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


8:10 a.m. Committee Updates

-         West Nile Virus Update Hira Nakhasi, Ph.D., OBRR, FDA and Theresa Smith, M.D., M.P.H., 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-         Draft Guidance on NAT for HIV-1 and HCV: Testing, Product Disposition, and Donor Deferral and Re-entry Paul Mied, Ph.D., OBRR, FDA (10)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 TSEAC meeting held on October 31, 2005 David Asher, M.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 and Susan Stramer, Ph.D., American Red Cross(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-

Jones, M.S., OraSure Technologies (20)


C. Changes in HIV Testing Practices and Counseling

Recommendations Bernard Branson, M.D., CDC (30)


D. Role of Quality Systems for Diagnostic Tests Devery

Howerton, 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 Arleen Pinkos, 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 Following Falsely

Elevated Glucose Measurements Resulting from Administration

of an IGIV Product Containing Maltose Ann Gaines, Ph.D.,

OBE, FDA, L. Ross Pierce, M.D., OBRR, FDA, and Patricia

Bernhardt, B.S., MT(ASCP), OIVD/CDRH, FDA and Discussion



9:00 a.m. Questions to the Speakers


9:30 a.m.


II.         Heterogeneity of Commercial Alpha-1-Proteinase Inhibitor

(Human) Products Implications for Longer-Term Safety and Efficacy


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)


11:00 a.m. Open Public Hearing


11:30 a.m. Break


11:45 a.m. Committee Discussion


12:45 p.m. Adjournment