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Contract Opportunity

REQUEST FOR INFORMATION

Proposed New Contracting Approach for Sentinel System 3.

FDA is seeking industry feedback on the contracting approach described below for the Sentinel System 3.0. No proposals will be accepted at this time, this is a request for information only. However, we encourage and welcome comments. Although questions won’t receive a response, submitted questions are also welcome and will alert us to points eventually requiring fuller clarity.

• FDA is considering a Multiple award IDIQ, Tiered contract based on task levels:
  
  
  
  • Multiple vendors compete for, and may be awarded, task orders in a particular tier.
  
  
  • An individual vendor does not have to meet requirements for all tiers but could be awarded task orders in more than one tier.
  
  
  • It would be a requirement for all awardees to coordinate with other awardees for interconnected work.
  
  
  • Number of vendors included in each tier is contingent on program requirements and funding availability.
  
  
  • There would likely be Small Business set asides for some Tiers
  
  
  
  

Proposed CDER Sentinel System 3.0 Multiple Award IDIQ may include the following task-based tiers:

Tier 1 Commercial Healthcare Insurance Claims

Provide access to large (millions) national commercial health insurance plan claims for services provided and administered by nongovernmental entities. Access to medical charts to support efficient/cost-effective medical record review process, as needed.

Tier 2 Commercial Healthcare Insurance Claim Aggregators

Provide access to third-party claims aggregators that collect, and digest adjudicated claims data from multiple sources (private and public payers) and make it ready for analysis. This aggregated data usually includes medical claims, pharmacy claims, and eligibility and provider files.

Tier 3 Claims-EHR Linked

Provide access to insurance claims data linked to electronic health record (EHR) data to facilitate the evaluation of product safety using data that more clearly and completely captures patients' experiences.

Tier 4 Scientific Support Services

Provide scientific support services including subject matter expertise and capabilities to conduct pharmacovigilance and pharmacoepidemiology research (e.g., plan and conduct analyses using statistical and epidemiologic data); data science (e.g., expertise in statistical computer languages, data architecture and advanced statistical concepts; data source linkage); artificial intelligence (e.g., natural language processing and machine learning); software programming (e.g., expertise in development, testing and analysis using relevant software applications); scientific program and project management (including program performance metrics tracking and reporting), regulatory operations support, scientific research project development and management support, methods development to address emerging safety issues and public health emergencies.

Tier 5 Website

Development and operations/maintenance of program website to support FDA’s commitment to transparency. Manage website content provided by FDA and its contractors including analytic packages, study results, and other program documents.

Tier 6 Business Informatics Support

Implement and maintain a secure information exchange portal to allow secure data exchange between FDA and other contractors in the Sentinel System 3.0 ecosystem. Implement and maintain workflow and document management systems compliant with FDA records management requirements and Federal Information Security Management Act (FISMA).

Tier 7 Specialty Healthcare EHRs

Provide access to healthcare data pertaining to special populations (e.g., pediatrics, geriatric) and inpatient healthcare delivery venues (e.g., intensive care unit, pediatric hospital).

Tier 8 Registries

Provides access to product- or disease-based registries.

Tier 9 Mother-Infant Linked Data

Provides access to large database of mother-infant linked records ready for regulatory and public health safety surveillance research.

Tier 10 CMS – Medicare and Medicaid Claims

Provide access and scientific expertise in the use of Medicare and Medicaid data to conduct regulatory and public health safety surveillance research.

Tier n TBD (if needed)

Additional Tiers to be included based on other FDA’s requirements

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