Status of Recordkeeping and Administrative Detention

• FDA published proposed rules on May 9, 2003 with a 60 day comment period
  • Establishment and Maintenance of Records (68 FR 25188)

  • Administrative Detention (68 FR 25242)

• FDA evaluating public comments it received

  • 200 comments on records; 100 comments on detention

• Publication goal for final rules: May 2004