[Federal Register Volume 64, Number 54 (Monday, March 22, 1999)]
[Rules and Regulations]
[Pages 13678-13679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6807]


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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 two supplemental abbreviated 
new animal drug applications (ANADA's) filed by PennField Oil Co. The 
ANADA's provide for a zero-day withdrawal period for use of 
oxytetracycline hydrochloride (OTC HCl) soluble powder in the drinking 
water of turkeys and for an additional package size.

EFFECTIVE DATE:  March 22, 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: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, filed two supplements to ANADA 200-026. One supplement 
provides for a zero-day withdrawal period for turkeys using PennField 
Oil Co.'s Oxytetracycline HCl-343 (oxytetracycline hydrochloride) 
treated drinking water. The other supplement provides for use of a 
package containing 512 grams of OTC HCl per 23.9 ounces of soluble 
powder for making medicated drinking water for cattle, swine, sheep, 
chickens, and turkeys. The medicated drinking water is used for the 
control and treatment of bacterial infections caused by oxytetracycline 
susceptible organisms.
     The supplemental ANADA's are approved as of February 5, 1999, and 
21 CFR 520.1660d(a)(8) and (d)(1)(ii) are amended 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, 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 in paragraphs (a)(8), 
(d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) by adding a 
sentence to the end of each paragraph to read as follows:


Sec. 520.1660d  Oxytetracycline hydrochloride soluble powder.

     (a) * * *
     (8) * * * Each 677.5-gram packet (23.9 ounce) contains 512 grams 
of OTC HCl.
* * * * *
     (d) * * *
     (1) * * *
     (ii) * * *
     (A) * * *
     (3) * * * Zero-day withdrawal for those products sponsored by No. 
053389.

[[Page 13679]]

     (B) * * *
     (3) * * * Zero-day withdrawal for those products sponsored by No. 
053389.
     (C) * * *
     (3) * * * Zero-day withdrawal for those products sponsored by No. 
053389.
* * * * *

    Dated: February 26, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-6807 Filed 3-19-99; 8:45 am]
BILLING CODE 4160-01-F