2_JA Nicoya.docx
DOCX document 23 KB Posted
- Attached to
- Nicoya Alto Extended Warranty
- Solicitation number
- RFQ-NIAID-25-2269820
About this file
This document is a Justification and Approval (J&A) for a sole-source procurement of a Nicoya Alto Extended Warranty by the National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC). The procurement is for one Alto Digital Surface Plasmon Resonance (SPR) instrument extended warranty, which includes original equipment manufacturer (OEM) parts, repairs, travel, software updates, and licenses. The acquisition is being processed under Simplified Acquisition Procedures with a brand name restriction, using NAICS code 811210 and a small business size standard of $34M.
The procurement supports the Vaccine Immunology Program's need to maintain FDA compliance for phase 3 clinical trials, specifically requiring software with individual user log-in capabilities. The warranty will support pre-clinical and clinical endpoint testing for infectious disease research, including HIV, Influenza, and Ebola. The delivery location is NIAID at 9 West Watkins Road in Gaithersburg, Maryland, with a delivery timeline of 10 days after receipt of order. The government intends to award a firm fixed-price purchase order to the sole responsible source, Nicoya, located in Kitchener, Ontario, Canada.
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| File | Type | Posted |
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| 52.212-5 Jan 2025 Services.docx | DOCX document |
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Justification and Approval (J&A) at or Below the Simplified Acquisition Threshold
Project Title: Alto Extended Warranty
I. Identification of the agency and contracting activity
DHHS, NIH, NIAID, VRC, VIP
Address of the requesting lab/office: 9 West Watkins Mill Road Gaithersburg, 20878 II. Description of the project, and supplies or services required to meet the agency’s needs Project Background The Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola, and other ongoing clinical trials. Support is through the state-of-the-art laboratory performing pre-clinical as well as Phase 1 and Phase 3 clinical end point testing to inform further study designs, research questions and vaccine modification and design. To be compliant with FDA guidelines for phase 3 testing, the VIP must maintain CFR 21 part 11 compliance, which requires implementation of software suites that are individual user log-in compliant.
A. Description of the supplies or services to be purchased
Quantity
Description
| 1 |
| Nicoya Alto Extended Warranty |
III. Identification of the statutory authority permitting other than full and open competition ☒ 41 USC 253(c)(1) and FAR Part 6.302-1: Only one responsible source
IV. Demonstration that the proposed contractor unique qualifications or the nature of the acquisition requires use of the authority cited.
A. Name and address of the proposed contractor
Nicoya 29 King St E Kitchener ON N2G2K4
B. Describe why only the requested supply/service will meet the government’s needs The need for a comprehensive understanding of the humoral immune response in response to vaccination and infection is a health care priority, including support of phase 3 trials under GCLP guidelines.
Currently, VIP has a Nicoya Alot that is government owned and operated that needs service and preventative maintenance to ensure it remains in service for various clinical trials.
File details come from the government source that posted it. Updated .