MessageFrom: Gross, Mary Sent: Thursday, August 08, 2002 12:09 PM To: Butler, Jennie C Subject: FW: Bar code meeting in June -----Original Message----- From: Weniger, Bruce [mailto:bgw2@cdc.gov] Sent: Wednesday, July 17, 2002 8:05 PM To: Gross, Mary C. (FDA) Subject: RE: Bar code meeting in June Dear Mary, Here's the short summary text you requested. If too long, just cut off the 3rd paragraph. A longer version for the written record will be supplied later. Thanks, Bruce ++++++++++++++++++++++++++++++++++++++++++++++++++++++ Brief summary of comments at FDA hearing on barcoding by: Bruce G. Weniger, MD, MPH Assistant Chief for Vaccine Development Vaccine Safety and Development Branch National Immunization Program Centers for Disease Control and Prevention Atlanta, GA 30333 Mandated barcoding of National Drug Code (NDC), lot number, and expiration date on unit-of-use packaging of pharmaceutical products would greatly facilitate the voluntary goals of the Vaccine Identification Standards Initiative (VISI, www.cdc.gov/nip/visi). This intersectoral effort is designed to improve the convenience and accuracy of transferring vaccine identities and lot numbers into medical records, as required by Federal law. Currently, missing information and transcription errors in medical records hamper major vaccine safety surveillance systems. Three quarters of vaccinations are reported to immunization registries because of the extra work involved. VISI calls for primary vaccine packaging (vials and prefilled syringes) to contain barcodes with NDC, lot number, and expiration date (plus human-readable data) on both the permanent label and duplicate or triplicate peel-off stickers. The latter would be for medical records, immunization registry reporting forms, and patient immunization "passports" in clinics without scanners and computers. Essential to success of the FDA initiative is to specify the use of reduced-space barcoding symbologies promulgated by international organizations (UCC.EAN) which already set the standards for existing barcodes on pharmaceuticals, foods, and most other products in global commerce. This would avoid the danger of incompatible symbologies, with codes other than the NDC, appearing on products from different manufacturers. Technologies are now becoming available for fast "online" printing onto peel-off vial stickers to permit barcoding of data available only at the time of vial filling, such as lot numbers and expiration date. # # # -----Original Message----- From: Gross, Mary [mailto:GrossM@cder.fda.gov] Sent: 2002 July 16 18:15 To: HHS-Weniger, Bruce (CDC) Subject: RE: Bar code meeting in June Hi - Please see the attached letter regarding speaking at the barcode meeting. Thanks. Mary -----Original Message----- From: Weniger, Bruce [mailto:bgw2@cdc.gov] Sent: Tuesday, July 16, 2002 2:56 PM To: Gross, Mary C. (FDA) Subject: RE: Bar code meeting in June Dear Mary, Fine, I'll have something short for you by tomorrow, and later provide a lengthier abstract. What is the number of minutes I should plan to speak? May I illustrate my remarks with a Powerpoint computer presentation? If so, will NIH or FDA have the projector ready and available? Thanks, Bruce -----Original Message----- From: Gross, Mary [mailto:GrossM@cder.fda.gov] Sent: 2002 July 16 09:30 To: HHS-Weniger, Bruce (CDC) Subject: RE: Bar code meeting in June An outline or a couple of sentences for today. You should include a lengthier version of your remarks for the written record though since time for presenting will be very short because of the numbers of people asking to speak. Mary -----Original Message----- From: Weniger, Bruce [mailto:bgw2@cdc.gov] Sent: Monday, July 15, 2002 5:39 PM To: Gross, Mary C. (FDA) Subject: RE: Bar code meeting in June Dear Mary, Yes, I definitely am interested and have my TDY orders in hand. What length and detail are needed for the summary of my remarks? One sentence? A few sentences? A few paragraphs? Thanks, Bruce -----Original Message----- From: Gross, Mary [mailto:GrossM@cder.fda.gov] Sent: 2002 July 15 16:26 To: HHS-Weniger, Bruce (CDC) Subject: RE: Bar code meeting in June Are you still interested in speaking at this meeting on July 26? If so, I need a summary of your remarks as soon as possible. Thanks. Mary -----Original Message----- From: Weniger, Bruce [mailto:bgw2@cdc.gov] Sent: Friday, June 14, 2002 10:21 AM To: Gross, Mary C. (FDA) Cc: Chen, Robert (Bob) (NIP); Broom, William L. Subject: FW: Bar code meeting in June Importance: High Dear Mary, Would you please add me to FDA's email list (see below) of recipients to learn about notices and meetings regarding the FDA barcoding issue? I coordinate the Vaccine Identification Standards Initiative (VISI), which includes detailed recommendations for barcoding on vaccine packages and labels (http://www.cdc.gov/nip/visi). May I have some time to address the meeting to summarize the VISI barcoding proposals? Thank you. Bruce G. Weniger, MD, MPH Assistant Chief for Vaccine Development Vaccine Safety and Development Branch National Immunization Program Centers for Disease Control and Prevention ------------------------------------------ Postal Mail: 1600 Clifton Road (E-61) Atlanta, GA 30333 USA Couriers: 12 Corporate Boulevard Atlanta, GA 30329 USA ------------------------------------------ Tel: [+1] 404-639-8779 Fax: [+1] 404-639-8834 bgw2@cdc.gov http://www.cdc.gov/nip/dev -----Original Message----- From: Roberts, John [mailto:JRoberts@uc-council.org] Sent: Friday, 2002-Jun-14 09:47 Subject: FW: Bar code meeting in June Importance: High fyi message from FDA, have not seen yet in CFR -----Original Message----- From: Gross, Mary [mailto:GrossM@cder.fda.gov] Sent: Wednesday, June 12, 2002 3:22 PM To: 'Raney, Elizabeth [JANUS]'; 'rkriozere@digi-trax.com'; 'leed@hhp.com'; 'jennifer_paine@baxter.com'; 'Hospital@aol.com'; Roberts, John; 'stephen_hess@merck.com'; 'Wark_Boucher@hc-sc.gc.ca'; 'Derrick.Gallagher@aventis.com'; 'laura.nottingham@secure.abbott.com'; 'james.mctiernan@roche.com'; 'RVogel@LScan.com'; 'JohnsSB@HPD.Abbott.com'; 'dbc2644@GlaxoWellcome.com'; 'cgilles@trackingsolutionsinc.com'; 'AGOLDHAM@phrma.org'; 'MDW@nnpi.com'; 'Matthew_Williams@PremierInc.com' Subject: RE: Bar code meeting in June Importance: High Hi: The FDA public meeting will be held on July 26 at Natcher auditorium in Bethesda, MD. We expect a Federal Register notice to publish late this week or early next that articulates questions and areas where FDA is seeking specific feedback on barcode requirements. Instructions for potential speakers and others wishing to attend the meeting as observers will also be detailed in the FR. Thank you for expressing interest in the barcoding issue. Mary