External Quality Assurance Program Oversight Laboratory (EQAPOL)

Introduction: This is a R&D Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources, including small and small disadvantaged businesses, to perform a potential R&D requirement. Background: The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to increase basic knowledge of the pathogenesis and transmission of the human immunodeficiency virus (HIV), support the development of therapies for HIV infection and its complications, and support the development of vaccines and other prevention strategies. Reliable laboratory data are essential to the clinical evaluation of candidate HIV vaccine platforms and immunogens. Data from multiple laboratories performing assays in support of vaccine or antibody candidate trials must be accurate and reproducible. The purpose of the EQAPOL contract is to provide confidence that individual laboratories generate reliable data to support vaccine immunogen advancement. EQAPOL supports these efforts by participating in the development and availability of validated assays, providing common and well-characterized reagents and Standard Operating Procedures (SOPs), and providing EQA programs to measure and monitor laboratory performance. EQAPOL has established proficiency testing programs that serve over 60 laboratories in more than 40 sites worldwide, and has provided a panel of fully characterized viruses from early acute HIV infections to develop new assays and validate assay platforms. The contract also established a peripheral blood mononuclear cell (PBMC) bank and an EQA reagent repository of characterized material that supports EQAPOL proficiency testing programs and are made available to NIAID-supported investigators. As a result of a solicitation, which utilized full and open competitive procedures, a cost-reimbursement, term type/level of effort contract (Contract No. HHSN272201700061C) for - External Quality Assurance Program Oversight Laboratory (EQAPOL) was awarded to Duke University Medical Center, 2200 West Main St., Suite 820, Erwin Square Plaza, Durham, NC 27705, on August 29, 2017, for the delivery of 1,682% direct labor effort per year. The total value of the contract, including options, was $41,463,666. The Base Period of the contract was from September 30, 2017 through September 29, 2018. The contract includes options for the extension of the term (Options 1-6), for a total maximum performance period of 7 years, through September 29, 2024, and quantity options for increases in the level of effort during the term of the contract, as follows: options for additional level of effort to support unanticipated increases in demand (Options 7-34), and options for the development and implementation of an EQA Program for HIV Incidence Assays (Options 35-41). The contract's scope involves quality assurance/quality control (QA/QC) and operational activities, including the following: QA/QC activities include: (1) providing proficiency testing programs and evaluating the performance of laboratories conducting assays measuring cellular, antibody, and cytokine responses in a variety of tissue types; (2) developing new assays; and (3) acquiring/establishing/characterizing unique clade-specific virus panels. Operational activities include: (1) the maintenance and expansion of a specimen and reagent repository; (2) the maintenance of a database to support contract activities; and (3) providing advice on assay validation, regulatory compliance and statistical issues. The COVID-19 Prevention Trials Network (CoVPN) was established by NIAID in 2020 to respond to the global COVID-19 pandemic, by investing in and coordinating the development and testing of COVID-19 vaccines and monoclonal antibodies to prevent COVID-19 disease and/or virus transmission. The CoVPN was formed by merging the capacities and expertise of four existing NIAID-funded clinical trials networks: the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN), the Infectious Diseases Clinical Research Consortium (IDCRC), and the AIDS Clinical Trials Group (ACTG). These individual networks continue to perform clinical trials for HIV vaccine and prevention, and other infectious diseases, in addition to their new COVID-19 roles. The CoVPN employs a harmonized vaccine protocol, which enables analyses of correlates of protection across multiple clinical trials. More than 100 trial sites across the United States and internationally perform assessments of COVID-19 countermeasures under the CoVPN. The CoVPN-affiliated laboratories have relevant expertise to perform serologic and cellular assays. Data from these assays, combined with systems immunology computational approaches, allow potential identification of correlates of protection, in efficacy trials of SARS-Cov-2 vaccines and antibodies. Performing laboratories have close integration with quality assurance programs in applying rigorous research methodology, quality control verification, and appropriate transfer of sample analyses for clinical trials. The institutions are compliant with Good Clinical Laboratory Practice (GCLP) and have expertise in rapidly onboarding new assay types through assay qualification and validation. However, it is imperative that primary laboratories are able to transfer the immunology assays to backup Contract Research Organization (CRO) laboratories, in order to ensure adequate laboratory capacity. Assay transfer requires close monitoring of laboratory performance, in order to ensure that all stakeholders have confidence in the data to support emergency use authorization and/or Biologics Licensure Applications (BLAs) for the vaccines and monoclonal antibodies. On October 7, 2020, in response to the COVID-19 pandemic, the contract was modified (Contract Modification No. 4) to procure SARS-CoV-2 EQA programs to monitor binding and neutralizing antibodies for this virus, and assay transfer support services for the Operation Warp Speed (OWS)-funded CRO labs (which are responsible for performing the immunology assays after transfer from the CoVPN-affiliated academic laboratories). The above referenced COVID-19 support services included the following specific activities: - Design, set up, manage, and coordinate EQA programs for neutralization and binding antibodies to SARS-CoV-2 to provide an unbiased assessment of data quality from participating laboratories; - Develop, maintain and expand an EQA reagent repository to support the SARS-CoV-2 immune assays; - Provide data management, biostatistics and project management support for the EQA programs; and - Monitor and trend positive/negative control assay results to determine any shifts in data as an indication of laboratory performance. The action resulted in the creation of Options 42 (315% effort) and 43 (315% effort), which were incorporated into the contract via Modification No. 4 (executed on November 12, 2020), and are broken out as follows: - Option 42 (11/12/2020 - 9/29/2021): $613,865 - Option 43 (9/30/2021 - 10/31/2021): $ 43,203 Total (Options 42 and 43): $657,068 As a result of Contract Modification No. 4, the total maximum potential contract value [i.e., the total value if the Base Period all options (Options 1-43) are exercised] was increased by $657,068, from $41,463,666 to $42,120,734. Since the focus of the EQAPOL contract is currently HIV/AIDS, the above required COVID-19 support services were outside of the original scope of the contract. As such, the additional work was added to the contract on a sole source basis, as a result of the HHS Class J&A for unusual and compelling urgency for the COVID-19 Response. This Sources Sought Notice (SS) is for information and planning purposes only, and shall not be construed as a solicitation or as an obligation on the part of the NIAID. Purpose and Objectives: The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP), if it deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against the NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID's use of such information, as either part of our evaluation process or in developing specifications of any subsequent requirement. At this time, in order to provide intra-laboratory reliability of fit-for-purpose humoral antibody assays with new mutant SARS-Cov-2 virus strains (for example B1.1.7 and B.1.351, P.1, identified in the UK, South Africa and Brazil, respectively), the implementation of a SARS-Cov-2 Neutralizing Assay Concordance Survey (SNACS) program is urgently needed. The program will be designed to provide data on the comparability of the different live virus, pseudovirus neutralizing antibody assays, and other humoral assays performed with different SARS-CoV-2 virus strains. The data from this program will determine how the data from these assays correlate with the results from Spike-binding assays and/or assays that measure blocking antibodies that block Spike protein from binding to the angiotensin-converting enzyme 2 (ACE2) receptor, as possible surrogates of neutralization among performing laboratories. The data generated will provide critical information about the assays accuracy, specificity, precision, and comparability among different laboratories, but, more importantly, it will provide critical information about the in vitro fitness of vaccines and antibody preparations against new mutant SARS-Cov-2 virus strains. We anticipate that about 50 laboratories, in the United States and abroad, will participate in the program. The purpose of this action is to provide a SARS-CoV-2 Internal Quality Control (IQC) and External Quality Assurance (EQA) program and reagent repository, assay transfer support (from the Operation Warp Speed-funded laboratories to identified CRO laboratories), development of SOPs, a SARS-Cov-2 Neutralizing Assay Concordance Survey (SNACS), and biostatistical support, for CRO laboratories working in COVID-19 vaccine and/or antibody preparations. The CRO laboratories will perform the immunology assays after transfer from the CoVPN-affiliated academic laboratories. This additional work is necessary in light of the need to rapidly license COVID-19 vaccines and prepare for the new SARS-CoV-2 mutant variants, which may result in potential booster shots or be in combination with the original vaccines. Reliable laboratory data are essential to the clinical evaluation of candidate SARS-Cov-2 vaccine and antibody platforms. Based on the foregoing, the Government will require additional support to address these needs. The objective of this acquisition is to procure 606% effort per year, to be delivered to the Government during the period of September 30, 2021 through September 29, 2024. These additional resources are needed to provide the support, as listed above. The effort required includes the effort of any proposed subcontractors and consultants. Project requirements: Specifically, the Contractor shall: - Maintain, adjust, and expand an Internal Quality Control (IQC) and External Quality Assurance (EQA) program and reagent repository (e.g., viruses, monoclonal antibodies, convalescent and vaccine clinical trial plasma/serum/cells), to support SARS-CoV-2 immune assays; - Design, set up, manage, and coordinate proficiency programs for fit-for-purpose neutralization and binding antibody assays with mutant SARS-CoV-2 virus strains [i.e., the SARS-Cov-2 Neutralizing Assay Concordance Survey (SNACS)], to provide an unbiased assessment of data quality from participating laboratories; and - Provide data management, biostatistics, and project management support for the IQC and EQA programs. The NIAID intends to modify the existing contract with Duke University Medical Center, in order to accommodate this work/provide an increase to the required Level of Effort under the contract, as follows [since the work associated with this action is specifically for COVID-19 and must be tracked separately, new options must be created to accommodate/fund this work (Options 44, 45, and 46), which will align with the remaining three term options/contract years (i.e., the period of performance of Options 44, 45, and 46 will align with the period of performance of Contract Years 5-7, respectively)]: Option Period of Performance Level of Effort Required Option 44 Contract Year 5 (9/30/2021 - 9/29/2022) 606% Option 45 Contract Year 6 (9/30/2022 - 9/29/2023) 606% Option 46 Contract Year 7 (9/30/2023 - 9/29/2024) 606% Note: The level of effort requirement includes the level of effort of any proposed subcontractors and consultants. Anticipated period of performance: The period of performance of the contract will not change. The increase in level of effort is anticipated to occur during the period of September 30, 2021 through September 29, 2024. Other important considerations: Any alternate vendor would need extensive demonstrated expertise and experience in the following areas: - Virology - expertise in the field of virology is necessary to understand the mechanism of SARS-CoV-2 viral mutation, as well as for the manipulation, maintenance, and generation of viruses and pseudoviruses as assay reagents and repository for participant CRO laboratories; - Immunology - the activities will require a deep understanding of the immune response to vaccines, generation, acquisition, and development of protein and preventive and/or therapeutic monoclonal and polyclonal antibody preparations, as well as development of immunological assays, for evaluation of the aforementioned products. Specifically, expertise in the development, qualification, and validation of virus neutralization and binding assays are critical; - Biostatistics - the evaluation of the SNACS program will heavily depend on methodologies to define critical assay parameters, such as accuracy, precision, and sensitivity. Moreover, given the large number of participant institutions, the biostatistical support needed will require the ability to manage and analyze large databases; and - Laboratory management - the complex structure necessary to procure, select, aliquot, and maintain the repository of assay reagents, controls, and samples employed in the surveillance programs depends on a well-structured organization. The team will be in charge of coordinating shipments of samples for each survey and receipt of results for statistical processing. Capability Statement/Information Sought: Capability statements submitted as a result of this announcement should demonstrate the offeror's qualification, expertise and experience, specifically providing evidence as to the capability to perform this requirement. Capability statements should clearly convey information regarding the respondent's capabilities, including: (1) staff expertise, including their availability, experience and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of a similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested Contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort, which includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator/co-PI, which reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., large business, non-profit, educational institute, small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/ Responses must be submitted no later than 3:00 PM (EST), on April 6, 2021. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via e-mail) to Shane Sarchiapone, Contracting Officer, at shane.sarchiapone@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify RDSS-75N93021R00012. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted, tailored capability statements are due not later than 3:00 PM (EST), on April 6, 2021. CAPABILITY STATEMENTS WILL NOT BE RETURNED AND WILL NOT BE ACCEPTED AFTER THE DUE DATE. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contracting Officer: Shane Sarchiapone Email Address: shane.sarchiapone@nih.gov Contracting Officer: John Manouelian Email Address: manouelj@mail.nih.gov Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.