[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44383-44384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22266]


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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 a supplemental new animal drug 
application (NADA) filed by Pfizer Inc. The supplemental NADA provides 
for added package sizes of oxytetracycline hydrochloride (OTC HCI) 
soluble powder to be used in the drinking water of poultry for control 
of specific diseases, in the drinking water of cattle, swine, and sheep 
for control and treatment of specific diseases, and for control of 
specific diseases of bees.

EFFECTIVE DATE: August 19, 1998.

FOR FURTHER INFORMATION CONTACT: William G. Marnane, Center for 
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0678.

SUPPLEMENTARY INFORMATION: Pfizer Inc., 235 East 42d St., New York, NY 
10017, filed supplemental NADA 8-622 that provides for use of 2.25 
pound jars and 4.5 pound pails of Terramycin-343 
(oxytetracycline hydrochloride) soluble powder for making drinking 
water for poultry for control of specific OTC-susceptible diseases, 
drinking water for cattle, swine, and sheep for control and treatment 
of specific OTC-susceptible diseases, and for control of specific OTC-
susceptible diseases of bees. The supplemental NADA is approved as of 
June 19, 1998, and 21 CFR 520.1660d(a)(3) is amended to reflect the 
approval.
    Approval of this supplemental NADA does not require additional 
safety or effectiveness data. A freedom of information summary as 
provided under 21 CFR part 20 and 514.11(e)(2)(ii) is not required.
    The agency has determined under 21 CFR 25.33(a)(4) 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)(3) to 
read as follows:

[[Page 44384]]

Sec. 520.1660d   Oxytetracycline hydrochloride soluble powder.

    (a) * * *
    (3) Each 1.32 grams of powder contains 1 gram of OTC HCl (packets: 
2.39, 4.78, and 9.55 oz.; jars: 2.25 lbs.; and pails: 4.5 lbs.).
* * * * *

    Dated: July 29, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-22266 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F