36C24E23Q0192.docx
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- Solicitation number
- 36C24E23Q0192
About this file
This special notice from the Department of Veterans Affairs announces the agency's intent to sole source a contract with Knight Mechanical Testing for mechanical testing and FDA regulatory approval application reports. The San Francisco VA Medical Center requires mechanical testing and reports in accordance with applicable ISTO and ASTM standards to submit an investigational device exemption application for a novel VA hip implant. Testing must evaluate micromotion, implant migration, and fatigue. Reports must adhere to FDA IDE submission standards. Knight Mechanical Testing co-developed the required tests and protocol with VA researchers and is the sole provider capable of performing the uniquely designed mechanical tests. Interested parties may submit capability statements by September 19, 2023 detailing how their services meet the requirement. The agency will determine whether to compete the requirement based on responses received.
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Special Notice Special Notice
| SUBJECT* |
| Notice of Intent to Sole Source Mechanical Testing Reports |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 15215-1802 |
| SOLICITATION NUMBER* |
| 36C24E23Q0192 |
| RESPONSE DATE/TIME/ZONE |
| 09-19-2023 9:00 AM EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 30 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
| PRODUCT SERVICE CODE* |
| AN41 |
| NAICS CODE* |
| 541715 |
| CONTRACTING OFFICE ADDRESS |
| Veterans Health Administration |
Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802
POINT OF CONTACT*
Shannon Hukriede shannon.hukriede@va.gov
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
The Department of Veterans Affairs, San Francisco VA Medical Center (VAMC) intends to negotiate on a sole source basis, pursuant to FAR 6.302-1, with Knight Mechanical Testing for Mechanical Testing and FDA Regulatory Approval Application Reports in support of VA funded research studies. The San Francisco VAMC requires mechanical testing and reports to submit an FDA investigational device exemption (IDE) regulatory approval application for a novel and proprietary VA hip joint implant. Mechanical testing for micromotion, implant migration, and fatigue, must be performed in accordance with applicable ISTO and ASTM standards as required by the approved study test protocol. Reports must be in accordance with FDA IDE regulatory submission standards. VA researchers collaborated with Knight Mechanical Testing to design and create the required mechanical tests, and to develop the study test protocol for FDA review. Knight Mechanical Testing are the co-developers of the uniquely designed protocol with VA and the sole known providers of the uniquely designed mechanical tests required for this IDE approval process, which are not available from any other known sources.
This is a notice of intent and is not a request for competitive quotes; however, any responsible source who can provide an equivalent service with the features described above, may submit a capability statement to the contracting office no later than Tuesday, September 19, 2023, 9:00 AM, EDT. Interest/capability statements which specifically detail how your service meets the requirement may be sent to Shannon Hukriede at shannon.hukriede@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.
| *= Required Field |
| Special Notice |
Special Notice
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