Intent to Sole Source-OPQR St. Louis ISO Accreditation
Closed Special Notice Posted
- Solicitation number
- 75F40124Q00515
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- Place of performance
- Saint Louis, Missouri 63110, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Special Notice is published by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services (FDA Office of Acquisition and Grant Services) and describes the government's intent to negotiate and solicit a sole-source contract with the American Association for Laboratory Accreditation (A2LA) to provide auditing services for an unbiased assessment and certification of the OPQR St. Louis quality management system and lab.
The purpose of this Special Notice is to obtain a third-party vendor to provide these auditing services under the authority of FAR 13.106(b)(1)(i). This is not a request for competitive proposals, but any responsible offeror may submit a quote for consideration. The solicitation is being issued as a Request for Quote (RFQ) with the associated NAICS code of 813920 and a small business size standard of $23.5M. The government has identified specific line items and quantities for the auditing services, which include a base year and four option years. While this is a sole-source acquisition, the government will give due consideration to any quotes submitted.
Notice text
The Government intends to negotiate and solicit with only one source American Association for Laboratory Accreditation (A2LA), 5202 Presidents Court, Suite 220 Frederick, MD 21703 to obtain a third-party vendor to provide auditing services for an unbiased assessment and certification of the OPQR St. Louis quality management system and lab under the authority of FAR (13.106(b)(1)(i). This is not a request for competitive proposals; however, any responsible offeror may submit a quote which will be given due consideration by the agency.
This acquisition is issued as a Request for Quote (RFQ).
The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-06.
For purposes of this acquisition, the associated NAICS code is 813920. The small business size standard is $23.5M. This action is being solicited as a sole source.
Line-Item Structure: The following is a list of line-item number(s) and items, quantities, and units of measure, (including option(s), if applicable) and should be reflected in the Offeror’s quote/proposal:
Description of Deliverable Quantity Price
Line Item 0001: OPQR St. Louis ISO Accreditation – Base Year 1
Line Item 0002: OPQR St. Louis ISO Accreditation – Option 1 1
Line Item 0003: OPQR St. Louis ISO Accreditation – Option 2 1
Line Item 0004: OPQR St. Louis ISO Accreditation – Option 3 1
Line Item 0005: OPQR St. Louis ISO Accreditation – Option 4 1
Specifications/Requirement: OPQR St. Louis ISO Accreditation.
Place of Performance/Delivery Location
Audits will be performed for the site at the following addresses:
U.S Food and Drug Administration
Center for Drug Evaluation and Research / Office of Pharmaceutical Quality Research
645 Newstead Ave., St Louis, MO 63110
Files
| File | Type | Posted |
|---|---|---|
| JA.pdf |
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