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6515--6515 - Intent to Sole Source CVRx Barostim NEO2 System Michael E. DeBakey VA Medical Center

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36C25623Q0584Federal

Contract Overview

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

AI Contract Overview

The Network Contracting Office 16 plans to award a sole source, firm-fixed-price delivery order to USVetServ LLC, a Service-Disabled Veteran Owned Small Business located in Simpsonville, SC, under their VA Federal Supply Schedule. This delivery order is intended for the Michael E. DeBakey VA Medical Center in Houston, TX, and involves procurement of the CVRx Barostim Neo2 System, an FDA-approved implantable neuromodulation device used to treat heart failure symptoms by delivering electrical pulses to carotid artery baroreceptors to restore autonomic nervous system balance. The system includes a generator, combined kit, and implant tools, with improvements such as a 10% reduction in implantable pulse generator size and a 20% extension in battery life, which reduces the need for frequent replacements. The estimated annual quantity for this system is 24 units. This acquisition is conducted under the NAICS code 339113, which covers Surgical Appliance and Supplies Manufacturing, with size standards allowing up to 750 employees. The purchase aligns with FAR Part 8.405 requirements for sole source procurements from required and limited sources. The contract award is anticipated around April 17, 2023, and is not open for competition, but the notice invites interested parties to demonstrate their capability and potential benefit of competition within seven calendar days of the notice. Interested contractors must provide detailed information regarding company ownership, size status, existing contracts, manufacturing or distribution roles, certification status, and compliance with Buy American and Trade Agreement requirements. Questions may be addressed to the contracting officer by mid-March 2023.

General Info

Sole source contract to USVetServ for 24 CVRx Barostim Neo2 heart failure systems.

Agency

Department Of Veterans Affairs → 256-NETWORK Contract Office 16 (36C256)

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

Set-Aside

NONE

Documents

36C25623Q0584 - Intent to Sole Source Michael E. DeBakey VA Medical Center CVRx Barostim NEO2 System

special-notice

High

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Timeline

PostedMar 8

special-notice

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Organization & Contact Information

AgencyDepartment Of Veterans Affairs → 256-NETWORK Contract Office 16 (36C256)

Contacts1 person available

OfficeRIDGELAND, MS, 39157, USA

Organization / AgencyDepartment Of Veterans Affairs → 256-NETWORK Contract Office 16 (36C256)

Office AddressRIDGELAND, MS, 39157, USA

Contacts

Ross FutchContratcing Officer

contact@example.gov

Full Description

NOTICE OF INTENT TO AWARD SOLE SOURCE I. The Network Contracting Office (NCO) 16, located at Galleria Financial Center, 5075 Westheimer Rd, Ste 750, Houston, TX 77030, intends to solicit and award a Sole Source, Firm-Fixed-Price, Delivery Order to one Service-Disabled Veteran Owned Small Business (SDVOSB) source under their VA Federal Supply Schedule 36F79722D0041, USVetServ LLC. Located at 355 English Oak Rd, Simpsonville, SC 29681. The Delivery Order will be for the Michael E. DeBakey VA Medical Center (MEDVAMC), 2002 Holcombe Boulevard, Houston, TX 77030. USVetServ LLC is the sole source authorized distributor to the government for the CVRx Barostim Neo2 System. Contractor shall provide: CVRx Barostim Neo2 System; Manufacturer s Part Number 100069-202 Includes: 1 Model 2104 Barostim NEO2 Generator 1 Model 1036 CSL Combined Kit CSL lead, short buckle, 2mm; Implant Tool, Implant Adapter CVRx Barostim Neo2 System is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. This device is the first and only known FDA approved neuromodulation device on the market to treat the symptoms of heart failure and it reduces the size of the IPG by 10% and extends battery life by 20%, reducing the frequency of device replacements for patients and surgeons. Description Unit of Issue Estimated Annual Quantity CVRx Barostim Neo 2 System Manufacturer s Part Number 100069-202 EA 24 II. The North American Industry Classification (NAICS) code for this acquisition is 339113 Surgical Appliance and Supplies Manufacturing, size standards: 750 Employees III. This purchase will be made under Required Sources of Supplies and Services in accordance with FAR Part 8.405 and Limited Sources, as authorized by FAR 8.405-6. The Government intends to award a Firm-Fixed-Price contract, in accordance with FAR 16.202-1. IV. The anticipated award date is April 17, 2023. The Government intends to award a Firm-Fixed-Price Delivery Order. V. Please note that this is not a request for competitive quotes and is being posted for informational purposes only. Interested contractors, in addition shall provide the following information as an attachment to your response: 1. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Contractors shall provide their point(s) of contact name, address, telephone number, and email address; and the company's business size, and SAM Unique Entity Identification Number. 2. Is your company a small business, SDBs, HUBZone, or 8A concern? Please provide proof of qualifications. Is your company considered small under the NAICS code: 339113? 3. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies you are considering a Joint Venture and the ownership of each company. 4. Do you have an existing BPA s, GSA or VA, Federal Supply Schedule contract to procure the product being requested, please include the contract details in your response. 5. Do you (Contractor) manufacture the product itself or a distributor of the items being researched above? 6. Are you an authorized distributor/reseller? Provide evidence from original equipment manufacturer (OEM). 7. Do you (Contractor) supply a product manufactured by another domestic small business, if it is a nonmanufacturer? 8. Do you (Contractor) supply the product of any sized manufacturer if SBA has granted a waiver to the nonmanufacturer rule? 9. Is your (Contractor) Buy American Certificate completed in SAM? Please provide evidence with response. 10. Is your (Contractor) Trade Agreement Certificate completed in SAM? Please provide evidence with response. 11. Information for the product being requested, is it manufactured outside the US-Domestic non-available? 12. Information for the product being requested, is it a foreign manufactured end product under the trade agreement? 13. What is your schedule of delivery after receipt of order for the product? VI. Interested parties shall identify their interests and capability in response to this notice within Seven (7) calendar days of the publication of this notice. Any response to this notice shall show clear and convincing evidence that competition would be advantageous to the Government. VII. Questions regarding this notice should be sent to Contracting Officer Ross Futch no later than March 17, 2023 by 6:00pm (est) at contact@example.gov.