[Federal Register Volume 65, Number 40 (Tuesday, February 29, 2000)]
[Rules and Regulations]
[Pages 10705-10706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Chlortetracycline 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 Pennfield Oil Co. The supplemental NADA 
provides for a revised withdrawal time for use of chlortetracycline 
(CTC) powder in swine drinking water.

DATES: This rule is effective February 29, 2000.

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, is sponsor of NADA 65-480 that provides for use of CTC 
hydrochloride soluble powder for making medicated drinking water for 
swine and cattle for treatment and control of bacterial enteritis and 
bacterial pneumonia. The firm filed a supplemental NADA that provides 
for a zero-day slaughter withdrawal period after use of the product for 
treatment

[[Page 10706]]

and control of disease in swine. The supplemental NADA is approved as 
of December 22, 1999, and 21 CFR 520.445b(d)(1)(i)(A)(2) is amended to 
reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of 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.
    FDA 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to congressional review requirements in 5 
U.S.C. 801-808.

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.


Sec. 520.445b  [Amended]

    2. Section 520.445b Chlortetracycline powder (chlortetracycline 
hydrochloride or chlortetracycline bisulfate) is amended in paragraph 
(d)(1)(i)(A)(2) by removing the phrase ``; do not slaughter animals for 
food within 5 days of treatment''.

    Dated: January 28, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-4731 Filed 2-28-00; 8:45 am]
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