66620 Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Rules and Regulations

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 524.802 is added to read as

follows:

§ 524.802 Enrofloxacin, silver sulfadiazine

emulsion.

(a) Specifications. Each milliliter

contains 5 milligrams (mg) enrofloxacin

and 10 mg silver sulfadiazine.

(b) Sponsor. See No. 000859 in

§ 510.600(c) of this chapter.

(c) Conditions of use—Dogs—(1)

Amount. 5 to 10 drops for dogs

weighing 35 pounds (lb) or less and 10

to 15 drops for dogs weighing more than

35 lb; applied twice daily for up to 14

days.

(2) Indications for use. For the

treatment of otitis externa in dogs.

(3) Limitations. Federal law restricts

this drug to use by or on the order of

a licensed veterinarian. Federal law

prohibits the extra-label use of this drug

in food-producing animals.

Dated: October 26, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–28520 Filed 11–6–00; 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; Decoquinate and

Chlortetracycline

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 new animal drug

application (NADA) filed by Alpharma,

Inc. The NADA provides for use of

approved decoquinate and

chlortetracycline (CTC) Type A

medicated articles to make two-way

combination Type B and Type C

medicated feeds for calves, beef and

nonlactating dairy cattle used for

prevention of coccidiosis, treatment of

bacterial enteritis, and treatment of

bacterial pneumonia.

DATES: This rule is effective November

7, 2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION: Alpharma

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

Fort Lee, NJ 07024, filed NADA 141–147

that provides for use of Deccox (27.2

grams per pound g/lb) and ChlorMaxTM

(50, 65, or 70 g/lb CTC) Type A

medicated articles to make combination

drug Type B and Type C medicated

feeds for calves, beef and nonlactating

dairy cattle. The combination Type C

feeds are for prevention of coccidiosis

caused by Eimeria bovis and E. zuernii,

for treatment of bacterial enteritis

caused by Escherichia coli, and for

treatment of bacterial pneumonia

caused by Pasteurella multocida

organisms susceptible to CTC. The

NADA is approved as of September 29,

2000, and the regulations are amended

in the table in 21 CFR 558.195(d) to

reflect the approval. The basis of

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, 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)(2) 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 558

Animal drugs, Animal feeds.

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 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.

2. Section 558.195 is amended in the

table in paragraph (d) by adding an

entry following the indication for

‘‘Cattle’’ at the 13.6 to 27.2 grams per

ton decoquinate dose level and before

the entry for ‘‘Cattle’’ at the 13.6 to

535.7 grams per ton dose level, to read

as follows:

§ 558.195 Decoquinate.

* * * * *

(d) * * *

Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Rules and Regulations 66621

Decoquinate in

grams per ton

Combination in grams

per ton Indications for use Limitations Sponsor

*******

Chlortetracycline approximately 400,

varying with body

weight and feed consumption to provide

10 mg/lb of body

weight per day.

Calves, beef and nonlactating dairy cattle: prevention of coccidiosis caused

by Eimeria bovis and E. zuernii, for

treatment of bacterial enteritis caused

by Escherichia coli, and for treatment

of bacterial pneumonia caused by

Pasteurella multocida organisms susceptible to chlortetracycline.

Feed Type C feed to provide 22.7 mg

decoquinate and 1 g chlortetracycline/

100 lb body weight (0.5 mg/kg)/day

for not more than 5 days. Type C

feed may be prepared from Type B

feed containing 535.8 to 5,440 g/ton

decoquinate and 6,700 to 80,000 g/

ton chlortetracycline. When consumed, feed 22.7 mg decoquinate/

100 lb body weight/day for a total of

28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter. Do

not feed to calves to be processed for

veal. Do not feed to animals producing milk for food.

046573

*******

Dated: October 26, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–28524 Filed 11–6–00; 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; Pyrantel Tartrate

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

Farnam Companies, Inc. The ANADA

provides for use of pyrantel tartrate in

horse feed for the prevention and

control of various species of internal

parasites.

DATES: This rule is effective November

7, 2000.

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: Farnam

Companies, Inc., 301 West Osborn,

Phoenix, AZ 85013–3928, is sponsor of

ANADA 200–282 that provides for use

of CONTINUEXTM (pyrantel tartrate)

Daily Dewormer. The ANADA provides

for use of pyrantel tartrate in horse feed

for the prevention and control of various

species of internal parasites. The

ANADA is approved as a generic copy

of Pfizer Inc.’s NADA 140–819 for

STRONGID 48. ANADA 200–282 is

approved as of September 26, 2000, and

the regulations are amended in 21 CFR

558.485 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, 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 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.

2. Section 558.485 is amended by

adding paragraph (a)(29) to read as

follows:

§ 558.485 Pyrantel tartrate.

(a) * * *

(29) To 017135: 48 grams per pound,

paragraph (e)(2) of this section.

* * * * *

Dated: October 26, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–28523 Filed 11–6–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600 and 606

[Docket No. 97N–0242]

Biological Products: Reporting of

Biological Product Deviations in

Manufacturing

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulation requiring licensed