Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 /Rules and Regulations 25163

FDC Date State City Airport FDC

Number SIAP

04/23/98 AR West

Memphis.

West Memphis Muni ........................................... FDC 8/

2427

NDB RWY 17, AMDT 10

04/23/98 IN North

Vernon.

North Vernon ...................................................... FDC 8/

2421

GPS RWY 23, ORIG

04/23/98 MD Salisbury Ocean City Wicomico Regional .......................... FDC 8/

2416

ILS RWY 32, AMDT 5A

04/23/98 NC Charlotte Charlotte/Douglas Intl ......................................... FDC 8/

2397

ILS RWY 36R (CAT I,II AND III), AMDT 8

04/23/98 NH Concord Concord Muni ..................................................... FDC 8/

2429

ILS RWY 35, AMDT 1

04/23/98 NJ Teterboro Teterboro ............................................................ FDC 8/

2399

ILS RWY 6, AMDT 28

04/23/98 NJ Teterboro Teterboro ............................................................ FDC 8/

2400

COPTER ILS RWY 6, ORIG

04/23/98 NJ Teterboro Teterboro ............................................................ FDC 8/

2401

NDB OR GPS RWY 6, AMDT 17A

04/23/98 NJ Teterboro Teterboro ............................................................ FDC 8/

2402

VOR/DME OR GPS–B, AMDT 2

04/23/98 VA Franklin Franklin Muni–John Beverly Rose ..................... FDC 8/

2442

VOR/DME OR GPS RWY 27, AMDT 9

04/23/98 WV Charleston.Yeager ................................................................ FDC 8/

2415

ILS RWY 5, AMDT 4

04/24/98 LA New Orleans.New Orleans Intl (Moisant Field) ........................ FDC 8/

2468

LOC RWY 19, ORIG

04/24/98 NH Lebanon Lebanon Muni ..................................................... FDC 8/

2463

ILS RWY 18 AMDT 4

04/27/98 NY New York John F. Kennedy Intl .......................................... FDC 8/

2536

ILS RWY 31L AMDT 9A

04/28/98 FL Jacksonville.Jacksonville Intl .................................................. FDC 8/

2567

ILS RWY 25 ORIG–A

04/28/98 TN Jackson McKellar-Sipes Regional .................................... FDC 8/

2568

LOC BC RWY 20 AMDT 5A

04/23/98 DH Whitefield.Mount Washington Regional .............................. FDC 8/

2430

LOC RWY 10, AMDT 4

[FR Doc. 98–12134 Filed 5–6–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 529

Certain Other Dosage Form New

Animal Drugs; Competitive Exclusion

Culture

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 BioScience

Division of Milk Specialties Co. The

NADA provides for use of a competitive

exclusion culture (lyophilized bacterial

cultures) for early establishment of

intestinal microflora in chickens to

reduce Salmonella colonization.

EFFECTIVE DATE: May 7, 1998.

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:

BioScience Division of Milk Specialties

Co., Illinois and Water Sts., P.O. Box

278, Dundee, IL 60118, is sponsor of

NADA 141–101 that provides for the use

of PreemptTM, a competitive exclusion

culture (lyophilized bacterial cultures),

for the early establishment of intestinal

microflora in chickens to reduce

Salmonella colonization. The NADA is

approved as of March 13, 1998, and the

regulations are amended by adding 21

CFR 529.469 to reflect the approval. The

basis of approval is discussed in the

freedom of information summary.

In addition, BioScience Division of

Milk Specialties Co. has not been

previously listed in the animal drug

regulations as sponsor of an approved

application. At this time, 21 CFR

510.600(c)(1) and (c)(2) are amended to

add entries for the firm.

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)(i) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(i)), this

approval for food-producing animals

qualifies for 5 years of marketing

exclusivity beginning March 13, 1998,

because no active ingredient (including

any salt or ester of the active ingredient)

has been approved in any other

application.

The agency has determined under 21

CFR 25.33(c) 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

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,
25164 Federal Register / Vol. 63, No. 88 /Thursday, May 7, 1998 /Rules and Regulations

Reporting and recordkeeping

requirements.

21 CFR Part 529

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 parts 510 and 529 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding an entry for

‘‘BioScience Division of Milk

Specialties Co.’’and in paragraph (c)(2)

by numerically adding an entry for

‘‘032761’’ to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

BioScience Division of Milk Specialties Co., Illinois and Water Sts., P.O. Box

278, Dundee, IL 60118 032761

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

032761 BioScience Division of Milk Specialties Co., Illinois and Water Sts., P.O. Box

278, Dundee, IL 60118.

* * * * * * *

PART 529—CERTAIN OTHER DOSAGE

FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 529 continues to read as follows:

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

2. Section 529.469 is added to read as

follows:

§ 529.469 Competitive exclusion culture.

(a) Specifications. Each packet of

lyophilized culture contains either

2,000 or 5,000 doses in frozen pellets to

be reconstituted for use.

(1) For 2,000-dose packet, add

contents of one 2,000-dose packet of

reconstitution powder to 490 milliliters

of deionized water. Mix. Add contents

of one 2,000-dose packet of lyophilized

culture. Mix thoroughly.

(2) For 5,000-dose packet, add

contents of one 5,000-dose packet of

reconstitution powder to 1,250

milliliters of deionized water. Mix. Add

contents of one 5,000-dose packet of

lyophilized culture. Mix thoroughly.

Allow to stand for 45 minutes before

use. Use within 5 hours of

reconstitution.

(b) Sponsor. See No. 032761 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use. Chickens—(1)

Amount. Apply 25 milliliters of

reconstituted culture as a topical spray

on each tray of 100 chicks (0.25

milliliter per chick).

(2) Indications for use. For early

establishment of intestinal microflora in

chickens to reduce Salmonella

colonization.

(3) Limitations. Administer as soon as

possible after hatch, preferably at less

than 1 day of age. Expose chicks to light

for at least 5 minutes after spray

treatment to encourage preening for oral

uptake of the organisms. Provide access

to feed and water as soon as possible

after treatment. Do not administer

antibiotics to treated chickens.

Dated: April 22, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–12056 Filed 5–6–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD01–08–015]

RIN 2115–AA97

Safety Zone; Greenwood Lake

Powerboat Classic, Greenwood Lake,

New Jersey

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone for

a powerboat race located on Greenwood

Lake, New Jersey. This safety zone is in

effect from 10 a.m. until 7 p.m. on

Saturday, May 16, and Sunday, May 17,

1998. This action is necessary to

provide for the safety of life on

navigable waters during the event. This

action is intended to restrict vessel

traffic in the southern end of

Greenwood Lake, New Jersey.

DATES: This temporary final rule is

effective from 10 a.m. until 7 p.m. on

Saturday, May 16, and Sunday, May 17,

1998.