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| Dockets Entered
On October 12, 2006
Table of Contents
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| Docket #
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| Title
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1998D-0777
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| Investigating out of Specification(OOS)Test Results fr Pharm
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0297
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| 2006M-0389
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| P050042 - ARCHITECT Anti-HCV Assay; ARCHITECT Anti-HCV Calibrator and ARCHITECT Anti-HCV Control
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0130
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
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| 2006N-0292
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| Unique Device Identification
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| 2006P-0369
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| ANDA Suitability for Alclometasone Dipropionate Lotion, 0.05%
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| 2006P-0394
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| Revise the labeling requirements for eggs sold in the United States
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| 2006P-0395
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| To permit an ANDA Suitability for Metoprolol Tartrate Tablets
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| 2006P-0415
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| Petition Seeking Regulation of Cloned Animals
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT 770
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| Statistical Report - Month of September 2006
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| Vol #:
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| 55
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 354
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| Natural ASA
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| Vol #:
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| 272
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| RPT 355
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| Archer Daniels Midland Company
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| Vol #:
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| 275
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| RPT 356
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| Iwade Research Institute of Mycology Co Ltd
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| Vol #:
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| 279
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| RPT 357
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| National Center for Tobacco Research
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| Vol #:
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| 270
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| 1998D-0777
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| Investigating out of Specification(OOS)Test Results fr Pharm
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| GDL 2
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| Guideline
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| Vol #:
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| 2
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| NAD 2
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| FDA
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| Vol #:
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| 2
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| 2004D-0443
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| Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations
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| EC 9
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| American Celiac Society
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| Vol #:
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| 2
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| 2005H-0271
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| Civil Money Penalty: TMJ Implants, Inc.
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| CS 18
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| FDA/DDM
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| Vol #:
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| 6
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| CS 19
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| FDA/DDM
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| Vol #:
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| 6
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| MO 20
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| TMJ Implants and Robert W. Christensen and Maureen K. Mooney
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| Vol #:
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| 6
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| OR 18
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| FDA/Administrative Law Judge
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| Vol #:
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| 6
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| OR 19
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| Administrative Law Judge
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| Vol #:
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| 6
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| C 18158
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| K. Wolcott
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| Vol #:
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| 196
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| C 18159
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| L. Jackson
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| Vol #:
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| 196
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| C 18160
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| S. Williams
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| Vol #:
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| 196
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| C 18161
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| P. Ramsey
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| Vol #:
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| 196
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| C 18162
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| D. Lovell
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| Vol #:
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| 196
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| C 18163
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| Z. Gregory
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| Vol #:
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| 196
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| C 18164
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| C. Gross
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| Vol #:
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| 196
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| C 18165
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| H. Brown
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| Vol #:
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| 196
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| C 18166
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| D. Papili
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| Vol #:
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| 196
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| C 18167
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| M. Stevens-Johnson
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| Vol #:
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| 196
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| C 18168
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| K. Strickland
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| Vol #:
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| 196
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| C 18169
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| S. Rhoades
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| Vol #:
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| 196
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| C 18170
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| A. Medina-Webb
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| Vol #:
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| 196
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| 2006D-0297
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| International Conference on Harmonisation; Draft Guidance on Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Availability
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| EC 4
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| PDA
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| Vol #:
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| 1
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| EC 5
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| Berlex Inc.
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| Vol #:
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| 1
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| 2006D-0331
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| Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
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| EC 37
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| U.S. Army Medical Research and Materiel Command
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| Vol #:
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| 2
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| 2006D-0383
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| Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
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| REF 1
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| Draft Guidance for Industry
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| Vol #:
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| 2
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| 2006M-0389
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| P050042 - ARCHITECT Anti-HCV Assay; ARCHITECT Anti-HCV Calibrator and ARCHITECT Anti-HCV Control
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| CR 1
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| Abbott Laboratories
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| Vol #:
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| 1
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| EC 17
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| Mr. George Newman
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| Vol #:
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| 12
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| 2006N-0130
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
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| N 2
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| FDA
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| Vol #:
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| 1
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| 2006N-0292
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| Unique Device Identification
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| EC 26
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| European HIBCC (EHIBCC)
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| Vol #:
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| 1
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