Serological Assays for the Detection and Characterization of Influenza Viruses

Amendment / Modification

This amendment (Amendment 2) to Solicitation 75D30125R73235 makes the following changes:

• Updates to FAR clauses and provisions due to new Executive Orders.

• Revision of dates for various steps in the solicitation process.

• Addition of clarifications to the Phase I requirements.

• Inclusion of SF33 (Solicitation, Offer and Award) and SF30 (Amendment of Solicitation/Modification of Contract) forms for signature.

• Inclusion of an amended solicitation document with track changes.

• Addition of a Q&A document.

• Inclusion of a copy of the amendment with all changes accepted.

• Solicitation document (with track changes)

• Phase I requirements

• Forms (SF33, SF30)

• Q&A document

• Proposal deadlines and submission requirements may be affected by the updated dates and clarifications. Offerors must acknowledge receipt of this amendment.

Amendment / Modification

This amendment to Solicitation No. 75D30125R73235, dated 01/16/2025, makes several key changes:

• FAR Clauses and Provisions: Updates are made to comply with new Executive Orders.
• Timeline Adjustments: Dates for all solicitation process steps have been updated.
• Phase I Requirements: Clarifications have been added to the Phase I requirements.
• Included Documents: The amendment includes the SF33 and SF30 for signature, an amended solicitation with track changes, and a Q&A document.
• Accepted Changes: A copy of the amendment with all changes accepted is provided.

• The solicitation document itself has been amended.

• Specific FAR clauses and provisions have been updated.

• Dates for various stages of the solicitation process have been modified.

• Offerors must acknowledge receipt of this amendment.

• Offers must be received by the updated hour and date specified in the solicitation or as amended.

• Failure to acknowledge receipt may result in rejection of an offer.

• Changes to offers already submitted must reference this amendment and be received prior to the new opening hour and date.

Questions & Answers / Clarifications

This document provides clarifications and answers to questions raised by potential bidders regarding the Serology Phase I proficiency panel testing.

• Test Samples: The panel will contain 20 test samples.
• Controls: Known positive or negative control samples will be included.
• Antigen vs. Virus: The "antigen" referred to in the proficiency panel is a form of the test virus itself, not a substitute.
• Testing: Testing will be done per antigen, with 3 antigens to be tested individually.
• Back Titration: "Virus back titration" refers to the confirmation of antigen concentration in HAU.
• Pass/Fail Criterion: The threshold for defining positives is a 4-fold rise of paired samples.
• Viral Titer Level: Offerors must report viral titer, not just YES/NO responses. Information to be submitted includes virus back titration(s) and sample titers against the tested antigen(s).
• Strain Specification: The CDC will specify the virus antigen.
• RBC Type: While the lab typically uses Chicken, Turkey, Guinea Pig, and Horse RBCs, the suggestion is to use turkey red blood cells for this testing.

This Q&A document clarifies specific technical requirements and submission details, impacting how bidders should prepare their proposals and conduct testing.

Amendment / Modification

This amendment (00001) to Solicitation 75D30125R73235 modifies the original solicitation with the following key changes:

• Phase I Interest Due Date Extended: The due date for Phase I interest has been extended to February 21, 2025.

• Ship Date Changed: The ship date has been changed to March 10, 2025.

• Phase I Test Results Due Date Changed: The due date for Phase I test results has been changed to March 25, 2025.

• Notification Date Changed: The notification date has been changed to April 10, 2025.

• Phase II Dates Adjusted: All dates for Phase II have been adjusted (noted via track changes in the solicitation package).

• Overall Impact: As a result of these changes, both the Phase I and Phase II due dates have been extended.

• The solicitation package itself, with specific track changes indicating adjustments to Phase II dates.

• Offerors are required to acknowledge receipt of this Amendment 00001 with their proposal submission.

• The due date for Phase I interest has been extended to February 21, 2025.

Amendment / Modification

This amendment (00001) to solicitation 75D30125R73235 makes the following changes:

• Phase I Interest Due Date: Extended to February 21, 2025.
• Ship Date: Changed to March 10, 2025.
• Phase I Test Results Due Date: Changed to March 25, 2025.
• Notification Date: Changed to April 10, 2025.
• Phase II Dates: All dates for Phase II have been adjusted (details available via track changes in the solicitation package).
• Overall Impact: The Phase I due date is extended, and Phase II due dates are also extended.

This amendment modifies the original solicitation dated January 16, 2025.

Offerors must acknowledge receipt of this amendment with their proposal submission. The due date for receipt of offers is extended. Refer to Block 14 on page 1 of the Solicitation and Block 11 of this Amendment for details on acknowledging receipt.

Solicitation / RFP / RFQ

This solicitation is for "Serological Assays for the detection and characterization of influenza viruses." The Centers for Disease Control and Prevention (CDC) requires services to support the Influenza Division in testing human sera via hemagglutination inhibition (HAI) assay and to develop a new serology platform comparable to HAI. This is a competitive, full and open procurement under FAR Part 15, with NAICS code 325413.

• Core Requirement: Perform HAI serological assays on human samples. Base level is 6,000 samples per period of performance (POP). Includes SOP transfer, proficiency panel testing, sample testing, and result reporting.

• Optional Tasks:

  • Task 1: Gap Analysis - Literature search and expert consultation to identify knowledge gaps and evaluate existing technology for a new serology assay.
  • Task 2: Assay Development - Design, validate, and deliver an improved serology assay comparable to HAI, using high throughput technology.

• Surge Support: Optional CLINs for surge support are available at 50% (9,000 tests) and 75% (10,500 tests) above base levels.

• Deliverables: Include HAI SOP, proficiency panel reports, sample testing results, interim technical reports, final technical summary reports, and annual reports.

• Contract Type: Firm-fixed-price (FFP) with a cost-plus-fixed-fee (CPFF) completion optional task.

• Period of Performance: Base Period (June 4, 2025 - June 3, 2026) plus four 12-month option periods (through June 3, 2030).

• Place of Performance: Primarily off-site at the contractor's facility, with some work at the CDC campus in Atlanta, GA.

• Government Furnished Materials: Protocol for serological testing, antiserum, viruses/antigens, proficiency panels, and human samples.

• Proposal Submission: Two-phased process (Phase I: Letter of Interest and proficiency panel results; Phase II: Technical, Past Performance, and Cost/Price proposals).

• Phase I Due Date: February 26, 2025.

• Phase II Due Date: April 8, 2025.

• Evaluation Criteria: Best value tradeoff process. Factors are Technical (most important), Past Performance, and Cost/Price. Technical subfactors are Technical Approach, Management Plan, Staffing Plan, and Similar Experience (all equally weighted).

• NAICS Code: 325413

• Small Business Size Standard: 1,250 employees.

• This is a competitive, full and open procurement.

• Service Contract Act applies.

• Offerors must comply with HHS EIT accessibility standards (Section 508).

• Non-personal services contract.