In light of the increased use of CRA by federal agencies, the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) asked the National Research Council to convene an expert committee to develop and apply an evidence-based conceptual model and methods for ranking categories of products addressed by FDA programs. The conceptual model and methods were to focus on ranking product categories according to the ranges of magnitude of various potential health consequences to U.S. users of the products at the individual level and the population level, taking both adverse and beneficial effects into consideration. To accomplish its task, the committee was to include the following activities: consult with the sponsor to select FDA product categories to be ranked; consider products currently in use and near-term future products expected to come under FDA purview; review selected scientific literature bearing on adverse and beneficial health consequences; consider the scientific literature broadly to include social-science and economics literature, gray literature, and regulatory-policy literature; seek opportunities to assess health consequences in a way that allows results to be compared among broad product categories; identify information needed to address key uncertainties; assess the performance of the evidence-based model for ranking the selected product categories and identify next steps for model refinement; and where applicable and feasible, consider the potential effects on population health if risk-reduction strategies curtail the beneficial use of products.

Contents

• [Letter to Dr. Kathleen M. Koehler]
• BACKGROUND
• STATEMENT OF TASK AND COMMITTEE’S APPROACH
• RANKING MODEL
  • Conceptual Framework
  • Step A: Defining the Product Categories
  • Step B: Identifying the Attributes
  • Step C: Describing the Product Categories by Using the Attributes
  • Steps D and E: Conducting the Ranking and Analyzing the Results
• NEXT STEPS
• Attachment A STATEMENT OF TASK
• Attachment B COMMITTEE MEMBERSHIP
• Attachment C REFERENCES
• Attachment D ACKNOWLEDGMENT OF REVIEWERS