[Federal Register Volume 60, Number 169 (Thursday, August 31, 1995)]
[Notices]
[Pages 45486-45487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21622]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Availability of CDC Bacterial Isolates for Evaluating Bacterial
Identification Devices
AGENCY: Centers for Disease Control and Prevention (CDC), Public Health
Service, HHS.
ACTION: Notice of availability.
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[[Page 45487]]
SUMMARY: Gram-negative bacterial isolates for quality control of
bacterial identification devices are available from CDC. Charges are
listed under supplementary information.
EFFECTIVE DATE: September 1, 1995.
FOR FURTHER INFORMATION CONTACT: J. Michael Miller, Ph.D., or Caroline
O'Hara, Diagnostic Microbiology Section, Mailstop C16, Centers for
Disease Control and Prevention (CDC), Atlanta, GA 30333, telephone 404-
639-3029 or 404-639-2316, facsimile 404-639-3241.
SUPPLEMENTARY INFORMATION: Notice is hereby given of the availability
from CDC of a set of gram-negative bacterial isolates with known
biochemical characteristics. These organisms can be used by
manufacturers to fulfill the requirements for testing bacterial
identification devices as part of Food and Drug Administration 510(k)
or pre-market approval (PMA) submissions. Biochemical characterization
test results will be sent with each set.
The charge for the set of 115 gram-negative fermentative organisms
will be $2000.00. These charges were derived from the cost of materials
and labor required by CDC to acquire, test, maintain, and prepare each
set for shipment.
The catalog number for the set is GN-0115. This set can be obtained
by writing to Connie Flowers, Scientific Resources Program, Technical
Services Branch (C21), Centers for Disease Control and Prevention
(CDC), 1600 Clifton Road, NE., Atlanta, GA 30333. Orders may also be
sent by facsimile to: 404-639-3296. Telephone orders will not be
accepted. No individual organisms or partial sets will be made
available. The sets will be sent frozen on dry ice by overnight express
shipping.
Orders for sets should include the purchase order number, catalog
number, the name and account number of the company's overnight express
shipping service, the name and telephone number of the contact person
who will receive the isolates, and the company's shipping and billing
addresses. The materials will be shipped only after the company
executes a Non-disclosure Agreement which will be provided by CDC.
Companies will be billed the month after the isolates are shipped.
Dated: August 25, 1995.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 95-21622 Filed 8-30-95; 8:45 am]
BILLING CODE 4163-18-P
