CDC RISER Industry Day

Questions & Answers / Clarifications

This document contains questions and requests for clarification from potential bidders regarding the RISER (Research, Innovation, and Scientific Excellence) IDIQ opportunity. It seeks to provide clarity on the proposed execution model, funding strategies, domain modularity, integration, program management, and communication considerations.

• Execution Model: Bidders are asked to recommend an execution model (federated, non-federated, hybrid) and explain how it would accommodate programs with limited or delayed funding without hindering overall execution. Risks associated with a fully centralized model are also queried.
• Funding & Task Order Strategy: Questions focus on identifying centrally funded capabilities essential for program startup and continuity, and approaches for structuring task orders to allow independent program onboarding, phased participation, and incremental funding, while preventing early adopters from subsidizing later participants.
• Domain Modularity: Bidders should describe how RISER Domains (A-D) can be structured modularly to support partial participation, small business involvement, and incremental scaling, and identify risks of tightly coupled domains.
• Integration, IT, and Data Governance: The document inquires about baseline IT and data integration capabilities required for multiple independent task orders and how to manage Interface Control Documents (ICDs), data governance, and system-of-record authority in a federated environment.
• Program Management & Risk: Industry perspectives are sought on minimum program management structures for coordinating multiple programs, vendors, and funding streams, and methods for managing schedule, cost, and performance risk across independently funded task orders. Lessons learned from similar large IDIQs are also requested.
• Industry Day & Communication: Questions address what information industry needs prior to an Industry Day for meaningful feedback, which aspects of RISER benefit most from early industry engagement, and common government missteps to avoid during Industry Days.
• SOW Clarity & Executability: Bidders are asked to identify requirements in the current RISER SOW with the highest implementation risk in the first 12-18 months and areas where requirements appear overlapping or implicitly dependent on other domains.
• FAR Modernization & Compliance: The document seeks to understand the impact of recent FAR updates (e.g., Part 12/15 streamlining, small business emphasis, data rights, cybersecurity, supply chain) on contractor approaches to large, multi-domain IDIQs and if the current SOW requires clarification or flexibility to align with evolving FAR requirements.

This document provides critical clarifications and seeks industry input that may influence the final solicitation requirements, evaluation criteria, and overall approach to the RISER IDIQ. Bidders should review these questions and proposed answers carefully as they inform proposal development.

Statement of Work (SOW) / Performance Work Statement (PWS)

This Statement of Work (SOW) outlines the requirements for the Centers for Disease Control and Prevention's (CDC) Resources for Improvement of Surveillance and Emergency Response (RISER) contract. The primary goal is to support CDC's infectious disease surveillance, outbreak investigations, preparedness, and response efforts by ensuring the availability of high-quality reagents and materials.

The RISER contract aims to support the National Center for Immunization and Respiratory Diseases (NCIRD) and the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). Key responsibilities include:

• Producing or acquiring, characterizing, storing, and distributing reference pathogens, positive controls, detection kits, genomic sequencing components, and other surveillance/research reagents.
• Ensuring reliable availability of these reagents to CDC, public health laboratories, and research collaborators.
• Rapidly scaling reagent acquisition, production, and distribution for public health emergencies.
• Establishing and maintaining secure infrastructure for real-time data exchange and visualization of CDC-generated analysis outputs.
• The work is divided into four domains: Core Reagent Production and Catalog Management (Domain A), Facility Operations and Logistics (Domain B), Information Technology (IT) and Data Systems (Domain C), and Customer Service and Stakeholder Support (Domain D).

Performance will be measured against Key Performance Indicators (KPIs) detailed in Appendix D, including but not limited to:

• ≥95% of orders shipped within CDC-mandated timelines.
• ≥98% first-pass Quality Control (QC) pass rates.
• Demonstrated surge activation within 10 business days.
• ≥99.95% availability for RISER IT systems.
• Timely and complete reporting.

The contract structure includes a base period and option periods with varying durations. The primary place of performance is at the contractor's facilities within the United States, with potential for onsite work at CDC facilities in Atlanta, GA.

• Offerors must comply with quality specifications (Appendix B) and manufacturing standards (e.g., ISO 9001, ISO 13485, cGMP).
• IT systems must comply with Section 508 accessibility standards.
• Contractors must maintain cybersecurity measures and data governance plans aligned with CDC's Data Modernization Initiative (DMI).
• The contract is structured as a hybrid Indefinite Delivery/Indefinite Quantity (IDIQ) with potential for Firm-Fixed-Price (FFP), Cost-Plus-Incentive-Fee (CPIF), and Time-and-Materials (T&M) task orders.
• Optional tasks include ancillary reagent procurement and development of scientific workflows for diagnostic assay design.

Statement of Work (SOW) / Performance Work Statement (PWS)

This document details the tasks and requirements for the Reagent, Inventory, and Services Enhancement Resource (RISER) program, focusing on the development, maintenance, and operation of a reagent catalog, website, CRM system, and associated logistics.

• Domain A (Tasks 1, 3, 4): Develop Standard Operating Procedures (SOPs), establish and operate the RISER catalog (including reagent production/procurement, QA/QC, and inventory management), and manage reagent stability and shelf-life.

• Domain B (Tasks 2, 8): Establish facility requirements (including biosafety levels and environmental controls), and manage reagent order intake, packaging, shipping logistics, and cold chain integrity.

• Domain C (Tasks 5, 7, 9): Operate and maintain the RISER website and CRM system (Microsoft Dynamics 365), ensuring integration, security, and availability. Also responsible for managing the Shared Cost Allocation Plan (SCAP) for shared IT resources.

• Domain D (Task 6): Manage laboratory registration for RISER accounts, including vetting, user agreement management, and customer support for registration-related inquiries.

• Optional Tasks (10, 11, 12): Include surge support capabilities, outgoing transition to a new contractor, and development/validation of diagnostic assay workflows.

• Website and CRM uptime: >=99.95%

• Order processing and shipment timelines

• QA/QC pass rates

• Cold chain integrity

• Security compliance (FISMA Moderate, NIST SP 800-53 Rev. 5)

• Section 508 compliance

• Timely reporting and documentation submission

Not explicitly stated in this excerpt, but implies ongoing operations and potential for global distribution.

• Strict adherence to biosafety (BSL-1 to BSL-4) and select agent program requirements.
• Compliance with FDA regulations (21 CFR Part 820), ISO standards, and CDC policies.
• Robust cybersecurity measures, including Authority to Operate (ATO) and continuous monitoring.
• Detailed documentation, including SOPs, QA/QC plans, ICDs, and SCAPs.
• Personnel must undergo conflict-of-interest screening.
• Cross-domain coordination is essential for seamless operations.