[Federal Register Volume 62, Number 83 (Wednesday, April 30, 1997)]
[Rules and Regulations]
[Page 23356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11079]


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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 the Pennfield Oil Co. The ANADA provides 
for the use of a generic oxytetracycline hydrochloride soluble powder 
for the drinking water of cattle, swine, sheep, chickens, and turkeys.

EFFECTIVE DATE: April 30, 1997.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68137, filed ANADA 200-026, which provides for use of 102.4-
gram (g) oxytetracycline hydrochloride per 4.78-ounce (135.5-g) packet 
for making medicated drinking water for cattle, swine, sheep, chickens, 
and turkeys for control and treatment of bacterial infections caused by 
oxytetracycline susceptible organisms.
     ANADA 200-026 for Pennfield Oil Co.'s oxytetracycline 
hydrochloride water soluble powder is approved as a generic copy of 
Pfizer's NADA 8-622 Terramycin-343 (oxytetracycline hydrochloride) 
soluble powder. The ANADA is approved as of March 13, 1997, and the 
regulations are amended in 21 CFR 520.1660d by adding new paragraphs 
(a)(8) and (b)(6) 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 25.24(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).

    2. Section 520.1660d is amended by adding new paragraphs (a)(8) and 
(b)(6) to read as follows:


Sec. 520.1660d  Oxytetracycline hydrochloride soluble powder.

    (a) * * *
    (8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC 
HCl.
    (b) * * *
    (6) No. 053389 for use of OTC HCl concentrations in paragraph 
(a)(8) of this section in chickens, turkeys, swine, cattle, and sheep.
* * * * *

    Dated: April 2, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-11079 Filed 4-29-97; 8:45 am]
BILLING CODE 4160-01-F