21 CFR 524.1005(b)(1)) indicate that

Pfizer, Inc., is sponsor of NADA 32–319

for use of a 10 percent furazolidone

aerosol powder in dogs, horses, and

cattle. The NADA had been acquired by

Fort Dodge Animal Health, a Division of

American Cyanamid Co. At this time,

the regulation is amended in

§ 524.1005(b) to reflect the sponsor

change.

Approval of this supplemental NADA

provides for removal of a cattle use. It

does not affect the safety or

effectiveness data in the application.

Therefore, a freedom of information

summary is not 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

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 the

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. Section 524.1005 is amended by

revising paragraphs (b)(1) and (c)(3) and

by removing and reserving paragraph

(c)(2)(iii) to read as follows:

§ 524.1005 Furazolidone aerosol powder.

* * * * *

(b) * * *

(1) See No. 053501 in § 510.600(c) of

this chapter for use as in paragraphs

(c)(1), (c)(2)(i), (c)(2)(ii), and (c)(3) of

this section.

* * * * *

(c) * * *

(2) * * *

(iii) [Reserved]

(3) Limitations. For topical

application in horses, ponies, and dogs:

Clean affected area thoroughly, apply

drug once or twice daily, and repeat

treatment as required. Use only as

recommended by a veterinarian in

treatment of puncture wounds, wounds

requiring surgical debridement or

suturing, those of a chronic nature

involving proud flesh, generalized and

chronic infections of the skin, and those

skin conditions associated with intense

itching. If redness, irritation, or swelling

persists or increases, discontinue use

and consult a veterinarian. Not for use

in horses intended for food.

Dated: June 15, 2000.

Andrew J. Beaulieu,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 00–16977 Filed 7–5–00; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556

Tolerances for Residues of New

Animal Drugs in Food; 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

Hoechst Roussel Vet. The supplemental

NADA provides for establishing

tolerances for residues of fenbendazole

in edible tissues of cattle. Also, a

tolerance for parent fenbendazole in

goat muscle is established.

DATES: This rule is effective July 6,

2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–130), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION: Hoechst

Roussel Vet, Perryville Corporate Park

III, P.O. Box 4010, Clinton, NJ 08809–

4010, filed a supplement to NADA 128–

620 that provides for use of Safe-Guard

(fenbendazole) 10% Suspension for

Cattle and Panacur (fenbendazole)

10% Suspension for Cattle. The

supplement provides for establishing a

tolerance for parent fenbendazole in

cattle muscle. The supplement is

approved as of May 9, 2000, and the

regulations in § 556.275 (21 CFR

556.275) are amended to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary.

In addition, FDA is reviewing

information in the application and it is

establishing a tolerance for parent

fenbendazole in goat muscle. The

regulations are further amended in

§ 556.275 to reflect this action.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 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 Dockets Management Branch

(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 Part 556

Animal drugs, Foods.

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 556 is amended as follows:

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

1. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Section 556.275 is amended by

adding paragraphs (b)(1)(ii) and (b)(3)(ii)

to read as follows:

§ 556.275 Fenbendazole.

* * * * *

(b) * * *

(1) * * *

(ii) Muscle. The tolerance for parent

fenbendazole (the marker residue) is 0.4

ppm.

* * * * *

(3) * * *

(ii) Muscle. The tolerance for parent

fenbendazole (the marker residue) is 0.4

ppm.

Dated: June 19, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–16976 Filed 7–5–00; 8:45 am]

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