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Announcement for HL7 SPL WG Electronic Establishment Registration
Hands-On Training Session

A hands-on training session will be offered to individuals directly involved in the preparation and submission of establishment registration information to the FDA. You will have the opportunity to use the XForm tool to create SPL specific to your organization's Establishment Registration documentation. Attendees at the February Webinar and/or Face-to-Face meetings will benefit from this follow-up.

You must have your own examples of Establishment Registration in order to participate.

Background: The FDA Amendments Act placed into law the requirement for electronic establishment registration and drug listing. Release 4 of Structured Product Labeling (SPL) contains data elements that could enable this process. The XForm is one method of creating SPL files for Establishment Registration.

Targeted audience: Registration for this training session is extremely limited. Attendees of the February Webinar or Face-to-Face responsible for submission of Form 2656 for their organization are strongly encouraged to attend. Please ensure you are able to complete the following pre-work and meet the requirements for attendance:

• review the Draft Structured Product Labeling Implementation Guide for FDA Drug Registration and Listing and the SPL for Registration and Listing Guide (v.02) (link below);
• have examples of completed Form 2656 for your use during the training session, and
• be responsible for submission of Form 2656 for your organization (including pharmaceutical, biologic, OTC and animal products)
• have obtained the appropriate DUNS number for businesses included in registration (e.g., establishments, importers, US agents) (directions on how to obtain included in link 1 below)

Background information:

1. SPL Release Four Evaluation Material for Registration and Listing - the Draft Structured Product Labeling Implementation Guide for FDA Drug Registration and Listing, SPL for Registration and Listing v0.2 and Obtaining a DUNS Number v0.1
2. FDA Amendment Act of 2007 - Section 224 - Electronic Registration and Listing
3. xForm link

Webinar Information:

Date: Wednesday, April 9, 2008
Time: 1:30 p.m. – 2 :30 p.m. EST

Registration Information:

There is no registration fee for this training session, but pre-registration is required because of limited connections for the webinar. To register, please submit your first and last name and the name of your organization to spl@fda.hhs.gov. You will be limited to two phone/webinar lines per company.

For further information, contact: spl@fda.hhs.gov.

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