H965--Quality and Regulatory Support - New Contract (VA-24-00057385)
Closed Pre-Solicitation Posted
- Solicitation number
- 36C10X24Q0164
- Agency
-
VA Strategic Acquisition Center Frederick
Headquarters, Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- Place of performance
- Contractor facility with occasional travel to Government facilities.
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs (VA) Strategic Acquisition Center (SAC), on behalf of the Office of Advanced Manufacturing (OAM), is conducting market research to identify parties interested in and capable of providing Quality and Regulatory Support services. The required services include providing guidance and implementation support for establishing a quality management system (QMS) for VA's distributed manufacturing approach, assisting with FDA registration and regulatory compliance for VA's point-of-care advanced manufacturing facilities, and conducting regulatory assessments, strategic consulting, and training on advanced manufacturing for VA medical devices. Interested parties should provide their organization's details, including size and ownership status, as well as tailored capability statements addressing the specific requirements. The government will evaluate the responses to determine the appropriate acquisition method, which may involve a small business set-aside or full and open competition.
The applicable NAICS code is 541690 (Other Scientific and Technical Consulting) with PSC codes B528 (Regulatory Studies), H965 (Other QC SVCS/Medical-Dental-Vet EQ), and H165 (quality control- medical, dental, and veterinary equipment and supplies). The contract is anticipated to be a firm-fixed price with a base period of one year and four one-year option periods. The government will not provide feedback or evaluations to companies regarding their submissions in response to this notice.
Notice text
The Department of Veterans Affairs (VA) Strategic Acquisition Center (SAC), on behalf of the Office of Advanced Manufacturing (OAM), is issuing this sources sought notice as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for Quality and Regulatory Support for Office of Advanced Manufacturing OAM.
Additional information regarding the requirement is available in the draft Performance Work Statement (PWS) accompanying this notice. The result of this market research will contribute to determining the method of acquisition.
The applicable North American Industry Classification System (NAICS) code assigned to this acquisition is 541690 (Other Scientific and Technical Consulting) with PSC B528 (Regulatory Studies), H965 (Other QC SVCS/Medical-Dental-Vet EQ), and H165 (quality control- medical, dental, and veterinary equipment and supplies) codes.
There is no solicitation at this time. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.
Attached to this sources sought notice is a draft Performance Work Statement (PWS) which describes the required services.
To be considered as a potential source, please provide ALL of the following information:
1) organization name, address, email address, website address, telephone number, and size classification (Large or Small Business) and type of ownership (i.e., SDVOSB, WOSB, 8A etc.) for the organization; Include this information for any Teaming or Joint Ventures as well.
2) tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated to deliver technical capability, address the administrative and management structure of such arrangements and state the anticipated percentage each organization of the teaming effort will contribute to the total effort.
The government will evaluate market information to ascertain potential market capacity to:
1) provide services consistent in scope and scale with those described in this notice and otherwise anticipated.
2) provide services under a performance-based service acquisition contract.
Based on the responses to this sources sought notice/market research, this requirement may be set aside for small businesses or procured through full and open competition. The government will not provide feedback or evaluations to companies regarding their submissions in response to this notice.
Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this sources sought notice by 10:00 AM EST on 4/17/2024. All responses under this notice must be emailed to Chris Binkley, Christopher.Binkley@va.gov.
Attachments: Draft PWS Quality and Regulatory Support for OAM.
Files
| File | Type | Posted |
|---|---|---|
| Draft PWS - Quality and Regulatory Support - OAM.docx | DOCX document | |
| 36C10X24Q0164.docx | DOCX document |
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