FDA Notice Regarding Firms Offering Registration Services (Re: Bioterrorism Act)

From: Pamela Tom (pdtom@ucdavis.edu)
Date: Tue Jul 01 2003 - 21:49:35 PDT

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    Source: http://www.cfsan.fda.gov/~dms/fsbtnote.html
    June 30, 2003

    "FDA is aware that various firms may be offering their services to assist
    domestic and/or foreign facilities to register with FDA. Please note that
    these firms are not affiliated with FDA, nor has the agency contracted
    with any firms to register facilities. While facilities must be registered
    with FDA by December 12, 2003, there is no duty to register now as we have
    not yet issued a final rule containing the registration requirements, nor
    has FDA issued a final registration form for facilities to use to
    register. As the proposed rule states, FDA will not accept registrations
    before we publish the final rule (expected October 10th). We have received
    favorable feedback from industry in response to our demonstrations of the
    prototype registration system and we anticipate that registration over the
    Internet will be a very straightforward process. There will be no
    registration fee."

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