[Federal Register Volume 64, Number 42 (Thursday, March 4, 1999)]
[Rules and Regulations]
[Page 10389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5280]


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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 abbreviated new 
animal drug application (ANADA) filed by Merial, Ltd. The supplemental 
ANADA provides for use of a larger package size of oxytetracycline 
hydrochloride soluble powder in the drinking water of chickens, 
turkeys, swine, cattle, and sheep for the treatment and control of 
various bacterial diseases.

EFFECTIVE DATE: March 4, 1999.

FOR FURTHER INFORMATION CONTACT: Patricia D. Leinbach, Center for 
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6965.

SUPPLEMENTARY INFORMATION: Merial, Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, filed supplemental ANADA 200-144 that provides for use of a 
larger package size of oxytetracycline hydrochloride soluble powder in 
the drinking water of chickens, turkeys, swine, cattle, and sheep for 
the treatment and control of various bacterial diseases. The 
supplemental ANADA is approved as of December 16, 1998, and the 
regulations are amended in 21 CFR 520.1660d(a) and (b) to reflect the 
approval.
    Furthermore, the regulations had not been previously amended to 
reflect the sponsor change from Rhone Merieux Canada, Inc., to Merial, 
Ltd. The regulation in Sec. 520.1660d(b) is amended at this time to 
reflect the sponsor change.
    Approval of this supplemental ANADA does not require additional 
safety and effectiveness data. Therefore, a freedom of information 
summary for approval of this supplemental application is not required.
    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 adding paragraphs (a)(9) and 
(b)(7), and by revising paragraph (b)(2) to read as follows:


Sec. 520.1660d   Oxytetracycline hydrochloride soluble powder.

    (a) * * *
    (9) Each 2.73 grams of powder contains 1 gram of OTC HCl (packets: 
9.87 and 19.75 oz; pails: 5 lb).
    (b) * * *
    (2) No. 017144 for use of OTC HCl concentration in paragraph (a)(4) 
of this section in chickens, turkeys, and swine.
* * * * *
    (7) No. 050604 for use of OTC HCl concentration in paragraph (a)(9) 
of this section in chickens, turkeys, and swine.
* * * * *

    Dated: February 24, 1999.
 Woodrow M. Knight,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-5280 Filed 3-3-99; 8:45 am]
BILLING CODE 4160-01-F