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SAMDAILY.US - ISSUE OF JULY 27, 2023 SAM #7912
SPECIAL NOTICE

U -- Consultation Service - UH IDE

Notice Date
7/25/2023 1:49:51 PM
 
Notice Type
Special Notice
 
NAICS
611710 — Educational Support Services
 
Contracting Office
250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
 
ZIP Code
45428
 
Solicitation Number
36C25023Q0970
 
Response Due
7/25/2023 2:00:00 PM
 
Archive Date
08/24/2023
 
Point of Contact
Davina Perry, Davina.Perry@va.gov, Phone: 216-447-8300 x3814
 
E-Mail Address
davina.perry@va.gov
(davina.perry@va.gov)
 
Awardee
null
 
Description
SPECIAL NOTICE: Department of Veterans Affairs (VA), Louis Stokes VA Medical Center, Cleveland, Ohio, 44106 is soliciting and intends to award a firm fixed price contract for Investigational Device Exemption (IDE) Regulatory Support Core for the Louis Stokes VA Medical Center, Cleveland, Ohio, 44106. NAICS Code 611710, size standard $24 million. The Government intends, in accordance with FAR 6.302-1 (only one responsible source), to negotiate on a sole source basis with University Hospitals Cleveland Medical Center (11100 Euclid Ave, Cleveland, OH 44106), for this procurement because the Cleveland VAMC relies solely upon the Contractor to be readily available to provide efficient submission of an Investigational New Drug Application or an Investigational Device Exemption and guarantee that compliance requirements are met under the US Food and Drug (FDA) 2 CFR part 812 and 312. No solicitation package is available. A determination not to compete is solely within the discretion of the Government. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received NLT 17:00 EST on 7/26/2023. All responses must be emailed to Davina.Perry@va.gov.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/dc92fd9d5e004d369af4c1164aea254a/view)
 
Record
SN06762020-F 20230727/230725230045 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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