Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations 60657

CFR 520.1484(c)(3) and now for

ANADA 200–113 in § 520.1485(d)(3).

No additional effectiveness or safety

studies were required for this approval.

Therefore, a freedom of information

summary is not required. A summary of

data and information submitted to

support the original ANADA approval

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(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.

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. Section 520.1485 is amended by

revising the last sentence of paragraph

(d)(3) to read as follows:

§ 520.1485 Neomycin sulfate oral solution.

* * * * *

(d) * * *

(3) * * * Discontinue treatment prior

to slaughter as follows: For sponsor

059130: 30 days for cattle and goats, and

20 days for swine and sheep; for

sponsors 000009 and 050604: 1 day for

cattle, 2 days for sheep, and 3 days for

swine and goats.

Dated: October 10, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–29654 Filed 11-10-97; 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; Medicated Feed Applications;

Lasalocid; Technical Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

correct assay limits for lasalocid in Type

A medicated articles. Although a

supplement to the new animal drug

application (NADA) was approved, the

regulations had not been previously

amended to reflect that approval. At this

time the regulations are amended to

reflect the current assay limits in the

approved NADA.

EFFECTIVE DATE: November 12, 1997.

FOR FURTHER INFORMATION CONTACT:

Mary G. Leadbetter, Center for

Veterinary Medicine (HFV–143), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1662.

SUPPLEMENTARY INFORMATION: FDA is

amending the regulation concerning use

of animal drugs in medicated feeds in

§ 558.4(d) (21 CFR 558.4(d)) to reflect

that the assay limit for lasalocid Type A

medicated articles is 95 to 115 percent

of the labeled amount. Although the

original approval for NADA 96–298

Hoffmann-LaRoche, Inc., provided for a

10 percent overage (an assay limit of 100

to 120 percent), a supplemental

approval dated August 25, 1992, revised

that overage to 5 percent (95 to 115

percent). The regulation in § 558.4(d) is

amended in the table entitled ‘‘Category

I,’’ in the entry for ‘‘Lasalocid,’’

accordingly.

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.

§ 558.4 [Amended]

2. Section 558.4 Medicated feed

applications is amended in paragraph

(d), in the table entitled ‘‘Category I,’’ in

the entry for ‘‘Lasalocid,’’ in the second

column by removing ‘‘100–120’’ and

adding in its place ‘‘95–115’’.

Dated: October 21, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–29649 Filed 11-10-97; 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; Amprolium Plus Ethopabate

With Bacitracin Zinc and Roxarsone

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

Alpharma Inc. The ANADA provides for

using approved amprolium plus

ethopabate with bacitracin zinc and

roxarsone Type A medicated articles to

make Type C medicated broiler chicken

feeds used as an aid in the prevention

of coccidiosis and improved feed

efficiency or improved feed efficiency

and improved pigmentation.

EFFECTIVE DATE: November 12, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, filed ANADA 200–

214 that provides for combining

approved amprolium plus ethopabate

with bacitracin zinc and roxarsone Type

A medicated articles to make Type C

medicated broiler feeds. The Type C

medicated feed containing amprolium

113.5 grams per ton (g/t) plus

ethopabate 36.3 g/t with bacitracin zinc

10 to 50 g/t and roxarsone 15.4 to 45.4

g/t is used as an aid in the prevention

of coccidiosis where severe exposure to

coccidiosis from Eimeria acervulina, E.

maxima, and E. brunetti is likely to

occur, and for improved feed efficiency.

The Type C medicated feed containing

amprolium 113.5 g/t plus ethopabate