Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).Start Printed Page 42191
Notice of an evaluation study and request for public comment.
This notice announces a study to evaluate the effectiveness of Brain Heart Infusion Agar plates containing 6 μg of vancomycin (BHI-V) per ml to detect Vancomycin-resistant Staphylococcus aureus.
The CDC would like manufacturers of BHI-V to submit a total of 120 agar plates, 40 plates each of three different lots of BHI-V agar, for testing. The protocol is available on request.
The purpose of this study is to validate the use of BHI-V agar plates, which are currently approved by the Food and Drug Administration in the United States for detecting vancomycin-resistant Enterococcus species, for detecting vancomycin-resistant Staphylococcus aureus.
Comments on the CDC Evaluation of Brain Heart Infusion Agar plates containing 6 μg of vancomycin per ml to detect Vancomycin-resistant strains of Staphylococcus aureus must be received in writing on or before September 13, 2004.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dr. Roberta Carey at (404) 639-3032, e-mail: RCarey@cdc.gov, prior to 4 p.m. on Friday, September 7, 2004.End Further Info
Comments should be submitted to Dr. Roberta Carey, Centers for Disease Control and Prevention, National Center for Infectious Diseases, Division of Healthcare Quality Promotion (C-16), 1600 Clifton Rd., NE., Atlanta, GA 30333, or via e-mail: RCarey@cdc.gov.End Preamble Start Supplemental Information
Strains of Staphylococcus aureus that are resistant to the antimicrobial agent vancomycin pose both clinical and public health concerns. Such strains are difficult to treat and have the potential to spread broadly in healthcare settings causing outbreaks of infection. The first fully vancomycin-resistant isolate of S. aureus (VRSA) was isolated from a patient in Michigan in June 2002. A second isolate of VRSA was recovered from a patient in Pennsylvania in September 2002. Unlike the first isolate, resistance in the second isolate was difficult to detect in clinical laboratories using automated antimicrobial susceptibility testing methods. A third VRSA was recovered recently in New York (2004). This isolate also was not detected as fully resistant to vancomycin on initial testing with automated laboratory methods. To enhance the capability to detect VRSA, the CDC proposes that clinical microbiology laboratories inoculate a BHI-V agar plate with colonies of S. aureus, particularly methicillin-resistant strains of S. aureus, in conjunction with routine methods of antimicrobial susceptibility testing. Since the BHI-V plate is currently approved by FDA only for use with Enterococcus species, the reliability of these commercial media for S. aureus needs to be established. The CDC proposes to evaluate, free of charge, all commercially prepared BHI-V currently approved for distribution in the United States. The CDC requests that 120 plates, 40 plates each of 3 different lots of BHI-V agar, be provided to CDC by the manufacturers of these products. The data generated by CDC will be shared with FDA. Those manufacturers who wish to label their product for use with S. aureus can request review of these data by contacting Sally Selepak at 301-594-2096 in the Division of Microbiology, FDA. The study is to be initiated on September 13, 2004.Start Signature
Dated: July 9, 2004.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control and Prevention.
[FR Doc. 04-15912 Filed 7-13-04; 8:45 am]
BILLING CODE 4163-18-P