36C24E25Q0049.docx
DOCX document 24 KB Posted
- Attached to
- AN11--Research Services Reports Comparing Hip Prosthesis Device Development Federal contract opportunity
- Solicitation number
- 36C24E25Q0049
About this file
This is a Special Notice pre-solicitation document for a sole source contract from the Veterans Health Administration. The Department of Veterans Affairs intends to award a three-month firm fixed-price purchase order to Medical Device Development, a small business located in San Francisco, to conduct research comparing hip prosthesis devices. The specific requirement involves laboratory testing and evaluation of subject and predicate prostheses using synthetic bones and human cadaveric bones for the San Francisco VA Healthcare System's research department, with FDA clinical use approval contingent on these comparative evaluations.
The solicitation (Number 36C24E25Q0049) is not being competitively posted on SAM.gov, with the sole source justification based on maintaining project continuity and avoiding potential research outcome discordance. The contract is categorized under NAICS code 541720 with a $28 million standard, Product Service Code AN11, and is authorized under FAR 6.302.1-1 for "Only One Responsible Source". The response deadline is 07-16-2025 at 15:00 Eastern Time, with the contracting officer being Ann Marie Stewart, who can be reached at annmarie.stewart@va.gov for any inquiries about the procurement.
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Text version
Special Notice Special Notice
| SUBJECT* |
| Research Services Reports Comparing Hip Prosthesis Device Development |
Pre-Solicitation Notice of Intent to Sole Source.
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 15215-1802 |
| SOLICITATION NUMBER* |
| 36C24E25Q0049 |
| RESPONSE DATE/TIME/ZONE |
| 07-16-2025 15:00 EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 99 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
| PRODUCT SERVICE CODE* |
| AN11 |
| NAICS CODE* |
| 541720 |
| CONTRACTING OFFICE ADDRESS |
| Veterans Health Administration |
Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802
POINT OF CONTACT*
Contracting Officer Ann Marie Stewart annmarie.stewart@va.gov 401-919-0878
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
Pre-Solicitation Notice for notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source firm fixed price purchase order for a three-month period with Medical Device Development, 2390 Mission St., Suite 8, San Francisco, CA 94110, to support the US Department of Veterans Affairs (VA) research office. This requirement is for Medical Device Development, a small business, to provide an evaluation and reports comparing the subject and predicate prostheses in laboratory tests, using synthetic bones (“sawbones”) and human cadaveric bones for the San Francisco VA Healthcare System, research department.
The FDA requires the evaluation of the predicate and subject prostheses in both a synthetic bone model and in human cadaveric bones before allowing clinical use of the subject prostheses. Medical Device Development was awarded the previous contract for evaluation of the predicate and subject prostheses in human cadaveric bones using competitive procedures. This requirement is a continuation of the previous contract and part of a larger research project. To maintain continuity in this project, the recommendation is to sole source this three-month requirement to Medical Device Development. Contracting out to a different source will delay the project and lead to discordant outcomes between the results for synthetic bones and human cadaveric bones.
Since the intent is to procure this on a sole source basis, no solicitation will be posted on SAM.gov (Contract Opportunities). The applicable NAICS code is 541720 with a $28MIL standard. The PSC is AN11. The authority for this action is FAR 6.302.1-1 Only One Responsible source and no other supplies or services will satisfy agency requirements.
Interested persons may contact the Contracting Officer via email at annmarie.stewart@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.
Special Notice
Special Notice
File details come from the government source that posted it. Updated .