SECURE PLATFORMS SUPPORT FOR THE N3C DATA ENCLAVE (75N95023D00027)

THIS IS A NOTICE OF INTENT TO INCREASE THE CONTRACT CEILING ON AN EXISTING INDEFINITE DEVLIVERY/INDEFINITE QUANTITY (IDIQ) CONTRACT. THIS IS NOT A REQUEST FOR QUOTES/PROPOSALS.

The National Center for Advancing Translational Sciences (NCATS) requires an increase to the ordering limit for the IDIQ contract Secure Platforms Support for the N3C Data Enclave, contract number 75N95023D00027. This contract provides a secure cloud platform-as-a-service (PaaS) supporting the National Clinical Cohort Collaborative (N3C) Data Enclave. Raising the ceiling will ensure uninterrupted access to this critical data analytics platform pending reorganization of NIH IT services, NIH contracting, and NCATS mission realignment. The ordering limit will be increased by $23,504,928, from $68,000,000  to $91,504,928 .

The N3C Data Enclave has been recognized by the Department as a potential foundational component of the NIH Real World Data Platform. This increase preserves critical services, avoids duplicative costs, prevents a devastating lapse in programs, and adapts to the evolving research landscape.  Below we provide additional information on impact.  The increase does not extend the current ordering period/period of performance of the current award.  The Government expended the contract ceiling faster than anticipated due to more research requests including collaborations with NCI and ARPA-H.

Additionally there is a separate acquisition planning effort to determine next steps for the follow-on requirement to 75N95023D00027.  We are currently in the market research stage (FAR Part 10) and direct interested vendors to review the recently issued sources sought notice:

https://sam.gov/workspace/contract/opp/7cf23b004e5444b09b3e50717a6f5778/view

The NCATS Secure Scientific Platform Environment (the "Environment") is a specialized cloud-based data aggregation and analytics enclave that can integrate, manage, secure, and analyze any kind of scientific data, and provide secure, controlled access to internal and external collaborators. Within the Environment, multiple NIH institutes and centers (ICs), Federal agencies, and Federal task forces integrate, manage, secure, and analyze all types of scientific data using dedicated platforms, and, equally importantly, make that data available in specific and controlled collaborations with each other and with external collaborators. The Secure Platforms Support for the N3C Data Enclave contract was awarded on a sole-source basis to Palantir Technologies, Inc., effective September 28, 2023.

REGULATORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

The N3C Data Enclave, in particular, would pose a substantial migration challenge. The Enclave, established in 2020, now hosts over 33 billion rows of privacy-protected patient data on more than 22 million persons. N3C is disease-agnostic, but with the establishment of cancer and renal tenants the data can be mined to provide disease-specific research. To migrate the enclave to a new platform, an incoming contractor would have to study the data structures, security, user access, workflows, and all other aspects of the existing Environment; provide a secure, cloud-based, FedRAMP authorized environment; obtain an Authorization to Operate (ATO) for its specific implementation; develop a transition-in plan; and replicate the workflows, all while ensuring that access to the Environment continues uninterrupted. The Environment is implemented through a commercial off-the-shelf cloud product, but transitioning all of this to a new proprietary commercial product could take a year or more.

Additional reasons for using the cited authority areas are as follows:

1. Lapse of these contracts will result in irreparable harm to the Government.

NCATS’ ongoing research landscape, with research predating January 20, 2025, involves the data secured in NIDAP and N3C. This research includes everything from the raw and processed data generated by the NCATS laboratories (such as high-throughput screening data) to extensive anonymized clinical health observations supporting patient-level medical research.

It cannot be overstated that this data environment is absolutely, fundamentally essential to continued laboratory operations at NCATS, ongoing research using privacy-protected electronic health records and clinical data, extensive data science research, training and research in the use of AI/ML to enhance disease-related research, and other research missions.

N3C Data Enclave

The National Clinical Cohort Collaborative (N3C) Data Enclave is the nation’s largest enclave of general clinical data related to all diseases. The Enclave supports broad research using harmonized, privacy-protected electronic health records and clinical observations that require strict access and data use controls; assurance against alteration or corruption to ensure the integrity of scientific research; and guaranteed availability to researchers. N3C hosts more than 33 billion rows of privacy-protected clinical data related to more than 22 million persons. More than 80 member institutions contribute data, which also includes lab results, medication records, procedures, and clinical observations. This data is protected using privacy-preserving record linkage such that patient identification remains with the original owner/contributor outside the Enclave. Researchers using N3C only access de-identified records. The availability and integrity of this valuable U.S. Government data asset requires continuation of contractor support for the secure platform.

NIDAP-NCATS Instance

The NIH Integrated Data Access Portal (NIDAP) provides foundational support for NCATS data and workflows, and hosts critical research data supporting NCATS-led programs such as the Genetic and Rare Disease (GARD) Information Center, the Rare Disease Clinical Research Network (RDCRN) (a multi-IC initiative supporting more than 20 research consortia studying more than 200 rare diseases), as well as internal NCATS process such as High Throughput Screening (HTS), compound management (COMA), and the Rare Disease Informatics Platform (RDIP). The internal NCATS processes support all of NCATS laboratories and scientists. Many experiments extend for months or longer and require real-time access to data processing, sharing, and storage provided by NIDAP. Shut down at this time would jeopardize research begun prior to 1/20/2025 if scientists are unable to access the stored results or run confirmatory or follow-on procedures. Moreover, for example, external research networks such as RDCRN require access to the years of data they have obtained and shared.

NIDAP-NCI Instance Closeout

The NCI NIDAP instance will be phased out over the next year. Premature shut down would jeopardize the active clinical research data pipelines that rely on the platform.

AIM-AHEAD Data Science Training Enclave

AIM-AHEAD is an NIH-sponsored intramural data science research and learning program which may continue under the NIH Transition Guidance for Conduct of Science. Through AIM-AHEAD, the program sponsors real-world research projects using the National Clinical Cohort Collaborative (N3C) Data Enclave. The outcomes of this program are to develop researcher expertise in the development of artificial intelligence and machine learning (AI/ML) models and to improve the capabilities of this emerging technology, beginning with electronic health records (EHR) and extending to other data sets to address health inconsistencies. The program is managed by NCATS through a contract with Axle Informatics, Inc., which has developed the curriculum, research plans, and recruitment.

AIM-AHEAD’s data enclave is provided through a protected instance within the N3C Platform Environment to enable concierge services and training for AIM-AHEAD researchers and students to access and analyze N3C data using AI/ML models.

2.         Continuation of these contracts supports ongoing research and processes in support of research.

NCATS’ ongoing research landscape, with research predating January 20, 2025, involves the data secured in NIDAP and N3C. This research includes everything from the raw and processed data generated by the NCATS laboratories (such as high-throughput screening data) to extensive anonymized clinical health observations supporting patient-level medical research.

3.        Pending organizational changes at NIH, HHS, and GSA encourage NIH to defer recompetition.

Organizational changes at NIH, HHS, and GSA include:

•           Separation of foundational and scientific IT at NIH.

•           Centralization of foundational IT with NIH’s CIT.

•           Consolidation of acquisitions functions with GSA.

•           Reorganization within both NIH and HHS.

These organizational changes will not remove the need for these requirements, but will affect where and how they are met.

Raising the ordering limit will preserve the flexibility for NIH and HHS to tailor the structure of the follow-on vehicle(s) in accordance with the Administration’s priorities, while ensuring continuity of services. Subsequent proper recompetition of this requirement will involve early engagement with industry, market research, and adequate lead time for preparation and evaluation of proposals.

4.         This is a limited-term continuation of existing services.

By increasing the ordering limit, NCATS can bilaterally modify existing task orders (or issue additional task orders as necessary) consistent with the current statements of work to ensure continuity of science and preservation of research until a full recompetition can be accomplished.

Increasing the ceiling as requested will provide sufficient time to recompete these requirements for award in FY2026.

5.         Competing this requirement would result in unacceptable delays during transition and duplication of cost.

Migration of these requirements to a new platform is possible, but requires extensive planning, focused change management, and substantial funding. None of these factors are available at this time. Lapses in these task orders, which would deny the Government access to the extensive scientific data housed on the Platform until transition is complete, would pose unacceptable delay as identified in FAR 6.302-1(a)(2)(ii). Operation of the platforms themselves relay on constant availability for the ingestion of data and resulting analytics, and users rely on real-time access to the platform for analytics and data access.

The N3C Data Enclave, in particular, would pose a substantial migration challenge. The Enclave, established in 2020, now hosts over 33 billion rows of privacy-protected patient data on more than 22 million persons. N3C is disease-agnostic, but with the establishment of cancer and renal tenants the data can be mined to provide disease-specific research. To migrate the enclave to a new platform, an incoming contractor would have to study the data structures, security, user access, workflows, and all other aspects of the existing Environment; provide a secure, cloud-based, FedRAMP authorized environment; obtain an Authorization to Operate (ATO) for its specific implementation; develop a transition-in plan; and replicate the workflows, all while ensuring that access to the Environment continues uninterrupted. The Environment is implemented through a commercial off-the-shelf cloud product, but transitioning all of this to a new proprietary commercial product could take a year or more.

Transition would also, by definition, duplicate the cost of the existing Environment. The initial standup of the Enclave cost over $2 million, and the Government has invested over $89 million in compute, cloud services, and professional services for development and operations of the Enclave. All of the development would have to be duplicated for the new commercial platform. This assumes the new platform meets the essential characteristics of the existing commercial platform; otherwise, even more development would be required.

Finally, academic and Government researchers have used this Enclave for research since September 2020, and the data has supported extensive research and resulting publications. Replication of the work to support the data requirements of these users and training them on a new platform would amount to a new investment in technology and training. To ensure continuity of science would require implementation of a parallel system before changeover, which not only requires duplication of effort and cost but would require us to operate two systems providing the same capabilities at the same time.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to increase the ordering limit to an existing contract without providing for full and open competition is based upon the following rationale:

The N3C Data Enclave, in particular, would pose a substantial migration challenge. The Enclave, established in 2020, now hosts over 33 billion rows of privacy-protected patient data on more than 22 million persons. N3C is disease-agnostic, but with the establishment of cancer and renal tenants the data can be mined to provide disease-specific research. To migrate the enclave to a new platform, an incoming contractor would have to study the data structures, security, user access, workflows, and all other aspects of the existing Environment; provide a secure, cloud-based, FedRAMP authorized environment; obtain an Authorization to Operate (ATO) for its specific implementation; develop a transition-in plan; and replicate the workflows, all while ensuring that access to the Environment continues uninterrupted. The Environment is implemented through a commercial off-the-shelf cloud product, but transitioning all of this to a new proprietary commercial product could take a year or more.

The intended source is:

Palantir Technologies, Inc.

1555 Blake St, Ste 250

Denver, CO 80202-1866

Period of Performance:

The period of performance will remain unchanged: from 9/28/2023 through 9/27/2026.

NCATS plans to recompete this requirement in FY2026.

Contract Type:

This ordering limit increase will be awarded as an in-scope modification on a Firm Fixed-Price basis consistent with the contract terms and conditions of IDIQ contract 75N95023D00027.

CLOSING STATEMENT
THIS NOTICE OF INTENT TO AWARD AN ORDERING LIMIT INCREASE ON A SOLE-SOURCE BASIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed work based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purpose of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirements contained in this notice and include your Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM), www.sam.gov. All responses must provide evidence that they can provide the services immediately upon order and in accordance with all Federal Information System Security requirements.

All responses must be received by the closing date and time of this announcement and must reference the notice number, 75N95023D00027NOI22. Responses must be submitted electronically to  Brian O’Laughlin, Contracting Officer, at olaughlinb@nida.nih.gov.