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4. Status of Recordkeeping and Administrative Detention

Overview of Registration and Prior Notice Interim Final Rules

April 2004

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Status of Recordkeeping and Administrative Detention - see text below      

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
    
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