[Federal Register Volume 66, Number 222 (Friday, November 16, 2001)]
[Notices]
[Pages 57720-57721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28680]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Oxytetracycline in Fish; Availability of Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of human food safety data that sponsors may use in support 
of a new animal drug application (NADA) or supplemental NADA for the 
treatment of walleye and northern pike with oxytetracycline in 
medicated feed for bacterial infections. The U.S. Geological Survey, 
Upper Midwest Environmental Sciences Center (UMESC), La Crosse, WI, 
compiled the data that is contained in Public Master File (PMF) 5646.

ADDRESSES: Submit NADAs or supplemental NADAs to the Document Control 
Unit (HFV-199), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT: Julia A. Oriani, Center for Veterinary 
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6976, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Oxytetracycline, used for the treatment of 
bacterial infections in walleye and northern pike, is a new animal drug 
under section 201(v) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 321(v)). As a new animal drug, oxytetracycline is 
subject to section 512 of the act (21 U.S.C. 360b), which requires that 
its use in walleye and northern pike for bacterial infections be the 
subject of an approved NADA or supplemental NADA. Walleye and northern 
pike are minor species under 21 CFR 514.1(d)(1)(ii).
    Researchers from UMESC have provided human food safety data for the 
use of oxytetracycline in walleye and northern pike. The researchers 
conducted oxytetracycline tissue residue depletion studies in northern 
pike and walleye. These studies were conducted in accordance with good 
laboratory practices.
    Juvenile northern pike were fed medicated feed containing 
oxytetracycline at either 70.9 milligrams per kilogram (mg/kg) body 
weight/day for 10 days or 94.2 mg/kg body weight/day for 10 days at a 
water temperature of 13.8  deg.C. Juvenile walleye were fed medicated 
feed containing oxytetracycline at 89.0 mg/kg body weight/day for 10 
days at a water temperature of 17.5  deg.C. The treated fish were 
sampled at various timepoints.
    The tissues were analyzed for oxytetracycline residues using a 
validated high performance liquid chromatography (HPLC) method entitled 
``Determination of Oxytetracycline in the Edible Tissue of Fish 
Fillets'' (UMESC, SOP No. CAP 413.1, 3/30/98). This HPLC method has 
been bridged to the regulatory microbiological assay for 
oxytetracycline in tissue entitled ``Antibiotic Residues in Milk, Dairy 
Products, and Animal Tissues: Methods, Reports, and Protocol'' (U.S. 
HHS/PHS/FDA, Washington, DC, revised October, 1968). The tissue 
residues were below the tolerance of 2 parts per million at all 
timepoints (21 CFR 556.500) as shown in table 1 and 2 of this document.

 Table 1.--Mean Oxytetracycline (OTC) Concentrations (Parts per Million
 (ppm)) in Skin-On Fillet From Walleye Fed 89.0 Milligrams per Kilogram
  per Day OTC for 10 Days at Water Temperature of 17.5  deg.C (n=20 for
                  all Timepoints Except on Day 2, n=18)
------------------------------------------------------------------------
         Withdrawal Time (Days)              Mean OTC Residues (ppm)
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1......................................  0.7210.244
2......................................  0.5490.148
3......................................  0.6670.217
4......................................  0.6890.233
7......................................  0.4490.170
9......................................  0.4440.184
11.....................................  0.3610.110
14.....................................  0.3010.093
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[[Page 57721]]


 Table 2.--Mean Oxytetracyline Levels (Parts Per Million) in Skinless Northern Pike Muscle Following Dosing for
  10 Days With Medicated Feed at 13.8  deg.C (n=40 for all Sampling Timepoints Except for Day 10 Samples, n=39)
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                                              Fish Fed Biodiet Grower (Trout
          Withdrawal Time (Days)               Feed) at 70.9 Milligrams Per     Fish Fed Walleye Grower (Walleye
                                               Kilogram Per Day (mg/kg/day)          Feed) at 94.2 mg/kg/day
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1........................................  0.2030.042.............  0.3140.091
2........................................  0.1980.056.............  0.3190.098
4........................................  0.1620.034.............  0.2670.068
6........................................  0.1220.039.............  0.2110.053
8........................................  0.0980.026.............  0.1470.049
10.......................................  0.0680.017.............  0.1250.034
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    Data and information on safety are contained in PMF 5646. When you 
submit NADAs or supplemental NADAs, you may, without further 
authorization, reference the PMF to support approval of an application 
filed under 21 CFR 514.1(d). You must include a reference to the PMF 
and other information needed for approval when you submit an NADA or 
supplemental NADA. The information needed for approval in addition to 
the reference to the PMF includes effectiveness data; target animal 
safety data; data concerning manufacturing methods, facilities, and 
controls; animal drug labeling; and information addressing potential 
environmental impacts. If you need more information concerning the PMF 
or requirements for approval of an NADA or supplemental NADA, contact 
Julia A. Oriani (address above).
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety data and 
information provided in this PMF to support approval of an application 
may, upon approval of such application, be seen in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852, between the hours of 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: November 6, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-28680 Filed 11-15-01; 8:45 am]
BILLING CODE 4160-01-S