Dockets:

2005D-0330
BKG 1
Volume 1

Reference 1 - FDA Memorandum: Revised Guideline for the Collection of Platelets, Pheresis - 10/7/1988.

Reference 2 - FDA Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products, May 29, 1996.

Reference 3 - FDA Memorandum to Registered Blood and Source Plasma Establishments, Revision of FDA Memorandum of August 27,1982: Requirements for Infrequent Plasmapheresis Donors - 3/10/1995.

Reference 4 - FDA Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001 - 2/13/2001.

Reference 5 - Murphy S. Platelet storage for transfusion. Seminars in Hematology 1985 July; 22 (3): 165-77. Published Material

Reference 6 - Dumont LJ, VandenBroeke T. Seven-day storage of apheresis platelets: report of an in vitro study. Transfusion. 2003 Feb; 43 (2): 143-50. Published Material

Reference 7 - Blajchman MA. Incidence and significance of the bacterial contamination of blood components. Dev Biol 2002; 108: 59-67. Published Material

Reference 8 - Hillyer CD, Josephson CD, Blajchman, MA, Vostal JG, Epstein JS, Goodman JL. Bacterial contamination of blood components: risks, strategies, and regulation: Joint ASH and AABB Educational Session in Transfusion Medicine. Hematology 2003; 575-89. Published Material

Reference 9 - ASBPO Donor Deferral Criteria: Drugs and Medication Impact on Blood Donor Eligibility. www.tricare.osd.mil/asbpo/library/policies/downloads/medication_list.doc continued

Reference 10 - Patrono C, Coller B, Dalen JE, et al. Platelet-Active drugs. The relationships among dose, effectiveness, and side effects. Chest 2001 supplement; 119 (1): 39-63s. Published Material

Reference 11 - Federal Register, Proposed Rules, Vol. 50, No. 247, December 24, 1985. continued

Reference 12 - FDA Guideline on General Principles of Process Validation, May 1987, reprinted February 1993.

Reference 13 - FDA Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices 11/22/2000.

Reference 14 - FDA Guideline for Quality Assurance in Blood Establishments, July 11, 1995.

Reference 15 - Dumont LJ, Dzik WH, Rebulla P, et al. Practical guidelines for process validation and process control of white-cell reduced blood components: report of the Biomedical Excellence for Safer Transfusion (BEST) working party of the International Society of Blood Transfusion (ISBT). Transfusion 1996; 36: 11-20. Published Material

Reference 16 - CBER Device Clearances: http://www.fda.gov/cber/appr2002/2002approv.htm

Reference 17 - Brecher ME, Means N, Jere CS et al. Evaluation of an automated culture system for detecting bacterial contamination of platelets: an analysis with 15 contaminating organisms. Transfusion 2001 Apr; 41 (4): 477-482. Published Material

Reference 18 - McDonald CP, Roy A, Lowe P, et al. Evaluation of the BacT/Alert automated blood culture system for detecting bacteria and measuring their growth kinetics in leucodepleted and non-leucodepleted platelet concentrates. VOX Sang. 2001 Oct; 81(3): 154-60. Published Material

Reference 19 - Brecher ME, Heath DG, Hay SN, et al. Evaluation of a new generation of culture bottle using an automated bacterial culture system for detecting nine common contaminating organisms found in platelet components. Transfusion. 2002 Jun; 42(6): 774-9. Published Material

Reference 20 - FDA Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components - 8/10/2001.

Reference 21 - Lazarus EF, Browning J, Norman J, Oblitas J, Leitman SF. Sustained decreases in platelet count associated with multiple, regular plateletpheresis donations. Transfusion. 2001 June; 41: 756-761. Published Material

Reference 22 - Circular of Information for the Use of Human Blood and Blood Components. American Association of Blood Banks, America’s Blood Centers, American Red Cross, July, 2002.

Reference 23 - FDA Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture - 8/7/2001.

Reference 24 - Glaz J, Naus J, Wallenstein S. Scan Statistics 2001. Springer Publishing. Published Material