Inactive

Document Type: Combined Synopsis/Solicitation Solicitation Number: RFQ-NIAID-2084821 Posted Date: 07/07/2021 Response Date: 07/13/2021 Set Aside: No NAICS Code: 325414 Classification Code: 6810 Contra... Document Type: Combined Synopsis/Solicitation Solicitation Number: RFQ-NIAID-2084821 Posted Date: 07/07/2021 Response Date: 07/13/2021 Set Aside: No NAICS Code: 325414 Classification Code: 6810 Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/RML, 903 S. 4th Street, Hamilton, MT 59840 Primary Point of Contact: Dana Monroe: dana.monroe@nih.gov Description: 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-2074581and 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) 2021-05 March 10, 2021. The North American Industry Classification System (NAICS) code for this procurement is 325414, Biological Product Manufacturing with a size standard of 1250 employees. The requirement is being competed with a brand name restriction, and without a small business set-aside. The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for: GFAP (Banyan GFAP) Simoa Discovery Kit, catalog # 102336, Qty 13 EA Disc Kit for Simoa HD-1/X (rev 2), catalog # 103347, Qty 6 EA Shipping/handling fees associated with order, Qty 1 EA Glial fibrillary acidic protein (GFAP) is a type III intermediate filament (IF) protein mainly expressed by astrocytes in central nervous system (CNS); molecular weight of GFAP is 50 kDa. Activation of glial cells is common during various neurodegenerative conditions. NIH Neuroimmunological Diseases Section (NDS) has matched serum/CSF for >1200 clinic visits. The goal of this project is to generate matching serum and CSF GFAP data on ~1000 samples, in order to first determine whether there is correlation between serum and CSF GFAP concentration (as we have identified for neurofilament light), if yes, then determine covariates that influence correlation between CSF and serum GFAP samples. Because of very low serum concentrations of GFAP, serum GFAP can be measured only by ultrasensitive assay. There are currently 2 such ultra-sensitive validated serum GFAP assays available. Of these Quanterix SIMOA assay (Simgle Molecular Analyte) has been most widely used. NDS has Quanterix HD analyzer and has measured serum GFAP already in >50 subjects with neuroimmunological diseases and healthy donors. This current project represents an expansion of these data; therefore it is imperative that the same assay is used, to assure comparable results among all diagnostic categories and time-points. Previously we have analyzed neurofilament light chain (NfL, neuron specific intermediate filament protein) in >1000 matching serum/CSF samples using SIMOA assay. Like GFAP, NfL also diffuses from CSF to serum. NfL is released from CNS neurons into CSF which is diffused to blood but NfL is also directly released into blood from peripheral neurons (PNS). Thus by using just matching serum/CSF NfL data effect of covariates on CSF to blood cannot be identified completely. On the other hand GFAP is highly specific to astrocytes in CNS, so whatever concentration of GFAP observed in blood is mainly diffused from CSF only. So GFAP is an ideal candidate to identify effects of various covariates on diffusion of CNS-specific biomarkers from CSF to blood. There are there are 2 sources of super-sensitive assay necessary for measuring serum GFAP. They both need a special equipment. NDS has already purchased this equipment (Quanterix HD analyzer) for one of these sources, obtained though full Federal competition mechanism. NDS also already analyzed >50 serum GFAP samples using this single source (i.e., SIMOA). Therefore, switch to a new source would incur unacceptable cost of acquiring new machine and re-analyzing >50 samples. Place of Performance: NIH, 10 Center Drive, BLDG 10 Clinical Center, Bethesda, MD 20852, United States. FOB: Destination 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; technical capability to meet the requirements and price. The following FAR provisions apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items (JUN 2020) FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (FEB 2021) FAR 52.204-7 System for Award Management (OCT 2018) (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) 52.204–26 Covered Telecommunications Equipment or Services-Representation (OCT 2020) *** Must complete representation if attached to this solicitation- see attachment 52.204-26 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 (JAN 2021) *The applicable subparagraphs of FAR52.212-5 are included in the attachment to this posting. FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) FAR 52.204-13 System for Award Management Maintenance (OCT 2018) FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (DEC 2015) 52.252-2 -- Clauses Incorporated by Reference. (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://farsite.hill.af.mil/vffara.htm 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/far/loadmainre.html & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax. Submission shall be received not later than July 13, 2021 at 5:00pm PDST Offers may be e-mailed to Dana Monroe at dana.monroe@nih.gov. Offers shall include RFQ number in the subject line RFQ-NIAID-2084821. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f) 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 Dana Monroe at dana.monroe@nih.gov.