Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Background The Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Diseases (NIAID) supports a global research portfolio to advance biological knowledge of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), its related co-infections, and its co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” DAIDS develops and supports the infrastructure and biomedical research needed to: 1) reduce HIV incidence through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) develop interventions to treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) foster partnerships with scientific and community stakeholders to develop and implement effective interventions. High quality test results support the safety of study participants and the reliability of study results. DAIDS employs a variety of Laboratory Quality Assurance contractual resources to monitor and enhance the ability of laboratories to accurately and reliably perform trial-specified clinical laboratory testing (https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures). Purpose and Objectives The purpose of the NIAID Virology Quality Assurance (VQA) program is to provide a comprehensive quality assessment program for virologic assays for HIV and other viral pathogens (including emerging pathogens and pandemic response) performed on samples collected from participants enrolled in NIAID-sponsored and collaborative multisite clinical studies. The goal of the VQA program is to ensure the validity and inter- and intra-laboratory comparability of virologic laboratory data by providing laboratories with proficiency testing (PT) panels and real-time assay run controls, and analyzing PT panel and assay run data within each laboratory and across laboratories participating in the program. The VQA program implements standards of performance for new and existing state-of-the-art virologic assays, develops and employs biostatistical methods relating to the assays, and acquires, tests, stores and dispenses quality control materials (QCMs) and reagents. The VQA program is critical to the scientific integrity of on-going and future studies concerning HIV diagnosis, pathogenesis, drug resistance, and cure, including the assessment of vaccine and treatment efficacy, post-exposure prophylaxis (PrEP), other preventive measures, and response to emerging viral pathogens of pandemic potential. The VQA has been in operation since 1988 and has developed and standardized quality control procedures for numerous virologic assays in support of NIAID-sponsored and collaborative clinical trials. The VQA will continue to serve current and future NIAID-sponsored clinical trial networks, cohorts, and collaborating study groups (User Groups), as well as individual grantees conducting clinical research. The current contract is held by Duke University, Durham, North Carolina, under contract number 75N93019C00015. The period of performance of the current contract is September 21, 2019, through September 20, 2026. Project Requirements: The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking capability statements from qualified organizations to provide a comprehensive quality assessment program for virologic assays for HIV, and other viral pathogens. The Contractor shall provide laboratories (Labs) performing virologic testing for NIAID-sponsored and collaborative clinical trials with a comprehensive quality assessment program and real-time assay validation for virologic assays for HIV and other viral pathogens. The contract also provides for the planning and execution of single and multi-laboratory studies for the evaluation and development of new and existing virologic assays and supporting statistical methodologies. QCMs necessary for this work will be acquired, characterized, stored, catalogued, and dispensed as necessary. The Contractor shall serve Labs associated with current and future NIAID-sponsored clinical trial networks and collaborating study groups. Currently, the contract serves approximately 110 laboratories, with 55 international laboratories in 22 countries. The Government anticipates a potential need to increase the level of effort by exercising Options for the following additional support: (1) unanticipated increases in demand related to support of additional Labs; (2) performance of late-stage assay validation and/or testing of clinical samples in a CLIA-certified laboratory; and (3) additional expertise in response to emerging viral pathogens and other public health emergency needs. Anticipated Period of Performance: It is anticipated that one cost reimbursement, term/level of effort, type contact will be awarded. The period of performance will be for one year (Base Period) plus six (6) one-year options to extend the term of the contract that may be exercised by the Government unilaterally, for a total possible period of performance of seven (7) years, beginning approximately June 21, 2026. The requirement will be the delivery of 10.00 full time equivalents (FTEs) per year, including consultant and subcontractor effort, for the Base Period (Year 1) and 10.00 FTEs per year, including consultant and subcontractor effort, for Options 1-6 (Years 2-7). In addition, the Government may exercise options for an increased level of effort that may result from unanticipated increases in demand for the activities supported by the base requirements of this contract. Options for increased services may include: Options for Increased Level of Effort for Additional Labs : During the contract, it may be necessary to incorporate additional Labs to support new NIAID-sponsored and collaborative clinical trials. Such an addition would require an increase in the Contractor's activities to be activated, at the discretion of the Government, as an option. Each option of this type will implement work commensurate with the addition of 5 Labs. These options may be exercised during Years 2 through 7. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 0.20 FTE during the first year, including consultant and subcontractor effort. If the options for these Labs are exercised in any year after the first year, 0.10 FTE per year, including consultant and subcontractor effort, will be needed in subsequent years. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of the Option year in which the Option is exercised. Options for Increased Level of Effort for Additional Expertise : During the contract, it may be necessary to develop a quality assessment program for assays associated with HIV-related viruses and/or emerging pathogens that would directly support high priority NIAID research programs. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 3.65 FTE, including consultant and subcontractor effort, for each option exercised. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of Option year in which the Option is exercised. Options for Increased Level of Effort for the Addition of CLIA Certified Labs : During the contract, it may become necessary to use new and novel virologic assays in clinical trials where results will be used for clinical decisions within the trial. This will necessitate the use of a CLIA certified laboratory for late-stage validation of the assay and for clinical testing. If necessary, this will be provided through the exercise of options to this contract. Should the Government elect to exercise these options, the Contractor shall provide resources for the unanticipated increase in work volume by 1.0 FTE, including consultant and subcontractor effort, for each option exercised. The period of performance of an Option for increased level of effort for this purpose will not exceed the term of Option year in which the Option is exercised. Cap ability Statement/Information Sought: Interested small business organizations should submit a capability statement that demonstrates and documents the following: The program will require the ability to obtain quality control materials (QCMs) to be used in proficiency testing (PT) panels and assay run controls. This will require the ability to grow HIV in cell culture and will also require access to domestic and international populations of people living with and without HIV for donation of blood and other clinical specimens to be processed for use as QCMs for assay validation and PT panels, and in panels used for the evaluation of new and existing virologic assays. Current assays include HIV RNA in plasma and dried blood spots (DBS), total HIV nucleic acids in whole blood and DBS, and HIV sequencing for drug resistance mutations. The Contractor must have the ability to provide multiple domestic and international Labs with validation and PT panels and reagents and controls, must be able to retrieve and analyze data from all Labs, and must be able to disseminate PT results and other relevant information. This program will require staff with experience in the areas of HIV virology, HIV-associated viral co-pathogens, medical technology/pathology, statistical modeling, data management, quality assurance, and safety and ethics. The prospective contractor must have a Principal Investigator and staff with the experience and expertise to carry out a project of this size and complexity, must understand cultural sensitivity issues relevant to resource-constrained countries, and must have the flexibility to address emerging needs and expansion. The Contractor must obtain ISO/IEC 17043 certification for PT Providers within one year of the contract and maintain the certification throughout the life of the contract. Capability statements submitted in response to this announcement should demonstrate the offerors’ qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: Acquisition of QCMs : Interested parties must demonstrate experience and ability to acquire QCMs and process them for shipping to domestic and international laboratories as validation and PT panels and assay controls. This must include the ability to acquire specimens from people living with and without HIV both domestically and internationally. Provision of PT panels to Labs : Interested parties must demonstrate experience and ability to provide multiple domestic and international Labs with validation and PT panels and must demonstrate the ability to retrieve and analyze data and test results from multiple laboratories. Personnel/Management : Interested parties must demonstrate adequacy, appropriateness and relevant expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance : Past performance is considered essential. In addition to demonstrating the offeror has met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement (five-page limitation, excluding resumes). Capability statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11” in the US., A4 in Europe). All proprietary information should be marked as such. Required Business Information: Each response should include the following Business Information: DUNS Company Name Company Address Company Points of Contact, Phone and Email address Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought Do you have a Government approved accounting system? If so, please identify the agency that approved the system. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferably placed under the eligible small business concern’s name and address). Number of copies: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Shawnice Williams, Contract Specialist, at shawnice.williams@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify SBSS75N93024R00030. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted Capability Statements are due no later than September 26, 2024 at 3:00 p.m., EST. Capability Statements will not be accepted after the due date. Capability Statements will not be returned. 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 Presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. Respondents will be added to the prospective offerors list for any subsequent solicitation. However, responses to this notice will not be considered adequate responses to a solicitation. 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.
