Tab 1 - Busch MP. Closing the windows on viral transmission
by blood transfusion. In Stramer SL ed. Blood Safety in the
New Millenium. Bethesda, MD: American Association of Blood Banks,
2001: Chapter 2, p.36. Published
Tab 2 - Glynn SA, Kleinman SH, Wright DJ, Busch MP. International
application of the incidence rate/window period model. Transfusion
42:966-972 (2002). Published
Tab 3 - Dodd RY, Notari EP, Stramer SL. Current prevalence
and incidence of infectious disease markers and, estimated window
period risk in the American Red Cross blood donor population.
Transfusion 42: 975-979 (2002). Published
Tab 4 - Fiebig EW, Wright DJ, Rawal BD, et. al. Dynamics of
HIV-1 viremia and antibody seroconversion in plasma donors:
Implications for diagnosis and staging of primary HIV-1 infection.
AIDS 17:1871-1879 (2003). Published
Tab 5 -
FDA Memorandum to All Registered Blood Establishmeats: "Revised
Recommendations for the Prevention of Human Immunodeficiency
Virus (HIV-1) Transmission by Blood and Blood Products,"
April 23, 1992.
Tab 6 -
FDA Memorandum to All Registered Blood and Plasma Establishments:
"Recommendations for Donor Screening with a Licensed Test
for HIV-l Antigen," August 8, 1995.
Tab 7 -
FDA Memorandum to All Registered Blood Establishments: "Revised
Recotnmendations for Testing Whole Blood, Blood Components,
Source Plasma and Source Leukocytes for Antibody to Hepatitis
C Virus Encoded Antigen (Anti-HCV)," August 5, 1993.
8 - Federal Register, 11/16/00 (65 FR 69378), Proposed Rule:
Current Good Manufacturing Practice for Blood and Blood Components;
Notification of Consignees and Transfusion Recipients Receiving
Blood and Blood Components at Increased Risk of Transmitting
HCV Infection ("Lookback")
9 - Federal Register, 12/14/99 (64 FR 71147), Guidance for
Industry: In the Manufacture and Clinical Evaluation of In Vitro
Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency
Viruses Types 1 and 2, December 1999.
10 - Blood Products Advisory Committee, 69th Meeting, June
14, 2001, http://www.fda.gov/ohrms/dockets/ac/cber01.htm Blood
Products Advisory Committee. Part
Tab 11 - Alter HJ. To C or not to C: These are the questions,
Blood 85:1681-1695 (1995). Published
Tab 12 -
CDC, Recommendations for prevention and control of hepatitis
C virus (HCV) infection and HCV-related chronic disease. MMWR
47, (RR-19) (1998).
Tab 13 - See 21 CFR 610.40(b) for licensed test kits or 21
CFR 601.20(a) for licensed in-house assays. Published