Serological Assays for the Detection and Characterization of Influenza Viruses
ID: 75D30125R73235Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFCENTERS FOR DISEASE CONTROL AND PREVENTIONCDC OFFICE OF ACQUISITION SERVICESATLANTA, GA, 30333, USA

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

MEDICAL- LABORATORY TESTING (Q301)
Timeline
    Description

    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking proposals for "Serological Assays for the Detection and Characterization of Influenza Viruses." The procurement aims to secure services for performing Hemagglutinin Inhibition (HAI) assays on approximately 6,000 human samples annually, with the potential for surge support up to 10,500 tests, alongside the development of new high-throughput serology assays. This initiative is crucial for enhancing the CDC's capabilities in monitoring and responding to influenza outbreaks. Interested parties should note that the solicitation has been reopened, with key deadlines extended, and are encouraged to contact Jennifer Gartzke at jgartzke@cdc.gov for contractual inquiries. The contract will span a base period of 12 months with four additional option years, and all work must comply with Section 508 accessibility standards.

    Point(s) of Contact
    Jennifer Gartzke
    jgartzke@cdc.gov
    Files
    Title
    Posted
    Amendment 00001 to Solicitation 75D30125R73235, issued by the Centers for Disease Control and Prevention (CDC), extends key deadlines for a contract focused on serological assays for influenza viruses. The due date for Phase I interest is now February 21, 2025, the ship date is March 10, 2025, Phase I test results are due March 25, 2025, and the notification date is April 10, 2025. All Phase II dates are also extended. The contract, a competitive full and open procurement under NAICS Code 325413, is for one base year (July 21, 2025 – July 20, 2026) and four option years. It includes firm-fixed-price (FFP) services for 6,000 annual sample tests and optional surge support at 9,000 or 10,500 tests, plus cost-plus-fixed-fee (CPFF) optional tasks for gap analysis and new serology assay development. The contractor will perform HAI serological assays, develop SOPs, and participate in project management. Travel for training and CDC staff training on new assays is also included. All offerors must acknowledge this amendment. The purpose is to support the CDC's Influenza Division by outsourcing HAI assays and developing new, high-throughput serology platforms comparable to HAI.
    Amendment 00001 to Solicitation 75D30125R73235, issued by the Centers for Disease Control and Prevention (CDC), extends key deadlines for a contract focused on serological assays for influenza viruses. The due date for Phase I interest is now February 21, 2025, the ship date is March 10, 2025, Phase I test results are due March 25, 2025, and the notification date is April 10, 2025. All Phase II dates are also extended. The contract, a competitive full and open procurement under NAICS Code 325413, is for one base year (July 21, 2025 – July 20, 2026) and four option years. It includes firm-fixed-price (FFP) services for 6,000 annual sample tests and optional surge support at 9,000 or 10,500 tests, plus cost-plus-fixed-fee (CPFF) optional tasks for gap analysis and new serology assay development. The contractor will perform HAI serological assays, develop SOPs, and participate in project management. Travel for training and CDC staff training on new assays is also included. All offerors must acknowledge this amendment. The purpose is to support the CDC's Influenza Division by outsourcing HAI assays and developing new, high-throughput serology platforms comparable to HAI.
    Amendment 2 to Solicitation 75D30125R73235, issued by the CDC, details changes to a federal government RFP for "Serological Assays for the Detection and Characterization of Influenza Viruses." The amendment updates FAR clauses and provisions, revises solicitation process dates, clarifies Phase I requirements, and includes a Q&A document. Key changes involve adjusting the periods of performance for the base and option years, extending them from June-June to August-August. The contract is a firm-fixed-price (FFP) with cost-plus-fixed-fee (CPFF) optional tasks. The scope includes core sample testing services (6,000 tests annually, with surge options up to 10,500 tests) and optional tasks for developing improved serology assays. The contractor will perform work off-site, with some training at CDC, and must comply with Section 508 accessibility standards. Deliverables include technical reports, SOPs, and meeting minutes.
    This document, Amendment 2 to solicitation 75D30125R73235, outlines a federal government Request for Proposal (RFP) for serological assay services for the Centers for Disease Control and Prevention (CDC). The RFP seeks services for detecting and characterizing influenza viruses through sample testing and the development of new serology assays. The contract includes a 12-month base period and four 12-month option periods, with core requirements for testing approximately 6,000 human samples per year using Hemagglutinin Inhibition (HAI) assay, and optional surge support for up to 10,500 tests. Additionally, optional tasks involve gap analysis and development of an improved, high-throughput serology assay. The contract is a hybrid of Firm-Fixed-Price (FFP) for sample testing and travel, and Cost-Plus Fixed Fee (CPFF) for optional assay development tasks. Key deliverables include SOPs, proficiency reports, technical reports, and annual reports. The work will primarily be off-site at the contractor's facility, with some training at CDC. The solicitation emphasizes compliance with Section 508 accessibility standards and includes a performance matrix for quality and timeliness of services.
    Amendment 2 for Solicitation 75D30125R73235, issued by the CDC, details a competitive RFP for "Serological Assays for the Detection and Characterization of Influenza Viruses." The solicitation outlines a base period and four 12-month option periods, from August 2025 to August 2030, for sample testing services and the development of new serology assays. Key requirements include performing Hemagglutinin Inhibition (HAI) assays on human samples (base of 6,000 tests/year, with surge options up to 10,500 tests), developing and validating new high-throughput serology assays, and providing project management. The contract is a hybrid of Firm-Fixed-Price (FFP) for sample testing and Cost-Plus-Fixed-Fee (CPFF) for optional assay development tasks. Travel for training and staff meetings is also specified. All work must adhere to Section 508 accessibility standards and various FAR/HHSAR clauses. Deliverables include SOPs, proficiency test results, sample test results, technical reports, and annual reports. This amendment updates FAR clauses, Phase I dates, and includes necessary forms, extending the offer receipt date to May 22, 2025.
    Amendment 2 to Solicitation 75D30125R73235, issued by the CDC, modifies the original solicitation by updating FAR clauses, adjusting Phase I dates, and including revised forms. This Request for Proposal (RFP) is for "Serological Assays for the Detection and Characterization of Influenza Viruses," encompassing a 12-month base period and four 12-month option periods, from August 8, 2025, to August 7, 2030. The contract structure includes Firm-Fixed-Price (FFP) for core sample testing (6,000 tests annually, with surge options up to 10,500 tests) and travel, and Cost-Plus-Fixed-Fee (CPFF) for optional tasks like "Gap Analysis" and "Assay Development" to create new serology platforms. Work will primarily be off-site, with some activities at the CDC in Atlanta, GA. Deliverables include SOPs, proficiency test results, technical reports, and annual reports. The solicitation emphasizes compliance with Section 508 accessibility standards for Electronic and Information Technology (EIT).
    Amendment 00004 to solicitation 75D30125R73235, effective April 15, 2025, announces the suspension of the solicitation until further notice. This amendment also introduces Vic Veguilla (dhu3@cdc.gov) as the new point of contact, replacing Jennifer Gartzke. While the evaluation of Phase I will continue as samples are received, vendors are no longer required to submit results for positive controls for B/Yamagata and B/Victoria. Progress into Phase II of the solicitation is also suspended until further notice. All other terms and conditions of the original solicitation remain unchanged. The issuing and administering office is the OFR - Office of Acquisition Services, Chamblee Campus Building 102, Atlanta, GA 30341.
    Amendment 5 to solicitation 75D30125R73235, dated January 16, 2025, is issued to resume all associated procurement activities. This amendment extends the offer receipt date and makes several key updates. It retains Vic Veguilla (dhu3@cdc.gov) as the Point of Contact for technical matters and adds Jennifer Gartzke (xuy7@cdc.gov) as the Contracting Officer POC for contractual and administrative inquiries. Additionally, the amendment provides responses to the government's evaluation of Phase I. All other terms and conditions of the original solicitation remain unchanged.
    The Centers for Disease Control and Prevention (CDC) has issued Solicitation 75D30125R73235, a Request for Proposal (RFP) for "Serological Assays for the Detection and Characterization of Influenza Viruses." This competitive, firm-fixed-price contract with a cost-plus-fixed-fee optional task seeks services to support the CDC's Influenza Division. The core requirement involves performing Hemagglutinin Inhibition (HAI) serological assays on approximately 6,000 human samples annually, with optional surge support for up to 10,500 tests. Additionally, the contract includes optional tasks for developing and validating new serology assays comparable to HAI, utilizing high-throughput technology for influenza subtype-specific antibody detection. The contract spans a 12-month base period and four 12-month option periods, from June 2025 to June 2030. The majority of the work will be performed off-site, with some activities at the CDC campus in Atlanta, GA. Key deliverables include SOPs, proficiency panel reports, sample test results, and annual reports. The solicitation emphasizes compliance with Section 508 accessibility standards for Electronic and Information Technology (EIT).
    The document outlines Amendment 1 for the solicitation and contract 75D30125R73235 issued by the Centers for Disease Control and Prevention (CDC) for serological assay services for influenza virus detection. The amendment extends deadlines for proposals and updates testing schedules while maintaining all other terms unchanged. It establishes a contract structure comprising a base period and four additional option periods, focusing on sample testing and development of new serology assays, with the goal of enhancing influenza virus characterization. The contractor is responsible for conducting high-throughput testing of human samples, utilizing government-furnished materials and adhering to performance benchmarks outlined in the contract. The document emphasizes the importance of quality control throughout the assays and detailed reporting requirements while allowing for surge support in response to increased testing demands. Furthermore, it stipulates compliance with the Service Contract Act and outlines travel reimbursement guidelines. The purpose of this contract is to bolster the CDC's influenza surveillance capabilities through improved assay development and testing methodologies. Overall, it is a critical procurement effort to enhance public health response capabilities regarding influenza threats.
    The document outlines Amendment 1 for the solicitation and contract 75D30125R73235 issued by the Centers for Disease Control and Prevention (CDC) for serological assay services for influenza virus detection. The amendment extends deadlines for proposals and updates testing schedules while maintaining all other terms unchanged. It establishes a contract structure comprising a base period and four additional option periods, focusing on sample testing and development of new serology assays, with the goal of enhancing influenza virus characterization. The contractor is responsible for conducting high-throughput testing of human samples, utilizing government-furnished materials and adhering to performance benchmarks outlined in the contract. The document emphasizes the importance of quality control throughout the assays and detailed reporting requirements while allowing for surge support in response to increased testing demands. Furthermore, it stipulates compliance with the Service Contract Act and outlines travel reimbursement guidelines. The purpose of this contract is to bolster the CDC's influenza surveillance capabilities through improved assay development and testing methodologies. Overall, it is a critical procurement effort to enhance public health response capabilities regarding influenza threats.
    The document outlines an amendment to the solicitation 75D30125R73235, issued by the Centers for Disease Control and Prevention (CDC) for a contract aimed at providing serological assays for influenza virus detection and characterization. The amendment modifies the solicitation process, including updates to Federal Acquisition Regulation clauses, revised dates, and clarifications on Phase I requirements. It establishes a firm-fixed-price contract with optional cost-plus fixed-fee tasks spanning a base period and four subsequent option periods. The contract focuses on performing hemagglutination inhibition (HAI) assays on approximately 6,000 human serum samples annually, with provisions for increased testing capacity during outbreaks. It includes requirements for SOP development, proficiency testing, sample management, and the creation of reports on testing results. Optional tasks aim to develop new serology assays that could enhance testing capabilities. Key government-furnished materials will support testing and validation, while the contractor is responsible for quality assurance and compliance with safety regulations. The document reinforces the commitment to utilizing performance-based acquisition methods, ensuring the effective oversight of public health through improved influenza surveillance.
    The document outlines an amendment to the solicitation 75D30125R73235, issued by the Centers for Disease Control and Prevention (CDC) for a contract aimed at providing serological assays for influenza virus detection and characterization. The amendment modifies the solicitation process, including updates to Federal Acquisition Regulation clauses, revised dates, and clarifications on Phase I requirements. It establishes a firm-fixed-price contract with optional cost-plus fixed-fee tasks spanning a base period and four subsequent option periods. The contract focuses on performing hemagglutination inhibition (HAI) assays on approximately 6,000 human serum samples annually, with provisions for increased testing capacity during outbreaks. It includes requirements for SOP development, proficiency testing, sample management, and the creation of reports on testing results. Optional tasks aim to develop new serology assays that could enhance testing capabilities. Key government-furnished materials will support testing and validation, while the contractor is responsible for quality assurance and compliance with safety regulations. The document reinforces the commitment to utilizing performance-based acquisition methods, ensuring the effective oversight of public health through improved influenza surveillance.
    The document outlines Amendment 2 of solicitation 75D30125R73235 from the Centers for Disease Control and Prevention (CDC) for contract services focused on developing and verifying serological assays for influenza virus detection and characterization. The contract emphasizes a competitive procurement approach with firm-fixed-price and cost-plus-fixed-fee tasks. Key components include providing sample testing services, with an estimated 6,000 tests per year, and optional surge capacities to handle higher volumes as needed. The performance work statement details the responsibilities surrounding the serological assays, including standard operating procedure (SOP) development, proficiency panel testing, and results reporting. It specifies both core and optional tasks, with timelines for periodic reporting and meeting engagements. The contractor's accountability in project management is highlighted, ensuring compliance with quality standards and timely communication with the government. Additionally, the document stresses the importance of using efficient travel practices and outlines potential travel requirements associated with training. The overarching aim is to enhance influenza surveillance capabilities while adhering to federal regulations and best practices, thus reflecting the CDC's commitment to public health and safety through scientific collaboration.
    The document outlines Amendment 2 of solicitation 75D30125R73235 from the Centers for Disease Control and Prevention (CDC) for contract services focused on developing and verifying serological assays for influenza virus detection and characterization. The contract emphasizes a competitive procurement approach with firm-fixed-price and cost-plus-fixed-fee tasks. Key components include providing sample testing services, with an estimated 6,000 tests per year, and optional surge capacities to handle higher volumes as needed. The performance work statement details the responsibilities surrounding the serological assays, including standard operating procedure (SOP) development, proficiency panel testing, and results reporting. It specifies both core and optional tasks, with timelines for periodic reporting and meeting engagements. The contractor's accountability in project management is highlighted, ensuring compliance with quality standards and timely communication with the government. Additionally, the document stresses the importance of using efficient travel practices and outlines potential travel requirements associated with training. The overarching aim is to enhance influenza surveillance capabilities while adhering to federal regulations and best practices, thus reflecting the CDC's commitment to public health and safety through scientific collaboration.
    This document serves as Amendment 4 to the solicitation numbered 75D30125R73235, issued by the Office of Acquisition Services, effective from April 15, 2025. The amendment includes key modifications to the solicitation process, specifically suspending the solicitation until further notice, and updating the point of contact (POC) to Vic Veguilla, while removing Jennifer Gartzke from that role. The evaluation of Phase I will continue as samples are received, but vendors are exempt from submitting results concerning specific positive controls—B/Yamagata and B/Victoria. Notably, the advancement into Phase II has been suspended until further notice. All other terms of the solicitation remain unchanged. This amendment emphasizes procedural updates in the context of government RFPs, ensuring compliance and clarity for potential offerors regarding submission requirements and points of contact amidst changing evaluation conditions.
    The document outlines a government solicitation for a contract with the Centers for Disease Control and Prevention (CDC) to provide serological assays for the detection and characterization of influenza viruses. The contract spans a base period of one year starting June 4, 2025, with four optional extension periods. The core tasks include performing hemagglutination inhibition (HAI) assays to analyze human serum samples and developing new serology assays. Companies may also implement optional "surge support" testing to respond to unexpected demand. The contract requires compliance with various government regulations, including travel and operational safety standards. The contractor must meet performance-based metrics, such as maintaining high accuracy and timely reporting of results. Deliverables include technical reports, training of CDC staff on assay protocols, and regular status updates. Overall, the document serves as a formal request for proposals, emphasizing the need for high-throughput testing capabilities in response to ongoing public health challenges associated with influenza surveillance and vaccine effectiveness studies. The government is focused on achieving efficient, reliable testing services while fostering innovation in serological assay methods.
    This document outlines a series of questions and answers regarding the Serology Phase I proficiency panel, focusing on the Hemagglutination Inhibition (HAI) assay. Key clarifications include the panel containing 20 test samples with controls, and 3 individual antigens to be tested. The
    The document addresses technical questions regarding a proficiency panel related to serology testing, specifically using the hemagglutination inhibition assay (HAI). It details that the panel will consist of 20 test samples, including both positive and negative controls, and will feature three individual antigens that need separate testing. The primary objective is to determine serum titers against these antigens, with a requirement for back titration of the antigens to confirm their concentration in hemagglutination units (HAU). The matching seroconversion rate is defined by a 4-fold rise in paired samples, and laboratories must report viral titers, calibrated against a strain specified by the CDC. The document also indicates a preference for using turkey red blood cells for testing. This inquiry and response format highlights the specificity required in government RFPs related to public health testing standards and emphasizes compliance and clarity in protocol to ensure effective results from the proficiency panel.
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