MILLER REPORTING COMPANY, INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666DPEARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICEFOOD AND DRUG ADMINISTRATIONMEDICAL DEVICE ACTION PLANOPEN PUBLIC MEETING9:00 a.m.Tuesday, December 1, 1998Natcher Auditorium Balcony B National Institutes of Health Bethesda, MarylandMILLER REPORTING COMPANY, INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666AGENDAOpening Remarks Kathryn Zoon, Ph.D.3Budget Issues/Team BiologicsMark Elengold11Perspectives - Present Issues from the Device Industry, Manufacturers IssuesSoftware - HIMA Carolyn Jones, J.D., M.P.H.20Equipment/supplies, Baxter HealthcareSteven Binion, Ph.D.30Heart, Lung and Blood Institute Paul McCurdy, M.D.37Small Business Perspective ThermoGenesis CorporationPhil Coelho45Centers for Disease ControlBernard M. Branson, M.D.52Blood Industry, American Association of Blood BanksKay Gregory, MS, MT(ASCP)SBB59Office of Regulatory AffairsElaine Cole66Patient Perspective Gay Mens Health CrisisDerek Link73European Community Paul Ehrlich InstitutDr. Johannes Lower79Hogan thank you-four national experts who are theMILLER REPORTING COMPANY, INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666biologics national experts, who also report to ORAheadquarters, and two compliance officers, one of whom Iveseen here so far today.Theyre located in the field offices around thecountry but they report to the ORA headquarters staff in theDivision of Epidemiology and Inspectional Operations. Isthat right, Elaine?MS. COLE: You got the initials right.MR. ELENGOLD: I got the initials right. Thatgroup has changed names at least 20 times since Ive startedwith FDA.One of the comments we did hear during thegrassroots and 406(b) meetings was the need for improvedguidance material. Well, the Team Biologics process has ledto the formation of more of that. We have issued or are inthe final process of issuing compliance programs as productsmove from CBER lead to ORA lead. We have issued some andwill be issuing more inspection guides. We got specificinspection assignments with guidance in them, operationalSOPs so that everyone is doing everything the same wayacross the country. And the Turbo EIR, which is aninitiative that ORA started that we have assisted with,which speeds the reporting process so that actions can betaken and files closed faster.Training activities. This is probably the mostMILLER REPORTING COMPANY, INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666highly trained group of people in the FDA today. Weve hadsix blood banking and plasma courses. Weve had two courseson the fractionation industry. We had courses on IVDmanufacturing, which is a particular interest to this group.And many of you I know were at the industry workshop thatwe had in conjunction with the IVD training back over thesummer. Allergenic manufacturers training, biotechnology,and were planning for the summer a vaccine manufacturingtraining program for the Team Biologics. And were in theprocess of holding three or four quality auditing courses.One of the things that is a parallel issue butrelated is the GMP Working Group, which was put togetherunder the lead of the Office of Enforcement and the Officeof Regulatory Affairs. That group has been trying toaddress issues that are common across the Centers. Andthere are members of that group from ORA, CBER and CDER andat a recent meeting we decided to expand that group toinclude CDRH, so they will be coordinating on these issues,as well.And so far, some of the issues theyve discussedand tried to reach resolution on are viral and activationvalidation, reprocessing, reworking, blending, validation,particulate matter and inspectional issues.The implementation schedule for Team Biologics,the first products that went over October 1, 97-plasmaMILLER REPORTING COMPANY, INC. 507 C Street, N.E. Washington, D.C. 20002 (202) 546-6666fractionation products. April 1, 98, licensed IVD, andmany of you in the room are very familiar with that process.October 1 this year we transferred allergenics and thebiotech products. And the last group to go over October 1,99 are the vaccine products.And one of the things we hope to accomplish and wehave actually in the operations group that oversees the TeamBiologics roll-out just about finalized an evaluation plan,is to see how were meeting our goals. The things well belooking for are consistency of agency operations, enhancedcoordination, the importance of the program, both to the FDAside and the industry side, industry acceptance and support,which quite frankly has been mixed. Some manufacturers havetold me enthusiastically they think this is the greatestthings weve ever done. Others have reservations.Technical expertise of the staff. Theres acertification program so that eventually all peopleparticipating in this will be certified to a base level. And, of course, our overall goal of consumer prote