Inactive Total Small Business Set-Aside (FAR 19.5)

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 anno... 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 2022-07 August 10, 2022. For purposes of this acquisition, the associated NAICS code is 334516. 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 – Fourier-Transform Infrared Spectrometer (FTIR) Specifications/Requirements: The following are minimum requirements for the requested instrument that the contractor will deliver. The requested system must include an Attenuated Total Reflection (ATR) attachment and comply with regulatory components (IQ/OQ/PQ Documentation). Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by DETL prior to purchase. Installation required with initial qualification (IQ), operational qualification (OQ), and performance qualifications (PQ). A qualification report must be submitted to meet regulatory requirements and all materials to complete qualifications shall be included. A copy of the qualification report shall be reviewed and approved by the DETL Chemistry Supervisor or Laboratory Director prior to agreeing to completion of the installation of the instrument. Contract must provide adequate on-site training for new users to learn operation and maintenance. Training agenda will be determined post-instrument installation and qualification in respect to the user level knowledge and experience. Instrument familiarization, which is separate and different than user training and shall be conducted at the time of installation or scheduled no later than one (1) week after installation and qualification of the instrument. Vendor will provide copies of instrument and software manual. The contractor must provide a one-year (1) manufacture warranty for all parts, labor, travel, technical, on-line, software updates/patches/fixes, and telephone support service for a 12-month (one year) period after complete delivery, installation, and training at no additional cost to the government. The contractor shall provide full-service support for the installed equipment, including but not limited to labor, parts, travel on-site support, telephone support, retesting and re-qualification of the unit, software updates and enhancements. The contractor must provide continuous online and telephone support for the instrument. The support services shall include, but not limited to trouble shooting, equipment maintenance and repair, and provide responses to operator questions. The contractor shall provide a reasonable response time for all on-site service and repairs. The service engineer is to note/report, sign, and date all instrument service(s) performed in the instrument logbook assigned to that specific instrument. Instrument controller shall include Intel I7 Processor, >3 Ghz, 18GB RAM and 1 TB HDU or better. Spectrometer must provide a 10-year warranty on the interferometer, laser. Spectrometer must have a non-migrating hotspot single-point source with a 10-year warranty. The source energy/intensity must not degrade over the lifetime of the source to ensure consistent spectral results, especially through an attenuated total reflectance (ATR) accessory. Spectrometer must have an integrated touch panel for intuitive on-board control to maximize productivity and easily run standard operation procedures (SOPs) Spectrometer must include multi-colored LED scan bar for immediate instrument feedback and status updates Spectrometer system must be cloud-enabled with access to cloud-based spectroscopy software so users can analyze data anywhere, anytime, on any device Spectrometer must have 0.25 cm-1 spectral resolution for optimum spectral quality and line shapes, especially with gas-phase spectra Spectrometer must have wavenumber precision better than 0.0008 cm-1 for maximum scan to scan data reproducibility Spectrometer must have wavenumber accuracy better than 0.02 cm-1 for trustworthy identification and quantification results Spectrometer specifications must be factory verified on every instrument and must represent actual instrument performance, not just typical or achievable results Standard spectrometer software must include a library of over 9,000 reference spectra and multi-component search capabilities Spectrometer must include automated test routines to streamline the pharmacopeia compliance process, including European Pharmacopeia (Ph. Eur. 2018 and 2019), United States Pharmacopeia (USP), Japanese Pharmacopeia (JP) and Chinese Pharmacopeia (CP) Spectrometer must have a tungsten/halogen near-infrared source option for extended analytical capabilities in the mid-near infrared range Spectrometer must accept a wide-array of third party accessories and accessories from the entry-level FTIR instrument within the product family to maximize flexibility and minimize future upgrade costs Spectrometer must have purge-through windows to effectively purge only the accessory cavity, thereby minimizing the time it takes to purge the optical beam path Spectrometer must have an optional high-speed mercury cadmium telluride (MCT) detector for high-sensitivity and rapid scan analysis Spectrometer must have a maximum scan speed of 40 spectra/second at 16cm-1 resolution to enable the study of kinetics during chemical reactions Spectrometer must utilize a Michelson interferometer with dynamic alignment to provide high spectral resolution and compensate for tilt, shear, temperature effects, and vibrations that alter line shapes and negatively impact spectral results Must have internal optics for fast consistent results that must be at LightDriveTM Optical Engine or better and include a 10-year warranty. Spectrometer must have signal-to-noise ratio (50,000:1), wavenumber precision (0.0008cm-1) and wavenumber accuracy (0.02cm-1) specifications are among the best on the market. Instrument specifications must be factory verified and certified on each instrument. Microscope attached with FTIR must have 10X permanently aligned objective, provide simultaneous viewing the sample while collecting data, include a high intensity long-life LED, include wide spectra range, DTGS or MCT-A option, include data generation via transmission, reflection and potentially, Micro-ATR Works on 120VAC standard power outlet. Must include a field variable glass aperture option, motorized external beam mirror option, slide-on micro tip for ATR, FT-IR microscope Polystyrene standards kit, accessories to verify the accuracy of transmission such as a Smart OMNI. Microscope must have simultaneous view with video imaging capabilities including at least 1.3 megapixel camera, trinocular, binocular, and camera-only options with high intensity LED illumination. Microscope must have permanent alignment ready-to-use ATR. The instrument must be compatible with transmission, reflection, and ATR sampling modes, be pre-aligned with slide-on diamond crystals and an integrated pressure sensor for contact alert. Condenser must have z-focus position and permanent centration. Data system shall include at least an 8XDVD Drive, 19’ TFT Display, 2 network interfaces, and include Windows operating systems. Software must meet 21 CFR Part 11 Compliance Software must be capable of creating and searching libraries for identification of substances. Additional tools such as cluster analysis, conformity tests, and percentage match are required. Software must include a library for initial screening and capability to build. Software must be suitable for data acquisition, automated analysis, evaluation, and processing of data, including any quantitative analysis. Software must include a full feature report generator. Software must be capable of performing full spectrum multivariate analysis (PLS) method. Shall be able to provide a wide range of pre-processing and validation options. Additionally, it shall offer an automatic routine for optimization of calibration methods. Software must be compliant to cGMP/GLP and include the following Multilevel user manager, log-in with username and password Audit trail (history log function) All data including manipulation and evaluation results stored in one file Electronic signature of spectra and methods to support users’ daily routine work Additionally, it must provide online help, include functionality for lab journal, ability to run/create/edit macros and VB scripts, automate execution of repeated actions via calendar, and provide multimedia FT-IR tutorial. Additional features must include: Spectrum calculator Normalization features, calculate derivatives, ability to average spectra and subtract spectra. Capable of working on single and/or repeated measurements and potential autosampler attachment. Automated atmospheric correction for water vapor and CO2 in MIR without the need for reference spectra. It shall be able to deliver reliable results in short time. Automatic consistency test of measurement parameters. Tools to fit curve, peak pick, spectra interpretation, quick compare spectra, search spectra libraries, create your own libraries, analyze peak areas and heights for quantitative analysis based on principles of Lambert-Beer’s Law, automated multi-step evaluation of spectra, predefined print layouts and customizable print layouts, conversion of files to different file formats (e.g., JCAMP) Easy to export data to other programs Software must be validated and support the validation of the spectrometer including having automated OQ and PQ testing. Include a permanent instrument status indicator. Deliverables Deliverable Quantity Delivery Date Fourier Transform Spectrometer 1 Within 60 days of award IQ, OQ, PQ with qualification report 1 Within 30 days of delivery Onsite Training up to 4 FDA employees 1 Within 5 days of completion of IQ, OQ, PQ Warranty repair and service As required Within 3 days of submission of request for service Field Service Report As required Upon completion of each service call Shipping Destination FOB Destination: US Food & Drug Administration Detroit Laboratory ATTN: To be determined at the time of the award 300 River Place, Suite 6850 Detroit, MI 48207 The Contractor shall provide at least 72 hours’ notice for installation, set-up, and training date(s). Delivery shall occur (Monday – Friday) between the times of 8:00 AM – 4:00 PM, excluding Federal holidays or Federal Closures. Federal holidays are listed below, and specific dates can be found at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay: New Year’s Day Martin Luther King, Jr. Day Presidents Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Type of Contract: Firm-Fixed-Price (FFP); The Government anticipates issuing a firm fixed-price purchase order. Set Aside: Small Business Instructions to Offeror for Proposal Submission FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (Nov 2021) 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 Cynthia.Martin@fda.hhs.gov for the RFQ no later than September 23, 2022, 12:00 p.m. Eastern Time. Late submissions may not be evaluated. The subject line shall read: FDA-RFQ-22- 1254895– Fourier-Transform Infrared Spectrometer (FTIR) 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). 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 Products and Commercial Services, 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 Products and Commercial Services 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 (Jun 2020) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) 52.219-28, Post Award Small Business Program Representation (Sep 2021) 52.222-3, Convict Labor (June 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2022) 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 (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 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 (Nov 2021) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Nov 2021) 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.