[Federal Register Volume 62, Number 147 (Thursday, July 31, 1997)]
[Rules and Regulations]
[Pages 40932-40933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20081]


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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; Apramycin

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 two supplemental new animal 
drug applications (NADA's) filed by Elanco Animal Health, A Division of 
Eli Lilly & Co. The supplemental NADA's provide for revised tolerances 
for total residues of apramycin (i.e., the safe concentration) in 
edible swine tissues.

EFFECTIVE DATE: July 31, 1997.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, is sponsor 
of supplemental NADA 106-964 that provides for the use of 
Apralan (apramycin sulfate) soluble powder in swine drinking 
water and supplemental NADA 126-050 that provides for the use of 
Apralan (apramycin sulfate) Type A medicated article in swine 
feed, both for control of porcine colibacillosis (weanling pig scours) 
caused by strains of Escherichia coli sensitive to apramycin. These 
supplemental NADA's provide for a change in the tolerance for total 
residues of apramycin (i.e., the safe concentration) in edible swine 
tissues as provided in Sec. 556.52 (21 CFR 556.52). Review of these 
supplements involved a review of new toxicology studies and information 
in the original approvals.
    In evaluating these supplements, FDA's Center for Veterinary 
Medicine also considered that the proof of human food safety for 
antimicrobial animal drug residues includes a determination of their 
antimicrobial activity for all antimicrobial new animal drug products. 
In the absence of studies to determine the microbiological safety of 
antimicrobial drug residues, the acceptable daily intake (ADI) for 
apramycin is limited to 25 micrograms per kilogram (g/kg) of 
body weight per day (for appropriate studies see ``Guidance: Microbial 
Testing of Antimicrobial Drug Residues in Food,'' January, 1996). As 
indicated in the freedom of information summaries, the safe 
concentration for total apramycin residues is established at 5 parts 
per million (ppm) for muscle, 15 ppm for liver, and 30 ppm for fat and 
kidney. These revised safe concentrations warrant removal of the 
existing tolerances for total residues in Sec. 556.52, because those 
tolerances are now incorrect. Because this approval does not result in 
a different tolerance than that currently codified for marker residue 
in swine kidney, and because the sponsor did not petition FDA to change 
the tolerance, the tolerance of 0.1 ppm in swine kidney remains 
codified. FDA is also codifying the ADI for apramycin of 25 g/
kg of body weight per day. The supplement is

[[Page 40933]]

approved as of June 24, 1997, and the regulations in Sec. 556.52 are 
revised to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
    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 these 
applications 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 25.24(d)(1)(i) 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: Secs. 402, 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342, 360b, 371).

    2. Section 556.52 is revised to read as follows:

Sec. 556.52  Apramycin.

    A tolerance of 0.1 part per million is established for parent 
apramycin (marker residue) in kidney (target tissue) of swine. The 
acceptable daily intake (ADI) for total residues of apramycin is 25 
micrograms per kilogram of body weight per day.

    Dated: July 21, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-20081 Filed 7-30-97; 8:45 am]
BILLING CODE 4160-01-F