Food and Drug Administration, HHS.
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).
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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). Start Printed 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.Start Signature
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