6. Background: FDA's Regulatory Development Timeline

Overview of Registration and Prior Notice Interim Final Rules

April 2004

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Background: FDA’s Regulatory Development Timeline

• Oct. 28, 2003: Public meeting via satellite downlink to domestic and international sites
  • Transcripts available in English, French & Spanish
  • Outreach materials will be available on FDA’s website in Arabic , Chinese, French, Hindi, Japanese, Malay, Portuguese, and Spanish:
• http://www.fda.gov/oc/bioterrorism/bioact.html
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• Dec. 12, 2003: Interim final rules took effect
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• Dec. 24, 2003: First comment period on IFR closed; will reopen in April 2004 for 30 days