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 rules took effect

• Dec. 24, 2003: First comment period on IFR closed; will reopen in April 2004 for 30 days