Federal Register / Vol. 62, No. 37 / Tuesday, February 25, 1997 / Rules and Regulations 8371

1996, and the regulations are amended

by revising 21 CFR 520.2220a(b) 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.

FDA has determined under 21 CFR

25.24(d)(1)(i) that this action is of a type

that does not individually of

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).

§ 520.2220a [Amended]

2. Section 520.2220a

Sulfadimethoxine oral solution and

soluble powder is amended in paragraph

(b) by removing ‘‘000069 and 057561’’

and adding in its place ‘‘000069,

054273, and 057561’’.

Dated: February 3, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–4515 Filed 2–24–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lufenuron Suspension and 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 two supplemental new

animal drug applications (NADA’s) filed

by Ciba-Geigy Animal Health, CibaGeigy Corp. The supplements provide

that veterinary prescriptions are no

longer required for use of lufenuron

tablets for dogs and oral suspension for

cats.

EFFECTIVE DATE: February 25, 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–

026 that provides for oral administration

of Program (lufenuron) suspension for

cats and kittens for control of flea

populations and supplemental NADA

141–035 that provides for oral

administration of Program (lufenuron)

tablets for dogs and puppies for

prevention and control of flea

populations. The supplemental NADA’s

provide that veterinary prescriptions are

no longer required. The supplemental

NADA’s are approved as of December

31, 1996, and the regulations are

amended by revising 21 CFR

520.1288(c)(3) and 520.1289(c)(3) to

remove the limitation for veterinary

prescription use.

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).

§ 520.1288 [Amended]

2. Section 520.1288 Lufenuron tablets

is amended in paragraph (c)(3) by

removing the last sentence.

§ 520.1289 [Amended]

3. Section 520.1289 Lufenuron

suspension is amended in paragraph

(c)(3) by removing the last sentence.

Dated: February 3, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–4513 Filed 2–24–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Progesterone

and Estradiol Benzoate

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 Ivy

Laboratories, Inc. The supplemental

NADA provides for use of a

progesterone-estradiol benzoate ear

implant in suckling beef heifer calves

for increased rate of weight gain.

EFFECTIVE DATE: February 25, 1997.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0217.

SUPPLEMENTARY INFORMATION: Ivy

Laboratories, Inc., 8857 Bond St.,

Overland Park, KS 66214, filed a

supplement to NADA 110–315, which

provides for use of a progesteroneestradiol benzoate ear implant in

suckling beef heifer calves for increased

rate of weight gain. Studies have shown

no detrimental effects on reproduction

after use of the implants in heifer calves.

The supplement is approved as of

January 22, 1997, and the regulations

are amended in 21 CFR

522.1940(d)(1)(iii) to reflect the

approval by limiting the use to indicate