Blood Products Advisory Committee June 14-15, 2001

BLOOD PRODUCTS ADVISORY COMMITTEE

69th Meeting - June 14-15, 2001

Gaithersburg Hilton, 620 Perry Parkway

Gaithersburg, MD 20877

Thursday, June 14, 2001

8:30 a.m. Statement of Conflict of Interest

8:35 a.m. Welcome and Opening Remarks

8:40 a.m. Committee Updates

Meeting Summary on Blood Safety and Availability PHS Advisory Committee, April 19-20, 2001 - Stephen Nightingale, M.D.

Current Thinking: Clinical Trial Design and Performance Standards for Approval of Rapid HIV Tests - Elliot Cowan, Ph.D.

Proposed FDA Scientific Workshops - Linda A. Smallwood, Ph.D.

9:00 a.m. Open Committee Discussion

I. Re-entry for Donors Deferred Because of HIV or HCV NAT or Serological Test Results

A. Introduction and Background - Paul A. Mied, Ph.D. Deputy Director, Division of Emerging and Transfusion Transmitted Diseases, OBRR

B. Presentation - Michael Busch, M.D., Ph.D.,Blood Centers of the Pacific, CA

C. Presentation - Susan Stramer, Ph.D., American Red Cross

D. Presentation - Susan Galel, M.D., Stanford University

10:15 a.m. OPEN PUBLIC HEARING

10:45 a.m. BREAK

11:00 a.m. Open Committee Discussion

E. Questions for the Committee

F. Committee Discussion and Recommendations

12:30 NOON LUNCH

1:30 p.m. Open Committee Discussion

II. CLIA Criteria for In Vitro Diagnostic Tests: Applicability of Waivers to HIV Rapid Tests

A. Introduction and Background - Elliot Cowan, Ph.D. DETTD, OBRR, CBER

B. Historical Overview of CLIA Waivers - Thomas Hearn, Ph.D., CDC

C. Overview of FDA Draft Guidance for CLIA Criteria for Waiver - Joseph Hackett,Ph.D., DCLD, ODE, CDRH

D. Public Health Strategic Goals for HIV Testing - Ida Onorato, M.D., CDC

E. Requirements for Moderate Complexity Tests and HCFA Experience with CLIA Waived Tests in the Laboratory - Judith Yost, HCFA

F. FDA Perspectives on CLIA Waiver of Rapid HIV Tests and Questions for the Committee - Elliot Cowan, Ph.D., DETTD,OBRR, CBER

2:30 p.m. OPEN PUBLIC HEARING

3:00 p.m. Open Committee Discussion

G. Committee Discussion and Recommendations

4:00 p.m. BREAK

4:15 p.m. Open Committee Discussion

III. Revision of the Uniform Donor History Questionnaire - Informational Presentation

A. Overview and Introduction - Alan Williams, Ph.D. Director, Division of Blood Applications

B. Update on AABB Task Force Programs - Joy Fridey, M.D.,AABB

C. Presentation of Proposed Modifications to Uniform Donor History Questionnaire - Susan Orton, M.D. ARC

4:45 p.m. OPEN PUBLIC HEARING

5:00 P.M. Open Committee Discussion

D. Committee Discussion and Recommendations

5:30 p.m. RECESS (until 8:30 a.m., Friday, June 15, 2001)

Friday, June 15, 2001

8:30 a.m. Committee Updates

DHHS TSE/BSE Action Plan - Steven Nightingale, M.D.

OBRR TSE/BSE Action Plan - Mary Elizabeth Jacobs, Ph.D.

Update on Transmissible Spongiform Encephalopathies Advisory Committee Meeting to be held on June 28-29,2001 - TBD

9:00 a.m. Open Committee Discussion

IV. Transfusion-Related Acute Lung Injury - Informational Presentation

A. Introduction and Background - Leslie Holness, M.D., Medical Officer, Division of Blood Applications

B. Presentation - Mark Popovsky, M.D., Haemonetics Corp.

C. Presentation - Patricia Kopko, M.D., Sacramento Blood Center

D. Presentation - Lynn K. Boshkov, M.D., Oregon Health Sciences University

E. Presentation - John Finlayson, Ph.D., Associate Director for Science, OBRR

10:15 a.m. OPEN PUBLIC HEARING

10:45 a.m. BREAK

11:00 a.m. Open Committee Discussion

F. Committee Discussion and Recommendations

11:45 a.m. LUNCH

12:45 p.m. Open Committee Discussion

V. Studies on Leukoreduction Filtration Failures

A. Introduction and Background - Betsy Poindexter, Biologist, Lab. of Cellular Hematology, DH B. Presentation - Constance Noguchi,Ph.D., NIH

C. Presentaton - Thomas Walker, M.D., Canadian Blood Services

D. Presentation - Rebecca Haley, M.D., American Red Cross

E. Presentation - Cheri Jennings, Gulf Coast Blood Center

F. Presentation - Glenda Ford, Oklahoma Blood Institute

1:45 p.m. OPEN PUBLIC HEARING

2:15 p.m. Open Committee Discussion

G. Committee Discussion and Recommendations

2:45 p.m. VI. Report of the Intramural Site Visit of the Laboratory of Plasma Derivatives, Division of Hematology, OBRR

A. Introduction and Overview

- Neil Goldman, Ph.D., Associate Director for Research, CBER

- John Finlayson, Ph.D., Associate Director for Science, OBRR

- Basil Golding, M.D., Chief, Lab. of Plasma Derivatives, DH

3:15 p.m. Closed Committee Deliberations

B. Committee Discussion and Recommendations

3:45 p.m. Adjournment