Inactive Total Small Business Set-Aside (FAR 19.5)

The purpose of this Amendment 1 is to: 1) Provide response to solicitation questions received by the deadline of July 31, 2020; 2) to incorporate a Standard Form 18 (SF-18) to be completed by offerors... The purpose of this Amendment 1 is to: 1) Provide response to solicitation questions received by the deadline of July 31, 2020; 2) to incorporate a Standard Form 18 (SF-18) to be completed by offerors and returned with the quote; and 3) replace Attachment 4 “FAR 52.204-24 Representation” in its entirety with a revised version to be completed and submitted with the quote. ***SEE FULL COMBINED SYNOPSIS/SOLICITATION FOR COMPLETE TERMS AND CONDITIONS - ATTACHED*** INTRODUCTION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and any other written solicitation document will not be issued. SEE FULL COMBINED SYNOPSIS/SOLICITATION FOR COMPLETE TERMS AND CONDITIONS – ATTACHED. This solicitation is a Request for Quotation (RFQ). This solicitation 75N91020Q00087, is issued as a request for quote (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2020-06 (06-05-2020), simplified acquisition procedures for commercial items. The associated North American Industry Classification System (NAICS) code for this procurement is 541715, with a small business size standard of 1,000 employees. Only one award will be made as a result of this solicitation. This will be awarded as a Time and Materials purchase order. THIS ACQUISITION IS BEING CONDUCTED USING COMPETITIVE PROCEDURES under FAR 13.106-1(d) and is A TOTAL SMALL BUSINESS SET ASIDE. DESCRIPTION The National Cancer Institute is seeking to contract with a commercial Institutional Review Board (IRB) to serve as a Central IRB (CIRB) for the intake, processing and review of multi-state/site minimal risk registry linkage studies. The CIRB is intended to streamline the IRB application and review process, thereby saving time and resources associated with multiple local IRB approval processes and is a component of the Virtual Pooled Registry Cancer Linkage System (VPR-CLS) workflow. The requesting investigator must provide evidence of Institutional IRB review and approval (or exemption) to initiate the VPR-CLS linkage request process. Aside from VPR-CLS multi-site studies, the CIRB is also intended to review studies funded by and conducted by National Cancer Institute (NCI) staff within the Division of Cancer Control and Population Studies (DCCPS) or other NCI divisions with a related need for a CIRB review for those studies meeting the definition of minimal risk and eligible for expedited review.. All responsible sources may submit a response which, if timely received, must be considered by the agency. All interested companies shall provide quotation(s) for the requirement defined in Attachment 1 – Statement of Work. MANDATORY QUALIFICATION CRITERIA Mandatory Qualification Criteria establish conditions that must be met within the quote. The Government will not evaluate quotes that do not satisfy the Mandatory Qualification Criteria. The Offeror shall include all information which documents and/or supports that the Mandatory Qualification Criteria has been satisfied in one clearly marked section of its quote. 1. AAHRPP Accreditation: The Contractor shall maintain full accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) for the duration of this contract. Evidence of current AAHRPP accreditation shall be submitted with the initial quote/proposal.