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Rule

New Animal Drugs; Limitations of Use

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the limitations to conditions of use for products approved under 22 new animal drug applications (NADAs) and 5 abbreviated new animal drug applications (ANADAs). In error, a label statement warning against the use of these products in calves to be processed for veal was not codified at the time supplemental NADAs or ANADAs were approved. FDA is also amending the animal drug regulations to reflect the approved preslaughter withdrawal periods and milk withholding period in cattle following use of penicillin G procaine aqueous suspension. This action is being taken to improve the accuracy of the animal drug regulations.

DATES:

This rule is effective April 4, 2005.

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FOR FURTHER INFORMATION CONTACT:

Jeffrey Punderson, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4109, e-mail: jpunders@cvm.fda.gov.

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SUPPLEMENTARY INFORMATION:

Over the past decade, FDA's Center for Veterinary Medicine (CVM) asked sponsors of certain products approved for use in cattle to place this warning on their labels: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” This was done to reduce the frequency of unsafe residues of animal drugs in veal. While many sponsors complied and filed applications to change their labels, CVM did not always codify this limitation to approved conditions of use when the supplemental application was approved. At this time, FDA is amending the animal drug regulations to reflect the limitations to conditions of use for the following products:

Application No.21 CFR SectionTrade Name
NADA 011-060520.1660cTERRAMYCIN Scour Tablets
NADA 012-350558.55AMPROVINE 25%; AMPROL 25%
NADA 012-350520.100cCORID 1.25% Crumbles
NADA 012-965522.2640aTYLAN Injection 50 mg; TYLAN Injection 200 mg
NADA 013-149520.100aCORID 9.6% Solution
NADA 030-434520.540aAZIUM Powder
NADA 030-435520.540bAZIUM Boluses 10 mg
NADA 031-715520.2220bALBON; AGRIBON Boluses-2.5, -5.0, and -15.0
NADA 033-127520.2200aPRINZONE, PYRADAN, and VETISULID Boluses
NADA 033-165520.100bCORID 20% Soluble Powder
NADA 033-373520.2200bPRINZONE, PYRADAN, and VETISULID Powder
NADA 033-318522.2200PRINZONE, PYRADAN, and VETISULID Injection
NADA 041-245522.2220AGRIBON Injection 40%; ALBON
NADA 065-010522.1696bAGRICILLIN Pen Aqueous; AQUA-CILLIN; Penicillin G Co-op
NADA 065-110522.1696bPRO-PEN G in Aqueous Suspension
NADA 065-140520.2345dTET-SOL 10 and TET-SOL 324
NADA 065-269520.2345dPOLYOTIC Soluble Powder
NADA 065-441520.2345dPOLYOTIC Soluble Powder Concentrate
NADA 065-493522.1696bPenicillin G Procaine Aqueous Suspension
NADA 065-496520.2345dTetracycline Soluble Powder
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NADA 093-107520.2220bALBON S.R.
NADA 138-955522.2640aTylosin Injection
NADA 141-002520.1660cOXY 500 and 1000 Calf Boluses
ANADA 200-038522.2220DI-METHOX Injection 40%; Sulfadimethoxine Injection 40%
ANADA 200-049520.2345dTETRA-BAC 324 Soluble Powder; Tetracycline Hydrochloride Soluble Powder-324.
ANADA 200-136520.2345dTetracycline HCL Powder; Tetracycline Hydrochloride Soluble Powder-324.
ANADA 200-177522.2220Sulfadimethoxine Injection 40%
ANADA 200-234520.2345dTETRASOL Soluble Powder

Accordingly, the agency is amending the regulations in 21 CFR 520.100a, 520.100b, 520.100c, 520.540a, 520.540b, 520.1660c, 520.2200a, 520.2200b, 520.2220b, 520.2345d, 522.1696b, 522.2200, 522.2220, 522.2640a, and 558.55.

In addition, FDA has found that the animal drug regulations do not reflect the approved preslaughter withdrawal period for cattle, sheep, and swine for PRO-PEN G in Aqueous Suspension sponsored by Phoenix Scientific, Inc., approved under NADA 065-110. FDA has also found that the animal drug regulations do not reflect the approved milk withholding period for Penicillin G Procaine Aqueous Suspension sponsored by G.C. Hanford Manufacturing Co. (NADA 065-493) and AGRICILLIN Pen Aqueous, AQUA-CILLIN, and Penicillin G Co-op sponsored by Norbrook Laboratories Ltd. (NADA 065-010). At this time, the regulations are being amended in 21 CFR 522.1696b to correct these errors.

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.

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List of Subjects

and 522

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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,

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. Section 520.100a is amended in paragraphs (d)(2)(i)(

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3. Section 520.100b is amended in paragraphs (d)(1)(ii) and (d)(2)(ii) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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4. Section 520.100c is amended in paragraphs (d)(1)(ii) and (d)(2)(ii) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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5. Section 520.540a is amended in paragraph (c)(4) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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6. Section 520.540b is amended in paragraph (a)(3)(vi) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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7. Section 520.1660c is amended in paragraph (d)(3) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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8. Section 520.2200a is amended in paragraph (e)(3) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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9. Section 520.2200b is amended in paragraph (e)(1)(iii) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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10. Section 520.2220b is amended in paragraph (d)(1)(iii) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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11. Section 520.2345d is amended in paragraph (d)(1)(iii) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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12. The authority citation for

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Start Printed Page 16935 Authority: 21 U.S.C. 360b.

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13. Section 522.1696b is amended by revising paragraph (d)(2)(iii) to read as follows:

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Penicillin G procaine aqueous suspension.
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(d) * * *

(2) * * *

(iii) Limitations. Not for use in horses intended for food. Milk that has been taken during treatment and for 48 hours after the last treatment must not be used for food.

(A) For Nos. 053501 and 061623: Do not exceed 7 days of treatment in nonlactating dairy and beef cattle, sheep, and swine, or 5 days in lactating cattle. Discontinue treatment for the following number of days before slaughter: Nonruminating cattle (calves)—7; all other cattle—4; sheep—8; and swine—6.

(B) For Nos. 010515, 055529, and 059130: Treatment should not exceed 4 consecutive days. Discontinue treatment for the following number of days before slaughter: Cattle—10; sheep—9; and swine—7. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

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14. Section 522.2200 is amended in paragraph (e)(3) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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15. Section 522.2220 is amended in paragraph (a)(3)(iii)(

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16. Section 522.2640a is amended in paragraph (e)(1)(iii) by adding “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” at the end of the paragraph.

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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17. The authority citation for

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Authority: 21 U.S.C. 360b, 371.

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18. Section 558.55 is amended in paragraphs (d)(1)(i)(

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Dated: March 25, 2005.

Daniel G. McChesney,

Director, Office of Surveillance and Compliance, Center for Veterinary Medicine.

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[FR Doc. 05-6518 Filed 4-1-05; 8:45 am]

BILLING CODE 4160-01-S