Federal Register / Vol. 62, No. 205 / Thursday, October 23, 1997 / Rules and Regulations 55161

§ 524.900 [Amended]

4. Section 524.900 Famphur is

amended in paragraph (e) by removing

‘‘40 CFR 180.233 under the chemical

name’’ and adding in its place

‘‘§ 556.273 of this chapter.’’

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

5. The authority citation for 21 CFR

part 556 continues to read as follows:

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

6. Section 556.273 is added to subpart

B to read as follows:

§ 556.273 Famphur.

Tolerances are established for

residues of famphur including its

oxygen analog in or on meat, fat, or meat

byproducts of cattle at 0.1 part per

million.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

7. The authority citation for 21 CFR

part 558 continues to read as follows:

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

§ 558.254 [Amended]

8. Section 558.254 Famphur is

amended in paragraph (c) by removing

‘‘40 CFR 180.233’’ and adding in its

place ‘‘§ 556.273 of this chapter.’’

Dated: September 9, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–28016 Filed 10–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Miconazole Nitrate

Lotion and Spray

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 an abbreviated new animal

drug application (ANADA) filed by

Med-Pharmex, Inc. The ANADA

provides for use of miconazole nitrate

lotion and spray as topical antifungal

agents to treat certain infections of dogs

and cats.

EFFECTIVE DATE: October 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: MedPharmex, Inc., 2727 Thompson Creek

Rd., Pomona, CA 91767, filed ANADA

200–196, which provides for use of

miconazole nitrate lotion 1 percent and

miconazole nitrate spray 1 percent as

antifungal agents for topical treatment of

infections in dogs and cats caused by

Microsporum canis, M. gypseum, and

Trichophyton mentagrophytes.

Med-Pharmex’s ANADA 200–196 is

approved as a generic copy of

Mallinckrodt Veterinary’s Conofite

miconazole nitrate 1 percent lotion and

spray, NADA 95–184. ANADA 200–196

is approved as of August 4, 1997, and

the regulations are amended in 21 CFR

524.1443(b) to reflect the approval. The

basis for approval is discussed in the

freedom of information summary.

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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

The agency 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.

List of Subjects in 21 CFR Part 524

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 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 524.1443 is amended by

revising paragraph (b) to read as follows:

§ 524.1443 Miconazole nitrate cream;

miconazole nitrate lotion; miconazole

nitrate spray.

* * * * *

(b) Sponsor. See No. 011716 in

§ 510.600(c) of this chapter for use of

cream, lotion, and spray; see No. 051259

in § 510.600(c) of this chapter for use of

lotion and spray.

* * * * *

Dated: September 10, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–28014 Filed 10–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Bacitracin Zinc

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 hybrid abbreviated new

animal drug application (ANADA) filed

by ALPHARMA, Inc. The hybrid

ANADA provides for the use of

bacitracin zinc Type A medicated

articles to make Type C medicated feeds

for cattle, broiler chickens, turkeys,

pheasants, growing quail, and growing

and finishing swine, for increased rate

of weight gain and improved feed

efficiency, and for laying chickens for

improved feed efficiency and increased

egg production.

EFFECTIVE DATE: October 15, 1997.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1638.

SUPPLEMENTARY INFORMATION:

ALPHARMA, Inc., One Executive Dr.,

P.O. Box 1399, Fort Lee, NJ 07024, is

sponsor of hybrid ANADA 200–223 that

provides for use of bacitracin zinc Type

A medicated articles (bacitracin zinc

equivalent to 50 grams (g) of bacitracin

per pound) to make Type C medicated

feeds for cattle when fed at 35 to 70

milligrams per head per day, for

growing broiler chickens, turkeys, and

pheasants fed at 4 to 50 g per ton (g/t),

for growing quail up to 5 weeks of age

fed at 5 to 20 g/t, for growing and

finishing swine fed at 10 to 50 g/t, for

increased rate of weight gain and

improved feed efficiency, and for laying

chickens fed at 10 to 25 g/t for improved