Federal Register / Vol. 62, No. 44 / Thursday, March 6, 1997 / Rules and Regulations 10219

170 Interruptible transportation comprises less

than ten percent of total throughput on Panhandle,

NorAm (5.89 percent), and Tennessee (9.81

percent). Pipelines for which interruptible

transportation comprises greater than 10 percent of

total throughput are Williams (17.72 percent),

Natural (13.11 percent), Southern (11.17 percent),

and ANR. The weighted average percentage of

interruptible transportation throughput among all

pipelines that report such data is approximately 18

percent. The Commission has determined all of the

above percentages based on the pipelines’ reports,

pursuant to FERC Form No. 11, of the total volumes

they transported during the first nine months of

1996 and their interruptible volumes during the

same period.

the allocation of at least some GSR costs

to interruptible service.

However, on remand, the Commission

has determined not to require that the

percentage of GSR costs so allocated

must be 10 percent for all pipelines. As

the Court recognized, different pipelines

perform different levels of interruptible

service. Among the pipelines that

potentially could be affected by a

departure from the generic 10 percent

allocation, interruptible transportation

comprises a widely varying percentage

of the pipelines’ total throughput for the

first nine months of 1996—from 2.87

percent (Panhandle) to 21.68 percent

(ANR).170 Given this fact, it is not

appropriate to require all pipelines to

allocate the same percentage of their

GSR costs to interruptible service. If the

same percentage of GSR costs were

allocated to interruptible service no

matter how much interruptible service a

pipeline performs, interruptible

customers on pipelines performing little

interruptible service could bear a

disproportionate share of the pipeline’s

GSR costs (absent discounts).

Therefore, the Commission will,

instead, require each individual

pipeline, whose GSR proceedings have

not been resolved, to propose the

percentage of its GSR costs its

interruptible customers should bear in

light of the circumstances on its system.

Pipelines which have filed to recover

GSR costs before the date of this order,

and whose GSR recovery proceedings

have not been resolved by settlement or

final and non-appealable Commission

order, must file such proposals in their

individual GSR proceedings within 180

days of the date of this order. Interested

parties will be given an opportunity to

comment on each pipeline’s proposal. If

the pipeline’s proposal is protested, the

Commission will set the proposal for

hearing in the GSR cost recovery

proceeding in which the proposal is

made. Those hearings will permit the

interested parties to develop a record on

which the Commission can base its

ultimate decision in each case.

This approach will allow the

Commission and the parties to develop

an allocation of GSR costs to

interruptible service that is tailored to

the specific circumstances of the few

pipelines where the issue is still alive.

The Commission also expects that such

hearings will provide the parties a

forum to discuss settlement of this

issue. The Commission encourages the

parties to seek to settle this and all other

outstanding issues related to GSR

recovery.

The Commission Orders

(A) Order No. 636 is reaffirmed, in

part, and reversed, in part, as discussed

in the body of this order.

(B) Within 180 days of the issuance of

this order, any pipeline with a right-offirst-refusal tariff provision containing a

contract term cap longer than five years

must revise its tariff consistent with the

new cap adopted herein.

(C) Within 180 days of the issuance of

this order, pipelines which have filed to

recover GSR costs before the date of this

order, and whose GSR recovery

proceedings have not been resolved by

settlement or final and non-appealable

Commission order, must file, in their

individual GSR proceedings, a proposed

allocation of GSR costs to its

interruptible customers as discussed in

the body of this order.

By the Commission.

Lois D. Cashell,

Secretary.

[FR Doc. 97–5363 Filed 3–5–97; 8:45 am]

BILLING CODE 6717–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Sarafloxacin

Hydrochloride

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

Abbott Laboratories. The supplement

provides for use of sarafloxacin

hydrochloride solution for injection in

18-day embryonated broiler eggs for

control of early chick mortality

associated with Escherichia coli

organisms susceptible to sarafloxacin.

EFFECTIVE DATE: March 6, 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: Abbott

Laboratories, 1401 Sheridan Rd., North

Chicago, IL 60064–4000, filed a

supplement to NADA 141–018 that

provides for use of sarafloxacin

hydrochloride solution for injection

(SaraFlox Injection) in 18-day

embryonated broiler eggs in addition to

approved use in day-old broiler

chickens for control of early chick

mortality associated with E. coli

organisms susceptible to sarafloxacin.

The supplement is approved as of

January 21, 1997, and the regulations

are amended by revising 21 CFR

522.2095(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)(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

21, 1997, because this supplement

contains substantial evidence of the

effectiveness of the drug involved,

studies of animal safety, or human food

safety studies (other than

bioequivalence or residue studies),

required for approval and conducted or

sponsored by the applicant. Marketing

exclusivity applies only to use in 18-day

embryonated broiler eggs.

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 522

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner
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.