VPP Tangential Flow Filtration system

This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and solicitation for commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-NIAID-2026018 and the solicitation is issued as a Request for Quotes (RFQ). This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-06, Effective 06/05/2020. The North American Industry Classification System (NAICS) code for this procurement is 334516, Analytical Laboratory Instrument Manufacturing, with a small business size standard of 1000 employees. This requirement is NOT set-aside for small business. Background: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) in China at the end of 2019 has now caused a major global pandemic threatening large swaths of the human population. There is an urgent need for a stabilizing formulation buffer used in vaccine development and production. The Vaccine Production Program Laboratory (VPPL) advances candidate products from the laboratory to the clinic, develops manufacturing processes and tests that provide material for Phase I/II clinical trials, and produces vaccine components at VRC facilities. The VPPL needs a parallel tangential flow filtration system for the COVID-19 research and vaccine development. SARS-CoV-2 is a newly discovered coronavirus that has caused the global pandemic, COVID-19, resulting in hundreds of thousands of deaths since January 2020. In order to rapidly bring candidate vaccines to the public and put a stop to widespread illness and death, multiple vaccine candidates are undergoing parallel development at unprecedented speed. It is absolutely critical for the Vaccine Production Program to procure a machine capable of parallel tangential flow filtration development so that eight vaccine candidates may be processed in one experiment, improving throughput from one or two experiments per day to eight to sixteen per day. This machine must be compatible with small surface area filters, vastly reducing the amounts of product necessary for each experiment. Moreover, the machine must be capable of recording critical process parameters like pressure, flow rate, pH, and conductivity data automatically. These capabilities will allow operators to quickly process numerous vaccine candidates and develop a scalable manufacturing process with reduced material needs. It is imperative that this machine be received as soon as possible to respond to the ongoing COVID-19 pandemic. Please see attachment for minimum specifications. Place of Performance: 9 West Watkins Mill Rd Gaithersburg, MD 20878 Delivery date: 5 weeks ARO *Please include your DUNS number on quote *Include response to FAR 52.204-26 attachment and return with quote *Include response to FAR 52.204-24 if applicable Submission shall be received not later than 10:00 a.m. EST, June 25, 2020. The government intends to award a firm fixed price purchase order to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein. The award will be based on the following; price, capability to meet the requirements, delivery and the best value to the government. The following FAR provisions apply to this acquisition: FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Dec 2019) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Dec 2019) FAR 52.212-1 Instructions to Offerors Commercial Items (Jun 2020) FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (Jun 2020) Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) is updated in your SAM record) FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements – Representation (Jan 2017) The following FAR contract clauses apply to this acquisition: FAR 52-212-4 Contract Terms and Conditions Commercial Items (Oct 2018) FAR 52-212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (Jun 2020) *The applicable subparagraphs of FAR52.212-5 are included in the attachment to this posting. FAR 52.203-19 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (Jan 2017) FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov). Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax. Offers may be mailed, e-mailed or faxed to Ms. Skye Duffner, (E-Mail/ [email protected] 406-802-6092). Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f) (Oct 2018) All responsible sources may submit an offer that will be considered by this Agency. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Ms. Skye Duffner at [email protected].