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-24-2224320 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 2024-05 Effective May 22, 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 up to two Firm Fixed Price (FFP) awards under this solicitation.
By submitting a quote, the vendor acknowledges they are required to be registered and visible in the System for Award Management (SAM) database at the time of quote submission. The vendor must maintain this registration status until the time of award, throughout the performance of the contract, and until final payment is made for any contract 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 Production Program (VPP) of the Vaccine Research Center (VRC) is a seeking to acquire two (2) Biolayer Interferometer Instruments to support monoclonal antibody and vaccine projects. Quoters must be authorized resellers of the Biolayer Interferometer Instrument products/services being quoted.
Specifically, NIAID, VRC, VPP is seeking to acquire one (1) GatorPivot 16 (SKU 110055) system and one (1) GatorPro 32 Channel (SKU 110033) system (Brand Name or Equal) to meet the specifications and perform the applications listed below. The brand name and part numbers for the products/services are detailed in the attached Bill of Materials (BOM). To be considered for award, vendors quoting “equal” products/services, including “equal” products/services of the brand-name manufacturer, must meet the following minimum requirements/specifications:
The installation material, labor and training must be included with both BLI. The training should be a minimum of two (2) days on-site with an application specialist for up to six people.
A. Instrument #1: Salient/Key Requirements for Downstream Development Biolayer Interferometer:
1) Biolayer Interferometer (BLI): A BLI instrument is required to support the development of vaccines at the VPP. The BLI is used for high-throughput quantification of specific proteins and protein epitopes of interest from samples obtained during protein purification development. The BLI is used in conjunction with automated liquid handlers to rapidly screen purification procedures for specific desired protein antigens and tune purification conditions to exclude misfolded protein antigens that would hinder the resultant vaccine efficacy. The ability to isolate proteins of interest while controlling contaminants is critical to gaining regulatory approval of the vaccine candidates.
2) Acceptable size dimensions: Rigid limits of 79 cm in length x 87 cm in width x 92 cm in height for the equipment, potential key add-ons, and other key components combined. These dimensions are required due to the physical size constraints needed to integrate the instrument to an automation platform.
3) Power requirements: No more than 2x 220V plugs due to the power constraints of the lab.
4) Integration capability: Integration our liquid handling instrumentation is required to maintain the high throughput purification and analysis pipeline that is currently established. Integration allows for hands-off data generation and ability to process samples quickly and efficiently.
5) Kinetics Assay Specifications: These specifications are required to perform accurate binding assays with a BLI instrument during downstream process development.
a. Maximum sample capacity per run: 816
b. Molecular weight cutoff: >150 Da. We will be typically assaying proteins larger than 150 Da in size.
c. Association rate range: 10-107 M-1s-1
d. Dissociation rate range: 10-6-10-1 s-1
e. Measured affinity constant: 10 pM –1 mM. These are standard affinities measured during process development.
f. Epitope Binning Capacity: 20x20
g. Baseline noise: ≤ 4 pm. Minimal baseline noise is required for good curve fitting and processing of low nm shift on the instrument.
h. Baseline Drift: ≤ 0.1 nm/hour. Minimal baseline shift is important over long assays greater than 1 hour.
i. Acquisition rate: 2, 5, and 10 Hz acquisition. Variable acquisition is necessary due to the wide range of kinetics interactions observed during downstream development.
6) Temperature control: Temperature control ranging from 15°C to 40°C is required for ability to complete temperature dependent experiments.
7) Minimum Sample Volume: A minimum volume of 40uL is required to minimize lost sample due to analysis.
8) User friendly analysis software: Intuitive and user-friendly interface required for ease and flexibility in data analysis. Ease of export of raw data for other software analysis. The built-in analysis software should be as transparent as possible, showing curve fits and fitting parameters. The software should also be installable on other computers to allow for remote data analysis.
9) Large range of biological sensors with high sensing dynamic range:
a. Protein A, Protein G and Protein L sensors: 0.02-2,000 ug/mL.
b. Human fC sensor: 0.05-300 ug/mL.
c. Ni-NTA sensor: 0.25-1,000 ug/mL.
10) Anti-PEG biosensors: Required for process development of lipid nanoparticle-based vaccines.
11) Low Coefficient of Variation across all concentrations: Probes are required to have less than 10% variability in sample reads at all concentrations. This is extremely important for low concentration assays.
12) Minimal loss of signal due to regeneration: Regeneration of probes is used to reduce the cost and time to perform each experiment. Probe regeneration should minimize loss of binding signal to less than 10% per regeneration.
13) Simultaneous read capacity: Simultaneous read of both 8 and 16 channels is required and allows for flexibility in experiment design.
14) Evaporation Control: Evaporation control is required as evaporation of samples as can lead to inconsistencies in results and unreliable data.
15) Microplate format: Required to support both up to two 96 and 384 well microplates simultaneously.
16) Probe Tray Evaporation Reduction: The probe tray should also prevent evaporation of probe buffer by allowing the probes to make a seal in the well, extremely important for long experiment times.
B. Instrument #2: Salient/Key Requirements for Downstream Analytical Development Biolayer Interferometer:
1) Type of samples: Should be compatible to analyze proteins, antibodies, peptides, nucleic acids, liposomes, viruses, and small molecules.
2) Reading capacity: Should be able to simultaneously read and analyze up to 32 samples.
3) High through-put and sample capacity. Should be high through put with high sample testing capacity of greater than 1000 samples per batch with binning capacity of up to 32 parallel competitive reactions.
4) Sample molecular weight and volume: Should be able to test samples with molecular weight greater than 150 Da with minimal sample volume of less than 50 μL.
5) Kinetics and quantitation capability: Should be able to analyze following kinetics parameter range: (1) Association rate (Kon) of 101 to 107 M-1s-1. (2) Dissociation rate (Koff) of 10-6 to 10-1 s-1. (3) Affinity constant of (KD) of 10 pM – 1 mM. (4) Quatitation range of 0.02 – 2000 μg/mL.
6) Spectrometer and plate capacity: Should have at least 32 spectrophotometer which is capable to read and analyze 96-well and 384 well plate formats.
PERIOD OF PERFORMANCE
Delivery of equipment is needed as soon as possible and required within 90 days after receipt of award-estimated November 29, 2024. Installation and all services must be completed by March 25, 2024.
SHIPPING/DELIVERY INSTRUCTIONS
Delivery location is FOB Destination: 9 West Watkins Mill Road Gaithersburg, MD 20878. All equipment delivered shall contain a Packing Slip.
INSTRUCTIONS
All interested vendors are invited to submit a quote for the requirement as outlined above. Each quote must include the following details:
1. Price(s) (unit price, extended price, total price)
2. Shipping fees
3. Manufacturing country of origin of the products, including components
4. Documentation demonstrating vendor is either the manufacturer or authorized distributor/reseller of the product(s)
5. Estimated date of delivery
6. Point of contact: name, phone number & email
7. Unique Entity ID (UEI) and Cage Code from active SAM.gov registration
8. Business size under NAICS 334516
9. 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 4:30 PM EST on September 13, 2024. Quotes must be emailed to Hershea Vance, Contract Specialist, at hershea.vance@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 11, 2024, at 11:30 am to hershea.vance@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 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.acquistion.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)
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)
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 352.239-78 – 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 – Bill of Materials (BOM)
Attachment 2 - Full Text Clauses
