E7-22261. Oral Dosage Form New Animal Drugs; Chlortetracycline Powder

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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

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 § 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

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

§ 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.