Establishment and Maintenance of Records

FDA Actions on the Bioterroism Act of 2002

• Press Release: FDA Issues Final Rule on the Establishment and Maintenance of Records to Enhance the Security of the U.S. Food Supply Under the Bioterrorism Act, FDA also issues draft guidance regarding records access December 6, 2004
  
• Final Rule: Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 December 9, 2004
  • Correction to the Final Rule February 23, 2005
• Booklet (SECG): What You Need to Know About Establishment and Maintenance of Records December 2004 (also available in French and Spanish)
• Fact Sheet: FDA's New Food Bioterrorism Regulation: Establishment and Maintenance of Records Revised November 2005
• Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4) September 21, 2006
  (Federal Register Notice of Availability, September 26, 2006)
• Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 November 2005
• Domestic Outreach Grassroot Meetings (June 2005) FDA Updates: "Ensuring Compliance With the New Rule for Establishment and Maintenance of Records Implementing Section 306 of the Bioterrorism Act", May 2005
  • Public Meetings: Federal Register notice† May 13, 2005
  • Meeting Agenda†
  • Slide Presentation: Overview of Bioterrorism Act's Establishment and Maintenance of Records Final Rule June 2005
  • Transcript of June 9, 2005 meeting in College Park†
• Domestic Outreach Grassroot Meetings (January & February 2005)  Proposed Schedule for BT Final Rules: "What You Need to Know to Assure Compliance with the New FDA BT Final Regulation for Establishment and Maintenance of Records Final Rule that Implements Section - 306 of the Bioterrorism Act" December 6, 2004†
  • Public Meetings: Federal Register notice, December 9, 2004†
  • Meeting Agenda
    • Video of January 13, 2005 meeting in College Park†
    • Transcript of Meeting† (also available in French† and Spanish†)
    • Slide Presentation:  Overview of Bioterrorism Act Establishment and Maintenance of Records Final Rule January 13, 2005 (also available in French† and Spanish†)

 

† Temporarily unavailable on the web.