[Federal Register Volume 68, Number 153 (Friday, August 8, 2003)]
[Rules and Regulations]
[Page 47237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20245]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


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

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 the approved status of a new animal drug 
application (NADA) held by Pennfield Oil Co. The NADA provides for the 
use of three-way, fixed combination Type A medicated articles 
containing chlortetracycline, procaine penicillin, and sulfamethazine 
to make three-way 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.

DATES: This rule is effective August 8, 2003.

FOR FURTHER INFORMATION CONTACT: Andrew J. Beaulieu, Center for 
Veterinary Medicine (HFV-1), 7519 Standish Pl., Rockville, MD 20855, 
301-827-2954, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., 
Omaha, NE 68144, holds an approval for NADA 138-934 for use of 
PENNCHLOR SP 250 and PENNCHLOR SP 500 (chlortetracycline, procaine 
penicillin, and sulfamethazine) three-way, fixed combination Type A 
medicated articles to make three-way 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. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

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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, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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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]

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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. 03-20245 Filed 8-5-03; 4:09 pm]
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