NIH Data Access Program Management Support

NIH requires administrative and management consulting support for the Data Access Program across the United States.

Solicitation Summary

The Department of Health and Human Services, National Institutes of Health has a requirement for the Data Access Program.

Solicitation in a Nutshell

Item

Details

Agency Department of Health and Human Services, National Institutes of Health
Solicitation Number 75N95023R00003
Status Pre-RFP
Solicitation Date 03/2026 (Estimate)
Award Date 06/2026 (Estimate)
Contract Ceiling Value $46,748,000
Competition Type  Full and Open / Unrestricted
Type of Award  IDIQ – Agency Specific
Primary Requirement  Administrative, Logistics & Management
Duration  5 year(s) base
Contract Type  Indefinite Delivery Indefinite Quantity,TBD
No. of Expected Awards N/A
NAICS Code(s):
541611

Administrative Management and General Management Consulting Services
Size Standard: $24.5 million annual receipts

Place of Performance:
  • United States
Opportunity Website: https://sam.gov/opp/180e97fe5cab4693b99f561c5ede9778/view

Background

The National Institutes of Health (NIH) is the nation’s medical research agency. In response to NIH’s mission to “…expand the knowledge base in medical and associated sciences in order to enhance the Nation’s economic well-being and ensure a continued high return on the public investment in research,” several programs across NIH support data linkages with other federal agencies. Established in 2021 within the National Institute on Aging, the LINKAGE Program currently provides support to NIH funded studies with a federated data enclave (for analysis and data sharing) and technical assistance to facilitate linkages with Centers for Medicare & Medicaid Services (CMS) data and other studies. In providing these resources free of charge, LINKAGE aims to reduce resource cost and time barriers and promote access for researchers. Information about the current LINKAGE program can be found at https://www.nia.nih.gov/research/dbsr/nia-data-linkage-program-linkage. If applicable, the existing contract is anticipated to have a six month overlap with the awardee for the Data Access Program, hereafter also referred to as “the Program.” To the extent the transition period is provided, the new Contractor shall participate in Program transition activities. This will allow the incumbent Contractor to properly transition existing work, provide training, etc. to the incoming Contractor as appropriate based on the requirements detailed in this Statement of Work. This overlap period is not guaranteed, and the contractor must be prepared to start work without an overlap period.

NIH seeks contractor support 1) to aid the current portfolio of data linkages already enabled by the current award; 2) for the development of new or expanded partnerships to maximize data linkage opportunities for NIH grantees, researchers, and federal researchers; and 3) for an expanded number and type of datasets available for linkages to include additional Federal and non-federal datasets, private data sources, and potentially others including NIH-funded international studies. With respect to supporting the current portfolio of studies, the Data Access Program will provide services to NIH-supported studies and eligible researchers that link their data sets with CMS data or other federal and non-federal data for research purposes. If studies are willing to distribute their linked datasets, eligible researchers may access study datasets in the Enclave. For more information, visit the following website: Access or Share LINKAGE Data | National Institute on Aging (https://www.nia.nih.gov/research/dbsr/nia-data-linkageprogram-linkage/access-or-share-linkage-data). Moving forward, the NIH intends to expand the Data LINKAGE Program to serve all NIH institutes and centers. Expanding the Data Access Program involves accepting NIH-funded studies that are seeking to use the enclave for data sharing purposes and when data are transferred to NIH at the end of the study period (i.e., materials transfer agreement executed by NIH). Studies in this category may or may not require updated data linkage services.

In anticipation of expanding the number and types of datasets to include more than data from the CMS, the NIH seeks support to design and implement scalable, automated solutions for acquiring, ingesting, linking, and managing a range of data sources. Solutions should include standardized, repeatable workflows; automated quality checks and linkage validation; and enable efficient integration of federal, non-federal, and private datasets. All systems and services must operate within FISMA Moderate compliant environments and adhere to Zero Trust security principles, ensuring secure access control, identity assurance level 2 (IAL2) verification, and continuous monitoring. The contractor will support the development and maintenance of technical infrastructure to enable high-throughput, interoperable data processing that aligns with NIH’s broader data governance, privacy, and compliance objectives.

Requirements

The objective of this contract is to 1) host NIH funded studies with sensitive data for research purposes, including those studies that are seeking federated means for data storage and sharing, advance data sharing for NIH studies (including those that are not linking to CMS data), and 2) expand the options for linkage to additional Federal and private sector datasets. The Data Access Program’s primary requirements are structured under three tasks: enclave, data linkage delivery, and program operations

As part of these objectives, the contractor shall enhance and expand the user base of the program, and support data linkages, support privacy preserving linkage automation, deliver technical assistance, provide statistical and methodological consultation through a technical expert panel, procure public or private real-world data, and facilitate quality improvement within the Program to improve user experiences

The Contractor shall perform Task Assignments in areas that include, but are not limited to:

  • Developing and maintaining a secure cloud-based enclave to catalog, analyze, store, and distribute linked and non-linked datasets
  • Supporting master and metadata cataloging to enable high-performance and robust variable-level searchability and discoverability of available datasets
  • Implementing cloud-based infrastructure- and platform-as-a-service (IaaS and PaaS) technologies, including services such as AWS, Azure, and Google Cloud, for example
  • Provisioning enclave user areas or accounts in the enclave
  • Establishing and verifying researcher identities and data use agreements for studies
  • Reviewing data access requests
  • Conducting data linkages using automation to enhance e?iciency and scalability
  • Processing and creating research files (raw, annual, and longitudinal files)
  • Implementing validation protocols to ensure data quality and integrity
  • Maintaining and updating data documentation
  • Facilitating federated data services for studies that are not linked to CMS or other federal data sources
  • Providing end-user technical support for both the enclave environment and the linkage process; ? Supporting procurement of public or private real-world data
  • Facilitating expert panel meetings
  • Developing and implementing automated privacy-preserving record linkage methodology
  • Maintaining a robust security posture in alignment and compliance with Zero Trust principles and FISMA moderate requirements
  • Integrating software-as-a-service (SaaS) solutions that support operations of the Data Access Program
  • Monitoring program operations for quality improvement opportunities, proposing opportunities for improvement, and executing program improvement initiatives
  • Administering the program successfully in consultation with and at the direction of the COR.

The following distinct tasks have been identified as follows:

  • Task 1: Enclave
  • Task 2: Data Linkage
  • Task 3: Program Operations
  • Task 4: Privacy Preserving Record Linkage Automation

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