60656 Federal Register / Vol. 62, No. 218 / Wednesday, November 12, 1997 / Rules and Regulations

NOT APPLY. THIS IS VOR/DME OR

TACAN RWY 26, AMDT 10A.

[FR Doc. 97–29726 Filed 11–10–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Chlortetracycline Powder

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 an abbreviated new animal

drug application (ANADA) filed by

Phoenix Scientific, Inc. The ANADA

provides for oral use of chlortetracycline

hydrochloride soluble powder in the

drinking water of swine for control and

treatment of certain diseases caused by

pathogens susceptible to

chlortetracycline and chickens and

turkeys for control of certain diseases

caused by pathogens susceptible to

chlortetracycline.

EFFECTIVE DATE: November 12, 1997.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center For Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Phoenix

Scientific, Inc., 3915 South 48th Street

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–236 that

provides for oral use of chlortetracycline

hydrochloride soluble powder in animal

drinking water as follows: (1) Swine:

Control and treatment of bacterial

enteritis (scours) caused by Escherichia

coli and Salmonella spp., and bacterial

pneumonia associated with Pasteurella

spp., Actinobacillus pleuropneumoniae

(Haemophilus spp.) and Klebsiella spp.;

(2) Chickens: Control of infectious

synovitis caused by Mycoplasma

synoviae, and chronic respiratory

disease (CRD) and air-sac infections

caused by M. gallisepticum and E. coli;

and (3) Turkeys: Control of infectious

synovitis caused by M. synoviae and

complicating bacterial organisms

associated with bluecomb (transmissible

enteritis, coronaviral enteritis).

Approval of Phoenix Scientific Inc.’s

ANADA 200–236 chlortetracycline

hydrochloride soluble powder is as a

generic copy of ADM Animal Health &

Nutrition Div.’s NADA 65–256

ChlortetTM-Soluble-O chlortetracycline

hydrochloride soluble powder. ANADA

200–236 is approved as of September

24, 1997, and the regulations are

amended in 21 CFR 520.445b(b) 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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, 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.

§ 520.445b [Amended]

2. Section 520.445b Chlortetracycline

powder (chlortetracycline hydrochloride

or chlortetracycline bisulfite) is

amended in paragraph (b) by removing

‘‘No. 017519’’ and adding in its place

‘‘Nos. 017519 and 059130.’’

Dated: October 22, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–29650 Filed 11-10-97; 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;

Neomycin Sulfate Oral Solution

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 abbreviated

new animal drug application (ANADA)

filed by Pharmacia & Upjohn Co. The

supplemental ANADA provides for a

shorter withdrawal period following use

of neomycin sulfate oral solution in the

drinking water or in milk for cattle

(excluding veal calves), swine, sheep,

and goats for the treatment and control

of colibacillosis.

EFFECTIVE DATE: November 12, 1997.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Pharmacia

& Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

supplemental ANADA 200–113 that

provides for a shorter withdrawal period

following use of neomycin sulfate oral

solution in the drinking water or in milk

for cattle (excluding veal calves), swine,

sheep, and goats for the treatment and

control of colibacillosis (bacterial

enteritis) caused by Escherichia coli

susceptible to neomycin sulfate.

Approval of supplemental ANADA

200–113 is as a generic copy of the

sponsor’s approved supplemental

NADA 11–315. The supplemental

ANADA is approved as of February 7,

1997, and the regulations are amended

in § 520.1485(d)(3) (21 CFR

520.1485(d)(3)) to reflect the approval.

The previously approved supplement

to NADA 11–315 included data to

support revised tolerances for residues

of neomycin in the edible tissues of

cattle, swine, sheep, and goats. Based on

evaluation of the data as provided in the

‘‘General Principles for Evaluating the

Safety of Compounds Used in FoodProducing Animals Guidelines,’’

tolerances of 1.2 parts per million (ppm)

in muscle, 3.6 ppm in liver, and 7.2

ppm in kidney and fat, and withdrawal

times of 1 day for cattle, 2 days for

sheep, and 3 days for swine and goats

were established. The revised

withdrawal times were established in 21