[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19934]


[[Page Unknown]]

[Federal Register: August 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 Agri Laboratories, Ltd. The ANADA provides 
for the use of a generic oxytetracycline hydrochloride (OTC HCl) 
soluble powder as an antibacterial in drinking water for chickens, 
turkeys, and swine.

EFFECTIVE DATE: August 15, 1994.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St. 
Joseph, MO 64503, is the sponsor of ANADA 200-066, which provides for 
the use of a generic OTC HCl soluble powder as an antibacterial in 
drinking water for chickens, turkeys, and swine with the following 
conditions:
    1. In chickens: control of infectious synovitis caused by 
Mycoplasma synoviae, control of chronic respiratory disease and air sac 
infections caused by M. gallisepticum and Escherichia coli, and control 
of fowl cholera caused by Pasteurella multocida;
    2. In turkeys: control of hexamitiasis caused by Hexamita 
meleagridis, control of infectious synovitis caused by M. synoviae, 
control of complicating bacterial organisms associated with bluecomb 
(transmissible enteritis, coronaviral enteritis) in growing turkeys; 
and
    3. In swine: control and treatment of bacterial enteritis caused by 
E. coli and Salmonella choleraesuis and bacterial pneumonia caused by 
P. multocida. In breeding swine: control and treatment of leptospirosis 
(reducing the incidence of abortions and shedding of leptospira) caused 
by Leptospira pomona.
    ANADA 200-066 for Agri Laboratories, Ltd.'s Agrimycin-343 Soluble 
Powder is a generic copy of I.D. Russell Co. Laboratories' NADA 130-435 
for Oxytet Soluble. The ANADA is approved as of July 15, 1994, and the 
regulations are amended in 21 CFR 520.1660d 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 part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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)(6) and 
(b)(4), and by revising the last sentence in paragraphs 
(e)(1)(ii)(A)(3), (e)(1)(ii)(B)(3), (e)(1)(ii)(C)(3), and 
(e)(1)(iii)(C) to read as follows:


Sec. 520.1660d   Oxytetracycline hydrochloride soluble powder.

    (a) *  *  *
    (6) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 
4.78 oz.).
    (b) *  *  *
    (4) No. 057561 for use of OTC HCl concentration in paragraph (a)(6) 
of this section in chickens, turkeys, and swine.
* * * * *
    (e) *  *  *
    (1) *  *  *
    (ii) *  *  *
    (A) *  *  *
    (3) * * * Withdraw 5 days prior to slaughter those products 
sponsored by Nos. 000069, 017144, and 057561 in Sec. 510.600(c) of this 
chapter.
    (B) *  *  *
    (3) * * * Withdraw 5 days prior to slaughter those products 
sponsored by Nos. 000069, 017144, and 057561 in Sec. 510.600(c) of this 
chapter.
    (C) *  *  *
    (3) * * * Withdraw 5 days prior to slaughter those products 
sponsored by Nos. 000069, 017144, and 057561 in Sec. 510.600(c) of this 
chapter.
    (iii) *  *  *
    (C) * * * Administer up to 5 days; do not use for more than 5 
consecutive days; withdraw 13 days prior to slaughter those products 
sponsored by Nos. 017144 and 057561.
* * * * *

    Dated: August 8, 1994.
Richard H. Teske,
Deputy Director, Premarket Review, Center for Veterinary Medicine.
[FR Doc. 94-19934 Filed 8-12-94; 8:45 am]
BILLING CODE 4160-01-F