HHS LSJ(GSA-FSS) N3C Dynamic Workspaces_9_10_25_s_Redacted.pdf

In FY 2024 the scientific and technical support services for the N3C and Data COUNTS were procured together on GS35F023GA-75N95023A00001 BO 14 National Clinical Data Collaborative COUNTS (NacDacC). Procuring these services through one vendor on one task order has allowed the NCATS and ODSS to begin working together and creating efficiencies across N3C and Data COUNTS. By continuing under one unified task, NCATS and ODSS will be able to quickly, economically, and efficiently make changes to the N3C and Data COUNTS programs to allow them to fulfil the vision of the NIH Director�s Real- World Data Platform priority. During this transition phase it has been determined that a sole-source award to the existing vendor through the same GSA contract is needed. Combined and separate task orders on various existing contracting mechanisms other Government vehicles were explored but all options added some unacceptable combination of cost, delay, complexity, or uncertainty of execution.

The purpose of this acquisition is to provide NCATS continued services in accordance with FAR Subpart

The overarching objective of this work is to transition N3C to a Dynamic Workspaces architecture while ensuring operational continuity, enhancing data utility for the research community, and achieving full compliance with all CADR requirements. To accomplish this, NCATS has identified objectives across fifteen workstreams that will need to be run by the Awardee. Therefore, objectives are written in alignment with the workstreams:

1. Governance and Leadership: N3C�s large ecosystem requires continued support, oversight, and operational leadership. As the program transitions to the Dynamic Workspaces Model, all governance policies, data sharing agreements, and operational procedures must be revised to reflect the new model and ensure full compliance with CADR standards. This objective covers the development and maintenance of these new policies and institutional review workflows, and coordinating with all stakeholders to communicate a revised and unified vision of the program.

2. Platform and Technologies: The N3C platform and its associated technologies are the foundation of the entire endeavor. This objective involves the complex technical work of developing, testing, and deploying the Dynamic Workspace architecture within and complementary to the existing N3C platform. It includes designing the infrastructure for provisioning secure, logically isolated workspaces and a synthetic data playground to facilitate phenotype development, and implementing the enhanced access controls and user authentication mechanisms mandated by CADR. It also includes maintaining the public-facing website and dashboards to update the community on the work occurring within N3C.

3. Data Acquisition, Linkage, and Quality: Given the complexity and diversity of data contributed to N3C, this effort is focused on ensuring all data is accurately ingested, linked, and maintained with the highest quality within the new architectural model. This work involves adapting existing pipelines to handle disease-agnostic data submissions, managing privacy-preserving record linkage for external datasets, developing and validating phenotypes as reusable knowledge objects, and providing continuous data quality assessment and feedback to data partners.

4. Data Harmonization and Interoperability: Data harmonization is a critical component of the N3C program, ensuring that diverse clinical data can be integrated and standardized effectively. As new data flows into the updated platform, there is a continuous need to maintain the OMOP harmonization pipeline, improve the quality of ancillary data, and support interoperability between different common data models. This work is critical for researchers to actually model and understand their data within their dynamic Workspaces.

5. Health Data Science Training Program: The 2026 NCATS & AIM-AHEAD Health Data Science Training Program (HDSTP) aims to equip early-career scientists with the knowledge and skills necessary to apply artificial intelligence and machine learning (AI/ML) to real-world health data, thereby advancing health research and improving healthcare outcomes. The NCATS arm of the program is entering its third year.

6. Enhance Capabilities of the Data COUNTS Initiative: In partnership with data contributing healthcare organizations, enhance the current capabilities of the Data COUNTS initiative to facilitate delivery of EHR data to N3C.

7. Enhance Coordination of the Data COUNTS Ecosystem: Provide coordination and engagement of the data COUNTS partner health institutions with NIH.

8. Transition Preparedness: To ensure the platform and its data remain usable and transferable, make all RWDE data permanently discoverable, adopt open APIs, standard ontologies, and portable data models for workflows, AI tools, and interfaces, and train NIH personnel to use dashboards, visualizations, and integrate new datasets. Produce a �Transition Plan� detailing processes, tools, and costs for two scenarios (1) shifting analysis and development to a new vendor while keeping the SaaS platform, supported by a vendor onboarding training plan, and (2) migrating all data, workflows, interfaces, and reports to a government-selected platform, validated through a transition exercise that extracts and moves a representative subset of assets.

9. Scientific and Technical Research and Support: To support the community and N3C platform, and demonstrate the power of the new model, a targeted team of senior RWE SMEs is needed to provide scientific services. This objective includes creating exemplar studies that utilize the Dynamic Workspace model, developing and maintaining libraries of validated phenotypes and concept sets, creating decision support tools to guide researchers, and abstracting analysis tools and pipelines for use both inside and outside of N3C.

10. Education and Training: With advancements in data science and the transition to a new operational model, a formal expansion of the Educational Program is required to meet community needs. This objective focuses on creating, disseminating, and updating a comprehensive suite of materials, courses, and tutorials about the new N3C platform, the Dynamic Workspace model, revised data access policies, and user responsibilities under CADR. The goal is to ensure community education and capacity-building needs are met, regardless of where they lie in the N3Cl ecosystem.

11. Program and Project Management: The transition to a Dynamic Workspace model while maintaining ongoing operations is a massive endeavor requiring the synchronization and delivery across all other workstreams. This objective is accountable for the comprehensive management of this complex, multi-phase project, using the latest in project management, change management, and risk management techniques to ensure N3C runs smoothly and delivers on its mission.

12. Communications and Engagement: The program's success heavily relies on effective communication strategies to keep the community informed and engaged, especially during a period of significant change. This workstream will distill complex technical and policy changes into clear, concise messages for various stakeholders. It involves developing and executing a communication plan, translating technical findings into accessible content, and ensuring the community understands how to utilize the new Dynamic Workspace model to drive their research.

13. Data Contributing Site Engagement: Contributions of electronic health record data from partnering institutions is the lifeblood of the N3C. Engagement directly with the contributing sites is often required to facilitate data transfer. The N3C Cancer tenant requires the ongoing participation of 5-10 sites to meet its pilot objectives.

14. Integration of DataCOUNTS and N3C Platforms: DataCOUNTS and N3C are established platforms that are leading innovative real world data innovation at NIH. Currently, these platforms operate independently but utilize similar infrastructure. Therefore, to leverage each platform's strengths, reduce costs, and improve efficiency, new connections and integration pipelines between these platforms will need to be developed. This Objective ensures optimal integration and alignment of these two critical resources for maximal benefit and cost savings for NIH.

15. Geospatial and Environmental Data Integration: This objective focuses on enriching the N3C data resource by acquiring, processing, and linking key geospatial, environmental, and social datasets. The work involves establishing pipelines for these novel data types, creating specific data quality checks, and linking them to patient records to enable new population-level research into the social and environmental determinants of health.

b. Project Background.

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 apply that knowledge to enhance health, lengthen life, and reduce illness and disability by supporting and making medical discoveries. The National Center for Advancing Translational Science (NCATS) at the NIH focuses on all aspects of the translation of research with an innovative pipeline of treatment discoveries for all diseases. NCATS' mission is to improve health through smarter science that results in better treatments faster for all diseases, rare or common.

The National Clinical Cohort Collaborative (N3C) began as a collaborative vision for a national data resource that turned real-world evidence into the knowledge urgently needed to address the pandemic. It systematically collected data derived from electronic health records (EHRs) and other important repositories from different institutions and harmonized these data in a centralized resource available for collaborative research. The program has since expanded beyond its initial focus to encompass multiple Enclaves, focusing on various diseases.

Building upon this successful foundation, N3C is now ready for its next evolutionary step: a transition to a more scalable, flexible, and secure Dynamic Workspaces Model. This new model enhances collaboration and facilitates more impactful translational research across disparate disease areas by creating secure, project-specific analytical workspaces�or dynamic Workspaces�that provide approved researchers with access only to the data necessary for their study. This transition preserves the core principles of centralized data harmonization and a secure analytical environment while granting institutions more granular control over the use of their data through a transparent opt-out mechanism. This work will also ensure the platform achieves full compliance with new, stringent government requirements for Controlled-Access Data Repositories (CADR), reinforcing N3C as a leader in responsible data stewardship.

Together with the Data Collect Once Use Numerous TimeS (COUNTS) Initiative, N3C will form the foundational infrastructure of the NIH Real World Data Ecosystem (RWDE). The RWDE will integrate vast amounts of real-world data from electronic health records (EHRs), insurance claims, pharmacies, and other sources. Building on prior NIH-funded efforts, the RWDE will eliminate redundancies from data collection, linkage, and analysis infrastructures, and will dramatically reduce administrative overhead by relying on a unified set of data use and governance agreements. It will provide direct access to advanced computational resources to support cutting-edge artificial intelligence/machine learning (AI/ML) modeling, petabyte-scale storage/compute, and high-throughput analytics.

The Data COUNTS initiative serves as a foundational EHR data collection engine that ensures full provenance, traceability, and minimal data loss from health systems. Data COUNTS provides federated collection of EHR and other clinical data, as well as data and transmission architecture based on open-industry data and interoperability standards. It supports a broad array of use cases across HHS with appropriate adherence to data privacy, security, and data access policies.

In FY 2024 the scientific and technical support services for the N3C and Data COUNTS were procured together on GS35F023GA-75N95023A00001 BO 14 National Clinical Data Collaborative COUNTS (NacDacC). Procuring these services through one vendor on one task order has allowed the NCATS and ODSS to begin working together and creating efficiencies across N3C and Data COUNTS. By continuing under one unified task, NCATS and ODSS will be able to quickly, economically, and efficiently make changes to the N3C and Data COUNTS programs to allow them to fulfil the vision of the NIH Director�s Real-World Data Platform priority. During this transition phase it has been determined that a sole-source award to the existing vendor is the best fit. Combined and separate task orders on various existing contracting mechanisms were explored but all options added some unacceptable combination of cost, delay, complexity, or uncertainty of execution.

Description of the Supplies or Services Required to Meet the Agency�s Needs (including the Estimated Value).

Project Title - N3C Dynamic Workspaces

Project Description.

Requirement Type.

Support services (non-research & development) Supplies/equipment Information technology (IT) Other (specify): ____________________

Type of Action.

New requirement

Follow-on Other (specify): ______________________

Proposed Contract/Order Type.

Firm-fixed-price Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

Other (specify): Firm Fixed Price with time and material components

Acquisition Identification Number.

c. Total Estimated Dollar Value and Performance/Delivery Period.

4. Identification of the Justification Rationale [see 8.405-6(a) and (b)] and, if applicable, a demonstration of the proposed contractor�s unique qualifications to provide the required supply or service.

a. Acquisition Authority.

This acquisition is conducted under the authority of the Multiple Award Schedule Program. Consideration of schedule contractors will be restricted to fewer than the number required by Federal Acquisition Regulation (FAR) 8.405-6(a)(1) .

N3C has a very large ecosystem that needs continued support, oversight, advocacy, and operational leadership

. To support the extensive amount of governance required for the transition to the Dynamic Workspace model and to ensure full compliance with new data repository standards, the below aims are needed:

Lead the development and revision of a comprehensive agreement framework for the transfer, use, and linkage of real-world data across the CTSA and other data partners that supports the disease-agnostic data contribution model.

Work with NCATS stakeholders to revise the agreements and documents to align with all new Controlled-Access Data Repositories (CADR) requirements, including those for user verification and institutional attestations, and prepare for re-execution with all participating institutions.

Develop, document, and test the new Data Access Committee (DAC) review process for Data Access Requests (DARs), ensuring the process evaluates feasibility, compliance, and alignment with N3C-Clinical goals.

Design and formalize the institutional review workflow, including the secure dashboard-based notification system and the "opt-out" mechanism that preserves institutional authority over data use.

5.Support the creation and expansion of governance policies and procedures to support the overall governance of N3C and the secure management of dynamic Workspaces. This includes establishing policies for:

a) The sharing and reuse of phenotypes as knowledge objects.

b) The limited embargo option for newly submitted phenotypes.

c) Defining access tiers (e.g., de-identified vs. limited data) and associated researcher eligibility requirements.

6.Establish and document procedures for CADR-mandated user compliance, including requirements that DARs be submitted by permanent, senior-level employees and certified by an Institutional Signing Official.

7.Implement and maintain the fully revised Governance Policies and Procedures for the overall N3C program.

8.Serve on the N3C Download Committees and perform regular review of download requests.

9.Provide overall technical leadership across all N3C workstreams.

10.Coordinate with NCATS Project Managers, Leadership, and Scientists to identify and manage subcontracts for key SMEs and Teams instrumental in the execution of N3C strategy, planning, and operations.

11.Manage, coordinate, and communicate between these individuals/teams and NCATS to ensure the needs of NCATS are met in a timely and efficient manner.

12.Work with intramural and extramural stakeholders to communicate the revised and unified vision of the N3C Dynamic Workspace model.

13.Maintain and run the N3C Publication Committee, adapting its procedures as needed for research originating from dynamic Workspaces.

14. Provide ongoing support, communications, content, and leadership for all Domain Teams and the Logic Liaisons Group.

15. Given the complexity and diversity of the data contributed by various clinical sites to N3C, this effort focuses on ensuring that all data is accurately ingested, harmonized, and maintained to support the Dynamic Workspace model. The work involves adapting data acquisition pipelines to support a unified, disease-agnostic data contribution approach and ensuring that this broadly applicable dataset can support a wide variety of research questions. It also includes facilitating secure linkage of external datasets using privacy-preserving methods, the development of reusable phenotypes, and vigilant, continuous monitoring of data quality to give researchers transparency into potential biases or limitations.

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

Currently, to avoid a critical lapse in services only the incumbent can continue to perform these services. Continued acquisition support will ensure that the RWDE platform and its data remain permanently accessible and transferable by adopting open APIs, standard ontologies, and portable data models; providing NIH staff and contractors with dashboard-building and data-integration training; and delivering a comprehensive 90-day transition strategy for both retaining the existing SaaS platform under a new vendor and migrating all assets to a government-chosen system.

Additionally, while the community is engaged in research, NCATS has found that providing exemplar studies helps to inspire researchers by demonstrating what is possible with new data or platform capabilities. To showcase the power of the Dynamic Workspace model, a targeted team of senior Real World Evidence (RWE) Subject Matter Experts (SMEs) is continually needed to create high-caliber studies, tools, and resources.

c. Name and address of the proposed contractor(s).

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

Since (a) GSA has already determined the prices of the supplies and services under FSS contracts, including rates for services offered at fixed hourly rates, to be fair and reasonable; and (b) by placing an order against a schedule contract using the procedures in FAR 8.405, the ordering activity CO has concluded that the order represents the best value (see FAR 2.101) and results in the lowest overall cost alternative, the determination shall cite:

(i) whether any additional discounts will be sought before placing an order (see FAR 8.405-4); - Yes � will seek discounts

(ii) the type of pricing information, if any, that will be obtained from the schedule contractor(s) in relation to seeking additional discounts; and

(iii) the extent of the price evaluation anticipated in order to determine that the total price is reasonable � see FAR 8.405-2(d).

The CO will evaluate the proposed price prior to award against its GSA schedule, historical rates, and historical actual invoiced costs.

Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

See Market Research Report in file.

Any other facts supporting the justification.

In projecting NCATS acquisition needs, we examined the relationship to the prior order and considered the minimum acceptable period necessary to meet mission requirements. 12 months was determined because it provides time needed to encourage and solicit competition for a future requirement without critically disrupting services.

Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

Removal of barriers to competition. We do anticipate future needs for the same type of services. We plan to continue to examine ways to increase competition, while balancing small business goals, and category management.

Listing of sources, if any, that expressed an interest, in writing, in the acquisition. No other sources have expressed an interest, in writing, in the proposed acquisition.

Program Office Certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government�s minimum needs or requirements, or other rationale for limited sources, are accurate and complete.