Assay Kits for Lumipulse instrument

Title:     Assay Kits for Lumipulse instrument.

(i)           This is a combined synopsis/solicitation for commercial product prepared in accordance with the format in 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.

(ii)          The solicitation number is 75N95025Q00005-RFQ and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial product and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, and FAR Part 12—Acquisition of Commercial Product or Commercial Service and is not expected to exceed the simplified acquisition threshold.

(iii)         The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2025-01, with effective date November 12, 2024.

(iv)         The associated North American Industry Classification System (NAICS) code is 325413 – In-Vitro Diagnostic Substance Manufacturing and the small business size standard is 1,250 employees.  This requirement is full and open with no set-aside restrictions.

(v)          This requirement is for the purchase of assay kits for quantification of serum/plasma of abeta42, abeta40, and pTau 217. (Brand Name or Equal).

(vi)         See Purchase Description attached to this solicitation (Attachment 1). All deliverables required under this contract shall be packaged, marked, and shipped in accordance with Government specifications as stated in the Purchase Description.

(vii)        The Government anticipates award of a firm fixed-price purchase order for this acquisition.

Delivery will be f.o.b destination. The place of delivery and acceptance will be 251 Bayview Blvd, Baltimore, Maryland 21224.

(viii)       The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:  https://www.acquisition.gov/browse/index/far

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following FAR provisions apply to this acquisition and are incorporated by reference:

• FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements – Representation (Jan 2017).
• FAR 52.204-7, System for Award Management (Nov 2024).
• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020).
• FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders – Representation and Disclosures (Dec 2023).
• FAR 52.211-6 Brand Name or Equal (Aug 1999).
• FAR 52.212-1, Instructions to Offerors-Commercial Items (Sept 2023).
• FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2024).

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:

https://www.acquisition.gov/browse/index/far     https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html 

(End of clause)

The following FAR/HHSAR clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018).
• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020).
• FAR 52.212-4, Contract Terms and Conditions--Commercial Product or Commercial Service (Nov 2023).
• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015).

The following FAR/HHSAR provisions and clauses apply to this acquisition and are attached in full text.  Offerors MUST complete the provisions at 52.204-24, 52.204-26 and FAR 52.225-6 and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021). (Attachment 2)
• FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) – if not included in the current www.sam.gov registration. (Attachment 3)
• FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Product or Commercial Service (Nov 2024). (Attachment 4)
• FAR 52.225-6, Trade Agreements Certificate (Feb 2021) – if not included in the current www.sam.gov registration. (Attachment 5)
• HHSAR 352.239-78, Information and Communication Technology Accessibility Notice (Feb 2024) (DEVIATION). (Attachment 6)
• HHSAR 352.239-79, Information and Communication Technology Accessibility Notice (Feb 2024) (DEVIATION). (Attachment 7)

The following invoice instruction is included and will be incorporated in the final award:

• Invoicing Instructions with IPP (Mar 2023). (Attachment 8)

(ix)         The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (a) technical capability; (b) price, and (c) past performance [see FAR 13.106-2(b)(3)]. Technical capability and past performance, when combined, are significantly more important than price.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(x)          Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Commercial Product or Commercial Service (May 2024), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(xi)         There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xii)        The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiii)       Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations.

Respondents proposing on an equal product of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. 

The Unique Entity ID (UEI) from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All quotations must be received by 5:00 p.m., Eastern Time on January 15, 2025 (revised), and reference Solicitation Number 75N95025Q00005-RFQ. Responses must be submitted electronically to Iris Merscher, Contract Specialist, at iris.merscher@nih.gov.