Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations 41589

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 and Fenbendazole

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 new animal drug

application (NADA) filed by Alpharma,

Inc. The NADA provides for use of

approved bacitracin methylene

disalicylate and fenbendazole Type A

medicated articles to make combination

Type B and C medicated feeds for

growing and finishing swine and

pregnant sows for the removal of

various internal parasites, for increased

rate of weight gain and improved feed

efficiency, for control of swine

dysentery associated with Treponema

hyodysenteriae, and for control of

clostridial enteritis in suckling pigs

caused by Clostridium perfringens.

Technical corrections are also being

made.

DATES: This rule is effective July 6,

2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION: Alpharma,

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

Fort Lee, NJ 07024, filed NADA 141–144

that provides for use of BMD (10, 25,

30, 40, 50, 60, or 75 grams per pound

(g/lb) bacitracin methylene disalicylate)

and SafeGuard (18.1, 36.2, or 90.7 g/lb

fenbendazole) Type A medicated

articles to make combination Type B

and C medicated feeds for growing and

finishing swine and pregnant sows.

For growing and finishing swine, the

Type A medicated articles are used to

make combination Type B medicated

feeds that contain 300 to 1,780 grams

per ton (g/ton) of bacitracin methylene

disalicylate and 300 to 17,740 g/ton of

fenbendazole and combination Type C

medicated feeds that contain 10 to 30 g/

ton of bacitracin methylene disalicylate

and 10 to 300 g/ton of fenbendazole.

The combination Type C medicated

feeds are used for increased rate of

weight gain and improved feed

efficiency; and for the removal of adultstage lungworms (Metastrongylus apri

andM. pudendotectus); adult and larvae

(L3, 4 stages—liver, lung, and intestinal

forms) large roundworms (Ascaris

suum); adult-stage nodular worms

(Oesophagostomum dentatum, O.

quadrispinulatum); small stomach

worms (Hyostrongylus rubidus); adult

and larvae (L2, 3, 4 stages—intestinal

mucosal forms) whipworms (Trichuris

suis); and adult and larvae

kidneyworms (Stephanurus dentatus).

For growing and finishing swine and

for pregnant sows, the Type A

medicated articles are used to make

Type B medicated feeds that contain

7,460 to 14,837 g/ton of bacitracin

methylene disalicylate and 300 to

17,740 g/ton of fenbendazole and Type

C medicated feeds that contain 250 g/

ton of bacitracin methylene disalicylate

and 10 to 300 g/ton of fenbendazole.

The combination Type C medicated

growing and finishing swine feeds are

used for the control of swine dysentery

associated with T. hyodysenteriae in

growing and finishing swine on

premises with a history of swine

dysentery but where signs of disease

have not yet occurred, or following an

approved treatment of the disease; and

for the removal of adult-stage

lungworms (M. apri andM.

pudendotectus); adult and larvae (L3, 4

stages—liver, lung, and intestinal forms)

large roundworms (A. suum); adultstage nodular worms (O. dentatum,O.

quadrispinulatum); small stomach

worms (H. rubidus); adult and larvae

(L2, 3, 4 stages—intestinal mucosal

forms) whipworms (T. suis); and adult

and larvae kidneyworms (S. dentatus).

The combination Type C medicated

sow feeds are used for the control of

clostridial enteritis in suckling pigs

caused by C. perfringens; and for the

removal of adult stage lungworms (M.

apri and M. pudendotectus); adult and

larvae (L3, 4 stages—liver, lung, and

intestinal forms) large roundworms (A.

suum); adult-stage nodular worms (O.

dentatum, O. quadrispinulatum); small

stomach worms (H. rubidus); adult and

larvae (L2, 3, 4 stages—intestinal

mucosal forms) whipworms (T. suis);

and adult and larvae kidneyworms (S.

dentatus).

The NADA is approved as of April 7,

2000, and 21 CFR 558.76 and § 558.258

(21 CFR 558.258) are amended to add

new entries to reflect the approval. The

basis for approval is discussed in the

freedom of information summary.

Also, § 558.258 is amended to

redesignate paragraph (c) as paragraph

(d) and add paragraph (c) to reflect a

newer format.

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)(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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

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)(xxii) to read as

follows:

§ 558.76 Bacitracin methylene disalicylate.

* * * * *

(d) * * *

(3) * * *

(xxii) Fenbendazole as in § 558.258.

3. Section 558.258 is amended by

redesignating paragraph (c) as paragraph

(d) and reserving paragraph (c), and by

adding paragraphs (d)(1)(vi) and

(d)(1)(vii) to read as follows:

§ 558.258 Fenbendazole.

* * * * *

(c) [Reserved]

(d) * * *

(1) * * *

(vi) Amount. Fenbendazole, 10 to 300

grams per ton (to provide 9 milligrams

per kilogram body weight), and

bacitracin methylene disalicylate, 10 to

30 grams per ton.

(A) Indications for use. As an

anthelmintic (as provided in paragraph

41590 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

(d)(1)(i)(A) of this section) and for

increased rate of weight gain and

improved feed efficiency in growing/

finishing swine.

(B) Limitations. Feed as sole ration.

Under conditions of continued exposure

to parasites, retreatment may be needed

after 4 to 6 weeks. Consult your

veterinarian for assistance in the

diagnosis, treatment, and control of

parasitism. Bacitracin methylene

disalicylate as provided by 046573 in

§ 510.600(c) of this chapter.

(vii) Amount. Fenbendazole, 10 to 300

grams per ton, and bacitracin methylene

disalicylate, 250 grams per ton.

(A) Indications for use—(1) Growing/

finishing swine. As an anthelmintic (as

provided in paragraph (d)(1)(i)(A) of this

section) and for control of swine

dysentery associated withTreponema

hyodysenteriae on premises with a

history of swine dysentery, but where

signs of disease have not yet occurred;

or following an approved treatment of

the disease condition.

(2) Pregnant sows. As an anthelmintic

(as provided in paragraph (d)(1)(i)(A) of

this section) and for control of

clostridial enteritis in suckling pigs

caused by Clostridium perfringens.

(B) Limitations—(1)Growing/finishing

swine. Feed as sole ration. Not for use

in growing and finishing swine that

weigh more than 250 pounds. Diagnosis

of swine dysentery should be confirmed

by a veterinarian when results are not

satisfactory. Under conditions of

continued exposure to parasites,

retreatment may be needed after 4 to 6

weeks. Consult your veterinarian for

assistance in the diagnosis, treatment,

and control of parasitism. Bacitracin

methylene disalicylate as provided by

046573 in § 510.600(c) of this chapter.

(2) Pregnant sows. Feed as sole ration.

Diagnosis of clostridial enteritis should

be confirmed by a veterinarian when

results are not satisfactory. Under

conditions of continued exposure to

parasites, retreatment may be needed

after 4 to 6 weeks. Consult your

veterinarian for assistance in the

diagnosis, treatment, and control of

parasitism. Bacitracin methylene

disalicylate as provided by 046573 in

§ 510.600(c) of this chapter.

* * * * *

Dated: June 19, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–17020 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD13–00–022]

RIN 2115–AA97

Safety Zone Regulations, Seafair Blue

Angels Performance, Lake

Washington, WA

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone on

the waters of Lake Washington, Seattle,

Washington. The Coast Guard is taking

this action to safeguard the participants

and spectators from the safety hazards

associated with Seafair Blue Angels

Performance. Entry into this zone is

prohibited unless authorized by the

Captain of the Port, Puget Sound or his

designated representatives.

DATES: This is effective from 8:30 a.m.

Pacific Daylight Time on August 3

through 3 p.m. on August 6, 2000.

ADDRESSES: Documents as indicated in

this preamble are available for

inspection or copying at the U.S. Coast

Guard Marine Safety Office Puget

Sound, 1519 Alaskan Way South,

Building 1, Seattle, Washington 98134.

Normal office hours are between 7 a.m.

and 5 p.m., Monday through Friday,

except federal holidays.

FOR FURTHER INFORMATION CONTACT: LT

Paul Stocklin, c/o Captain of the Port

Puget Sound, 1519 Alaskan Way South,

Seattle, Washington 98134, (206) 217–

6232.

SUPPLEMENTARY INFORMATION:

Background and Purpose

Pursuant to 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 less

than 30 days from date of publication in

the Federal Register. Due to complex

planning and coordination

requirements, the Coast Guard was not

able to obtain details of the event thirty

days prior to its occurrence. Because of

this, following normal rulemaking

procedures would be impracticable and

contrary to the public interest. Prompt

regulatory action is needed in order to

provide for the safety of spectators and

participants during the event. If normal

notice and comment procedures were

followed, this rule would not become

effective until after the date of the event.

For this reason, following normal

rulemaking procedures in this case

would be impracticable and contrary to

the public interest.

Discussion of Proposed Rule

The Coast Guard is adopting a

temporary safety zone regulation on the

waters of Lake Washington, Seattle,

Washington, for the Seafair Blue Angels

Performance. The Coast Guard has

determined it is necessary to close the

area in the vicinity of the air show in

order to minimize the dangers that lowflying aircraft present to persons and

vessels. These dangers include, but are

not limited to excessive noise and the

risk of falling objects from any accidents

associated with low flying aircraft. In

the event that aircraft require emergency

assistance, rescuers must have

immediate and unencumbered access to

the craft. The Coast Guard, through this

action, intends to promote the safety of

personnel, vessels, and facilities in the

area. Entry into this zone will be

prohibited unless authorized by the

Captain of the Port. This safety zone

will be enforced by Coast Guard

personnel. The Captain of the Port may

be assisted by other federal, state, or

local agencies.

Regulatory Evaluation

This proposed 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. The Office

of Management and Budget has not

reviewed it 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). We expect the

economic impact of this proposed rule

to be so minimal that a full Regulatory

Evaluation under paragraph 10(e) of the

regulatory policies and procedures of

DOT is unnecessary. This expectation is

based on the fact that the regulated area

established by the proposed regulation

would encompass an area near the

middle of Lake Washington, not

frequented by commercial navigation.

The regulation is established for the

benefit and safety of the recreational

boating public, and any recreational

boating impact is offset by the benefits

of allowing the Blue Angels to fly. For

the above reasons, the Coast Guard does

not anticipate any significant economic

impact.

Small Entities

Under the Regulatory Flexibility Act

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

considered whether this rule would

have a significant economic impact on

a substantial number of small entities.