Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations 5319

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).

§ 520.2345d [Amended]

2. Section 520.2345d Tetracycline

hydrochloride soluble powder is

amended in paragraph (a)(1) by

removing ‘‘047864, 054273, and

057561’’ and adding in its place

‘‘047864, 054273, 057561, and 059130’’

and by removing and reserving

paragraph (c).

Dated: January 28, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–2819 Filed 2–4–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Ivermectin Chewables

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 Merck

Research Laboratories, Div. of Merck &

Co., Inc. The NADA provides for

veterinary prescription use of

ivermectin chewables in cats for the

prevention of feline heartworm disease

for a month after infection and removal

and control of certain hookworm

infections.

EFFECTIVE DATE: February 5, 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: Merck

Research Laboratories, Div. of Merck &

Co., Inc., P.O. Box 2000, RY32–209,

Rahway, NJ 07065–0914, filed NADA

141–078 that provides for oral use on

veterinary prescription of HeartgardTM

for Cats (ivermectin chewables) to

prevent feline heartworm disease by

eliminating the tissue stage of

heartworm larvae Dirofilaria immitis for

a month after infection and for the

removal and control of adult and

immature (L4) hookworms Ancylostoma

tubaeforme and A. braziliense. The

NADA is approved as of December 23,

1996, and the regulations are amended

by revising 21 CFR 520.1193 to reflect

the approval. The basis of approval is

discussed in the freedom of information

summary.

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

December 23, 1996, because the NADA

contains substantial evidence of the

effectiveness of the drug involved, any

studies of animal safety required for

approval and conducted or sponsored

by the applicant.

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 carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

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 520.1193 is amended by

revising the section heading and

paragraph (a), and by adding new

paragraph (d) to read as follows:

§ 520.1193 Ivermectin tablets and

chewables.

(a) Specifications—(1) Dogs. Each

tablet or chewable contains 68, 136, or

272 micrograms of ivermectin.

(2) Cats. Each chewable contains 55 or

165 micrograms of ivermectin.

* * * * *

(d) Conditions of use in cats—(1)

Amount. Up to 2.3 kilograms (up to 5

pounds), 55 micrograms; 2.3 to 6.8

kilograms (5 to 15 pounds), 165

micrograms; over 6.8 kilograms (15

pounds), a combination of the

appropriate chewables (recommended

minimum dose of 24 micrograms of

ivermectin per kilogram of body weight

(10.9 micrograms per pound).

(2) Indications for use. To prevent

feline heartworm disease by eliminating

the tissue stage of heartworm larvae

Dirofilaria immitis for a month (30 days)

after infection, and for removal and

control of adult and immature (L4)

hookworms Ancylostoma tubaeforme

and A. braziliense.

(3) Limitations. For use in cats 6

weeks of age and older. Administer once

a month. The initial dose must be given

within a month after cats first exposure

to mosquitoes. The final dose must be

given within a month after the cats last

exposure to mosquitoes. Federal law

restricts this drug to use by or on the

order of a licensed veterinarian.

Dated: January 28, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–2821 Filed 2–4–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Naltrexone

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 new animal drug

application (NADA) filed by Wildlife

Laboratories, Inc. The NADA provides

for use of naltrexone hydrochloride

sterile injection as an antagonist to

carfentanil citrate immobilization in

free-ranging or confined elk and moose

(Cervidae).

EFFECTIVE DATE: February 5, 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: Wildlife

Laboratories, Inc., 1401 Duff Dr., suite

600, Fort Collins, CO 80524, filed