HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-07-06

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

July 6, 2009

Attendees:

Norman Gregory (CVM), Mai Huynh (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Amy Malla (CBER), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), and Diane Miller (Alpharma)

  • If you have a new compound that is not in the Substance Registration System (SRS) it can be registered through SPL by contacting Lonnie Smith (Lonnie.Smith@fda.hhs.gov). The compound can be given a code and the other information about the compound can remain confidential.
  • Attached files will be stored in the same place as the XML filed.
  • Relative hyper links do work. Xerces still have problems validating, but XMLSpy will validate, could be a problem with Xerces.
  • The data types (IVL<TS>) will not allow P24M (ISO for period 24 months), only numeric value. It has a high, low and width. A 0 in the high value and nothing in the width would mean not approved, a 0 in high and a value in width would indicate proposed, and nothing in high and a value in width would indicate approved and the exact date would come from the manufactured material. So it would read:

Expiration: 24 month (approved) Expiration Date: 06-Jul-2009

  • In the "Expiration Dating:" field of the style sheet, will display a period (24 months) and a hard date (12-FEB-2009), along with either approved, proposed in parenthesis.
  • If the capTypeCode is not put in XML as an element it message will validate, did not need code.
  • The message header (top of XML file) is optional.

Agenda for July 13 2009 Teleconference: