66984 Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Rules and Regulations

21 CFR 522.1156 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, 12420 Parklawn Dr.,

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

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

Friday.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act,

this approval for use in nonfoodproducing animals qualifies for 3 years

of marketing exclusivity beginning

November 7, 1997, because the

application contains substantial

evidence of the effectiveness of the drug

involved and any studies of animal

safety or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval of the

application and conducted or sponsored

by the applicant.

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 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

2. New § 522.1156 is added to read as

follows:

§ 522.1156 Imidocarb dipropionate

solution.

(a) Specifications. Each milliliter of

injectable solution contains 120

milligrams of imidocarb.

(b) Sponsor. See No. 000061 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Dogs—(i)

Amount. 6.6 milligrams imidocarb per

kilogram (3 milligrams per pound) of

body weight.

(ii) Indications for use. Treatment of

clinical signs of babesiosis and/or

demonstrated Babesia organisms in the

blood.

(iii) Limitations. Use subcutaneously

or intramuscularly. Not for intravenous

use. Repeat the dose after 2 weeks for a

total of two treatments. Imidocarb is a

cholinesterase inhibitor. Do not use

simultaneously with or a few days

before or after treatment with or

exposure to cholinesterase-inhibiting

drugs, pesticides, or chemicals. Federal

law restricts this drug to use by or on

the order of a licensed veterinarian.

(2) [Reserved]

Dated: December 15, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–33486 Filed 12–22–97; 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; Salinomycin, 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 two abbreviated new animal

drug applications (ANADA’s) filed by

Alpharma Inc. The ANADA’s provide

for using approved salinomycin,

bacitracin zinc, and roxarsone Type A

medicated articles to make Type C

medicated broiler chicken feeds used for

prevention of coccidiosis, increased rate

of weight gain, and improved feed

efficiency.

EFFECTIVE DATE: December 23, 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, is sponsor of

ANADA’s 200–209 and 200–215 that

provide for combining approved

salinomycin, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated broiler feeds

containing salinomycin 40 to 60 grams

per ton (g/t), bacitracin zinc 10 to

50 g/t, and roxarsone 34.1 g/t. The Type

C medicated feed is used for the

prevention of coccidiosis caused by

Eimeria tenella, E. necatrix, E.

acervulina, E. brunetti, E. mivati, and E.

maxima, increased rate of weight gain,

and improved feed efficiency.

Alpharma Inc.’s ANADA 200–209

provides for using approved SACOX

(Hoechst-Roussel Vet’s salinomycin

ANADA 200–075), ALBAC (Alpharma

Inc.’s bacitracin zinc ANADA 200–223),

and 3–NITRO (Alpharma Inc.’s

roxarsone NADA 7–891) Type A

medicated articles to make the

combination drug Type C medicated

feeds. Alpharma Inc.’s ANADA 200–215

provides for using approved BIO-COX

(Hoffmann-LaRoche, Inc.’s salinomycin

NADA 128–686), ALBAC (Alpharma

Inc.’s bacitracin zinc ANADA 200–223),

and 3–NITRO (Alpharma Inc.’s

roxarsone NADA 7–891) Type A

medicated articles to make the

combination drug Type C medicated

feeds.

Alpharma Inc.’s ANADA 200–209 is

approved as a generic copy of HoechstRoussel Vet’s ANADA 200–143.

Alpharma Inc.’s ANADA 200–215 is

approved as a generic copy of

Hoffmann-LaRoche, Inc.’s NADA 139–

190. The ANADA’s are approved as of

December 23, 1997, and the regulations

are amended in 21 CFR

558.550(b)(1)(ix)(c) to reflect the

approvals. The basis for approval is

discussed in the freedom of information

summaries.

This approval is for use of three single

ingredient Type A medicated articles to

make combination drug Type C

medicated feeds. One ingredient,

roxarsone, is a Category II drug as

defined in 21 CFR 558.3(b)(1)(ii). As

provided in 21 CFR 558.4(b), an

approved form FDA 1900 is required to

make Type C medicated feed from a

Category II drug. Under section 512(m)

of the act (21 U.S.C. 360b(m)), as

amended by the Animal Drug

Availability Act of 1996 (Pub. L. 104–

250), medicated feed applications have

been replaced by a requirement for feed

mill licenses. Therefore, use of

salinomycin, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated feeds as

provided in ANADA’s 200–209 and

200–215 is limited to manufacture in a

licensed feed mill.

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 each of these applications

may be seen in the Dockets Management

Branch (HFA–305), Food and Drug
Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Rules and Regulations 66985

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 these actions are of a

type that do 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 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.

§ 558.550 [Amended]

2. Section 558.550 Salinomycin is

amended in paragraph (b)(1)(ix)(c) by

removing ‘‘No. 000004’’ and adding in

its place ‘‘Nos. 000004 and 046573’’.

Dated: October 30, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–33370 Filed 12–22–97; 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; Semduramicin 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 a new animal drug

application (NADA) filed by Pfizer, Inc.

The NADA provides for using approved

single ingredient Type A medicated

articles to make combination drug Type

C medicated broiler chicken feeds

containing semduramicin and roxarsone

used for prevention of coccidiosis.

EFFECTIVE DATE: December 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Estella Z. Jones, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017, filed NADA 141–066, which

provides for combining approved Type

A medicated articles containing

AviaxTM (semduramicin sodium) (22.7

grams per pound (g/lb.)) and 3-Nitro

(roxarsone) (45.4, 90, and 227 g/lb.) to

make combination drug Type C

medicated broiler chicken feeds

containing 22.7 grams per ton of

semduramicin and 45.4 grams per ton of

roxarsone. The Type C medicated feed

is used for the prevention of coccidiosis

caused by Eimeria acervulina, E.

brunetti, E. maxima, E. mivati/ E. mitis,

E. necatrix, and E. tenella including

some field strains of E. tenella that are

more susceptible to semduramicin

combined with roxarsone than

semduramicin alone. The NADA is

approved as of December 23, 1997, and

the regulations are amended by adding

21 CFR 558.555(b)(4) 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.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

the act (21 U.S.C. 360b(c)(2)(F)(ii)), this

approval for food-producing animals

qualifies for 3 years marketing

exclusivity beginning December 23,

1997, because the application contains

substantial evidence of the effectiveness

of the drug involved, any studies of

animal safety or, in the case of foodproducing animals, human food safety

studies (other than bioequivalence or

residue studies) required for approval

and conducted or sponsored by the

applicant.

This approval is for use of approved

Type A medicated articles to make

combination drug Type C medicated

feeds. One ingredient, roxarsone, is a

Category II drug as defined in 21 CFR

558.3 (b)(1)(ii). As provided in 21 CFR

558.4(b), an approved FDA form 1900 is

required for making a Type B or Type

C medicated feed as in this application.

Under section 512(m) of the act, as

amended by the Animal Drug

Availability Act of 1996 (Pub L. 104–

250), medicated feed applications have

been replaced by a requirement for feed

mill licenses. Therefore, use of

semduramicin and roxarsone Type A

medicated articles to make Type C

medicated feeds as provided in NADA

141–066 requires a feed mill license

rather than an approved FDA Form

1900.

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 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 558.555 is amended by

adding paragraph (b)(4) to read as

follows:

§ 558.555 Semduramicin.

* * * * *

(b) * * *

(4) Amount. Semduramicin 22.7

grams with roxarsone 45.4 grams per

ton.

(i) Indications for use. For the

prevention of coccidiosis caused by

Eimeria acervulina, E. brunetti, E.

maxima, E. mivati/E. mitis, E. necatrix,

and E. tenella, including some field

strains of E. tenella that are more

susceptible to semduramicin combined

with roxarsone than semduramicin

alone.

(ii) Limitations. Feed continuously as

sole ration. Withdraw 5 days before

slaughter. For broiler chickens only. Do

not feed to laying hens. Use as sole

source of organic arsenic. Roxarsone as

provided by 046573, semduramicin as

provided by 000069 in § 510.600(c) of

this chapter.

Dated: December 15, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–33376 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F