U099--Consultation Service - UH IDE

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.