Gas Chromatograph w/headspace system

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in 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. The solicitation is being issued in conjunction with FAR PART 13. The solicitation number is FDA-22-1255287. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-06, May 26, 2022. The associated North American Industry Classification System (NAICS) Code is- 334516 – Analytical Laboratory Instrument Manufacturing. This requirement is being competed as full and open, meaning any qualified vendor of that size status may submit a quote. Respondents are responsible for submitting proposal/quote and any supporting documents before 1:00 PM Eastern Time on August 16, 2022 by e-Mail to [email protected]. For information regarding this solicitation, please contact Julia Savage by e-Mail at [email protected]. 1. Solicitation Number: FDA-RFQ-22-1255287 2. Title: Gas Chromatograph (GC) with Headspace System 3. Product Service Code: 6640 4. NAICS Code: 334516 5. Posted Date: August 8, 2022 6. Response Date: August 16, 2022, 1:00 p.m. Eastern Time. Section B: Continuation of SF-1449 – Schedule of line items and pricing Section C: Contract clauses, including agency-specific clauses Section E: Instructions to offerors, including offeror Representations and Certifications. Section B: Continuation, SOW Background The Food and Drug Administration (FDA) monitors the quality of Active Pharmaceutical Ingredients (API) and Finished Dosage Forms. An important aspect of the monitoring is the determination of residual solvents. This allows the Agency to remove pharmaceuticals with toxic solvents from the market. To perform pharmaceutical residual solvents analysis, a GC equipped with Headspace sampling system is required. Purpose/Objective The Northeast Medical Products Laboratory (NMPL) of the FDA is frequently tasked with analyzing pharmaceutical ingredients and finished dosage forms for the presence of residual solvents. This type of analysis requires the use of a Gas Chromatograph with the capability of Headspace sampling. NMPL seeks to acquire a new Gas Chromatograph equipped with Headspace Sampling system to enhance its capability of monitoring the quality of pharmaceuticals. B-2 Statement of Work The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The Contractor shall provide a Gas Chromatograph (GC) system equipped with a Headspace Sampler. Minimum Performance Requirements All the following system requirements are minimum requirements: Minimum Technical Requirements: • GC shall be equipped with Flame Ionizing Detector (FID) optimized for capillary columns • Split/splitless GC inlet shall be capable of electronic control of carrier gas pressure, flow, and velocity. Inlet shall have pressure capability of up to 100 psi • The system shall have a connected liquid autoinjector with a choice of injection modes to match sample volume and viscosity • The autoinjector sample tray shall have a minimum capacity of 100 vials • The Headspace Sampler shall be integrated with the GC to allow a single interface for control of both components. • The Headspace Sampler shall be capable of electronic control of carrier gas pressure, flow and velocity. • The Headspace Sampler shall be capable of performing leak test on individual vials during vial pressurization to ensure vials are properly capped. • The Headspace Sampler shall be able to accommodate different vial sizes in the same run. • The Headspace Sampler shall have a minimum capacity of 100 vials. • The Headspace Sampler shall be equipped with a 1 mL sample loop. • The system shall be configured to allow Headspace sampler and Liquid sampler to be connected to the same GC inlet • The system shall be configured with software that controls the equipment and allows data acquisition and processing Trade and Service Specifications 1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. 2. FOB Point destination to include inside delivery and clean-up of area after installation. 3. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. 4. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. 5. Any necessary Preventative maintenance (PM) or Repair Services shall be included during the one-year warranty period. This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM. 6. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training. 7. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th work-day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed). Deliverables Table 1. Deliverables / Schedule Gas Chromatograph (GC) equipped with Headspace Sampler 1 Not later than December 1, 2022 Familiarization Training 1 Within two weeks after Government acceptance of instrument Service Reports Varies Not later that the 5th work day following the end of each month, (during any months during which warranty work is performed) Shipping Destination POC: To Be Identified at time of award Food and Drug Administration, Northeast Medical Products Laboratory 158-15 Liberty Avenue Jamaica, NY 11433-1034 The delivery or services must be during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM, excluding holidays. Period of Performance The period of performance begins the date of contract award execution. The anticipated Period of Performance is as follows: Delivery Location Inspection and Acceptance: The COR and/or COR designee will perform inspection and acceptance of equipment, installation, and services to be provided. The COR and/or COR designee – to be determined upon contract award. A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the COR and/or COR designee to ensure the services/products provided meet the requirements of the Statement of Work (SOW), and the Contractor shall make changes as requested during the inspection and acceptance process. Inspection and acceptance will occur at the place of performance and take place within five (5) business days of task being completed. The Government will provide written notification of acceptance or rejection within five (5) business days. Inspection will include review of the deliverables to ensure adequacy. The Government will accept goods, reports, and services only if they conform to all terms and conditions of the SOW, and satisfy the performance standards developed under this SOW. The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within fifteen (15) business days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this period, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within five (5) business days. Contract Type- Commercial Item - Firm fixed price with N30 payment terms Evaluation Criteria The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. Section C: Contract clauses, including agency-specific clauses FAR / HHSAR Clauses: I. 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. II. Evaluation Criteria - The specific evaluation criteria to be used are as follows: Lowest Price Technically Acceptable. III. Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer. IV. 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 – Not Applicable V. 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: 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) 52.219-28, Post Award Small Business Program Representation (Nov 2020) 52.222-3, Convict Labor (June 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-26, Equal Opportunity (Sept 2016) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) 52.222-50, Combating Trafficking in Persons (Oct 2020) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.204-7 System for Award Management (Oct 2018) 52.204-13 System for Award Management Maintenance (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) 52.204-24 Representations Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment 52.204-26 Covered Telecommunications Equipment or Services-Representation 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 352.239-73 Electronic and Information Technology Accessibility Notice (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (Dec 2015) 352.232-71 Electronic Submission of Payment Requests (FEB 2022) (a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE) VII. This acquisition is rated under the Defense Priorities and Allocations System (DPAS) as N/A VIII. The following notes apply to this announcement: N/A Section 508 Requirements The following standards are applicable for this requirement: • Must meet WCAG 2.0 A and AA • E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) • E203 Access to Functionality (Appendix A, Application and Scoping Requirements) • E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements) • E205 Electronic Content (Appendix A, Application and Scoping Requirements) • E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) • Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) • 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative. Section E: Instructions to offerors, including offeror Representations and Certifications. FAR 52.212-1 Instructions to Offerors—Commercial Items (Jun 2020) PROPOSAL SUBMISSION FORMAT: *The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.* QUOTES DUE: All quotes are due, electronically via email to [email protected] for the RFQ no later than June 7, 2022, 1:00 p.m. Eastern Time. The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022) (a) All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm (b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov. (c) ----- (1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts. (2) Registration emails are sent via email from [email protected]. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to [email protected] or phone (866) 973-3131. (3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days. (4) If your company is already registered to use IPP, you will not be required to re-register. (5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures. (d) Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable). (e) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. (1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred. - Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category; - Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount; - Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant; - Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed; - Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor; - Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and - Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable. (f) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (1) list of all invoices submitted to date under the subject award, including the following: - invoice number, amount, & date submitted - corresponding payment amount & date received - total amount of all payments received to date under the subject contract or order - and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance. (g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate. (h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO. (i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays. (j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort. (k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at [email protected]. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.