[Federal Register Volume 64, Number 52 (Thursday, March 18, 1999)]
[Rules and Regulations]
[Pages 13340-13341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride 
Soluble Powder

AGENCY: Food and Drug Administration, HHS.

ACTION:  Final rule.

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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 oxytetracycline hydrochloride soluble powder 
in the drinking water of chickens, turkeys, cattle, swine, and sheep 
for the treatment and control of various bacterial diseases.

EFFECTIVE DATE: March 18, 1999.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0212.

SUPPLEMENTARY INFORMATION:  Phoenix Scientific, Inc., 3915 South 48th 
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
247 that provides for use of oxytetracycline hydrochloride soluble 
powder (343 grams of oxytetracycline hydrochloride per pound) in the 
drinking water of chickens, turkeys, cattle, swine, and sheep for the 
treatment and control of various bacterial diseases.
    Approval of Phoenix Scientific, Inc.'s ANADA 200-247 
oxytetracycline hydrochloride soluble powder-343 is as a generic copy 
of Pfizer, Inc.'s NADA 8-622 Terramycin-343 (oxytetracycline soluble 
powder). ANADA 200-247 is approved as of February 10, 1999, and the 
regulations are amended in Sec. 520.1660d (21 CFR 520.1660d) by 
revising paragraph (a)(7) to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    Also, Sec. 520.1660d is amended by removing paragraph (c) and 
redesignating paragraphs (d) and (e) as paragraphs (c) and (d).
    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

[[Page 13341]]

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.

    2. Section 520.1660d is amended by revising paragraph (a)(7), by 
removing paragraph (c), and by redesignating paragraphs (d) and (e) as 
paragraphs (c) and (d) to read as follows:


Sec. 520.1660d   Oxytetracycline hydrochloride soluble powder.

    (a) * * *
    (7) Each 18.1 grams of powder contains 1 gram of OTC HCl (pails: 2 
and 5 lb), each 272.2 grams (9.6 oz) of powder contains 204.8 grams of 
OTC HCl, each 907.2 grams (2 lb) of powder contains 686 grams of OTC 
HCl, each 2.26 kilograms (5 lb) of powder contains 1,715 grams of OTC 
HCl.
* * * * *

    Dated: February 26, 1999.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 99-6532 Filed 3-17-99; 8:45 am]
BILLING CODE 4160-01-F