[Federal Register Volume 65, Number 88 (Friday, May 5, 2000)]
[Notices]
[Pages 26216-26217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Oxytetracycline in Shrimp; 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 may be used in support of a 
new animal drug application (NADA) or supplemental NADA for the 
treatment of shrimp with oxytetracycline via medicated feed for 
bacterial infections. The data, contained in Public Master File (PMF) 
5662, were compiled by FDA, Center for Veterinary Medicine (CVM), 
Office of Research (OR).

ADDRESSES: Submit NADA's or supplemental NADA's to the Document Control 
Unit (HFV-199), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855. Copies of the 
analytical methods used to analyze the feed and tissue samples used in 
this study are available from the Center for Veterinary Medicine, 
Office of Research, 8401 Muirkirk Rd., Laurel, MD 20708.

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.

SUPPLEMENTARY INFORMATION: Oxytetracycline used for the treatment of 
bacterial infections in shrimp 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), requiring that its use in shrimp be 
the subject of an approved NADA or supplemental NADA. Shrimp are a 
minor species under 21 CFR 514.1(d)(1)(ii).

[[Page 26217]]

    The OR and a researcher from the University of Arizona have 
provided human food safety data for the use of oxytetracycline in 
shrimp. The OR provided analytical support to complete a tissue residue 
depletion study conducted by the researcher from the University of 
Arizona for oxytetracycline in shrimp. The University of Arizona 
researcher directed the in-life portion of the study. Juvenile Pacific 
shrimp, Penaeus vannamei, were fed 3.4 grams oxytetracycline/kilogram 
feed for 14 days and then sampled at 0, 12, 24, 36, 48, 72, and 96 
hours after treatment.
    Feed and tissue samples were sent to the OR laboratory for 
analysis. The OR analyzed the feed samples by the regulatory high 
performance liquid chromatography (HPLC) method entitled 
``Determination of Oxytetracycline in Milk Replacer (FDA/CVM, Revision 
1.2, April 1, 1998).'' The tissue samples were analyzed by a 1997 
version of the regulatory HPLC method for determining oxytetracycline 
residues in shrimp. While validating the method prior to analyzing the 
test samples, the OR found that the 1997 method should be revised to 
emphasize complete collection of the aqueous phase during extraction. 
The revised regulatory method for analysis of oxytetracycline in shrimp 
is entitled ``Method for the Determination of Oxytetracycline Residues 
in Uncooked Shrimp Using High Performance Liquid Chromatography,'' by 
Steven W. Hadley, Susan K. Braun, and Marleen M. Wekell, FDA, Office of 
Regulatory Affairs, Division of Field Science, Seafood Products 
Research Center, December 23, 1999.
    At 0 hours withdrawal, oxytetracycline tissue levels ranged from 
3.2 to 5.6 parts per million (ppm); at 12 hours, 1.5 to 4.1 ppm; at 24 
hours, 1.5 to 2.1 ppm; at 36 hours, 1.2 to 2.0 ppm; at 48 hours, 0.31 
to 0.64 ppm; and at 72 hours, 0.25 ppm. The 96-hour samples were not 
analyzed because residues were below the lowest point on the standard 
curve by 72 hours withdrawal.
    Data and information on human food safety are contained in PMF 
5662. Sponsors of NADA's or supplemental NADA's may, without further 
authorization, reference the PMF to support approval of an application 
filed under 21 CFR 514.1(d). An NADA or supplemental NADA must include, 
in addition to reference to the PMF: Effectiveness data, target animal 
safety data, animal drug labeling, and other information needed for 
approval. Other information needed for approval may include data 
supporting extrapolation from a major species in which the drug is 
currently approved or authorized reference to such data; data 
concerning manufacturing methods, facilities, and control; and 
information addressing potential environmental impacts of the 
manufacturing process. Persons desiring more information concerning the 
PMF or requirements for approval of an NADA or supplement may contact 
Julia A. Oriani (address above).
    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 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 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: April 28, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-11329 Filed 5-4-00; 8:45 am]
BILLING CODE 4160-01-F