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horizonal rule
Dockets Management


Volume 1


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 Material

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 Material

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 Material

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 Material

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.

Tab 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")

Tab 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.

Tab 10 - Blood Products Advisory Committee, 69th Meeting, June 14, 2001, http://www.fda.gov/ohrms/dockets/ac/cber01.htm Blood Products Advisory Committee. Part 2

Tab 11 - Alter HJ. To C or not to C: These are the questions, Blood 85:1681-1695 (1995). Published Material

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 Material, Part 2

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