46668 Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Rules and Regulations

§ 1702.2 Procedural requirements and

recommendations.

(a) * * *

(1) Be mailed to the Office of the

Secretary, Consumer Product Safety

Commission, Washington, DC 20207, or

delivered to the Office of the Secretary,

Consumer Product Safety Commission,

4330 East West Highway, Bethesda, MD

20814.

* * * * *

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 97–23498 Filed 9–3–97; 8:45 am]

BILLING CODE 6355–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Tetracycline Hydrochloride Soluble

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

Med-Pharmex, Inc. The ANADA

provides for oral use of tetracycline

hydrochloride soluble powder in the

drinking water of swine and calves for

control and treatment of certain diseases

caused by pathogens susceptible to

tetracycline, and of chickens and

turkeys for control of certain diseases

caused by pathogens susceptible to

tetracycline.

EFFECTIVE DATE: September 4, 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: MedPharmex, Inc., 2727 Thompson Creek

Rd., Pomona, CA 91767–1861, filed

ANADA 200–234, which provides for

oral use of tetracycline hydrochloride

soluble powder in the drinking water of

calves, swine, chickens, and turkeys, as

follows: (1) For calves for control and

treatment of bacterial enteritis (scours)

caused by Escherichia coli, and bacterial

pneumonia (shipping fever complex)

associated with Pasteurella spp.,

Actinobacillus pleuropneumoniae

(Hemophilus spp.), and Klebsiella spp.

susceptible to tetracycline; (2) for swine

for control and treatment of bacterial

enteritis (scours) caused by E. coli, and

bacterial pneumonia associated with

Pasteurella spp., Actinobacillus

pleuropneumoniae (Hemophilus spp.),

and Klebsiella spp. susceptible to

tetracycline; (3) for chickens for control

of chronic respiratory disease (CRD or

air-sac disease) caused by Mycoplasma

gallisepticum and E. coli; infectious

synovitis caused by M. synoviae

susceptible to tetracycline; and (4) for

turkeys for control of infectious

synovitis caused by M. synoviae and

bluecomb (transmissible enteritis or

coronaviral enteritis) complicated by

bacterial organisms susceptible to

tetracycline.

Approval of Med-Pharmex’s ANADA

200–234 tetracycline hydrochloride

soluble powder is as a generic copy of

Fermenta’s NADA 65–496 tetracycline

hydrochloride soluble powder. ANADA

200–234 is approved as of July 22, 1997,

and the regulations are amended in 21

CFR 520.2345d(a)(1) 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 21 CFR 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 25.24(d)(1)(i) 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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 520.2345d [Amended]

2. Section 520.2345d Tetracycline

hydrochloride soluble powder is

amended in paragraph (a)(1) by

removing ‘‘047864, 000010, 057561, and

059130’’ and adding in its place

‘‘047864, 051259, 054273, 057561, and

059130’’.

Dated: August 22, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–23372 Filed 9–3–97; 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;

Clindamycin Hydrochloride Liquid

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 veterinary prescription use

in dogs of clindamycin hydrochloride

liquid for therapy of wounds, abscesses,

and dental infections, and therapy of

osteomyelitis.

EFFECTIVE DATE: September 4, 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 St.

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

64506–0457, filed ANADA 200–193 that

provides for veterinary prescription use

in dogs of clindamycin hydrochloride

liquid for therapy of wounds, abscesses,

and dental infections when

administered orally at 2.5 milligrams

per pound (mg/lb) every 12 hours, and

for therapy of osteomyelitis when

administered orally at 5.0 mg/lb every

12 hours.

Phoenix Scientific, Inc.’s, ANADA

200–193 clindamycin hydrochloride

liquid is approved as a generic copy of

Pharmacia & Upjohn’s NADA 135–940

Antirobe Aquadrops. The ANADA is

approved as of August 1, 1997, and the

regulations are amended in 21 CFR

520.447(b) to reflect the approval. The