10220 Federal Register / Vol. 62, No. 44 / Thursday, March 6, 1997 / Rules and Regulations

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 522.2095 is amended by

revising paragraph (d) to read as

follows:

§ 522.2095 Sarafloxacin solution for

injection.

* * * * *

(d) Conditions of use. 18-day

embryonated broiler eggs and day-old

broiler chickens:

(1) Amount—(i) 18-day embryonated

broiler eggs: 0.05 milligram sarafloxacin

in 0.1 milliliter dose in single in ovo

injection.

(ii) Day-old broiler chickens: 0.1

milligrams sarafloxacin per 0.2 milliliter

dose in single subcutaneous injection in

the neck.

(2) Indications for use. For control of

early chick mortality associated with

Escherichia coli organisms susceptible

to sarafloxacin.

(3) Limitations. Dilute 1 milliliter

with 99 milliliters of sterile water or

physiologic saline for use. Use entire

contents of diluted solution within 24

hours. No preslaughter drug withdrawal

period is required when the product is

used as directed. Use in a manner other

than that indicated or with dosages in

excess of that recommended may result

in illegal drug residues in edible tissues.

Do not use in laying hens producing

eggs for human consumption. Do not

use in eggs intended for human

consumption. The effects of sarafloxacin

on the reproductive function of treated

fowl have not been determined. Federal

law restricts this drug to use by or on

the order of a licensed veterinarian.

Dated: February 7, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–5452 Filed 3–5–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Gentamicin Topical

Spray

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 an abbreviated new animal

drug application (ANADA) filed by

Med-Pharmex, Inc. The ANADA

provides for use of gentamicin topical

spray in dogs for the treatment of

infected superficial lesions caused by

bacteria susceptible to gentamicin.

EFFECTIVE DATE: March 6, 1997.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Reese, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1617.

SUPPLEMENTARY INFORMATION: MedPharmex, Inc., 2727 Thompson Creek

Rd., Pomona, CA 91767–1861, filed

ANADA 200–188, which provides for

GentasprayTM Topical Spray (each

milliliter contains gentamicin sulfate

equivalent to 0.57 milligram (mg)

gentamicin, betamethasone valerate

equivalent to 0.284 mg betamethasone)

to be used topically for the treatment of

infected superficial lesions in dogs

caused by bacteria susceptible to

gentamicin.

Approval of ANADA 200–188 for

Med-Pharmex, Inc. ’s, GentasprayTM

Topical Spray (gentamicin sulfate with

betamethasone valerate) is as a generic

copy of Schering Plough’s NADA 132–

338 Gentocin Topical Spray

(gentamicin sulfate with betamethasone

valerate). The ANADA is approved as of

January 29, 1997, and the regulations in

21 CFR 524.1044f(b) are amended 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.

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 524

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 524 is amended as follows:

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 524 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

2. Section 524.1044f is amended by

revising paragraph (b) to read as follows:

§ 524.1044f Gentamicin sulfate,

betamethasone valerate topical spray.

* * * * *

(b) Sponsor. See Nos. 000061 and

051259 in § 510.600(c) of this chapter.

* * * * *

Dated: February 11, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–5453 Filed 3–5–97; 8:45 am]

BILLING CODE 4160–01–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 32 and 53

[CC Docket No. 96–150: FCC 96–490]

Accounting Safeguards Under the

Telecommunications Act of 1996:

Correction

AGENCY: Federal Communications

Commission.

ACTION: Final rule; Correction.

SUMMARY: This document contains a

correction to the effective date of the

Final Rules, which were published

Tuesday, January 21, 1997, (62 FR

2918). The rules related to accounting

safeguards that are necessary to satisfy

the requirements of Sections 260 and

271 through 276 of the Communications

Act of 1934, as amended by the

Telecommunications Act of 1996 (‘‘1996

Act’’). Specifically, this Order

prescribed the way incumbent local

exchange carriers, including the Bell

Operating Companies (‘‘BOCs’’), must

account for transactions with affiliates

involving, and allocate costs incurred in

the provision of, both regulated

telecommunications services and

nonregulated services, including

telemessaging, interLATA

telecommunications, information,

manufacturing, electronic publishing,

alarm monitoring and payphone

services, to ensure compliance with the

1996 Act.