Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Rules and Regulations 2415

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

Fermenta Animal Health Co. The

supplement provides for use of fixed

combination Type A medicated articles

containing chlortetracycline,

sulfathiazole, and penicillin in making

Type B and C medicated swine feeds for

swine from 10 pounds to 6 weeks postweaning.

EFFECTIVE DATE: January 26, 1996.

FOR FURTHER INFORMATION CONTACT:

James F. McCormack, Center for

Veterinary Medicine (HFV–128), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1607.

SUPPLEMENTARY INFORMATION: Fermenta

Animal Health Co., 10150 North

Executive Hills Blvd., Kansas City, MO

64153, filed a supplement to NADA 39–

077 CSPTM 250 (20 grams (g) of

chlortetracycline (as the hydrochloride),

20 g of sulfathiazole, and 10 g of

penicillin (as penicillin procaine), per

pound) and CSPTM 500 (40 g of

chlortetracycline (as the hydrochloride),

40 g of sulfathiazole, and 20 g of

penicillin (as penicillin procaine), per

pound). The NADA provides for use of

fixed combination Type A medicated

articles to make Type B and C

medicated swine feeds for prestarter,

starter, grower, and finisher rations. The

supplement provides for prestarter and

starter rations to be given to swine from

10 pounds of body weight to 6 weeks

postweaning for reduction of incidence

of cervical abscesses, treatment of

bacterial enteritis (salmonellosis or

necrotic enteritis caused by Salmonella

choleraesuis and vibrionic dysentery),

maintenance of weight gains in the

presence of atropic rhinitis, increased

rate of weight gain and improved feed

efficiency. The supplement is approved

as of January 26, 1996, and the

regulations are amended in § 558.155

(21 CFR 558.155) to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

In addition, the agency is revising the

section heading for § 558.155 to reflect

the active ingredients as on the label,

i.e., that the product is known as

chlortetracycline with sulfathiazole and

penicillin, not as chlortetracycline

hydrochloride with procaine penicillin

and sulfathiazole. The approvals

paragraph does specify the salts and

esters approved for use.

In § 558.155(d) the feed consumption

table is removed. The performance or

therapeutic claims of the product are

based on ad libitum consumption and

not the minimum desired daily feed

intake consumption values reported in

the table. This, together with changes in

weaning weights, renders the table

obsolete. Also, the indications for use

are editorially revised to clarify the

indications for each feeding group.

The product, chlortetracycline,

sulfathiazole, and penicillin, in

combination in a Type A medicated

article, is a new animal drug used to

make Type B and Type C medicated

feeds. As provided in § 558.4(b), the

combination drug product is a Category

II drug because it requires a withdrawal

period at its lowest continuous use

level. Therefore, it requires an approved

Form FDA 1900 for making Type B or

Type C medicated feeds as in approved

NADA 39–077 and in § 558.155.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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, rm. 1–23, 12420

Parklawn Dr., 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

supplemental approval does not qualify

for marketing exclusivity because the

supplement does not contain reports of

new clinical or field investigations

(other than bioequivalence or residue

studies) or human food safety studies

(other than bioequivalence or residue

studies) essential to the approval and

conducted or sponsored by the

applicant.

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 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Sec. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

2. Section 558.155 is amended by

revising the section heading and

paragraphs (d)(2) and (d)(3) to read as

follows:

§ 558.155 Chlortetracycline, sulfathiazole,

penicillin.

* * * * *

(d) * * *

(2) Indications for use. For reduction

of incidence of cervical abscesses.

Treatment of bacterial enteritis

(salmonellosis or necrotic enteritis

caused by Salmonella choleraesuis and

vibrionic dysentery). Maintenance of

weight gains in the presence of atrophic

rhinitis. Swine 10 pounds of body

weight to 6 weeks post-weaning:

Increased rate of weight gain and

improved feed efficiency. Swine 6 to 16

weeks post-weaning: Increased rate of

weight gain.

(3) Limitations. For swine raised in

confinement (dry-lot) or on limited

pasture. Feed as sole ration. Withdraw

7 days prior to slaughter.

Dated: January 3, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–1323 Filed 1–25–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD02–95–003]

RIN 2115–AE84

Regulated Navigation Area; Ohio River

Mile 466.0 to Mile 473.0

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is

establishing a regulated navigation area

on the Ohio River in the Cincinnati, OH

area. The rule is needed to control

vessel traffic while transiting

downbound at night during high water

conditions in the regulated area. The

rule will restrict commercial navigation

in the regulated area for the safety of

vessel traffic and the protection of life

and property along the river.

EFFECTIVE DATE: This rule is effective

February 26, 1996.

ADDRESSES: The Commanding Officer,

U.S. Coast Guard Marine Safety Office,

Louisville, KY, maintains the public

docket for this rule. The documents and
2416 Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Rules and Regulations

other materials referenced in this notice

will be available for inspection at the

U.S. Coast Guard Marine Safety Office,

600 Martin Luther King Place, Room

360, Louisville, KY 40202–2230. Normal

office hours are between 7:30 a.m. and

4 p.m., Monday through Friday, except

holidays.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Gregory A. Howard, Project

Officer, U.S. Coast Guard Marine Safety

Office, Louisville, Kentucky at (502)

582–5194.

SUPPLEMENTARY INFORMATION:

Drafting Information: The principal

persons involved in drafting this document

are Lieutenant Gregory A. Howard, Project

Officer for the Captain of the Port, Louisville,

Kentucky (502) 582–5196 and Lieutenant S.

Moody, Project Attorney, Second Coast

Guard District Legal Office, St. Louis, MO

(314) 539–3900.

Background and Purpose

On May 16, 1995 the Notice of

Proposed Rule Making was published in

the Federal Register at 60 FR 26012. No

comments were received from the date

of publication of the proposed rule until

the end of the comment period on July

17, 1995. Therefore the Coast Guard is

establishing this regulated navigation

area by this final rule with only a minor

change to the proposed rule.

The situation requiring this regulation

is periodic high water conditions on the

Ohio River in the vicinity of Cincinnati,

Ohio. The Ohio River in the Cincinnati

area is hazardous to transit under the

best conditions. To transit the area,

mariners must navigate through several

sweeping turns and seven bridges.

When the water level in the Ohio River

reaches 45 feet on the Cincinnati gauge,

river currents increase and become very

unpredictable, making it difficult for

downbound vessels to maintain

steerageway. During the period of 1983–

1993 there were 13 marine casualties

involving towboats from mile 468.5 to

mile 473.0 on the Ohio River. A review

of the case documentation showed that

seven of the thirteen cases mentioned

high water specifically or used terms

such as ‘‘swift current’’ or ‘‘heavy

current’’ as contributing factors to the

casualties. Nine of these cases involved

tows greater than 600 feet in length; six

of the cases involved downbound tows;

and five cases occurred at night. During

hours of darkness the background lights

of the city of Cincinnati hamper

mariners’ ability to maintain sight of the

front of their tow. This rule is intended

to protect the public and the

environment, at night during periods of

high water, from a potential hazard of

large downbound tows carrying

hazardous material through the

regulated area.

In the past, the Captain of the Port,

Louisville, Kentucky has responded to

this hazard by issuing a Temporary

Final Rule to establish a Safety Zone in

the area when warranted by high water

conditions. This rule is intended to

establish a permanent Regulated

Navigation Area in which restrictions

are activated and deactivated as a

function of river level. The number of

days that traffic will be affected by this

rule will vary from several days to

several weeks depending on the river

levels. A permanent Regulated

Navigation Area will permit vessels and

commerce using the Ohio River to plan

and schedule their tow traffic

accordingly.

Discussion of Regulations

This rule would establish a Regulated

Navigation Area on the Ohio River in

the Cincinnati, Ohio area. The

restrictions for the Regulated Navigation

Area will only be in effect from one-half

hour before sunset to one-half hour after

sunrise whenever the river level is at or

above 45 on the Cincinnati gauge. The

rule prohibits transit by downbound

tows containing cargoes regulated by

title 46 Code of Federal Regulations

Subchapter D and O which have a tow

length exceeding 600 feet in length not

including the tow boat; requires all

commercial vessels in the regulated

navigation area to monitor VHF–FM

radiotelephone Channel 13; requires all

downbound commercial vessels to

attempt to contact other vessels in the

regulated navigation area shortly before

entering the area (this is a change from

the Notice of Proposed Rule Making

which required contact shortly after

entering the area); and prohibits vessels

from loitering in the navigation channel.

Since the water level of the Ohio

River is seasonal and not predictable,

establishing fixed calendar dates for the

regulation is not practical. The rule is

structured to permit the Captain of the

Port, Louisville, Kentucky to activate or

deactivate the regulated navigable area

by issuing the proper notices. Broadcast

Notice to Mariners will be issued in

anticipation of high water, then again

when the river reaches 45 feet, and then

a termination broadcast will be issued

when the river falls below 45 feet.

These regulations are needed due to

the hazardous conditions that exist for

all vessels transiting the Cincinnati area

when the Ohio River is at high water

during hours of darkness.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

order. It has been exempted from review

by the Office of Management and

Budget under that order. It is not

significant under the regulatory policies

and procedures of the Department of

Transportation (DOT) (44 FR 11040;

February 26, 1979). The Coast Guard

expects the economic impact of this rule

to be so minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

must consider whether this rule will

have a significant economic impact on

a substantial number of small entities.

‘‘Small entities’’ include independently

owned and operated small businesses

that are not dominant in their field and

that otherwise qualify as ‘‘small

business concerns’’ under section 3 of

the Small Business Act (15 U.S.C. 632).

Because it expects the impact of this

rule to be minimal, the Coast Guard

certifies under 5 U.S.C. 605(b) that this

rule will not have a significant

economic impact on a substantial

number of small entities.

Collection of Information

This rule contains no collection of

information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.).

Federalism Assessment

The Coast Guard has analyzed this

rule in accordance with the principles

and criteria of Executive Order 12612,

and has determined that this rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

Environmental Assessment

The Coast Guard considered the

environmental impact of this rule and

concluded that, under section 2.B.2 of

Commandant Instruction M16475.1B, as

revised by 59 FR 38654; July 29, 1994,

this rule is categorically excluded from

further environmental documentation as

an action required to protect the public

and the environment.

List of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation

(Water), Reporting and recordkeeping

requirements, Security measures,

Waterways.

For the reasons set out in the

preamble, The Coast Guard amends
Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Rules and Regulations 2417

Subpart F of Part 165 of Title 33, Code

of Federal Regulations, as follows:

PART 165—[AMENDED]

1. The authority citation for Part 165

continues to read as follows:

Authority: 33 U.S.C. 1231; 50 U.S.C. 191;

33 CFR 1.05–1(g), 6.04–1, 6.04–6, and 160.5;

49 CFR 1.46.

2. A new § 165.205 is added to read

as follows;

§ 165.205 Ohio River at Cincinnati, OH;

regulated navigation area.

(a) Location. The following is a

regulated navigation area (RNA)—The

waters of the Ohio River between mile

466.0 and mile 473.0.

(b) Activation. The restrictions in

paragraphs (c) (i) through (iv) are in

effect from one-half hour before sunset

to one-half hour after sunrise when the

Cincinnati, Ohio, Ohio River Gauge is at

or above the 45 foot level. The Captain

of the Port, Louisville, Kentucky will

publish a notice in the Local Notice to

Mariners and will make announcements

by Coast Guard Marine Information

Broadcasts whenever the river level

measured at the gauge activates or

terminates the navigation restrictions in

this section.

(c) Regulations.

(i) Transit through the RNA by all

downbound vessels towing cargoes

regulated by Title 46 Code of Federal

Regulations Subchapters D and O with

a tow length exceeding 600 feet

excluding the tow boat is prohibited.

(ii) No vessel shall loiter, anchor,

stop, remain or drift without power at

any time within the navigation channel

of the RNA.

(iii) All commercial vessels shall

continually monitor VHF–FM channel

13 on their radiotelephone while in or

approaching the RNA.

(iv) Between Ohio River miles 464.0

and 466.0, downbound vessels shall

make a broadcast in the blind, on VHF–

FM channel 13 announcing their

estimated time of entering the RNA.

Dated: January 9, 1996.

Paul M. Blayney,

Rear Admiral, U.S. Coast Guard, Commander,

Second Coast Guard District, St. Louis, MO.

[FR Doc. 96–1386 Filed 1–25–96; 8:45 am]

BILLING CODE 4910–14–M

33 CFR Part 165

[COTP Louisville 96–001]

RIN 2115–AA97

Safety Zone; Ohio River, Cincinnati,

OH

AGENCY: Coast Guard, DOT.

ACTION: Temporary rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone on

the Ohio River. The regulation is needed

to control commercial vessel traffic in

the regulated area while transiting

downbound at night during high water

conditions. The regulation will restrict

commercial navigation in the regulated

area for the safety of vessel traffic and

the protection of life and property along

the river.

EFFECTIVE DATES: This regulation is

effective on January 19, 1996, at 2 p.m.

est. It will terminate at 8 a.m. est. on

February 1, 1996, unless sooner

terminated by the Captain of the Port

Louisville, Kentucky.

FOR FURTHER INFORMATION CONTACT:

LT Paul D. Thorne, Supervisor, Coast

Guard Marine Safety Detachment,

Cincinnati, Ohio at (513) 922–3820.

SUPPLEMENTARY INFORMATION:

Background and Purpose

The situation requiring this regulation

is high water in the Ohio River in the

vicinity of Cincinnati, Ohio. The Ohio

River in the Cincinnati area is

hazardous to transit under the best

conditions. To transit the area, mariners

must navigate through several sweeping

turns and seven bridges. When the

water level in the Ohio River reaches 45

feet, on the Cincinnati gage, river

currents increase and become very

unpredictable, making it difficult for

downbound vessels to maintain

steerageway. During hours of darkness

the background lights of the city of

Cincinnati hamper mariners’ ability to

maintain sight of the front of their tow.

The regulation is intended to protect the

public and the environment, at night

during periods of high water, from a

potential hazard of large downbound

tows carrying hazardous material

through the regulated area.

In accordance with 5 U.S.C. 553, a

notice of proposed rulemaking has not

been published for this regulation and

good cause exists for making it effective

in less than 30 days from the date of

publication. Following normal

rulemaking procedures would have

been impracticable. Specifically, the

high water periods in the Cincinnati,

Ohio, area are natural events which

cannot be predicted with any reasonable

accuracy. The Coast Guard deems it to

be in the public’s best interest to issue

a regulation now, as the situation

presents an immediate hazard to

navigation, life, and property.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

order. It has been exempted from review

by the Office of Management and

Budget under that order. It is not under

the regulatory policies and procedures

of the Department of Transportation

(DOT) (44 FR 11040; February 26, 1979).

Because the duration of this emergency

situation is anticipated to be short, the

Coast Guard expects the economic

impact of this regulation to be so

minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary.

To avoid any unnecessary adverse

economic impact on businesses which

use the river for commercial purposes,

Captain of the Port Louisville,

Kentucky, will monitor river conditions

and will authorize entry of restricted

vessels into the regulated area as

conditions permit. Changes will be

announced by Marine Safety

Information Radio broadcast (Broadcast

Notice to Mariners) on VHF marine

band radio, channel 22 (157.1 MHZ).

Mariners may also call LT Paul D.

Thorne, Supervisor, Coast Guard Marine

Safety Detachment, Cincinnati, Ohio at

(513) 922–3820 for current information.

Collection of Information

This rule contains no collection of

information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq).

Federalism Assessment

The Coast Guard has analyzed this

regulation under the principles and

criteria contained in Executive Order

12612 and has determined that it does

not raise sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

Environment

The Coast Guard considered the

environmental impact of this regulation

and concluded that, under section 2.B.2.

of Commandant Instruction M16475.1B,

this rule is categorically excluded from

further environmental documentation.

Lists of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation

(water), Reporting and recordkeeping

requirements, Security measures,

Waterways.

For the reasons set out in the

preamble, the Coast Guard amends 33

CFR Part 165 as follows:

1. The authority citation for Part 165

continues to read as follows: