4. Background: FDA's Regulatory Development Timeline

Overview of Registration Interim Final Rule Implementing the Bioterrorism Act

October 10, 2003

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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
• Dec. 12, 2003: Interim final rule takes effect
• Dec. 24, 2003: Comments due on interim final rule (comment period will reopen in March 2004)