Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations 14301

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.274 [Amended]

4. Section 558.274 Hygromycin B is

amended in paragraphs (a)(4) and

(c)(1)(i) and (c)(1)(ii) by removing the

number ‘‘017519,’’.

§ 558.485 [Amended]

5. Section 558.485 Pyrantel tartrate is

amended by removing and reserving

paragraph (a)(4).

§ 558.625 [Amended]

6. Section 558.625 Tylosin is

amended by removing and reserving

paragraph (b)(53).

§ 558.630 [Amended]

7. Section 558.630 Tylosin and

sulfamethazine is amended in

paragraph (b)(3) by removing the

number ‘‘,034500’’ and in paragraph

(b)(10) by removing the number

‘‘017519,’’.

Dated: March 13, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–7541 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lufenuron Tablets

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 Ciba-Geigy

Animal Health Corp. The NADA

provides for oral administration of

lufenuron tablets to cats and kittens 6

weeks of age and older for the control

of flea populations.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Marcia K. Larkins, Center for Veterinary

Medicine (HFV–112), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–0614.

SUPPLEMENTARY INFORMATION: CibaGeigy Animal Health Corp., P.O. Box

18300, Greensboro, NC 27419–8300,

filed NADA 141–062, which provides

for oral administration of Program

(Lufenuron) Cat Flavor Tablets for cats

and kittens 6 weeks of age or older, for

the control of flea populations. The drug

is given orally, once a month, at a

minimum of 13.6 milligrams (mg) of

lufenuron per pound of body weight (30

mg/kilogram), in tablets containing 135

or 270 mg lufenuron each. Lufenuron

has no deleterious effect on adult fleas,

but it prevents most flea eggs from

hatching or maturing into adults. The

NADA is approved as of March 3, 1997,

and the regulations are amended in 21

CFR 520.1288(a) and (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, 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

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

approval qualifies for 3 years of

marketing exclusivity beginning March

3, 1997, because the NADA contains

substantial evidence of effectiveness of

the drug involved or any studies of

animal safety, required for approval and

conducted or sponsored by the

applicant.

The agency has determined under 21

CFR 25.24(d)(1)(iii) 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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.1288 is amended by

revising paragraphs (a), (d) (1), and (d)

(3) to read as follows:

§ 520.1288 Lufenuron tablets.

(a) Specifications—(1) Dogs. Each

tablet contains either 45, 90, 204.9, or

409.8 milligrams (mg) lufenuron.

(2) Cats. Each regular tablet contains

either 90 or 204.9 mg lufenuron, each

flavor tablet contains 135 or 270 mg

lufenuron.

* * * * *

(d) Conditions of use in cats—(1)

Amount. Minimum of 13.6 mg

lufenuron per pound (lb) of body weight

(30 mg per kilogram). Recommended 90

mg regular tablet for cats up to 6 lb of

body weight, 204.9 mg regular tablet for

7 to 15 lb, 135 mg flavor tablet for up

to 10 lb, 270 mg flavor tablet for 11 to

20 lb. Cats over 15 lb (regular tablet) or

over 20 lb (flavor tablet) are provided

the appropriate combination of tablets.

* * * * *

(3) Limitations. For oral use in cats or

kittens 6 weeks of age or older, once a

month, directly or broken and mixed

with wet food. Administer in

conjunction with a full meal to ensure

adequate absorption. Treat all cats in the

household to ensure maximum benefits.

Because the drug has no affect on adult

fleas, the concurrent use of insecticides

that kill adults may be necessary

depending on the severity of the

infestation.

Dated: March 17, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–7549 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ivermectin

and Clorsulon

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 Merck

Research Laboratories, Division of

Merck & Co., Inc. The supplemental

NADA provides for persistent control of

gastrointestinal roundworms and

lungworms following use of ivermectin

and clorsulon injection for cattle.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.
14302 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Rules and Regulations

SUPPLEMENTARY INFORMATION: Merck

Research Laboratories, Division of

Merck & Co., Inc., P.O. Box 2000,

Rahway, NJ 07065, is sponsor of NADA

140–833, which provides for the use of

Ivomec Plus Injection (1 perecent

ivermectin and 10 percent clorsulon) for

cattle for the treatment and control of

gastrointestinal roundworm, lungworm,

grub, lice, and mange mites. The

supplement provides for control of

infections of Dictyocaulus viviparus and

Ostertagia ostertagi for 21 days after

treatment, and Haemonchus placei,

Trichostrongylus axei, Cooperia

punctata, C. oncophora, and

Oesophagostomum radiatum for 14

days after treatment. The supplement is

approved as of February 24, 1997, and

the regulations are amended in 21 CFR

522.1193(d)(2) 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)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

supplemental approval for foodproducing animals qualifies for 3 years

of marketing exclusivity beginning

February 24, 1997, because the

supplement contains substantial

evidence of effectiveness of the drug

involved, 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

supplement and conducted or

sponsored by the applicant. Exclusivity

applies only to the additional

indications.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 522.1193 is amended by

adding a new sentence to the end of

paragraph (d)(2) to read as follows:

§ 522.1193 Ivermectin and clorsulon

injection.

* * * * *

(d) * * *

(2) * * * It is also used to control

infections of D. viviparus and O.

ostertagi for 21 days after treatment, and

H. placei, T. axei, C. punctata, C.

oncophora, and O. radiatum for 14 days

after treatment.

* * * * *

Dated: March 17, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–7544 Filed 3–25–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs;

Oxytetracycline Hydrochloride

Injection

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

Boehringer Ingelheim Animal Health,

Inc. The supplemental NADA provides

for the subcutaneous use (in addition to

the approved intravenous and

intramuscular use) of 100 milligrams/

milliliter (mg/mL) of oxytetracycline

hydrochloride injection in cattle for the

treatment of diseases caused by

oxytetracycline susceptible organisms,

for a 2-day withdrawal period following

the subcutaneous use, and for a 13-day

withdrawal period following the

intramuscular and intravenous use.

EFFECTIVE DATE: March 26, 1997.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION:

Boehringer Ingelheim Animal Health,

Inc., 2621 North Belt Hwy., St. Joseph,

MO 64502, is the sponsor of NADA 97–

452, formerly sponsored by Fermenta

Animal Health Co. The firm has filed a

supplement to NADA 97–452, which

provides for subcutaneous use of 100

mg/mL of oxytetracycline hydrochloride

injection in addition to the approved

intravenous and intramuscular use in

beef and nonlactating dairy cattle for the

treatment of pneumonia and shipping

fever associated with Pasteurella spp.,

Haemophilus spp., and Klebsiella spp.,

caused by organisms susceptible to

oxytetracycline. In cattle, a 2-day

withdrawal period is required following

subcutaneous use, and a 13-day

withdrawal period is required following

intramuscular and intravenous use. The

product is also approved for

intramuscular and intravenous use in

swine. The supplemental NADA is

approved as of February 21, 1997, and

the regulations are amended in 21 CFR

522.1662a(g)(3)(i)(c) 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)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval for food-producing animals

qualifies for 3 years of marketing

exclusivity beginning February 21,

1997, because the supplemental

application contains substantial

evidence of the effectiveness of the drug

involved, 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

supplement and conducted or

sponsored by the applicant.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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.