5526 Federal Register / Vol. 62, No. 25 / Thursday, February 6, 1997 / Rules and Regulations

(3) * * * For use in preruminating

calves including veal calves only, not

for use in other animals which are

raised for food production. * * *

3. Section 520.88e is amended by

revising the heading for paragraph (d),

paragraph (d)(2), and the first sentence

in paragraph (d)(3) to read as follows:

§ 520.88e Amoxicillin trihydrate boluses.

* * * * *

(d) Conditions of use. Preruminating

calves including veal calves—

* * * * *

(2) Indications for use. Treatment of

bacterial enteritis when due to

susceptible Escherichia coli in

preruminating calves including veal

calves.

(3) Limitations. For oral use in

preruminating calves including veal

calves only, not for use in other animals

which are raised for food production.

* * *

Dated: January 27, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation Center for Veterinary Medicine

[FR Doc. 97–3015 Filed 2–5–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Tilmicosin

Phosphate Injection

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

Elanco Animal Health, a Division of Eli

Lilly and Co. The supplemental NADA

provides for subcutaneous use of

tilmicosin phosphate injection for the

control of respiratory disease in cattle at

high risk of developing bovine

respiratory disease (BRD) associated

with Pasteurella haemolytica.

EFFECTIVE DATE: February 6, 1997.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1659.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, a Division of Eli Lilly

and Co., Lilly Corporate Center,

Indianapolis, IN 46285, is sponsor of

NADA 140–929, which provides for the

subcutaneous use of Micotil 300

(tilmicosin phosphate) Injection for the

treatment of cattle with bovine

respiratory disease (BRD) associated

with P. haemolytica. The drug is limited

to use by or on the order of a licensed

veterinarian. The firm filed a

supplemental NADA, which provides

for use of Micotil for the control of

respiratory disease in cattle at high risk

of developing BRD associated with P.

haemolytica. The supplement is

approved as of December 30, 1996, and

21 CFR 522.2471(d)(1)(ii) is amended to

reflect the approval. The basis of

approval is discussed in the freedom of

information summary.

Also, certain limitation statements for

use of the product are revised to reflect

current wording. Section

522.2471(d)(1)(iii) is amended by

revising two sentences.

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 for food-producing animals

qualifies for 3 years of marketing

exclusivity beginning December 30,

1996, because the supplemental

application contains substantial

evidence of the 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. The 3 years

of marketing exclusivity applies only to

the new claim, control of respiratory

disease in cattle at high risk of

developing BRD associated with P.

haemolytica, for which the the

supplemental application was

approved.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that this

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

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).

2.Section 522.2471 is amended by

revising paragraph (d)(1)(ii) and the last

four sentences of paragraph (d)(1)(iii) to

read as follows:

§ 522.2471 Tilmicosin phosphate injection.

* * * * *

(d) * * *

(1) * * *

(ii) Indications for use. For the

treatment of bovine respiratory disease

(BRD) associated with Pasteurella

haemolytica. For the control of

respiratory disease in cattle at high risk

of developing BRD associated with P.

haemolytica.

(iii) * * * A withdrawal period has

not been established for this product in

preruminating calves. Do not use in

calves to be processed for veal. Do not

slaughter within 28 days of last

treatment. Federal law restricts this drug

to use or on the order of a licensed

veterinarian.

* * * * *

Dated: January 27, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation Center for Veterinary Medicine

[FR Doc. 97–3016 Filed 2–5–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[COTP San Juan 96–077]

RIN 2115–AA97

Safety Zone Regulations: Southeast

End of Vieques Island, PR

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a safety zone on the
Federal Register / Vol. 62, No. 25 / Thursday, February 6, 1997 / Rules and Regulations 5527

southeast end of Vieques Island during

small boat operations and testing

conducted by the U.S. Navy. This safety

zone will remain in effect for all vessels

during the following times: from 5 p.m.

until 6 a.m. local time, between

February 5 to February 9, 1997, and

from 5 p.m. until 6 a.m. local time,

between February 11, to February 15,

1997. The U.S. Navy will be testing

vessels at high speed in the safety zone.

Therefore, these regulations are

necessary to provide for the safety of life

on navigable waters during the naval

operations. Entry into this safety zone is

prohibited unless authorized by the

Captain of the Port.

EFFECTIVE DATES: This regulation

becomes effective on January 31, 1997,

at 5 p.m. local time. The safety zone will

terminate on February 15, 1997 at 6 a.m.

local time.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Junior Grade M.J. Simbulan

or Ensign Jose A. Pena at (787) 729–

6800, ext. 380/381, Marie Safety Office,

San Juan, P.O. Box 9023666, San Juan,

PR 00902–3666.

SUPPLEMENTARY INFORMATION: In

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

of proposed rulemaking was not

published for this regulation and good

cause exists for making it effective in

less than 30 days after Federal Register

publication. Publishing an NPRM and

delaying its effective date would be

contrary to the public interest since

immediate action is needed to minimize

the potential for hazards to the vessels

affected and the environment. The

information on this event was received

within sufficient time to publish

proposed rules in advance or provide

for a delayed effective date.

Discussion of Regulations

The Coast Guard is establishing a

safety zone on the southeast end of

Vieques Island during small boat

operations and testing conducted by the

U.S. Navy. This safety zone will remain

in effect for all vessels during the

following times: from 5 p.m. until 6 am

local time, between January 31 to

February 4, 1997, from 6:30 a.m. until

4 p.m. local time, between February 5 to

February 9, 1997, and from 5 p.m. until

6 a.m. local time, between February 11

to February 15, 1997. The U.S. Navy

will be testing vessels at high speed in

the safety zone. Therefore, these

regulations are necessary to provide for

the safety of life on navigable waters

during the naval operations. Entry into

this safety zone is prohibited unless

authorized by the Captain of the Port.

The safety zone will encompass an

area of approximately 13 square miles.

The safety zone extends northward from

latitude 18–05.0 N to the South coast of

Vieques Island or latitude 18–08.0 N.

The safety zone is bound on the east by

longitude 065–21.0 W and on the west

by longitude 065–16.0 W. This

regulation is issued pursuant to 33

U.S.C. 1225 and 1231 as set out in the

authority citation for all of Part 165.

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 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 polices

and procedures of DOT is unnecessary.

This safety zone will be effective for a

limited number of days and affect a

small area.

Small Entities

Under the Regulatory Flexibility Act

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

must consider the economic impact on

small entities of a rule for which a

general notice of proposed rulemaking

is required. ‘‘Small entities’’ may

include (1) small businesses and not-forprofit organizations that are

independently owned and operated and

are not dominant in their fields and (2)

governmental jurisdiction with

populations of less than 50,000. The

Coast Guard certifies that this rule will

not have a significant economic impact

on a substantial number of small entities

because the regulation will be effective

for a limited number of days and affect

a limited area.

Collection of Information

This rule contain no collection-ofinformation 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

the rulemaking does not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

Environmental Assessment

The Coast Guard has considered the

environmental impact of this proposal

consistent with 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. In accordance with

section 2.B.2.e.(34)(g), the Coast Guard

has completed an Environmental Impact

Determination and a Categorical

Exclusion Checklist.

List of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation

(water), Reporting and recordkeeping

requirements, Security measures,

Waterways.

Temporary Regulations

In consideration of the foregoing,

Subpart C of Part 165 of title 33, Code

of Federal Regulations, the Coast Guard

amends 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.T96–077 is added to

read as follows:

§ 165.T96–077 Safety Zone: Southeast end

of Vieques Island, PR.

(a) Location. The following area is a

safety zone:

A four-sided box bounded on the

north by the south shore of Vieques or

latitude 18–08.0 N, bounded on the

south by latitude 18–05.0 N, bounded

on the east by longitude 65–16.0 W, and

bounded on west by longitude 65–21.0

W.

(b) Effective date. This regulation

becomes effective at 5 p.m. local time on

31 January 1997. It will terminate at

approximately 6 am local time on 15

February 1997, unless terminated

sooner by the Coast Guard Captain of

the Port.

(c) Regulations. In accordance with

the general regulations in § 165.23 of

this part, entry into this zone is

prohibited unless authorized by the

Coast Guard Captain of the Port.

Dated: January 24, 1997.

B.M. Salerno,

Commander, U.S. Coast Guard, Captain of

the Port, San Juan, Puerto Rico.

[FR Doc. 97–3002 Filed 2–5–97; 8:45 am]

BILLING CODE 4910–14–M