Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Rules and Regulations 12085

(3) A statement that a solution

containing an additive drug should not

be stored.

(d) This section does not apply to a

biological product licensed under the

Public Health Service Act of July 1,

1944 (42 U.S.C. 201).

§ 310.510 [Removed]

14. Section 310.510 Use of aerosol

drug products containing zirconium is

removed.

§ 310.513 [Removed]

15. Section 310.513 Chloroform, use

as an ingredient (active or inactive) in

drug products is removed.

§ 310.525 [Removed]

16. Section 310.525 Sweet spirits of

nitre drug products is removed.

§ 310.526 [Removed]

17. Section 310.526 Camphorated oil

drug products is removed.

Dated: March 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6411 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lufenuron Tablet

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 CibaGeigy Animal Health, Ciba-Geigy Corp.

The supplemental NADA provides for

oral administration of lufenuron tablets

at a minimum dose of 30 milligrams per

kilogram (mg/kg) for the control of flea

populations on cats.

EFFECTIVE DATE: March 14, 1997.

FOR FURTHER INFORMATION CONTACT:

Marcia K. Larkins, Center for Veterinary

Medicine (HFV–112), Food and Drug

Administration, 7500 Standish P1.,

Rockville, MD 20855, 301–594–0614.

SUPPLEMENTARY INFORMATION: CibaGeigy Animal Health, Ciba-Geigy Corp.,

P.O. Box 18300, Greensboro, NC 27419–

8300, filed supplemental NADA 141–

035, which provides for oral

administration of Program (lufenuron)

tablets to cats 6 weeks of age or older.

The drug is approved in 90- or 204.9-mg

tablets, given once a month, directly or

broken and mixed into wet food, for the

control of flea populations. Lufenuron

has no deleterious effect on adult fleas

but it prevents most flea eggs from

hatching or maturing into adults. The

supplemental NADA is approved as of

January 23, 1997, and the regulations

are amended in 21 CFR 520.1288 by

revising the heading for paragraph (c)

and by adding new paragraph (d) 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 qualifies for 3 years of

marketing exclusivity beginning January

23, 1997, because the application

contains substantial evidence of

effectiveness of the drug involved,

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 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 the heading for paragraph (c)

and by adding new paragraph (d) to read

as follows:

§ 520.1288 Lufenuron tablets.

* * * * *

(c) Conditions of use in dogs—

* * * * *

(d) Conditions of use in cats—(1)

Amount. 90-milligram tablet for cats up

to 6 pounds of body weight, 204.9-

milligram tablet for cats 7 to 15 pounds,

a combination of tablets for cats over 15

pounds (a minimum of 13.6 milligrams

per pound (30 milligrams per

kilogram)).

(2) Indications for use. For control of

flea populations.

(3) Limitations. For oral use in cats 6

weeks of age or older, once a month,

directly or broken and mixed into 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: February 11, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–6412 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 556 and 558

Animal Drugs, Feeds, and Related

Products; Chlortetracycline and

Tiamulin

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 Fermenta

Animal Health Co. The NADA provides

for the use of separately approved Type

A medicated articles containing

chlortetracycline and tiamulin in

making Type C combination medicated

feed. The feed is used in swine for

treatment of bacterial enteritis and

bacterial pneumonia and for control of

swine dysentery. The regulations are

also amended to increase the tolerance

for tiamulin residue in swine liver.

EFFECTIVE DATE: March 14, 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: Fermenta

Animal Health Co., 10150 North

Executive Hills Blvd., Kansas City, MO

64153–2314, filed NADA 141–011,