14634 Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Rules and Regulations

lungworms, grubs, lice, and mange

mites infections.

EFFECTIVE DATE: March 27, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Merck

Research Laboratories, Division of

Merck & Co., Inc., P.O. Box 2000,

Rahway, NJ 07065, is sponsor of NADA

128–409, which provides for the use of

Ivomec Injection (1% ivermectin) for

cattle for the treatment and control of

gastrointestinal roundworm, lungworm,

grub, lice, and mange mite infections.

The supplement provides for control of

infections of Dictyocaulus viviparus and

Ostertagia ostertagi for 21 days after

treatment, and Haemonchus placei,

Trichostrongylus axei, Cooperia

punctata, C. oncophora, and

Oesophagostomum radiatum for 14

days after treatment. The supplement is

approved as of February 24, 1997, and

the regulations are amended in 21 CFR

522.1192(d)(2)(ii) 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), approval of

this supplement qualifies for 3 years of

marketing exclusivity beginning

February 24, 1997, because the

supplement contains substantial

evidence of effectiveness of the drug

involved, any 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 of the

supplement and conducted or

sponsored by the applicant. Exclusivity

applies only to the additional

indications.

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 522

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 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).

§ 522.1192 [Amended]

2. Section 522.1192 Ivermectin

injection is amended in paragraph

(d)(2)(ii) by adding to the end of the

paragraph the sentence ‘‘It is also used

to control infections of D. viparus and

O. ostertagi for 21 days after treatment,

and H. placei, T. axei, C. punctata, C.

oncophora, and Oesophagostomum

radiatum for 14 days after treatment.’’

Dated: March 17, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–7789 Filed 3–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD8–95–026]

Drawbirdge Operation Regulation;

Bonfouca Bayou, LA

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is revising

the regulation governing the operation

of the swing span drawbridge across

Bonfouca Bayou, mile 7.0, at Slidell, St.

Tammany Parish, Louisiana. A notice of

proposed rulemaking was published on

May 1, 1996, and a supplemental notice

of proposed rulemaking (SNPRM) was

published on December 27, 1996,

because of comment received. This final

rule maintains the operating times

published in the SPRM to which no

comments were received.

DATES: This regulation becomes

effective on April 28, 1997.

FOR FURTHER INFORMATION CONTACT:

Mr. Phil Johnson, Bridge Administration

Branch, Eighth Coast Guard District,

telephone (504) 589–2965.

SUPPLEMENTARY INFORMATION:

Regulatory History

The Coast Guard published a notice of

proposed rulemaking [61 FR 19223] on

Wednesday, May 1, 1996. Comments

received prompted the Coat Guard to

reevaluate the proposed rule. Mariners

and business owners, located upstream

of the bridge commented on the

proposal, stating that their business

would suffer if vessels were not

permitted to transit above the periods of

three continuous hours. Additionally,

local commercial marine interests

requested that the draw open on

demand from 9 p.m. to 5 a.m. if at least

4 hours advance notice is given, in lieu

of 12 hours notice. Subsequently, a

notice of supplemental proposed

rulemaking along with a notice of

temporary deviation was published

Friday, December 27, 1996 [61 FR

68198] incorporating changes in the

proposed rule. No comments were

received on the latter notice.

Accordingly, the Coast Guard will

maintain the operating times as noted in

the notice of supplemental proposed

rulemaking.

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 cost

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

order. It has not been reviewed 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’’ may include (1) small

businesses and non-for-profit

organizations that are independently

owned and operated and are not

dominant in their field and (2)

governmental jurisdictions with

populations of less than 50,000.

Since this final rule was revised in

response to comments, concerns and

suggestions of local mariners and

maritime business interests, the

economic impact of this final rule is

expected to be minimal. Therefore, the

Coast Guard certifies under 5 U.S.C.
Federal Register / Vol. 62, No. 59 / Thursday, March 27, 1997 / Rules and Regulations 14635

604(b) that this rulemaking will not

have a significant economic impact on

a substantial number of small entities.

Collection of Information

This final rule contains no collection

of information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.).

Federalism

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612 and it has been determined that

this rulemaking does not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

Enviornment

The Coast Guard considered the

environmental impact of this final rule

and concluded that under paragraph

2.B.2.g(5) of Commandant Instruction

M16475.1B, this rulemaking is

categorically excluded from further

environmental documentation. A

‘‘Categorical Exclusion Determination’’

has been prepared and placed in the

rulemaking docket.

List of Subjects in 33 CFR Part 117

Bridges.

Regulations

In consideration of the foregoing, Part

117 of Title 33, Code of Federal

Regulations, is amended as follows:

PART 117—DRAWBRIDGE

OPERATION REGULATIONS

1. The authority citation for part 117

continues to read as follows:

Authority: 33 U.S.C. 499; 49 CFR 1.46; 33

CFR 1.05–1(g); section 117.255 also issued

under the authority of Pub. L. 102–587, 106

Stat. 5039.

2. Section 117.433 is revised to read

as follows:

§ 117.433 Bonfouca Bayou.

The draw of the S433 bridge, mile 7.0,

at Slidell, shall operate as follows:

(a) The draw need not open for

passage of vessels from 7 a.m. to 8 a.m.

and from 1:45 p.m. to 2:45 p.m.,

Monday through Friday except Federal

Holidays.

(b) The draw need open only on the

hour and half-hour from 6 a.m. to 7 a.m.

and from 3 p.m. to 6 p.m., Monday

through Friday except Federal holidays.

(c) The draw shall open a signal from

9 p.m. to 5 am., if at least 4 hours notice

is given to the Louisiana Department of

Transportation and Development

Security Service at (504) 375–0100.

(d) At all other times the draw shall

open on signal.

Dated: March 7, 1997.

T.W. Josiah,

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

Eighth Coast Guard District.

[FR Doc. 97–7730 Filed 3–26–97; 8:45 am]

BILLING CODE 4910–14–M

33 CFR Part 162

[CGD09–97–005]

Temporary Speed Limits for the St.

Marys River

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is making a

temporary amendment to the speed

limits for the St. Marys River during the

1996–97 icebreaking season. This

amendment reduces the speed limit by

2 miles per hour through that part of the

system, between Munuscong Channel

Lighted Buoy 8 (LLNR 13065) and Lake

Nicolet Light 80 (LLNR 13465) upbound

and between Lake Nicolet Light 80

(LLNR 13465) and West Neebish

Channel Light 9 (LLNR 13715)

downbound. These temporary changes

to the speed regulations are a

precautionary measure to minimize any

possible damage to the environment due

to movement of large commercial

vessels through the ice.

DATES: This regulation is effective from

March 13, 1997, through April 15, 1997.

FOR FURTHER INFORMATION CONTACT:

Lieutenant (Junior Grade) John Marian,

U.S. Coast Guard, Group Sault Ste.

Marie, 337 Water Street, Sault Ste.

Marie, Michigan, 49783, (906) 635–

3303.

SUPPLEMENTARY INFORMATION: 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. Publication of a notice of

proposed rulemaking and delay in the

effective date would be contrary to the

public interest because immediate

action is necessary to prevent possible

damage to the environment.

Discussion of Proposed Regulation

In a letter received on February 26,

1993, the Michigan Department of

Natural Resources advised the

Commander of the Ninth Coast Guard

District of concerns over the

environmental impact of ship transits

through the St. Marys River during the

period of March 21 to April 1. March 25

is the fix date for the opening of the

locks at Sault St. Marie, which allows

large commercial shipping access to the

St. Marys River from Lake Superior. In

accordance with an agreement reached

on June 29, 1993, with the U.S. Army

Corps of Engineers, the U.S. Fish and

Wildlife Service and the Michigan

Department of Natural Resources, the

Commander of the Ninth Coast Guard

District is making this temporary change

to the speed regulations during periods

when ice breaking is being conducted in

the vicinity of Neebish Island, St.

Mary’s River, Michigan. This speed

reduction is a precautionary measure to

minimize possible damage to the

environment. The speed limit is being

reduced by 2 statute miles per hour in

the area between Munuscong Channel

Lighted Buoy 8 (LLNR 13065) and Lake

Nicolet Light 80 (LLNR 13465),

upbound, and between Lake Nicolet

Lighted Buoy 80 (LLNR 13465) and

West Neebish Channel Light 9 (LLNR

13715), downbound. The West Neebish

Channel Light 9 checkpoint has been

added to extend the reduced speed limit

area past Winter Point, thereby

protecting the sensitive environment

between Winter Point and West Neebish

Channel Light 9. Speed limits apply to

the average speed between established

reporting points.

Federalism Implications

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612, and it has been determined that

the rulemaking does not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

Environment

A recent environmental impact study

by the United States Army Corps of

Engineers indicated that March 21 is the

optimal opening date of the locks at

Sault Ste. Marie. [see U.S. Army Corps

of Engineers Draft Environmental

Impact Statement, Opening Operations

of the Lock Facilities on March 21

(February 1993), Supplement III to the

Final Environmental Impact Statement,

Operations, Maintenance, and Minor

Improvements of the Federal Facilities

at Sault Ste. Marie, Michigan (July

1997)]. The same study by the Corps of

Engineers indicates that there is no

significant impact on fish populations

due to movement of large commercial

vessels through the ice. However, the

Michigan Department of Natural

Resources asserts that there may be such

an impact during the early period of

March 21 to April 1. The Ninth Coast

Guard District has adopted the U.S.

Army Corps of Engineers EIS, EIS

Supplements, and EIS studies on

Operations, Maintenance, and Minor

Improvements of the Federal Facilities