[Federal Register Volume 72, Number 219 (Wednesday, November 14, 2007)]
[Rules and Regulations]
[Pages 63986-63987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22261]


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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 Fort Dodge Animal Health, Division of Wyeth 
Holdings Corp. The supplemental NADA provides for label revisions for 
chlortetracycline soluble powder.

DATES: This rule is effective November 14, 2007.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl.,

[[Page 63987]]

Rockville, MD 20855, 301-827-7571, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth 
Holdings Corp., P.O. Box 1339, Fort Dodge, IA 50501, filed a supplement 
to NADA 65-440 for AUREOMYCIN (chlortetracycline) Soluble Powder 
Concentrate, approved for oral use in medicated drinking water of 
chickens, growing turkeys, swine, calves, beef cattle, and nonlactating 
dairy cattle for the control and/or treatment of various bacterial 
diseases. The supplemental NADA provides for label revisions. The 
supplemental application is approved as of October 18, 2007, and the 
regulations are amended in 21 CFR 520.445b to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under Sec.  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 the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Parts 520

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  520.445b, revise paragraph (b)(2) and add paragraph (d)(5) 
to read as follows:


Sec.  520.445b  Chlortetracycline powder.

* * * * *
    (b) * * *
    (2) No. 053501 for use as in paragraph (d)(5) of this section.
* * * * *
    (d) * * *
    (5) Use in a drench or drinking water as follows:
    (i) Chickens--(A) Amount. 200 to 400 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of infectious synovitis caused by 
M. synoviae susceptible to chlortetracycline.
    (2) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 14 consecutive 
days; do not use in laying chickens; do not administer to chickens 
within 24 hours of slaughter.
    (B) Amount. 400 to 800 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of chronic respiratory disease 
(CRD) and air-sac infections caused by M. gallisepticum and E. coli 
susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section.
    (C) Amount. One thousand mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of mortality due to fowl cholera 
caused by Pasteurella multocida susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(i)(A)(2) of this section.
    (ii) Growing Turkeys--(A) Amount. 400 mg/gal, for 7 to 14 days.
    (1) Indications for use. Control of infectious synovitis caused by 
Mycoplasma synoviae susceptible to chlortetracycline.
    (2) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 14 consecutive 
days; do not administer to growing turkeys within 24 hours of 
slaughter.
    (B) Amount. 25 mg/lb body weight daily, for 7 to 14 days.
    (1) Indications for use. Control of complicating bacterial 
organisms associated with bluecomb (transmissible enteritis, 
coronaviral enteritis) susceptible to chlortetracycline.
    (2) Limitations. As in paragraph (d)(5)(ii)(A)(2) of this section.
    (iii) Swine--(A) Amount. 10 mg/lb body weight daily, for 3 to 5 
days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by E. coli and Salmonella spp., and bacterial 
pneumonia associated with Pasteurella spp., A. pleuropneumoniae, and 
Klebsiella spp. susceptible to chlortetracycline.
    (C) Limitations. Prepare fresh solution daily; use as the sole 
source of chlortetracycline; do not use for more than 5 days; do not 
administer to swine within 24 hours of slaughter.
    (iv) Calves, beef cattle, and nonlactating dairy cattle--(A) 
Amount. 10 mg/lb body weight daily in divided doses, for 3 to 5 days.
    (B) Indications for use. Control and treatment of bacterial 
enteritis (scours) caused by Escherichia coli and Salmonella spp., and 
bacterial pneumonia associated with Pasteurella spp., Histophilus spp., 
and Klebsiella spp. susceptible to chlortetracycline.
    (C) Limitations. Prepare fresh solution daily; use as a drench; use 
as the sole source of chlortetracycline; do not use for more than 5 
days; do not administer to cattle within 24 hours of slaughter; do not 
use in lactating dairy cattle; do not administer this product with milk 
or milk replacers; administer 1 hour before or 2 hours after feeding 
milk or milk replacers; a withdrawal period has not been established in 
preruminating calves; do not use in calves to be processed for veal.

    Dated: November 2, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-22261 Filed 11-13-07; 8:45 am]
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