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 quotation (quote) are being requested. The Solicitation number is RFQ-NIAID-24-2224319 and the solicitation is issued as a Request for Quotation (RFQ).
This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP), FAR Subpart 13.5 – Simplified Procedures for Certain Commercial Items. The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2024-06 Effective August 29, 2024.
The North American Industry Classification System (NAICS) code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing with a size standard of 1,000 employees. The Product or Service Code (PSC) is 6640 – Laboratory Equipment and Supplies. The requirement is being competed as full and open competition, with a brand name or equal purchase description, and without a small business set-aside.
The government anticipates making up to two (2) firm-fixed-price (FFP) awards to the responsible offeror as a result of this RFQ, that will include the terms and conditions set forth herein. By submitting a quote, the vendor acknowledges they are required to be registered, active and visible in the System for Award Management (SAM) database at the time of the quote submission. The vendor must maintain this active registration status until the time of award, throughout the performance of the purchase order, and until final payment is made for any order resulting from this solicitation (www.sam.gov). By submitting a quote(s), the offeror is accepting that all government terms and condition shall prevail over the award.
STATEMENT OF NEED
The proposed purchase is for Brand Name or Equal products/services.
The National Institute of Allergy and Infectious Disease (NIAID), Vaccine Production Program (VPP), at the Vaccine Research Center (VRC), is seeking to acquire two (2) automated liquid handling systems, to continue developing potential lifesaving vaccines for HIV, Ebola, Zika, Malaria, SARS-COV-2, Influenza, and other known pathogens and get these potentially lifesaving products into the clinic for first-in-human clinical trials. The VPP’s Data Science and Automation (DSA) group supports the product development activities of three different functional teams at the VPP: Cell Line Development (CLD), Cell Culture Development (CCD), and Downstream Process Development (DPD). A key form of this support is high-throughput, flexible, microscale protein purifications and product characterizations performed by DSA’s automated liquid handlers and their integrated analytical equipment packages. The automated liquid handling systems would provide the ability to perform small-scale pressurized liquid chromatography using commercially available chromatography resins; and the flexibility necessary to support the growing number of purification and analytical schemes employed by the VPP.
The Vaccine Production Program (VPP) applies cutting-edge science and engineering approaches to plasmid design, cell expression, purification, formulation, and analytics. The Downstream Process Development employs diverse purification techniques to produce high-quality recombinant products from mammalian or microbial culture harvests. The unit operations include bulk filtration (removal of cells, cell debris, or other particulate matter), specialized chromatography steps (to separate soluble impurities like host cell proteins and DNA), and specialized filtration and/or buffer exchange steps. Ultimately, the process is transferred externally for cGMP execution at scales supporting up to 2000 L cell culture harvests. At this manufacturing scale, a high-yielding process is capable of delivering up to kilogram yields of clinical product. The automated liquid handling systems are needed for small-scale, high-throughput protein purification, particularly when the purification schemes have already been partially developed. The initial clonal cell culture harvest volumes are typically less than 50 mL and cannot be effectively purified using lab-scale manual chromatography techniques. The proposed automated liquid handling systems will be able to process up to eight clonal harvests of less than 20 mL simultaneously, with straightforward parallelization of up to 96 or more clones. Also, the proposed automated liquid handlers will share significant commonalities with other small-scale automated liquid handlers operated by the Data Science and Automation (DSA) for Downstream Process Development (DPD) scientists, enabling the rapid implementation of nonstandard, project-specific protein purification processes to protect critical early-stage project timelines. Instrument commonalities also provide robustness against disruptions in instrument availability due to project timelines or unforeseen downtime.
The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for a brand name or equal for two (2) Automated Liquid Handling Systems. The brand name and part numbers for the products/services are provided in full detail in the attached Bill of Materials (BOM) – Attachment 2. To be considered for award, vendors quoting “equal” product/services, including “equal” products/services of the brand-name manufacturer, must meet the following minimum requirements/specifications:
Two (2) Automated Liquid Handling Systems
1. Early phase purification development microchromatography liquid handler with biolayer interferometry detection:
- In-line integration with biolayer interferometry instruments
- Agreement with the manufacturer of the biolayer interferometry instruments to ship a loaner to the awardee to do the integration of the two pieces of equipment.
- In-line integration with Tecan Spark spectrophotometers.
- Compatible with library of Tecan liquid handling scripts and Tecan Fluent Control.
- Compatible with Atoll RoboColumn pressurized microchromatography columns.
- Minimum of 8 channel simultaneous pipetting with disposable and fixed tips.
- Capacity of up to 1 mL per disposable pipetting channel, up to 0.5 mL fixed.
- Disposable pipet precision of 5 µL with ≤ 5% CV, fixed pipet precision of 20 µL with ≤ 5% CV.
- Programmable gripper capable of eccentric and concentric microplate and tool manipulation.
- Capacity for at least 20 SBS/SLAS footprint microplates.
- In-line integration with centrifuge capable of >6000 rcf.
- Capable of mounting Tecan EVO and Tecan Fluent deck carriers.
- Capable of future expansion to include thermostatting for at least two microplates or programmable thermocycler for single microplate.
- Facility Requirements:
- Weight: 800 lbs. or less (full loaded)
- Space Clearance around instrument
- Distance to object in rear of the instrument: 4-6 inches
- Outreach of the front safety panel: Maximum of 22 inches
- Outreach of the short (open) front safety panel: Maximum of 16 inches
- Distance to object in front of the instrument: Between 38-42 inches
- Footprint of instrument
- Footprint Depth: maximum of 32 inches
- Overall Depth: 38 inches
- Overall Length: 85 inches
2. Purification screening and upstream process development microchromatography liquid handler:
- In-line integration with Tecan Spark spectrophotometers.
- Compatible with library of Tecan liquid handling scripts and Tecan fluent control.
- Compatible with Atoll RoboColumn pressurized microchromatography columns.
- Minimum 8 channel simultaneous pipetting with disposable and fixed tips.
- Capacity of up to 1 mL per disposable pipetting channel and up to 0.5 mL fixed.
- Disposable pipet precision of 5 µL with ≤ 5% CV, fixed pipet precision of 20 µL with ≤ 5% CV.
- Programmable gripper capable of eccentric and concentric microplate and tool manipulation.
- Capacity for at least 20 SBS/SLAS footprint microplates.
- In-line integration with centrifuge capable of >6000 rcf.
- Capable of mounting Tecan EVO and Tecan Fluent deck carriers.
- Capable of future expansion to include thermostatting for at least two microplates or programmable thermocycler for single microplate.
- Facility Requirements:
- Weight: 800 lbs. or less (full loaded)
- Space Clearance around instrument
- Distance to object in rear of the instrument: 4-6 inches
- Outreach of the front safety panel: Maximum of 22 inches
- Outreach of the short (open) front safety panel: Maximum of 16 inches
- Distance to object in front of the instrument: Between 38-42 inches
- Footprint of instrument
- Footprint Depth: maximum of 32 inches
- Overall Depth: 38 inches
- Overall Length: 65 inches
QUOTING REQUIREMENT
All elements below must be included in the quote for your quote to be considered responsive:
- If not brand name, documentation to prove how the “of equal” model/part meets the salient physical, functional, or performance characteristic specified in this solicitation.
- Country of Origin
- Place of Manufacture
- Estimated date of delivery
- Estimated shipping fees
PERIOD OF PERFORMANCE
Delivery is requested as soon as possible. Estimated lead time for delivery of equipment is 65 days upon Vendor’s receipt of the purchase order.
SHIPPING/DELIVERY INSTRUCTIONS
Delivery location is 9 West Watkins Mill Road, Rm 250, Gaithersburg, MD 20878. FOB: Destination. All equipment delivered shall contain a Packing Slip (with serial numbers when applicable).
INSTRUCTIONS
All interested offerors are invited to submit quotes for the requirement as outlined above and in Attachment 1 – Statement of Needs (SON).
- Price(s) (unit price, extended price, total price);
- Shipping fees;
- Manufacturing country of origin of the products, including components;
- Documentation demonstrating vendor is either the manufacturer or authorized distributor/reseller of the product(s);
- Estimated date of delivery;
- Point of contact: name, phone number & email;
- UEI#; Cage Code from active SAM.gov registration;
- Business size under NAICS 334516;
- Payment terms.
Each response must clearly indicate the capability of the vendor to meet all specifications and requirements. The Government will evaluate only those quotes that fully meet the requirements as outlined above and respond to the solicitation instructions and requirements.
NIAID intends to issue one RFQ with the possibility of making up to two (2) awards. However, preference will be given to quotes that offer a comprehensive solution, allowing for a single award. Vendors should clearly demonstrate how their quote meets all the specified requirements.
Vendors are encouraged to submit quotes that address the entire scope of the requirements. If a vendor can only meet part of the requirements, they may still submit a quote for that portion. In such cases, the quote should clearly specify which requirements are being addressed.
NIAID reserves the right to make up to two awards if it is determined to be in the best interest of the government. However, the preference is to make a single award to a vendor that can provide a comprehensive solution. By following these instructions, vendors can ensure their quotes are aligned with NIAID's preference for a single award, while also allowing for the possibility of multiple awards if necessary.
If providing an equal product(s)/services(s), please supply descriptive data for evaluation purposes to determine the validity of how it is an EQUAL. The following FAR provision applies to this a solicitation FAR 52.211-6 Brand Name or Equal (Aug 1999):
(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.
(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-
(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;
(2) Clearly identify the item by-
(i) Brand name, if any; and
(ii) Make or model number;
(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and
(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.
(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.
(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.
(End of provision)
Quotes are due by 12:00 pm EST, September 23, 2024. Quotes must be emailed to Daveta H. Brown, Contract Specialist, at daveta.brown@nih.gov. Late quotes will not be considered. All responsible sources may submit an offer that will be considered by this Agency. Any questions or concerns regarding this combined synopsis/solicitation should be emailed to daveta.brown@nih.gov.
EVALUATION
NIAID will evaluate quotes to determine the best value to the government. NIAID will make that determination based on technical acceptability, past performance, a comprehensive solution and price. NIAID will evaluate past performance and price only for those quotes which are rated as technically acceptable. In the event quotes are evaluated as technically equal, past performance, and price will become major considerations in selecting the successful Quoter. Preference will also be given to quotes that provide a complete solution, thereby allowing NIAID to make a single award. Vendors should clearly demonstrate how their quote meets all the specified requirements.
SPECIAL NOTICE TO OFFERORS
Offerors are advised that the Government may share your information with non-government personnel who are assisting with the evaluation of quotes. The exclusive responsibility for source selection will reside with the Government. By submitting your quote, you will be consenting to disclosure of your quote to non-government personnel for purposes of evaluation.
ELECTRONIC INVOICING
The successful offeror may submit an invoice once a shipment is delivered. NIAID will only accept invoices for units that have been delivered to NIAID.
NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). For contractors that have transitioned to IPP, the Contractor must submit invoices to the Department of Treasury's Invoice Processing Platform (IPP) at https://www.ipp.gov. For contractors that have not transitioned to IPP, the Contractor shall submit invoices to the National Institutes of Health (NIH)/Office of Financial Management (OFM) via email at invoicing@nih.gov with a copy to the approving official until the Contractor has been notified of its transition to IPP.
PROVISIONS AND CLAUSES
FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)
This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquistion.gov/
The following FAR provisions apply to this acquisition:
FAR 52.203-18 – Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements – Representations (Jan 2017)
FAR 52.204-7 – System for Award Management (Oct 2018)
FAR 52.204-16 – Commercial for Government Entity Code Reporting (Aug 2020)
FAR 52.204-24 – Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
FAR 52.204-26 – Covered Telecommunications Equipment or Services-Representation (Oct 2020)
FAR 52.209-7 – Information Regarding Responsibility Matters (Oct 2018)
FAR 52.211-6 – Brand Name or Equal (Aug 1999)
FAR 52.212-1 – Instructions to Offerors – Commercial Products and Commercial Services (Sep 2023)
FAR 52.212-3 – Offeror Representations and Certifications – Commercial Products and Commercial Services (May 2024)
FAR 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/these address(es): https://www.acquistion.gov/
FAR 52.204-13 – System for Award Management Maintenance (Oct 2018)
FAR 52.204-18 – Commercial and Government Entity Code Maintenance (Aug 2020)
FAR 52.204-21 – Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)
FAR 52.212-4 – Contract Terms and Conditions – Commercial Products and Commercial Services (Nov 2023)
FAR 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)
By reference the Department of Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses that are applicable to this requirement. Copies are available from http://www.hhs.gov/policies/hhsar/:
Clauses
HHSAR 352.203-70 – Anti-lobbying (Dec 2015)
HHSAR 352.208-70 – Printing and Duplication (Dec 2015)
HHSAR 352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)
By full text the Department of Health and Human Services Acquisition Regulation (HHSAR):
HHSAR 352.232-71 - Electronic Submission of Payment Requests (February 2, 2022)
HHSAR 352.239-78 – Information and Communication Technology Accessibility Notice (Feb 2024) (DEVIATION)
HHSAR 352.239-79 – Information and Communication Technology Accessibility (Feb 2024) (DEVIATION)
The following additional clauses are applicable to this requirement and provided in full text as Attachments.
FAR 52.212-5 - Contract Terms and Conditions Required to Implement Status or Executive Orders – Commercial Products and Commercial Services (May 2024)
LIST OF ATTACHMENTS
Attachment 1 – Statement of Needs (SON)
Attachment 2 – Bill of Materials (BOM)
Attachment 3 – Full Text Clauses
