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Registration Review Decision Document:
Work Group Recommendations
July 20, 2005
Document Design
- Keep it Brief
- Address different audiences
- High-level overview
- Should be flexible enough to handle easy-off and ones with risk concerns
- Provide both links and references
- Free standing document when printed
Elements
- Reference to previous regulatory document
- Description of use
- Changed since last comprehensive assessment
- Summary of new data
- Describe risks of concern, mitigation and decision
- Describe any new DCI and reasoning
- No tolerance discussion unless dietary risk of concern
Other Considerations
- Fact sheet may be useful
- When possible, identify significant policy changes and their impact
- As appropriate describe any upcoming activities that may affect (E.g.; new data requirement)