Data Package Requirements

You should provide the following information to support your request:

  1. A description of the services requested including a detailed description of the technology, potential advantages over standard methods, and potential alternative methods
  2. An estimation of the cost of all equipment, test kits, and reagents necessary to perform the assay along with a well-developed standard operating procedure that will be used for the evaluation
  3. The investigator’s development plan for the product with a description of the importance of NIAID-sponsored evaluations to the plan
  4. Preliminary validation data to support the product’s proposed use, including validation data specified by Good Clinical Laboratory Procedures for tests that are not Food and Drug Administration (FDA) approved
    • Reportable range including Analytical Measurement Range (AMR) and Clinically Reportable Range (CRR)
    • Analytical Sensitivity
    • Accuracy
    • Precision
    • Analytical Specificity (Interfering Substances)
    • Reference Intervals (normal values) - if appropriate
  5. Discussion of the funding sources available to the Investigator to develop the product outside the assistance of NIAID contract services, including descriptions of other studies performed or to be performed under these funding sources
  6. Discussion of interactions with FDA or other regulatory groups regarding the product, including clarification of the intellectual property status of product (patents under consideration, submitted and pending, or issued)
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