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1. Solicitation Number: FDA-RFQ-22-1255691 2. Title: Three (3) Open Vision DX C-Arm Digital Real Time X-Ray Imaging Systems with wireless monitors (or equal). 3. Product Service Code: 6640 4. NAICS Co... 1. Solicitation Number: FDA-RFQ-22-1255691 2. Title: Three (3) Open Vision DX C-Arm Digital Real Time X-Ray Imaging Systems with wireless monitors (or equal). 3. Product Service Code: 6640 4. NAICS Code: 334517 5. Posted Date: July 26, 2022 6. Response Date: August 3rd, 2022, 10:00 a.m. Eastern Time. 7. 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. This acquisition is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through FAR FAC 2021-05 March 10, 2021. For purposes of this acquisition, the associated NAICS code is 334517. Line Item Structure: The following is a contract line item number(s), quantities and units of measure, (including option(s), if applicable): Line Item 0001 – Three (3) Open Vision DX C-Arm Digital Real Time X-Ray Imaging Systems with wireless monitors (or equal). BACKGROUND The U.S. Food and Drug Administration – Office of Criminal Investigations (FDA-OCI) protects the public health and furthers the FDA mission by investigating alleged criminal violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and other related statutes. FDA-OCI concentrates its resources on investigations that pose a significant danger to public health. As part of an Agency wide effort, OCI has moved aggressively to target and disrupt violative shipments of FDA products in support of its mission to combat health and safety related crime. One reoccurring challenge is the early and accurate detection of violative products without first having to manually open and examine each parcel. To rectify this issue, OCI requires the acquisition of three (3) digital, real-time X-ray imaging systems. OCI anticipates that these x-ray systems will greatly improve OCI’s ability to conduct enforcement operations, share and exchange information, operate in austere environments, and lead capacity building exercises. With the capability to conduct such enforcement operations, OCI will greatly enhance its working relationship with the U.S. Customs and Border Protection and international law enforcement partners to help curtail the flow of illicit FDA-regulated products through the international and domestic mail stream. OBJECTIVE The purpose of this acquisition is to procure obtain three (3) Open Vision DX C-Arm Digital Real Time X-Ray Systems with wireless monitors, or equivalent. REQUIREMENT The Contractor shall provide three (3) complete Open Vision DX C-Arm digital real time x-ray systems, or equivalent, with required accessories, equivalent to the items below. The contractor shall ensure that the digital x-ray imaging system provides live video output for real-time inspection and reporting. The salient functional characteristics for the OpenVision DX C-Arm Digital Real Time X-Ray Imaging System are provided below. If an alternative solution is proposed, the proposed solution shall meet or exceed the following specifications: C-arm mounted 70 kV x-ray source and a digital imager X-ray outputs at 12”: Low – 40 kV, Medium – 55kV, High 70kV Real Time Video Imager – 4”x6” field of view, continuously moveable Image Resolution: 250 microns (0.01in) Built in Controller Ergonomic Adjustable Trigger Handle USB Port for File Transfers w/64 GB USB Flash Drive System weight: Total packaged system shall be no more than 50lbs. (23kg) C-arm weight: no more than 15lbs. Dimensions: X-ray tube to imager: 9.5 in. to 20.8 in. Throat depth: no more than 21 in. Imager Thickness: no more than 2.5in. X-ray tube thickness: no more than 3.4 in. ISO 9001:2015 compliant The Contractor shall provide all accessories and equipment for full functionality of the x-ray system including: Two (2) 18V Lithium-Ion battery packs 1 hour battery charger (110V or 230V) Radiation Scatter Boot Assembly 7-Piece Allen Wrench Set Pelican Field Case Equipment instruction manual Wireless tablet monitor Shall include all software/operating system necessary to utilize and view live video feed from the digital x-ray system Shall have WiFi capability Shall have between 9 – 11 inches touchscreen Shall have recording capability with a minimum of 8GB of internal storage and expandable 128GB memory Shall have a USB port for image/video transfer Shall include charging cable The Contractor shall provide training for FDA users for the provided equipment. The training shall: Instruct FDA users how to perform radiographic inspections using the provided x-ray system Be provided in-person Accommodate approximately 20 FDA users DELIVERY All deliverables shall be provided F.O.B Destination within 30 days after contract award to: FDA, Office of Criminal Investigations 7500 Standish Place, Room 250N Rockville, MD 20855 In-person training shall occur at the address above, unless otherwise agreed to with the COR. Delivery shall be performed during normal business hours of Monday through Friday, excluding federal holidays, between 8 am and 4 pm local time. Contractor shall provide at least 48-hour advance notice of delivery and installation. Point of contact will be provided at the time of award. Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather.? Government Holidays January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) June (Juneteenth) December (Christmas Day) July (Independence Day) DELIVERABLES Open Vision DX C-Arm Digital Real Time X-Ray Imaging System, complete inclusive of all accessories - Qty 3- Equivalent Product Number - OVDX-SEC-70. Wireless monitor - Qty 3- Equivalent Product Number - 415430 Shipping - Qty 3 In-person training for FDA users - Qty 1 (To be scheduled with the COR after delivery of equipment) PERIOD OF PERFORMANCE THE PERIOD OF PERFORMANCE BEGINS THE DATE OF CONTRACT AWARD EXECUTION. The systems shall be delivered within 30 days after award. GOVERNMENT POINT OF CONTACT (POCs) Contracting Officer (CO): Kathy Harrigan Contract Specialist (CS): Elena Tatarov Contracting Officer Representative (COR): TBA Technical POC (TPOC): TBA Type of Contract: Firm-Fixed-Price (FFP); The Government anticipates issuing a firm fixed-price purchase order. Set Aside: N/A Contracting Officer Authority: The CO is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds. The COR or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the Contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the delivery order. Authorized Reseller/Servicing Agents: By providing the required equipment, the Contractor shall not void any Original Equipment Manufacturer (OEM) warranties, usage terms and conditions of the provided equipment. The Contractor shall notify the Contract Specialist / Contracting Officer immediately if this requirement is registered by a reseller with the OEM. Order of Precedence: The Contractor shall follow the terms and conditions of this order. Should the Contractor include any additional terms and conditions resulting in conflicts between this document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4, dated October 2018. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. The Contractor shall provide all terms and conditions with their quotations as attachments, appendixes, etc. In the event of any inconsistencies between any licensing agreement incorporated into this contract as an attachment and the FAR and HHSAR Clauses incorporated into this contract, the FAR or HHSAR Clauses shall take precedence. Conformance with Applicable Laws, Regulations, Policies, and Standards: The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, HHS, and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov/. 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/contractors/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 ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov 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 Indirect)- 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 ERIC@fda.hhs.gov. 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. (END OF CLAUSE) 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 (LPTA). 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) 52.211-6, Brand Name or Equal (Aug 1999) 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 52.211-6 Brand Name or Equal.(Aug 1999) 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. Instructions to Offeror for Proposal Submission 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 Elena.Tatarov@fda.hhs.gov for the RFQ no later than August 3, 2022, 10:00 a.m. Eastern Time. Late submissions may not be evaluated. The subject line shall read: FDA-RFQ-22- 1255691– Three (3) Open Vision DX C-Arm Digital Real Time X-Ray Imaging Systems with wireless monitors (or equal). Equal to quotes must submit a separate Technical quote with a detailed point-by-point description of how the equal to products meet all the salient characteristics of this SOW. 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. Basis for Award/Evaluation Criteria The Government shall award a firm fixed price contract resulting from this solicitation to the responsible Quoter using the lowest price, technically acceptable (LPTA) evaluation method. The Government intends to evaluate quotes and award an order without discussions. Quoters' initial quote should contain the Quoters’ best terms from a price standpoint. The Government requests the Contractor to provide discounts off their established pricing for each line item. The Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The following factors shall be used to evaluate quotes: Lowest price, technically acceptable (LPTA).