[Federal Register Volume 63, Number 53 (Thursday, March 19, 1998)]
[Rules and Regulations]
[Page 13337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7057]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556


Tolerances for Residues of New Animal Drugs In Food; Carbadox

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 a supplemental new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides 
for a revised tolerance for residues of carbadox used in Type A 
medicated articles to make Type C medicated swine feeds.

EFFECTIVE DATE:  March 19, 1998.

FOR FURTHER INFORMATION CONTACT: Lynn G. Friedlander, Center for 
Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0675.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, is sponsor of NADA 41-061 that provides for the use of 
Mecadox 10 (carbadox) Type A medicated articles used to make 
Type C medicated swine feeds used for control of swine dysentery, 
control of bacterial swine enteritis, increased rate of weight gain, 
and improved feed efficiency. The sponsor filed a supplemental NADA 
that provides for a revised finite tolerance for residues of carbadox 
and its metabolites in edible swine tissues. The supplement is approved 
as of January 30, 1998, and the regulations are revised in Sec. 556.100 
(21 CFR 556.100) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    A tolerance for no residues of carbadox or its metabolites and the 
method to determine said residues in the edible swine tissues had been 
previously established. Because better and more accurate regulatory 
procedures are found in general use, the analytical procedure is no 
longer codified. At this time, the method of analysis is removed and a 
finite tolerance for residues of quinoxaline-2-carboxylic acid (marker 
residue) in liver (target tissue) is established by amending 
Sec. 556.100.
    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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), approval of this 
supplement qualifies for 3 years of marketing exclusivity beginning 
January 30, 1998, because the supplement contains substantial evidence 
of effectiveness of the drug involved, studies of animal safety or, in 
the case of food producing animals, human food safety studies (other 
than bioequivalence or residue studies) required for approval of the 
supplement and conducted or sponsored by the applicant. Exclusivity 
applies only to the new tolerance as established by human food safety 
studies (total residue depletion and metabolism) which are summarized 
in the freedom of information summary.
    The agency has determined under 21 CFR 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.

List of Subjects in 21 CFR Part 556

    Animal drugs, Foods.
    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 556 is 
amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    1. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

    2. Section 556.100 is revised to read as follows:

Sec. 556.100  Carbadox.

    A tolerance of 30 parts per billion is established for residues of 
quinoxaline-2-carboxylic acid (marker residue) in liver (target tissue) 
of swine.

    Dated: February 26, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-7057 Filed 3-18-98; 8:45 am]
BILLING CODE 4160-01-F