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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Chlortetracycline, Procaine Penicillin, and Sulfamethazine

DATES: This rule is effective August 8, 2003.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approved status of a new animal drug application (NADA) held by Pennfield Oil Co. The NADA provides for the use of threeway, fixed combination Type A medicated articles containing chlortetracycline, procaine penicillin, and sulfamethazine to make threeway combination drug Type C medicated swine feeds used for growth promotion, increased feed efficiency, and the management of several bacterial diseases. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to remove certain obsolete or redundant sections of the new animal drug regulations. That proposed rule contains background information about those regulations and also for this action.

SUMMARY: Chlortetracycline, procaine penicillin, and sulfamethazine,

SUPPLEMENTAL INFORMATION

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, holds an approval for NADA 138934 for use of PENNCHLOR SP 250 and PENNCHLOR SP 500 (chlortetracycline, procaine penicillin, and sulfamethazine) threeway, fixed combination Type A medicated articles to make threeway combination drug Type C medicated swine feeds for use for growth promotion, increased feed efficiency, and the management of several bacterial diseases. This product is subject to the transitional approval provision of section 108(b)(2) of the Animal Drug Amendments of 1968 and is currently subject to interim marketing under Sec. 558.15(g)(1) (21 CFR 558.15(g)(1)). At this time, 21 CFR 558.145 is being amended to reflect this approved application.

We note the drug sponsors designated for this product in Sec. 558.15(g)(1), American Cyanamid Co. and Pfizer, Inc., are incorrect. Likewise, the provision states that the use levels and indications for use for this medicated article are listed in Sec. 558.15(g)(2), but this information was apparently never listed in Sec. 558.15(g)(2).

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. 801808.
List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.
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 558 is amended as follows:
PART 558NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.
Sec. 558.145 [Amended]
2. Section 558.145 Chlortetracycline, procaine penicillin, and sulfamethazine is amended in paragraph (a)(2) by adding ``and 053389'' after ``046573''.

Dated: August 1, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 0320245 Filed 8503; 4:09 pm]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Andrew J. Beaulieu, Center for Veterinary Medicine (HFV1), 7519 Standish Pl., Rockville, MD 20855, 3018272954, email: abeaulie@cvm.fda.gov.