CIVICs Data Management and Coordinating Center (DMCC)

Sources Sought Notice Information 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 In 2019, to advance research and development of promising new influenza vaccines that provide broader and more durable protection and immunity, NIAID supported a coordinated multi-disciplinary effort under Research Area 003 of the Broad Agency Announcement (BAA) HHS-NIH-NIAID-BAA2018 that established the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. An additional contract was awarded under RFP-NIAID-DAIT-NIHAI201800018 for the CIVICs Statistical, Data Management and Coordination Center (SDMCC) to provide statistical analysis, pre-clinical and clinical data management, and study coordination services. The overarching goals of the CIVICs program included: (1) supporting improvements in the immunogenicity and durability of seasonal influenza vaccines; (2) developing innovative influenza vaccine approaches that provide robust, durable, broadly protective mucosal and systemic anti-influenza immunity; and (3) conducting iterative vaccine design based on detailed immunologic assessment of influenza vaccine candidates through preclinical animal studies, early phase clinical trials, and healthy volunteer controlled human infection studies. The CIVICs program made significant progress during the current funding period, including: conduct of several Phase 1 clinical trials to assess vaccine candidates; conduct of clinical trials of additional human influenza challenge viruses (dose-finding studies); GMP manufacturing of additional vaccine candidates; ongoing process development studies with several Phase 1 trials being planned for 2025; and pre-clinical assessment of numerous promising influenza vaccine candidates. SDMCC accomplishments include the development and launch of: The CIVICs public website: https://www.niaidcivics.org. Development of data standards and a data submission and validation pipeline for the CIVICs program that facilitated submission of CIVICs-generated data to public repositories, including submission of over 22 studies, involving more than 2,600 subjects, to the ImmPort public repository (www.Immport.org). A single ecosystem, termed the SDMCC Private Portal, which provides a Single-Sign-On (SSO) solution infrastructure connected it to a Nextcloud collaboration platform, which is used by the CIVICs investigators and NIAID for sharing internal documents, resources, and reagents across the program. CIVICs database models for collection and sharing of CIVICs-generated research data. This database system consists of an Amazon Web Service (AWS) DynamoDB, which is a NoSQL database that supports both key value and document data models. DynamoDB is made available through AWS Cloud as a fully managed serverless service that automatically scales to accommodate demand. CIVICs Data Submission portal, which is part of the Nextcloud platform and is being used by the CIVICs investigators to submit research data and associated meta-data. CIVICs Data Standards and Data submission templates. These standards and templates are based upon those created and used by the ImmPort data repository (https://www.immport.org ), which serves as the primary public repository for CIVICs-generated datasets. The CIVICs program is being recompeted (NIAID-DAIT-NIHAI201800018), with an anticipated award date in or around July 2026. The renewed CIVICs program is anticipated to include at least four (4) Vaccine Centers that are responsible for comprehensive design, development, and immunologic evaluation of candidate influenza vaccines. To simplify the CIVICs program, the re-competition will not include separate Clinical Cores. These activities will be supported by existing clinical infrastructure and programs at NIAID. Furthermore, the re-competition will not support a separate Manufacturing and Toxicology Core. Vaccine Centers supported under the recompeted BAA will be responsible for all required end-to-end activities of the vaccine development pipeline (excluding clinical trials). Therefore, each Center will consist of a coordinated multi-disciplinary effort of guided discovery, iterative vaccine design, and facilitated product development and manufacturing, with the goal of advancing promising new influenza vaccines into early phase clinical trials and controlled human infection model studies via the existing NIAID/DMID clinical infrastructure. The CIVICs Data Management and Coordination Center (DMCC) is being renewed under a separate solicitation, as described in this Sources Sought Notice. Since the CIVICs program will utilize NIAID's existing clinical trial infrastructure, the renewing DMCC program will not be responsible for direct data management of CIVICs-related clinical trials. Purpose and Objectives This solicitation supports the renewal of the CIVICs Data Management and Coordination Center (DMCC). The DMCC will support the CIVICs program by conducting the following activities: I. Data management, analyses, and sharing across the CIVICs program and with the broader research community, including submission of CIVICs data and meta-data to NIAID-designated public repositories. II. Maintenance and further development of a CIVICs public and private portal. III. CIVICs program coordination, training, and communication. Project requirements The technical requirements for each DMCC component are summarized below: Data Management, Analysis and Sharing Operation and maintenance of a scalable, flexible data management system for the collection, management, storage, quality control, analysis, sharing, and query/retrieval of all data and relevant meta-data generated by the CIVICs program. The system must be interoperable with and based on the data standards used by relevant NIAID-designated databases/repositories (e.g., ImmPort (www.immport.org), Bioinformatics Resource Centers (www.fludb.org). Extensible system that will not require major refactoring to support new data types generated by the CIVICs program; provides all necessary data quality controls (100% verifications) and protections (e.g., Federal Information Management Security (FISMA), HIPPA requirements; and follows FAIR data-sharing guidelines. Establish or adopt/maintain/update (from the current contractor) a CIVICs Portal, within 90 calendar days after the effective date of the contract, capable of controlled access for sharing research data and information with the COR, other relevant NIAID staff, and the CIVICs program, and for providing public access to information about the CIVICs program. Provide coordination, training, and communication across the CIVICs program, including: Product and Reagent/Resource Tracking Formation and operation of CIVICs working groups and subcommittees Logistical support for the organization and execution of the CIVICs annual meeting A secure process of internal NIAID review of CIVICs vaccine candidates or pilot projects Coordination of the CIVICs External Advisory Group (EAG) activities Training CIVICs investigators to use DMCC-supported systems, software, and computing resources Manage communication amongst CIVICs investigators, NIAID, and/or with external investigators Reporting requirements include Quarterly, annual and final progress reports SOPs and training manuals Entity relational diagrams, use cases, and graphical user interfaces for all portal components Source code and documentation for all data analysis tools and data management systems and portals developed or implemented All information in the DMCC data management systems Anticipated period of performance NIAID anticipates making one term, level-of-effort (LOE), severable award for the DMCC. The total performance period, comprised of the base and any options, shall not exceed seven (7) years, in alignment with the CIVICs program. Awards are anticipated to be made in or around July 2026. Capability statement / information sought Respondents must provide: Demonstrated expertise, including availability and experience with the subject matter Current in-house capability and capacity to perform the work Prior completed projects of similar complexity and size Corporate experience and management capabilities Examples of prior completed Government contracts, references, and other related information Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 15 pages, 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 U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: UEI. Company Name. Company Address. Company Point 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 System for Award Management (SAM) located at https://www.sam.gov/SAM/pages/public/index.jsf. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Maribel Miranda, Contracting Officer, at Maribel.Miranda@nih.gov MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify NIH-NIAID(AI)-SBSS-75N93025R00002. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00PM (Eastern Prevailing Time) on 1/23/2025. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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 at beta.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).