[Federal Register Volume 69, Number 134 (Wednesday, July 14, 2004)]
[Notices]
[Pages 42190-42191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15912]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


CDC Evaluation of Brain Heart Infusion Agar Plates Containing 6 
[mu]g of Vancomycin Per ml To Detect Vancomycin-Resistant Strains of 
Staphylococcus aureus

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (DHHS).

[[Page 42191]]


ACTION: Notice of an evaluation study and request for public comment.

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SUMMARY: This notice announces a study to evaluate the effectiveness of 
Brain Heart Infusion Agar plates containing 6 [mu]g 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.

DATES: Comments on the CDC Evaluation of Brain Heart Infusion Agar 
plates containing 6 [mu]g of vancomycin per ml to detect Vancomycin-
resistant strains of Staphylococcus aureus must be received in writing 
on or before September 13, 2004.

FOR FURTHER INFORMATION CONTACT: Dr. Roberta Carey at (404) 639-3032, 
e-mail: [email protected], prior to 4 p.m. on Friday, September 7, 2004.

ADDRESSES: 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: [email protected].

SUPPLEMENTARY 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.

    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