85th Meeting November 3-4, 2005

Gaithersburg Holiday Inn

2 Montgomery Village Avenue

Gaithersburg, MD 20877


Thursday, November 3, 2005

8:00 a.m. Welcome, Statement of Conflict of Interest, Announcements


8:15 a.m. Committee Updates

-         West Nile Virus Update Hira Nakhasi, Ph.D., OBRR, FDA and Theresa Smith, M.D., CDC (15)


-         Draft Guidance on NAT for HIV-1 and HCV: Testing, Product Disposition, and Donor Deferral and Re-entry Paul Mied, Ph.D., OBRR, FDA (10)


-         Summary of the DHHS Advisory Committee on Blood Safety and Availability Jerry Holmberg, Ph.D., Executive Secretary, Advisory Committee on Blood Safety and Availability (10)


-         Re-entry of Donors Deferred Based on anti-HBc Test Results Gerardo Kaplan, Ph.D., OBRR, FDA (10)


9:00 a.m. Open Committee Discussion


9:45 a.m. Break


10:00 a.m.


I.              Approaches to Over-the-Counter (OTC) Home-Use HIV Test Kits


A. Introduction and Questions to the Committee Elliot Cowan, Ph.D., OBRR, FDA (20)

B. Proposal for an OTC Home-Use HIV Test Kit Sue Sutton-Johns, M.S., OraSure Technologies (20)

C. Approach to HIV Testing - Detection and Counseling Recommendations - Robert Janssen, M.D., CDC (30)

D. Role of Quality Systems for Diagnostic Tests - Tom Hearn, Ph.D., CDC (30)

E. Psychological/Social Issues Associated with HIV Testing and OTC Home-Use HIV Tests Joseph Inungu, M.D., M.P.H., Dr.P.H., Central Michigan University (30)

F. Human Factors in OTC Testing Steven Gutman, M.D., OIVD, CDRH, FDA (20)


12:30 p.m. Open Committee Discussion


1:00 p.m. LUNCH


2:00 p.m. Open Public Hearing


3:45 p.m. Break


4:00 p.m. Questions to the Committee and Committee Discussion


5:30 p.m. Adjournment



Friday, November 4, 2005


8:00 a.m. Information - Serious Adverse Events Resulting from Interference with Measurement of Blood Glucose following Infusion of Maltose-Containing Immune Globulin Intravenous (Human) - L. Ross Pierce, M.D., OBRR, FDA, Ann Gaines, Ph.D., OBE, FDA and Patricia Bernhardt, B.S., MT(ASCP), OIVD/CDRH, FDA and Discussion (60)


9:00 a.m.


II.         Alpha-1-Proteinase Inhibitor


A.  Introduction and Questions to the Committee Andrew Shrake, Ph.D., OBRR, FDA (10)


B.  Observations on Marketed alpha-1-Proteinase Inhibitor Products Ewa Marszal, Ph.D., OBRR, FDA (10)


C.  Identification and Possible Implications of a Human Plasma Purified Anodal Variant of Alpha-1-Antitrypsin Mark Brantly, M.D., Alpha-1-Foundation (15)


D.  Characterization of Aralast Compared to Other A1PI Preparations - Hans Peter Schwarz, M.D, Baxter Healthcare (15)


E.  Safety Reporting for Alpha-1-PI products Tina Khoie, M.D., M.P.H., OBE, FDA (10)


F.  Post-Marketing Study Commitments for Licensed Alpha-1 PI Products - Rationale L. Ross Pierce, M.D., OBRR, FDA (10)


G.  Licensed Therapeutic Protein Products with Known Structural Modifications Andrew Chang, Ph.D, OBRR, FDA, and Kurt Brorson, Ph.D, CDER, FDA (20)


10:30 a.m. Open Public Hearing


11:00 a.m. Break


11:15 a.m. Committee Discussion


12:15 a.m. Lunch


1:15 p.m. Overview of research conducted in the Office of Blood Research and Review (Summary of Subcommittee Site Visit held on July 22, 2005)


2:15 p.m. Closed Session - Discussion of the OBRR Office Site Visit Review Report


3:30 p.m. Adjournment