38474 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 /Rules and Regulations

Cylicocyclus spp., Cylicodontophorus

spp., (Cylicostephanus spp.), pinworms

(adult and fourth-stage larvae) (Oxyuris

equi); ascarids (third- and fourth-stage

larvae and adults) (Parascaris equorum);

hairworms (adult) (Trichostrongylus

axei); large-mouth stomach worms

(adult) (Habronema muscae); stomach

bots (oral and gastric stages)

(Gastrophilus spp.); lungworms (adults

and forth-stage larvae) (Dictyocaulus

arnfieldi); intestinal threadworms

(adults) (Strongyloides westeri); summer

sores caused by Habronema and

Draschia spp. cutaneous third-stage

larvae; and dermatitis caused by neck

threadworm microfilariae (Onchocerca

spp.).

Approval of ANADA 200–202 for

Phoenix Scientific, Inc.’s, ivermectin

oral liquid is as a generic copy of Merial

Ltd.’s, NADA 140–439 Eqvalan 

(ivermectin) liquid for horses. The

ANADA is approved as of June 5, 1998,

and the regulations are amended in 21

CFR 520.1195(b) 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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33(a)(1) 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 520

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 520.1195 [Amended]

2. Section 520.1195 Ivermectin liquid

is amended in paragraph (b) by

removing ‘‘No. 050604’’ and adding in

its place ‘‘Nos. 050604 and 059130’’.

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19028 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Bacitracin Methylene Disalicylate

Soluble

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

Alpharma Inc. The supplemental NADA

provides for using soluble bacitracin

methylene disalicylate (BMD) powder to

make a medicated drinking water for

growing quail for prevention of

ulcerative enteritis.

EFFECTIVE DATE: July 17, 1998.

FOR FURTHER INFORMATION CONTACT:

William T. Flynn, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, filed supplemental

NADA 65–470 that provides for use of

BMD Soluble (BMD soluble powder)

to make a medicated drinking water for

growing quail containing the equivalent

of 400 milligrams of bacitracin per

gallon used for prevention of ulcerative

enteritis due to Clostridium colinum

susceptible to BMD. The supplemental

NADA is approved as of May 27, 1998,

and the regulations in 21 CFR 520.154a

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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33(d)(4) 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 520

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Section 520.154a is amended in

paragraph (a) by removing the phrase

‘‘paragraph (d)(3)’’ and by adding in its

place the phrase ‘‘paragraphs (d)(3) and

(d)(4)’’ and by adding paragraph (d)(4)

to read as follows:

§ 520.154a Soluble bacitracin methylene

disalicylate.

* * * * *

(d) * * *

(4) Growing quail—(i) Amount. 400

milligrams per gallon in drinking water.

(ii) Indications for use. For prevention

of ulcerative enteritis due to Clostridium

colinum susceptible to bacitracin

methylene disalicylate.

(iii) Limitations. Prepare fresh

solution daily. Use as sole source of

drinking water.

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19026 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Bacitracin Methylene

Disalicylate, Decoquinate, and

Roxarsone

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the
Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 /Rules and Regulations 38475

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Alpharma

Inc. The NADA provides for using

approved bacitracin methylene

disalicylate, decoquinate, and roxarsone

Type A medicated articles to make

combination drug Type C medicated

broiler chicken feeds.

EFFECTIVE DATE: July 17, 1998.

FOR FURTHER INFORMATION CONTACT:

Charles J. Andres, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1638.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is sponsor of NADA

141–100 that provides for combining

approved Type A medicated articles

containing BMD (10, 25, 30, 40, 50, 60,

or 75 grams per pound (g/lb) bacitracin

methylene disalicylate) with Deccox (6

percent or 27.2 g/lb decoquinate), and 3-

Nitro (45.4, 90, or 227 g/lb roxarsone)

to make Type C medicated broiler feeds

containing 50 g/ton (g/t) bacitracin

methylene disalicylate, 27.2 g/t

decoquinate, and 22.7 to 45.4 g/t

roxarsone. The Type C medicated

broiler feeds are used as an aid in the

prevention of necrotic enteritis, for the

prevention of coccidiosis, and for

increased rate of weight gain, improved

feed efficiency, and improved

pigmentation in broiler chickens. The

NADA is approved as of June 2, 1998,

and the regulations are amended in 21

CFR 558.76(d)(3) and 558.195(d) by

adding new entries, and 558.530(d)(5)(x)

is revised 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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

This approval is for use of single

ingredient Type A medicated articles to

make combination drug Type C

medicated feeds. One ingredient,

roxarsone, is a Category II drug as

defined in 21 CFR 558.3(b)(1)(ii). Prior

to enactment of the Animal Drug

Availability Act of 1996 (Pub. L. 104–

250) (ADAA), an approved medicated

feed application (MFA) was required for

feed mills to make Type C medicated

feeds from Type A medicated articles

containing Category II drugs. The ADAA

revised the Federal Food, Drug, and

Cosmetic Act to replace the requirement

for MFA’s with a requirement for feed

mill licenses.

The agency has determined under 21

CFR 25.33(a)(2) 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: 21 U.S.C. 360b, 371.

2. Section 558.76 is amended by

adding paragraph (d)(3)(xv) to read as

follows:

§ 558.76 Bacitracin methylene disalicylate.

* * * * *

(d) * * *

(3) * * *

(xv) Decoquinate and roxarsone as in

§ 558.195.

3. Section 558.195 is amended in the

table in paragraph (d) by adding an

entry for ‘‘27.2 (0.003 pct)’’ following

the entry for ‘‘Bacitracin 10 to 50’’ and

before the entry for ‘‘Chlortetracycline

100 to 200’’ to read as follows:

§ 558.195 Decoquinate.

* * * * *

(d) * * *

Decoquinate in grams per ton Combination in grams per

ton Indications for use Limitations Sponsor

* * * * * * *

27.2 (0.003 pct) ........................ Bacitracin methylene disalicylate 50 and roxarsone

22.7–45.4.

Broiler chickens; for prevention of coccidiosis caused

by Eimeria tenella, E.

necatrix, E. mivati, E.

acervulina, E. maxima, E.

brunetti; as an aid in the

prevention of necrotic enteritis caused or complicated by Clostridium

spp. or other organisms

susceptible to bacitracin;

for increased rate of weight

gain, improved feed efficiency, and improved pigmentation.

Feed continuously as sole ration. Withdraw 5 days before slaughter. Do not feed

to laying chickens. Not for

use in breeder chickens.

Use as sole source of organic arsenic. Poultry

should have access to

drinking water at all times.

Drug overdosage or lack of

drinking water may result

in leg weakness or paralysis. Decoquinate, bacitracin methylene disalicylate, and roxarsone, as

provided by No. 046573 in

§ 510.600(c) of this chapter.

046573

* * * * * * *

3. Section 558.530 is amended by

removing and reserving paragraph (c),

and by revising paragraph (d)(5)(x) to

read as follows:

§ 558.530 Roxarsone.

* * * * *
38476 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 /Rules and Regulations

(c) [Reserved]

(d) * * *

(5) * * *

(x) Decoquinate alone or in

combination as in § 558.195.

* * * * *

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19025 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD07–98–006]

RIN 2115–AE46

Security Zone; Coast Waters Adjacent

to Florida

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: Pursuant to Presidential

Proclamation No. 6867, declaring a

national emergency, the Coast Guard,

after consultation with the Department

of Justice, established a security zone,

restricting the operation of certain

vessels within the internal waters and

territorial seas of the United States,

adjacent to or within the coastal waters

around southern Florida. The Coast

Guard is revising the security zone to

encompass all of the internal waters and

territorial seas of the United States

adjacent to or within the State of Florida

and within the boundaries of the

Seventh Coast Guard District (defined in

33 CFR 3.35–1); that is, all the described

waters in and off Florida with the

exception of those waters west of 083–

50 W. The Coast Guard Captain of the

Port (COTP) may exercise complete

control over all vessel operations and

movements within the security zone.

Non-public vessels of less than 50

meters (165 feet) in length, may not get

underway in or depart the security zone

with the intent to enter Cuban territorial

waters, absent express authorization

from the COTP. These vessels control

measures are necessary to provide for

the safety of the United States citizens

and residents and to prevent threatened

disturbances of the international

relations of the United States.

DATES: This rule is effective July 14,

1998 and will terminate when the

National Emergency as declared by the

President in Presidential Proclamation

No. 6867 terminates. The Coast Guard

will publish a separate document in the

Federal Register announcing

termination of this rule.

ADDRESSES: Permission of a Captain of

the Port (COTP) to depart the security

zone with the intent of entering Cuban

territorial waters may be obtained from

the following U.S. Coast Guard units:

Marine Safety Office Miami, 51 S.W.

First Avenue, Miami, FL 33130, ph.

(305) 536–5693; Marine Safety Office

Tampa, 155 Columbia Drive, Tampa, FL

33603, ph. (813) 228–2195; Marine

Safety Office Jacksonville, 7802

Arlington Expy., Suite 400, Jacksonville,

FL 32211–7445; Station Miami Beach,

100 MacArthur Causeway, Miami

Beach, FL 33139, ph. (305) 535–4368;

Station Fort Lauderdale, 7000 N. Ocean

Dr., FL 33004, ph. (305) 927–1611;

Station Marathon, 1800 Overseas

Highway, Marathon, FL 33050, ph. (305)

743–1945; Station Islamorada, PO Box

547, 183 Palermo Dr., Islamorada, FL

33036, ph. (305) 292–8862; Station Key

West, Key West, FL 33040, ph. (305)

292–8862; Station Fort Myers Beach,

719 San Carlos Drive, Fort Myers Beach,

FL 33931, ph. (813) 463–5754.

Additional locations may be

established.

FOR FURTHER INFORMATION CONTACT:

Chief, Marine Safety Division, Seventh

Coast Guard District, 909 SE First

Avenue, Brickell Plaza Federal

Building, Miami, FL 33931, Phone (305)

536–5651.

SUPPLEMENTARY INFORMATION:

Background and Purpose

Regulatory History

On March 1, 1996, the President of

the United States signed Proclamation

No. 6867 declaring a national

emergency following the February 24

1996, shooting down of two Brothers to

the Rescue aircraft by Cuban armed

forces. The Proclamation, which

addressed the disturbances or

threatened disturbances of United States

international relations, the President

authorized the Secretary of

Transportation to regulate the anchorage

and movement of domestic and foreign

vessels. Order No. 96–3–7, signed by the

Secretary of Transportation delegated

this authority to the Commandant,

United States Coast Guard. This

authority has been further delegated to

the Commander, Seventh Coast Guard

District and appropriate Captains of the

Port. To secure the rights and

obligations of the United States and to

protect its citizens and residents from

the use of excessive force upon them by

foreign powers, the Coast Guard on

March 8, 1996 (61 FR 9348), pursuant to

its regulatory authority in 50 U.S.C. 191

and as supplemented by the authority

delegated to the Secretary of

Transportation in the Presidential

Proclamation, established a security

zone.

This security zone established on

March 1, 1996, restricted the operation

of vessels within the internal waters and

territorial seas of the United States,

adjacent to or within the coastal waters

around southern Florida. The security

zone prohibits private, noncommercial

vessels less than 50 meters in length

from departing the security zone with

the intent to enter Cuban territorial

waters, absent express authorization

from the Captain of the Port (COTP).

On May 14, 1997 (62 FR 26390) the

Coast Guard published a temporary rule

revising the security zone by additional

security measures that prohibit a similar

class of vessels from getting underway

in or departing the security zone with

the intent to enter Cuban territorial

waters without express authorization

from the COTP. Additionally, under the

revised security zone, commercial

vessels less than 50 meters in length

became subject to the same restrictions

as private, noncommercial vessels less

than 50 meters in length.

Discussion of Rule

This temporary rule further amends

the security zone by expanding its

geographic scope of the Florida

peninsula. During the Pope’s visit to

Cuba in January, 1998, several boaters

asserted that they had evaded the

requirements of the security zone by

departing for Cuba from a port north of

Fort Lauderdale, outside the geographic

limits of the prior security zone.

Expansion of the geographic limits of

the security zone around Florida will

cure this potential enforcement

problem, thereby enhancing boater

safety and better preventing a possible

disturbance of the foreign relations of

the United States.

The Coast Guard has determined that

control of the movement of non-public

vessels less than 50 meters in length in

the security zone, or departure of such

vessels from the security zone, with the

intent to enter Cuban territorial waters

(hereinafter ‘‘subject vessels’’), is

necessary to protect the safety of United

States citizens and residents and

prevent threatened disturbance of the

international relations of the United

States. These controls do not apply to

foreign flag vessels in innocent passage

in the territorial sea of the United States.

Maintaining such control of vessel

movement will necessitate some

temporary limitations on traditional

freedoms of navigation. Efforts will be

made to keep these limitations to a

minimum.