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58. Confidentiality of Registration Information

Overview of Registration and Prior Notice Interim Final Rules

April 2004

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Confidentiality of Registration Information - see text below

Confidentiality of Registration Information

  • The Bioterrorism Act precludes FDA from publicly disclosing registration numbers and related registration information.

  • Facilities are not precluded from sharing their registration numbers with third parties, but are urged to treat them as sensitive business information.

    • In some instances, a facility will need to provide its registration number to persons who may be submitting prior notice for a product manufactured by the facility.
    
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