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U099--Investigational Device Exemption (IDE) for Louis Stokes VAMC

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36C25020Q0919Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Department of Veterans Affairs Network 10 Contracting Office plans to enter into a contract with University Hospitals Cleveland Medical Center to support the submission and compliance processes related to Investigational New Drug Applications and Investigational Device Exemptions. The contract involves a base period plus two option years and aims to ensure adherence to FDA regulatory requirements under 2 CFR parts 812 and 312. The procurement will be conducted as a sole-source negotiation under FAR 13.106(b)(2), and the Government retains discretion over any competitive solicitation decisions. The contract is aligned with NAICS code 611710, with a size standard of $15 million. This notice is not a solicitation but an intent notification, emphasizing that responses must provide strong justification for competition benefits if proposed. All responses were required in writing by July 24, 2020, submitted solely via email to the designated point of contact, with no telephone inquiries accepted. The procurement supports the Louis Stokes VA Medical Center and underscores the Government's focus on regulatory compliance and efficient investigational submission processes.

General Info

Contract with University Hospitals to support FDA compliance for drug/device submissions, sole-source, base plus two options.

Agency

Department Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)

NAICS

611710 - Educational Support Services

Place of Performance

Set-Aside

NONE

Documents

Special Notice for Investigational Device Exemption at Louis Stokes VAMC

special-notice

Low

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

CLEATUS splits the solicitation into Uniform Contract Format (UCF) sections: scope, pricing, deliverables, and evaluation criteria.

Timeline

PostedJul 23

special-notice

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Organization & Contact Information

AgencyDepartment Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)

Contacts1 person available

OfficeDAYTON, OH, 45428, USA

Organization / AgencyDepartment Of Veterans Affairs → 250-NETWORK Contract Office 10 (36C250)

Office AddressDAYTON, OH, 45428, USA

Contacts

Davina Perry

contact@example.gov

Full Description

The Department of Veterans Affairs, Network 10 Contracting Office, in accordance with FAR 13.106(b)(2) (soliciting from a single source) intends to negotiate on a single source basis a base plus two option year contract with University Hospitals Cleveland Medical Center, Cleveland, OH 44106, to provide services that are necessary to ensure the 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. NAICS Code is 811710, and Size Standard is $15 Million. This notice of intent is not a request for competitive proposals, solicitations, or request for offers. 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. No telephone inquiries will be accepted. Responses must be submitted in writing by July 24, 2020, and shall be sent via email to contact@example.gov. No telephone inquiries will be accepted.