Intent to Sole Source-OPQR St. Louis ISO Accreditation

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