Inactive

Amendement #1 The purpose of this amendment to revise the requirements document, all changes to the requirements document has been highlighted. Response date has been extended. Contracting Office Addr... Amendement #1 The purpose of this amendment to revise the requirements document, all changes to the requirements document has been highlighted. Response date has been extended. Contracting Office Address: 4041 Powder Mill Road, Adelphi, MD, 20705 Solicitation Number: FDA-RFQ-23Q1266425 Subject: To obtain a fully functional modern Ultra-High Performance Liquid Chromatograph with improved analytical capabilities Classification Code: 6632 NAICS Code: 334516 Response Date: 24 July 2023, 11:59 PM Eastern time due via email to the Primary Point of Contact listed in the Sam.gov webpage for this combined synopsis-solicitation. Description: The Food and Drug Administration (FDA), San Juan Medical Products Laboratory (SJNLMP) needs to replace an existing Liquid Chromatography (LC) system used for routine LC sample analysis with a new Ultra-High Performance Liquid Chromatography (UHPLC) System. The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The system is used to analyze medical product samples using specific protocols and methods established by USP, internal FDA, DOD SLEP, and the FCC program. (i) Disclaimer: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) This acquisition is issued as a Request for Quote (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-02; March 16th, 2023 (iv) For purposes of this acquisition, the associated NAICS code is 334516. Lowest Price Technically Acceptable (LPTA) will be used for evaluation purposes. (vi) Specifications/Requirement: “SEE ATTACHED DOCUMENT TITLED Requirement Document”. (vii) The FOB destination is U.S. Food and Drug Administration, San Juan Medical Products Laboratory, 466 Fernandez Juncos Ave, San Juan, PR 00901-3223 (viii) The provision at 52.212-1, Instructions to Offerors – Commercial DEVIATION 2018-O0018, applies to this acquisition. The following addenda have been attached to this provision: In addition to the requirements set for the in FAR 52.212-1, all offers responding to this solicitation must provide their business size in relation to the NAICS code contained in this solicitation and shall identify any socioeconomic categories to which they belong. (ix) Evaluation Criteria - The specific evaluation criteria to be used are as follows: Lowest Price Technically Acceptable (LPTA) basis. (x) Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer. (xi) The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to this clause: N/A . (xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-3 Convict Labor (JUN 2003) 52.222-19 Child Labor-Cooperation with Authorities and Remedies (DEC 2022) 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (SEP 2016) 52.222-36 Equal Opportunity for Workers with Disabilities (JUN 2020) 52.222-50 Combating Trafficking in Persons (NOV 2021) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) 52.225-13 Restrictions on Certain Foreign Purchases (FEB 2021) 52.232-33 Payment by Electronic Funds Transfer System (OCT 2018) (xiii) The following additional contract requirement(s) or terms and conditions apply: 52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018) 52.204-10 REPORTING EXECUTIVE COMPENSATION AND FIRSTITIER SUBCONTRACT AWARDS 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018) 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016) 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019) 52.209-6 PROTECTING THE GOVERNMENTS INTERSEST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED SUSPENDED, OR PROPOSED FOR DEBARMENT (OCT 2015) 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS (DEC 2015) 352.232-71 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS 352.239-73 ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE (DEC 2015) (xiv) This acquisition is rated under the Defense Priorities and Allocations System (DPAS) as N/A. (xv) Date, Time, and Place offers are due: 24 July 2023 at 11:59 PM Eastern Standard Time (xvi) Name and Telephone Number of the Individual to Contact for Information Regarding the Solicitation: POC: Contract Specialist: Warren Jackson warren.jackson@fda.hhs.gov Phone: 301-837-7147 Alternate POC: James O’Keefe James.OKeefeIII@fda.hhs.gov Phone: 301-796-7371