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PRESOLICITATION NOTICE The Government is seeking Capability Statements on behalf of The National Institute on Drug Abuse (NIDA) from Business organizations under the North American Industry Classifica... PRESOLICITATION NOTICE The Government is seeking Capability Statements on behalf of The National Institute on Drug Abuse (NIDA) from Business organizations under the North American Industry Classification System (NAICS) code 518210, that can provide a scalable data sharing platform according to anticipated future needs as the data collection grows and potential new use cases arise for NIDA’s ABCD study as well as other potential datasets. This data sharing platform shall include project management, data analytics, operations, database, and data analytics support, software engineering, managing a help desk, infrastructure support to the research community who are trying to deposit or access data, scientific support to program staff and other federal employees, and quality assurance checks on the data provided. This is a Presolicitation Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations, however, potential offerors can submit a capability statement. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; and (2) 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. The established NAICS code is 518210, Data Processing, Hosting, and Related Services. The U.S. Small Business Administration establishes a size standard for 518210 as $40,000,000 in revenue or less. BACKGROUND INFORMATION AND OBJECTIVE: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The platform will provide a data sharing ecosystem for large, population neuroscience studies such as the Adolescent Brain Cognitive Development (ABCD) Study. The ABCD Study® is an ongoing longitudinal study that is following the development of youth enrolled when they were 9-10 years of age and followed until they are 19-20 years old. The ABCD Study has been collecting multi-modal data and making those data available with the research community since 2018 (the study launched in 2016). Multi-modal longitudinal research data is being continuously gathered from nearly 12,000 individual participants of the ABCD Study for the research community to mine and analyze to provide new knowledge related to adolescent brain development. The current database used for storage and dissemination of data is no longer capable of supporting the growing dataset and the increased demand for access to the data. The ABCD Study needs a data sharing platform capable of facilitating in situ computations of complex data sets, instead of only supporting download of multiple copies of the data and thereby increasing security risks and expenses. The ABCD program seeks to transfer the entire data collection to a more capable and robust platform that will securely store the data while also providing an easily accessible workspace from which data can be processed and analyzed using a variety of data analysis tools. As a repository holding de-identified human subjects research data, the data sharing platform must efficiently comply with all relevant federal regulations related to security and research subject privacy. The platform must also have the capacity to support additional multimodal data from the HBCD Study, a population neuroscience study of infant and early childhood development. PROJECT REQUIREMENTS: Capable vendors shall demonstrate expertise in managing and expanding a research infrastructure that will be responsible for hosting the storage and access of multiple research data types from the ABCD Study, and other large datasets. This includes, but is not limited to, demonstrating the capability to share de-identified data from minimally, 12,000 research participants and the capability of storing at least 200 terabytes of data within a single infrastructure. Interested small business organizations must demonstrate the required capabilities and in-depth knowledge in the areas listed below: Project Management. Capable vendors must demonstrate their experience and expertise with providing overall project management of health science data sharing platform, with past experience in ensuring that the technical and operational implementation meets the scientific, technical, and program needs of NIDA. Interested vendors should demonstrate the capability to = extend the existing infrastructure to establish and maintain an improved centralized data management, tracking, and distribution platform capable of providing secure storage, analysis, curation, and public access of raw/derived data. Interested parties should describe their approach to ensuring that NIH data sharing policies and standard operating procedures are followed. Additionally, past experience in research infrastructure is requested to demonstrate the capability to participate in scientific and technical presentations and panels as requested by the NIH in their efforts to meet project specific goals. Operation and Database Support. Capable vendors should demonstrate their ability to perform system base installation, configuration and implementation for the NIH data sharing platform. Once established, the platform will be hosted in the Cloud and use Single Sign On with 2-factor authentication. Vendors must demonstrate their capability to scale, tune and optimize the platform to accommodate approximately 3,000 users per year with full operation, monitoring and maintenance. This includes providing support for a help desk and training videos for users. Interested vendors must demonstrate their capability to provide ABCD specific branding and customization of the portal, and additional study branding as needed, to support user-level and administrative-level dashboards and messaging system configurations. Capable vendors should describe their approach for making the platform available to the research community 99.5% of the time, exclusive of planned maintenance and upgrades being installed. Interested vendors shall describe their capability to implement and maintain a disaster recovery plan utilizing Cloud services and/or NIH internal disaster recovery capabilities. Program Support. Interested vendors shall be capable of providing the following support: (1) work with independent groups to support data analysis tools and pipelines being developed by the field; (2) curate and maintain over 300 data dictionaries associated with the ABCD Study; (3) be knowledgeable in how supported data (e.g., developmental research, mental health, and addiction science) are collected and shall help educate the research community on how to access, use, and share genomics, neuroimaging, and other complex datatypes that are needed by the research community; (4) quality assurance; and (5) policy support, including the development of policy documents, support the NIH to obtain OMB approvals for data submission/access agreements, and work with NIH program and grants management staff to ensure that data sharing terms of award are properly defined and used. Software Engineering Maintenance and Extension. Interested vendors should describe their capability to support the following core functionality: Data Validation and Submission – The contractor will require all data to conform to the ABCD Data Dictionaries and allow submission of data through csv file validation and upload, receipt of data through contractor databases. Data Sharing – Support automated data sharing at predefined times as defined by the NIH. Systems Integration – The contractor is required to integrate with all applicable NIH enterprise systems. Query and Data Delivery – A data cart capability allowing data to be queried and downloaded by assessment, element, project, study, subject, ontological concept, omic alteration/gene/location. Search – The contractor is required to maintain search capabilities through the data sharing platform and query tools and allow search results to be made available directly within the cloud to the research community. Access, Authorization and Permissions – The contractor will allow summary data to be made available anonymously. Study Definition – Allow data to be shared with a DOI. Direct Data Capture – The contractor will need to extend its capabilities to acquire all of its data directly through web services from the ABCD Data Analysis, Informatics & Resource Center (DAIRC). The contractor will be required to efficiently support direct data access from the DAIRC through web services. Content Management - the contractor is required to provide seamless integration of text, video and training content throughout the data sharing platform, providing an integrated information architecture across the platform and each of its supported research domains. Data Dictionary Extension – All data dictionaries have been harmonized and curated using administrative tools specific for this purpose. The contractor will extend these tools allowing research labs to propose additions and changes that are approved by NIH and the ABCD project team. Electronic Data Access Approvals – the contractor will be required to implement an efficient electronic access authorization system allowing signing officials at NIH-recognized institutions to sponsor access using the NIH single sign on infrastructure. Help Desk Support - the contractor shall maintain Help Desk phone support from 7AM to 7PM ET, excluding weekends and holidays using a Government approved help desk ticketing system proposed by the contractor Hosting - Data from the ABCD Study will be housed in the Amazon Cloud as well as on premises with the contractor. The contractor must support and have experience hosting 200 terabytes of human subjects’ research data – principally genomics and neuroimaging files stored in the Amazon Cloud and on its premises. The contractor shall host in a manner designed to securely link data from various databases to create cohesive HIPAA-sensitive datasets for research and operational analysis. Outreach and Training. Interested vendors shall provide their approach to implementing training sessions for the research community and internal NIH staff on how to effectively use infrastructure provided by the data sharing platform. This training will include, but is not limited to webinars, meetings, and training videos. Transition In. Interested vendors shall describe their approach to ensuring that there will be minimum service disruption to vital Government business and no service degradation during and after transition. This approach should detail how these transition activities will be completed 60 calendar days after the start date of the award. Transition Out. Interested vendors shall identify how they will coordinate with an incoming contractor and/or Government personnel to transfer knowledge regarding the following: Project management processes Points of contact Location of technical and project management documentation Status of ongoing technical initiatives Appropriate contractor to contractor coordination to ensure a seamless transition Transition of Key Personnel Schedules and milestones Actions required of the Government Interested organizations must demonstrate and document in the submitted capability statement extensive experience in the technical areas listed above. INSTRUCTIONS: Capability statement /information sought. Companies that believe they possess the capabilities to provide the required product/service should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The established NAICS code is 518210. Respondents must provide clear and convincing documentation of their capability of providing the products and support services specified in this notice. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) capability to perform the work; (c) prior completed projects of similar nature; (d) compliance with requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement paragraphs stated herein. A cover page and an executive summary may be included but is not required. Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Rob Bailey at Rob.Bailey@nih.gov, NO LATER THAN 4:00 p.m. EST on January 5, 2024. The Subject line for the submission should include this Presolicitation Notice Number and organization name. NIDA will not accept paper or faxed capability statements. THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. 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 presolicitation 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 solicitation may be published on 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).