[Federal Register Volume 63, Number 41 (Tuesday, March 3, 1998)]
[Rules and Regulations]
[Pages 10303-10304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5344]


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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, 
Bacitracin Methylene Disalicylate

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 an abbreviated new animal drug 
application (ANADA) filed by Hoffmann-La Roche, Inc. The ANADA provides 
for use of single ingredient Type A medicated articles containing 
chlortetracycline and bacitracin methylene disalicylate to make a Type 
C medicated swine feed.

EFFECTIVE DATE: March 3, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., 340 Kingsland St., 
Nutley, NJ 07110-1199, filed ANADA

[[Page 10304]]

200-242 that provides for using Aureomycin 50, 70, 80, 90, or 
100 Type A medicated articles containing chlortetracycline calcium 
complex (CTC) equivalent to 50, 70, 80, 90, or 100 grams per pound (g/
lb) chlortetracycline hydrochloride, and BMD (bacitracin 
methylene disalicylate) 25, 30, 40, 50, 60, or 75 equivalent to 25, 30, 
40, 50, 60, or 75 g/lb bacitracin activity, to make Type C medicated 
swine feed. The Type C medicated swine feed contains approximately 400 
g/ton (t) chlortetracycline, varying with body weight and feed 
consumption to provide 10 milligrams/lb CTC of body weight daily, and 
10 to 30 g/t bacitracin methylene disalicylate, to be fed for not more 
than 14 days. It is used in swine feeds for: (1) Treatment of bacterial 
enteritis caused by Escherichia coli and Salmonella choleraesuis; (2) 
bacterial pneumonia caused by Pasteurella multocida, susceptible to 
CTC; (3) increased rate of weight gain; and (4) improved feed 
efficiency.
    Hoffmann-La Roche, Inc.'s ANADA 200-242 is approved as a generic 
copy of Alpharma Inc.'s NADA 141-059. The ANADA is approved as of 
January 16, 1998, and the regulations are amended in 21 CFR 
558.76(d)(1)(iv) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, 21 CFR 558.128 is amended in paragraph (d)(3) by 
redesignating paragraph (d)(3)(xiv) as paragraph (d)(3)(iii) to place 
the combination with bacitracin methylene disalicylate in alphabetical 
order.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(2) 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.

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 558--NEW 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. 558.76   [Amended]

    2. Section 558.76 Bacitracin methylene disalicylate is amended in 
the table in paragraph (d)(1) in entry (iv), in the columns 
``Limitations'' and ``Sponsor'' by removing ``046573'' and adding in 
its place ``000004 and 046573''.


Sec. 558.128   [Amended]

    3. Section 558.128 Chlortetracycline is amended by redesignating 
paragraph (d)(3)(xiv) as paragraph (d)(3)(iii).

    Dated: February 6, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-5344 Filed 3-2-98; 8:45 am]
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