BLOOD PRODUCTS
ADVISORY COMMITTEE
85th Meeting – November 3-4, 2005
Gaithersburg,
MD 20877
Thursday, November 3, 2005
8:00 a.m. Welcome, Statement of Conflict of
Interest, Announcements
-
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Draft Guidance on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