BLOOD PRODUCTS ADVISORY COMMITTEE
69th Meeting - June 14-15, 2001
Briefing Information
June 14, 2001
Contents pdf
I. Re-entry for Donors Deferred Because of HIV or HCV NAT or Serological Test Results
A. Introduction, Background, Paul A. Mied, PhD, Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, OBRR, FDA
Reentry for Donors Deferred Because of HIV or HCV NAT or Serological Test Results pdf
Attachment 1, NAT Testing Algorithm for Whole Blood pdf
Attachment 2, Reentry for Donors Deferred Because of HIV Test Results pdf
Attachment 3, Reentry for Donors Deferred Because of HCV Test Results pdf
Articles*
B. Presentation - Michael Busch, MD, PhD, Blood Centers of the Pacific, CA ppt html
D. Presentation - Susan Galel, MD, Stanford University pdf
II. CLIA Criteria for In Vitro Diagnostic Tests: Applicability of Waivers to HIV Rapid Tests
B. Historical Overview of CLIA Waivers - Thomas Hearn, PhD, CDC pdf
Clinical Laboratory Improvement Advisory Committee, June 14, 2001, Lee Richardson pdf html
Public Health Service; CLIA Program; Categorization of Waived Tests, September 13, 1995, 60FR47534 pdf txt
Guidance for Clnical Laboratory Improvement Amendmends of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA Applications html
Overview of FDA Draft Guidance for CLIA Criteria for Waiver, Joseph Hackett, PhD, DCLD, ODE, CDRH pdf
Requirements for Moderate Complexity Tests and HCFA Experience with CLIA Waived Tests in the Laboratory - Judith Yost, HCFA pdf
III. Revision of the Uniform Donor History Questionnaire - Informational Presentation
Overview and Introduction - Alan Williams, PhD, Director, Division of Blood Applications pdf
Update on AABB Task Force Programs - Joy Fridey, MD, AABB pdf
May 8, 2001 Letter to Jay Epstein, MD, Director, Office of Blood Research and Review from Joy L Fridey MD pdf
Attachment 1 to May 8, 2001 letter pdf
Attachment 2 to May 8, 2001 letter pdf
Articles*
Presentation of Proposed Modifications to Uniform Donor History Questionnaire - Susan Orton, MD, ARC pdf
Association Bulletin #99-10, New Uniform Donor History Questionnaire Issued, Dated December 2, 1999 pdf
*Articles contain copyrighted material. These documents may be viewed at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 between the hours of 9:00 am and 4:00 pm Monday through Friday, except for Federal holidays.