Research and Development Sources Sought - Surveillance of Acutely Ill Adults with Respiratory Viruses, including SARS-CoV-2

Research and Development Sources Sought - Surveillance of Acutely Ill Adults with Respiratory Viruses, including SARS-CoV-2 THIS IS A SOURCES SOUGHT NOTICE. THIS NOTICE IS ISSUED FOR MARKET RESEARCH PURPOSES ONLY. THIS IS NOT A SOLICITATION OR INVITATION FOR OFFERORS TO SUBMIT PROPOSALS AND NO CONTRACT WILL BE AWARDED AS A RESULT OF THIS NOTICE. A SYNOPSIS OF THE PROPOSED CONTRACT ACTION MAY BE POSTED AT A LATER DATE THAT WILL PROVIDE INSTRUCTIONS FOR OFFERORS TO RESPOND TO THIS OPPORTUNITY. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. THE GOVERNMENT IS NOT OBLIGATED TO AND WILL NOT PAY FOR ANY INFORMATION RECEIVED FROM POTENTIAL SOURCES AS A RESULT OF THIS NOTICE. The Centers for Disease Control and Prevention (CDC) is conducting market research to determine the availability and feedback from qualified and interested businesses, including, but not limited, to Small Business Concerns (including Small Business, Service-Disabled Veteran Owned Small Business, Certified HUBZone, Woman Owned Small Businesses, Economically Disadvantaged Woman Owned Small Businesses, and Certified Section 8(a) Small Businesses), capable of providing surveillance services of acutely ill adults with respiratory viruses, including SARS-CoV-2, as described below. Additionally, this will provide an opportunity for potential sources to learn about this program and submit information which will permit evaluation of market capability including, but not limited, the potential for a set-aside acquisition in lieu of full and open competition. A submission is not a prerequisite to any potential future offerings, but participation will assist the Government in tailoring requirement to be consistent with industry. BACKGROUND: CDC seeks to evaluate vaccine effectiveness (VE) against respiratory viruses (i.e., SARS-CoV-2, influenza, and eventually RSV) among hospitalized U.S. adults. CDC's primary need is to monitor vaccine effectiveness against inpatient COVID-19 and influenza to understand protection against emerging variants of concern, duration of protection, and high-risk groups such as immunocompromised and persons with multiple underlying conditions. CDC also has an immediate need to understand severe ARI; establish and evaluate correlates of protection; generate evidence for the need and criteria for booster doses; refine severity scores; ascertain susceptibility to severe COVID-19; understand mechanisms of disease attenuation; and monitor severe vaccine failures. REQUIREMENT: To effectively monitor VE against COVID-19, influenza and RSV, CDC requires an observational, multi-center, prospective public health surveillance network comprised of nationally representative geographic and demographic populations coordinated by the successful contractor (the "Surveillance Network"). The Surveillance Network must include between fifteen (15) and 30 (thirty) nationally recognized and technically qualified hospitals, medical centers, and universities (collectively called the - Institutions and individually called an - Institute) that meet minimum requirements. The minimum requirements for each Institute include, having highly skilled scientific and medical staff who can (a) identify, recruit and enroll critically ill or hospitalized patients for surveillance as case-patients and control-patients; (b) collect, test and store biospecimens; (c) collect medical data including vaccine history and other important patient data and provide timely reporting; and (d) participate in the Surveillance Network adhering to an IRB-approved framework (i.e., established protocols, IRB approvals, standard operating procedures, specimen collection and testing plans) coordinated by the successful contractor. The specific goals of this project are to: 1) Evaluate effectiveness of vaccination against laboratory-confirmed, symptomatic, hospitalized SARS-CoV-2 and influenza as well as to expand surveillance to include respiratory syncytial virus (RSV). CDC's goal is to continue enrollment with an increased focus on variant-specific vaccine effectiveness, duration of protection, risk factors for vaccine failure, and disease attenuation of COVID-19 vaccines. 2) Enroll hospitalized patients with acute respiratory illness (ARI) as either cases (i.e., PCR-confirmed SARS-CoV-2, influenza, or RSV) or controls (i.e., negative PCR test results for SARS-CoV-2, influenza, or RSV), using a case-control design and routine respiratory viral panel (RVP) testing. 3) Evaluate vaccine effectiveness of SARS-CoV-2 vaccination against COVID-19 associated hospitalization by vaccine product and assess the duration of protection of these vaccines. 4) Ensure that key sub-populations disproportionately affected by COVID-19 (e.g., African Americans, Hispanics, persons over 65 years, persons with immunosuppression as well as chronic medical conditions including diabetes and/or obesity) are adequately represented. 5) Access documented results of SARS-CoV-2, influenza, and RSV testing performed for clinical purposes, and collect and test (by PCR) respiratory specimens for SARS-CoB-2, influenza, RSV and other respiratory viruses. Submit all eligible SARS-CoV-2 respiratory specimens for sequencing to allow for sentinel genomic surveillance of hospitalized patients. 6) Conduct interviews or surveys, medical record reviews, and verify vaccination status of cases and controls to allow for refining and validating COVID-19 and influenza-specific severity scores that can be applied for evaluating vaccine effectiveness against disease progression. 7) For a subset of inpatients, collect biospecimens (blood and an additional respiratory specimen) from SARS-CoV-2, influenza, and RSV positive and negative patients of varying gradients in severity to facilitate understanding of COVID-19, influenza, and RSV severe ARI, including vaccine failures, evaluation of strains and immune responses, antibody kinetics, cellular responses, correlates of protection, and microbiome differences. 8) Provide analytic dataset (and samples as appropriate) to CDC in a timely manner using data tools that CDC has existing access to (i.e., REDCap) and provide support as needed to CDC with data analysis. Anticipated period of performance start is 1 September 2022. The successful contractor must be capable of (a) identifying and recruiting a sufficient number (between fifteen (15) to thirty (30)) and diversity of healthcare facilities to ensure a nationally representative geographic and demographic patient population; (b) having IRB, protocol and other operational frameworks in place to achieve the timelines and objectives of this requirement; (c) having highly skilled subject matter expertise, staffing and knowledge in the relevant disciplines in place; and (d) having the ability to complete Phase I activities (update participating healthcare facilities and protocol) by the end of September 2022 so that the Phase II activities (enrollment) can begin on October 1, 2022 and the Phase III activities (project artifacts) can be completed through 31 August 2023. Multiple optional years may be considered to repeat this work dependent on need and funding. INFORMATION SOUGHT: Respondents are asked to provide only the most pertinent information, data, and materials necessary to adequately convey a declaration of capability and provide meaningful feedback in line with the notice. The Government reserves the right to follow-up with respondents to clarify submissions or seek additional market research information. These follow-ups are for market research purposes only. Respondents are asked to provide Company Profile information that contains the following information: 1) Company Name/DBA 2) All points of Contact information (email addresses, phone numbers, and mailing address) 3) DUNS number and CAGE Code 4) Number of Employees 5) Office location(s) including facility(s) where work will be performed 6) Statement regarding small business designation and status 7) Entity Structure/Type 8) Identification of services on any Federal Supply Schedules or Multi Agency Contract Vehicles (if other than CDC) and the relevant schedule/contract numbers 9) General information on the company's line of services and market capabilities 10) Do you have a Government-approved accounting system. If so, what is the agency that approved this system. Respondents are asked to provide response to the following market research questions: 1) Comments, questions, concerns relative to this requirement 2) Specific experience same or similar to this effort. The submission should include a detailed description of the experience and how it is similar, periods of performance, Customer (clarifying if Government or other), role served as either the Prime or Subcontractor, CLIN structure/pricing methodology, and Contractor vs Subcontractor division of work 3) Contract type recommendations including rationale 4) Comments/feedback relative to the selected NAICS and PSC 5) Ability to execute this effort under an existing contract vehicle. Include contract vehicle information 6) An assessment of Risks (cost, schedule, performance) and ideas for mitigating 7) Potential Subcontracting opportunities including opportunities available to Small Businesses 8) What, if any, of the requirements/goals would or could prevent you from being able to submit a proposal 9) Recommended CLIN structure/pricing methodology (i.e. price per phase, price per case study, price per institution, etc.) 10) Other than stated above, what makes a company qualified to do this work 11) Draft/preliminary (not binding) approach to execute this requirement, including, but not limited to, proposed surveillance network, eligible institutes, Contractor team structure, and for the minimum standards identified. SUBMISSION INSTRUCTIONS: Response Due Date: RESPONSE ARE DUE by 4 pm EST, on January 31, 2022. Email submission of the package WILL be accepted, please submit to contact@example.gov. Fax submissions WILL NOT be accepted. Questions or comments regarding this notice may be addressed to Contract Specialist Mark Draluck, contact@example.gov. Responses submitted after the identified time and date will NOT be accepted. Page Limitation: Responses should be limited to TEN (10) single-spaced pages including cover page. Pages should be formatted as follows: MS Word (editable format), 8 - X 11 page, 11 pitch, Times New Roman font with one (1) inch margins. Disclaimer and Important Notes: The Government reserves the right to use information provided by respondents for any purposed 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 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 SAM.Gov. 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(s). Please be advised that all submissions become the property of the Government and will not be returned.