This notice is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulations (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and Solicitation for Commercial Items”, as applicable, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; (a written solicitation will not be issued) and quotations (quotes) are being requested. The solicitation number is RFQ-NIAID-24-2220774 and the solicitation is issued as a Request for Quotation (RFQ).
This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures, 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 small business size standard of 1,000 in employees. This requirement is not set-aside for small business. The Government anticipates making a single award Firm Fixed Price (FFP) purchase order. By submission of a quote, the Offeror acknowledges the requirement that a prospective awardee shall be registered and viewable in the System for Award Management (SAM) database prior to award, during performance, and through final payment resulting from this solicitation (www.sam.gov).
STATEMENT OF NEED
The proposed purchase is for Brand Name or Equal products/services.
The National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Production Program (VPP) is seeking to acquire two (2) Brand Name Sartorius Ambr 250 High Throughput or Equal High Throughput Bioreactor Systems for its Cell Culture Development (CCD) team. The VPP is the development arm of the VRC at the NIAID. The mission of the VRC is to create and develop potentially lifesaving vaccines for HIV, Ebola, Zika, and other known pathogens and get these potentially lifesaving products into the clinic. This acquisition seeks to ensure the VPP’s CCD team maintains smooth operation by replacing end-of-life equipment. Multiple mechanical failures due to aging components of the existing instrument have negatively affected hitting target milestones of multiple projects and ultimately the VRC’s timeline. Unplanned downtime while the instruments are being repaired have led to delays in critical studies to select top clones for production and have led to delays in the selection of top cell lines for master cell bank production. With the procurement of the replacement equipment, it will help to prevent bottlenecks and work stoppage, as well as provide rapid response, available throughput, and operational preparedness for the entire VPP.
Specifically, NIAID, VRC, VPP is seeking two (2) High Throughput Bioreactor Systems that includes delivery, installation, training, and 12-months warranty, including parts and labor, as well as all components and services outlined in the Bill of Materials (BOM). To be considered for award, the vendor quoting “equal” products/services, including “equal” products/services of the brand-name manufacturer must meet all the technical requirements listed below:
- Must be high throughput, 24 reactor, scale-down model designed for process development.
- Each unit must have a length no greater than 400 cm (13ft 2in) and a depth of not more than 115 cm (3ft 10 in), and a height not more than 249 cm (8 ft 2in) excluding space for PC, chiller, and other ancillary equipment to ensure it fits within the available laboratory space.
- Must work on available power, 3 phase (plus neutral and primary earth) 380-440 VAC (phase to phase, 50/60Hz and capable of a minimum of 15A per phase and have an electrical disconnect isolator.
- Both systems must possess the ability to be hardwired.
- Both Systems must include a chiller which operates on 230 V supply @50 Hz with rated load current of approximately 8.8 AMPs.
- Each system must have ability to support unlubricated oxygen, nitrogen, and carbon dioxide supplies between 1.5 to 2 bar (20-29 psi).
- Perfusion system must allow for up to 3.5 bar compressed air inlet to instrument via supplied 6mm OD polyurethane tubing.
- Stirred tank system must allow for up to 2 bar compressed air inlet to instrument via supplied 6mm OD polyurethan tubing.
- Working area is equivalent to a Class II Biosafety Cabinet (BSC) interior.
- Suitable for both perfusion and standard fed-batch cell culture processes.
- Should provide individual bioreactor control for DOE optimization.
- Capable of integrating automated sampling with at-line analysis options for pH, cell count, or metabolite analysis.
- Capable of inputting processes algorithms for Design of Experiments (DOE) protocols.
- Perfusion Towers:
- Support and control perfusion pump chambers, pinch valve cassette, and perfusion filter.
- Flow Control and Collection System:
- Includes perfusion crossflow and permeate pumps.
- Automated bleed functions.
- Collection sets with bags and tubing management features for both permeate and bleed fluids.
- Walk-away permeate sampling system for samples up to 10 mL.
- Liquid Handling Unit:
- Facilitates addition of media, feed, cells, and reagents.
- Capable of sampling from bioreactor vessels using either 10 mL or 300 µL pipettes.
- Transfer samples to deck locations or integrated analyzers.
- Control Software:
- User interface optimized for protocol configuration, control, and visualization of multiple parallel bioreactors.
- Full control over individual bioreactors.
- High Productivity System:
- Automation must enable a single user to conduct multiple bioreactor experiments, including DOE.
- Single-use bioreactors must reduce operator time needed for cleaning and setup.
- Capability to utilize single use bioreactors to reduce the need for bioreactor wash-up and autoclaving.
- Supports automatic clean-in-place (CIP).
- Consistency and Reliability:
- Automated control and liquid addition to reduce variation and human error.
- Consistent data sets for better analysis and decision-making.
- Automated Sampling:
- Aseptic pipetting to reduce operator time significantly.
- Integration with at-line analyzers for pH, cell count, and metabolite analysis. (existing ViCell Blu and NovaFlex II instruments)
- SCADA integration:
- Must be able to be integrated into Program’s current system which is Lucullus.
PERIOD OF PERFORMANCE
Delivery of equipment is preferred as soon as possible and required within 65 days after receipt of award – estimated delivery date is December 4, 2024, which includes a 12-months warranty to take effect upon installation of the system.
SHIPPING/DELIVERY INSTRUCTIONS
Delivery location is FOB Destination: Vaccine Research Center, 9 West Watkins Mill Road, Gaithersburg, MD 20878. All equipment delivered shall contain a Packing Slip.
INSTRUCTIONS
All interested vendors shall provide a quote for the requirement as outlined in this solicitation. All quotes shall include:
- 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
- Unique Entity ID (UEI) and cage code from a valid and 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. Failure to furnish a full and complete quote as instructed will result in the Quoter’s response being considered non-responsive and will therefore be eliminated from further consideration and award.
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 3:00 PM EST on September 17, 2024. Quotes must be emailed to Kathy Song, Contract Specialist at kathy.song@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 by September 12, 2024 at 3:00 PM EST to kathy.song@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, 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.
SPECIAL NOTICE TO QUOTERS
Quoters 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 vendor may submit an invoice once a shipment is delivered. NIAID will only accept invoices for completed services and 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.acquisition.gov/
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 and 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 Certification – Commercial Products and Commercial Services (May 2024)
The following HHSAR provision is applicable and provided in full text below:
HHSAR 352.239-78 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE (FEB 2024) (DEVIATION)
(a) Any offeror responding to this solicitation must comply with established HHS Information and Communication Technology (ICT) accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/section-508/index.html.
(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-79 Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies, products, platforms, information, and documentation meet applicable Section 508 accessibility standards, offerors must submit an appropriate HHS Section 508 Accessibility Conformance Checklist (see https://www.hhs.gov/web/section-508/accessibility-checklists/index.html) or an Accessibility Conformance Report (ACR) (based on the Voluntary Product Accessibility Template (VPAT) see https://www.itic.org/policy/accessibility/vpat), in accordance with the completion instructions. The purpose of the checklists and conformance reports are to assist HHS acquisition and program officials in determining whether proposed ICT supplies, products, platforms, information, and documentation conform to applicable Section 508 accessibility standards. Checklists and ACRs evaluate—in detail—whether the ICT conforms to specific Section 508 accessibility standards and identifies remediation efforts needed to address conformance issues.
(c) If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies, products, platforms, information, documentation, or services support delivered do not conform to the described accessibility standards, remediation of the supplies, products, platforms, information, documentation, or services support to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.
(d) In order to facilitate the Government's determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit an Accessibility Conformance Report, in accordance with its completion instructions and tailored to the requirements in the solicitation. The purpose of the Report is to assist HHS acquisition and program officials in determining whether proposed ICT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document, in detail, whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available at https://Section508.gov/.
(e) In order to facilitate the Government's determination whether proposed ICT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the ICT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.
(f) Respondents to this solicitation must identify any inability to conform to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.
(g) Items delivered as electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/. Materials, other than items incidental to contract management, that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Contracting Officer’s Representative.
(End of provision)
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 52.242-15 – Stop-Work Order (Aug 1989)
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 (December 18, 2015)
HHSAR 352.208-70 – Printing and Duplication (December 18, 2015)
HHSAR 352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 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 352.239-79 – 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 – Bill of Materials (BOM)
Attachment 2 – Full Text Clauses
Amendment 001: Publish general questions and answers received. No other changes have been made to the RFQ. The due date for quotes remains the same.
