Cliff

Docket Number: FDA-2013-S-0612 Issued by: Center for Biologics Evaluation and Research This memorandum transmits Revised Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments, August, 1993. These revised recommendations modify those issued on April 23, 1992, in regard to testing for anti-HCV. A donor who currently tests, or who in the past had tested, repeatedly reactive for anti-HCV with a solid phase enzyme linked immunoassay (ELISA), licensed by the Food and Drug Administration (FDA), may now be considered for re-entry provided that certain criteria, described in this document, are fulfilled.

Deferral of Blood and Plasma Donors Based on Medications

Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research This memorandum transmits recommendations regarding license amendments and procedures pertinent to irradiated blood and blood products. Irradiation of these products is a practice which has developed over many years to reduce the risk of transfusion-­associated graft-versus-host disease in recipients at this complication. Since labeling of blood and blood products as irradiated pertains to safety and intended use, irradiated and non-irradiated products are considered different products by the Center for Biologics Evaluation and Research. Recommendations are provided here regarding manufacturing and quality control procedures, labeling and other aspects of production and use of irradiated blood and blood products.

Revision of October 7, 1988 Memorandum Concerning Red Blood Cell Immunization Programs

Volume Limits for Automated Collection of Source Plasma

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research The increased number of automated plasma collection devices with varying capacities for tailoring each collection to the specific donor has resulted in the existence of multiple Food and Drug Administration (FDA) approved nomograms which specify, for each piece of equipment, the maximum volume of plasma to be harvested from each donor category. Current considerations in determining the volume of plasma to be collected include gender, height, weight, hematocrit, and in some centers, the length of time in process or the number of cycles. Because multiple equipment types commonly coexist in a location, the potential for error due to application of an inappropriate nomogram is significantly increased. The use of various anticoagulant solutions, differing concentrations of the anticoagulant, and a range of anticoagulant to plasma ratios, additionally complicates some schema and creates additional opportunity for error.

Nomenclature for Monoclonal Blood Grouping Reagents

Change in Equipment for Processing Blood Donor Samples

Inspections of Military Blood Establishments, Revised Instructions for Command Notification

Use of Genetic Systems HIV-2 EIA

Exemptions to Permit Persons with a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma: Alternative Procedures

Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products

Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research This memorandum transmits Recommendations for Testing for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV) in Blood Establishments, April 1992. These recommendations supersede those issued on 29 November 1990 which should be archived.

Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing

Disposition of Blood Products Intended for Autologous use that Test Repeatedly Reactive for Anti-HCV

FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)

Docket Number: FDA-2013-S-0613 Issued by: Center for Biologics Evaluation and Research The Food and Drug Administration (FDA) is now regulating as licensed biologic products test kits that detect total (IgG and IgM) antibody to hepatitis B core antigen (anti-HBc). After 31 March 1991 anti-HBc kits shipped in interstate commerce and labeled for use in screening blood and blood products must bear a U.S. license number.

Revision to 26 October 1989 Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease Markers ("High Risk" Donors)

Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood and Blood Components

Deficiencies Relating to the Manufacture of Blood and Blood Components

FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia Enterocolitica

Use of the Recombigen HIV-1 LA Test

Autologous Blood Collection and Processing Procedures