Multi-Antigen Diagnostic Tests

COMBINED SYNOPSIS SOLICITATION I. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services”, as supplemented with additional information included in this notice. The procedures from FAR Parts 12, 15, and 19 are being utilized as part of the Request for Proposal (RFP).

This announcement constitutes the only solicitation; proposals are being requested, and a written solicitation will not be issued. II. The solicitation number is 75A50424R00006 which is a Request for Proposal (RFP). The solicitation document and incorporated provisions and clauses are currently in effect through Federal Acquisition Circular 2024-06 effective August 29, 2024. III. Contract Type will be Firm Fixed Price (FFP).

NOTICE TO Offerors: This acquisition is being posted as a 100% Small Business Set-Aside in accordance with FAR 19.502-2 Total small business set-asides.

NAICS Code: 325413 - In Vitro Diagnostic Substance Manufacturing. The size standard is 1,250 employees.

Product Service Code: 6550 – In Vitro Diagnostic Substances, Reagents, Test Kits and Sets. This includes in vitro diagnostic aids, such as test tablets, test slides, test strips, test cards, test papers, test solutions, reagents; sets and kits designated for in vitro qualitative and quantitative tests on specimens, such as blood, urine, feces, and the like, for the purposes of aiding in the medical diagnosis of disease, determining body organ dysfunction, or other abnormal conditions. IV.

a. The U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Center for Industrial Base Expansion and Supply Chain (IBMSC) has a requirement for commercial off-the-shelf multi-antigen diagnostic tests kits, also known as multiplex tests, which are capable of detecting SARS, CoV-2, and Influenza A/B.

b. The Government intends to evaluate offers and award a single-award, Firm-Fixed Price contract without discussions.

c. Award is anticipated for a total one million commercial off-the-shelf multi-antigen diagnostic tests kits, also known as multiplex tests, which are capable of detecting SARS, CoV-2, and Influenza A/B. One award to the lowest price technically acceptable offeror (LPTA) is anticipated. This RFP does not represent the guarantee that any contract awards will be made. This requirement is a 100% small business set-aside.

d. Offerors are encouraged to provide their lowest price, best offer in response to this request for proposal. The Government is asking for any and all discounts, including spot discounts, one-time discounts, prompt payment discounts, and volume discounts. The proposed unit price shall include all shipping and delivery costs to the Government’s warehouses. V. See Sections B and C below for description of requirements, including a list of line-item number(s), quantities, and units of measure. VI.

The delivery period will begin 15 days after receipt of award (ARO) with a period of performance of 12 months. See Section F.1 below for additional delivery information. VII. The FAR provision at 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision include submission instructions. VIII. The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, applies to this acquisition.

Addenda to the provision include evaluation approach and factors. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services, with its offer, if not available in the System for Award Management (SAM). IX. The Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition.

X. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (May 2024), applies to this acquisition and FAR clauses applicable include, but are not limited to:

52.219-9, 52.219-14, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See Sections D through I. XI. There are no special contract requirements or terms and conditions related to contract financing arrangements. XII.

HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A-Health Resources Priorities and Allocations System. XIII. Proposals are due via e-mail by 4:00PM ET on Tuesday, September 17, 2024, to IBMSCC-Submissions@hhs.gov and copied to christopher.newell@hhs.gov .

The proposal shall include a single point of contact (name, title, phone number, email) who is authorized to commit the company financially. The proposal shall be submitted in accordance with ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES. FORMATTING AND PAGE LIMITATIONS A. Formatting for proposals • Proposals should not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. • Font size should be 11 point.

B. Page limitations: The technical proposal should be no more than 15 pages in length. This page limit does not include cover pages, table of contents, cross reference Matrix, appendixes and attachments. If the Offeror includes appendixes with information not expressly allowed herein, the Offeror should note that such information may not be evaluated.

Proposal pages should be numbered “Page 1 of 15, “Page 2 of 15” etc. Only Electronic submissions will be accepted and shall be submitted via email to IBMSCC-Submissions@hhs.gov and copied to christopher.newell@hhs.gov. All submissions must include the solicitation number and the word “SUBMISSION”. It is recommended that offerors limit email submissions to 2MB. If submissions are going to exceed this size, it is recommended that offerors submit them as clearly titled and numbered separate emails or as a zip file.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All questions regarding this RFP must be submitted electronically by email to IBMSCC-Submissions@hhs.gov and copied to christopher.newell@hhs.gov no later than 4:00pm ET, Thursday, September 12, 2024. For proper submission of questions, include the solicitation number and the word “QUESTION” in the subject of the email.

The Government’s responses to questions will be posted as an amendment to the combined synopsis/solicitation posting. Please be advised that the Government reserves the right to transmit those questions and answers of a common interest to all prospective offerors. The Government also reserves the right to respond or not respond to any questions at its discretion. No calls will be accepted.

All questions received by the stated deadline will be answered via a solicitation amendment and posted on the Contracting Opportunities (https://sam.gov/) website. The point of contact for information regarding this combined synopsis/solicitation are:

Contracting Specialist: Christopher Newell Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA) Administration for Strategic Preparedness & Response (ASPR) U.S. Department of Health and Human Services (DHHS)

Email: christopher.newell@hhs.gov Contracting Officer: Tonya Woodford Purce Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA) Administration for Strategic Preparedness & Response (ASPR) U.S. Department of Health and Human Services (DHHS)

Email: tonya.purce@hhs.gov XIV. Vendors are required to complete all fill-in Provisions listed in the solicitation. The combined synopsis solicitation notice includes the following:

The FAR provision at 52.212-1, Instructions to Offerors -- Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision include submission instructions. The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, applies to this acquisition. Addenda to the provision include evaluation approach and factors.

Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services, with its offer, if not available in the System for Award Management (SAM). Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition.

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 and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition and found in Section I - Contract Clauses and Provisions.

The FAR Provision found at 52.204-7(b)(1) requires that an Offeror is to be registered in SAM when submitting an offer or proposal and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. All interested Offerors must be registered in SAM prior to submitting a proposal. You may access the SAM website at https://sam.gov/content/home . All Offerors must be certified as with the appropriate NAICS code on the SAM website.